This time out of Massachusetts. And in an opinion authored by a female judge. This isn't something we would normally take the time to point out, but as we embark on the 39th Women's History Month, the combination of Massachusetts and a female judge stood out to us. Afterall, Massachusetts was home to Abigail Adams, one of her husband's closest advisors. It was Abigail who implored John Adams in 1776 to "Remember the ladies and be more generous and favorable to them than your ancestors." While that may be her most famous quote, it does not end there. Her letter continued: "If particular care and attention is not paid to the Ladies we are determined to foment a Rebellion, and will not hold ourselves bound by any Laws in which we have no voice, or Representation." It would only take another 144 years for women to be granted the right to vote in America. And, while the first woman was appointed to the bench in 1928, women still only account for 27% of currently presiding federal judges. So, maybe it is worth pointing out that today's decision is authored by a Massachusetts woman, following in the footsteps of so many great ladies of that state (Louisa May Alcott, Emily Dickinson, Susan B. Anthony, Clara Barton, Rachel Fuller Brown, Dorthea Dix, Amelia Earhart, Elizabeth Freeman, and Helen Keller – to name a few).
The case is Plourde v. Sorin Group USA, Inc., 2021 WL 736153 (D. Mass. Feb. 5, 2021). Plaintiffs daughter died following complications from a surgery to remove an aortic bioprosthetic heart valve manufactured by defendants. Id. at *1. In 2018, the court granted in part and denied in part defendants' motion to dismiss. (2018 WL 1542361). The only claim that survived the pleadings stage was plaintiff's failure to report adverse events to the FDA. In that opinion the court made clear that it had not decided whether Massachusetts law imposed such a duty but would afford plaintiffs an opportunity to demonstrate that it did. Id.
The valve at issue is a Class III, PMA device that was approved by the FDA in 2007. Id. at *3. The Instructions for Use (IFUs) that accompanied the valve, and that were approved by the FDA, provide a warning that patients under the age of 55 "may experience accelerated calcification" of the valve. Id. The risk of accelerated calcification in younger patients is "common knowledge" in the medical community due to more active bone turnover and increased cardiac output. Id. at *5. Indeed, plaintiffs' expert testified it was a risk he learned about in medical school in the 1990s and he co-authored, with plaintiff's implanting surgeon, a study concluding the risk was greater in younger patients. A study that they published a few months before plaintiffs' daughter's procedure. Id. The implanting surgeon discussed this risk, and others, with plaintiffs before deciding to proceed with a bioprosthetic valve in part because it would not require daily Coumadin treatment. Id.
The facts in this case also demonstrated that defendants' adverse event reporting process had been subject to both FDA and independent audit with no deficiencies found. Id. at *4. Despite that, plaintiffs claimed that defendants failed to report all of the events they should have to the FDA.
Plaintiffs argued that the failure to report to the FDA was the basis for their failure to warn, breach of implied warranty, breach of express warranty, and unfair business practices claims. However, where the basis for the breach of implied warranty claim is a failure to warn, Massachusetts collapses the two causes of action into essentially one. Id. at *9.
That is where the court's legal analysis began – failure to warn. Plaintiffs argued that had defendants reported additional adverse events to the FDA, the FDA would have made the information public which would have provided doctors and patients with more information about the risks. Id. at *10. The court did not have to address the attenuated causation problem with plaintiffs' argument, but we reference it as it has been a sticking point in other cases where failure to report was recognized. Instead, the court focused on the fact that plaintiffs had "not identified binding or persuasive authority that manufacturers of medical devices have a common law or statutory duty to report advents to the FDA." Id. Further, Massachusetts recognizes the learned intermediary doctrine and plaintiffs could not cite to any law to support a basis to extend the duty to warn physicians to a duty to warn the FDA. Id.
Therefore, the court held that Massachusetts does not recognize a cause of action for failure to report. Without a state-law duty, there can be no parallel claim. Plaintiffs' failure to warn claim is "different from" federal law and therefore preempted. Id. at *11-12.
Plaintiff's breach of express warranty claim failed because (i) the performance of the product must be judged against its warnings and (ii) plaintiffs did not identify any specific false statement made to them or the implanting surgeon. Id. at *13. Plaintiffs' unfair business practices claim failed because it was derivative of plaintiffs' failure to warn claim. The statutory claim is only independent if plaintiff "offers separate arguments in support." Id. at *14. Here, the claim was based on the same failure to report, the claim was likewise dismissed.
"If we mean to have heroes, statesmen and philosophers, we should have learned women."
Originally Published by Reed Smith, March 2021
This article is presented for informational purposes only and is not intended to constitute legal advice.