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Johnson & Johnson

Executive Summary

It is an American company founded in 1886 that deals the manufacture of medical devices, packaged goods and pharmaceuticals. Dow Jones Industrial Average is the common stock component of the company. The company is ranked among the largest corporations in the United States by total revenue. The company’s headquarters is in New Brunswick New Jersey USA with 250 subsidiary companies in 60 countries whereas its products are sold to over 175 countries in the world.

The company is involved in most number of litigations. This is because of its business of consumer health products, pharmaceuticals and medical devices. They include the following;

  • Intellectual Property

This is cases where the company is suing to keep off the market a generic product or on the other hand defending an invalidation of one of its patent by a generic company. The cases the is litigating or has already settled includes the following

-Six lawsuits to protect the patent for cancer drug Zytiga.

-Settled litigation of HIV drug Complera

-Litigation against the University of Texas alleging that there infringement of its patents by sutures made by Ethicon which is a subsidiary company.

  • Government Suits

These are lawsuits brought by cities, counties or any other government body like the case litigated by a number of states for the damage Opioid has caused to its citizens.

  • Product liability

The company is facing a lot of legal suits against its products. It is facing litigation on 53,000 suits against the product Pelvic Mesh, 13,000 against schizophrenia drug Risperdal and 6,600 against Talcum powder.

History of Johnson & Johnson

Robert Wood Johnson through an inspiration by lawyer Joseph Lister joined his two brothers Edward Mead Johnson and James Wood Johnson in creating surgical dressing ready to use in 1885. The company then produced its first products in the following year 1886 and then in the year 1887, the company was incorporated. 

Robert Wood Johnson took the helm of the company as the first president of the company and worked towards improving the sanitation practices in the 19th century. Upon his death in 1910, he was succeeded by his brother James wood Johnson who worked until 1932 and was succeeded by his son Robert Wood Johnson II.

Johnson & Johnson Subsidiaries

There are over 250 subsidiary companies of Johnson & Johnson in over 60 countries all over the world.

The following are some and major subsidiaries of Johnson & Johnson;

  1. McNeil Medical Products and McNeil Consumer Products(McNeil Consumer Healthcare)

In 1879, McNeil consumer healthcare was formed by Robert McNeil. In 1933, McNeil laboratories was formed which dwelt on direct marketing to doctors, hospitals and pharmacists of their prescription drugs. In 1959, Johnson & Johnson acquired McNeil laboratories which within one year was able to sell Tylenol for the first time without any prescription. In the year 1977, two subsidiary companies were created; the McNeil Medical products and the McNeil Consumer products which is also known as the McNeil Consumer Healthcare. This company markets prescription and over the counter medicals products for both adults and children.

  1. Cilag (Chemical Industry Laboratory AG)

In Schaffhausen Switzerland, Bernhard Joos set a very small laboratory in 1933. This grew slowly and later in may 1936, Cilag Company was formed from the set basis of Cilag. Later Cilag joined Johnson & Johnson group of companies in 1959 and became one the subsidiaries of Johnson & Johnson. Cilag involved itself on the over the counter operations and research and development and other international services through manufacturing.

  1. Janssen Pharmaceuticals

Constant Janssen got the distribution right to distribute pharmaceuticals products of Richter, a company from Hungary in 1933. He was a father to Paul Janssen and was distributing in Belgium and Netherlands. Within the Richter Company, Paul Janssen formed his own research laboratory in 1953. The name of this company changed to NV Laboratoria Pharmaceutical C. Janssen, the name of the father. On February 1964, the company after gaining its own entity was acquired by Johnson & Johnson company, the American based hence becoming its subsidiary. The company then involved itself in over the counter operations and other research and manufacturing of pharmaceutical products. Its scope of business is over the world and also offering some other international pharmacy services.

  1. DePuy

The company was acquired by the Johnson & Johnson Company in 1998 setting it to medical devices family and group.

  1. Micrus Endovascular

This company was majorly involved in hemorrhage and ischemic strokes manufacturing its invasive devices. It was operating under Codman Neurovascular. In 2010, Johnson & Johnson Company completed the acquisition of this company becoming among its major subsidiary companies in the world.

  1. Janssen Biotech

The company was founded in Philadelphia in 1979 and was formerly called Centocor Biotech. It is a biotechnology company. The company was made wholly and acquired by Johnson & Johnson to be part of its lager family group in 1999. Since then, the operations of Janssen Biotech have increased tremendously with both research and sales going high.

  1. Ethicon

A facility was opened by George F. Merson in 1915 and its functions were to manufacture, package and sterilize Catgut, nylon and silk sutures in Edinburg. In 1947, Johnson & Johnson Company acquired Mr. George Mersons’ facility and renamed it Ethicon Sature Laboratories. The company became part of the J & J family and on itself acquired other companies like Ethicon Endo Surgery.

  1. Actelion

There was a fierce completion for Swiss drug maker company Actelion by Johnson & Johnson Company and Sanofi. But in January 2017, Johnson & Johnson acquired it making it one of its many subsidiary companies all over the world at a cost of $30 billion.

The Johnson & Johnson Company has acquired other many companies and still acquiring some. All its subsidiaries work in the scope of its business and none of them works outside the pharmaceutical industry and manufacture of medical devices.

Popular Johnson & Johnson Products

The company’s business is divided into three categories namely;

-Pharmaceuticals

-Medical Devices

-Consumer products

Pharmaceutical Products

The major franchise of the company in the pharmaceutical category includes; infectious disease, immunology, oncology and Neuroscience.

The major Infectious Disease products includes the following; inhibitors (Hepatitis C Protease, HIV Polymerase, HIV Protease), Incivio, and prezista.

The main Immunology products of Johnson & Johnson company includes; Anti tumor necrosis factor antibodies, Simponi and Sterala.

The oncology products include velcade and Zytiga for the treatment of prostate cancer.

Medical Devices

In medical devices the company is active in the following sectors; Aesthetics, Hernia surgery, ear nose and throat infections, diabetes care and cardiovascular diseases offering all the medical devices required in this sectors and many other more ailments.

Consumer Products

In Consumer products, Johnson & Johnson is very active in the following sectors; Nutritionals, Baby care, over the counter medicines and oral health. The company offers great and quality products under the sectors and many other more.

Johnson & Johnson Product Recalls and Lawsuits

  1. 1982 Chicago Tylenol Scare and Murders

In Chicago metropolitan area in 1982, seven individuals after ingesting the more strength Tylenol died. The Tylenol was deliberately laced with Cyanide. Within a period of one month, Johnson & Johnson Company recalled over 1 million bottles of Tylenol from retailers with the USA making it one of the major recalls in the history of America. This case remains unresolved up to now and no suspects have ever been charged over the same issue.

  1. 2010 Hip Replacement Recall

A subsidiary of the Johnson & Johnson Company called Depuy recalled its ASR (Articlar surface replacement) hip prostheses from its market in August 2010. It had several effects and it had failed in some patients prompting for the recall. Its effects left some patients with long term disability because it affected the soft tissues surrounding the joints. In 2013, the company was ordered to pay one man over $8.3 million and more than 10,000 other cases pending.

  1. 2010 children’s product recall

McNeil Consumer healthcare, a subsidiary of Johnson & Johnson Company in April 2010 recalled 43 over the counter medicines. This recall was done after an inspection was done to the manufacturing of this products and it was revealed that some products did not meet the specific requirements and specifications. All the products were listed and recalled back to the company.

  1. Shareholders Suit

The board of Johnson & Johnson Company was sued by some group of directors in 2010. They claimed that the board allegedly failed totally to take any action and prevent very serious illegalities and failings since the 1990s. The case was dismissed in September 2011 but the judge allowed the plaintiff to refile the case in a later time or date.

Johnson & Johnson Settlements

Talcum Settlement for over $1.5 Million

The company Johnson & Johnson reached an agreement to settle a woman in New York who claimed the talcum powder caused her cancer. The settlement amount was $1.5 million.

The company is also engaged in many other appeal cases which have not been concluded for settlement.

 

AstraZeneca

Executive Summary

The company is the Swedish – British multinational that deals with pharmaceuticals and biopharmaceuticals and other drug related services. It is headquartered in London United Kingdom. It has a portfolio of products for major diseases which includes for instance like cancer, respiratory, neuroscience, inflammation and cardiovascular and numerous vaccinations which are used all over the world.

The company is currently involved in much litigation concerning its products. Some of the cases are still pending and ongoing in various courts. They include;

  • Product litigations some which have been settled and others have not; where we can take an example of Seroquel drug product manufactured by the company which has numerous lawsuits in which some litigations have been settled and others are still pending in courts not yet finalized.
  • Management Lawsuits which involve the company and its employees or between employees themselves but involving the company. An example is the fraud case involving one of the chief executive officer of defrauding the company a lot of money and being involved in sexual harassment to female co workers.
  • Government lawsuits. This are cases involving the government agencies and AstraZeneca. An example is where the company was sued by the UK government over tax issues. The company also was sued in a case involving doping in cycling by the sports agencies through using the drugs manufactured by the company which were not yet released for commercial use. The cyclist tested positive.

History of AstraZeneca

A group of doctors who were roughly 400 doctors and Apothecaries in 1913 founded a company called Astra AB in a town called Sodertalje in Sweden. It operated its pharmaceutical business in Sweden from that date onwards. In 1993, a British company which deals with chemicals called ICI demerged its agrochemicals, pharmaceuticals and specialty business to form Zeneca group in UK.

In the year 1999, Astra AB and Zeneca group came together and merged to form AstraZeneca Company with its headquarters in London. From that time the company has been operating under the new name and its operations from London UK it is more expanding and is still expanding moving all over the world by opening more branches and engaging in mergers and acquiring more other companies doing the same business together. This is the reason it is widening its subsidiary base all over the world and acquiring many subsidiary companies in many parts like in the United States of America.

AstraZeneca Subsidiaries

There are many subsidiaries companies or groups all over the world that AstraZeneca has acquired as subsidiaries. It has also opened many branches worldwide. The following are the main subsidiary companies that have been acquired by AstraZeneca Company:

  1. Takeda Respiratory Business

This is a company which is based in Japan that was acquired by AstraZeneca in April 2016 at a cost of $575 million. The company manufactures and develops all drugs mostly relating to the respiratory system or therapeutics. It helps to sell these drugs to all over the world and upon acquiring it; it became one of the main subsidiaries of AstraZeneca.

  1. Acerta Pharma

This is the company which is located in California United States which deals with the discovery of drugs and the development services for autoimmune and oncology diseases. AstraZeneca acquired this company in December 2015 for a cost of $60 million. The company has helped AstraZeneca on the field of oncology so much producing almost all drugs concerning the oncology diseases and its related services with also doing research on the same.

  1. Arrow Therapeutics

This is a small pharmaceutical company that deals and focuses on the discovery of Novel anti infective. It based in London, United Kingdom. It was acquired by AstraZenica Company in February 2007 at a cost of $40 million.

  1. Pearl Therapeutics

This is a company located in Redwood City of California United States. It was acquired by AstraZeneca in June 2013 at a cost of $247 million. The Pearl Therapeutics Company deals with the treatment of respiratory diseases and it develops a combination of products for the treatment of the same which also includes obstructive pulmonary chronic disease.

  1. ZS Pharma

This company’s task is to develop the ion therapies which are used to treat some life threatening condition which are very dangerous like the liver diseases and hyperkalemia. It was acquired in November 2015 at a cost of $123 and it is located in Texas United States.

  1. Omthera Pharmaceuticals

This company was acquired in May 2013 at a cost of $60 million and it located in New Jersey United States. The company develops therapies for those patients who have elevated triglyceride levels and also the high risk of the common cardiovascular diseases.

  1. MedImmune

This is a company wholly owned by AstraZeneca Company as one of the main subsidiaries which was purchased in 2007 for $15.6 billion. It is highly considered as one of the major subsidiary of AstraZeneca. It is located in Cambridge in the United Kingdom. This company produces two main drugs i.e. Synagis which is a drug used to prevent respiratory infections in children and infants and the drug FluMist which is a vaccine for Nasal spray influenza.

Popular AstraZeneca Products

There are many products that are manufactured and distributed by AstraZeneca Company. They are used to treat different ailments in the body. They include the following;

  1. Seroquel

This is one the major products of AstraZeneca Company which is used to treat the disorders of Schizophrenia and Biplar. It gives so much high turnout in terms of sales and regarded as one of the major products AstraZeneca is selling currently.

  1. Crestor

This is another major AstraZeneca product that is in the market. It is used as anti cholesterol drug. Although facing a lot of completion, it is one the major sales of the company is enjoying at the moment.

  1. Nexium

This is the drug used for stomach ulcer and heartburn. It sold all over the world and ranked among the top products that is manufactured and sold by AstraZeneca Company. It has also a high sales turnout per year and among the top selling products of the company.

  1. Symbicort

This is one of the best selling drugs of the respiratory system and is used to treat asthma. It is one of AstraZeneca’s best drug and gives high sales turnout and ranked among the best products of the Company.

  1. Arimidex

It is among the top best selling drugs of AstraZeneca although facing a lot of generic competition. It a drug used to treat breast cancer and does well in terms of turnover sales for the company.

AstraZeneca Product Recalls and Lawsuits

 

  • Recall of Brilinta 90ml Tablets

 

In May 2017, the company made a voluntary recall of Brilinta 90ml tablets in bottles of 8 tablets as a precautionally measure. This recall was due to a report that the professional sample bottle which containing the 8 tablets also contains in it another 200mg tablet medicine produced by the company too called Zurampic. This recall measure was limited to United States only and for the bottles that were supplied to the doctors and physicians between the month of March and April 2017. This recall did not affect Zurampic and other forms of Brilinta apart from the 8 bottled tablets.

  • Recall of 8 Lots of LYNPARZA (Olaparib) Capsules

In February 2018, AstraZeneca made a voluntary recall of 8 lots of Olaparib capsules, 50mg which were 112 per bottle. This was due to the elevated levels of attribute quality polymorph. These affected lots were distributed to the market between the date of 22nd November 2016 and 20th December 2017. Other lots outside these dates were not affected at all. The overall risk after full assessment is none.

  • Texas Lawsuit Claiming AstraZeneca pushed Antipsychotic to kids

The company is still litigating to settle down this case where it was sued for targeting states’ Medicaid program by directing doctors to prescribe the power antipsychotic seroquel to children over six years which was unauthorized.

AstraZeneca Settlements

The company has been involved in many lawsuits others which are ongoing and others have been settled. The following are fully settled litigation either through payment or cases dismissed. They include:

  • The Seroquel Liability settlement;

In April 2010, the company settled a lawsuit which was brought by Stefan Kruszewski totaling for $520 million for settlement of allegations of defrauding Medicaid, Medicare and other state funded programs which came about through the company’s promotional and marketing practices for Seroquel.

In the year 2011 march, the company settled a lawsuit amounting to $68.5 million which was divided between 38 states involved in the United States.

  • Whistleblower lawsuit settlement

AstraZeneca agreed to settle and pay whistleblower $7.9 million in February 2015. This was to resolve allegations that the company in the form of price concessions paid kickbacks to Medico Health solutions benefit manager to give AstraZeneca’s drugs like Nexium exclusive and sole status. It offered price concessions on other company drugs like Prilosec and plendil.

  • Tax Dispute

In the year 2010, AstraZenica in its transfers made a mistake in pricing which resulting to tax avoidance. The company agreed to settle this UK tax dispute and paid $505 million in full settlement.

Sources:

https://www.telegraph.co.uk/finance/8208884/AstraZeneca-five-best-selling-drugs.html

https://en.wikipedia.org/wiki/AstraZeneca#Controversies

https://www.bloomberg.com/news/articles/2018-08-07/astrazeneca-to-pay-110-million-to-settle-texas-drug-suits-jkk6v647

https://en.wikipedia.org/wiki/AstraZeneca#History

https://www.crunchbase.com/organization/astrazeneca/acquisitions/acquisitions_list#section-acquisitions

https://www.baumhedlundlaw.com/astrazeneca-agrees-settle-whistleblower-lawsuit-7-9-million/

Pfizer

Executive Summary

It is a research based pharmaceutical company whose mission is to provide quality and accessible healthcare to its customers or consumers. It is one of the world’s largest pharmaceutical giant Company headquartered in New York United States. The research headquarters are based in Groton Connecticut. It also listed in the New York stock exchange, and its share has ever been components of Dow and Jones Industrial average.

History of Pfizer

Charles Pfizer and Charles Erhat, two Germany immigrants to the USA in their mid twenties established the Company in 1849. Using a loan borrowed from Pfizer’s father, they set up a fine chemicals business in Brooklyn factory.

A palatable anti parasitic drug was the company’s first drug which tasted like coffee was a success and it set the pace for the company’s future development. The company has grown tremendously has acquired so many other likeminded business across the world.

Current ongoing Litigations:

Nigeria’s Kano Trovafloxacin Case; the case started in 1996 when there was an outbreak of cholera an meningitis in Kano area Nigeria. Pfizer researchers travelled to Nigeria to set up a clinical trial and set up an experiment on antibiotic Trovafloxacin to around 200 children. According to the local reports, more than 50 children died from the experiment while the surviving others developed physical and mental deformities.

In 2001, the families and the Nigerian government filed lawsuits against the company concerning the treatment and accused the company of using the outbreak to do unlawful and unapproved human testing experiment. The facts of the case remain in dispute and unresolved.

Pfizer Subsidiaries

  1. Warner – Lambert Acquisition

Warner – Lambert was founded as a drug store in Philadelphia by William R. Warner in 1956. In the year 2000, Pfizer acquired Warner – Lambert at a cost of $111.8 billion. This became the second largest company dealing with pharmaceuticals.

  1. Pharmacia Acquisition

The desire for Pfizer to acquire the full rights of Celebrex made the company to merge with Pharmacia in 2002. Pharmacia Company had been formed through a number of mergers and acquisitions and upon acquiring it, Pfizer closed many of these Pharmacia subsidiaries leading to loss of many jobs. They include Searie, Upjohn and Sujen. 

  1. Wyeth Acquisition

After a long talk which lasted more than a year, Pfizer finally came to a conclusion to buy its pharmaceutical rival competitor Wyeth for a cost of $68 billion which was funded through cash, shares, loans which included an amount of $22.5 billion from Wall Street banks lent to the company. This merger deal made Pfizer become the largest pharmaceutical company in the world and this was the largest merger in the corporate world.

  1. King Pharmaceuticals Acquisition

In the year 2010 October, Pfizer agreed to buy King Pharmaceuticals for $3.6 billion in cash or $14.25 per share. This acquisition made the company broaden its business base and widen its business activities.

  1. Hospira Acquisition

In 2015 February, Pfizer acquired Hospira at an agreed price of $15.2 billion. This deal was to the shareholders of Hospira earn $90 for each share they owned. Hospira being the largest producer of injectable generic pharmaceuticals in the entire world was acquired by Pfizer and became one of its largest subsidiaries all over the world.

Pfizer Popular Products 

There are many products that are manufactured and supplied by Pfizer and its subsidiaries in the pharmaceuticals industry. They main and popular products of Pfizer include the following;

  1. Atorvastatin (Lipitor); 

Lipitor was developed by Pfizer subsidiary Warner – Lambert and it was first set to the market in 1996. It is used for the treatment of Hypercholesterolemia. The name Lipitor was used from 1996 to 2012 when if officially came to be called Atorvastatin. It is the best drug among the statins and has become the world’s best selling drug of all time.

  1. Prevnar; 

This is a vaccine that is used to prevent invasive Pneumococcal infections. The original 7 valent version yielded 75% reduction incidences of invasive pneumococcal infections to children under the age of 5 years. The current version of the 13 valent version which was introduced in 2010 and increased the rate of reduction by 50%.

  1. Norvasc;

This is an antihypertensive drug. It is also called Amlodipine. It is a very important medicine that is always required in the basic health system that is why it is in the World Health organization list of essential medicines. 

  1. Diflucan;

This is the first oral medicine for severe fungal infections. It is also called Fluconazole. This medicine is very much highly recommended as the first line treatment of invasive Candidiasis and it is mostly and widely used in treatment of very severe fungal infections in infants or children.

  1. Zithromax (Azithromycin);

This is an antibiotic that is manufactured by Pfizer which is widely used in the treatment of community acquired pneumonia.

  1. Flagyl (Metronidazole);

This is a nitroimidazole antibiotic medication Pfizer product which is widely used for anaerobic bacteria and protozoa. This medicine is antibacterial against the anaerobic organisms.

  1. Lyrica;

This is a Pfizer product which is very popular which is used for neuropathic pain. 

  1. Zoloft;

This is the popular Pfizer product also known as sertraline which was introduced to the market in 1991. It is primarily prescribed for the major depressive disorder in the adults while in children and adults as obsessive compulsive panic disorders.

Pfizer Product Recalls and Lawsuits

  1. Six Lots of Thermacare Heatwraps Recall

In November 2018, the company made a recall of six lots of Thermacare Heatwraps product up to the level of the consumer. The products from these lots had a potential leakage of its ingredients contained in the heatwrap. This leakage of heat cell wrap was very harmful and dangerous because there was a likelihood causing injuries like blisters and severe burns to the skin.

  1. Children’s Advil Product Recall

In August 2018, Pfizer recalled the Children Advil product after they confused the measuring cup millimeters with teaspoons. The product had already been supplied to all states in the United States between May and June 2018. The instructions for the medicine were noted in millimeters while the included measuring cup was noted in teaspoons which prompted the company to make a recall. The medicine itself was okay and it had no issue.

  1. Drug Amvalo Recall 

In February 2019, a Pfizer subsidiary in Japan recalled the drug Amvalo which treats high blood pressure due to availability of a carcinogenic substance or impurity causing cancer. Tablets more than 763,000 which were manufactured between April 2018 and July 2018 by Mylan Laboratories in India were affected. There were no reports of any health damage or any litigation that was put forward.

  1. Recall of Piperacillin and Tazobactam Antibiotics

In May 2018, Pfizer recalled over 1.8 million vials of Piperacillin and Tazobactam antibiotics that were manufactured by Pfizer subsidiary Hospira Healthcare in India. The two combinations are used to treat some infections caused by bacteria. They were found to have some elevated levels of impurities that result in reduced potency. These antibiotics were supplied in the United States. No cases or health issue was reported from this recall.

  1. Pfizer Recalls Antidepressant Effexor Because It Is Not A Heart Medicine

In July 2014 the Company recalled two lots of Effexor antidepressant after it was discovered by a pharmacist there was a different medicine inside one bottle of the drug. The capsule of Tikosyn which could have caused fatal health issues according to the FDA.

Pfizer Litigation Settlements

  1. $486 Million Settlement of Celebrex, Bextra Litigation

In August 2016, Pfizer agreed to pay the shareholders or investors a sum of $486 million on along decade case involving the two painkillers Celebrex and Bextra. The investors who owned stock between October 2001 and October 2005 accused the company of failing to provide the information that would reveal that the use of the two pain relievers might increase the risk of the patient getting stroke or heart attack. They were also accused of not revealing out the tests performed as early as from the year 1998 for the two. 

When the information was released to the public, they claimed that the shares reduced significantly by $70 million.

They were paid to settle the loss they incurred when the prices dropped significantly.

  1. $43 Million Settlement for Misleading Marketing of Drugs

In December 2012, 33 states and the Columbia district reached an agreement of settlement of $43 million with the company over a litigation where the company ignored the FDA warning and went ahead to make misleading marketing claims about its two drugs Zyvox and Lyrica. In their marketing, the company claimed that their Zyvox is more superior to Vancomycin, a very powerful generic drug which was actually not the case hence misleading the public to the states involved in the suit.

  1. $325 million settlement to Blue cross blue shield company

The health insurance company sued Pfizer for marketing their drugs Geodon, Lyrica and Bextra illegally where they persuaded doctors to prescribe the drugs through kickbacks so that the doctors can highly prescribe the three drugs. The case was settled in 2014 by the company paying the insurance company $325 million for settlement.

Sources:

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/pfizer-inc-recalls-1-8-million-vials-of-antibiotics/articleshow/64290635.cms

https://consumerist.com/tag/pfizer/index.html

https://pharmaphorum.com/views-and-analysis/a_history_of_pfizer/ https://en.wikipedia.org/wiki/Pfizer#Litigation

https://en.wikipedia.org/wiki/Pfizer#Warner%E2%80%93Lambert_acquisition

https://en.wikipedia.org/wiki/Pfizer#Products

Bayer Pharmaceuticals

Executive Summary

It is a Germany multinational company that deals with pharmaceuticals and life sciences. It is also one of the largest pharmaceutical companies in the world. Its headquarters are in Leverkusen German and has been headed by Werner Baumann as Chief executive officer since the year 2016. Its areas of business includes Consumer health products, Human and veterinary pharmaceuticals, biotechnology products and agricultural products. 

Bayer Lawsuits;

  • The Mirena Law suit

Mirena law suits accuse Bayer of hiding the side effects of the birth control device Mirena. Many women are claiming that it perforated their uterus, dislodge and causing pressure buildup. They accused the company and claim that mirena complications led to their life diminishing and uncertain of other future complications. The case is still on and no full agreement of settlement has been reached.

History of Bayer Pharmaceuticals

The company was established in 1863 in Barmen as a dyestuffs factory manufacturing synthetic dyestuffs. It was formed through the partnership of Friedrich Bayer together with Johann Friedrich Weskott. The company grew tremendously and by 1881, it had over 300 employees. 

Between the years 1881 and 1914, the company was transformed and changed into a chemical one internationally, then the company also built a scientific research laboratory which brought in new research standards to the company and internationally. This laboratory was used to produce the first medicine of the company called Aspirin by Felix Hoffman.

  • Cipro, Levaquin & Avelox Lawsuits

Patients who took this antibiotic sued the company for the effects it caused and even others death. They suffered from aortic dissection that required surgery. They also incurred tendon problems and nerve damage. The case is not yet finalized and settlement not yet reached. From the past cases of the same nature, settlement were $700,000 jury verdict and if this reaches a conclusion it might go the same route of the amount or any other decided amount by the jury. This case is not affecting only Bayer pharmaceuticals but also other companies also that deal and supply pharmaceuticals like Johnson & Johnson and others.

Bayer Pharmaceuticals Subsidiaries

  1. Monsanto

In June 2018, Bayer purchased Mosanto Company, a US company that deals with chemical and crop protection. This brought a wide range of exceptional ideas and skills on the field of seeds and traits. The cost of this purchase was 48 million Euros which pertained to intangible assets, plant and equipments and goodwill.

  1. Bayer Zydus Pharma

This company was in joint venture with Bayer pharmaceuticals but Bayer had a 50% stake of shares. On May 2018, Bayer pharmaceuticals increased these shares to 75% at a purchase price of 28 million Euros which then agreed to take over the remaining 25% by 2021. 

Bayer Zydus Pharma is core in the Indian pharmaceuticals and focuses mainly on women health issues including oncology, cardiovascular diseases, diagnostic imaging and diabetes.

  1. Cydectin Company

On January 2017, Bayer acquired the company which is in the United States which comprised of Cydectin pour on, oral injection and oral drench for cattle and sheep. It was purchased at a price of 158 million Euros which mainly comprised of goodwill and trademarks.

  1. Schering Acquisition

Schering Company was founded in 1851 and by the year 2006, it had acquired a lot and had a turnover of 5 billion Euros and had employees over 20,000 in over 140subsidiaries worldwide. Bayer pharmaceuticals purchased much of the shares in 2007 at a cost of 14.6 billion Euros and took over it forming Bayer Schering Pharma.

Bayer Pharmaceuticals Products

The Bayer products can be categorized into three categories namely;

  • Consumer health/Pharmaceuticals
  • Animal Health 
  • Crop Protection

Consumer Health/Pharmaceuticals;

These are the products that are majorly used by human being in medication. They are thousands of drugs produced by Bayer under this category. They include the following;

  1. Afrin

 This is a consumer health product produced by Bayer that is used to treat cough and cold in both adults and children. It is used to relief nasal congestion caused by severe cough and cold.

  1. Redoxon

This is another popular product produced by Bayer pharmaceuticals and sold all over the world to support human health. It supports the immune health of both the adults and the children.

  1. Canesten

This is a Bayer pharmaceutical popular product which is very popular and useful in the human health sector. It is very essential in dealing with intimate health challenges and conditions like bacterial vaginosis, nail or athletes foot fungus. It provides relief from the unusual skin embarrassments.

  1. Elevit

This is a consumer health product manufactured and distributed by Bayer Pharmaceuticals. It is a pregnancy multivitamin and also it is a mineral supplement to the body of the pregnant mothers. It is highly formulated and made to meet all the nutritional needs of women who are in either of three stages i.e. trying to conceive, pregnant or breastfeeding.

  1. Aspirin

This is a pain reliever manufactured by Bayer pharmaceuticals and it is mainly used to relive or kill pain. Mostly common for headaches but also can be used to relieve pain of the muscles, joints and acute back aches. It is highly used to reduce damage to the human heart when there is heart attack.

  1. Iberogast

This is a plant based medicine manufactured by Bayer pharmaceuticals that is used to serve many functions of health issues in human body. It helps solve problems like abdominal pains, cramps and heaviness, bloating, nausea and heartburn.

 Animal Health;

These are products manufactured and distributed by Bayer Pharmaceuticals specifically to treat animals either domestic or wild. There are products in this category and they include the following;

  1. Veraflox

This is a popular product of Bayer pharmaceuticals which is used to treat animals. It is normally used to treat infections which include wounds and skin infections in dogs and cats.

  1. Baycox

This product is used to treat animals. It is an anticoccidial parasiticide which is majorly used in veterinary and it has a wide range of uses in domestic animals like poultry, cattle and piglets.

  1. Drontal

This is an animal drug manufactured by Bayer pharmaceuticals. It kills all intestinal worms which are most common found in dogs and cats.

  1. Advocate

This is an endectocide which is used to treat animals. It is very effective against ecto and endoparasites which includes fleas, mites and lice with also other different types of worms.

Crop Protection;

This are drugs which are produced by Bayer pharmaceuticals which are used to treat crops and protect them from harmful nature. They include the following;

  1. Serenade

This is a biological fungicide which is very effective on fire bright, sour rot, powdery mildew, white mold and bacterial spot. It is also very efficient on soil diseases such as rhizoctonia, pythium, phytophthora and fusarium.

  1. Confidor

It is widely used in combating insecticide pests in more than 150 crops which also includes the common vegetables.

  1. Agroeste

These are seeds and traits offering Brazilian farmers soy, sorghum and corn solutions and improve their productivity and get more returns.

  1. Corvus

This is a residual and follar herbicide that is mostly used to combat weeds in corn. It belongs to the Adengo family brand of drugs.

Bayer Pharmaceuticals Product Recalls and Lawsuits

  1. Recall of Alka-Seltzer Plus

In March 2018, Bayer pharmaceuticals recalled this product from the market which was sold in the markets of United States. This was because the ingredients in front sticker did not match the ingredients in the carton. This was to lead to consumers having side effects like allergy or cause other serious health issues that could have brought many challenges later. There were no reported cases of ill health caused by this product and therefore there was no any other litigation put against this product for its consequences before the recall.

  1. $1.1 Billion Baycol Settlement

In 2005, the company Bayer pharmaceuticals settled for $1.1 billion to the affected patients who used the drug and were affected. Around 3000 death and injury claims were put across for the use of this drug that majorly focused on Rhabdomyolysis which is a very serious muscle condition which causes death.

Bayer Pharmaceuticals Settlements

  1. $775 Xarelto Lawsuit Settlement

The xaretto users sued the three companies that manufacture xarelto including Bayer Corporation, Johnson & Johnson Company and Janssen pharmaceuticals. After taking the most popular ant-clotting drug, the users claimed that they suffered from wound leakage and internal bleeding. The companies won around six cases but agreed to settle the affected users for $775 in March 2019. The two companies agreed to pay half the amount each for this settlement.

  1. $2.04 billion Yaz Settlement Lawsuit

In 2016 the company agreed to pay and settle over 10000 lawsuits that claimed the pill Yaz and its related Yasmin which are both for birth control. The pills caused gallbladder issues, blood clots, strokes and heart attacks. The company settled them with the $2.04 billion and the remaining case is willing to settle with another $1.5 billion.

Sources:

https://nastlaw.com/bayer/

https://en.wikipedia.org/wiki/Bayer#Acquisitions

https://www.bayer.com/en/products-from-a-to-z.aspx

https://www.investor.bayer.de/en/bayer-group/ueberblick/acquisitions-and-divestitures/

https://www.drugwatch.com/manufacturers/bayer/

Merck Co. Pharmaceuticals

Executive Summary

Merck is one of the largest pharmaceutical Companies in the world. It is based in United States of America having its headquarters in Kenilworth New Jersey. Kenneth C. Frazier is the current CEO and the company has employees all over the world which is around 69,000 people.  The company manufactures very common and well known drugs, animal health products and vaccines. It is very well known for being the first one to make the vaccine for smallpox in the United States. It is also commonly known for the painkiller Vioxx. The company operates in four segments namely;

  • Pharmaceutical; which includes the human health products and vaccine products.
  • Animal Health; which comprises of manufacturing, marketing, discovery and development of animal health products which also includes animal vaccines.
  • Healthcare services; this segment offers services and medical solutions which focuses on health analysis, clinical services and engagement.
  • Alliances; which includes its widespread role and acquisitions and joint ventures with other pharmaceutical industry sector players.

The company has been very much successful but also it has never missed its share on legal suits and other scandals and controversies in the health industry.

Lawsuits involved in by the company;

  1. Propecia Lawsuits

When the company changed the label of propecia of possible side effects of sexual side effects and cancer, many people came to the reality of the side effects and opened many lawsuits against the company. As of may 2018, there are over 900 lawsuits in court that have not been settled and still pending.

  1. Januvia Lawsuits

Januvia is a product which is manufactured by the Merck Company. This product has been associated with severe joint pain and pancreatic cancer. According to these lawsuits, it is alleged that some users of this drug have died and some left with major side effects. The court dismissed the case in 2015 but later in 2018 the appeal court reinstated so many of the pancreatic cancer lawsuits which are still pending in the courts and no settlement has been done whatsoever. 

History of Merck

The company had its origins in Darmstadt Germany in the year 1668 by a man called Friedrich Jacob Merck who opened a pharmaceutical company and called this company Angel Pharmacy which sold three products namely codeine, cocaine and morphine.

In the year 1827, the company changed its course of business after the company became a manufacturer and changed to its new name E. Merck by Heinrick Emmanuel Merck.

In 1887, E. Merck opened its new office in the US and four years later in 1891, Merck co. was opened as a branch. This was headed by George Merck who was Heinrick’s grandson. This branch grew big and established a manufacturing plant in New Jersey in the year 1902.

In 1917, the US government took over the company and set it as an independent company and this was after World War 2. Its association with the original Germany Company ceased and the Germany Company up to now is called Merck KGaA and there is no affiliation whatsoever between these two companies.

Subsidiaries of Merck

The company has spread all over the world and has so many subsidiaries and branches worldwide dealing with the company’s four segments. The subsidiaries include the following.

  1. Idenix Pharmaceuticals

This is a pharmaceutical company that was founded by Jean-Pierre Sommadossi in 1998. This company was acquired in June 2014 by Merck co. for a cost of $3.85 billion. Its headquarters are located at Cambridge Massachusetts, United States.

The company is mostly engaged in the discovery and development of drugs which will be used in the treatment of human viral diseases in France and the United States. Its primary and main focus is in the treatment of Hepatitis C virus (HCV).

  1. Cubist Pharmaceuticals

Cubic pharmaceuticals is one of the biggest subsidiary companies of Merck Co. The company was found in 1992 by John Clarke. Its headquarters are in Lexington Massachusetts United States. The company was acquired by Merck in the year 2014 December at a cost of $8.40 billion.

The company majorly focuses on research and development and commercialization of pharmaceutical products which addresses mainly on the acute care environment medical needs.

  1. Antelliq Group

In December 2018, Merck acquired Antelliq group at a cost of 3.25 billion Euros which was to be shared as 2.1 billion Euros for the acquiring of all outstanding shares and 1.15 billion Euros for the payment antelliq’s debts.

Antelliq deals mostly with animal health and focuses in digital animal identification, monitoring and traceability solutions. 

This acquisition saw Merck become a leader in animal health portfolio of pharmaceuticals and vaccines.

  1. Afferent Pharmaceuticals

Afferent pharmaceutical was established in 2009 and it is a biopharmaceutical company that deals with development of medicines which treats chronic and acute pain.

The company was acquired in June 2016 by Merck at a cost of $1.25 billion. This deal saw Merck pay $500 million cash upfront for all the stock of afferent and the remaining sum of $750 million will go to the shareholders.

The company offers programs in the areas of respiratory diseases, hypertension, cardiovascular and chronic pain

The company has its headquarters in San Mateo California United States.

  1. Sirna Therapeutics

This company was founded in 1992 and it has its headquarters in San Francisco California United States. The company was acquired by Merck in 2006 at a cost of $1.1 billion.

It is a biotechnology company which majorly explores the use of RNA interference in the human disease therapy.

Popular Products of Merck

There are many popular products which range from pharmaceuticals to vaccines. They include the following;

  1. Propecia

This is a drug for men’s prescription which is used to treat the male hair pattern loss. It is a one day pill treatment. 

  1. Recombivax HB

This is a product under the vaccine category which is used for the vaccination of Hepatitis B. 

  1. Keytruda

This is a monoclonal antibody which is used to treat unresectable melanoma and disease progression. It is used to treat certain type of cancers.

  1. Singulair

This is the medication that people normally use to treat and prevent asthma and allergy symptoms to people of 12 years and above. It is taken once a day and in the evening.

  1. Zostavax

This is a live attenuated vaccine for life vaccination of in prevention of herpes zostar in individuals 50 years of age and older.

  1. MMR (Measles Mumps Rubella)

This is a vaccine which is used to prevent mumps and measles to children.

  1. Rotateq

A product of the Merck Company under the vaccines which is used to prevent certain virus infection which causes high fever, vomiting and diarrhea in children. It is given in the first 6 to 12 weeks.

  1. Zocor

This is a drug statin that lowers the lipids and cholesterol levels. It is normally used in conjunction with lifestyle changes such as low fat, exercises and low cholesterol.

Product Recalls and Lawsuits

  1. Vioxx Recall in 2004

Vioxx is the company’s well known pain reliever. The drug was highly linked with causing cardiovascular problems or diseases like stroke and heart attack when being used. Although Merck denied the allegations from the first instance, but later after a clinical trial, the company decided to pull the drug out the market and make a recall in September 2004. This drug was mostly sold in the US and mostly affected the US citizens.

  1. Gardasil HPV Vaccine Recall

On December 2016, Merck implemented a voluntary recall of one lot of Gardasil (Human Papillomavirus Quadrivalent – type 6, 11, 16 and 18 Vaccine Recombinant). This was because it was established that there were small pieces of glass particles contained in the very small vials of the vaccine. The glass particles came about as a result of breakages during the manufacturing process. 

The vials that were in question were the one which were manufactured between August 20th 2013 and October 9th 2013. The other lots manufactured before this dates or after this dates were okay and were not affected by this recall. There have been so many claims about the vaccine prior to the recall and after the recall. The court awarded some 49 victims $6 million in April 2010 and over 200 lawsuits are still pending for this particular vaccine.

Litigation Settlements

  1. $100 NuvaRing Settlement Litigation

Nuvaring is manufactured by Organon which is a subsidiary of Merck. This is a birth control ring which is majorly associated with blood clots that is life threatening. It had so many side effects and due to this, the FDA in 2011 issued drug safety communication and NuvaRing was found to breach a number of them and many people who were affected sued the company for the damages. The lawsuits were heard and determined and the company in 2014 settled all of them to a tune of $100 million and the issue was cleared and settled.

  1. $7 Billion Vioxx Settlement Litigation

Vioxx a pain reliever was largely associated with heart attack and stroke which are cardiovascular diseases and the company did not react to it. Thousands of affected patients opened so many lawsuits against the company for the side effects of the use of Vioxx. The company was in constant denial but after doing its own clinical test called APPROVe, the truth in it was found and eventually settled all the people involved of about $7 billion. 

They claimed the drug caused 3400 deaths and this settlement ended over the 47,000 people and 265 potential class cases that were opened against the company for this drug’s side effects. The class settlement was $830 million with $232 million as fees and litigation expenses.

Sources:

https://www.fiercepharma.com/regulatory/merck-reaches-830m-settlement-long-running-vioxx-litigation

https://www.drugwatch.com/manufacturers/merck/

https://www.reuters.com/finance/stocks/company-profile/MRK

https://www.merckvioxxsecuritieslitigation.com/

https://www.washingtontimes.com/news/2014/dec/31/us-court-pays-6-million-gardasil-victims/

https://craft.co/merck-&-co

https://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=32271

https://www.crunchbase.com/organization/cubist-pharmaceuticals#section-overview

Otsuka America Pharmaceuticals Inc.

Executive Summary

This company was established in 1989 as a subsidiary of Otsuka Pharmaceuticals, a parent company that is based in Japan. Its headquarters is in San Francisco, California United States. It is a holding company having many other subsidiaries and it offers very innovative products in the consumer, pharmaceutical and nutraceutical markets. These different markets work entirely to make Otsuka America great and offer products as follows;

  1. Consumer Market;

This business market under the Otsuka is mainly dedicated to give out the best and most pure water as well as the most flavored wines to the market.

  1. Pharmaceutical Market;

This sector deals with developing and marketing the company’s products for treatment of diseases in the areas of oncology, the central nervous system, cardiovascular system and ophthalmology.

  1. Nutraceutical Market;

This market is highly associated in the improvement of human health through giving out quality minerals, vitamins and other supplements in order to ensure that nutrition is complete.

Collaborations and Agreements:

-ABILIFY MYCITE

In August 2018, Otsuka America Pharmaceutical Inc made its first collaboration agreement to facilitate Abilify Mycite system to the selected regional networks which were contracted by Magellan Health.

The Abilify Mycite system is the provision of an opportunity for a well connected care approach to treatment for the intended patients which is done through a sensor which is embedded to Aripiprazole tablet, the mycite app which is obviously a Smartphone app and the mycite dashboard. 

This system was to understand how it normally fits with the patients with serious mental illness and their caregivers and how they will benefit from the information that is given or received from this system. It was also intended to help doctors focus on the future improvement on the treatment of the same.

Lawsuits Currently Involved in:

Abilify Lawsuits:

In 2005 and 2016, the FDA warned the public of the dangers of Abilify when using it. This included mortality among the elderly, suicidal thoughts among the children, compulsive behaviors like sexual activities, excessive eating and gambling which were associated with the use of Abilify. All these behaviors stopped immediately when those affected stopped using the drug Abilify or reduced its dosage drastically.

Many of the affected patients sued the company Otsuka America Pharmaceutical which is the manufacture of this drug and Bristol-Myers Squibb which is the sole marketer of this drug. 

They claimed that the companies knew of the risk which was associated with this drug of the additive behavior from using the drug and totally failed intentionally to warn the public of the risk involved or the consequences.

Currently there are more than 2,300 cases still pending in courts which has not been settled or concluded concerning the use of this drug Abilify.

History of Otsuka America Pharmaceuticals

The history of Otsuka America Pharmaceuticals began in 1921 when Busaburo Otsuka established his company called Otsuka Seiyaku Kogyo – bu factory in Tokushima Japan. In 1964, Otsuka Pharmaceuticals Ltd was established and started its core business in pharmaceuticals and nutraceuticals globally. The company first established it branches to Europe and in 1989, it opened the subsidiary in the United states called Otsuka America Pharmaceuticals inc which has really developed with time and opened other branches all over the great US and other areas. This is the major subsidiary company in the United States of the larger Otsuka group of companies.

Subsidiaries of Otsuka America Pharmaceuticals  

  1. Astex Pharmaceuticals

Astex was formerly formed through the merger of two companies, Astex therapeutics based in UK and SuperGen based in US in the year 2011. The company then was acquired in 2013 by Otsuka America Pharmaceuticals at a cost of $886 million. Astex Pharmaceuticals mainly focuses on cancer drugs and this would boost the cancer department very much. Astex Pharmaceuticals then became one of the Otsuka America Pharmaceuticals’ subsidiaries joining the Otsuka family at large. This acquisition saw Otsuka expand in the lager United States base and broaden its services to the US citizens in reaching them near and near.

  1. Avanir Pharmaceuticals 

Avanir Pharmaceuticals is another great subsidiary of Otsuka Pharmaceuticals which was founded in 1988. The company was acquired by Otsuka America Pharmaceuticals in December 2014 at a cost of $3.5 billion. This is a biopharmaceutical company which whose focus is to bring medicine to patients with nervous system disorders and treat them to completion. 

Through the pipeline, Avanir through regular innovations continuously develops solutions for patients who are suffering from very much complicated and difficult brain disorders.

  1. Visterra Inc.

This is a subsidiary of Otsuka America Pharmaceuticals which was acquired in July 2018 at a cost of $430 million all of which was cash in the agreement. Visterra was established in 2007 and it is much involved in the area of designing and engineering of antibody based therapies. Visterra was fully owned by Otsuka America and it became part of the whole family of Otsuka Pharmaceuticals Ltd. It is based in Waltham, Massachusetts United States.

  1. Neurovance Inc.

Neurovance is a company that was established in 2011. In April 2017, Otsuka America Pharmaceutical acquired Neurovance Inc at a cost of $250 million as acquisition fee. Neurovance then became a wholly subsidiary of Otsuka America Pharmaceutical. It is a neuroscience company which actually focuses mostly on the development of therapies for both adult and children with hyperactivity disorders. It is based and headquartered in Cambridge, Massachusetts United States.

Popular Products

There are a number of products produced by Otsuka America Pharmaceutical Inc which are mostly used in the United States. They include the following;

  1. Abilify (Aripiprazole)

This is the drug which is made by Otsuka America Pharmaceutical which is known by its generic name Aripiprazole. Its generic availability is tabs, orally disintegrating tabs and soln. It is used by both adults and children but children are given lower dosage and from the age of 10 to 17 years.

In Psychosis its indications are schizophrenia which is tourette’s disorder. It is also used to treat acute manic or mixed episodes in bipolar disorder monotherapy

  1. Ability Mycite

In psychosis its indications are schizophrenia which is used by adults only and no children. It is swallowed as whole tab.

Its adverse reactions are anxiety, constipation, vomiting, nausea, dizziness and fatigue.

  1. Rexulti

This is a drug manufactured and marketed by Otsuka America Pharmaceutical Inc which is used under psychiatric disorders. Its generic name is Brexpiprazole and has the following formulations; 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg, tabs.

It is not given to children and its adverse reactions are weight gain, headache, tremor, restlessness and anxiety.

  1. Busulfex

This is a popular drug manufactured by Otsuka America Pharmaceutical which is used to treat lymphomas, leukemia and other hematologic cancers. Its generic name is Busulfan and in the following formulations; 6mg, soln for infusion after being diluted.

It is prescribed to both adults and children but under strict full labeling and following the formulations carefully. Its adverse reactions are vomiting, nausea, diarrhea, fever, headache and abdominal pain.

  1. Jynarque

This is a very popular drug which is manufactured by the Otsuka America Company and is being used for urological disorders whose generic name is Tolvaptan and has the following formulations; 15mg, 30mg, 45mg, 60mg, 90mg, tabs. 

It is used to treat and prevent miscellaneous urogenital disorders. It is prescribed for only adults and not for children. This is because it can cause fatal liver injuries and should be carefully administered.

Its adverse reactions include the following; hepatic injury, dehydration, thirst and nocturia.

  1. Samsca

This is a drug for cardiovascular diseases. Its generic name is Tolvaptan and its generic formulations are; 15mg, 30mg and tabs.

It is used and indicated for electrolyte disturbances and administered to adults only and it not yet established for the children.

Its adverse reactions include the following; dry mouth, thirst, constipation, hyperglycemia, liver injuries and hyperkalemia.

Product Recalls and Lawsuits

  • Class 2 Device UBiTIR300 Infrared Spectrophotometer Recall

Otsuka America Pharmaceutical Inc recalled back from the market Class 2 device UBiTIR300 infrared Spectrophotometer in January 2008.

This recall was subject due to the reason that the device’s power supply has a fault and may very much overheat and produce much smoke from the device. This recall affected both the devices given out to the nationwide distributors and Mexico.

From this recall, there was no harm that was reported and no lawsuit was filed against the company for any damage or lose caused by this device due to this fault.

Litigation Settlements

  1. $4 million Settlement of Abilify Off-label Marketing

In March 2008, Otsuka America Pharmaceutical agreed to pay $4 million to settle and resolve completely a case which it was involved in the off label marketing. The government alleged that Otsuka America Pharmaceutical promoted highly the sale and use of Abilify in directing this sales force urging all prescriptions for pediatric patients to be prescribed for Abilify. 

The amount was paid as $2.3 million as federal recovery and $1.7 to Medicaid programs.

Sources:

http://www.otsuka-america.com/story/

https://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=3428649

https://www.baumhedlundlaw.com/bristol-myers-abilify-settlement-19-billion/

https://www.mlg.law/defective-drugs/abilify-lawsuit/

https://www.empr.com/manufacture/otsuka-america-pharmaceutical-inc/

https://medtruth.com/abilify-settlement-illegal-marketing/

https://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapid=182413794

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69717

https://www.justice.gov/archive/opa/pr/2008/March/08_civ_244.html

Endo Pharmaceuticals

Executive Summary

Endo Pharmaceuticals is a global company which is focused on matters of improving the lives of patients and creating more value to everyone in the health sector. It is located in Northeastern US and headquartered in Malvern, Pennsylvania, United States.

The company deals with biotechnology, healthcare and pharmaceuticals. The company also provides the much needed healthcare solution to both America and internationally all over the whole world. The company offers many types of products and most of them are branded prescription products.

The company has expanded its territories by acquiring many other companies in the same field of healthcare thus taken the lager market in the wider United States.

Cases involved;

Opioid (OPANA) Litigation

This is the case where Endo Pharmaceuticals and other manufacturers of Opioid Opana have been accused of downplaying the risks of opioids and marketing the drugs as non addictive which led to massive prescription by the physicians and other healthcare personnel.

This turned the other way where many patients who used this drug had severe effects of addictive in nature and overdose. 

These litigations are still going on and no settlement yet has been reached.

History of Endo Pharmaceuticals

The history of Endo pharmaceuticals dates back to 1997 when three executives of DuPont Merck decided to buy out some products and all the laboratories with $277 million from Kelso and company financing. This led to the birth of Endo pharmaceuticals.

Subsidiaries of Endo Pharmaceuticals

  1. Par Pharmaceuticals

This is a company that was established in the year 1978. It located in the northeastern United States and its headquarters being at Malvern, Pennsylvania, United States.

It develops, manufactures and markets and number of great cost effective and innovative generic pharmaceutical products around the United States.

Par Pharmaceuticals was acquired by Endo pharmaceuticals in May 2015 at a cost of $8.1 billion, being the highest cost acquisition up to date. Since then, par pharmaceuticals has been a champion in developing and manufacturing great products in the pharmaceutical industry.

Due to its uncompromising high quality products, the company has gained a lot of trust and relied upon by many patients and physicians all over the United States. This makes Endo pharmaceutical become among the top 5 biggest generic pharmaceutical companies in the entire United States.

  1. Auxilium Pharmaceuticals

Auxilium Pharmaceuticals in a pharmaceutical company situated in the United States that was established in 1999 by Geraldine Henwood, and its focus is to develop, manufacture and market pharmaceutical products that associate mostly with urology and sexual health.

It is located in the northeastern United States and its headquarters are at Centerbrook, Connecticut, United States.

Auxilium pharmaceuticals was acquired by Endo pharmaceuticals in September 2014 at a total cost of $2.6 billion. The company has developed tremendously to meet the growing medical needs of the US citizens.

  1. American Medical Systems

This is a pharmaceutical company located in the United States and its headquarters are in Minnetonka, Minnesota, United States. It was established in 1972 and deals with the supplier of medical devices and procedures which are aimed at curbing incontinence, erectile dysfunction, pelvic floor prolapse, benign prostatic hyperplasia and many other disorders of the pelvic in both men and women.

These effects in both men and women obviously affect the social life and diminish their lives significantly and American medical systems is there to ensure that this doesn’t happen and instead make this life prolonged.

American medical systems company was acquired by Endo pharmaceuticals in June 2011 at an agreed cost of $2.9 billion on cash terms. It became part of the Endo pharmaceutical family.

  1. Qualitest Pharmaceuticals

Qualitest pharmaceuticals is a company based in US and headquartered at Huntsville, Alabama, United States. It is ranked as the sixth largest generic companies in the US based on prescription filled.

The company was acquired by Endo pharmaceuticals in September 2010 at a cost of $1.2 billion. 

The company mostly deals with generic products and distributes quite a great number to the US citizens.

  1. Dava Pharmaceuticals

This company was established in 2004 and engages in developing and highly marketing of a wide portfolio of pharmaceutical products. It is headquartered in Fort Lee, New Jersey, United States. The company is keenly building and widening its product portfolio through partnerships, mergers, acquisitions and alliances. 

The company was acquired by Endo pharmaceuticals in August 2014 at accost of $575 million. Since then it has remained to be under Endo pharmaceuticals family and widening its product portfolio. 

  1. Penwest Pharmaceuticals

This is the company that was founded in 1991 and it is headquartered in Patterson, New York, United States. The company develops and offers drugs to patients all over the United States.

The company was acquired by Endo pharmaceuticals in August 2010 at a cost agreed in shares of 30,810,778 shares at $4.2 each. This was approximately 82% of the shares making Endo Pharmaceuticals acquire the company.

Popular Products of Endo Pharmaceuticals

  1. Oxymorphone (Opana)

This is an opioid agonist greatly indicated for the management of the pain which is very severe enough to require daily, around the clock and long term opioid treatment for which other alternative medications have proved to be inadequate. Its major role is to suppress and manage pain. Because of the addiction and misuse and major great risks of having an overdose, it is recommended that you reserve OPANA for use in patients only whose alternative treatments have totally failed to be effective.

Its dosage and administration should be; to be prescribed by only health practitioners, who have the knowledge in the use of opioids in pain management, use the much available lowest dosage possible, dosing should be based highly on severity of the pain and administer at least one to or prior to eating or after.

  1. Dilatrate – SR

This is a drug manufactured and marketed by Endo pharmaceuticals which is used to treat chest pain. It can also be used for other purposes but through the doctors’ prescription.

When taking this drug, you may have some side effects like headache which goes away with time after taking this drug, dizziness and fast or slow heartbeat. When this effect comes out, it is recommended you see the doctor immediately.

The drug should be stored in places with room temperature; very dry place and much protected from light and always keep out of the reach of children.

  1. Robaxin – 750

This is another popular product from Endo Pharmaceuticals whose generic name is Methocarbamol. It is a muscular relaxer which is used together with muscular therapy to treat muscle conditions like pain or injuries.

This drug should not be taken if you are allergic to it and if you are using opioids or narcotic medication and during early pregnancies because it can cause effects.

Take this medicine as recommended, do not take in larger or smaller quantities and reduce the dose after taking it for the first 2 or 3 days.

Its common side effects include dizziness, slow heartbeat, fever, nausea and vomiting and sleep problems.

  1. Semplex – D

This drug’s generic name is Acrivastine and pseudoephedrine. This is a combination medicine which is normally used to treat or diagnose running or stuffy nose, watery eyes, itching and sneezing.

This drug should not be used at all with patients who have uncontrolled blood pressure or diabetes without a proper prescription of the doctor. When taking this medicine, always follow the doctors’ prescription or the prescription on the labels. Also avoid alcohol because it brings other side effects with this drug.

The common side effects of this drug include; dry mouth, nausea and headache. Always store in a cool dry places and away from the reach of children.

  1. Endodan

Its generic name is called Oxycodone and Aspirin. This medicine is used to easy pain. It taken with or without food and when it causes stomach upsets, frequently take it with food.

  1. Nascobal

This is a drug which is used to treat vitamin B12 deficiency in patients with anemia and other conditions. Its generic name is Cyanocobalamin. 

Its side effects are easy bruising and unusual bleeding, headache and runny nose.

Product Recalls and Lawsuits

  1. Robaxin Recall 2018

In September 2018, Endo pharmaceuticals made a voluntary recall of two lots of Robaxin 750mg tablets. This was due to incorrect dosing on the label. The daily dosing that was on 750mg 100 count bottle packs was incorrect prompting for the recall. The daily dosing was erroneously indicated as two to four tablets four times a day instead of two tablets three times daily. This was a mistake that was not to be avoided because it could have led to overdose and not taking the correct dosage as per daily and for the correct number of days.

The patients who followed this incorrect dosing experienced drowsiness or dizziness. Up to this day, Endo pharmaceuticals has not received any complaint from this error and recall hence there is no any lawsuit concerning this recall.

  1. Edex Recall 2017

Endo pharmaceuticals in February 2017 made a voluntary recall of Edex (Alprostadil for injection). The drug is normally used to treat male erectile dysfunction. This was because the clamp defect that is used in the manufacturing process and it was potentially seen that this might compromise the container closure and thus doubting its integrity. This hence could have resulted to affecting the assurance of the sterility of the whole drug. This can lead to very serious and grave effects in the long run.

The company then made this voluntary recall of this drug in order to avoid future repercussions.

The recalled product was estimated to be in 2 count cartons and was distributed between December 13 2016 and February 13 2017.

The company has not received any claim or complains concerning this recall and there is no issue whatsoever regarding this recall. The product is still fully in the market.

Litigation Settlements

  1. Testosterone Liability Suits Settlement

Endo Pharmaceuticals made an agreement in June 2018 to settle over 1300 lawsuits of its testosterone replacement drug with an amount of over $200 million. The company was accused of marketing this drug in a very irresponsible way ignoring and not putting in mind all the potential risks involved.

Sources:

https://www.crunchbase.com/organization/endo-pharmaceuticals#section-current-team

http://www.endo.com/endopharma/our-products

https://www.empr.com/home/news/drugs-in-the-pipeline/carbavance-gets-priority-review-for-complicated-uti/

http://www.endo.com/about-us/history

https://www.drugs.com/manufacturer/endo-pharmaceuticals-inc-51.html

Purdue Pharma

Executive Summary

This is a private pharmaceutical company which is highly committed to serving healthcare community and improving patient’s lives. It is located in Stamford, Connecticut, United States. The company has grown tremendously having acquired many other companies in the same field of healthcare.

The company has had its fare share of law suits which others are still pending up to now. The current lawsuit includes;

-Oxycontin Lawsuits

Purdue Pharma the maker of Oxycontin faces numerous lawsuits of its opioid painkiller Oxycontin. Many of these lawsuits filed claims that the company failed to warn patients of the side effects of the opioid Oxycontin which it produces and distributes to doctors for sale.

Many patients who used these opioid pain killers had severe side effects which led to a number of them being addicted and some died. Although some settlements were made and paid, many lawsuits are still pending and many people have not yet been settled because it affected thousands of people.

The targeted defendants are the company itself and the owners of the company the Sackler family. If these cases are settled and people paid then it means Purdue Company will pay a lot of money which might lead to it being declared bankrupt. The cases are ongoing and others are still on the process of starting up. 

History of Purdue Pharma

Purdue Pharma was established in 1892 by two physicians John Purdue and George Frederick. In 1952, the company was sold to Mortner and Raymond Sackler. These two have owned the company and hence the company finally became the Sackler family company and is privately owned like that by this family. The company has continuously grown acquiring and expanding speedily to other parts of United States.

Subsidiaries of Purdue Pharma

  1. Imbrium Therapeutics

This is a clinical stage biopharmaceutical company which is dedicated solely through advancing medical science by developing new therapies in treating pain, cancer and disorders of the central nervous system.

Imbrium therapeutics was founded in 2019 as a subsidiary of Purdue Pharma with its area focus being therapy. It does this in full compliance of the laws governing the therapeutic and pharmaceutical industry.

  1. Delphian Technology

The company was founded in 1999 which is based or located in Stamford Connectcut, United States. The company majorly focuses on development, manufacture and distribution of analytical instruments which are widely used in the pharmaceutical industry. 

The company is a subsidiary of Purdue Pharma and has Purdue to improve largely on the side of technology through this subsidiary. 

  1. Rhodes Technologies

This is the company which is a subsidiary of Purdue Pharma. It normally engages on production, marketing and sale of mainly pharmaceutical ingredients plus chemicals and other forms of finished dosage of pharmaceutical products. This company was established in 1999 which is found in Washington United States. It has also grown and also acquiring some other pharmaceutical companies thus expanding widely the family of Purdue Pharma.

Popular Products of Purdue Pharma

  1. Oxycontin

This is a product manufactured by Purdue pharma. Its generic name is Oxycodone. This is an opioid pain medication which is also called narcotic. It is a very strong medicine only prescribed when a patient requires an opioid in managing very severe pain which requires round the clock treatment in a daily basis.

This medicine is not used with people with Asthma or any blockage in the stomach or having any breathing problems. Should not be used by pregnant mothers and not taken along with alcohol. 

Its side effects include weak pulse, noisy breathing, confusion and convulsions.

  1. Betadine

This is another drug from Purdue pharma which is used to prevent or treat bacterial infections. Its generic name is providone-iodine. It is should be used as per the prescription of the doctor.

Its side effects are like allergic reactions like rushes, itching, swollen or blistered skin. It has also very bad irritation where it is being used.

It should always be stored in a place with room temperature and always do not freeze. It should also be protected from heat.

  1. Hysingla ER

Its generic name is Hydrocodone. This is an opioid pain medication. It is used for severe pain suppression and treatment. This medicine should not be used in large quantities because it can stop or slow breathing. Also taking too much can lead to addiction as opioids are mostly known for major addictions.

It has some side effects which includes; burning or pain when urinating, slow pulse or heart rate, noisy breathing, severe drowsiness and tremors.

  1. Betasept

This is a medine for the skin. Its generic name is Chlorhexidine topical. It is used mainly to clean the skin in the process of preventing any infection that may be caused by skin injury, surgery and injections. It causes very rare allergic reactions which are life threatening.

This medicine should be used as directed by the doctor or as per labels indicated and do not use for longer periods or shorter periods than recommended or prescribed. 

Its side effects includes severe itching, swelling, blistering and severe irritation of the treated skin.

  1. Dexmethylphenidate

This is a mild stimulant mostly to the central nervous system. It normally affects the chemicals which contribute to the impulse control in the brain. It is specifically used to treat ADHD (Attention Deficit Hyperactivity Disorder). This drug should not be used if you have glaucoma, severe anxiety and agitation.

Always take this medicine as prescribed by the doctor otherwise it may cause blood circulation problems, causing numbness or discoloration of fingers or toes. Avoid taking in the evening because it may cause sleep problems and always be careful when doing something that requires you to be alert after taking this medicine because it causes blurred vision and may impair your thinking.

  1. Colace

Its generic name is Docusate. This is a drug that is used to treat constipation. It used to soften stool and makes bowel movements easier and softer to pass. This prevents rectal damage or pain which is normally caused by hard stools or the strain that comes when passing the bowels. But this drug should not be used when one has blockage in the intestines and when having stomach aches, or sick with nausea or vomiting.

The dosage for this medicine should be followed according to the doctors’ prescription but adults and children should not use the same dosage as it will lead to overdose or under dose of one of them.

The side effects of this drug are; rectal bleeding or irritation, vomiting and stomach cramps, pounding heartbeats and continued constipation.

  1. Intermezzo

Its generic name is called Zolpidem Sublingual. It is a sedative which affects chemicals in the brain that becomes unbalanced and causes sleep problems. It is used to treat insomnia.

Product Recalls and Lawsuits

  1. Hydromorph Contin Recall April 2019

Purdue Pharma made this recall because of the safety reasons. This is because the recalled lots had hydromorphone levels which were outside those that were labeled in the drug itself.

This recall targeted the public at large and the wholesalers and distributors. After this recall was made, no claim has been made concerning any effect from the labeling issue and still the recall is in process.

Litigation Settlements

  1. $270 Million Opioid Settlement

Purdue Pharma reached a final settlement of $270 million in which it was sued for its opioid contribution to the deaths of many people.

Opioids are painkillers which are very strong and very high side effects when used. They are normally prescribed when other pain killer drugs have been used and failed totally then these opioid can be used but with high integrity prescription.

The lawsuit which was filed by Oklahoma which in its suit claimed that the company and other pharmaceutical companies selling and producing opioids deliberately and falsely downplayed the risks involved with the opioids and persuaded doctors to prescribe their painkillers without actually revealing the side effects.

These opioids made many people become addicts from using these painkillers which are only used in severe painkillers where the other treatments have totally failed. Also other were overdosed and many died through the use of these opioids and this is why these companies were sued for claiming the lives of many through this illegal sale of very deadly painkillers which are very strong and not rarely prescribed without prior prescriptions.

Purdue payment was to go the construction and maintenance of an addiction centre in Oklahoma University. 

Sources:

https://www.purduepharma.com/healthcare-professionals/products/

https://www.drugs.com/manufacturer/purdue-pharma-lp-160.html

https://www.bbc.com/news/business-47710332

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/69658r-eng.php

http://money.com/money/5640480/oxycontin-opioid-crisis-purdue-pharma-sackler-family-lawsuits/

AbbVie

Executive Summary

AbbVie Inc. (AbbVie) is a research-based biopharmaceutical company. AbbVie is engaged in the discovery, development, manufacture and sale of a range of pharmaceutical products. Its products are focused on treating conditions, such as chronic autoimmune diseases in rheumatology, gastroenterology and dermatology; oncology, including blood cancers; virology, including hepatitis C virus (HCV) and human immunodeficiency virus (HIV); neurological disorders, such as Parkinson’s disease and multiple sclerosis; metabolic diseases, including thyroid disease and complications associated with cystic fibrosis, and other serious health conditions. 

History of Merck

On October 19, 2011, biopharma giant Abbott Laboratories announced its plan to separate into two publicly traded companies. The “new” Abbott Laboratories would specialize in diversified products including medical devices, diagnostic equipment and nutrition products, while AbbVie would operate as a research-based pharmaceutical manufacturer. The separation was effective January 1, 2013, and AbbVie was officially listed on the New York Stock Exchange (ABBV) on January 2, 2013.

According to Miles White, CEO at the time, the purpose of the split was to allow markets to value the two businesses separately; White said that investors would “benefit from two fundamentally different investment opportunities with distinct strategic profiles and business priorities.” Some investors were concerned that the split was done to protect the value of the device business from the loss of value facing the drug division due to the imminent expiration of patents on Humira, which accounted for about half of the drug division’s revenue. 

As of December 2015, the company employed in excess of 28,000 globally, and provided products to individuals in more than 170 countries.

Subsidiaries of AbbVie

The following companies are listed by the United States Securities and Exchange Commission as subsidiaries of AbbVie, as of December 2017:

AbbVie Biopharmaceuticals LLC Delaware
AbbVie Bioresearch Center Inc. Delaware
AbbVie Biotech Ventures Inc. Delaware
AbbVie Biotherapeutics Inc. Delaware
AbbVie Endocrine Inc. Delaware
AbbVie Endocrinology Inc. Delaware
AbbVie Holdings Inc. Delaware
AbbVie Pharmaceuticals LLC Delaware
AbbVie Products LLC Georgia
AbbVie Purchasing LLC Delaware
AbbVie Resources Inc. Delaware
AbbVie Resources International Inc. Delaware
AbbVie Respiratory LLC Delaware
AbbVie Stemcentrx LLC Delaware
AbbVie US Holdings LLC Delaware
AbbVie US LLC Delaware
AbbVie Ventures LLC Delaware
Aeropharm Technology, LLC Delaware
BioDisplay Technologies, Inc. Illinois
Fremont Holding L.L.C. Delaware
IEP Pharmaceutical Devices, LLC Delaware
Knoll Pharmaceutical Company New Jersey
KOS Pharmaceuticals, Inc. Delaware
Life Properties Inc. Delaware
Organics L.L.C. Delaware
Pharmacyclics LLC Delaware
Rowell Laboratories, Inc. Minnesota
Sapphire Merger Sub, Inc. Delaware
Unimed Pharmaceuticals, LLC Delaware
Foreign Subsidiaries Incorporation
AbbVie S.A. Argentina
AbbVie Pty Ltd Australia
AbbVie GmbH Austria
AbbVie Bahamas Ltd. Bahamas
AbbVie SA Belgium
AbbVie Ltd Bermuda
AbbVie Biotechnology Ltd Bermuda
AbbVie Holdings Unlimited Bermuda
AbbVie d.o.o. Bosnia
AbbVie Farmacêutica Ltda. Brazil
AbbVie Participações Ltda. Brazil
AbbVie EOOD Bulgaria
AbbVie Corporation Canada
AbbVie Holdings Corporation Canada
Pharmacyclics Cayman Ltd. Cayman Islands
Stemcentrx Cayman Ltd. Cayman Islands
AbbVie Productos Farmacéuticos Limitada Chile
AbbVie Pharmaceutical Trading (Shanghai) Co., Ltd. China
Pharmacyclics (Shanghai) Management Consulting Services Limited China
AbbVie S.A.S. Colombia
AbbVie d.o.o. Croatia
AbbVie Limited Cyprus
AbbVie s.r.o. Czech Republic
AbbVie A/S Denmark
AbbVie, S.R.L. Dominican Republic
AbbVie L.L.C. Egypt
AbbVie Oy Finland
AbbVie SAS France
AbbVie Holdings SAS France
Abbott Products GmbH Germany
AbbVie Biotechnology GmbH Germany
AbbVie Deutschland GmbH & Co. KG Germany
AbbVie Komplementär GmbH Germany
AbbVie Real Estate Management GmbH Germany
AbbVie (Gibraltar) Holdings Limited Gibraltar
AbbVie (Gibraltar) Limited Gibraltar
AbbVie Pharmaceuticals Societe Anonyme Greece
AbbVie, S.A. Guatemala
AbbVie Limited Hong Kong
AbbVie Kft. Hungary
AbbVie Biopharmaceuticals Private Limited India
AbbVie Ireland Holdings Limited Ireland
AbbVie Ireland Unlimited Company Ireland
AbbVie Limited Ireland
AbbVie Manufacturing Management Limited Ireland
Fournier Laboratories Ireland Ltd. Ireland
Pharmacyclics (Europe) Limited Ireland
AbbVie Biopharmaceuticals Ltd. Israel
AbbVie S.r.l. Italy
AbbVie GK Japan
AbbVie Holdings KK Japan
AbbVie UK Biopharmaceuticals Ltd Jersey
AbbVie UK Ltd Jersey
AbbVie Ltd Korea, South
AbbVie SIA Latvia
AbbVie UAB Lithuania
AbbVie (Gibraltar) Holdings Limited Luxembourg S.C.S. Luxembourg
AbbVie International S.à r.l. Luxembourg
AbbVie Investments S.à r.l. Luxembourg
AbbVie Overseas S.à r.l. Luxembourg
AbbVie S.à r.l. Luxembourg
AbbVie Sdn. Bhd. Malaysia
AbbVie Farmacéuticos, S.A. de C.V. Mexico
AbbVie B.V. Netherlands
AbbVie Central Finance B.V. Netherlands
AbbVie Finance B.V. Netherlands
AbbVie Ireland NL B.V. Netherlands
AbbVie Japan Holdings B.V. Netherlands
AbbVie Logistics B.V Netherlands
AbbVie Nederland Holdings B.V. Netherlands
AbbVie Pharmaceuticals B.V. Netherlands
AbbVie Research B.V. Netherlands
AbbVie Venezuela B.V. Netherlands
AbbVie Venezuela Holdings B.V. Netherlands
AbbVie Limited New Zealand
AbbVie AS Norway
AbbVie, S. de R.L. Panama
AbbVie Polska Sp. z o.o. Poland
AbbVie Sp. z o.o. Poland
AbbVie, L.da Portugal
AbbVie Promoção, L.da Portugal
AbbVie Corp Puerto Rico
Knoll LLC Puerto Rico
S.C. AbbVie S.R.L. Romania
AbbVie Limited Liability Company Russia
AbbVie Operations Singapore Pte. Ltd. Singapore
AbbVie Pte. Ltd. Singapore
AbbVie Holdings s.r.o. Slovakia
AbbVie s.r.o. Slovakia
AbbVie Biofarmacevtska družba d.o.o. Slovenia
AbbVie (Pty) Ltd. South Africa
AbbVie Spain, S.L. Spain
Fundación AbbVie Spain
AbbVie AB Sweden
AbbVie AG Switzerland
AbbVie Biopharmaceuticals GmbH Switzerland
Pharmacyclics Switzerland GmbH Switzerland
AbbVie Ltd. Thailand
AbbVie Sarl Tunisia
AbbVie Tıbbi İlaçlar Sanayi ve Ticaret Limited Şirketi Turkey
AbbVie Australasia Holdings Limited United Kingdom
AbbVie Biotherapeutics Limited United Kingdom
AbbVie Investments Limited United Kingdom
AbbVie Ltd United Kingdom
AbbVie Trustee Company Limited United Kingdom
AbbVie UK Holdco Limited United Kingdom
AbbVie S.A. Uruguay
AbbVie Pharmaceuticals SCA Venezuela

Popular Products of AbbVie

AbbVie’s most popular products are the following:

  1. Humira (adalimumab) – Humira is one of the most popular drugs in the world, selling USD 18 billion worth of the drug in 2017 alone. It is used in the treatment of rheumatoid arthritis and Crohn’s disease. It is very expensive, costing aroun USD 5,000 per prescription. It was responsible for 61% of AbbVie’s revenue in 2018. 
  2. Imbruvica (ibrutinib) – Imbruvica is used to treat chronic lymphocytic leukemia (CLL), Waldenstrom’s macroglobulinemia, and as a second-line treatment for mantle cell lymphoma, marginal zone lymphoma, and chronic graft vs host disease. The typical cost of ibrutinib in the United States is about USD 148,000 a year.
  3. Creon (Pancreatic enzymes) – Creon, or Pancreatic enzymes, and also known as pancrelipase and pancreatin, are commercial mixtures of amylase, lipase, and protease. They are used to treat malabsorption syndrome due to certain pancreatic problems. These pancreatic problems may be due to cystic fibrosis, surgical removal of the pancreas, long term pancreatitis, or pancreatic cancer, among others. The preparation is taken by mouth.
  4. Venclexta (venetoclax) is a BCL-2 inhibitor used to treat adults with CLL or SLL, with or without 17p deletion, who have received at least one prior treatment. In addition, Venclexta is used in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who are 75 years of age or older or have other medical conditions that prevent the use of standard chemotherapy.
  5. Mavyret (glecaprevir/pibrentasvir) is approved in the United States and European Union (MAVIRET) for the treatment of patients with chronic HCV genotype 1-6 infection without cirrhosis and with compensated cirrhosis (Child-Pugh A). It is also indicated for the treatment of adult patients with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both. It is an 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment.
  6. Lupron (Leuprorelin) is a manufactured version of a hormone used to treat prostate cancer, breast cancer, endometriosis, uterine fibroids, and early puberty. It is given by injection into a muscle or under the skin.
  7. AndroGel (Testosterone in gel) – AndroGel is a testosterone replacement therapy for males diagnosed with symptomatic low testosterone due to certain underlying conditions.
  8. Marinol (Dronabinol) – AbbVie’s Marinol was the first FDA-approved cannabis drug. Solvay Pharmaceuticals developed the drug. It is an appetite stimulant, antiemetic, and sleep apnea reliever

Product Recalls and Lawsuits

  1. Humira lawsuits blame the drug for fungal infections, nerve damage, and an increased risk of cancer in children and adolescents. In 2013, a jury ordered AbbVie to pay $2.24 million to a patient who suffered from a fungal infection. Some patients have died from these infections, according to the FDA.
  2. More than 7,750 men have filed testosterone lawsuits against AbbVie and other manufacturers of testosterone replacement therapy products. Nearly 6,000 remained pending in federal court in Illinois in June 2018. AndroGel lawsuits blame the product for blood clots, heart attack, stroke and sudden death.
  3. AbbVie’s multiple sclerosis drug Zinbryta was pulled from the shelves altogether in March 2018. It led to the deaths of three patients. The drug was a joint venture with Biogen. There were Reports of serious inflammatory brain disorders, including encephalitis and meningoencephalitis, and patient deaths; possible severe immune reactions affecting other body organs
  4. AbbVie’s Zemplar injection was recalled in 2015 because a single vial contained free floating glass particles. 
  5. In 2013, AbbVie’s Synthroid had to be recalled because of a labelling error. 

Litigation Settlements

  1. Depakote lawsuits say children suffered birth defects after their mothers took Depakote during pregnancy. AbbVie assumed all rights and responsibilities for Depakote when it separated from Abbott. In June 2018, a judge halted more than 600 lawsuits so lawyers on both sides could discuss settlements.
  2. After a court ruling against AbbVie in April 2018, the company plans to settle other AndroGel cases, as of 2019. 

Sources:

https://investors.abbvie.com/stock-information/stock-quote

https://www.sec.gov/Archives/edgar/data/1551152/000155115218000014/abbv-20171231xex21.htm

https://www.statista.com/statistics/417063/revenue-of-abbvie-from-key-products/

https://www.investopedia.com/articles/markets/040115/how-abbvie-makes-its-money-abbv.asp

https://investors.abbvie.com/static-files/47b78f29-de86-46fd-ae82-83878c1a72f1

https://www.drugwatch.com/manufacturers/abbvie/

https://www.pharmaceutical-technology.com/?s=abbvie

Takeda Pharmaceuticals

Executive Summary

Takeda Pharmaceuticals is a global biopharmaceutical company which is patient focused and value based which is highly committed in changing people’s lives to the better and giving them a brighter future though healthcare. The company has its presence over 80 countries all over the world having leading positions in Japan and United States.

The US position leads in all Takeda Revenue giving 48%, Japan giving 19% and the rest of the world giving out 33%. 

-Takeda Lawsuits

Takeda Pharmaceuticals is facing so many lawsuits concerning it diabetes type 2 drug Actos. The patients who were prescribed this drug started feeling and experiencing very adverse reactions from the side effects of this medicine. 

This reactions and problems which were caused by Actos side effects were; bladder cancer and heart failure. These two became the main reasons for the many lawsuits filed against Takeda pharmaceuticals. 

The company has been accused of hiding information about the side effects of Actos hence causing all this problems to patients who used this drug.

Many of these charges have been filed as MDL (Multi District Litigations) where several federal lawsuits have been grouped together into one court case so that the process of litigation can be easier and simpler.

History of Takeda Pharmaceuticals

Takeda Pharmaceuticals was founded in 1998 and was ranked as one of the top most Pharmaceutical companies in the United States. Their success has been entirely brought by their drug for treating type 2 diabetes.

The company was originally founded in Osaka Japan in 1781 where it began importing the pharmaceutical products from the west in the same year and at that time it was known as cooperative union not Takeda. In 1925, they changed their name and was called Chobel Takeda & company ltd and had grown that time its net worth being approximately $1 million.

In the of the Second World War, Takeda supplied Penicillin and B vitamins and after the end of the war, it started supplying its stock internationally. The company grew since then expanding its US and European markets.

Subsidiaries of Takeda Pharmaceuticals

  1. Shire PLC

Takeda pharmaceuticals in January 2019 acquired Shire plc the Irish based drug maker at a cost of $57 billion. This deal almost doubled Takeda revenue in the larger US region. 

Shire plc deals with the development of medicines like for hemophilia and others that will expand Takeda pharmaceuticals product base and help the company achieve its goals.

  1. TiGenix

In August 2018, Takeda Pharmaceuticals acquired TiGenix at a cost of $608 million through the purchase of ordinary shares. Though this purchase, TiGenix became a whole subsidiary of Takeda pharmaceuticals.

TiGenix is a biopharmaceutical company which develops stem cell therapies. It is locally mandated to treat very complex perianal fistulas in these patients with non active luminal diseases who have inadequate response to conventional therapy.

  1. Millennium Pharmaceuticals

In April 2008, Takeda Pharmaceuticals acquired biotechnology company Millennium Pharmaceuticals at a cost of $8.8 billion. This is a US based pharmaceuticals which deals mostly with developing and manufacturing cancer drugs.

This acquisition saw Takeda pharmaceuticals own fully the US based company and secured its promising pipelines and technologies developed by the company at large.

It also cemented the deal that Millennium’s main cancer drug Velcade to be added to Takeda’s products portfolio.

  1. Nihon Pharmaceuticals

This is another subsidiary of Takeda Pharmaceuticals which was established in 1960. It deals with development and manufacture of pharmaceutical products in the Japan and it based in Tokyo Japan. 

This added to the Takeda family and its widening product portfolios all over the world.

  1. Nycomed Pharmaceuticals

This is a pharmaceutical company situated in Johannesburg South Africa which was established in 1996 in which it markets and sells Takeda’s pharmaceutical products in the larger South Africa. This company was acquired in 2011 by Takeda Pharmaceuticals at a cost of $12.9billion on cash basis. The company’s focus was to improve on emerging markets in Asia, Europe and The US markets.

Popular Products of Takeda Pharmaceuticals

There are many products that are developed, manufactured and distributed by Takeda Pharmaceuticals Company both the main and its subsidiaries. They include the following;

  1. Prevacid

Its generic name is Lansoprazole and formulated as 15mg, 30mg and granules in caps. It is a proton pump inhibitor which decreases the high amount of acid which is being produced in the stomach.

It is normally used to treat and in the prevention of intestinal and stomach ulcers and the also prevents the danger and damage caused to the esophagus from excessive stomach acids.

Over the counter prevacid is also used to treat heartburn that occurs frequently usually once or twice a week but not very severe.

Use Prevacid carefully as directed or prescribed by the doctor or as directed on the label. The capsule should be swallowed whole and not crushed. Be careful too not to overdose or under dose because it can then lead to other side effects which are life threatening.

  1. Dexilant

This is another popular product which is manufactured and distributed by Takeda Pharmaceuticals. Its generic name is Dexlansoprazole. It decreases the amount of acid which is produced in the stomach.

Dexilant is also used to treat heartburn which is normally caused by gastroesophageal reflux disease (GERD) and to heal any damage caused to the esophagus from the acids which are produced in the stomach.

Dexilant can cause kidney problems, new or worsening symptoms of Lupus and broken bones if taking Dexilant daily or more than once per day and even long term.

Taking Dexilant should be strictly followed according to the prescription label or the doctor’s prescription and advice. Do not overdose or under dose because it can also bring other side effects.

  1. Actos

Its generic name is called Pioglitazone. This is an oral medicine for diabetes which is used to control blood sugars. It is used together with diet and exercise to improve the blood sugar controls in adults with diabetes type 2. It is not for treating type 1 diabetes.

This medicine is taken once daily with or without food. Low blood sugar (Hypoglycemia) can happen to anyone with diabetes. The doctor can sometimes prescribe glucagon emergency injection kit to be used in case one has very severe hypoglycemia and in the process cannot eat or drink anything.

In taking this drug, follow the doctor’s prescription carefully and do not over or under dose. Always store this medicine at a room temperature where there is no heat, moisture and light. Keep the bottle tightly closed when not in use.

  1. Duetact

Its generic name is called glimepiride and pioglitazone. 

Duetact is a combination of oral diabetes medicines which are glimepiride and pioglitazone which helps in controlling blood sugar levels. It is used together with diet and exercise to improve the control of blood sugar in grownups with type 2 diabetes mellitus. Duetact is not at all used to treat diabetes type 1.

Duetact can sometimes cause heart congestion or failure. It should not be used with patients who have cancer unless directed by the doctor. Also it is not for children but only for adults. Always should be taken as per the doctor’s prescription to avoid over or under dosing.

  1. Colcrys

This is a Takeda pharmaceutical product whose generic name is Colchicine. This drug is designed to respond to acidic uric crystals thus reducing swelling and pain. This drug has been approved to treat familial Mediterranean fever in adults and children aged 4 years and above and in treating gout only in adults. The medicine is also used to prevent gout and the symptoms of behcets syndrome but it is not a cure for gout.

The common side effects of Colcrys include, muscle pain or weakness, diarrhea, vomiting and stomach pains

  1. Leuprorelin Acetate

This is a GnRHa (Gonadotropin releasing hormone agonist) used for the treatment of hormone responsive diseases like cancer e.g. prostate cancer and breast cancer in women

It is also a medicine which is used in treating children with central precocious puberty, infertility and women with endometriosis. It also improves anemia in women with fibroids.

  1. Vortioxetine

Its brand name is Trintellix which one of the popular products developed, manufactured and distributed by Takeda Pharmaceuticals. It is mainly used to treat major depressive disorder (MDD).

Product Recalls and Lawsuits

  1. Omontys (Peginesatide) Injection Recall

On February 2013, Takeda pharmaceuticals together with Affymax Inc Company made a voluntary recall of all lots of Omontys injection up to the consumer level.

This recall was made because of emerging post marketing reports of very serious hypersensitivity reactions which can be life threatening including anaphylaxis.

This medicine is mainly used in the treatment of anemia. There has been few cases and the company is investigating these issues. No lawsuits have been filed yet concerning this recall.

  1. Pamol Recall 2017

In February 2017, Takeda pharmaceuticals made a voluntary recall of pamol, only some patch which was packed in packs of 300 film coated tablets. This was because there was a discovery of Ibumetin 600mg which contains ibubrofen in some packs.

These two medicines are used to treat mild pains but they work in totally different ways and it was anticipated that they may cause adverse or severe reactions

Litigation Settlements

  1. $2.4 Billion Settlement of Actos Litigations

In April 2015, Takeda pharmaceuticals settled to pay over 9000 lawsuits mostly of bladder cancer litigations that emerged from the use of Actos. Many patients incurred injuries from the use of this drug resulting to too many lawsuits of which others are still pending which are not yet finalized or settled.

Sources:

https://www.empr.com/manufacture/takeda-pharmaceutical-company/

https://www.drugs.com/manufacturer/takeda-pharmaceuticals-u-s-a-inc-137.html

https://www.drugdangers.com/manufacturers/takeda-pharmaceuticals/

https://www.takeda.com/who-we-are/company-information/company-facts/

https://www.reuters.com/article/us-millennium/takeda-to-buy-millennium-pharma-for-8-8-billion-idUST18218420080410

https://laegemiddelstyrelsen.dk/en/news/2017/takeda-pharma-as-recalls-batch-of-pamol-in-packs-of-300-film-coated-tablets/

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