Orthopedic Alerts for Patients - Implant Recalls

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

July 20, 2017 A government alert slowed inferior vena cava implants in 2010 but the U.S. still uses far more of the controversial clot-blocking devices than European countries, a new study found. The rate of inferior vena cava (IVC) filter placements in this country dropped 29 percent to 39.1 per 100,000 patients in 2014. That’s still dramatically higher than the IVC filter implantation rate in five large European countries of 3 in 100,000 patients, a study in JAMA Internal Medicine on July 10 said. “In the United States, the IVC filter implantation rates are 25 fold higher than in Europe,” research leader Dr.

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July 14, 2017 Two former sales representatives for an Arizona-based drug company pled guilty this week to participating in a multimillion-dollar kickback scheme designed to boost sales of a powerful prescription painkiller, federal officials announced. The now-defunct program at Insys Therapeutics ostensibly involved paying doctors an “honorarium,” typically $1,000 to $3,000, in exchange for brief speeches at high-end restaurants to other health care professionals about the benefits of Subsys, a drug containing the opioid fentanyl. “In truth, the events were usually just a gathering of friends and co-workers, most of whom did not have the ability to prescribe Subsys, and no educational component took place,” the U.S.

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  The first Xarelto bellwether trial began on April 24, 2017 in New Orleans, and the plaintiff accused Johnson & Johnson and Bayer of failing to warn that the blood thinner could cause serious or fatal bleeding. Joseph Boudreaux took Xarelto to help cut his stroke risk, but instead the drug caused serious gastrointestinal bleeding, according to his lawsuit. Boudreaux spent a week in the intensive care unit and needed several blood transfusions and heart procedures. He also claimed that the drug makers failed to warn patients and doctors that the drug had no antidote or a way to determine which patients were at higher risk for bleeding.

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July 6, 2017 A month after the U.S. Food and Drug Administration’s unprecedented request that a painkiller be taken off the market because of issues with abuse, Endo International has agreed to voluntarily stop selling Opana ER and recall the drug from the U.S. market. The company “continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER…when used as intended, and notes that the company has taken significant steps over the years to combat misuse and abuse,” Endo said in a news release July 6.

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  An additional 3,000 plaintiffs filed Risperdal (risperidone) gynecomastia lawsuits against Johnson & Johnson and Janssen Pharmaceuticals in 2017, bringing the total to more than 5,500, Forbes reported. According to reports from the Philadelphia Court of Common Pleas, plaintiffs filed the suits in the first three months of 2017. About 80 percent of cases in the CLC come from out-of-state plaintiffs. Philadelphia’s Complex Litigation Center Director Stanley Thompson told Forbes the CLC would “deal with [the lawsuits] in due course.” Claims against J&J and its Janssen subsidiary say the drug giant failed to warn the antipsychotic Risperdal can cause gynecomastia — a condition where young men and boys grow female breasts.

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  A Philadelphia jury has awarded a $20 million verdict in favor of a New Jersey woman who suffered complications after a June 2007 pelvic-mesh procedure. The award — $17.5 million of which was for punitive damages — is the latest against Ethicon, a subsidiary of Johnson & Johnson, which has faced thousands of lawsuits in connection with its vaginal-mesh products. In February 2015, the company settled more than 100 lawsuits filed by women who claimed the Mentor ObTape Transobturator Sling devices caused them permanent injuries. The company has maintained that the benefits of the devices outweigh the risks.

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  As Americans continue to file hernia mesh lawsuits, Canadians began their hernia mesh class action claiming they weren’t warned of the implant’s risks. The device at the center of the claims is Ethicon’s Physiomesh Hernia Mesh which Health Canada recalled in 2016. The Canadian agency’s action came after it learned that recurrence and reoperation rates with the device were higher than those of other meshes. After the recall, Canadians who received Physiomesh suffered severe pain and had to undergo additional surgeries to repair hernias that reoccurred. Canadian lawyer Jill McCartney is representing plaintiffs in the class action.

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  A federal jury in New Orleans recently sided with drugmakers Bayer AG and Johnson & Johnson in the first bellwether trial from plaintiffs alleging they were harmed by the blood-thinning drug Xarelto. Joseph Boudreaux, 75, of Louisiana blamed the drugmakers for life-threatening bleeding after taking the drug. He is the first in a series of four Xarelto bellwether cases (test trials) set to take place this summer in a consolidated legal action called a multidistrict litigation that involves nearly 20,000 plaintiffs. The verdicts in these trials will assist other plaintiffs and the drug companies assess potential outcomes and values of similar claims in pending litigation.

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A Texas man filed a lawsuit against Bristol-Myers Squibb and AstraZeneca claiming the Type 2 diabetes drug Onglyza (saxagliptin) caused heart failure, according to court documents. According to Wrendell Chester’s complaint for damages filed on Feb. 1, 2017 in the United States District Court for the Southern District of Texas, he took both Onglyza and Kombiglyze XR (saxagliptin and metformin extended release) between 2010 and 2015. After taking the drugs, he suffered congestive heart failure, heart failure and acute hypoxic respiratory failure — a condition where there is not enough oxygen in the blood.

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