Orthopedic Alerts for Patients - Implant Recalls
Alerts and implant recalls for patients with orthopedic bone and joint conditions.
- Written by Chris Elkins
- Category: Alerts
Lawsuits involving one of the biggest pharmaceutical companies and one of the most controversial medical devices in the U.S. now are centralized to a single court. Johnson & Johnson is accused of hiding knowledge that its power morcellator could cause an accidental spread of uterine cancer during hysterectomies and surgeries to remove fibroids. The Judicial Panel on Multidistrict Litigation transferred at least 28 morcellator lawsuits to the U.S. District Court for the District of Kansas, a multidistrict litigation (MDL) court. “This decision by the panel is an extremely important one because it ensures that these cases will move at the fastest possible pace,” said Paul Pennock, a lead attorney at Weitz & Luxenberg who led the arguments for consolidation.
- Written by Chris Elkins
- Category: Alerts
The inventor of Bair Hugger warming blankets is warning of the risk for infections the device could cause when used during orthopedic surgeries. Dr. Scott D. Augustine invented the Bair Hugger warming blanket and introduced it in 1988, but now he is claiming the device is more risky than once thought. “I am very proud of the old technology,” Augustine told the New York Times. “But I am also proud to spread the word that there is a problem.” Doctors use the warming blankets in millions of surgeries every year to prevent hypothermia – a condition where the body loses heat quicker than it can produce it.
- Written by Michelle Llamas
- Category: Alerts
The U.S. Food and Drug Administration (FDA) warned that Type 2 diabetes drugs in the Dipeptidyl peptidase-4 (DPP-4) inhibitors class may cause severe joint pain. A new warning will be added to the labels of all drugs in the class, said the FDA. These medications control blood sugar by blocking an enzyme in the body called dipeptidyl peptidase-4, allowing the body to make more insulin. The first approved medication in this class is Merck’s Januvia (sitagliptin) which hit the market in 2006. From 2006 to 2013, the agency noted 33 cases of severe, disabling joint pain.
- Written by Chris Elkins
- Category: Alerts
The lawsuits of families claiming the anti-nausea drug Zofran caused birth defects in their children are now consolidated to a single court in the Eastern District of Pennsylvania. The transfer order issued by the U.S. Judicial Panel on Multidistrict Litigation found sufficient evidence that 12 cases involved similar facts and a similar defendant – drugmaker GlaxoSmithKline. In order to increase efficiency and decrease costs, the cases were consolidated in a process called multidistrict litigation (MDL). An estimated 1 million women take Zofran (ondansetron) every year to treat nausea and vomiting during pregnancy (NVP), but the U.S.
- Written by Chris Elkins
- Category: Alerts
Testimony from a Johnson & Johnson biochemist revealed the company hid study results linking its antipsychotic drug Risperdal to dangerous hormonal levels from the U.S. Food and Drug Administration. A recent article in New Brunswick Today made testimony from the February trial of Austin Pledger public. A jury awarded the Alabama man $2.5 million for side effects he suffered from taking Risperdal (risperidone) as a child. Janssen Pharmaceuticals, a subsidiary of J&J, funded the 2003 study which concluded it found no link between elevated prolactin levels and long-term risperidone treatment.
- Written by Michelle Llamas
- Category: Alerts
Lawsuits against Pfizer alleging that its blockbuster cholesterol drug Lipitor (atorvastatin) – a statin taken by millions of Americans – caused Type 2 diabetes continue to mount, as the first bellwether cases in federal multidistrict litigation (MDL) move closer to trial. According to the latest report from the U.S. Judicial Panel on Multidistrict Litigation, more than 2,400 cases are pending before Judge Richard M. Gergel in the United States District Court for The District of South Carolina, Charleston Division. Plaintiffs assert that they developed Type 2 diabetes after taking Lipitor and must now face additional health risks and loss of quality of life.
- Written by Michelle Llamas
- Category: Alerts
The U.S. Food and Drug Administration (FDA) approved the first drug to treat loss of female sex drive this week. The agency’s approval of Addyi (flibanserin) – dubbed by the media as the “little pink pill” and “female Viagra” – has supporters cheering, calling it a victory for women. But critics call the drug marketed by Sprout Pharmaceuticals a “big mistake” and a “blunder,” citing a lack of evidence that the drug even works and a long list of side effects. About 10 percent of women suffer from hypoactive sexual desire disorder (HSDD), according to one survey, and this drug is approved to treat this condition in women who do not suffer from a loss of desire because of an illness, relationship problems or side effects of other drugs.
- Written by Chris Elkins
- Category: Alerts
Medical device manufacturer C.R. Bard may have known about its Recovery inferior vena cava (IVC) blood filter’s risks for complications before receiving permission to market it, according to an NBC News investigation. Bard might have also forged a signature on its application for FDA clearance, and a private study sponsored by Bard indicated the device was riskier than similar devices long before the manufacturer removed it from the market. IVC filters are inserted into a person’s vein to prevent blood clots from reaching the heart. The Recovery filter is associated with 27 deaths and about 300 other adverse events, according to NBC.
- Written by Chris Elkins
- Category: Alerts
When the U.S. House of Representatives approved the 21st Century Cures Act on July 10, the Food and Drug Administration’s (FDA) ability to protect consumers was one step closer to losing strength. The bill is currently awaiting U.S. Senate approval, but the FDA’s authority took a different hit when a federal district court judge ruled the agency’s off-label drug policy violated the free speech rights of pharmaceutical companies. The 21st Century Cures Act would allow potentially dangerous medical devices to reach the market more quickly and with less proof of safety. The judge’s free speech ruling opens the door to allowing pharmaceutical companies to more easily market drugs without FDA approval.