Alerts and implant recalls

There’s nothing like an anniversary or commemoration to remind you about things you take for granted or people that have inspired you. The AMC movie network pays tribute to die-hard consumer advocate, Erin Brockovich. I still remember watching Julia Roberts portray Erin Brockovich for the first time. The movie came out in 2000, but its themes still ring true. It is the true story of a down-to-earth single mother of three who stood up for those injured by the nefarious business practices of a big company, Pacific Gas & Electric (PG&E). It is a classic David vs.

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Amid growing concerns about the link between the blood-thinner Xarelto (rivaroxaban) to dangerous bleeding risks, a new serious side effect of the drug is coming to the forefront: post-surgical infections that could send people back into the hospital. Attorney Ellen Relkin of New York-based law firm Weitz & Luxenberg joins us on this week’s episode of Drugwatch Radio to explain what makes Xarelto dangerous and why patients and their families are filing lawsuits. FREE XARELTO CASE REVIEW If you took Xarelto and had internal bleeding or a pulmonary embolism, you may have legal options.

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Under pressure to strengthen oversight on the superbug scope that killed two people and possibly infected hundreds of others at UCLA, the Food and Drug Administration (FDA) is creating an advisory panel to deal with the spread of potentially deadly bacteria linked to contaminated duodenoscopes. The FDA Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee meets May 14-15 to examine the threat posed to patients by superbugs like carbapenem-resistant Enterobacteriaceae (CRE), which may lurk in these scopes and infect patients after endoscopic retrograde cholangiopancreatography (ERCP) procedures, according to the FDA. “FDA is convening this committee to seek expert scientific and clinical opinion related to reprocessing of duodenoscopes and other endoscopes, as well as automated endoscope reprocessors, based on available scientific information,” the agency said in its notice.

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After several years of hard-fought litigation, Takeda Pharmaceutical Company and its American subsidiary, Takeda Pharmaceuticals U.S.A., this week settled thousands of lawsuits in one of the largest drug company payouts in U.S. history. The Japanese drug company agreed to pay $2.37 billion to plaintiffs who claimed the company’s blockbuster Type 2 diabetes drug, Actos (pioglitazone), gave them bladder cancer. Complaints also said that the company hid the risk from patients and doctors and failed to warn the public. The drug maker announced the settlement Wednesday after its board of directors signed off on it.

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The company that manufactured the endoscope linked to UCLA’s deadly superbug infections never obtained approval from the Food and Drug Administration (FDA) for the device, an agency official told CNN. Doctors use these scopes in more than 500,000 procedures annually, and a patient infected by the superbug scope is now suing the device maker. The scope in question, Olympus’ TJF-Q180V duodenoscope, is used routinely in a procedure called endoscopic retrograde cholangiopancreatography (ERCP) to diagnose or treat diseases of the liver, bile ducts and the pancreas, including types of cancer. Doctors insert the flexible snake-like device into the body through the throat or anus.

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U.S. lawmakers are wondering why European hospitals were warned about contaminated duodenoscopes two years before the deadly Superbug outbreak in Los Angeles and U.S. health care providers weren’t warned until earlier this year. Two warning letters Olympus Corp sent to European hospitals in 2013 and 2014 about contamination of the TJF-Q180V duodenoscope recently surfaced, adding more fuel to the controversy surrounding the medical devices used to diagnose and treat a number of diseases. Olympus Corp., the manufacturer of the scrutinized endoscope, did not take action in the U.S. until after the February 2015 outbreak at UCLA and Cedars-Sinai medical centers.

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The Food and Drug Administration (FDA) ordered testosterone drugmakers to add heart attack and stroke risk warnings to medication labels and also warned doctors against over-prescribing the medication. The agency announced recently that pharmaceutical companies must clarify that testosterone drugs are only approved for use in men with low testosterone caused by an injury or disease. They also must warn physicians and patients that the treatment is not without risks, that the medication may increase the risk of cardiovascular problems including heart attack and stroke. “FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging,” the agency said.

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The largest knee implant maker in the world recently recalled thousands of its Persona Knee implants, leading the Food and Drug Administration to issue a warning that the implants can loosen early and cause complications. The manufacturer, Zimmer, says its recall is voluntary. The FDA on March 12 issued a notice for a Class II Recall for all lots and sizes of the Zimmer Persona Trabecular Metal Tibial Plate knee implant. According to the agency, 11,658 devices are affected by the recall. “Zimmer Inc. is initiating a voluntary recall of Persona Trabecular Metal Tibial following an increase in complaints of radiolucent lines and loosening.

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Johnson & Johnson and subsidiary Janssen Pharmaceuticals face ongoing legal troubles with Risperdal after the drug giant was slapped with two multimillion dollar verdicts this week – one awarded to a family of a young man who claimed he grew breasts while on the drug and the other to South Carolina for marketing fraud. A Philadelphia jury awarded $2.5 million after finding J&J liable for the side effects suffered by plaintiff Austin Pledger and his family. The company was judged to have failed to warn that the medication could cause gynecomastia, a condition where young men and boys develop breasts.

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