fosamax appeal

Supreme Court Sends Merck’s Fosamax Product Liability Case Back to Appeals Court

The US Supreme Court vacated and remanded a products liability case involving claims alleging a failure to warn about risks of stress fractures related to the use of Fosamax, which is manufactured by Merck Sharpe & Dohme Corp. (“Merck”).

Fosamax is a drug that treats and prevents osteoporosis in post-menopausal women. Merck argued that the claims should be dismissed as they submitted “clear evidence” that FDA regulations prohibited them from changing the Fosamax label to include the stress fracture risk warnings. The Supreme Court held that the Third Circuit incorrectly determined that “clear evidence” is a question of fact for a jury; rather, the Court held that “clear evidence” is a question of law as it involves a legal determination about an agency decision.

The FDA approved the sale of Fosamax in 1995. At that time, the Fosamax label did not warn of the risk of atypical femoral fracture, a type of stress fracture in the thigh bone. However, through post-market surveillance, Merck later concluded that the use of Fosamax was associated with an increase risk of these fractures. In 2008, Merck submitted to the FDA a labeling change proposal that would have included the risk of “stress fractures,” however the FDA rejected that proposal. Merck contends that FDA would also have rejected a labeling change proposal with the more specific language warning of the risk of “atypical stress fracture.”

500 individuals who took Fosamax between 1999 and 2010 and suffered atypical femoral fractures sued Merck under state tort laws with the theory that state laws imposed on Merck a duty to warn of the risk of these atypical femoral fractures. In the District Court, Merck argued that the respondents’ state law claims should be dismissed as pre-empted by federal law, as it would have been impossible for Merck to comply with both state law (which requires risk warnings) and federal law (which prohibits labeling changes unless approved by the FDA). The District Court agreed with Merck, and granted summary judgment dismissing the suit.

US Supreme Court Tosses Ruling Against Merck on Fosamax Osteoporosis Drug

The U.S. Supreme Court on Monday handed a victory to Merck & Co – at least for now – by throwing out a lower court ruling that had revived hundreds of lawsuits accusing the company of failing to properly warn patients of debilitating thigh-bone fractures from taking its osteoporosis drug Fosamax.

The nine justices unanimously directed the Philadelphia-based 3rd U.S. Circuit Court of Appeals to reconsider its decision allowing the lawsuits to proceed even though federal regulators had rebuffed Merck when the company sought to add a warning to Fosamax’s label about the fracture risk.

The decision added clarity to a defense used by drug makers against product liability claims in which they argue that such litigation is preempted under federal law and the U.S. Constitution when a federal agency takes certain actions, as the Food and Drug Administration did in this case.

In a decision written by Justice Stephen Breyer, the court said that judges, not juries, must decide disputes over preemption, and that a drug manufacturer must show that it “fully informed” the FDA of the need for a warning before it was rebuffed. Lower courts now must revisit the case reflecting the Supreme Court’s guidance.

Fosamax Lawsuits’ Future to be Decided by Supreme Court

The fate of about 500 lawsuits involving the drug Fosamax is now in the hands of the U.S. Supreme Court.

The nation’s highest court has agreed to consider overturning an appellate court ruling that reinstated the lawsuits after a federal trial judge dismissed them.

The issue involves whether Merck, the manufacturer of the osteoporosis drug, failed to warn of the danger that patients taking Fosamax could develop a specific type of thigh bone fractures.

Merck argues that it asked the U.S. Food and Drug Administration to approve such a warning on its label, but the FDA denied its request.

Lawyers for the injured patients say Merck asked for a warning about a different kind of fracture than those involved in the lawsuits.

The Third Circuit Court of Appeals ruled in March 2017 that jurors should decide the issue. But the Trump administration — invited by the Supreme Court to weigh in — maintained this issue should be decided by judges.

Merck wins Supreme Court hearing in pivotal Fosamax pre-emption case

Merck & Co. has another chance for a reprieve in its long-running fight against Fosamax liability lawsuits. After an appeals court revived hundreds of patient claims last year, the U.S. Supreme Court has decided to hear Merck’s bid to put them to rest again.

Merck argues that the FDA rebuffed its 2008 bid to update the osteoporosis drug’s label to warn of a link to severe bone fractures, but decided to order a warning in October 2010, when Merck did so. Now, Merck shouldn’t be held liable for that lack of a warning, because the FDA’s labeling power shields it, the company says.

And the high court will now review that argument, in an important development for the drug industry. The question of FDA pre-emption has made its way through multiple courts in recent years, and Merck’s Supreme Court appeal could settle it. That, in turn, could affect product liability cases across pharma.

For decades, scientists have used sandwich ELISA assays as a reliable tool for understanding disease mechanism, progression, and prognosis. Bio-Techne, a global life sciences company, recently conducted a blind survey to see how researchers have been using ELISAs lately and how they select and verify assays for their studies.

The results were surprising. Learn which ELISA features are most important to scientific researchers in 2021, the impact of in-house validation studies to research workflows, and more.

The history in Merck’s case is similar to a few other legal battles. Back in 2014, a federal judge dismissed a set of Fosamax fracture claims, saying the FDA’s decisions pre-empt state-court claims from patients. An appeals court in New Jersey revived those lawsuits—about 500 of them—and ordered them to be tried before a jury, because the facts weren’t a question for a judge to decide.

In reviewing Merck’s request for a hearing, the high court asked the U.S. Solicitor General to weigh in, and in its amicus brief backing Merck, the office says exactly the opposite: that FDA pre-emption is a legal question for a judge, not a jury. The FDA’s decision to reject Merck’s proposed label change supported pre-emption because it “prevented [Merck] from modifying the relevant labeling before late 2010.” Thus, he added, the court of appeals made a mistake in rejecting Merck’s defense. 

Merck seeks to reverse ruling reviving Fosamax injury lawsuits

Merck & Co Inc is urging a U.S. appeals court to reconsider a ruling that revived hundreds of lawsuits accusing the company of failing to adequately warn about the risks of thigh bone fractures associated with its osteoporosis drug Fosamax.

In papers filed on Wednesday, Merck asked the 3rd U.S. Circuit Court of Appeals in Philadelphia to grant a rehearing by the three-judge panel that issued the March 22 ruling or for a rehearing by the full 14-judge court.

* Word-Use Disclaimer

Legal funding is not a loan. It is the non-recourse purchase of an equitable lien in a plaintiffs’ legal claim. Words such as ‘loans,’ ‘lending,’ ‘borrow,’ etc., are used for search and marketing purposes only.
More info

TriMark Legal Funding LLC
1056 Green Acres Rd #102
Eugene, OR 97408