Orthopedic Alerts for Patients - Implant Recalls

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

Lawyers for patients suing Johnson & Johnson and Bayer over severe bleeding injuries caused by the blockbuster blood thinner Xarelto say the drug makers failed to provide clinical trial data, the New York Times reported. Documents filed in court say a re-analysis conducted by Duke published by the New England Medical Journal of Medicine was missing key information that could have affected clinical trial data comparing Xarelto to warfarin in its 2011 ROCKET-AF study. J&J and Bayer stayed silent and helped deceive editors of the journal, lawyers said. The trial in question compared the safety of Xarelto and warfarin.

Read more ...

After months of deliberation, the U.S. Food and Drug Administration announced it is mandating stronger warnings and more studies for Bayer’s controversial Essure Permanent Birth Control device. The decision ignited a social media firestorm among women who say the device caused them severe, permanent injuries and led to hundreds of fetal deaths. Essure is a permanent birth control device made up of two nickel-titanium coils that doctors implant into a woman’s fallopian tubes. In about 3 months, scar tissue forms, blocking the tubes and preventing eggs from being fertilized. But, tens of thousands of women have spoken out about severe complications linked to the device, including organ perforation, severe pain and ectopic pregnancies.

Read more ...

Johnson & Johnson offered a large settlement to resolve its first big group of transvaginal mesh lawsuits, Bloomberg reported. The company agreed to settle as many as 3,000 cases for more than $120 million, according to Bloomberg’s anonymous sources. Women who filed the suits say they suffered complications because of the implants manufactured by J&J’s Ethicon unit and said the products were faulty. Transvaginal mesh — also called surgical mesh — started hitting the market in the 1990s. Surgeons insert a net-like piece of plastic through the abdomen or vaginal to treat incontinence or to support sagging pelvic organs in women.

Read more ...

A new study on testosterone gel revealed that the benefits of drugs like AndroGel are more modest than previously thought. Some doctors are still unsure about encouraging widespread use of the drug without more data on long term health risks like heart problems and prostate cancer. Makers of popular gels like AndroGel have been criticized for overhyping the benefits of testosterone replacement drugs and promising increased libido, energy and better mood while downplaying side effects. Results of the study suggest that testosterone gels are not cure-alls for the more than one million men that have been smearing gels on their bodies in recent years.

Read more ...

The federal judge overseeing lawsuits in the Zofran (ondansetron) anti-nausea drug multidistrict litigation in Massachusetts denied GlaxoSmithKline’s motion to dismiss the lawsuits. The judge sided with more than 200 families that sued GlaxoSmithKline for failing to warn them the morning sickness drug, Zofran, could cause birth defects. Pharma giant GSK argued that all the federal Zofran lawsuits should be thrown out because plaintiffs’ allegations of failure to warn are based on numerous state laws, not federal, and the FDA would have denied a request for label change. United States District Judge F. Dennis Saylor IV ruled on January 22, 2016 that plaintiffs will be allowed to continue with discovery, for now.

Read more ...

Did you develop cancer after a Hysterectomy? Get a Free Case Review A hysterectomy is a surgery for the removal of a woman’s uterus, also called the womb. This also stops a woman’s menstrual cycle and ability to become pregnant. This surgery is more common in the U.S. than anywhere else in the world. According to the Centers for Disease Control and Prevention, 600,000 women undergo the procedure each year and about 20 million American women have already had it done — making this surgery the second most frequently performed procedure for women in the U.S.

Read more ...

Five former Levaquin users filed a lawsuit against Johnson & Johnson and its Janssen unit claiming the drug giant deliberately downplayed side effects of the medication to boost profits. The plaintiffs’ lawsuit said J&J mislabeled and misbranded the popular antibiotic, causing “significant harm and/or death to consumers of Levaquin, including plaintiffs.” In addition to J&J, the plaintiffs name additional defendants, including former FDA commissioner Margaret Hamburg. The suit falls under the under the federal Racketeer Influenced and Corrupt Organizations (RICO) act, the law used to prosecute organized crime. Plaintiffs seek more than $800 million, about $120 million in compensatory damages and around $750 million in punitive damages — damages meant to punish companies and discourage the same kind of behavior in the future, according to Fierce Pharma.

Read more ...

A Missouri jury awarded the family of a woman a multi-million dollar verdict against Johnson & Johnson after she sued the Big Pharma giant claiming the company’s talcum powder caused her ovarian cancer. The St. Louis jury found J&J knew about the link between talc-based products and cancer for decades and failed to warn the public. They found the company liable for fraud, negligence and conspiracy. The jury ordered J&J to pay $10 million in compensatory damages and $62 million in punitive damages. This is the first verdict to award damages in a talcum powder case. For decades, women used talcum powder for feminine hygiene, sprinkling it on undergarments and the vaginal area to prevent odor or extra moisture.

Read more ...

Big Pharma paid out big settlements and got hit with some big jury verdicts in 2015. The year’s hardest hit companies include Johnson & Johnson, Takeda, Wright Medical and Boston Scientific. Lawsuits against the companies alleged the drug and device makers made false marketing claims, sold faulty products and failed to warn consumers about dangerous side effects, some fatal. A number of highly prescribed drugs and popular medical devices were at the heart of the litigation, including Type 2 diabetes medication, antipsychotic drugs and a number of medical devices like hip implants. Here are highlights of some of 2015’s big settlements, verdicts and controversies surrounding dangerous drugs and medical devices.

Read more ...