At Issue Is Whether Failure-To-Warn Claims By Plaintiffs Are Blocked By Federal Preemption Legal Doctrine, As Merck Contends
The U.S. Supreme Court on [December 4, 2017] asked the [US Solicitor General] to weigh in on an attempt to end multidistrict litigation against Merck Sharp & Dohme Corp. over its alleged failure to warn about fracture risks from its osteoporosis drug Fosamax that hinges on a U.S. Food and Drug Administration decision.
The court asked the [US Solicitor General] to file a brief explaining the government’s position on Merck’s request that the court end the suit alleging a failure to warn about potential femoral fractures...
In March 2017 the Third Circuit Court of Appeals decided to reverse a ruling by U.S. District Court Joel Pisano which had dismissed all the federal court Fosamax - femur fracture cases on federal preemption grounds. In turn, hundreds of those Fosamax lawsuits have been reinstated at the trial court level.
Now, by means of an August 2017 legal filing, Merck wants the U.S. Supreme Court to reverse this appeals court decision reinstating those cases.
As background, from our article about that development, "Fosamax - Femur Fracture Lawsuits In Federal Court MDL: March 2017 Appellate Court Ruling Reinstates Lawsuits":
Essentially, the Third Circuit held that the ultimate question of whether the FDA would have rejected a Fosamax label change by Merck to warn about an increased risk of femur fractures is a question of fact for the jury -- rather than for Judge Pisano -- to decide....
Certainly the Third Circuit's ruling on the Fosamax appeals is a positive development for the patients who suffered femur fractures after long-term Fosamax use and filed drug injury lawsuits against Merck.
However, it is just a first step in terms of the Fosamax - femur fracture litigation moving forward. Significantly, at the present time we do not know Merck’s plans regarding any further appeal to the United States Supreme Court.
Thereafter, the Third Circuit denied Merck’s motion for rehearing and rehearing en banc on April 24, 2017.
On June 23, 2017, Samuel Alito, an Associate Justice of the Supreme Court of the United States, extended the time for Merck to file a certiorari petition to the Supreme Court until August 22, 2017.
It was on the final day of this extension of time when attorneys for Merck filed their Petition For A Writ Of Certiorari, which sets the stage for Merck's Fosamax appeal to the Supreme Court with the following:
The question presented is: Is a state-law failure-to-warn claim preempted when the FDA rejected the drug manufacturer’s proposal to warn about the risk after being provided with the relevant scientific data; or must such a case go to a jury for conjecture as to why the FDA rejected the proposed warning?
We get some contextual information from an August 23, 2017 article, "Merck Wants SCOTUS to Review Decision Reviving Fosamax Suits", by reporter Julie A. Steinberg, which was published in Bloomberg BNA's Product Safety & Liability Reporter:
The U.S. Court of Appeals for the Third Circuit said warning claims involving a branded drug are preempted, or barred by federal law, only if a jury finds it “highly probable” the Food and Drug Administration would have rejected the warning a plaintiff sought....
Its ruling is the latest in a series of plaintiff-friendly decisions that misconstrued the Supreme Court’s landmark 2009 ruling in Wyeth Inc. v. Levine and gutted the pharmaceutical industry’s critical preemption defense, Merck says in an Aug. 22 petition for certiorari, or Supreme Court review.
Levine said failure-to-warn claims are blocked by federal law if a drug company can show “clear evidence” the FDA would have nixed a proposed warning....
But here, Merck submitted data and analysis to the FDA suggesting that Fosamax may be associated with certain bone fractures, and proposed a warning. The FDA rejected the proposed addition, saying it wasn’t supported by the data, Merck says.
The Third Circuit, though, said a jury could find the FDA might have allowed a differently phrased warning.
That decision displaces the court as the gatekeeper applying the rule of law, and invites a lay jury to speculate about why an expert federal agency did what it did, Merck argues.
We will watch to see whether Merck's request for review is granted by the Supreme Court.
If it is, then counsel for plaintiffs in the Fosamax - femur fracture litigation will have an opportunity to tell the Supreme Court why these drug injury products liability lawsuits against Merck should be allowed to go forward.
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