Tags
DePuy, Federal preemption, Food and Drug Administration, Hip Replacement, Johnson, Judge Perry, lawsuit, Preemption, Sarah May, Smith & Nephew, state law claims, United States federal judge
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.
This is top class for those that qualify. ALL your material is superbly presented, and certainely should have been published. Maybe one day, when your health and family issues are sorted.I for one would be happy to help get you excellent work published if humanely possible from across the ditch. Take care of yourself and your loved ones.Your comments of Every’ birthday is a ‘milestone’, is the ‘nuts and bolts’ of it all, after such disgracefull proceedures, where truth and facts, are plain old dirty words in todays over regulated world of PC Correctness. .
Hope Joan well prepared for pending op. If wel informed and you have chosen a well exerienced surgeon and right size prothesis, you cannot go wrong, and worst case scenarios will not be applicable