An important role of the FDA is its responsibility for the approval and regulation of medical devices and implants. Medical advances have provided new options for sick or injured patients, and for those seeking cosmetic enhancements. Medical device manufacturers have profited from this growing need, in some cases putting safety aside to increase their bottom line. While millions of Americans depend on medical devices to stay healthy and alive, thousands lose their lives as a result of serious defects.

Breit Drescher Imprevento & Walker are nationally recognized attorneys in product liability, medical malpractice and personal injury law. Our experience and success representing plaintiffs in cases involving defective medical devices and implants can be evidenced by the verdicts and awards we have delivered on behalf of our clients. Some of our more recent cases have involved:

Defective Defibrillators: Defibrillators are implanted in an electronic device used to establish a normal heartbeat. Defibrillator makers Guidant and Medtronic issued separate recalls for several models of their defibrillators. In June 2005, Guidant was aware of 43 reports of device failures, and two patient deaths. Guidant has acknowledged that the actual rate of failure may be higher than the reported rate and that the number of associated deaths may be underreported, since implantable cardio-defibrillators are not routinely evaluated after death. The FDA and Guidant have advised physicians and patients to make individual decisions about whether to remove and replace the affected defibrillators on the basis of the specific medical situation of the patient.

Defective Stents: Stents are devices that are placed in a body structure (such as a blood vessel or the gastrointestinal tract) to provide support and keep the structure open. In 2003, more than 60 patients who had a Cypher heart stent implant died. The stents were coated with a drug that created blood clots around the device, increasing the risk of heart attack.

Defective Breast Implants: Silicone breast implants can leak, and long-term studies have shown that there is a possible link between silicone and diseases such as lupus, rheumatoid arthritis and illnesses that damage the immune system. More than 100,000 women who have had breast implant surgery have reported various chronic illnesses, and many breast implant patients have required two or more additional corrective surgeries.

If you are suffering from a defective medical device or implant, or have lost a loved one due a defective medical device, Breit Drescher Imprevento & Walker can provide experienced legal counsel today. If you live in Norfolk, Virginia Beach, Chesapeake, Suffolk or Portsmouth, call us or click here for a free consultation to review your case.

A growing risk

When the FDA decided to pull the plug on expanding the Medical Product Surveillance Network (or Med Sun), they limited the only system that allows doctors to notify the FDA directly about problems with defective medical implants and other medical devices. Without Med Sun, most of the 20,000 hospitals in the U.S. must report defects directly to the manufacturer at fault, and they are responsible for reporting the problem to the FDA. Critics point out that manufacturers can filter out and distort damaging information. Others say the FDA has become too close to the companies it is supposed to oversee, and isn’t proactive in enforcing the high standards of safety Americans should expect. Whatever the case, only 350 U.S. hospitals (less than 2 per cent) have direct access to Med Sun technology. This means that device manufacturers have almost exclusive power to determine the threats posed by their own products, pick and choose what they report and how it is reported.

What makes this situation worse is that lobbyists and special interest groups are hard at work to limit the rights of the thousands who die prematurely each year because of defective medical devices and implants.

Federal legislators have been working to prevent people from suing the manufacturers of defective medical products. They argue that patients lose the right to sue once a product has been approved by the FDA. But if the FDA receives its data from device manufacturers, isn’t the basis of its authority being compromised?

Americans can no assume that the FDA or other regulatory agencies have a grip on their primary mission: to protect and serve the American public. Instead, Americans must turn to experienced attorneys not afraid to confront American business head on and challenge them in court for acts of wrongdoing or harm to consumers.

To talk to an attorney at Breit Drescher Imprevento & Walker, call us at 757-622-6000 or email us for a free consultation. An experienced attorney will contact you within 24 hours to listen to your case.