Drug & Device News

Doctor Fined for Writing PRescriptions for Non-Patients(s)

The federal government has entered into a settlement agreement with Avinit Mitra, M.D., to conclude an investigation that led to civil claims that the doctor prescribed medications to a person or persons who were not his patient. The drugs in question were Opana and Oxycontin, both Schedule II controlled substances' usually prescribed for controlling severe pain. As a psychiatrist, Dr. Mitra is legally authorized to write prescriptions, but pain relief medications are not generally ordered by those in his specialty. The settlement, which requires the doctor to pay the gorvernment $45,000, was announced by the Office of the U.S. Attorney for the District of Connecticut in a release, which explained, “Congress, with the passage of the Controlled Substances Act, took steps to attempt to create 'a closed system' of distribution for controlled substances in which every facet of the handling of the substances, from their manufacture to their consumption by the ultimate user, was to be subject to intense governmental regulation. This mission was taken against the backdrop of trying to prevent the diversion and abuse of legitimate controlled substances while at the same time ensuring an adequate supply of those substances needed to meet the medical and scientific needs of the United States.”

RICO Claims Viable

Racketeer Influenced and Corrupt Organizations Act (RICO) claims brought by three labor union benefit funds survived Avandia manufacturer GlaxoSmithKline's motions to dismiss in federal court in Philadelphia. The plaintiffs claimed that they were induced to prioritize use of Avandia over other drugs for their beneficiaries because the pharmaceuticals manufacterer hid their safety concerns from the public. The plaintiffs relied in part on an article published by Steven Nissen and Kathy Wolski in the New England Journal of Medicine, which described a 2007 study showing an increased likelihood of heart problems in patients taking Avandia to control their blood sugar levels.

While U.S. District Judge Cynthia M. Rufe of the Eastern District of Pennsylvania held that the plaintiffs' related unjust enrichment claims must be dismissed, she found the RICO claims could go forward because “all three complaints allege that through its public statements and marketing efforts, GSK engaged in deceptive behavior with regard to the safety of Avandia, even after the Nissen study was published, and it took steps to avoid detection of their deceptive behavior.”

Warnings Came Too Late

A federal jury in Orlando has awarded a woman $1.3 million dollars for jawbone injuries she suffered after using the cancer treatment drug Zometa. The plaintiff, Nancy Guenther, began using the drug in 2002. In 2003, Zometa's manufacturer, Novartis Pharmaceutical Corp., changed its warning label to include cautioning that the nitrogenous bisphosphonates in the drug could cause so-called “phossy jaw,” a necrosis of the jawbone associated with overexposure to phosphorus. Novartis unsuccessfully tried to keep evidence from the jury indicating that it should have known before 2003 that phosphorus could cause these problems and should have studied this possibility; the plaintiff wanted to present independent studies of the effects of phosphorus overexposure that existed before Guenther began using Zometa, as well as historical data on the well-documented cases of phossy-jaw in 19th- and 20th-century workers affected by white phosphorus in match factories. The court allowed the evidence, as it was not convinced by the drug company's bare assertion that the substances in Zometa are different. The jury concluded that Novartis negligently failed to warn the plaintiff.

Generic Painkillers

In an appeal filed with the U.S. Court of Appeals for the Sixth Circuit, plaintiffs allegedly injured by generic versions of the painkillers Darvon and Darvocet are seeking to revive their dismissed claims. Plaintiffs in the approximate 200 dismissed cases assert that theirs is an issue of first impression: Can patients bring a viable claim against a generic drug's manufacturer if it continued to sell its drugs after the brand-name equivalent was required to change its warning label or was pulled from the market?

The cases were dismissed by U.S. District Judge Danny Reeves, who is overseeing the multidistrict litigation, on the basis of the U.S. Supreme Court's decision in Pliva v. Mensing. Mensing held that generic drug manufacturers cannot be held liable for failure to warn patients of potential harm if their warning labels carry the same warnings as those approved by the U.S. Food and Drug Administration (FDA) for their brand-name equivalents. The reasoning is that generic drug manufacturers must be held harmless because they are required to carry those same, exact, warnings approved for the brand-name equivalent; any deviation is a violation of federal law. This case is different, say the plaintiffs, because Darvon and Darvocet were pulled from the market by the FDA, but generic makers continued to sell their products for some time afterward even though they should have known that this was dangerous to consumers.'

Doctor Fined for Writing PRescriptions for Non-Patients(s)

The federal government has entered into a settlement agreement with Avinit Mitra, M.D., to conclude an investigation that led to civil claims that the doctor prescribed medications to a person or persons who were not his patient. The drugs in question were Opana and Oxycontin, both Schedule II controlled substances' usually prescribed for controlling severe pain. As a psychiatrist, Dr. Mitra is legally authorized to write prescriptions, but pain relief medications are not generally ordered by those in his specialty. The settlement, which requires the doctor to pay the gorvernment $45,000, was announced by the Office of the U.S. Attorney for the District of Connecticut in a release, which explained, “Congress, with the passage of the Controlled Substances Act, took steps to attempt to create 'a closed system' of distribution for controlled substances in which every facet of the handling of the substances, from their manufacture to their consumption by the ultimate user, was to be subject to intense governmental regulation. This mission was taken against the backdrop of trying to prevent the diversion and abuse of legitimate controlled substances while at the same time ensuring an adequate supply of those substances needed to meet the medical and scientific needs of the United States.”

RICO Claims Viable

Racketeer Influenced and Corrupt Organizations Act (RICO) claims brought by three labor union benefit funds survived Avandia manufacturer GlaxoSmithKline's motions to dismiss in federal court in Philadelphia. The plaintiffs claimed that they were induced to prioritize use of Avandia over other drugs for their beneficiaries because the pharmaceuticals manufacterer hid their safety concerns from the public. The plaintiffs relied in part on an article published by Steven Nissen and Kathy Wolski in the New England Journal of Medicine, which described a 2007 study showing an increased likelihood of heart problems in patients taking Avandia to control their blood sugar levels.

While U.S. District Judge Cynthia M. Rufe of the Eastern District of Pennsylvania held that the plaintiffs' related unjust enrichment claims must be dismissed, she found the RICO claims could go forward because “all three complaints allege that through its public statements and marketing efforts, GSK engaged in deceptive behavior with regard to the safety of Avandia, even after the Nissen study was published, and it took steps to avoid detection of their deceptive behavior.”

Warnings Came Too Late

A federal jury in Orlando has awarded a woman $1.3 million dollars for jawbone injuries she suffered after using the cancer treatment drug Zometa. The plaintiff, Nancy Guenther, began using the drug in 2002. In 2003, Zometa's manufacturer, Novartis Pharmaceutical Corp., changed its warning label to include cautioning that the nitrogenous bisphosphonates in the drug could cause so-called “phossy jaw,” a necrosis of the jawbone associated with overexposure to phosphorus. Novartis unsuccessfully tried to keep evidence from the jury indicating that it should have known before 2003 that phosphorus could cause these problems and should have studied this possibility; the plaintiff wanted to present independent studies of the effects of phosphorus overexposure that existed before Guenther began using Zometa, as well as historical data on the well-documented cases of phossy-jaw in 19th- and 20th-century workers affected by white phosphorus in match factories. The court allowed the evidence, as it was not convinced by the drug company's bare assertion that the substances in Zometa are different. The jury concluded that Novartis negligently failed to warn the plaintiff.

Generic Painkillers

In an appeal filed with the U.S. Court of Appeals for the Sixth Circuit, plaintiffs allegedly injured by generic versions of the painkillers Darvon and Darvocet are seeking to revive their dismissed claims. Plaintiffs in the approximate 200 dismissed cases assert that theirs is an issue of first impression: Can patients bring a viable claim against a generic drug's manufacturer if it continued to sell its drugs after the brand-name equivalent was required to change its warning label or was pulled from the market?

The cases were dismissed by U.S. District Judge Danny Reeves, who is overseeing the multidistrict litigation, on the basis of the U.S. Supreme Court's decision in Pliva v. Mensing. Mensing held that generic drug manufacturers cannot be held liable for failure to warn patients of potential harm if their warning labels carry the same warnings as those approved by the U.S. Food and Drug Administration (FDA) for their brand-name equivalents. The reasoning is that generic drug manufacturers must be held harmless because they are required to carry those same, exact, warnings approved for the brand-name equivalent; any deviation is a violation of federal law. This case is different, say the plaintiffs, because Darvon and Darvocet were pulled from the market by the FDA, but generic makers continued to sell their products for some time afterward even though they should have known that this was dangerous to consumers.'