Personal Injury law – Supreme Court Gives Immunity to Pharmaceutical Corporations
June 24, 2013
The Supreme Court of the United States has issued its opinion in the Mutual Pharmaceutical v. Bartlett case and in the words of the dissenting opinion, it has achieved an astonishing coup in favor of the pharmaceutical corporations:
[T]he majority effectively makes a highly contested policy judgment about the relationship between FDA review and state tort law—treating the FDA as the sole guardian of drug safety—without defending its judgment and without considering whether that is the policy judgment that Congress made.
Congress adopted the FDCA’s premarketing approval requirement in 1938 and then strengthened it in 1962 in response to serious public-health episodes involving unsafe drugs. See Future of Drug Safety 152. Yet by the majority’s lights, the very act of creating that requirement in order to “safeguard the consumer,” United States v. Sullivan , 332 U. S. 689, 696 1948, also created by operation of law a shield for drug manufacturers to avoid paying common-law damages under state laws that are also designed to protect consumers. That is so notwithstanding Congress’ effort to disclaim any intent to pre-empt all state law. See supra, at 4. The majority’s reasoning thus “has the ‘perverse effect’ of granting broad immunity ‘to an entire industry that, in the judgment of Congress, needed more stringent regulation.’ ”