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Supreme Court Gives Merck Procedural Victory in Fosamax Litigation


A common tactic employed by manufacturers in dangerous drug cases is to argue that federal law “preempts” state law claims raised by injured patients. For example, defective drug lawsuits often allege the manufacturer violated state law by failing to properly disclose certain risks on their product labels. The manufacturer will then argue that it would have been impossible to comply with such a labeling requirement under federal law.

Breyer: Judges, Not Juries, Should Decide When FDA Action Preempts State Law

The U.S. Supreme Court recently took up the issue of “impossibility preemption” and issued a decision that attempts to clarify the law in this area. The underlying lawsuit, Merck Sharp & Dohme Corp. v. Albrecht, involves the drug Fosamax, which is used to treat osteoporosis in postmenopausal women. In recent years, there have been a number of lawsuits alleging the use of Fosamax led to patients suffering “atypical femoral fractures,” i.e., a complete, low-energy break in patient’s thigh bone.

Merck, which produces Fosamax, argued in the lower federal courts the plaintiffs’ claims were subject to impossibility preemption. That is to say, the plaintiffs’ claims for “failure to warn” under state law were preempted by the FDA’s exclusive authority to regulate drug labels. Merck maintained that even if it had wanted to change the label on Fosamax earlier–during the time when the plaintiffs took the drug–the FDA would have rejected such an attempt based on the evidence available at the time.

The U.S. Third Circuit Court of Appeals in Philadelphia told Merck that it would have to submit its impossibility preemption claim to a jury. Merck then asked the Supreme Court to review that decision, arguing the trial judge should decide the question before the case goes to a jury. The Supreme Court agreed to review the case and ultimately agreed with Merck on this point.

Writing for the Supreme Court, Justice Stephen Breyer said that in order for an impossibility preemption defense to succeed, the drug manufacturer must provide “clear evidence” that the FDA would have rejected a proposed drug warning ostensibly required by state law. But the question of whether the FDA would have disapproved is ultimately one that should be answered by the trial judge, not the jury.

Breyer explained the question of agency disapproval “is primarily one of law,” not fact, and that “judges, rather than lay juries are better equipped to evaluate the nature and scopr of an agency’s determination, and are better suited to understand and to interpret agency decisions in light of the governing statute and regulatory context.”

The trial judge in this case previously determined the FDA had preempted the plaintiff’s proposed “failure to warn” claims via a letter it sent to Merck. The Supreme Court’s decision effectively affirms that ruling.

Speak with a Clinton Dangerous Drugs Lawyer Today

Although the Supreme Court’s decision may present a short-term victory for Merck and other drug manufacturers, it does not mean they are off the hook for putting dangerous and defective drugs on the market. If you have been injured as the result of using any drug or medical device and need advice from an experienced Clinton dangerous drugs lawyer, contact Fox, Farley, Willis & Burnette, Attorneys at Law, today to schedule a free consultation.



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