Supremes leaning toward pre-emption?

Yesterday court-watchers got another sneak peek at which way the Supreme Court might lean when they hear the big drug liability case next term. In hearing arguments over Michigan's law that shields pharma from liability suits unless they commit fraud to get their drug approved, Justices Stephen Breyer and Anthony Kennedy "expressed broad skepticism" about liability suits against drug makers, Forbes reports. Breyer said--and this is key--that the suits second-guess the FDA's decision to approve the drug. An expert agency is better qualified to make decisions about a drug's safety than is a jury of 12 randomly selected citizens, Breyer said.

Of course, that sentiment is just what drugmakers would like to see borne out when the Court takes on the case of Wyeth v. Levine in October. In that case, the court is being asked to determine whether FDA approval pre-empts personal injury lawsuits. Last week, the Supremes decided that for medical devices, a specific type of rigorous FDA approval does shield manufacturers from liability suits.

If the wind were ever blowing in drugmakers' favor on this issue, it's now. Before the Bush administration, the FDA argued that lawsuits gave patients additional protection, the New York Times notes. Now, the administration says lawsuits conflict with the agency's ability to do its job. So, apparently, believes Justice Samuel Alito, who asked yesterday whether a state lawsuit should be allowed to proceed even though it might "very seriously interfere with what the FDA is doing."

Ironically, part of the government's argument in this case is that the FDA competently oversees the drug and device markets. An assessment that, after recent expert critique and importation snafus, is certainly open to question.

- read the Forbes article
- check out the NYT article

Suggested Articles

Intercept presented a data analysis that found treatment with Ocaliva led to "early and consistent improvements" in a range of noninvasive tests.

Intent-driven audiences are inspired to make health-improving changes after a positive online experience. Find out what they’re driven to do.

Days before Amarin faces a pivotal FDA vote on its Vascepa expansion, advisors are set to scrutinize the placebo used in its pivotal outcomes trial.