Alerts and implant recalls

Prescription drug abuse reached epidemic levels in the U.S. in the last decade. As the world’s leader and trendsetter in a multitude of areas, the country has a history of setting examples for the rest of the world – both good and bad. The abuse of pharmaceuticals hasn’t officially reached pandemic levels across the globe, but it’s grown to be a major cause for concern. According to the International Narcotics Control Board (INCB), prescription drugs as a category moved up to second on the list of the most abused and trafficked types of drugs in the world.

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Victims of transvaginal mesh injuries earned another victory over device manufacturers. C.R. Bard agreed to pay $200 million to settle roughly 3,000 cases, concluding about 20 percent of remaining lawsuits against mesh manufacturers. The settlement resolved the majority of the company’s transvaginal mesh cases remaining in multidistrict litigation (MDL) courts. Plaintiffs filed more than 80,000 cases in MDLs, claiming the devices injured them. Thus far, manufacturers agreed to settlements or lost verdicts resulting in more than $1 billion of payments. Transvaginal mesh is a device made of polypropylene plastic which doctors insert through a woman’s vagina to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

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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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Medical device giant Zimmer took a loss over the Durom Cup hip replacement system after a Los Angeles jury awarded $9.2 million to a man who says the implant caused him permanent injuries. Gary Kline, 59, filed the lawsuit against the device manufacturer after he received the implant and suffered complications and had to undergo two revision surgeries to correct problems. The trial lasted three weeks and the jury returned its verdict after only a few hours. It found Zimmer failed to warn of the dangers associated with the Durom Cup and that its design was faulty.

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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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It kills more people than car accidents every year. The Centers for Disease Control and Prevention (CDC) classified it as an epidemic and the World Health Organization (WHO) reported it threatened the achievements of modern medicine. Prescription drug abuse is a global problem, and the U.S. is the world’s biggest addict. Americans account for 99 percent of the world’s hydrocodone (Vicodin) consumption, 80 percent of the world’s oxycodone (Percocet and Oxycontin) consumption and 65 percent of the world’s hydromorphone (Dilaudid) consumption, according to the New York Times. Major causes of preventable death – like car accidents – have been on the decline, but deaths from drug abuse doubled in the last decade, according to the L.A.

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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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July marked the 50th anniversary of the Medicare and Medicaid programs, the primary funders of more than 15,000 nursing homes in the U.S. The White House’s Department of Health and Human Services used the moment to propose a major overhaul to the requirements for nursing homes to qualify for Medicare and Medicaid payments. It’s not the first national action proposed to improve the quality of care elderly citizens receive in nursing homes. Government agencies and professional organizations have attempted to do that by proposing legislation and launching initiatives for years.

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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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