Another preemption loss in the Supreme Court for consumers injured by generic drugs

by Brian Wolfman

The Supreme Court today held in Mutual Pharmaceutical Co. v. Bartlett that FDA approval of a generic  prescription drug preempts a state-law damages claim premised on the drug's design defect. The 5-4 majority opinion is written by Justice Alito. Basically, Justice Alito says that a design-defect claim is, in effect, a claim that the drug's label should be changed to warn of the drug's design-induced hazards, and state law has no business premising a tort duty on a change in an FDA-approved generic drug label (which is what the Court held earlier in PLIVA v. Mensing). There's a dissent by Justice Breyer joined by Justice Kagan and a dissent by Justice Sotomayor joined by Justice Ginsburg. Another loss for injured consumers' access to the courts. So, after this loss, let's see where we are with access to the courts for people injured by prescription drugs and medical devices.

In 2011, the Court held 5-4 in PLIVA v. Mensing that FDA approval of a generic prescription drug and its labeling generally preempts a state-law damages claim premised on a failure to warn of the drug's hazards. In 2009, the Supreme Court held 6-3 in Wyeth v. Levine that, in general, FDA approval of a brand-name prescription drug and its labeling does not preempt a state-law damages claim premised on the drug manufacturer's failure to warn of the drug's hazards. Taking today's decision along with PLIVA and Wyeth, we have a nonsensical scheme of access to the civil justice system for people harmed by prescription drugs. If you (the patient) happen to have been prescribed a brand-name drug and that drug injures you, your suit against the manufacturer can go forward; but if you were prescribed the brand-name drug's generic copy -- which public policy has favored for three decades -- your suit against the generic manufacturer is kaput. Got that?

The situation is hardly more rational with respect to medical devices. In 1996, the Supreme Court held, 5-4 in some respects and 9-0 in others, in Medtronic v. Lohr that the federal Medical Device Amendments (MDA) generally do not preempt state-law injury claims against  manufacturers of devices approved on the basis of their "substantial equivalence" to already-marketed devices (so-called 510(k) devices). 510(k) devices comprise the vast majority of devices. But 12 years later, in 2008, the Court held 8-1 in Riegel v. Medtronic that state-law claims alleging injuries from devices that go through the more thorough "pre-market approval" process -- which applies to devices most likely to cause injury and death when they fail -- are preempted by the MDA, unless the state-law claims "parallel" federal device requirements.

More later.

Comments

[Ronen]

" If you (the patient) happen to have been prescribed a brand-name drug and that drug injures you, your suit can go forward; if you were prescribed the brand-name drug's generic copy -- which public policy has favored for three decades -- your suit against the generic manufacturer is kaput. Got that?"

Well - the idea is that the generic manufacturer has no freedom (and thus - cannot err) in labeling its product. FDA requires the label to be identical to that of the original drug. It does make perfect sense.