Product Liability Lawyer

When people taking the diabetes drug Actos were diagnosed with bladder cancer, they turned to product liability lawyers to hold Takeda Pharmaceutical Company accountable for their illness.

Lawsuits against companies that make defective prescription drugs and medical devices are common examples of product liability lawsuits. When people are injured by a drug or medical device and they hope to be compensated, it’s important they find an attorney who is an expert in the specific liability laws that apply and who knows what it takes to make a case.

And that’s what happened when lawyer Paul J. Pennock of Weitz & Luxenberg represented patients hurt by Actos. Through his efforts, as well as others, Takeda agreed to pay $2.37 billion into a settlement fund to compensate them for their injuries.

As of November 2022, some active examples of product liability lawsuits include: Baby formula lawsuits, CPAP lawsuits and Zantac lawsuits.

It’s vitally important to pick an attorney who has experience and who has been successful. Experts say it’s similar to picking a surgeon for a complicated operation.

One way is to ask a lawyer who specializes in something else, or is even a general litigator, but knows the reputations and specializations of colleagues. It’s common that when lawyers refer cases that wind up being big cases, they will be paid referral fees.

Consumers who want to find product liability attorneys to represent them and who don’t know other lawyers have to do research. “If you don’t know how to find somebody who’s really good, you could end up in some kind of mill,” said John T. Nockelby, who directs the Civil Justice Program at Loyola Law School in Los Angeles. “I think it’s hard for people to choose, just as it’s hard for non-doctors to choose a doctor.”

Tony J. Sbarra Jr., a Boston attorney who chairs the Products Liability Committee of the Tort Trial and Insurance Practice Section of the American Bar Association (TIPS) suggested checking lawyer websites to see if they are belong to organizations, such as TIPS, which has 22,000 members.

“There are a million lawyers,” said law professor John T. Nockleby, director of the Civil Justice Program at Loyola Law School. “Who’s decent? That’s very hard for the ordinary consumer. What I would say is that no respectable lawyer is going to file a products liability case on their own without the backup of a larger firm that has the money and the expertise to handle it. It’s just impossible for a solo (practitioner) to handle that… They would have to be really good and be adequately capitalized.”

Nockleby said reputable plaintiff lawyers won’t take cases unless they believe the cases have merit. In other words, they have good reason to think they can win. He said solo practitioners typically can’t handle product liability because the cases are expensive to investigate and assemble. They involve a huge up-front investment of money for experts, as well as lawyer time. “It’s not easy to get these cases going on the plaintiff’s side,” he said.

“Joe Schmoe filing a big case without adequate resources or expertise is going to get smashed,” Nockleby said. “The defense firms are very, very good. They have the expertise; they have the capital… They have all the resources they need to defend a case. The plaintiffs’ lawyer is instantly disadvantaged” going up against large corporations. So it’s crucial that a big law firm is confident that a case has merit, Nockleby said, “otherwise they’ll lose their shirts — hundreds of thousands of dollars plus hundreds of lawyer hours” invested with nothing to show for it.

The laws and regulations governing prescription drugs and medical devices are particularly complex, according to Lars Noah, professor at the University of Florida College of Law. The regulatory environment is so layered and nuanced that a general legal practitioner can get into real trouble if he or she tries to dabble in products liability litigation in this area.

“When talking about products liability litigation, these products, more so than just about any other consumer good, are so closely regulated by a federal agency, (the Food and Drug Administration), that you need to have a feel for how it imposes its requirements , how they’re applied in practice,” Noah said. Noah said he’s seen general, commercial lawyers get into trouble venturing into the field without a solid understanding of the regulations that only someone who is fully immersed in the area can have.

For example, a particular lawsuit against a drug maker may be barred in many instances because of what the courts call “preemption,” meaning that if the manufacturer followed the requirements of the FDA, they may be protected from lawsuits. Experienced, knowledgeable attorneys, who specialize in prescription drugs and medical devices, can identify what potential lawsuits have merit under these circumstances and which ones have little or no chance of succeeding.

Legal Doctrine of Preemption

And the complexity goes even deeper, according to Noah. For medical devices, the legal doctrine here is express — or clearly stated — preemption. With prescription drugs, it’s implied preemption, a much tougher standard to master. Lawyers on either side, for example, will duke it out to determine how the regulatory agency might have acted if given the option for a clearer warning about a particular risk, using proposals and memoranda showing discussions behind the scenes. “It’s unusual, and you might even say it’s a subterranean form of law making,” Noah said. “You rarely have the agency say unambiguously, ‘No, you can’t do that.’”

The FDA does a lot of things in ways that suggest its requirements are nonbinding, asking the industry to behave in a particular way, but not ordering it. “In practice, these suggestions are mandatory,” Noah said. But a lot of lawyers, and even some judges, don’t completely grasp how this works.

In addition to that, the courts have also created “so many peculiar rules” in this particular area of law “that getting a handle on those can be daunting,” Noah said.

Mastering the Science

Another reason lawyers tend to specialize in cases involving distinct types of products is that it’s important to master the science behind the products and be able to find and communicate with the right experts, according to Sbarra, who works primarily as a defense attorney for the automobile and truck industry when product liability cases are filed against corporations. “The lawyers on both sides of product liability have to become well versed on how a product works, how it’s designed and how it’s appropriately used,” he said.

How Lawyers Pick Specialties

Understanding pharmaceuticals and how they work is vastly different than knowing how automobiles function, for instance. A lawyer who specializes in pharmaceutical product liability has to know a lot about chemistry, according to Nockleby. One attorney can’t effectively do it all. But larger law firms can have people who specialize in different types of products.

How do lawyers decide to specialize in product liability? Sometimes it just happens through circumstance, according to Sbarra. When people graduate from law school, they usually just want a job. And that first job may turn out to be in an area they love. Or they may go through four or five different jobs before they find the area of law where they belong. “I wanted to try cases, and I wanted to be in court, and I love cars,” Sbarra said. “So it was a good mix for me.” A lot of lawyers also have an engineering background, and so they are drawn to the cases that require an understanding of engineering, he added.

Examples of plaintiffs’ lawyers who have a track record of success in prescription drug and medical device litigation include Paul J. Pennock and Ellen Relkin, who both work at Weitz & Luxenberg, a leading law firm in the highly specialized area of litigation.

Pennock has been chair of the firm’s Drug and Medical Device Litigation practice group for 20 years.

He is the co-lead counsel of federal court multidistrict litigation for the diabetes drug Actos, leading the way in a trial that resulted in a $9 billion jury verdict. The award was later cut by a judge to $36.8 million. During the trial, the drug makers, Takeda Pharmaceutical and Eli Lilly & Co., were accused of failing to warn patients that Actos increased the risk of bladder cancer.

He is also co-lead counsel nationally of the federal multidistrict litigation over a medical device called the power morcellator, which has been associated with the spread of cancer in women during operations. The National Law Journal says Pennock is one of “America’s Elite Trial Lawyers.”

Relkin has practiced for more than 30 years in the area of defective drugs and medical device liability. She has represented thousands of people injured by defective medical products and has been appointed by the courts to serve as co-lead counsel on cases against different manufacturers of defective hip implants.

She was involved in a trial that resulted in a $13.5 million verdict against the makers of the painkiller Vioxx. Jurors found that Merck had misled the Food and Drug Administration about the risks of the drug. She was part of the team who represented John Darby, a diabetes patient who suffered a heart attack after taking Vioxx for four years. He broke his hip in a fall during the heart attack and then had to start using a wheelchair. The verdict, which included $9 million in punitive damages, was awarded in New Jersey after the state enacted laws giving drug makers special protection. It was the first time a jury in the state awarded punitive damages against a drug maker.

Liability refers to the fact that someone else bears responsibility or is at fault for something that happened. Lawsuits may be brought when products are defective in design or something happens in the manufacturing process to make them dangerous, and the product then causes people to be injured. Another kind of legal claim may be brought by an injured party when a manufacturer or distributor of a product fails to adequately warn of the risks of using it.

Millions of products are used every day. By and large, “I think industry and the producers of these products do a phenomenal job designing, testing, researching and marketing their products in a way consumers can benefit from them,” Sbarra said.

But sometimes using something results in injury either through misuse or because the products were designed or made wrong, or the appropriate warnings were not given to the consumer. If the injury results from misuse, then it’s the fault of the consumer and nothing can be done. If it can be proven that the manufacturer or seller was at fault, then they may have to pay damages, or money to the person who was hurt. And when manufacturers are on the wrong side of jury verdicts, this can lead to improved safety overall as changes are made.

Lawyers who specialize in product liability are in the best position to help you determine whether your claim has merit and is likely to result in compensation. They are also best equipped to decide how to negotiate with drug and medical device companies to reach a potential settlement in your favor.

The timing of litigation varies. This is very specific to the facts of a particular case, experts say, and almost impossible to predict. As a general rule, product-liability litigation can stretch out over years.

On occasion, Nockleby said, a case will involve a high-profile issue in which a corporation messed up and was the subject of a lot of negative news reporting. In those instances, the best defense lawyers and the companies involved will do everything they can to resolve the cases quickly.

Other times, a case can be repetitive of cases that have already resolved, Sbarra said. Both sides know the issues and can reach an agreement relatively quickly. But absent those circumstances, an ordinary bad-design case without clear wrongdoing will likely take more than a year and can stretch out over years. After the case is researched and a complaint is filed, then there usually is a process called discovery in which information is exchanged between the parties. Often, there will be disputes over what information has to be provided, and those disagreements will be refereed by the judge.

Then there are pretrial motions, and if the case is not settled or dismissed along the way, there will be a trial. After that, appeals can take months or years.

Experts say product liability cases virtually always are handled through contingency fees. That means the attorney doesn’t get paid unless he or she wins the case. And then he or she takes a portion — usually a third — of the award or settlement. The costs of making the case, such as paying for experts and transcripts of depositions, are also taken from the ultimate award.

Sometimes, Nockleby said, a case is so complicated and risky that a law firm won’t take it unless the client is willing to pay more than a third of the award. And occasionally, a case may be so strong and likely to conclude in a quick settlement that the law firm might agree to take less than a third. Sbarra said states generally have strict rules about the amount law firms can charge in contingency fees.

“The reputable lawyers are not taking advantage of anybody,” Nockleby said. Firms have a cost structure in place. They have to pay the salaries of their employees, etc. “The strong cases end up supporting the much more complex cases, in effect.”

Sometimes, the results of a case are deemed inadequate to compensate a client who has, for example, a lifetime of medical expenses. In those instances, some firms will adjust their fees to take less and help the client, but they typically don’t advertise that they do that.

Technically, the plaintiff is responsible for the law firm’s costs even if the case is lost. But both Sbarra and Nockleby said attorneys often don’t require that. “Most lawyers I know don’t expect that,” Sbarra said.

Clients who lose their cases don’t have the resources to shoulder the expenses, and “the law firm is not going to pursue the client,” Nockleby said. This is why law firms are careful to take only cases they feel confident will lead to a fair result that will not only compensate the client, but will cover the firm’s expenses and the attorneys’ time.