Product liability

In a nutshell

Product liability

Product liability involves personal injury or property damage litigation arising from alleged design and manufacturing defects, or information/warning deficiencies, in products. Litigation can consist of individual cases arising from one-off injuries, though in recent years much of it has been conducted through mass torts. Mass torts comprise class actions and/or multiple related individual cases brought by plaintiffs. Most cases within a mass tort do not usually go to trial as they tend to be resolved early through mediation or settlement.

Product liability lawyers also advise on how to avoid litigation, since clients are increasingly interested in prevention and mitigation of the costs and risks of significant product liability litigation. Attorneys are also often required to advise on related, nontraditional product claims, such as government investigations, which frequently arise alongside private claims. This quasi-criminal aspect involves defending the client against suits filed by state attorneys general and investigations conducted by the Department of Justice, often simultaneously.

The major industries that see the lion's share of product liability suits are tobacco, pharmaceutical, consumer products, chemicals and medical devices. BigLaw firms normally defend the manufacturers of the products.


What lawyers do

  •      Meet with company witnesses to put together the company's defense.
  •      Fact investigation and discovery – find out what actually happened.
  •      Product investigation – get to know the product.
  •      Choose and prepare experts; arrange for experiments if necessary.
  •      File motions under the Frye or Daubert doctrines to dismiss inadequate plaintiffs' experts.
  •      Write briefs on evidentiary, class action and dispositive motion issues, as well as legal analysis.
  •      Take and defend fact and expert depositions.
  •      Argue cases before juries.
  •      Manage post-trial steps.


Realities of the job

  • Mass torts typically include some form of consolidation or aggregation of the claims, ranging from a class action – in which plaintiffs have significant issues in common – to a federal multidistrict proceeding coordinating all the cases for pretrial purposes.
  • Cases are heard all across the country, though plaintiffs may like certain jurisdictions better than others for tactical reasons. These include East Texas, Atlantic County in New Jersey, and Philadelphia. The 'bank district' in Los Angeles is popular for its history of awarding multimillion and billion-dollar verdicts. It has been described by advocates of tort law reform as "judicial hell on earth."
  • Not all cases are tried the same way. There are a variety of different trial models that judges are experimenting with, including the bifurcated, reverse-bifurcated and bellwether models. Depending on the model, different strategies will be needed, and will sometimes require a mock jury exercise to see what will work best. Attorneys can suggest alternate trial plans, though the judge has the final say. Once the trial has begun, it is difficult to change how it is tried, though with mass tort, which involves many cases, it is possible to try iterative cases differently. Judges experimented extensively with the thousands of cases in the fen-phen litigation in the Philadelphia courts.
  • The main drivers of complex product liability litigation are the business and strategic decisions made by the plaintiffs' Bar, which do not necessarily involve pure scientific analysis of a product.
  • Plaintiff lawyers jump from product to product and industry to industry, and try to apply the same model to different cases. The tobacco industry has often seen plaintiffs' innovations before any other, whereafter plaintiffs will experiment with those approaches in different industries.
  • Many clients work extensively with the Food and Drug Administration (FDA), so current FDA employees cannot be used by the defense as expert witnesses, due to the conflict of interest. Instead, attorneys will work with retired FDA employees to learn about the regulatory and approval processes.
  • Much of the work done preparing for trial will turn out to be for cases that never make it to trial, since most mass torts are resolved before then. But attorneys do not know which of the 20,000 to 30,000 claims filed will actually be tried. There is, however, a winnowing process whereby judges eventually select a smaller pool of cases to be tried.
  • There is a large amount of routine paper and electronic discovery required, though many firms use staff and contract attorneys to do this job.
  • You don’t have to have a background in science to be a product liability lawyer, though to be a successful one you will have to learn about areas outside the law like engineering, medicine and science. You will also have to be able to communicate complicated scientific ideas to a judge or jury in a clear and simple fashion.
  • You may work with some of the leading scientists and doctors in the country and the world.
  • The job often involves extensive travel for trials and meeting with experts.
  • Most product liability work is domestic.


Current issues

June 2023 

  • The product liability market has historically remained quite distinct in different jurisdictions, compared to other markets that have long been more globally integrated. However, the globalization of product liability seems to be on the rise recently. For instance, clients don't sell to a single region as often as before, and as such firms with global and/or cross-jurisdictions practices and resources are becoming a more popular choice for product liability cases.   

  • According to Duane Morris’ Class Action Review, class action lawsuit settlements, including product liability, consumer fraud, and antitrust, set a new record in 2022 by exceeding a total value of $63 billion. It was reported that product liability actions and mass torts settlements racked up more than $50 billion – an increase of 267% in just one year. 

  • Big businesses can’t hide from this kind of scrutiny: Johnson & Johnson is facing no fewer than 9,000 lawsuits alleging that daily use of their baby powder causes ovarian cancer. Missouri’s Supreme Court recently ordered the company to pay $4.7 billion in damages to 22 women who claimed they developed ovarian cancer after using baby powder containing asbestos. Six of the women died.  

  • In April 2023, Johnson & Johnson agreed to paynearly $9 billion to settle these lawsuits – a figure significantly higher than the $2 billion it initially offered.  

  • In 2022, the Senate passed a bill introduced by a Texan mother whose 18-month-old daughter died after swallowing a battery button. Reees’s Law, named after the toddler, requires the Consumer Product Safety Commission to develop stronger safety standards for button batteries, including warning labels and child-resistant packaging. 

  • The opioid crisis in the US, with opioid-based medication having been over-prescribed in recent years, has led to a significant rise in overdoses. State and local governments continue to seek reimbursement for the health costs from opioid use. Claims have included negligence, public nuisances, and violations of federal and state racketeering statutes. 

  • In February 2022, the CDC sought to loosen guidance around opioid prescription, after the tightening of rules in 2016 in hopes to reverse the opioid overdose endemic had had a reverse effect, with deaths occurring from opioid overdoses rising instead of falling. In the same month, Johnson & Johnson, AmerisourceBergen, Cardinal Health and McKesson were ordered to pay $26 billion to settle claims of fueling the opioid crisis. This is the largest opioid-related settlement to date. 

  • Purdue Pharma is the subject of a Netflix docudrama, Dopesick, which explores the pharmaceutical company’s drug OxyContin and its role in the opioid epidemic. The Sackler family, owners of Purdue, have agreed to pay up to $6 billion to resolve litigation stemming from the epidemic. 

  • The advent of 'innovator liability' is a contentious area. According to Paul Boehm, partner at Williams & Connolly, this has been driven “by plaintiffs' lawyers’ desire to circumvent the Supreme Court’s decision in Mensing. Since plaintiffs, under Mensing, cannot sue a generic drug manufacturer for failure to warn, plaintiffs' attorneys have advanced the theory that the ‘original innovator’ of the product, rather than the manufacturer of the product plaintiff actually used, can be liable under state-based ‘failure to warn’ claims. This theory would represent a fundamental change in some basic principles of tort law. Three state courts have allowed 'failure to warn' cases founded on the theory of ‘innovator liability,' but most courts continue to reject it.” High courts in California and Massachusetts have both allowed some form of innovator liability, but this has not led to a rise in these cases in these states. On the other hand, trials in Idaho and Delaware continue to rule against holding an innovator accountable for injuries.    

  • The development of driverless cars has generated new queries for the practice area – does an accident involving one constitute a product liability case, or is a crash the fault of the, for want of a better term, 'driver'? Current consensus suggests this will indeed be a product liability issue, but the conundrum demonstrates how technology can evolve faster than the law surrounding it. Questions about culpability are only starting to be addressed: in an incident in March 2018 in which a pedestrian was hit and killed in Arizona by a self-driving Uber, it was uncovered that the 'backup' driver was watching a TV talent show at the time of the crash. In 2020, driverless car producer Nuro was given the go-ahead to pilot its delivery cars in California without anyone behind the wheel – as long as they stay below 35mph. There are currently no self-driving cars available to US consumers.  

  • 3D printing is leading to similar deliberations on product liability issues and the question of who is culpable if there is an issue. As of 2021, there are no regulations specifically dealing with the liabilities surrounding 3D printing in the USA, EU or UK.  

  • Litigation surrounding the topic of vaping and e-cigarettes is expected to grow; there have been a number of deaths and illnesses allegedly related to the devices. Some claims focus on the product liability aspect in terms of defective e-cigarettes leading to injuries, while some focus on the potential misleading marketing of the products. E-cigarette heavyweight Juul is under fire for presenting misleading information about the source of nicotine in their products, as well as intentionally marketing to minors. November 2021 saw JUUL pay $14.5 million to settle a lawsuit in Arizona which accused the brand of marketing its products to minors. The company still faces over 2,000 similar lawsuits. 

  • Litigation involving ESG claims and greenwashing is on the up. In February this year, it was alleged that Shell’s renewable energy investment claims were misrepresented in a filing with the SEC’s Climate and ESG Task Force. Coca-Cola, Exxon Mobil, and Nestle have all faced similar accusations of greenwashing. Such claims can lead to administrative complaints, investor-led litigation, product liability lawsuits, and consumer protection cases. 

  • It’s typical to see product liability litigation surrounding physical products, but as we move into a world that is becoming more and more digital, it’s hardly surprising that we’re seeing an uptick in litigation surrounding social media platforms. Plaintiffs have alleged that platforms like Instagram, Facebook and Tiktok are leading to declined mental health among teenagers, and that the deliberate configurations of the algorithms are causing addiction. As the case develops and plaintiffs file a complaint, we’ll see the ways in which product liability laws can apply in this context. 

  • One example is the recent push by plaintiff attorneys to bypass the immunity that Section 230 grants to social media companies. Section 230 outlines that social media companies and their users are not liable for content published by a third-party on the platform; put more simply, social media platforms are not considered the publishers of content posted by users, and are therefore currently not held liable for unlawful content. 

  • In May 2022, a product liability lawsuit was filed against TikTok (and its parent company ByteDance) alleging the social media company played a part in the death of a 10-year-old child attempting the ‘Blackout Challenge’ – a challenge widely circulated on the app. The lawsuit claims the algorithm used by TikTok, which tailors content for users based on their use of the platform, promoted the content on the child’s ‘For You’ page. 




Advice from top product liability lawyers...

Harvey Kaplan, partner and chair emeritus of the pharmaceutical and medical device litigation division, Shook, Hardy & Bacon:

“Thorough preparation is the key. You have to dedicate yourself. Turn over every stone and develop the drive to nail down the facts, which sometimes means – lo and behold! – you'll have to get out of your office and interact with people. The facts are all-important.”

“An understanding of the science involved is paramount when you're dealing with pharmaceutical and medical device litigation. You have to educate yourself.”

“As a junior associate you'll be working with busy partners who may be very experienced but don't know all the details about a particular case. It's a great opportunity to make yourself indispensable by being the person with the in-depth knowledge of the documents.”