One Of The Legal Issues Is Whether Merck Could Have And Should Have Strengthened The Drug Label Warnings About This Apparent Side Effect, Or Not
UPDATE: On March 22, 2017 the Third Circuit Court of Appeals reversed the dismissal by U.S. District Court Joel Pisano of all the pending federal court Fosamax - femur fracture cases nationwide on federal preemption grounds. The Third Circuit significantly held that the ultimate question of whether the FDA would have rejected a Fosamax label change by Merck for the increased risk of femur fractures is a question of fact for the jury, rather than for the court, to decide.
The title of our last article about the Fosamax drug injury litigation, "Fosamax - Femur Fracture Update September 2015: Litigation Remains In "Holding Pattern" Awaiting Appellate Court Rulings", could well be (unfortunately) the title of this status update, with a simple change of the month and year.
Currently, we have some additional information about the arguments of the plaintiffs' attorneys and those of the lawyers for the drug company, Merck, in one of the pending appeals. However, no federal appellate court rulings have been made, yet.
What is at issue in that particular appeal is referred to as "impossibility preemption" in legal circles. This relatively new defense argument is not unique to the Fosamax - femur fracture litigation.
Essentially, the drug companies argue that at some time in the past -- which is now the focus of a current pharmaceutical products liability case -- it was impossible for them to add the now-controverted side effect warning without FDA approval, and therefore the plaintiffs' drug injury claims are preempted by federal law.
As regards the Fosamax - femur fracture litigation, our source for what the respective parties reportedly argued to the United States Court of Appeals for the Third Circuit is the publication Law360, which is available by paid subscription only. As such, the excerpts below are short and we are not linking to the published report as we usually do,
First, from this December 22, 2015 Law360 report, "Fosamax Users Rip Merck's Fracture Warnings In 3rd Circ.":
Osteoporosis sufferers pushing the Third Circuit to revive allegations that Merck failed to warn of painful leg fractures linked to its drug Fosamax disputed on Monday that the company had proposed stronger warnings only to be rebuffed by federal regulators.
The Fosamax users told the court that, contrary to claims by Merck Sharp & Dohme Corp. and the Pharmaceutical Research and Manufacturers of America, the drugmaker had in fact suggested alterations to its labels that the U.S. Food and Drug Administration found to be inadequate....
Second, from this January 11, 2016 Law360 report, "FDA Forbade Fosamax Warnings, Merck Tells 3rd Circ.':
Merck told the Third Circuit on Monday that the U.S. Food and Drug Administration prohibited it from warning patients about the risk of its osteoporosis drug Fosamax causing irregular hip fractures, saying there is clear evidence the agency blocked a proposed warning.
Merck Sharp & Dohme Corp. argued a U.S. Supreme Court ruling [in Wyeth v. Levine] barred claims like those brought by Fosamax users over Merck's alleged failure to warn of painful leg fractures associated with the drug....
Though we do not yet know which way the Third Circuit will rule on this appeal, we point out a very recent development at the Supreme Court of the United States that may someday have bearing on this "impossibility preemption" argument made by Merck in this Fosamax - femur fracture litigation.
Just yesterday the Supreme Court declined to accept for hearing an appeal for the case Johnson & Johnson, et al., Petitioners v. Lisa Reckis, et vir (see US Supreme Court docket for case).
From this January 19, 2016 Reuters news report, "U.S. top court won't hear J&J appeal of $140 million judgment":
The U.S. Supreme Court said on Tuesday it will not hear Johnson & Johnson’s appeal of a $140 million judgment in a lawsuit alleging it failed to warn that Children’s Motrin pain and fever medication could cause a devastating skin condition.
The decision leaves intact one of the largest verdicts ever awarded by a Massachusetts jury.
Johnson & Johnson and its McNeil-PPC Inc subsidiary had asked the high court to decide whether it should be held liable because they say federal drug regulators would not have approved adding warnings to the drug’s labels about the life-threatening condition suffered by the plaintiff, Samantha Reckis.
J&J’s petition had been closely watched by pharmaceutical industry trade groups.
They had urged the court to hear the case in order to clarify what constitutes "clear evidence" that the U.S. Food and Drug Administration (FDA) would have rejected a label warning about the diseases at issue in the lawsuit. If regulators did not think a warning was necessary, they argued, companies should not be liable for failing to
warn consumers about that risk.....
Of course, there are factual differences between the Reckis Motrin case trial verdict appeal and the Fosamax - femur fracture litigation on several levels. However, both sides in this litigation certainly are aware that the Supreme Court just declined the Reckis case appeal by Johnson & Johnson and, with it, their opportunity to weigh-in on this increasingly popular "impossibility defense" being asserted by drug company defendants in various drug injury lawsuits across the country.
Be assured that we are watching for rulings by the Third Circuit on the pending appeals in this federal court Fosamax - femur fracture MDL.