Preemption Ruling: Federal Appeals Court Strikes Strict Liability and Warranty Claims As to “Off-Label” Use of Bone Graft Device

Last week, the U.S. Court of Appeals for the 10th Circuit in Denver, in a 2-1 decision, upheld a trial court ruling dismissing a complaint on the grounds that federal law preempted a plaintiff’s state law breach of warranty and design defect claims. The claims stem from complications following the alleged “off-label” manner of implantation of a spinal bone graft system. Click here for the opinion in Caplinger. Background As the majority explained, under the Food, Drug, and Cosmetics Act, and the Medical Device…
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Beware: Claims of Efficacy of “Off-Label” Uses of Hyperbaric Oxygen Therapy

Hyperbaric oxygen therapy (HBOT), which involves exposure of the body in a chamber to 100% oxygen under pressure, is widely know as a treatment for “the bends,” the common name for decompression illness in divers. The FDA long ago approved this use of HBOT.  The benefit obtained from HBOT for that and other approved uses derives from injured tissue being exposed to up to three times greater oxygen than is dissolved in the blood through breathing ordinary oxygen at normal air pressure. Hyperbaric chambers are…
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Green Light for Aetna in RICO Suit

On April 3, 2013, the First Circuit held that Aetna, Inc. can sue Pfizer, Inc. for its off-label marketing of Neurontin®.  Neurontin® was approved for the treatment of epilepsy, but was allegedly marketed for the treatment of bipolar disorder and neuropathic pain in the mid 1990’s.  Aetna brought RICO and Pennsylvania Insurance Fraud Statute claims based on the off-label marketing. In reinstating the case, the Court found that the plaintiffs were not required to prove that the doctor’s off-label prescriptions were caused by the off-label…
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