New Legal Analysis Indicates FDA Preemptions May Not Apply to DePuy Litigants

In October, this blog published a post discussing the potential interplay between the preemption rules of In re: Medtronic, Inc., and the forthcoming DePuy hip implant litigation. If one recalls, In re: Medtronic involved defective heart defibrillators that shocked implant recipients. When patients affected by the shocks attempted to file lawsuits to recover for their injuries against Medtronic, the federal Eighth Circuit Court of Appeals ruled that the plaintiffs’ state law claims were preempted by the FDA, and, therefore, plaintiffs could not proceed with their lawsuits. This blog then surmised in its original posting on the subject that recipients of recalled DePuy ASR hip implants might face similar hurdles in their own claims against DePuy. Since that time, however, further legal analysis by attorneys have discovered that the In re: Medtronic, Inc. ruling may in fact have no effect on recipients of defective DePuy hip implants after all.

The reason why DePuy plaintiffs may fair better than their Medtronic counterparts has to do with the different approval processes conducted by the Food and Drug Administration (FDA). While both the heart defibrillators manufactured by Medtronic and the ASR hip implants manufactured by DePuy were considered by the FDA to be Class III medical devices, each was subjected to a differing approval standard. In the case of the heart defibrillators, those medical products were subjected to a strict review standard and were scrutinized carefully for years by the FDA before given final approval. On the other hand, the DePuy ASR hip implants were considered by the FDA to be “substantially equivalent to legally market predicate devices marketed in interstate commerce,” and were accordingly not subjected to the same strict review standard.

From a legal perspective, the FDA testing standard a medical product is subjected to is very important. For example, when the FDA has highly scrutinized a manufacturer’s product and subsequently approves it for marketing, courts are reluctant to hold that manufacturer responsible for defects that are later discovered by consumers. The rationale behind this is that the FDA has been granted the power to set minimum safety standards for medical products by Congress. These minimum safety standards cannot be contradicted by higher safety standards a state legislature or court might promulgate. Consequently, courts believe it is unjust for the FDA to declare a product to be in compliance of FDA regulations when, simultaneously, the same product might be in violation of a more demanding state standard. In order to maintain a fluid marketplace, courts prefer manufacturers comply with one, uniform federal safety standard, rather than fifty opposing state standards.

Devices that are held to be “substantially equivalent,” on the other hand, are not scrutinized or tightly investigated by the FDA. Instead, products approved under the “substantially equivalent” standard are simply given administrative approval for marketing without any assurances by the FDA that the device complies with FDA regulations. The FDA does not set a minimum safety standard when it declares a medical device to be “substantially equivalent.” This means that if the device is discovered to be defective later on by consumers, those consumers can sue under their state tort laws without running into any of the preemption issues that the strict testing standard presents, as explained in the previous paragraph.
Because the DePuy ASR hip implants were given “substantially equivalent” approval, it is likely that the In re: Medtronic preemption rulings will not bar patients from suing DePuy for injuries caused by the defective hip implants. This is encouraging news for patients who wish to retain an attorney in order to recover for harm they have experienced.

As additional information arises pertaining to the potential legal difficulties plaintiffs might face when pursuing a claim against DePuy, Berniard Law Firm will continue to keep abreast of such developments.

Contact Berniard Law Firm today if you have any questions relating to the DePuy ASR hip implant recall.

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