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Johnson & Johnson to Stop Selling Talcum Powder

After manufacturing a talc-based baby powder for over a century, Johnson & Johnson (J&J) announced in May that it’ll stop selling the product in the United States and Canada. In recent years, they’ve faced several lawsuits related to regular use causing both ovarian cancer and mesothelioma. Still, it wasn’t these lawsuits that caused them to stop manufacturing the product. It was the rapid spread of COVID-19 this spring and the need to place a priority on producing higher-demand items as well as the need to practice social distancing at both manufacturing and distribution facilities. Stores will continue to sell their existing inventory with no restocks planned.

Johnson & Johnson’s History of Lawsuits

Given the history of lawsuits related to J&J’s talcum powder, it’s surprising that the product has never been recalled. 

Despite tens of thousands of lawsuits filed by women who developed ovarian cancer after using talcum powder — and the loss of multimillion dollars as a result of these cases — J&J continues to stand behind the safety of the product. Other companies have put warning labels on their talcum powders, but J&J refuses to do so. More research needs to be completed, but it’s important to note that some scientific studies do show that women have an increased risk of ovarian cancer after consistent use of talcum powder in their genital area.

A separate set of lawsuits ties the product to mesothelioma, as talc is often mined near asbestos. Scientists testified that they found asbestos in samples of the product, but J&J argued that their product was asbestos-free. 

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JUUL Labs Faces “Substantive Scientific Review” from the FDA

JUUL Labs, one of the companies behind the production of electronic cigarettes, has landed itself in the headlines again. A recent study from Stanford University’s School of Medicine revealed that teens and young adults who use e-cigarettes are at “a substantially increased risk of COVID-19.” Specifically, the study divulged that young people who used both cigarettes and e-cigarettes in the previous month were five times as likely to experience COVID-19 symptoms as someone who never smoked or vaped.

To read more about E-Cigarettes and Vaping, click here

The Need for Regulation of Electronic Cigarettes

In response to these results, JUUL Labs filed Premarket Tobacco Product Applications for its e-cigarettes and nicotine cartridges, which will undergo a “substantive scientific review” by the Food and Drug Administration (FDA). 

“Now is the time,” stressed Dr. Bonnie Halpern-Felsher, the study’s author. “We need the FDA to hurry up and regulate these products. And we need to tell everyone: If you are a vaper, you are putting yourself at risk for COVID-19 and other lung diseases.”

Currently facing over 650 lawsuits as well as a criminal investigation that was launched in September 2019, JUUL Labs is committed to working collaboratively with regulators, legislators, attorneys general, and public health officials to “combat underage use and transition adult smokers from combustible cigarettes.” As part of the process, the company has halted all television, print, and digital advertising as it builds up the science and evidence-based research behind its products. 

E-Cigarettes and Vaping

Executive Summary

Use of electronic cigarettes, or “e-cigarettes”, “e-cigs” or “vaping” has exploded in the United States and elsewhere – particularly among teens and young adults.  Frequently touted by manufacturers and promoters as less dangerous than combustible smoking or as a valuable tool for smoking cessation altogether, e-cigarettes such as Blu and Juul can now be found just about everywhere, including high schools and college campuses.  And despite claims of being safer than traditional cigarettes, the core function of all of these devices still is to deliver nicotine, a dangerous and addictive chemical, either just as efficiently or more efficiently than combustible cigarettes.  Furthermore, the vapor produced by e-cigarettes typically contains aerosolized chemical flavoring additives; propylene glycol, and other contaminants; the potential effects of which on a developing teen’s lungs, heart and nervous system are only now being fully appreciated.  In fact, due to the growing number of claimed injuries stemming from vaping one e-cig brand in particular, lawsuits have now been filed alleging that these devices have been improperly and aggressively marketed to teenagers while simultaneously actively downplaying the risks associated with vaping.

What Are E-Cigarettes?

E-cigarettes are battery-powered devices that function by heating a liquid into an aerosol that can be inhaled then exhaled.  The liquid in e-cigarettes typically contains the following:

  • Nicotine
  • Propylene Glycol
  • Glycerin Flavorings
  • Other Chemicals

Research into e-cigarette aerosol vapor has shown that it frequently contains additional substances such as metals like lead and other cancer-inducing chemicals.  Beyond that, flavored e-cigarette products have been shown to contain chemicals such as diacetyl – which has been linked to lung disease.

E-cigarettes were first invented by the Chinese pharmacist – Hon Lik, who was issued a patent on the device in 2003.  Unlike traditional cigarettes which use flame combustion to burn a tobacco leaf and release tar-laden smoke with nicotine, the e-cigarette relies upon a lithium battery to heat a nicotine liquid into a vapor or mist that the user inhales.  Although the exact design specifications may differ among different e-cigarette brands, this lithium battery is typically connected to a vaporization chamber (essentially a hollow tube) that contains an “atomizer” which creates vapor.  Prior to activation of the battery and the chamber, the user will attach a “cartridge” containing liquid nicotine (among other various chemicals) and this cartridge will frequently serve as the mouthpiece from which to inhale as well.

Why Are E-Cigarettes So Popular?

E-cigarette manufacturers are often the first to tout their products as safer alternatives to combustible tobacco smoking and a resource in the effort to reduce overall tobacco use among adults through smoking cessation.  However, some of the highest rates of adoption and use of e-cigarettes are among high school students.  In fact, e-cigarettes are today the most common type of tobacco product used among U.S. middle and high school students in the United States – a population decidedly not among those demanding smoking cessation assistance.  

The U.S. Food and Drug Administration (FDA) and U.S. Centers for Disease Control and Prevention (CDC) studied self-reported reasons for the use of e-cigarettes among middle and high schools students and found that the most common reasons for choosing to start vaping involved:

  • A friend or family member uses e-cigarettes.
  • Availability of flavors such as mint, candy, fruit, or chocolate.
  • A belief that e-cigarettes are not harmful or less harmful.
  • Seeing famous celebrities using them.

The CDC estimates that up to 69% of middle and high school students are exposed to e-cigarette advertisements in retail stores, on the Internet, in magazines/newspapers or on TV and movies.  The e-cigarette manufacturer campaign for youth adoption doesn’t stop in middle and high school either.  Campaigns on college campuses nationwide, designed to convince students that e-cigarettes are a safer alternative than smoking tobacco cigarettes has resulted in a skyrocketing number of users – especially among students who had never actually smoked in the first place.

Real Risks from Exposure to E-Cigarettes

Because e-cigarettes do not combust tobacco like regular cigarettes, users frequently believe the claims that there are relatively few health risks associated with vaping.  However, in addition to nicotine and glycerin chemicals, e-cigarettes have been shown to emit:

  • Aerosolized particulates into the lungs
  • Diethylene glycol
  • Nitrosamines
  • 1,2-Propanediol
  • Acetic acid
  • Acetone
  • Isoprene
  • Formaldehyde
  • Acetaldehyde
  • Propaldehyde

Furthermore, some of the tested aerosols generated by e-cigarettes have been shown to contain metals and silica particles traced back to wick and heating coil constituents in the device itself.  Accordingly, the cancer risk associated with exposure to common ingredients found in e-cigarettes, combined with the known addictive properties of nicotine, which is toxic to developing fetuses and harmful to adolescent and young adult brain development, creates the potential for long term harm from continued exposure to vaping.

E-Cigarette Battery Explosions

If the risk from vaping exposure isn’t enough, the risk from vaping explosions adds an extra layer of potential danger to e-cigarettes.  Defective e-cigarette batteries have caused fires and explosions, some of which have resulted in serious injuries.  Most of these explosions occurred while e-cigarette batteries were being charged.

Health Effects Associated with E-Cigarettes

E-cigarettes have only been on the market in the United States for a fraction of the time that combustible tobacco cigarettes have.  With that in mind, the amount of comprehensive research available is still accumulating while doctors and scientists study e-cigarettes to understand more completely the effect they have on human health.  What they do understand thus far is the following:

E-Cigarettes Typically Contain Nicotine.

The health effects of exposure to highly-addictive nicotine are well-documented.  Short-term exposure to even low levels of nicotine has been shown to include tremors and an increase in the heart rate, respiratory rate, and blood pressure.  Ingestion and inhalation of nicotine can cause nausea, vomiting, abdominal pain, headache, dizziness, confusion, agitation, restlessness, and burning sensations in the mouth, throat, and stomach.  Additionally, nicotine is a teratogen – meaning it has the potential to promote the growth of tumors.

E-Cigarettes are Particularly Dangerous for Pregnant Mothers and Small Children.

Nicotine presents special risks for pregnant mothers. Prenatal exposure to even small amounts of nicotine can result in fetal brain cell damage and other neurological deficits in the fetus. Also, the nicotine laden “e-juice” in the cartridges associated with e-cigarettes contain concentrations of nicotine that are potentially lethal if ingested by a small child.

E-Cigarettes May Contain Other Harmful Substances.

E-Cigarettes with menthol or tobacco flavoring may contain other heavy metals or particles, such as lead, that can be inhaled deep into the lungs along with other cancer-causing chemicals.  Being near someone using an e-cigarette can expose even non-users to aerosolized vapors with these chemicals in them (similar to second-hand smoke).

Current Regulation of E-Cigarettes and FDA Ban on Flavoring:

In 2016, the FDA finalized a rule giving the Center for Tobacco Products (CTP) regulatory authority to cover all tobacco products – including those that the FDA defines as “Electronic Nicotine Delivery Systems” (ENDS). This rule allows the FDA to regulate the marketing, manufacture, importation, packaging, labeling, and sale of ENDS and its components. Typically regulated ENDS components are:

  • E-liquids and their glass/plastic vials
  • Cartridges
  • Atomizers
  • Certain batteries
  • Cartomizers and clearomizers
  • Digital displays or lights
  • Tank systems
  • Drip tips
  • Flavorings
  • Programmable software

Following further study and growing public concern about the impact of vaping on teenagers and young adults, in January 2020, the FDA finalized a rule banning the sale of flavored e-cigarette cartridges (except for menthol and tobacco).  Under the new policy, companies are required to cease the manufacture, sale, and distribution of unauthorized flavored cartridge-based ENDS products.  The banned flavor profiles include fruit, gum and mint flavors, among others, which particularly appealed to children and teens. 

What is JUUL and How Is It Different from Other E-Cigarettes?

Juul is a brand name for a particular type of e-cigarette that is very popular and accounts for about 40% of all e-cigarette sales in the market.  Juuls are shaped like USB flash drives and do not resemble traditional, more bulky e-cigarettes.  The cartridge packs that come with Juuls frequently contain more nicotine than actual combustible tobacco cigarettes.  Juul has become so popular that kids and teens refer to the practice of vaping with a Juul device as “juuling”.

Juul was established in 2015 as “Juul Labs, Inc.” by two entrepreneurs, Adam Bowen and James Monsees who developed the technology themselves.  Manufactured in China, Juul grew dramatically in the intervening years and in July 2018, raised $650 million giving the company a valuation of approximately $15 billion.  Later, global tobacco producer, Altria, purchased a 35% interest in Juul making the company worth an estimated $38 billion at the end of 2018.

Juul and Its Marketing Practices

Juul benefited substantially from marketing on social media platforms popular with teenagers and young adults, such as Instagram, spending over $2 million for online advertising in 2015 and 2016 alone.  This type of marketing, largely key to Juul’s success, was criticized for also targeting young customers with influencers and affiliate programs.  In January 2019, Juul announced a $10 million advertising campaign to rebrand Juul as a smoking cessation product targeted to adults.  However, following a warning from the FDA in September 2019, Juul announced that it would stop all marketing in the United States going forward. 

Government Investigations

In addition to the added scrutiny of the FDA, the U.S. Attorney for the Northern District of California announced a criminal investigation of Juul Labs on September 23, 2019.  This announcement was followed by a further announcement in February 2020 that 39 U.S. states are looking into the marketing and sales practices of Juul Labs as well as its products.

Lawsuits

In 2018, two lawsuits were filed in California alleging that Juul was inappropriately marketed as safe even though it contains more nicotine than a traditional cigarette.  Thus began a wave of civil lawsuits naming Juul which have now been consolidated into Multi-District Litigation (MDL) before the federal court in the Northern District of California.  As of this moment, MDL-2913 has approximately 651 cases pending and is growing.

Sources Cited:

1) “White Paper Summarizes New Research on Potential  Hazards of e-Cigarette Use” https://synergist.aiha.org/201905-white-paper-e-cigarette-use#:~:text=White%20Paper%20Summarizes%20New%20Research%20on%20Potential%20Hazards%20of%20e%2DCigarette%20Use&text=Last%20month%2C%20AIHA%20issued%20a,and%20emitted%20from%20e%2Dcigarettes.

2) “Electronic Cigarettes in the Indoor Environment” https://aiha-assets.sfo2.digitaloceanspaces.com/AIHA/resources/Electronic-Cigarettes-in-the-Indoor-Environment-White-Paper.pdf

3) “Backgrounder on WHO report on regulation of e-cigarettes and similar products” https://www.who.int/nmh/events/2014/backgrounder-e-cigarettes/en/

4) “About Electronic Cigarettes (E-Cigarettes)” https://www.cdc.gov/tobacco/basic_information/e-cigarettes/about-e-cigarettes.html

5) “E-cigarettes and National Adolescent Cigarette Use: 2004–2014” https://pediatrics.aappublications.org/content/139/2/e20162450

6) “Youth and Tobacco Use” https://www.cdc.gov/tobacco/data_statistics/fact_sheets/youth_data/tobacco_use/index.htm

7) “Think E-Cigs Can’t Harm Teens’ Health?” https://www.fda.gov/tobacco-products/public-health-education/think-e-cigs-cant-harm-teens-health

8) “E-CIGARETTES: FLAVORED PRODUCTS FUEL A YOUTH EPIDEMIC” https://www.tobaccofreekids.org/what-we-do/industry-watch/e-cigarettes

9) “Surgeon General’s Advisory on E-cigarette Use Among Youth” https://e-cigarettes.surgeongeneral.gov/documents/surgeon-generals-advisory-on-e-cigarette-use-among-youth-2018.pdf

10) “How Juul Hooked a Generation on Nicotine” https://www.nytimes.com/2019/11/23/health/juul-vaping-crisis.html

11) “E-Cigarette Vapor Linked to Cancer in Mice” https://www.nih.gov/news-events/nih-research-matters/e-cigarette-vapor-linked-cancer-mice

12) “The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon General.” https://www.ncbi.nlm.nih.gov/books/NBK294308/

13) “Juul Shipped At Least A Million Contaminated Pods, New Lawsuit Says” https://www.buzzfeednews.com/article/stephaniemlee/juul-lawsuit-contaminated-pods

14) “What We Know About Electronic Cigarettes” https://smokefree.gov/quit-smoking/ecigs-menthol-dip/ecigs#:~:text=E%2Dcigarettes%20are%20battery%2Dpowered,%2C%20flavorings%2C%20and%20other%20chemicals.

15) “NIH Drug Facts: Vaping Devices” https://www.drugabuse.gov/publications/drugfacts/vaping-devices-electronic-cigarettes

16) “How Electronic Cigarettes Work” https://science.howstuffworks.com/innovation/everyday-innovations/electronic-cigarette.htm

17) “The Three Main Reasons Youth Use E-Cigarettes” https://truthinitiative.org/research-resources/emerging-tobacco-products/3-main-reasons-youth-use-e-cigarettes

18) “FDA finalizes enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint” https://www.fda.gov/news-events/press-announcements/fda-finalizes-enforcement-policy-unauthorized-flavored-cartridge-based-e-cigarettes-appeal-children

19) “E-cigarette Ads and Youth” https://www.cdc.gov/vitalsigns/ecigarette-ads/index.html

20) “A closer look at vaping and e-cigarettes on college campuses” https://www.wildcat.arizona.edu/article/2019/11/n-vaping-health

21) “Did the FDA Ban E-Cig Flavors? Here’s What to Know” https://www.healthline.com/health-news/e-cig-flavor-ban-what-to-know

22) “Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) and Other Deemed Products on the Market Without Premarket Authorization” https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-priorities-electronic-nicotine-delivery-system-ends-and-other-deemed-products-market

23) “Are Vaping and Juuling the Same Thing?” https://www.therecoveryvillage.com/teen-addiction/faq/are-vaping-and-juuling-the-same/

24) “Juul is under criminal investigation by federal prosecutors” https://www.theverge.com/2019/9/23/20880625/juul-criminal-investigation-ftc-fda-federal-probe

25) “E-Cigarettes: Current Evidence and Policy” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6140188/

26) “Xu X, Bishop EE, Kennedy, et al. Annual Healthcare Spending Attributable to Cigarette Smoking. American Journal of Preventive Medicine. 2015;48(3):326–333” https://www.sciencedirect.com/science/article/abs/pii/S0749379714006163

27) “Electronic Cigarettes: A Policy Statement From the American Heart Association. Circulation.” https://www.ahajournals.org/doi/full/10.1161/CIR.0000000000000107

28) “E-cigarettes: How “safe” are they? The Journal of Family Practice” https://www.mdedge.com/clinicianreviews/article/109243/addiction-medicine/e-cigarettes-how-safe-are-they

29) “Four hundred and sixty brands of e-cigarettes and counting: implications for product regulation.” https://tobaccocontrol.bmj.com/content/23/suppl_3/iii3.short

30) “Progression of Poly-tobacco Product Use Patterns in Adolescents” https://www.sciencedirect.com/science/article/abs/pii/S0749379716300964

31) “U.S. Department of Health and Human Services . A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2016. E-Cigarette Use Among Youth and Young Adults.” https://books.google.com/books?hl=en&lr=&id=Oy95lDRWJPUC&oi=fnd&pg=PA1&ots=tIjXD2x-EO&sig=U3wfXsGKmGqL1zBCWxTY-5oOOtQ#v=onepage&q&f=false

31) “E-cigarettes: Who’s using them and why? The Journal of Family Practice” https://pdfs.semanticscholar.org/ad48/cf94cc48f44cdeeeeceaab3c7e542ef9283c.pdf

32) “Electronic Cigarettes Among Priority Populations.” https://www.sciencedirect.com/science/article/abs/pii/S0749379715003578

33) “Behavioral Counseling and Pharmacotherapy Interventions for Tobacco Cessation in Adults, Including Pregnant Women: A Review of Reviews for the US Preventive Services Task Force.” https://www.acpjournals.org/doi/full/10.7326/M15-0171

34) “A Longitudinal Analysis of Electronic Cigarette Use and Smoking Cessation.” https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/1846627

35) “Electronic cigarettes: human health effects.” https://tobaccocontrol.bmj.com/content/23/suppl_2/ii36.short

36) “Electronic Cigarettes: A Short Review. Respiration.” https://www.karger.com/Article/Abstract/353253

37) “Retail Sales of Tobacco Products” https://www.fda.gov/tobacco-products/compliance-enforcement-training/retail-sales-tobacco-products

38) Tobacco Control Legal Consortium, Public Health and Tobacco Policy Center . E-Cigarette Regulation: A 50 State Review, 2016” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5730213/

39) “158th Annual Convention, House of Delegates Votes on Resolutions” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6170109/

Frequently Asked Questions (FAQs)

Lawsuit Frequently Asked Questions (FAQ)
Frequently Asked Questions (FAQs) About Drug & Device Lawsuits & Settlements

Read below for some of the most commonly asked questions regarding drugs, medical devices and the lawsuits and settlements that, at times, accompany them, when things go wrong.

I have taken a dangerous drug or undergone a procedure with a dangerous medical device. Am I eligible to file a lawsuit?

Dangerous drugs and devices include, but are not limited to, those that cause injuries due to either or some combination of a: manufacturing defect, design defect, or a defect in their marketing (“failure to warn”).  If you have suffered an injury, that is – you have either taken a dangerous drug or used a dangerous medical device and experienced serious medical issues or physical harm, then you may be able to file a lawsuit to recover damages for medical expenses, pain and suffering and possibly more. Additionally, if you have lost a family member or loved one due to death or disability because of a dangerous drug or device, you may be able to file a lawsuit as well.

Legal actions that allege harm from dangerous drugs and medical devices are typically called “product liability lawsuits”.  Product liability lawsuits refer to the ability of the law to hold manufacturers or sellers liable for putting defective drugs and devices into the hands of patients and medical professionals.  In essence, this is where the law works to ensure that products meet the ordinary expectations of the consumer.  

Product liability lawsuits fall into three categories:

Manufacturing Defect
A product defect that occurs in the manufacturing process and which causes the product not to meet specifications set by the manufacturer itself.  Manufacturing defect claims usually involve a single product unit or device (as opposed to an entire product line).  Manufacturers are usually held to the standard of “strict liability” for these types of defects.

Design Defect
A design defect is a mistake in a product’s intended design that causes injuries to a consumer; and which could have been prevented by an alternate design.  Unlike manufacturing defects, design defects address multiple product units across an entire line or family of products.

Marketing Defect (“Failure-to-Warn”)
Marketing or “Failure-to-Warn” defects are the result of when a drug or device manufacturer fails to provide appropriate information about a product’s known hazards and how to avoid them.  If these hazards pose an undue risk of harm to consumers, the manufacturers can be held liable for that harm.

Are drug manufacturers potentially liable for the side effects caused by the products?

Most, if not all, medications have some sort of potential side effects.  Sometimes side effects are less severe: insomnia; dry mouth; or drowsiness, for example.  Other times, side effects can be serious and life-threatening.  Either way, you – the consumer is entitled to know, in advance what the potential risks of taking any medication or using any medical device are.  With that knowledge, consumers can make a judgment as to whether the risks of these side effects balance out the benefits they offer.  However, if a drug or device manufacturer is aware of a side effect or defect and chooses not to disclose that side effect while the consumer is using that drug or device, the manufacturer could potentially be held liable for not sharing that information with the consumer beforehand.

Who can sue for harm from dangerous drugs and devices?

If you:

  • Personally, have been injured by a dangerous drug or Medicaid device; or
  • Are the legal guardian of someone injured by a dangerous drug or medical device; or
  • You are the representative of the estate of someone who has died from a dangerous drug or medical device;

You potentially have the “standing” to bring a lawsuit for damages if that lawsuit alleges one of the three product liability claims discussed above.

Who is on the other side of the lawsuit?

Patients, consumers and other parties who have suffered harmful side effects or other injuries from dangerous drugs and devices, and can prove they are consumers of these products, may be able to sue the drug or device manufacturer under theories which allege either manufacturing defects, design defects or marketing defects. This is true for both non-generic prescription and over-the-counter dangerous drugs which have been approved by the FDA.

When should I file a lawsuit?

There are limits on the timeframe for when injured parties can file a lawsuit alleging product liability and they vary by state.  Known as “Statutes of Limitation” or “Statutes of Repose”, they require injured parties to file claims within a specified period of time either after they have been injured or the injury is discovered or when they should have known about or discovered their injury.  

The time limits for filing a lawsuit can be as narrow as two years in some states to as broad as four years or more in others.  It is important to know what the statute of limitations or repose is in your state before filing a lawsuit.  If an injured party does not file a lawsuit before the statute expires, the Court can throw out the case despite how meritorious the claims are within.

Click here for an up-to-date list of Statutes of Limitation and Repose by state.

Should I hire a lawyer to file a lawsuit?

Generally speaking, the legal system and courts of the United States do not bar non-attorneys from representing themselves in lawsuits. With that in mind, lawsuits concerning serious injuries and in particular, products liability lawsuits, involve complex procedural rules, briefings, motions, arguments, and rules concerning the collection and introduction of evidence. Additionally, it helps to have a skilled negotiator with you during encounters with opposing counsel for the manufacturer. And you can be assured – they will have a team of highly compensated professionals on their side. Therefore, it is generally always a good idea to hire an experienced legal professional to handle your case and advise you about your options.

Which lawyer should I choose?

The selection of a lawyer to represent your interests is a profoundly personal choice and one which should be guided principally by your level of comfort and trust in his or her abilities to effectively pursue your case and achieve a favorable outcome. With that in mind, you should, at a minimum, hire counsel with experience in product liability and who has experience litigating these types of cases before the court. Furthermore, most attorneys in the field of product liability law will always offer a free initial consultation to any potential client with whom they are meeting to discuss a case.

How much will it cost to hire a lawyer?

In the field of products liability, attorneys will almost exclusively handle cases on a “contingency” fee basis. This means that you will not be expected to pay an up-front retainer, hourly legal fees, or the expenses associated with litigation. The attorney’s fees and expenses are paid as a percentage of your recovery (typically 30-40% depending upon the state where the attorney is licensed and the amount recovered) either as a result of litigation or settlement between the parties. In some cases where your lawsuit is part of a larger “class action” or “multi-district litigation”, the Court will set the rate of contingent fees.

What happens if I lose my case?

Generally speaking, if you lose your case and you have a contingency fee agreement with your lawyer, you will not be on the hook for any additional expenses or the other party’s attorneys fees. However, there are unique rules concerning these provisions in each state. Be sure to ask your attorney about them before signing an agreement for representation.

What damages can I seek for harm from a dangerous drug or device?

The level and types of damages that a consumer who has suffered harmful side effects can seek vary largely by the factual circumstances of each case. You will want to talk about these facts in great detail with your attorney. Bearing that in mind, sufferers may be entitled to: compensatory/economic damages; non-economic damages; and possibly punitive damages.  

These are more commonly framed as:

  • Medical Costs
  • Lost Wages
  • Non-Medical Expenses
  • Pain and Suffering

Punitive damages are those which are awarded by the Court for harm suffered as the result of intentional (i.e. more than negligent) conduct on the part of a drug or device manufacturer.  They are intended to “punish” the malfeasance of the manufacturer inasmuch as they compensate the victim.

What must I prove in my lawsuit?

At the core of every products liability and dangerous drug/device case, the party seeking compensation for harm must, at a minimum, prove:

  • That they have suffered injury or harm;
  • That the drug or device is defective by virtue of a:
    • Manufacturing Defect
    • Design Defect
    • Failure-to-Warn (Marketing Defect)
  • That the defect caused the injury or harm suffered;
  • That you were using the product as it was intended.

These are all questions that turn on the facts of your particular case and which must be discussed in detail with your attorney when evaluating the potential for a lawsuit.

Will I be expected to testify?

For the most part, individual lawsuits for harm from dangerous drugs and devices tend to settle before they ever reach a courtroom.  However, if your case does go to trial, you will likely be expected to testify in order to advance your case. Again, there are a great many other facts and circumstances to consider before your case ever reaches the courtroom. You should take the opportunity at the outset to discuss the possibility of your being called to testify with your attorney against the backdrop of the specific facts involved in your case.

When will I receive compensation?

There is no hard and fast rule as to how quickly your case will be resolved, and no guarantee whatsoever that it will be resolved in your favor.  Whether your case is filed as an individual lawsuit, class action, or MDL, depending upon when it is filed and the factual circumstances of your case, it could take weeks or even years before a harmed party receives payment. 

Typically lawsuits conclude in either one of two ways:

  • Judgment: The harmed party and the manufacturer present their cases in court, either before a judge or a jury and a verdict is reached.  If the verdict is in favor of the harmed party, then the judge or the jury will set a damage award.  The losing party may still yet appeal the case or the damage award, which could further prolong the time any amounts are paid to the harmed party.
  • Settlement: The parties to a lawsuit may meet prior to heading into the courtroom and reach an agreement on an amount to be paid to the harmed party instead of going through the rigors of either a bench or jury trial.  The timeframe for payment of the settlement amount will depend upon the agreement of the parties, as well as the rules of the court where the lawsuit was filed.

Sources Cited:

1) “Civil Statutes of Limitation” https://www.nolo.com/legal-encyclopedia/statute-of-limitations-state-laws-chart-29941.html

2) “Time Limits for Filing Product Liability Cases: State-by-State” https://injury.findlaw.com/product-liability/time-limits-for-filing-product-liability-cases-state-by-state.html

3) “Time Limits for Filing a Defective Product Liability Claim” https://www.nolo.com/legal-encyclopedia/time-limits-filing-product-liability-claim-29558.html

4) “What is Product Liability” https://injury.findlaw.com/product-liability/what-is-product-liability.html

5) “Multidistrict Litigation: New Forms of Judicial Administration” https://books.google.com/books?id=VRNHW_o2trgC&pg=PA737#v=onepage&q&f=false

6) “When Can Patients Sue Drug Companies?” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2697102/

7) “FDA Device Regulation” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6140070/

8) “Products Liability: Major Treatises by Topic” https://lawresearchguides.cwru.edu/majortreatises/productsliability

9) “Products Liability in the United States” file:///Users/AsherLaw/Downloads/Product%20Liability%20in%20the%20United%20States%20Issues%20for%20Dutch%20Companies.pdf

10) “Owens and Davis on Products Liability” http://umil.iii.com/record=b2012693

Cook Medical

Executive Summary

Cook Medical is a subsidiary division of the Cook Group Incorporated, a privately-held company headquartered in Bloomington, Indiana.  The Cook Group is involved in the manufacture of medical devices, building materials, and plastic packaging/containers.  In recent years, Cook Medical has been the focus of lawsuits over defects involving its line of Inferior Vena Cava (IVC) filter products, its transvaginal meshes, and a voluntary recall of its CrossCath support catheters in 2019.  The Cook Group has more than 12,000 employees and revenue of over $2 billion.  In 2008, Forbes magazine ranked the Cook Group as #324 on its list of “America’s Largest Private Companies”.

History

Cook Medical began as Cook Incorporated in 1963 when founder Bill Cook and his wife began manufacturing catheters in their spare bedroom with lengths of plastic tubing and a blow torch.  The company would grow from there and specialize in the manufacture and sale of catheters, needles, and wire guides for minimally invasive procedures in patients that are considered too high risk for surgery.  In the 1970s, the company rapidly expanded to Europe and Asia and shipped enough products to allow doctors to perform 2,000 cardiovascular catheterizations a day.  In the 1990s, Cook Medical introduced the world’s first intravascular coronary stent and began work on treatments for chronic disease management.

Lawsuits

IVC Filter Products

IVC Filters are miniature devices implanted in veins that supply blood running from the leg to the heart.  They are designed to catch and filter blood clots before they reach the heart or lungs causing sudden illness or death.  Along with Bard and Johnson & Johnson, Cook Medical was one of the three largest manufacturers of IVC Filters worldwide.  In recent years, it has emerged that some IVC filters, and in particular, some manufactured by Cook, are implicated inpatient complications as well as some deaths due to dislodgement in the vein or perforation of the vein itself.

Known primarily for three types of IVC filter products:

  • Celect Platinum Vena Cava Filter
  • Gunther Tulip Vena Cava Filter
  • Bird’s Nest Vena Cava Filter

Today, there are thousands of pending IVC lawsuits naming Cook Medical as a defendant which have been consolidated into Multi-District Litigation (MDL) in federal court for the Southern District of Indiana. In February 2019, a bellwether jury trial found Cook Medical liable for a patient’s suffering following the fracture of her Cook IVC filter and ordered the company to pay $3 million in damages. Cook appealed that verdict and in January 2020, a judge vacated the jury verdict and granted the parties a new trial.

Recalls

CloverSnare 4-Loop Vascular Retrieval Snare (2014)

Cook voluntarily recalled 696 of its CloverSnare 4-Loop Vascular Retrieval Snare devices because of a potential for the loop to separate from the shaft.  This separation causes the tip of the device to travel through the patient’s vascular system elevating the potential for embolism unless the patient undergoes a follow-up surgical procedure for removal.

Single Lumen Central Venous Catheters and Pressure Monitoring Sets and Trays (2016)

Cook voluntarily recalled 17,827 of its Single Lumen Central Venous Catheters and Pressure Monitoring Sets and Trays due to the potential for catheter tip fracture or separation.  The risk to the patient following separation or fracture involved potential vascular blockage and the necessity for a follow-up procedure to remove the fragment.

Beacon Tip Technology (2016)

Cook voluntarily recalled all of its catheters utilizing Beacon Tip technology due to complaints of tip splitting and fracture.

Roadrunner UniGlide Hydrophilic Wire Guides (2016)

DSM Biomedical B.V. in the Netherlands, Cook Medical’s supplier of hydrophilic coating for the Roadrunner UniGlide Hydrophilic Wire Guide product recalled 8,750 units due to concerns about possible glass particle contamination during the manufacturing process.

CrossCath Support Catheters (2019) 

CrossCath Support Catheters are designed to support a wire guide during access to blood vessels, allow for the exchange of wire guides, and provide a pathway for the delivery of saline solutions or diagnostic contrast agents.  Cook Medical agreed to a voluntary Class I (the most severe) recall after identifying an error during manufacturing which may cause marker bands to be too loose and possibly dislodge in patients.

Sources Cited:

1) “How Cook Medical Got Its Start” https://www.cookmedical.com/about/history/

2) “Cook Pharmica Sold To Catalent For $950M, Cook Group Buys GE Plant” https://indianapublicmedia.org/news/cook-pharmica-sold-catalent-950-million-127683.php

3) “Cook Medical Recalls CrossCath® Support Catheters Due to a Manufacturing Error Which May Cause the Marker Bands to Dislodge or Cause Buckling” https://www.fda.gov/medical-devices/medical-device-recalls/cook-medical-recalls-crosscathr-support-catheters-due-manufacturing-error-which-may-cause-marker#:~:text=Medical%20Device%20Recalls-,Cook%20Medical%20Recalls%20CrossCath%C2%AE%20Support%20Catheters%20Due%20to%20a,to%20Dislodge%20or%20Cause%20Buckling&text=The%20FDA%20has%20identified%20this,cause%20serious%20injuries%20or%20death

4) “Federal court vacates judgment in IVC filter litigation case, Cook Medical continues fight for physician access to life-saving filter technology” https://www.cookmedical.com/newsroom/federal-court-vacates-judgment-ivc-filter-litigation-case/

5) “Court Grants New Trial In Cook Medical Lawsuit” https://indianapublicmedia.org/news/court-grants-new-trial-in-cook-medical-lawsuit.php

6) “Bill Cook, Medical Device Maker” https://www.nytimes.com/2011/04/26/business/26cook.html

7) “Bloomington’s Med-Tech Industry Is A Lifesaver” https://www.fastcompany.com/1836156/bloomingtons-med-tech-industry-lifesaver

8) “CloverSnare™ 4-Loop Vascular Retrieval Snare Recall” https://www.cookmedical.com/newsroom/cloversnare-4-loop-vascular-retrieval-snare-recall-2/

9) “Cook Medical issues fourth recall in 18 months” https://www.ibj.com/blogs/the-dose/57229-cook-medical-battling-quality-issues-issues-another-recall

10) “Cook deluged by product lawsuits” https://www.ibj.com/articles/53869-cook-deluged-by-product-lawsuits

11) “Cook Medical issues global recall of select lots of Central Venous Catheters and Pressure Monitoring Sets and Trays” https://www.cookmedical.com/newsroom/cook-medical-issues-global-recall-of-select-lots-of-central-venous-catheters-and-pressure-monitoring-sets-and-trays/

12) “Cook Medical issues global voluntary recall of catheters with Beacon Tip technology” https://www.cookmedical.com/newsroom/cook-medical-issues-global-voluntary-recall-of-catheters-with-beacon-tip-technology/#:~:text=May%202nd%2C%202016-,Cook%20Medical%20issues%20global%20voluntary%20recall%20of%20catheters%20with%20Beacon,with%20Beacon%C2%AE%20Tip%20technology.&text=The%20catheters%20were%20recalled%20on,tip%20splitting%20and%2For%20fracture

13) “Cook Medical Issues Global Recall of Roadrunner® UniGlide® Hydrophilic Wire Guides due to raw materials issue” https://www.cookmedical.com/newsroom/cook-medical-issues-global-recall-of-roadrunner-uniglide-hydrophilic-wire-guides-due-to-raw-materials-issue/

White House Meeting With Top Pharmaceutical Executives Is Off

Top pharmaceutical executives planned to meet with the president on Tuesday.

“A White House meeting with top pharmaceutical executives that President Donald Trump promised for Tuesday is off, five industry sources familiar with discussions told POLITICO. Three said the drug-pricing discussion was canceled because the major drug lobbies, reeling from Friday’s cluster of executive orders on the topic, refused to send any members.

Drugmakers and Trump were slated to discuss an executive order, signed Friday but not yet released, that would order health officials to release a plan linking Medicare payments for certain medicines to lower costs paid abroad. The provision, known as a most-favored-nations rule, has been lambasted by the drug industry and some patient groups that say it would curb innovation and reduce drug access.

Trump said Friday that drugmakers would have a month to present a better option to the rule.

The drug lobbies PhRMA and BIO were reluctant to send representatives from their member companies — many of them multibillion-dollar manufacturers of the world’s best-selling medicines and vaccines — after conflicting reports last week about whether the White House would include the rule and little information to date about what the new rule would look like, three people familiar with the discussions said.

To read the full article, please visit Politico.

FDA’s Woodcock Discusses Operation Warp Speed

Operation Warp Speed (OWS)

Food and Drug Administration (FDA) Centers for Drug Evaluation and Research Director Janet Woodcock discussed Operation Warp Speed (OWS).

 

Therapeutics Development

Woodcock, who recused herself from FDA’s approval decision, is leading OWS’s effort on therapeutics development. Woodcock said, “Even with success, some people will not respond to vaccines, and some people will not get vaccinated. So, therapeutics will always be needed.” There is hope convalescent plasma could lessen the severity of a COVID-19 infection, but it is still unclear if the therapy works. She noted the limited window to retrieve plasma from recovered COVID-19 patients.

Antibody Development Programs + Protocols

Around 50 monoclonal antibody development programs are currently active. The Biomedical Advanced Research and Development Authority sponsored an antibody treatment developed by Regeneron, which is now in Phase II trials. An Eli Lilly antibody treatment is in a Phase I trial. Officials hope uniform clinical trial designs or “master protocols” will make expectations of drug manufacturers clear, make it easier to compare the safety and efficacy of different treatments and speed the development process.

OWS and the National Institutes of Health developed two master protocols for COVID-19 monoclonal antibody clinical trials. One will test the use of monoclonal antibodies in the outpatient setting, and another is for inpatient use. They are scheduled to start testing this month.

Stay tuned for additional details, and in the meantime …

Dexamethasone Shows Promise for COVID-19 Patients

In June, Oxford University researchers announced preliminary clinical trial results that showed the low-dose steroid dexamethasone appeared to lower the risk of death in COVID-19 patients. Further details of the study were not revealed with the announcement.

Dexamethasone has been effective in treating inflammation related to arthritis, asthma, and similar conditions. With this thought in mind, the clinical trial team wanted to test the drug’s effectiveness in treating lung inflammation in high-risk, hospitalized COVID-19 patients. For the clinical trial participants, it cut the risk of death by a third for patients on ventilators and by a fifth for patients on oxygen. Had the drug been used in the United Kingdom from the start of the outbreak, up to 5,000 lives could have been saved.

Additionally, the adoption of dexamethasone may be a major breakthrough for COVID-19 patients in poorer countries, as it only costs six dollars per patient. It’s also widely available: the United Kingdom currently has 200,000 courses available — enough to handle a potential second wave and spike in hospital admittance.

However, Dr. Kirsten Lyke , an infectious disease specialist at the University of Maryland School of Medicine, believes that we should “be extremely cautious” when using treatments that have not completed a full-scale vetting process. Given the urgency in finding treatment options for COVID-19, “people want to get results out quickly,” she explains. “But at the same time, if things are released too early or there’s harm that occurs from the intervention, that really erodes public trust.”

Read more about Covid-19 and your health, here >

Legal Relief & Compensation for Drug and Medical Device Injuries

It is important for consumers to know that they have options if they have been injured by a drug or medical device. Throughout the United States, consumers have rights under product liability laws that enable them to seek legal remedies against negligent manufacturers of pharmaceuticals and medical devices. However, the first step toward compensation for injuries suffered may involve filing a lawsuit or other legal action in a court of law.

What is the Process for Seeking Compensation?

Liability for harm caused by a manufacturer’s pharmaceutical and medical device has its roots in the laws of each state.  Typically, this requires a plaintiff (the consumer) to bring a defective product claim for damages against a manufacturer for injuries sustained while using the drug or device.  The normal range of damages available for these claims are:

  • Recovery of Medical Expenses
  • Disability
  • Pain and Suffering
  • Lost Earnings and Earning Capacity
  • Property Damage
  • Emotional Harm

Within the realm of drug and medical device litigation, there are general three types of civil claims that can be pursued against manufacturers:

Manufacturing Defect

A manufacturing defect occurs during the manufacturing process and causes the drug or device to fail to meet the design specifications established by the manufacturer itself.  This defect in turn causes an injury to the consumer (or even third party).  This type of claim only involves contesting the manufacturing quality of single unit of a drug or device, as opposed to the entire product line.  These types of cases hold the manufacturer to a standard of “strict liability” to the injured party.

Design Defect

A design defect is a mistake in the drug or device’s intended design that caused injuries to the consumer which could have been prevented by an alternative design.  Unlike manufacturing defect claims, a design defect claim examines the safety of an entire family of pharmaceuticals or medical devices.

Warning Defects

Warning Defects, also known as “Failure to Warn” or “Marketing Defects” are the result of when a drug or device manufacturer fails to provide appropriate information about a product’s known hazards and how to avoid them, and these hazards represent an undue risk of harm to consumers.

Engaging Counsel and Filing a Lawsuit

Legal Relief & Compensation

With all of this in mind, if a consumer believes that she has been injured through the negligence of a drug or device manufacturer, then the first step toward receiving compensation through our legal system is to file a lawsuit in court. Although consumers can always represent themselves in civil lawsuits, given the case management complexities involved in this type of litigation, it is generally recommended that consumers seek the assistance of counsel with expertise in this field to file their lawsuit and guide their case. Furthermore, consumers should remember that the drug and device manufacturers will undoubtedly have their own counsel representing them at all stages of your case backed by billions of dollars in insurance coverage.

A qualified attorney can also advise injured consumers about important pre-requisites to filing lawsuits. Perhaps most significantly, there are time limits on an injured party’s ability to file a lawsuit. These limits, known as “Statutes of Limitation” can preclude a potential plaintiff from their day in court if a lawsuit is not initiated within a window of time following injury. These limits vary from state to state, but are nonetheless important to any case an injured consumer might contemplate.

What Will Hiring a Lawyer Cost?

Typically in cases involving drug and device manufacturer liability, lawyers representing injured consumers (plaintiffs) will not charge an up-front fee or hourly fees. They will operate under “contingency fee agreements” which entitles them to a portion of the plaintiff’s recovery for their fees and expenses. Put simply, the attorney only gets paid if you do.

In addition to alleviating the obstacles associated with the expense of upfront retainers and hourly rates, contingency fees give consumers the added reassurance that their attorneys are just as motivated to win cases and recover the highest amount possible for their clients.

What is Multi-District Litigation?

Through your own research or encounters with legal professionals, you may have heard about “Multi-District Litigation” or MDL as it concerns cases involving drug and device manufacturers. MDL is a procedure used to consolidate and/or coordinate lawsuits which are pending before various district federal courts (in this case, manufacturing defect lawsuits). Cases are considered ideal for MDL when there are numerous cases with common questions of fact pending. 

A seven-member panel of judges selected by the Chief Justice of the U.S. Supreme Court, known as the “Panel on Multi-district Litigation” reviews cases for selection to MDL status, determines if they are eligible for MDL, and then selects a “transferee court” in which to host or consolidate the cases. Thereafter a single judge will oversee all of the MDL cases. If a drug and device manufacturer decides to settle a case once it has reached MDL status, plaintiffs may participate in the settlement  or elect to proceed with their own case to trial.

What is a Class Action?

Similar to, but not exactly like MDL, the rules governing civil procedure in federal courts allow cases, with similar legal and factual circumstances to to be “certified” as a “class” and heard together. Some of the most famous cases to be certified as a class action lawsuit involve:

  • Asbestos
  • Agent Orange
  • The Dalkon Shield IUD

Although class actions were popular tools for attorneys in the past, their popularity has waned in recent years for two main reasons: 1) the increasing difficulty with respect to the ability to get a case certified  in district courts; and 2) the blanket settlement policy in class actions that requires all class members to accept the same settlement amount regardless of the severity of injury.  For these reasons, product liability lawyers generally tend to prefer individual lawsuits that may evolve to MDL as opposed to seeking outright certification as a class.


Sources Cited (11)

1. “Products Liability: A Legal Overview”, Congressional Research Service, January 28, 2014. https://www.everycrsreport.com/files/20140128_R40148_73b84d8c0b03e61b9c2d64dedac6f8b44742acc5.pdf

2. Prosser, Handbook of Law of Torts, 143 (4th Ed. 1971). https://digitalcommons.law.lsu.edu/cgi/viewcontent.cgi?article=1889&context=lalrev

3. “The Road to Federal Product Liability Reform”, Victor E. Schwartz & Mark A. Behrens, 55 Md. L. Rev. 1363 (1996). https://digitalcommons.law.umaryland.edu/mlr/vol55/iss4/11/

4. “Enhancing Drug Effectiveness and Efficacy Through Personal Injury Litigation”, Anita Bernstein, Emory Public Law Research Paper No. 07-13; Emory Law and Economics Research Paper No. 07-12 (2007). https://papers.ssrn.com/sol3/papers.cfm?abstract_id=990431

5. “FDA Device Regulation”, Madelyn Lauer, MD; Jordan Barker, MD; Mitchell Solano, BA; Jonathan Dubin, MD; Mo. Med. 2017 Jul-Aug; 114. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6140070/

6. “Multidistrict Litigation: New Forms of Judicial Administration”, Colvin Peterson and John T. McDermott; ABA Journal, August 1970. https://books.google.com/books?id=VRNHW_o2trgC&pg=PA737#v=onepage&q&f=false

7. “The Long Arm of Multidistrict Litigation”, Andrew Bradt, William & Mary Law Review Vol. 59 (2018). https://scholarship.law.berkeley.edu/cgi/viewcontent.cgi?article=3797&context=facpubs

8. “When Can Patients Sue Drug Companies?”, Robert I. Field, PhD, JD, MPH; Pharmacy and Therapeutics, May 2009. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2697102/

9. “Is Multidistrict Litigation a Just and Efficient Consolidation Technique?  Using Diet Drug Litigation as a Model to Answer This Question”, Danielle Oakley, Nevada Law Journal 2005/2006. https://scholars.law.unlv.edu/cgi/viewcontent.cgi?article=1370&context=nlj

10. “The Decline of Class Actions”, Robert H. Klonoff, Washington University Law Review, Volume 90, Issue 3 (2013). https://openscholarship.wustl.edu/cgi/viewcontent.cgi?referer=&httpsredir=1&article=6004&context=law_lawreview

11. “Report to Congress: Medicare and the Health Care Delivery System – An Overview of the Medical Device Industry”, MedPAC June 2017. http://www.medpac.gov/docs/default-source/reports/jun17_ch7.pdf?sfvrsn=0

Frequently Asked Questions (FAQs)

Read below for some of the most commonly asked questions regarding drugs, medical devices, and the lawsuits and settlements that, at times, accompany them, when things go wrong.

I have taken a dangerous drug or undergone a procedure with a dangerous medical device. Am I eligible to file a lawsuit?

Dangerous drugs and devices include, but are not limited to, those that cause injuries due to either or some combination of a: manufacturing defect, design defect, or a defect in their marketing (“failure to warn”).  If you have suffered an injury, that is – you have either taken a dangerous drug or used a dangerous medical device and experienced serious medical issues or physical harm, then you may be able to file a lawsuit to recover damages for medical expenses, pain, and suffering and possibly more. Additionally, if you have lost a family member or loved one due to death or disability because of a dangerous drug or device, you may be able to file a lawsuit as well.

Legal actions that allege harm from dangerous drugs and medical devices are typically called “product liability lawsuits”. Product liability lawsuits refer to the ability of the law to hold manufacturers or sellers liable for putting defective drugs and devices into the hands of patients and medical professionals. In essence, this is where the law works to ensure that products meet the ordinary expectations of the consumer.  

Product liability lawsuits fall into three categories:

Manufacturing Defect
A product defect that occurs in the manufacturing process and which causes the product not to meet specifications set by the manufacturer itself.  Manufacturing defect claims usually involve a single product unit or device (as opposed to an entire product line). Manufacturers are usually held to the standard of “strict liability” for these types of defects.

Design Defect
A design defect is a mistake in a product’s intended design that causes injuries to a consumer; and which could have been prevented by an alternate design. Unlike manufacturing defects, design defects address multiple product units across an entire line or family of products.

Marketing Defect (“Failure-to-Warn”)
Marketing or “Failure-to-Warn” defects are the result of when a drug or device manufacturer fails to provide appropriate information about a product’s known hazards and how to avoid them. If these hazards pose an undue risk of harm to consumers, the manufacturers can be held liable for that harm.

Are drug manufacturers potentially liable for the side effects caused by the products?

Most, if not all, medications have some sort of potential side effects.  Sometimes side effects are less severe: insomnia; dry mouth; or drowsiness, for example. Other times, side effects can be serious and life-threatening.  Either way, you – the consumer is entitled to know, in advance what the potential risks of taking any medication or using any medical device are.  With that knowledge, consumers can make a judgment as to whether the risks of these side effects balance out the benefits they offer. However, if a drug or device manufacturer is aware of a side effect or defect and chooses not to disclose that side effect while the consumer is using that drug or device, the manufacturer could potentially be held liable for not sharing that information with the consumer beforehand.

When should I file a lawsuit?

There are limits on the timeframe for when injured parties can file a lawsuit alleging product liability and they vary by state.  Known as “Statutes of Limitation” or “Statutes of Repose”, they require injured parties to file claims within a specified period of time either after they have been injured or the injury is discovered or when they should have known about or discovered their injury.  

The time limits for filing a lawsuit can be as narrow as two years in some states to as broad as four years or more in others.  It is important to know what the statute of limitation or repose is in your state before filing a lawsuit.  If an injured party does not file a lawsuit before the statute expires, the Court can throw out the case despite how meritorious the claims are within.

Click here for an up-to-date list of Statutes of Limitation and Repose by state.

Who can sue for harm from dangerous drugs and devices?

If you:

  • Personally, have been injured by a dangerous drug or Medicaid device
  • Are the legal guardian of someone injured by a dangerous drug or medical device
  • You are the representative of the estate of someone who has died from a dangerous drug or medical device;

You potentially have the “standing” to bring a lawsuit for damages if that lawsuit alleges one of the three product liability claims discussed above.

Should I hire a lawyer to file a lawsuit?

Generally speaking, the legal system and courts of the United States do not bar non-attorneys from representing themselves in lawsuits. With that in mind, lawsuits concerning serious injuries  and in particular, products liability lawsuits, involve complex procedural rules, briefings, motions, arguments and rules concerning the collection and introduction of evidence. Additionally, it helps to have a skilled negotiator with you during encounters with opposing counsel for the manufacturer. And you can be assured – they will have a team of highly compensated professionals on their side. Therefore, it is generally always a good idea to hire an experienced legal professional to handle your case and advise you about your options.

Which lawyer should I choose?

Selection of a lawyer to represent your interests is a profoundly personal choice and one which should be guided principally by your level of comfort and trust in his or her abilities to effectively pursue your case and achieve a favorable outcome. With that in mind, you should, at a minimum, hire counsel with experience in product liability and who has experience litigating these types of cases before the court. Furthermore, most attorneys in the field of products liability law will always offer a free initial consultation to any potential client with whom they are meeting to discuss a case.

How much will it cost to hire a lawyer?

In the field of products liability, attorneys will almost exclusively handle cases on a “contingency” fee basis. This means that you will not be expected to pay an up-front retainer, hourly legal fees or the expenses associated with litigation. The attorney’s fees and expenses are paid as a percentage of your recovery (typically 30-40% depending upon the state where the attorney is licensed and the amount recovered) either as a result of litigation or settlement between the parties. In some cases where your lawsuit is part of a larger “class action” or “multi-district litigation”, the Court will set the rate of contingent fees.

What happens if I lose my case?

Generally speaking, if you lose your case and you have a contingency fee agreement with your lawyer, you will not be on the hook for any additional expenses or the other party’s attorneys fees. However, there are unique rules concerning these provisions in each state. Be sure to ask your attorney about them before signing an agreement for representation.

What damages can I seek for harm from a dangerous drug or device?

The level and types of damages that a consumer who has suffered harmful side effects can seek vary largely by the factual circumstances of each case. You will want to talk about these facts in great detail with your attorney. Bearing that in mind, sufferers may be entitled to: compensatory/economic damages; non-economic damages; and possibly punitive damages.  

These are more commonly framed as:

  • Medical Costs
  • Lost Wages
  • Non-Medical Expenses
  • Pain and Suffering

Punitive damages are those which are awarded by the Court for harm suffered as the result of intentional (i.e. more than negligent) conduct on the part of a drug or device manufacturer. They are intended to “punish” the malfeasance of the manufacturer inasmuch as they compensate the victim.

When will I receive payment?

There is no hard and fast rule as to how quickly your case will be resolved, and no guarantee whatsoever that it will be resolved in your favor. Whether your case is filed as an individual lawsuit, class action, or MDL, depending upon when it is filed and the factual circumstances of your case, it could take weeks or even years before a harmed party receives payment. 

Typically lawsuits conclude in either one of two ways:

  • Judgment: The harmed party and the manufacturer present their cases in court, either before a judge or a jury and a verdict is reached. If the verdict is in favor of the harmed party, then the judge or the jury will set a damage award. The losing party may still yet appeal the case or the damage award, which could further prolong the time any amounts are paid to the harmed party.
  • Settlement: The parties to a lawsuit may meet prior to heading into the courtroom and reach an agreement on an amount to be paid to the harmed party instead of going through the rigors of either a bench or jury trial. The timeframe for payment of the settlement amount will depend upon the agreement of the parties, as well as the rules of the court where the lawsuit was filed

Sources Cited

1) “Civil Statutes of Limitation” https://www.nolo.com/legal-encyclopedia/statute-of-limitations-state-laws-chart-29941.html

2) “Time Limits for Filing Product Liability Cases: State-by-State” https://injury.findlaw.com/product-liability/time-limits-for-filing-product-liability-cases-state-by-state.html

3) “Time Limits for Filing a Defective Product Liability Claim” https://www.nolo.com/legal-encyclopedia/time-limits-filing-product-liability-claim-29558.html

4) “What is Product Liability” https://injury.findlaw.com/product-liability/what-is-product-liability.html

5) “Multidistrict Litigation: New Forms of Judicial Administration” https://books.google.com/books?id=VRNHW_o2trgC&pg=PA737#v=onepage&q&f=false

6) “When Can Patients Sue Drug Companies?” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2697102/

7) “FDA Device Regulation” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6140070/

8) “Products Liability: Major Treatises by Topic” https://lawresearchguides.cwru.edu/majortreatises/productsliability

9) “Products Liability in the United States” file:///Users/AsherLaw/Downloads/Product%20Liability%20in%20the%20United%20States%20Issues%20for%20Dutch%20Companies.pdf

10) “Owens and Davis on Products Liability” http://umil.iii.com/record=b2012693

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It is important for those who have suffered injury from dangerous drugs and medical devices to know that they have may have options.

Consumers have the ability to seek legal remedies for their injuries resulting from the negligence of drug and device manufacturers. The first step toward justice and recovery is sharing your story with effective legal counsel. An attorney will help you to better understand the issues and discuss the possibility of compensation for your suffering.

Once you complete the information request above, Drug Law Journal will send the information to a specialist at our legal sponsor’s firm, the DDP Injury Law Group, in Washington, D.C. That specialist will follow-up with you directly to gather further specific information about your case and make an evaluation. If the firm is able to move forward on your case, they will also discuss next steps. Remember – the entire consult and evaluation is free to you. You only need to take the first step to fill out the contact form or call: (800) 597-1870 for immediate assistance.