A Forward-Looking Perspective on Mass Tort Practice

As with most things, the future of mass torts will likely mimic its past. Cancer cases, like those associated with tobacco and asbestos in the past, are driving current and future mass tort litigation.

New and ongoing litigation continues for products such as:

  • Zantac
  • Roundup
  • Talc
  • Valsartan
  • Sunscreen
  • PFAS
  • Metformin
  • CPAP

With technological and scientific innovation, identifying signature injuries can be easier to determine. Mass tort litigation will continue to grow in prevalence as claimants seek compensation for damages caused by dangerous products corporate manufacturers refuse to reformulate or recall.

FDA and Big Pharma

The Food and Drug Administration and Big Pharma should be on the front lines of continued safety monitoring once products reach the market. Instead, post market surveillance is minimal and bogged down in a bureaucratic free-for-all.  Pharmaceutical giants and FDA are doing little to protect consumer safety once products reach the market.

Independent labs, like Valisure in the Zantac and Valsartan MDLs, are sounding alarms. Valisure reported the link between Zantac and its generics to the known carcinogen NDMA to FDA in June 2019. In September, Valisure filed a petition with FDA asking that all products containing ranitidine be recalled. Valisure, alongside university researchers, established that NDMA resulted from the inherent instability of ranitidine molecules. NDMA is a Group 2A carcinogen, meaning it is likely to cause cancer in humans.

FDA’s response to the report from Valisure was muted and downplayed the potential risks associated with ranitidine. The agency issued an alert saying it had learned that some ranitidine medications contained low levels of NDMA. The report went on to state that it was not advising people to discontinue the drug and that they should talk with their physician if they were concerned.  The Valisure report made it abundantly clear that every version of ranitidine tested contained high levels of NDMA and that the problem was inherent to the ranitidine molecule, meaning there is no safe version of the drug.

Why would FDA downplay the danger once alerted to the problem? Sounding an alarm about a dangerous drug would bring attention to the problems that plague post market surveillance and oversight by FDA. In addition to a lack of monitoring, FDA has limited power when a recall is warranted. The agency was granted power to order recalls of food, vaccines, medical devices, tobacco products, and infant formula in 2011. Last year, FDA was given the additional capacity to issue a mandatory recall of opioids deemed dangerous, but FDA cannot issue a mandatory recall of any other prescription drugs.

The agency can issue voluntary recalls in which they suggest drug manufacturers recall potentially dangerous drugs, but compliance is voluntary. While most pharmaceutical companies comply with voluntary recall requests to avoid public relations nightmares and potential liability, the obvious question is why FDA shies away from its authority to issue mandatory recalls? Could it be the revolving door? Scott Gottlieb, former FDA commissioner, left FDA in 2019. While he frequently appears on the news in his capacity as former FDA commissioner while hawking Pfizer’s COVID vaccine, he fails to disclose that he has sat on the Board at Pfizer since June 2019.

Mass Tort Attorney Fees

Mass tort reform has been a hot-button topic as the number of cases filed in MDLs increases each year. One matter of dispute is capped fees for plaintiff attorneys. In the Opioid MDL, U.S. District Judge, Dan Polster, capped attorney fees at 15% of the total judgment.  Capping fees below the standard for mass tort cases could lead to unintended consequences. In this case, the MDL has already been in process for several years. If there are parties who hold out because of the capping order, it could result in further delays in the case.

Nothing about the current system is perfect, but the table-pounding about contingency and common benefit fees utterly fails to account for the problems defendants’ hourly billing arrangements create. Defendants might be more likely to achieve long term resolution if they would look inside

Mass Tort Discovery

One of multidistrict litigation’s purposes is to promote efficiency in discovery, but defense discovery abuses need closer scrutiny by the courts. Powerhouse defense firm Arnold & Porter is currently facing civil contempt in New York state court for what appears to be a pattern of discovery abuses in their representation of Endo Pharmaceuticals. Citing at least 12 inaccurate statements by the defense firm, a Tennessee state court recently granted plaintiffs a default judgment on liability and discovery abuse sanctions.

MDLs, by nature, serve as an advantage to corporate defendants. It is easier and less expensive to litigate in one court instead of countless state courts.  However, as seen with Endo Pharmaceuticals, discovery abuses can domino across multiple jurisdictions. Flaunting basic norms of practice by concealing data and dumping it on opposing counsel at the eleventh hour is an ongoing issue in vastly complex mass tort litigation that should be addressed before it becomes normalized.



be the first to comment on this article

Leave a Reply