Highlights

When someone is deciding whether to undergo a medical procedure, they think about a lot of things: How much does the procedure cost? What are the risks? What are the benefits? They probably don't consider whether their medical care will result in a manufacturer-liability opinion from Massachusetts's highest court. But for some (un)lucky few, including Patricia Dunn, that's exactly what happens.

The Decision

In Dunn v. Genzyme Corp., 486 Mass. 713 (2021), the Massachusetts Supreme Judicial Court (SJC) clarified the standard for determining whether the federal Medical Device Amendments to the Food, Drug, and Cosmetic Act (the MDA) preempt state manufacturer-liability claims. The SJC decided that Dunn's particular claims were not preempted. Importantly, it also provided further color to the pleading standard for products liability claims in the Commonwealth by deciding that the complaint lacked sufficient factual allegations to survive Genzyme's motion to dismiss. The court emphasized that "labels and conclusions" not grounded in sufficient "factual allegations," which many manufacturers encounter in bare-boned complaints, are simply "insufficient" to "plausibly ... suggest an entitlement to relief." Id. at 722 (quotations omitted, alterations adopted).

Dunn brought state-law claims against Genzyme arising out of her allegation that she experienced severe side effects after receiving injections of a Genzyme-manufactured product designed to help the osteoarthritis in her knee. Id. at 716. In reviewing the lower court's decision denying Genzyme's motion to dismiss, the SJC first addressed whether the MDA preempted Dunn's claims. Id. at 718. It applied the U.S. Supreme Court's two-part test for determining MDA preemption: First, does the U.S. Food and Drug Administration (FDA) regulate the product at issue? Second, are the state-law claims preempted because they attempt to impose requirements different than those established by federal law? Id. (citing Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)).

The SJC easily determined that the FDA regulates Genzyme's product. Id. at 719. It then decided that the claims in the sparse complaint were not preempted because they sought to enforce requirements "parallel" to, rather than distinct from, those that federal law created. Id. The court expressly declined to require detailed pleading to overcome the preemption hurdle, stating, "We will not require plaintiffs who are asserting parallel State law claims to plead specific facts, such as the precise Federal regulations purportedly violated or the precise relationship between State and Federal requirements, to meet our ordinary, notice-pleading standard." Id.

The SJC went on to decide that Dunn's complaint did not pass muster even under this "ordinary" standard because it did not sufficiently allege causation. Dunn's complaint attempted to allege this element by pointing to the "temporal proximity" between the product's injection and Dunn's injury. Id. at 722. This was not enough for the court. There were no factual allegations of causation drawing upon the defendant's own admissions, for example, or allegations that the manufacturer received complaints about and issued a recall for the product at issue. Id. at 722-23. The complaint simply alleged "no facts -- regulatory, medical, or otherwise," to connect "Genzyme's actions with the purported harm." Id. at 723. Moreover,the SJC's opinion suggested that the imbalance in information available to a plaintiff and a product manufacturer about a particular product "does not nullify a plaintiff's pleading obligations." Id..

Takeaways and Conclusion

The next time a company is faced with a complaint, at least in Massachusetts, it should take a look at whether the complaint makes more than a superficial effort at alleging causation. If the complaint relies on temporal proximity or other vague and conclusory assertions, then it's ripe for dismissal. Manufacturers might also beef up any preemption arguments they decide to make. At least in the medical manufacturer-liability context, the SJC has announced that courts should examine the complaint to decide for itself whether the plaintiff is trying to make an end-run around federal law. A defendant can make the court's job easier by performing that analysis itself.