As you’ve probably heard at sites like Overlawyered and Drug & Device Law, the sky is falling upon us because the Supreme Court didn’t override Congress and the FDA and decide to pre-empt state failure-to-warn tort suits against prescription drug manufacturers.
Wyeth manufactures pharmaceuticals, subject to FDA regulation. The FDA sets a minimum standard for the use of these drugs and their labeling; it does not dictate the text of warning labels, though it does have to approve them, which it does after intense lobbying by the manufacturers, lobbying generally unopposed by anyone at all, where the sole “evidence” are manufacturer-sponsored studies, studies which have repeatedly come under fire for conflicts of interest.
Nonetheless, under the “changes being effected” regulation, a drug company can unilaterally change its warning labels to improve patient safety.
Does this regulatory authority preclude all state tort suits alleging drug companies promoted or failed to warn against unsafe uses of these drugs?
Vested interests have spent a lot of money trying to convince judges (and the public) that this question is so hard to answer on purely legal grounds that it requires the judges start making policy instead of law.
Because the law is very clear, as the Supreme Court ruled, 6-3:
As it enlarged the FDA’s powers to “protect the public health” and “assure the safety, effectiveness, and reliability of drugs,” id., at 780, Congress took care to preserve state law. The 1962 amendments added a saving clause, indicating that a provision of state law would only be invalidated upon a “direct and positive conflict” with the FDCA [Food, Drug and Cosmetics Act]. §202, id., at 793. Consistent with that provision, state common-law suits “continued unabated despite . . . FDA regulation.” Riegel v. Medtronic, Inc., 552 U. S. ___, ___ (2008) (slip op., at 8) (GINSBURG, J., dissenting); see ibid., n. 11 (collecting state cases). And when Congress enacted an express pre-emption provision for medical devices in 1976, see §521, 90 Stat. 574 (codified at 21 U. S. C. §360k(a)), it declined to enact such a provision for prescription drugs.
Slip op. at 10.
Congress has had numerous opportunities, while amending the FDCA, to change that. It didn’t.
The FDA has had numerous opportunities, while promulgating regulations with the force of law (as opposed to mere policy positions, which are not binding on courts), to change that. It didn’t.
There was no “direct and positive conflict” between plaintiff’s claims and the FDA approval.
There’s nothing more to say here.
The Supreme Court is to be commended for refraining from telling Congress and the FDA they didn’t know how to set policy, and for sticking to basic principles of judicial, statutory and regulatory interpretation.
Thanks for refraining from judicial activism.