When it comes to injured victims trying to seek redress in the courts, cranky old Scrooge-like Supreme Court Justices are clearly ruling the day this term. On Thursday, we told you about Justice Scalia’s decision in American Express v. Italian Colors Restaurant, which Public Justice’s Paul Bland called an “unmitigated disaster.” Not to be outdone, today Justice Alito (he’s only 63 but I’m qualifying him) wrote in Mutual Pharmaceutical v. Bartlett, that a severely injured victim of a generic drug has no remedy whatsoever. That means you, 85% of all Americans who take drugs, er ummm, legal drugs.
To understand the cruelty of this decision, let’s review what we wrote when the case was argued:
You take the generic medicine and suddenly, your skin starts burning off. You spend two months in a burn unit, months in a medically induced coma, a year on a feeding tube, and end up severely disfigured with permanent lung, esophagus, and vision damage. You can no longer read, drive, go to work, or even eat normally. So you bring a lawsuit, hoping to be compensated for being given a drug that was obviously “unreasonably dangerous” to you. And indeed, you find out that there were more adverse event reports to the FDA over sulindac than any other similar nonsteroidal anti-inflammatory medications on the market; that sulindac knew its rate of life threatening conditions was comparable to that of a drug the FDA recommended be removed from the market - but it never told the FDA this. And after a 14-day trial, the jury agrees that whatever benefits might exist for this drug, they were clearly outweighed by the risks, and awards $21 million.
Yet today, Justice Alito for the 5-4 majority, threw out this verdict giving the victim, Karen Bartlett, nothing. Justice Sotomayor issued a particularly blistering dissent, noting how the Court has turned preemption law completely on its head for the purpose of protecting corporations from liability exposure and wiping out traditional state tort remedies. And what’s more, Congress seemingly intended to do the opposite, leading her to call the majority decision “frankly astonishing:”
[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.’ ”
Not to mention the fact that, as she points out “this decision threatens to disturb a considerable amount of state law.” So that should get some people furious.
This decision was just 1 of 3 that led Andrew Cohen at The Atlantic to call today, "A Great Day for Corporations." Really? Another one?
Your move, Congress.