Devices

Court Rejects Res Ipsa in Breast Implant Case: Attorney

A New Jersey federal court has reiterated that plaintiffs challenging the safety or effectiveness of Class 3 medical devices with premarket approval can’t rely on the res ipsa loquitur (occurrence of an accident implies negligence) doctrine to satisfy their pleading obligations. Attorney Andrew Tauber (Winston & Strawn) writes in an online post that the court dismissed manufacturing defect, warranty, and failure-to-warn claims against Johnson & Johnson arising from an allegedly defective breast implant.

Tauber says plaintiffs asserting manufacturing defect claims often don’t allege any facts suggesting that the particular unit they received deviated from its intended design. Rather, they rely on the res ipsa doctrine to argue that one can infer from their injury alone that the unit they received suffered from a manufacturing defect.

The court said that plaintiffs “cannot simply demonstrate a defect or a malfunction and rely on res ipsa loquitur” to state a manufacturing defect claim, Tauber writes. It held that since malfunctions can occur even if a manufacturer adheres to the FDA-approved manufacturing process, one cannot infer a manufacturing defect from the mere fact that a Class 3 medical device malfunctioned.

While the plaintiffs alleged that the company violated FDA current good manufacturing practice regulations, the court found that the suit’s “laundry list of alleged CGMP violations” was not sufficient because they were not tied to a defect in the manufacture of the specific unit received.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome