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Riegel Redux: Delaney v. Stryker Finds PMA Preemption

By James M. Beck and Mark Herrmann

Sometimes, we try to be encyclopedic in our blog posts. Sometimes, we try to be funny. (Yeah, yeah: "Try" is the operative word.) Today, we're just being descriptive.

In Delaney v. Stryker Orthopedics, No. 08-03210 (DMC), 2009 U.S. Dist. LEXIS 16865 (D.N.J. Mar. 5, 2009), Delaney underwent hip replacement surgery with a hip prosthesis manufactured by the predecessor to Stryker. The ceramic femoral ball component later shattered and was replaced. The hip prosthesis had been approved through the premarket approval process.

Stryker moved to dismiss, and the trial court granted the motion in large part. As for claims of failure to warn, design defect, negligence and recklessness, and implied warranties, the court applied Riegel without hesitation. ""[T]he FDA imposed the same requirements regarding safety and effectiveness as were imposed on the Riegel device. As in Riegel, these claims are expressly preempted . . . . " Id. at *10.

The express warranty claim was a different matter. "Riegel did not specifically address preemption with regard to a claim for breach of an express warranty." Id. at *14. "[T]he absence of Supreme Court guidance means that the [earlier Third Circuit opinion in] Michael v. Shiley" controls. Id. Under Shiley, "express warranty claims based on FDA approved product packaging are not preempted by the'" Medical Device Amendments. Id. at *15. According to the court, it's thus theoretically possible for an express warranty claim to survive preemption in the Third Circuit.

Delaney had not, however, specified exactly what words constituted the purported warranty. Citing Bell Atlantic v. Twombley, the court required Delaney to replead his express warranty claim with more specificity. Id.

Delaney also pleaded manufacturing defect claims, but he didn't identify "a defect or a deviation from the FDA-reviewed . . . manufacturing specifications regarding the [device] implanted in him." The court thus dismissed the manufacturing defect claim. Id. at *19.

Finally, as the New Jersey Supreme Court held in Sinclair v. Merck, any claim under the New Jersey Consumer Fraud Act was subsumed under the New Jersey Products Liability Act. Id. at 20.

All of the counts were thus dismissed with prejudice, except for the express warranty claim, which Delaney can replead. (But he won't. We don't know anything about those hip implants or that package insert, but we'll bet the mortgage that there's no express warranty tucked in there.)

Although this post was purely descriptive, it's another nice arrow in the quiver of folks defending medical devices. Please put Delaney to good use.

Full post as published by Drug and Device Law on March 23, 2009 (boomark / email).