Drug & Device News

New Jersey U.S. District Judge Joel Pisano has dismissed Barbara Gaynor's claims against Merck & Co. for a fractured femur she suffered after taking osteoporosis drug Fosomax. The court concluded that Gaynor's claim must fail because she used the product after Merck revised its labeling in 2010 to warn of the potential for fractures in Fosomax consumers. And it did not matter that Gaynor began taking the drug in 1996; her doctor was properly warned of the dangers after the label was changed and yet continued to prescribe Fosomax for Gaynor despite the change. Plaintiff counsel Paul Pennock of Weitz & Luxenberg in New York said the decision was “clearly wrong” because Gaynor's fractured femur was “a fait accompli” by the time Merck changed Fosomax's warning label. But Merck spokeswoman Lainie Keller said, “ We are pleased with the court's ruling that the updates to the Fosamax label in 2011 were adequate as a matter of law and that Merck adequately communicated those changes to others. The company provided appropriate and timely information about Fosamax to consumers and to the medical, scientific and regulatory communities.”

High-Ranking Pharmacist Charged with Trafficking Stolen Oxycodone

Prosecutors have charged the former head-pharmacist of New York City's Sinai Beth Israel Hospital with drug trafficking after he admitted to taking about 200,000 oxycodone pills with a street value of more than $5 million from the hospital's pharmacy. Anthony D'Alessandro allegedly requisitioned the pills for scientific studies that never took place, and then distributed them to others. The defendant pleaded not guilty to trafficking, sticking by his April confessional statement that he took the pills for his own use. Prosecutors were unconvinced, however, because of the sheer number of pills diverted since 2009, which would likely have killed D'Alessandro had he taken all of them himself.

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Allergan Says Kickback Allegations Are 'Baseless'

In its response to whistleblower claims filed in the U.S. District Court for the Eastern District of Pennsylvania, Allergan ' the pharmaceuticals company best known for producing Botox ' says allegations that it illegally induced ophthalmologists to prescribe its eye-care products are “baseless.” Among the company's eye-care products is the well-advertised prescription medication Restasis. The complaint was brought by relators Dr. Herbert Nevyas and Dr. Anita Nevyas-Wallace, both Pennsylvania ophthalmologists, who claim that “[a]s a direct result of defendant's improper practices, federal and state health insurance programs … have been caused to pay false or fraudulent claims for reimbursement of the defendant's prescription drugs that resulted from defendant's illegal kickbacks.” In support of its motion to dismiss, Allergan countered, in papers filed June 30, that the relators had advanced a “peculiar and baseless theory of liability, where the primary allegation is that Allergan openly advertised and charged eye care practices in the amount of several hundreds of dollars on an annual basis for product and practice management consultative services and that this program somehow constitutes an unlawful kickback scheme.”

Warning Label Change Gave Adequate Warning, Despite Plaintiff's Previous Use Of Fosomax

New Jersey U.S. District Judge Joel Pisano has dismissed Barbara Gaynor's claims against Merck & Co. for a fractured femur she suffered after taking osteoporosis drug Fosomax. The court concluded that Gaynor's claim must fail because she used the product after Merck revised its labeling in 2010 to warn of the potential for fractures in Fosomax consumers. And it did not matter that Gaynor began taking the drug in 1996; her doctor was properly warned of the dangers after the label was changed and yet continued to prescribe Fosomax for Gaynor despite the change. Plaintiff counsel Paul Pennock of Weitz & Luxenberg in New York said the decision was “clearly wrong” because Gaynor's fractured femur was “a fait accompli” by the time Merck changed Fosomax's warning label. But Merck spokeswoman Lainie Keller said, “ We are pleased with the court's ruling that the updates to the Fosamax label in 2011 were adequate as a matter of law and that Merck adequately communicated those changes to others. The company provided appropriate and timely information about Fosamax to consumers and to the medical, scientific and regulatory communities.”

High-Ranking Pharmacist Charged with Trafficking Stolen Oxycodone

Prosecutors have charged the former head-pharmacist of New York City's Sinai Beth Israel Hospital with drug trafficking after he admitted to taking about 200,000 oxycodone pills with a street value of more than $5 million from the hospital's pharmacy. Anthony D'Alessandro allegedly requisitioned the pills for scientific studies that never took place, and then distributed them to others. The defendant pleaded not guilty to trafficking, sticking by his April confessional statement that he took the pills for his own use. Prosecutors were unconvinced, however, because of the sheer number of pills diverted since 2009, which would likely have killed D'Alessandro had he taken all of them himself.

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