Drug & Device News

FDA Warns Maker of Heart Defibrillators

In January, St. Jude Medical received a warning letter from the FDA that cited manufacturing and quality control issues at the company's facility in Sylmar, CA, where it manufactures its Durata and Riata ST Optim high-voltage implantable cardiac leads. The company has not been told to recall any of its products or to stop manufacturing the Durata and Riata ST Optim products at the Sylmar plant, but until the discrepancies are remedied to the FDA's satisfaction, St. Jude cannot manufacture any new product lines at the facility.

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New York City Public Hospitals: Some Painkillers Banned

The City of New York has instituted new restrictions on the prescription of certain painkillers in City public hospital emergency rooms. The policy change, announced in January by Mayor Michael Bloomberg, was instituted in light of the findings of the Mayor's Task Force on Prescription Painkiller Abuse, whose initial report noted that City emergency room visits involving opioid painkillers nearly tripled between 2004 and 2010. Henceforth, City emergency departments will not be permitted to prescribe long-acting opioid painkillers like extended-release oxycodone, fentanyl patches or methadone. Even permitted opioid painkillers may only be prescribed (in most cases) in three-day doses; lost or stolen prescriptions will not be refilled. “These new guidelines effectively balance our mission to relieve patients' pain against concerns about drug abuse, dependency and the illicit diversion of opioid medications,” said Dr. Ross Wilson, Senior Vice President and Chief Medical Officer for the New York City Health and Hospitals Corporation in a release. “Under these guidelines, we can still treat acute pain of individual patients responsibly while limiting the risks that arise from significant quantities of unused narcotics sitting in someone's medicine cabinet.”

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Ninth Circuit Says Device Failure-to-Warn Claim Not Preempted

The U.S. Court of Appeals for the Ninth Circuit has declared that state-law claims against medical device manufacturers are not preempted by federal medical device law so long as the duty of care imposed by the state runs “parallel” to a duty established through federal law. The ruling in Stengel v. Medtronic, which puts the Ninth Circuit in the non-preemption camp with the Fifth and Seventh Circuits, reinstates a state-law claim against Medtronic over an implanted pump and catheter device it provided to plaintiff Richard Stengel. The device was meant to deliver pain relief directly to Stengel's spine, but he claims it also caused his permanent paralysis. Stengel's Arizona lawsuit asserts that Medtronic learned of problems with the pump subsequent to the device's approval by the FDA in 1999, yet failed to inform the FDA, medical providers or the public. Medtronic prevailed in a 2012 Ninth Circuit panel decision in which the court ruled that the federal Medical Device Amendments to the Food, Drug, and Cosmetic Act (FDCA) preempt any state law claim. But after this en banc rehearing, the justices unanimously sided with the plaintiff, concluding that even though the remedies available under Arizona law are more extensive than those provided by federal law, Arizona's laws protecting its citizens' health and safety impose the same duty of reasonable care that the amendments to the FDCA impose. Therefore, this state law claim is not pre-empted.

However, according to the concurring opinion authored by Judge Paul Watford, the plaintiffs have a “causation hurdle” ahead of them if they want to prove the case on the merits. “To prevail, they will ultimately have to prove that if Medtronic had properly reported the adverse events to the FDA as required under federal law, that information would have reached Mr. Stengel's doctors in time to prevent his injuries,” wrote Watford.

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FDA Warns Maker of Heart Defibrillators

In January, St. Jude Medical received a warning letter from the FDA that cited manufacturing and quality control issues at the company's facility in Sylmar, CA, where it manufactures its Durata and Riata ST Optim high-voltage implantable cardiac leads. The company has not been told to recall any of its products or to stop manufacturing the Durata and Riata ST Optim products at the Sylmar plant, but until the discrepancies are remedied to the FDA's satisfaction, St. Jude cannot manufacture any new product lines at the facility.

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New York City Public Hospitals: Some Painkillers Banned

The City of New York has instituted new restrictions on the prescription of certain painkillers in City public hospital emergency rooms. The policy change, announced in January by Mayor Michael Bloomberg, was instituted in light of the findings of the Mayor's Task Force on Prescription Painkiller Abuse, whose initial report noted that City emergency room visits involving opioid painkillers nearly tripled between 2004 and 2010. Henceforth, City emergency departments will not be permitted to prescribe long-acting opioid painkillers like extended-release oxycodone, fentanyl patches or methadone. Even permitted opioid painkillers may only be prescribed (in most cases) in three-day doses; lost or stolen prescriptions will not be refilled. “These new guidelines effectively balance our mission to relieve patients' pain against concerns about drug abuse, dependency and the illicit diversion of opioid medications,” said Dr. Ross Wilson, Senior Vice President and Chief Medical Officer for the New York City Health and Hospitals Corporation in a release. “Under these guidelines, we can still treat acute pain of individual patients responsibly while limiting the risks that arise from significant quantities of unused narcotics sitting in someone's medicine cabinet.”

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Ninth Circuit Says Device Failure-to-Warn Claim Not Preempted

The U.S. Court of Appeals for the Ninth Circuit has declared that state-law claims against medical device manufacturers are not preempted by federal medical device law so long as the duty of care imposed by the state runs “parallel” to a duty established through federal law. The ruling in Stengel v. Medtronic, which puts the Ninth Circuit in the non-preemption camp with the Fifth and Seventh Circuits, reinstates a state-law claim against Medtronic over an implanted pump and catheter device it provided to plaintiff Richard Stengel. The device was meant to deliver pain relief directly to Stengel's spine, but he claims it also caused his permanent paralysis. Stengel's Arizona lawsuit asserts that Medtronic learned of problems with the pump subsequent to the device's approval by the FDA in 1999, yet failed to inform the FDA, medical providers or the public. Medtronic prevailed in a 2012 Ninth Circuit panel decision in which the court ruled that the federal Medical Device Amendments to the Food, Drug, and Cosmetic Act (FDCA) preempt any state law claim. But after this en banc rehearing, the justices unanimously sided with the plaintiff, concluding that even though the remedies available under Arizona law are more extensive than those provided by federal law, Arizona's laws protecting its citizens' health and safety impose the same duty of reasonable care that the amendments to the FDCA impose. Therefore, this state law claim is not pre-empted.

However, according to the concurring opinion authored by Judge Paul Watford, the plaintiffs have a “causation hurdle” ahead of them if they want to prove the case on the merits. “To prevail, they will ultimately have to prove that if Medtronic had properly reported the adverse events to the FDA as required under federal law, that information would have reached Mr. Stengel's doctors in time to prevent his injuries,” wrote Watford.

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