Federal Judge Refuses to Dismiss DePuy Total Hip System Lawsuit

Earlier this month, Judge Catherine Perry of the U.S. District Court for the Eastern District of Missouri rendered key pretrial rulings in a pivotal DePuy Total Hip System lawsuit, sending the device maker’s arguments that the plaintiff’s claims were federally preempted down to defeat.

Her findings were attributed to the fact that the Total Hip System and the AML Small Stature Stem implanted in the plaintiff had been cleared through the FDA’s abbreviated “510(k) process” and were thus not subject to federal safety requirements specific to those products. The judge further found, despite DePuy’s claims to the contrary, that the plaintff’s claims of negligence and strict liability had been adequately pled and that the case would be permitted to go forward.

Background of DePuy Total Hip System lawsuit

In the spring of 2008, plaintiff Judith Redd underwent a hip replacement procedure in which a DePuy Total Hip System and AML Stem were implanted on the left side of her body. Within four years, she had suffered a broken stem and complete failure of her hip replacement. Redd argues that the stem component was susceptible to sudden and premature fractures due to fatigue stemming from insufficient material strength, limited ductility and inadequate annealing of the alloy used to make it.

Ultimately, Redd filed suit against DePuy, alleging negligence strict liability and failure to warn. DePuy responded with a motion to dismiss the lawsuit, arguing that the plaintiff’s state law claims were preempted by the 1976 Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act.

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.

Impact of rulings on DePuy hip litigation

Judge Perry’s pretrial rulings are significant in that the plaintiff in this case has brought one of the relatively few cases involving DePuy’s “cementless” implants. These devices were introduced in the 1980s and were touted as a safe, durable option for improving mobility in a wide range of patients. Since then, however, the implants have been linked to unduly lengthy post-surgery recovery periods, debilitating pain, loose joints, broken components and total system failure.

The problems with the Total Hip System have only added to DePuy’s legal woes, which have also included costly litigation over the company’s Pinnacle and ASR hip systems.

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