Tags

, , , , , , , , , , ,


Full Article Link: DePuy Total Hip System Lawsuit – Claims Not Preempted.

Federal Judge Refuses to Dismiss DePuy Total Hip System Lawsuit

SEPTEMBER 23, 2014 By: Sarah May

This ruling is very interesting – can it be applied to Smith & Nephew who still hide behind Preemption?

Judge Perry’s rulings

Supreme Court precedent provides that for a state law claim to be barred by the MDA in this type of case, it must be found that the state law claim imposes requirements on the manufacturer that are different from or in addition to those imposed by the federal law. However, Judge Perry found that the AML Total Hip System and the AML Stem came to the market via the 510(k) process and thus did not undergo a stringent pre-market approval procedure. She also held that the only guidance issued by the FDA relating to the hip system was simply descriptive in nature and did not impose special controls or requirements. Therefore, federal preemption of Redd’s state law claims did not occur, according to Judge Perry.

In addressing DePuy’s argument that Redd failed to properly plead her claims of negligence and strict liability, Judge Perry stated that the plaintiff did indeed include sufficient facts to “allow the court to draw the reasonable inference” that the defendant should be held liable for the alleged misconduct. Further, the judge disagreed with DePuy’s assertion that Redd had an obligation to defeat the so-called “learned intermediary doctrine” by including facts intended to demonstrate her physician’s level of knowledge about the product’s defects.

While conceding that the doctrine in question may indeed apply in the DePuy hip lawsuit before her, Judge Perry held that the plaintiff had no duty to plead facts aimed at negating it in order for the case to proceed.

 

 

 

Advertisements