San Antonio Personal Injury Lawyer - Medical Devices & Implants

Lawsuits Consolidated against Manufacturer of Defective Urinary Device

Beth Janicek — Wed, 07 Jan 2009 10:03:56 GMT

I wrote a blog last month about the FDA’s quick review of certain medical devices and I referenced a “fast-track” approved device meant to help women with urinary issues but the device ended up being recalled. Similar urinary devices have made the news again due to recent lawsuits against a device manufacturer. The problematic device is a sling that is surgically implanted to treat stress urinary incontinence, which often is brought on by coughing, sneezing or exercise, and is common in women after childbirth. The product was removed from the market in 2006.

Now there are 32 pending lawsuits against Mentor Corp., a Santa Barbara, Calif.-based cosmetic surgery device manufacturer. The Plaintiffs claim Mentor was negligent in their design of the ObTape device and that they failed to properly warn patients of the risks of injury created by the device. The FDA issued a general warning to doctors about potential risks connected to these slings but the FDA did not specifically name the ObTape device.

A recent California jury verdict came down in favor of Mentor because the jury concluded the doctors knew of the risks involved when they implanted the ObTape. But, the litigation does not end there; a U.S. District Court in Georgia recently consolidated 22 lawsuits against Mentor regarding the ObTape device. Gary Blasingame, a lawyer handling some of the women’s cases said, “What they’re claiming is that because of the defective device, this ObTape, these women have experienced serious medical injuries and problems. We think it's a significant series of cases, and we think this product is one that we have alleged in our complaint and anticipate will be proven is defective."

Originally posted at InjuryBoard by Beth Janicek

Doctors Prescribing Medical Devices for Uanpproved Uses?

Beth Janicek — Tue, 07 Oct 2008 16:39:37 GMT

Pharmaceutical and medical device companies should develop high-quality, innovative products which assist Doctors in providing the best possible care for their patients. Instead it seems there are some companies using kickbacks such as money and trips to entice Doctors to prescribe their products—even if the product is not approved for a particular use. One such company is Medtronic, the world’s largest device maker, which has attracted the attention of two Senators, Charles Grassley, R-Iowa and Herb Kohl, D-Wis., who have asked Medtronic to provide details about physicians who receive company payments for consulting services. In attempt to prevent, or at least expose, such unethical practices, Sen. Grassley and Sen. Kohl have written a bill which would require companies to disclose all payments to physicians over $500.

This isn’t the first time Medtronic has been questioned about their physician-payment practices. In 2006 they reached a $40 million settlement with the U.S. Department of justices to settles charges that Medtronic paid doctors millions in kickbacks to use its spinal repair products. As a part of the settlement, the government agreed to seek dismissal of two law suits brought by former employees.

A recent Wall Street Journal Law Blog discussed one of these law suits, which includes such allegations that Medtronic sales staff took physicians to strip clubs and picked up the tab. The problem is even greater because there is widespread off-label use of Medtronic Infuse, a bone graft device, and some believe these non-approved uses stem from doctors who received kickbacks. This situation worsens because serious complications have been reported, and the Food and Drug Administration has warned doctors that using Infuse for off-label procedures, such as neck surgeries, has led to problems swallowing, breathing, and speaking which in some cases required additional surgery.

Originally posted at InjuryBoard by Beth Janicek

Squeaking Hips – Is It Grandpa’s Ceramic Hip?

Beth Janicek — Thu, 15 May 2008 19:02:36 GMT

Artificial hips have a basic design: a socket implanted in the pelvis, into which a spherical head is fitted. A spike is attached to the head which his driven into the femur, or thigh bone for anchorage. Hip replacements are very common and more than 250,000 Americans get hip implants each year. The procedure costs approximately $45,000.00. The success rate is more than 90% based on generally pain-free mobility after recovery. The recovery period varies and can be from a few months to a year.

In the United States in 2003, a medical products company, Stryker, began marketing highly durable ceramic hips. Many patients chose the highly durable ceramic hip to avoid a second replacement later in life. These ceramic hips were promoted as lasting more than the 15 years for the conventional joints made of steel and plastic. Prior to that, squeaking was very rare after hip replacement. Individuals who opted to go with the ceramic hip are now saying that the squeaking hips is interfering with their daily life. Mr. Mueller, a software executive in Scottsdale, Arizona has become so frustrated with squeaking and popping noises from his ceramic hip that he has displayed his problem on YouTube.

“One study in the Journal of Arthroplasty found that 10 patients of 143 who received ceramic hips from 2003 to 2005, or 7 percent, developed squeaking. Meanwhile, no squeaks occurred among a control group of 48 patients who received hips made of metal and plastic.”

Patients and their surgeons fear that the squeaky ceramic hips may be an alarm that the joints are wearing out prematurely.

Originally posted at InjuryBoard by Beth Janicek