Articles Tagged with defective medical device

Lawsuits against Atrium Medical Corp. for its C-QUR hernia mesh product alleging these devices were not safe for use by humans. hands

One of the most recent cases is one filed in Florida Middle District Court in Orlando just this past month. In his filing, which alleges negligent manufacturing and strict product liability, plaintiff alleges he underwent surgery in April 2013 to repair multiple hernias. His surgeon used the C-QUR product. Subsequently, plaintiff alleges, he suffered injury.

Although the recent Florida Record article reporting the filing does not offer specific details on the man’s injury, we can make the inference based on previous claims, the type of liability asserted here and also what we know about the company’s history.  Continue reading

Hernia mesh manufacturer Atrium Medical Corp. will face multi-district litigation (MDL) in a federal New Hampshire court, after a  judicial panel surgeryagreed to centralize all federally-filed claims against the company for its C-QUR product. More than a dozen claims are pending at this juncture.

Atrium’s C-QUR hernia mesh was produced for use in reinforcing the abdominal wall as a permanent solution after hernia surgery. The company has said its unique Omega-3 coating lowers the risk of adhesions to internal organ tissue – which had been a major problem with other hernia mesh devices. However, plaintiffs in these pending lawsuits say the polypopylene patches were negligently designed and the company fraudulently convinced doctors the product was safe when executives and scientists with the firm knew it wasn’t.

Specifically, plaintiffs allege the netting of the product is “biologically incompatible” to be used with human tissue. This resulted in an unreasonable risk of serious medical complications, including infections.  Continue reading

A subsidiary of product manufacturing behemoth Johnson & Johnson is facing a product liability lawsuit for allegedly selling defective breast implants to unsuspecting women, causing them to suffer health woes such as muscle pain and nausea. The defective implants are reportedly made of a silicone base, and leakage has resulted in a host of problems for patients. woman

Bloomberg reports the subsidiary, Mentor Worldwide, is accused of negligence for its alleged failure to carry out proper studies of its implants. In particular, plaintiff alleges the company refused to explore potential health risks, as it was required by federal regulation agencies to do. The lawsuit, filed in a state court in California, alleges that leaks occur as a result of normal use, and the silicone in the products cause serious injury when it seeps out of the device and into the body.

You may recall that the U.S. Food & Drug Administration had forbidden any companies from selling silicone-based breast implants for nearly 15 years, beginning in 1992. The devices were shown to cause cancer and Rheumatoid arthritis. Initially, a $4 billion settlement was reached to cover all those claims, but that deal eventually fell apart and several firms filed for bankruptcy. The blanket ban on breast implants was lifted in 2006 and today, there are still only three companies – Mentor Worldwide included – that are permitted to sell silicone-based breast implants. Last year, the total market for breast implants nationally topped nearly $640 million. According to the American Society of Plastic Surgeons, about 8 in 10 women undergoing breast implant procedure choose to have the silicone-based product. Continue reading

Robotic surgery nearly killed her. That’s what plaintiff in Zarick v. Intuitive Surgical Inc. alleges in her $300 million product liability lawsuit. Although she survived, she suffered enormous physical pain and suffering and mental and emotional distress. She experienced the horror and agony of her intestines prolapsing through her vagina. She endured a life-threatening second surgery to repair the damage. Her internal injuries were significant, permanent and have all but annihilated her sexual relationship with her husband.surgery1

“It forever changed my life for the worse,” she told a reporter in 2013, four years after she had undergone hysterectomy surgery with the assistance of the Da Vinci robotic surgical system.

Her case is the first of many pending against the robotic surgery manufacturer, Intuitive Surgical, Inc. The 44-year-old alleges she underwent the surgery to address bleeding caused by benign cysts. She said she was convinced by her doctor to undergo the procedure because it was minimally invasive and, she was told, one of the safest and most effective ways to treat her condition. Continue reading