Innovator Liability and New Considerations for Brand-Name Manufacturers. It has long been a well-settled principle of tort law that a manufacturer can only be responsible for tort claims arising from its own product. However, a recent decision of a Massachusetts state court permitting generic drug users to sue brand-name pharmaceutical companies pursuant to an “innovator liability” tort theory suggests a potential shift away from this long-standing principle. Any expansion of tort liability for branded companies may have broader implications, with claimants seeking to disturb the scope of tort liability more generally and in other contexts.
By way of background, claimants have long sought to hold brand-name drug manufacturers liable for injuries allegedly sustained as a result of their ingestion of generic bioequivalents. The overwhelming majority of courts have rejected attempts to impose such “innovator liability,” finding it contrary to well-established tenets of product liability law and principles of fundamental fairness to deem an innovator pharmaceutical company responsible for injuries associated with a product it did not manufacture. The seminal case in this area, Foster v. American Home Products Corp., reasoned that imposing liability on the branded manufacturer where the product ingested by the plaintiff was actually manufactured and sold by a generic competitor would be unfair and would “stretch the concept of foreseeability too far.” 29 F.3d 165, 171 (4th Cir. 1994). In so doing, it noted that “[t]here is no legal precedent for using a name brand manufacturer’s statements about its own product as a basis for liability for injuries caused by other manufacturers’ products, had no control” and that doing so “would be especially unfair when, as here, the generic manufacturer reaps the benefits of the name brand manufacturer’s statements by copying its labels and riding on the coattails of its advertising.” Id. at 170. Foster also reasoned that it would not be foreseeable to branded manufacturers that generic users would rely on their labeling, as generic manufacturers are responsible for their own labels and “are also permitted to add or strengthen warnings and delete misleading statements on labels, even without prior FDA approval.” Id.
The Supreme Court’s decision in PLIVA, Inc. v. Mensing—which found that state law tort claims against generic drug manufacturers are preempted by federal drug regulations—has since altered the landscape. 564 U.S. 604 (2011). In Mensing, the Supreme Court found that generic manufacturers could not possibly create “safer” labeling (as Plaintiffs alleged should have been done in pursuing their state law tort claims) and simultaneously comply with the federal requirement to keep their labeling the same as the branded counterpart’s. Id. at 624. Indeed, the Hatch-Waxman Act—which sought to simultaneously make pharmaceutical drugs more accessible (by lessening the testing and approval burdens on generic manufacturers) and incentivize innovation (by extending patent terms for branded companies)—generally requires generic manufacturers to maintain the same label and warnings as its brand-name competitor once FDA approval is received. Of course...
