Orthopedic Alerts for Patients - Implant Recalls

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

A government report revealed limitations in the U.S. Food and Drug Administration’s adverse event reporting system led to a 23-year delay in warning the public about serious risks linked to surgical devices called power morcellators. In 2015, the Government Accountability Office began investigating the FDA and power morcellators at the request of Representatives Mike Fitzpatrick and Louise Slaughter and others over concerns the device could spread uterine cancer. The GAO report released on Feb. 7, 2017 found doctors, hospitals and individuals did not properly report morcellator problems to the FDA through its adverse event reporting system, causing a delay in the agency’s action to warn the public.

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Ethicon will defend against claims that its hernia mesh caused serious injuries in a trial slated to begin in 2018, according to court documents. The trial is the first Ethicon will face over its Physiomesh Flexible Composite Mesh. The plaintiff, Matthew Huff, was one of the first to file a lawsuit after Ethicon pulled the hernia mesh from the market in 2016. According to the company, it stopped selling the product because of higher rates of hernia recurrence and re-operation compared to similar products. Ethicon issued a voluntary recall in Europe and other countries, but only a “market withdrawal” in the U.S.

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A coalition of 20 states is suing six generic drug manufacturers, alleging they illegally conspired to inflate prices of two medications as part of an industrywide price-fixing scheme. The alleged scam, hammered out during dinners, “girls nights out” and parties, “caused a significant, lasting and ultimately harmful rippling effect in the United States healthcare system…” the lawsuit alleges. The suit stems from an investigation Connecticut launched in July 2014 amid outrage over “unexplained and suspicious price increases” for generic drugs.

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After its initial $1 billion dollar settlement offer in 2014, Stryker Corporation and Howmedica Osteonics Corp. reached a new agreement to compensate additional hip implant patients, according to a press release. In December 2016, Stryker announced it will “compensate additional eligible U.S. patients who had surgery to replace their Rejuvenate Modular Neck Hip Stem and ABG II Modular Neck Hip Stem, known as a revision surgery, prior to December 19, 2016.” Enrollment for the new program began Jan. 17 and ends March 1, 2017. Stryker requires 95 percent of eligible patients involved in lawsuits to enroll in the 2016 Settlement Program in order to begin paying out benefits.

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Bristol-Myers Squibb has reached a nearly $20 million settlement with a coalition of U.S. states after accusations the company improperly marketed the blockbuster antipsychotic drug Abilify (aripiprazole). The pharmaceutical giant will pay $19.5 million to 42 states and the District of Columbia to resolve claims it engaged in unfair or deceptive trade practices when marketing Abilify. The company denied any wrongdoing. The settlement was announced December 8, 2016.  Court approval is pending. Abilify generated $5.5 billion in sales in 2014.

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A study linked heartburn drugs called proton pump inhibitors — such as Nexium (esomeprazole) and Prilosec (omeprazole) — to increased risk of potentially serious stomach infections. The study published on Jan. 5 in the British Journal of Clinical Pharmacology followed about 565,000 adults in Tayside, Scotland. Dr. Thomas M. MacDonald and colleagues split patients into two groups: Those who used proton pump inhibitors and H2 receptor agonists — another kind of acid blocker — and a control group.

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The Judicial Panel for Multidistrict Litigation issued an order to consolidate dozens of Invokana (canagliflozin) diabetic ketoacidosis (DKA) and kidney damage lawsuits to New Jersey federal court, according to court documents filed Dec. 7. Effective immediately, the Panel transferred Invokana and Invokamet (canagliflozin and metformin) lawsuits from districts in Illinois, Kentucky, Missouri, Minnesota, Virginia and West Virginia to the District of New Jersey before U.S. District Judge Brian R. Martinotti. Invokana and Invokamet belong to a class of Type 2 diabetes drugs called SGLT2 inhibitors that work by stopping the kidneys from reabsorbing blood sugar.

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More than half of the nearly $5 billion recovered under the federal False Claims Act during the last budget year came from the health care industry. The U.S. Department of Justice secured roughly $4.7 billion in settlements and judgments from civil cases involving fraud and false claims during the budget year that ended Sept. 30. Of that, $2.5 billion came from the health care industry, including drug companies, medical device companies, hospitals, nursing homes, laboratories and physicians.

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The U.S. Senate has passed legislation intended to speed up Food and Drug Administration drug and device approvals and “cut red tape” at the agency, but critics say it benefits the industry more than patients. The U.S. House of Representatives already approved the bill— known as the 21st Century Cures Act — and the Senate passed it on Wednesday. Now it makes its way to President Obama, who said he would sign it.

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