Orthopedic Alerts for Patients - Implant Recalls

Alerts and implant recalls for patients with orthopedic bone and joint conditions.

Johnson & Johnson offered a large settlement to resolve its first big group of transvaginal mesh lawsuits, Bloomberg reported. The company agreed to settle as many as 3,000 cases for more than $120 million, according to Bloomberg’s anonymous sources. Women who filed the suits say they suffered complications because of the implants manufactured by J&J’s Ethicon unit and said the products were faulty. Transvaginal mesh — also called surgical mesh — started hitting the market in the 1990s. Surgeons insert a net-like piece of plastic through the abdomen or vaginal to treat incontinence or to support sagging pelvic organs in women.

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The federal judge overseeing lawsuits in the Zofran (ondansetron) anti-nausea drug multidistrict litigation in Massachusetts denied GlaxoSmithKline’s motion to dismiss the lawsuits. The judge sided with more than 200 families that sued GlaxoSmithKline for failing to warn them the morning sickness drug, Zofran, could cause birth defects. Pharma giant GSK argued that all the federal Zofran lawsuits should be thrown out because plaintiffs’ allegations of failure to warn are based on numerous state laws, not federal, and the FDA would have denied a request for label change. United States District Judge F. Dennis Saylor IV ruled on January 22, 2016 that plaintiffs will be allowed to continue with discovery, for now.

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People who suffer traumatic injuries face a “life-threatening” risk for blood clots, but inferior vena cava (IVC) filters don’t give them a survival benefit, according to a new study. IVC filters are metal devices inserted into the vein of a person at risk for pulmonary embolisms – blood clots that can block the lungs. Experts estimate pulmonary embolisms are the third-highest cause of death in trauma patients who survive more than 24 hours after a traumatic injury. The filters are supposed to block the blood clot from reaching the lungs, but reports linked some IVC filters to high perforation rates.

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Five former Levaquin users filed a lawsuit against Johnson & Johnson and its Janssen unit claiming the drug giant deliberately downplayed side effects of the medication to boost profits. The plaintiffs’ lawsuit said J&J mislabeled and misbranded the popular antibiotic, causing “significant harm and/or death to consumers of Levaquin, including plaintiffs.” In addition to J&J, the plaintiffs name additional defendants, including former FDA commissioner Margaret Hamburg. The suit falls under the under the federal Racketeer Influenced and Corrupt Organizations (RICO) act, the law used to prosecute organized crime. Plaintiffs seek more than $800 million, about $120 million in compensatory damages and around $750 million in punitive damages — damages meant to punish companies and discourage the same kind of behavior in the future, according to Fierce Pharma.

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A Georgia jury handed Wright Medical an $11 million dollar loss in the first federal trial over its Conserve hip implant. The jury found Wright’s implant was defective, unreasonably dangerous and the manufacturer misrepresented the product’s safety. The trial began on Nov. 10 and ran for two weeks. Wright tried to place some of the fault on the plaintiff, former ski instructor Robyn Christiansen. The jury sided with the plaintiff and found the implant manufacturer 100 percent at fault. Christiansen’s Wright Conserve hip implant was replaced after it began causing her severe pain. She underwent additional surgery to replace it after only six years.

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Big Pharma paid out big settlements and got hit with some big jury verdicts in 2015. The year’s hardest hit companies include Johnson & Johnson, Takeda, Wright Medical and Boston Scientific. Lawsuits against the companies alleged the drug and device makers made false marketing claims, sold faulty products and failed to warn consumers about dangerous side effects, some fatal. A number of highly prescribed drugs and popular medical devices were at the heart of the litigation, including Type 2 diabetes medication, antipsychotic drugs and a number of medical devices like hip implants. Here are highlights of some of 2015’s big settlements, verdicts and controversies surrounding dangerous drugs and medical devices.

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Medical device manufacturer Boston Scientific recalled two cardiology devices after receiving reports of deadly fractures. The company sent letters to hospitals and health care facilities in October, voluntarily recalling 955 RotaWire Elite and wireClip Torquer devices. The devices are part of the Rotablator Rotational Atherectomy System which is used for removing plaque from arteries. The system uses a tiny wire to guide a diamond-tipped burr to a clogged artery. The tip of the tool rotates at high speeds to debulk or modify plaque buildup. “During the limited market release, Boston Scientific received three complaints for wire fracture,” the company said in the recall notice.

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This past Friday Olympus Corp. announced that it would recall a controversial medical scope linked to deadly superbug infections and give the device a design overhaul, according to an FDA statement. The scope in question, the TJF-Q180V duodenoscope, is used about 700,000 procedures each year, including those to treat pancreas problems, stomach disorders and cancer. The scope is mounted on a flexible tube and inserted through the mouth or anus. Olympus manufactures about 85 percent of all scopes used in the U.S. The recall and redesign came in response to a Senate committee report released on January 13, 2015 showing the company knew about the faulty design of its scopes since 2012.

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The number of Zofran birth defect lawsuits continues to climb after the U.S. Judicial Panel on Multidistrict Litigation issued the order to consolidate cases before Judge F. Dennis Saylor in Massachusetts. Parents of babies born with serious birth defects filed lawsuits against GlaxoSmithKline, claiming the company promoted the drug for unapproved uses and didn’t warn about the risk. The U.S. Food and Drug Administration approved GlaxoSmithKline’s Zofran (ondansetron) in 1991 for treating nausea and vomiting caused by cancer treatments such as chemotherapy. However, doctors began using the drug off-label to treat women with morning sickness.

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