A federal judge in Texas has ruled that a lawsuit against a device maker can proceed, because preemption - as defined in a closely watched US Supreme Court ruling earlier this year - does not apply in this instance. And the decision suggests device makers may no longer be immune from some cases they have been unwilling to settle.
Here's some background: Last February, the US Supreme Court voted to 8-1 that patients can’t file lawsuits against device makers when their products were approved by the FDA. Medtronic successfully argued that the Food, Drug, and Cosmetic Act expressly preempts state law claims brought by patients who were hurt by devices that received premarket FDA approval.
The ruling gave device makers an eagerly anticipated defense in product-liability lawsuits and drugmakers are hoping for a similar ruling this fall when the court hears a case involving a Wyeth medication. [Preemption is the legal notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue that preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness. Unlike medical devices, however, there is no statute providing for preemption for drugs.]
But in an 8-page ruling last week, US District Court Judge Barbara Lynn wrote that preemption does not preclude a family from pressing a lawsuit against Bionics over two Cochlear devices that were implanted in their son's ears in 2005. The family charged the implants were adulterated because Bionics failed to use an approved manufacturer for a component; failed to obtain premarket approval for design modifications and manufacturing processes didn't comply with FDA requirements. The FDA filed suit in 2006.
In her decision, Lynn noted that "the relevant issue here is whether plaintiffs’ strict liability and implied warranty claims impose duties on medical device manufacturers 'different from, or in addition to' those arising under the Medical Devices Amendments of 1976, triggering preemption." She went on to conclude that "plaintiffs’ strict liability claims are predicated solely on violations of federal law," and as a result, preemption is not warranted.
4 Comments
I must say I find this case hard to follow - perhaps a DDL commentary will clarify.
But the following point stands out based on the facts as summarized:
The manufacturer did, indeed, violate FDA manufacturing standards. The FDA itself successfully brought suit against manufacturer on that basis. So, deliberately or otherwise, this device was not in compliance with FDA at the time it was implanted. The FDA said so in their own suit.
Thus, it seems to me that a version of Buckman figures in somewhere. If FDA itself finds a problem of this sort, can a suit go forward? If the problem was deliberate fraud, the Buckman precedent would suggest "no." Ironically, then, this seemingly lesser negligence (relative to felony fraud) may be in a different category as judged here.
The other issue that arises is how much plaintiffs' actions were themselves the trigger for FDA's eventual suit. The decision notes: "Bionics assured Plaintiffs that the device conformed to manufacturing specifications and was not malfunctioning. However, in September of 2004,Bionics issued a voluntary recall of all HiRes90k devices containing Astro Seal feed-thrus. Although the recall covered only non-implanted devices, Plaintiffs elected to have B.P. undergo surgery to remove his two cochlear implants. Bionics tested those units and determined that the moisture levels in them were 2.159% and 3.0312%—well above the maximum moisture level of .5% provided in the manufacturing specifications and approved by the Food and Drug Administration (“FDA”)."
Was this, I wonder, the basis of FDA's own suit? If so, a further example of how FDA, on its own, is unlikely to catch problems of this kind.
Arguing preemption on a record that includes an actual FDA prosecution is always dicey. Defense counsel made a serious error filing a Rule 12 preemption motion and not including the argument that Texas law does not recognize tort claims amounting to a private claim that the defendant violated the FDCA. Texas law is pretty clear on that point.
Post-Riegel, non-preemption arguments for the proposition that FDCA-based causes of action are not viable under state law will be much more important.
Thanks, Jim Beck. We are hearing from an expert, indeed - for folks who don't know, Jim is one-half of the Drug and Device Law Blog team.