Google Screened

The FDA Needs Better Checks on Defective Medical Products

Philadelphia Defective Medical Device Lawyers Report on Investigation into Faulty Medical Devices

A recent investigation by investigative journalism group ProPublica reveals that the U.S. Food and Drug Administration (FDA) allows many faulty medical devices to be sold and implanted in peoples’ bodies without any clinical trials to ensure their safety.

Several implantable devices, such as hip prosthetics, heart valve rings, heart defibrillator leads and surgical mesh, were all introduced into the market under the FDA’s 510(k) process. Under that program, the FDA does not require clinical trials for new products as long as the manufacturer can show that the device is “substantially equivalent” to another device already on the market. The FDA touts the process as a means of getting life-saving devices to patients as fast as possible.

Unfortunately, many of these 510(k) devices have failed and caused injury to patients. A recent Institute of Medicine study, which examined data from 2005 to 2009, revealed that two thirds of the medical devices recalled during that period had gone through the 510(k) process instead of clinical trials. The findings led the Institute to recommend abolishing the 510(k) program. Though fast-tracking critical medical devices is desirable, it is often worth the extra time to ensure that medical products do not ultimately make matters worse.

Take for example, DePuy Orthopaedics’ hip implant. Approved under 510(k), the prosthetic was implanted in approximately 93,000 people before the company recalled it. Initial data had indicated that one in eight devices required revision surgery within five years. Thousands of patients suffered as metallic particles seeped into tissue and the blood stream, which is a tragedy that could have been prevented with proper pre-market testing.

The FDA also does a notoriously poor job of monitoring the performance of approved medical devices. As the FDA relies on self-reporting by manufacturers, life-threatening problems can go unnoticed for years. St. Jude’s Medical Inc. disputes the claim that its Riata defibrillator caused 20 deaths by malfunctioning at high voltage; however, the company made design changes to address these very safety issues. The FDA did not step in at any point.

There are many ways that the manufacturer of a defective medical device can be held accountable for injuries caused by a faulty product. Liability can arise from defects in the device’s design, in its manufacturing or in the way the product was marketed (if patients were not adequately warned of the potential risks involved in the product’s use). Moreover, a medical professional who knows of risks but fails to convey them to a patient may be liable for medical malpractice.

McCann Dillon Jaffe & Lamb, LLC:  Experienced Philadelphia Defective Medical Device Lawyers

If you or a loved one has been injured or killed by a defective medical device, contact an experienced and specialized products liability lawyer to discuss your situation in order to better ensure you get the full compensation you deserve. To schedule your free initial consultation with a member of the legal team at  McCann Dillon Jaffe & Lamb, LLC, call us today at 215-569-8488 or contact us online. We represent clients in Pennsylvania, Delaware and New Jersey.