Executive Summary

Eli Lilly and Company, Inc. (Lilly) is a global pharmaceutical manufacturer founded in 1876 by the company’s eponymous founder, Eli Lilly, an Indiana cotton farmer turned pharmacy entrepreneur.  Today, Lilly is a Fortune 500 company netting over $20 billion dollars a year from pharmaceutical and over-the-counter drug sales.  Through its global research and supply network, Lilly products are sold in over 120 countries around the world.  Its most widely prescribed and consumed products are Prozac (despression and anxiety), Zyprexa (schizophrenia and bipolar disorder), Byetta (type 2 diabetes) and Cialis (erectile dysfunction).

History of Lilly

So the story goes,  Colonel Eli Lilly, a veteran of the Civil War and the founder of the global pharmaceutical giant, started his humble drug company due to his alleged dissatisfaction with the quality of contemporary medicine in his day.  One of the first drugs that Colonel Lilly produced was quinine, a drug for the treatment of malaria.  Lilly was also known as an innovator for first coating pills and capsules with gelatin.  Over the years, Lilly grew considerably and established a landmark manufacturing facility in its present-day headquarters in Indianapolis, Indiana.  In the 1970s, Lilly hit $1 billion in sales for the first time.  Today, Lilly employs over 40,000 people worldwide.

Lilly, Prozac and the Market for Psychiatric Medication:

Lilly is perhaps best known for production of the psychiatric drug Prozac (fluoxetine) the first Selective Serotonin Reuptake Inhibitor (SSRI) to arrive on the market in 1988.  It is hard to overstate what a huge impact Prozac was both for Lilly and the booming market for psychiatric drugs.  Soon after its introduction, Prozac was netting close to $1 billion a year in sales for Lilly.  Suffice to say, Prozac went on to embed itself in popular culture and has come to be one of the most recognized drug names for the treatment of depression today.

Lilly and Issues with Dangerous Drugs:

As remarkable as Lilly’s history, growth and success over the past 150 years have proven, the company’s business and reputation have suffered in recent years from a string of issues arising from dangerous drugs pushed into the market.  Some of the more notable cases to make headlines have arisen from:

Axiron

Marketed in 2011 as an underarm testosterone replacement gel for men, Axiron was billed by Lilly as an easy and effective method for treatment of low-testosterone levels.  Due to a rash of studies in recent years, which have indicated that low testosterone may be responsible for a number of common ailments in older men – notably fatigue and loss of sexual ability, treatments to boost testosterone have become remarkably popular.  Unfortunately, they also tend to be overprescribed and aggressively marketed at men who may not actually be suffering from low testosterone levels.  Many men who began testosterone treatments, some under the most specious of circumstances, later began suffering increased risk from heart attacks, strokes and sudden death at a much greater rate than normal.  Consequently, Lilly has been embroiled in lawsuits resulting from these complications and Axiron has been withdrawn from the market.

Actos

Approved by the U.S. Food and Drug Administration (FDA) in 1999, Actos (pioglitazone hydrochloride) was a drug jointly-marketed by Lilly and pharmaceutical giant, Takeda Pharmaceutical Co. for the treatment of type 2 diabetes mellitus.  The FDA issued a black-box warning for Actos in 2007 due to concerns over increased risk for heart failure associated with the drug.  In 2011, the American Diabetes Association reported its findings that Actos could also be associated with increased risk for bladder cancer.  Litigation against both Takeda and Lilly ensued culminating with verdicts against both companies totalling $9 billion for masking cancer risks associated with Actos.

Zyprexa

One of the more popular medications for treatment of schizophrenia and bipolar mania upon its introduction to the market, Zyprexa (olanzapine) was also frequently prescribed alongside of Prozac as “Symbyax”.  In 2005, the FDA mandated that both drugs receive black box warnings for the risk of death from heart failure and various infections for elderly patients who were prescribed the drugs for the treatment of dementia (an off-label use, for which the FDA did not expressly approve the drug).  Additionally, Lilly modified the label for Zyprexa in 2007 due to concerns about increased suicidal thoughts and ideation in children who were prescribed the medication.  It should be noted that Zyprexa was never approved for use in patients under the age of 18 (another off-label use).  In 2009, Lilly plead guilty and admitted that it illegally marketed Zyprexa as appropriate for elderly dementia patients and children despite not being approved for such use on its label by the FDA.

Tradjenta

A medication for type 2 diabetes, Tradjenta (linagliptin) is part of a larger family of drugs known as dipeptidyl peptidase-4 (DDP-4) inhibitors.  This family also includes other diabetic medications such as Januvia, Byetta and Victoza.  Also known as mimetics, these drugs have been cited by the FDA for their increased risk of pancreatitis and related pre-cancerous cell changes.  In 2013, the agency announced that it would be investigating the unpublished findings of several academic researchers who examined post-mortem tissue samples from patients for further evidence of the pancreatic linkage.

Sources Cited:

1) “About Lilly” https://www.lilly.com/who-we-are/about-lilly

2) “Novartis Takes Aim at Eli Lilly with Cosentyx FDA Nod in Spondyloarthritis” https://www.fiercepharma.com/pharma/novartis-takes-aim-at-eli-lilly-fda-nod-for-cosentyx-spondyloarthritis

3) “Eli Lilly pharmaceutical company starts Phase 3 coronavirus trial with drug used to treat arthritis” https://www.foxnews.com/health/lilly-starts-phase-3-coronavirus-trial-for-baricitinib-arthritis-drug

4) “Eli Lilly (LLY) Stock Sinks As Market Gains: What You Should Know” https://www.yahoo.com/news/eli-lilly-lly-stock-sinks-214509929.html

5) Eli Lilly and Company SEC Filings http://www.getfilings.com/sec-filings/160219/LILLY-ELI-and-CO_10-K/lly-20151231x10kexhibit21.htm

6) “25 Years After Prozac” https://www.pharmacist.com/25-years-after-prozac

7) “Selling Prozac at the Life-Enhancing Cure for Mental Woes” https://www.nytimes.com/2014/09/22/us/selling-prozac-as-the-life-enhancing-cure-for-mental-woes.html

8) “Testosterone Treatment: Fountain of Youth or Heart Attack Risk?” https://www.indystar.com/story/money/2014/11/21/testosterone-treatment-fountain-youth-heart-attack-risk/70041122/

9) “Lilly Adds Strong Warning Label to Zyprexa, a Schizophrenia Drug” https://www.nytimes.com/2007/10/06/business/06zyprexa.html

10) “The Trouble with Zyprexa” https://pro.psychcentral.com/the-trouble-with-zyprexa/

11) “FDA Warns About Using Antipsychotic Drugs for Dementia” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC556368/

12) “Zyprexa Medication Guide” https://www.fda.gov/files/drugs/published/Zyprexa-Medication-Guide.pdf

Executive Summary

DePuy Synthes is a franchise of orthopaedic and neurosurgery companies. They have been part of the Johnson & Johnson Family of Companies since 1998. DePuy develops and markets products under the Codman, DePuy Mitek, DePuy Orthopaedics, and DePuy Spine brands. 

Notably, DePuy Orthopaedics also has one of the world’s most comprehensive portfolios of orthopaedic products and services in the areas of joint reconstruction, trauma, spine, sports medicine, cranio-maxillofacial, power tools, and biomaterials. Its primary products aim to reconstructure damaged or diseased joints and for repairing and reconstructing traumatic skeletal injuries.

Most recently, DePuy Synthes has had trouble with its Articular Surface Replacement technology and Pinnacle hip implants, with more than 20,000 people filing lawsuits against the company. Verdicts and settlements in the lawsuits have already totaled more than $6 billion.

History of DePuy Synthes

In 1895, a 35-year-old chemist and pharmaceutical salesman named Revra DePuy came up with the idea of starting a business to manufacture fiber splints that could be customized to fit patients and would be an advance over the wooden splints that were commonly used in the late nineteenth century.

DePuy opened his business, which he named DePuy Manufacturing Company, in a hotel room in downtown Warsaw, a city in northern Indiana that is home to several natural lakes and which DePuy had grown fond of during his work-related travels.

Even before Revra DePuy made his first sale, he made history. His business became the first orthopaedic manufacturing business in the world, and his decision to set up shop in Warsaw was the catalyst for Warsaw becoming the “Orthopaedic Capital of the World.”

Over the next quarter century, until his death in 1921, Revra DePuy continued to make splints and grow his business. He replaced his fiber splints with wire cloth splints. He added more than a dozen employees to the payroll. He also complemented his mail-order business with a small team of salesmen, one of whom was Justin Zimmer, who later started his own splint manufacturing company in Warsaw.

In the decades following Revra DePuy’s death, the orthopaedics industry changed dramatically. New scientific advances led to the development of artificial joints, as well as techniques for correcting spinal deformities, repairing broken bones with internal fixation devices and many other innovations. DePuy Manufacturing not only adapted to the changing orthopaedic industry, it helped shape it. Through a series of leaders, owners, acquisitions, collaborations and joint ventures, DePuy Manufacturing transformed from a company that made splints to a leader in developing and manufacturing implants and instruments to treat a wide range of diseases and disorders of the musculoskeletal and neurological systems.

Along the way, there were many company “firsts.” DePuy introduced the first mobile bearing knee system in the United States, the LCS® Knee System. It pioneered POROCOAT® Porous Coating, which is composed of sintered alloy beads that allow biological fixation to bone without the use of bone cement. During the 1980’s, DePuy’s AML® Hip System became the first cementless porous-coated implant indicated for biological fixation in the world.

Innovation and growth were further fueled by several mergers and acquisitions. In 1990, DePuy’s parent company at the time acquired Chas. F. Thackray Limited (Leeds, United Kingdom). Thackray played a key role in the development of cemented fixation through its work with Sir John Charnley, the “father” of total hip replacement. DePuy’s work in biologic fixation and Thackray’s contributions to cemented fixation continue to shape new innovations to this day. Interestingly, not only did DePuy go on to manufacture and market the CHARNLEY Hip for many years , it also had marketing rights for some time to the Müller® Hip, named after Swiss orthopaedic surgeon Maurice E. Müller, whose cemented straight stem has remained virtually unchanged since its inception decades ago.

In 1998, Johnson & Johnson, one of the world’s largest healthcare companies, acquired DePuy, by then known as DePuy, Inc. Later, in 2012, Johnson & Johnson acquired global medical device company Synthes, Inc., and combined that company with the DePuy franchise to create one of the world’s largest orthopaedic and neurological businesses.

DePuy Synthes Subsidiaries

DePuy Synthes has the following companies operating under it:

• Codman & Shurteff, Inc.
• DePuy Mitek, Inc.
• DePuy Orthopaedics, Inc.
• DePuy Spine, Inc

Popular DePuy Synthes Products

One of DePuy Synthes’ flagship products is the Attune Knee System lineup. The Attune rotating platform design increases the level of conformity to provide stability while delivering freedom of mobility. Rotating platform knees aim to restore more natural movement to the joint by allowing the bearing to rotate in the same manner as an anatomical knee. Rotating knees also are designed to reduce stress and wear on the implant by 94 percent.

The second-most popular product made by DePuy Synthes is the Pinnacle Acetabular Cup System (ACS). It is a modular cup system designed with a wide range of acetabular cup options, biological and mechanical fixation alternatives and advanced bearing technologies that allows surgeons the flexibility to choose intraoperatively from among the most advanced technologies available depending on their patients’ individual needs.

DePuy also manufactures the RECLAIM® Modular Revision Hip System, which combines design features with comprehensive testing and engineering. Designed to be a durable and flexible system to manage the unexpected in moderate to severe hip revision surgery.

Another product marketed by DePuy is the SUMMIT® Tapered Hip System, which has achieved over 15 years of clinical history, and it remains a viable treatment option for patients today. A comprehensive set of implants, featuring both cemented and cementless options, treat a wide range of patients with differing needs. The SUMMIT Tapered Hip System utilizes a common set of instrumentation. The streamlined approach maximizes efficiency in the operating room, while still providing intraoperative flexibility.

For the spine, DePuy manufactures the EXPEDIUM® 5.5 System, which provides technological advancements to treat a range of spinal pathologies. The EXPEDIUM Spine System offers a comprehensive solution for rigid posterior fixation of the thoracolumbar regions of the spine.

DePuy Synthes Product Recalls and Lawsuits

1. In 2010, DePuy Orthopaedics recalled its ASR XL Acetabular metal-on-metal hip replacement system on August 24, 2010. The recall came after data from a study indicated that the five year failure rate of this product is approximately 13%, or 1 in 8 patients. Even if the defective device is replaced, it can leave behind dangerous, possibly deadly fragments that may not be discovered for years. DePuy identified reasons for the failure of the hip replacement system as component loosening, component malalignment, infection, fracture of the bone, dislocation, metal sensitivity and pain. Additional complications from the hip replacement system may include increased metal ion levels in the blood, bone staining, necrosis, swelling, nerve damage, tissue damage and/or muscle damage.

About 93,000 persons worldwide received an ASR implant. The first lawsuit in the United States against DePuy Orthopaedics was filed on June 15, 2010. 

On March 17, 2016, United States District Judge Ed Kinkeade, after receiving the juries verdict, signed final judgment and issued a combined award of $120 million against DePuy Orthorpaedics Inc, and a combined award $240 million against Johnson & Johnson.

1. In December 2017, DePuy Synthes recalled a stand-alone element of its Sigma HP partial knee replacement, the Sigma HP PFJ cemented trochlear implant, “based on elevated revision rates observed as part of the company’s post-market surveillance process.” “Further distribution or use of the affected implants is to cease immediately, and the product is now discontinued. The company recommends that surgeons use alternative implants or consider a total knee replacement,” the company said in a field safety notice dated December 2017.
2. More than 20,000 people have filed lawsuits over DePuy’s Articular Surface Replacement (ASR) and Pinnacle hip implants. Verdicts and settlements in the lawsuits have already totaled more than $6 billion. The metal-on-metal technology used in DePuy’s Articular Surface Replacement (ASR) and Pinnacle hip implants offered high-hopes of long-lasting implants when it first hit the market, but it was plagued with problems and many implants failed within just a few years.
3. Plaintiffs say friction between the all-metal parts released metal ions into the body, which led to complications and implant failures – and, ultimately, 20,000 lawsuits. Settlements and verdicts involving the hip implants total roughly $6.2 billion, though courts have reduced some of the jury awards. As of July 2019, there were more than 11,000 lawsuits still pending over DePuy hip replacements and more lawsuits are likely to be filed. Of those, 9,893 were lawsuits over the Pinnacle hip and 1,434 were over the ASR hip.

DePuy Synthes Settlements

1. In December 2018, Bloomberg reported that DePuy offered to settle roughly 3,300 Pinnacle lawsuits for $400 million. That would have resolved roughly a third of the active lawsuits over the hip replacement. Bloomberg relied on court documents from the MDL in Texas federal court for its reporting. 

In February 2019, HarrisMartin Publishing reported that DePuy was also willing to reach settlements with 17 plaintiffs who won jury verdicts in three bellwether trials. That announcement came as the MDL court was preparing to retry one of the cases. No details of the negotiations were released at the time.

Sources: https://projects.propublica.org/docdollars/company/100000005601https://www.drugwatch.com/hip-replacement/depuy/lawsuits/https://www.jnjmedicaldevices.com/en-US/companies/depuy-syntheshttps://www.beckersspine.com/orthopedic-a-spine-device-a-implant-news/item/44397-depuy-synthes-reports-1-9-drop-in-sales-for-2018-5-things-to-know.htmlhttps://www.jnjmedicaldevices.com/en-EMEA/product/expedium-55-spine-systemhttps://www.massdevice.com/revision-rates-prompt-recalls-johnson-johnsons-depuy-synthes-zimmer-biomet/

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.

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/

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

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/

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

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