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Defective Medical Devices

While gaps, flaws and conflicts of interest in the Food & Drug Administration’s handling of the prescription drug approval process loom large in the public eye, another important role of the FDA is frequently overlooked. The FDA also has jurisdiction over approval and regulation of medical devices and implants. As medical advances provide more options for sick or injured American patients, and for Americans seeking cosmetic enhancements, medical device manufacturers have sought to maximize profits on this growing need by putting safety aside in order to increase their bottom line. Today, millions of Americans depend on these medical devices to stay healthy and alive. But each year, thousands of those millions lose their lives to defective medical devices. Many of these instances were preventable, had the FDA been doing its job. But as with prescription drugs, the FDA has fallen well short of its purpose in protecting Americans from defective medical devices.

For instance, last summer, the FDA decided to pull the plug on expanding the Medical Product Surveillance Network (or Med Sun), a system that allows doctors to notify the FDA directly about problems related to defective medical implants and other medical devices. Without Med Sun, most of the 20,000 hospitals in the U.S. must report defects or failures to the device manufacturer at fault, which in turn is responsible for reporting the problem to the FDA. Critics of the latter process say that device manufacturers filter out and distort damaging information about adverse effects in these reports. Others say that, in today’s business-first political climate, the FDA has become complicit with the companies it is supposed to oversee, and that upon receiving reports on defective medical devices, the FDA 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 exclusive power to assess the threats of their own products, pick and choose what they report and how it is reported. It’s safe to assume that such a system does not serve the best interests of the millions of Americans living with medical devices and implants.

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. The Bush administration, always steadfast in the interests of its big business supporters, is working to prevent people from suing the manufacturers of defective medical products. The administration is arguing 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?

These examples are part of a larger pattern developing today that shows Americans can no longer consistently rely on the integrity of the FDA and other regulatory agencies that have lost their 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.

As nationally recognized attorneys in product liability, medical malpractice and personal injury law, the attorneys of Breit, Drescher & Imprevento have had experience and success representing plaintiffs in cases involving defective medical devices and implants. Some of our more recent cases have involved:

Defective Defibrillators: Defibrillators are implanted in an electronic device used to establish normal heartbeat. Recently, defibrillator makers Guidant and Medtronic issued separate recalls for several models of defibrillator. As of 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, contact Breit Drescher & Imprevento for experienced legal counsel today.

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