Orthopaedic Alerts - Implant Recall
Orthopedic Alerts for Patients - Implant Recalls
Alerts and implant recalls for patients with orthopedic bone and joint conditions.
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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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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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- By Michelle Llamas
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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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- By Michelle Llamas
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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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- By Michelle Llamas
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Proton pump inhibitors (PPIs) — a class of heartburn drugs that includes Nexium, Prilosec and Prevacid — may increase the risk of stroke, according to research presented at the American Heart Associations’ Scientific Sessions 2016.
Dr. Thomas Sehested of the Danish Heart Foundation in Copenhagen Denmark — the study’s lead author — presented his findings at the Scientific Sessions held on Nov. 12 to 16 in New Orleans, Louisiana.
PPIs are some of the most commonly used drugs in the U.S.
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- By Michelle Llamas
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A Texas jury has ordered pharmaceutical giant Johnson & Johnson to pay over $1 billion to six plaintiffs who said the implant maker hid flaws in its hip implants.
A federal jury in Dallas on December 1 concluded that J&J’s DePuy Orthopaedics unit knew about the risk that its Pinnacle hip implants would fail but did not warn patients or doctors.
According to plaintiffs, metal debris from the Pinnacle metal-on-metal hips entered the bloodstream and caused a number of complications that led to implant failure.
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- By Michelle Llamas
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The U.S. Food and Drug Administration (FDA) has received reports of acute pancreatitis linked to SGLT2 inhibitor Type 2 diabetes medications, the agency announced on its website.
The FDA said it was “evaluating the need for regulatory action” for acute pancreatitis in the SGLT2 inhibitor class of drugs.
The statement was included in the Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) list from April to June 2016.
“The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk,” the FDA said on its website.
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- By Michelle Llamas
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UK-based medical device company Smith & Nephew announced a recall of its Modular SMF and Modular Redapt hip implants after it received reports of complaints and adverse events.
Smith & Nephew issued an Urgent Field Safety Notice on November 15, 2016 to its customers with a list of affected lots and products. The company “initiated a voluntary market removal for all lots of modular neck hip prostheses due to a higher than anticipated complaint and adverse event trend,” according to the notice.
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- By Michelle Llamas
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Federal judges have consolidated dozens of lawsuits alleging the blockbuster antipsychotic drug Abilify (aripiprazole) caused compulsive gambling, sex addiction and other disorders.
U.S. District Judge M. Casey Rodgers will preside over about 43 compulsive-behavior lawsuits in multi-district litigation in the Pensacola-based Northern District of Florida.
Plaintiffs allege the drug’s makers, Bristol-Myers Squibb and Otsuka Pharmaceuticals, failed to properly warn patients about the drug’s possible side effects, including binge eating, compulsive gambling and sex addiction.
The Judicial Panel on Multidistrict Litigation issued the order to consolidate cases on Oct.
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