Orthopedic Alerts for Patients - Implant Recalls
Alerts and implant recalls for patients with orthopedic bone and joint conditions.
- Written by Michelle Llamas
- Category: Alerts
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.
- Written by Michelle Llamas
- Category: Alerts
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.
- Written by Michelle Llamas
- Category: Alerts
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.
- Written by Chris Elkins
- Category: Alerts
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.
- Written by Michelle Llamas
- Category: Alerts
A study published in the Journal of Arthroplasty found the Apex K2 hip implant manufactured by OMNI — formerly OMNIlife Science, Inc. — has an above average rate of wearing down and complications. Some may fail in as little as a year after being implanted. This news may be troubling for patients who received these implants. The study conducted by Dr. Michael Kent and colleagues at the Perth Orthopaedic Institute in Australia involved 95 patients who received Apex K2 hip stems. Researchers followed study participants for two years. The goal of the study was to evaluate the stability and clinical outcomes of the hip stems.
- Written by Michelle Llamas
- Category: Alerts
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.
- Written by Chris Elkins
- Category: Alerts
Danish manufacturer Coloplast increased the transvaginal mesh litigation provision in its budget by 3 billion Danish crowns ($448 million). The provision is set aside to cover settlement and legal costs in the U.S. More than 2,000 lawsuits against Coloplast are pending in a multidistrict litigation court in the Southern District of West Virginia. “We have been ordered by the judicial system in the U.S. to take preliminary steps towards actual litigation on 200 specific cases,” Coloplast president and CEO Lars Rasmussen said in a press release. “This means that our costs in relation to the litigation will increase.
- Written by Chris Elkins
- Category: Alerts
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.
- Written by Michelle Llamas
- Category: Alerts
Takeda Pharmaceuticals reached settlement agreements with two Nevada plaintiffs who say the company’s Type 2 diabetes drug Actos gave them bladder cancer. After more than a month of arguments and testimonies, the Japanese drugmaker reached confidential settlements with the two plaintiffs and stopped the jury trial. Earlier this month, Takeda also announced that more than 97 percent of plaintiffs opted into its multi-billion-dollar settlement plan, increasing Takeda’s original offer of $2.37 billion to $2.4 billion, Law 360 reported. Legal experts say that Takeda is motivated to close down the Actos bladder cancer litigation and keep making settlements.