Deceiving the public about Fosamax side effects, was it the FDA or Merck?

Merck Fights Broken-Leg Claims in 3rd Circuit



     NEWARK, N.J. (CN) — Remaining class-action lawsuits claiming one of Merck’s drugs caused weakened bones and eventual femur fractures should not go to a jury trial, the pharmaceutical company’s attorney argued Thursday before the Third Circuit.
     A federal judge in 2014 dismissed more than 1,000 so-called Fosamax Femur cases, tossing the allegations that Merck had failed to adequately warn consumers about osteoporosis drug Fosamax’s risks because the U.S. Food and Drug Administration had not officially approved or rejected the label’s language.
     In arguments today before the Third Circuit, Skadden Arps attorney John Beisner said the massive class-action lawsuit should be dismissed because Merck is protected by the “impossibility preemption” doctrine, which in this case means that Merck should not be liable because the FDA had not determined whether its label language was acceptable.
     Merck argued in court filings that the FDA had prohibited the company from warning consumers about certain health risks of Fosamax due to concerns about the language used. The company also said that the FDA had wanted to wait to gather information to issue an industry-wide stance on Fosamax..
     Beisner argued that now the Third Circuit — and not a jury — must now rule on whether Merck is protected under the preemption doctrine.
     “This is not a jury issue,” he said, noting the preemption issue was a question of law akin to deciding federal jurisdiction, and not subject to the whims of a jury, which might give different answers. “Either an issue is preempted or it isn’t.”
     But David Frederick, attorney for the consumers, argued that the case should move forward.
     “We’re talking about throwing these people out of court,” he said.
     In making his case, Frederick pointed to a 2009 U.S. Supreme Court ruling, in which the high court decided 6-3 against the preemption doctrine in a separate product liability case, Wyeth v. Levine, finding that state law had not been preempted in that case.
     In the Fosamax case, Frederick said the Third Circuit should allow the case to move forward to determine whether there is “clear evidence” that the FDA had any disputes with Merck’s labeling.
     During questioning, Judge Julio Fuentes said the issue of clear evidence has not been adequately defined by the Supreme Court, but that it seems to “stem from clear and convincing evidence without the word ‘convincing.'”
     Frederick argued that a 2009 memo from the FDA shows that the agency had problems with how Merck defined the possibility of atypical fractures — the pharmaceutical company used the term “stress fractures,” which are typically caused by exercise and heal normally.
     Fosamax, a drug used primarily by women with osteoporosis, has been linked to necrotic “jaw death,” as well as fractured bones due to bone decay.

Categories: Lethal or Unintended Side Effects, Pharmaceutical - Medical Devices

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