DePuy Hip Recall Due to FDA Loophole?

As DePuy hip recall attorneys, we have heard many disturbing reports which place the blame for the DePuy hip recall squarely at the doorstep of the United States . FDA "Approves" Implants by Default Although most hip implant patients assumed that their hip replacement manufacturer (e.g., DePuy, Zimmer, Johnson & Johnson, Stryker, etc.) received approval from the FDA for their device, this assumption is not entirely accurate. For years, the FDA has permitted a regulatory loophole under FDA 510(k) which permits the release of new medical devices like the DePuy hip implant, Zimmer NexGen knee implant, and other medical devices, to be … [Read more...]

Help Pass The Medical Safety Device Act

In February 2008, the Supreme Court of the United States ignored Congressional intent and disregarded 30 years of experience under the 1976 Medical Device Amendments (MDA), during which FDA regulation and state tort law worked together to protect consumers from dangerous devices. The court’s recent decision in Riegel v. Medtronic gave total immunity to device manufacturers who fail to adequately warn consumers about device risks. The court, failing to understand that FDA approval does not mean a device is entirely safe, sided with the corporate world over the rights of its citizens, preventing the public from suing when a medical device fails … [Read more...]

Supreme Court Overrules Public Safety

A Supreme Court ruling last year has begun to show its true colors, as many federal cases against Medical Technology Corporations will go unheard. In February of 2008, the high court decided to restrict the legal options for patients who claim they have been injured by a defective device. If the Food and Drug Administration has approved the device after, “rigorous review,” than a suit cannot be filed under state laws. This unjust ruling will prevent many individuals who have been subject to hard due to faulty design from collecting the compensation they need to maintain a reasonable quality of life. Devices that are not properly … [Read more...]