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 2021 

  • 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. 
  • March 2021 saw Amazon become involved in a product liability case after a child suffered injuries from a product bought from its site. The product-dispensing giant claimed it wasn’t responsible as it hadn’t made the item sold. This case, brought in Texas, is one of several product liability claims brought against Amazon in recent years.
  • The FDA Reauthorization Act of 2017 extended the amount of time drug and device manufacturers have to report product malfunctions, from 30 to 90 days for possible safety issues that haven't yet caused serious harm. The change has garnered criticism for potentially increasing the risk to patients who use or come into contact with certain medical products. However, the FDA maintains that the emphasis on patient safety is still preserved via measures including the 30-day reporting limit on issues that have already caused serious harm or have been encountered with any product that has been on the market for under two years.  
  • In 2018, California was the first state to implement regulations on ‘Internet of Things’ (IoT) devices – physical devices connected to the internet. As ‘connected devices’ are classed as physical objects as opposed to technology, this could affect product liability claims. This is key when considering the rise of digital health technologies and the use of AI in healthcare-related products, like wireless medical devices. In February 2020, the European Commission published a report that stated that, though current guidelines work for most products, they’re not comprehensive enough to cover all new IoT devices.
  • Consumer fraud class actions continue to be on the rise in venues across the United States, particularly in California. These actions tend to be filed when plaintiffs’ counsel allege that “defendants mislead consumers as to the benefits of their products,” explains Michael Davis, head of Sidley Austin’s product liability and mass torts practice. These actions often arise when a product “claims to be ‘natural’ or have a specific health benefit, or when there are technical issues with labeling.”  
  • Some frequently named defendants, in addition to the traditional consumer, food and pharmaceutical companies, are “energy drink manufacturers who allegedly fail to adequately label their products, helmet manufacturers, and NFL franchises for concussion injuries players allegedly suffered over time,” according to Michael Davis. Energy drinks are an ever-growing product, with sales forecast to break $3 billion in the US in 2021.
  • 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 2021, consultancy firm McKinsey (which influenced the sales tactics used to sell opioids such as OxyContin) was ordered to pay $574 million to US states. This follows OxyContin producer Purdue Pharma being ordered to pay $8.3 billion (the company has filed for bankruptcy).
  • 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 Nuvo was given the go-ahead to pilot its delivery cars in California without anyone behind the wheel – as long as they stay below 25mph. 
  • 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 company Juul is under fire for presenting misleading information about the source of nicotine in their products, as well as intentionally marketing to minors.


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.”

Will Goodman, member, Watkins & Eager:

“I've been defending pharmaceutical and chemical companies most of my career. I have enjoyed learning about subjects I never thought I'd be interested in – such as genetically modified rice or the metabolism of the liver.”

“Defending big companies at trial is an exceptional challenge – I've been able to work with some top national and international firms along the way and to try cases outside my home state. If you want a more regular lifestyle, you might consider a practice area other than trial work, where you have some control over your schedule. In product liability we just do what we have to do. My record is 47 consecutive days away from home. There are a lot of long hours, and a lot of time and effort goes into preparing and trying complex cases.”

“Teamwork is so important now. Clients rarely hire just one firm and I've been fortunate to be part of virtual firms in several major litigations. A spirit of cooperation and a controlled ego is required. Clients nowadays are impatient with a personality that doesn't mesh well with others.”