According to a New York Times article, the Supreme Court’s rulings over the last few years on federal preemption of state-law tort claims against brand-name and generic prescription drugs affect potentially millions of people. Nearly 80 percent of prescriptions in the United States are filled by a generic, and most states permit pharmacists to dispense a generic in place of a brand name. More than 40 judges have dismissed cases against generic manufacturers since the Supreme Court ruled last June in Pliva v. Mensing, including some who dismissed dozens of cases consolidated under one judge.
The doctrine of federal preemption has produced inconsistent results. Medical device manufacturers are well aware that whether a tort lawsuit based on state law can proceed or be dismissed as preempted by federal law depends on whether the article in question was approved via the FDA’s 510(k) process (“substantial equivalence”) or whether the article was approved by the agency’s premarket approval (PMA) process. This inconsistency is especially pronounced when it comes to pharmaceuticals. In 2009, the Court held in Wyeth v. Levine that state law failure to warn claims were not preempted for brand-name prescription drugs.
Last year, the Court sided with generic drug manufacturers in holding that generic prescription drugs were not as accountable. The Supreme Court’s ruling, which was split 5 to 4, has its roots in the Hatch-Waxman Act (P.L. 98-417), the 1984 law that opened the pathway for generic drugs. Under Hatch-Waxman, companies were allowed to bypass the lengthy FDA approval process required for new drugs if they could prove that the generic drug was equivalent to its brand-name counterpart. With very few exceptions, it also required generic manufacturers to use the same labels — the lengthy list of a drug’s uses, dosages and risks — used by the brand names.
As a result, if a problem develops down the road with the drug’s indications, the brand-name companies are responsible for changing the label, and the generic companies must follow their lead. The Supreme Court used this as its rationale for ruling that generic companies cannot be held responsible for failing to alert patients to problems with their drug – in essence because the generic pharmaceutical manufacturers were bound. The dissent argued that generic companies nevertheless have a responsibility to report problems to the FDA and should be held liable for failing to warn patients.
The fallout from these decisions is that patients may be forced to move away from generic drugs, if permitted, in order to “protect” any interests down the road. Basically, patients may be giving up any legal remedies they have by using generic drugs. While the FDA has noted that it needs more time to resolve the matter, consumer advocacy groups have begun to petition the agency to give generic companies more discretion over their labeling. From the side of the generic manufacturers, more discretion could potentially raise the cost of generic drugs. Generic companies have argued that forcing them to revise labeling would in effect make the generic drug a brand-name drug.
Thus, it remains to be seen whether federal preemption will be something generic drug companies can rely upon in the future.