Alerts and implant recalls

One of the first laparoscopic power morcellator lawsuits filed in federal court settled for an undisclosed amount last week before it was scheduled to reach trial. Scott Burkhart filed the lawsuit against LiNA Medical in March 2014 after his wife, Donna, died of a uterine cancer called myelosarcoma  after she underwent a hysterectomy performed with a power morcellator. The company settled the case before it was set to go to trial later this year, ahead of about 20 other morcellator lawsuits, but did not comment on the settlement. As many as 1 in 350 women is suspected of having undiagnosed uterine sarcoma that may be spread during morcellation, according to the U.S.

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New studies may point to more data calling Johnson & Johnson’s blockbuster blood thinner Xarelto’s safety into question – most notably the possibility of an increase in stomach bleeds and eye hemorrhaging. In the first study, Drs. Judy H. Hun and John C. Hwang reported that patients in their practice in their 70’s and 80’s who transitioned from warfarin to Xarelto (rivaroxiban) suffered a “vitreous hemorrhage” – a bleed that occurs in space between the lens and retina of the eye – which they say were confirmed with tests. The patients previously took warfarin and as soon as they began weaning off of it and taking Xarelto, the bleeds occurred.

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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 Food and Drug Administration (FDA) warned that a new class of Type 2 diabetes drugs, including Johnson & Johnson’s blockbuster Invokana, may cause a serious condition that can lead to hospitalization. J&J’s Invokana (canagliflozin) works by causing blood sugar to leave the body through urine and is the most popular medication in a class of Type 2 diabetes drugs called SGLT2 inhibitors. According to the FDA’s warning, the drugs can cause a condition called ketoacidosis that happens when the body produces too many acids called ketones. Warning symptoms of the condition include nausea, vomiting, difficulty breathing, confusion, abdominal pain and unusual fatigue or sleepiness.

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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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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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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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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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