Thanks to Supreme Court decision, Merck gets another chance to throw out Fosamax claims
In a temporary relief for Merck amid ongoing legal drama surrounding its osteoporosis drug Fosamax, the Supreme Court has vacated the judgment of a lower court and directed it to reconsider a ruling that allowed lawsuits to go to trial.
While the justices did not weigh in on the merits of those lawsuits, the decision revives Merck’s hopes of throwing out hundreds of patients claims, which accuse the pharma giant of violating state laws by neglecting to warn them of risks associated with Fosamax for over a decade. Even though scientists had speculated that Fosamax — a bisphosphonate designed to prevent osteoporotic fractures — could increase the risk of atypical femoral fractures before the FDA approved the drug in 1995, the label did not feature a warning on that score. Despite subsequent evidence from patient reports confirming the risk, a warning was not added until 2010 following an order from regulators.
Why didn’t Merck do anything about it during that time? It’s not for lack of trying, the company argues. Rather, its attempt to add a warning to the label was rejected by the FDA, freeing it of any legal responsibility for failure to warn.
Key to validating that argument is a legal principle in federal-state relations known as pre-emption. In this case — following a 2009 precedent set in Wyeth v. Levine — it means that when there is “clear evidence” that the FDA would not have approved the warning that state law requires, the drug manufacturer could not be blamed for failing to comply with that state law.
The plaintiffs might disagree on whether that criteria is met. In fact, Justice Stephen Breyer acknowledged in the majority opinion that the FDA turned down Merck’s proposed change on the grounds that it was “inadequate” and invited them to resubmit an application to fully address its deficiencies. But that’s up for a judge, not a jury, to decide — contradicting the decision of the 2017 ruling by the Court of Appeals for the Third Circuit.
That’s where the case, 17-290 Merck Sharp & Dohme Corp. v. Albrecht, is headed back now.
From the headnote summing up the unanimous ruling:
The question of agency disapproval is primarily one of law for a judge to decide. The question often involves the use of legal skills to determine whether agency disapproval fits facts that are not in dispute. Moreover, judges, rather than lay juries, are better equipped to evaluate the nature and scope of an agency’s determination, and are better suited to understand and to interpret agency decisions in light of the governing statutory and regulatory context. While contested brute facts will sometimes prove relevant to a court’s legal determination about the meaning and effect of an agency decision, such factual questions are subsumed within an already tightly circumscribed legal analysis and do not warrant submission alone or together with the larger pre-emption question to a jury.
Lawsuits against Merck on Fosamax first emerged around 2009, after the drug had gone generic. It still garnered $209 million in sales last year, according to financial reports.
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