Plaintiff’s counsel and defense counsel are equally guilty of the well-known and respected legal strategy called “throw everything against the wall and see if something sticks” strategy. It starts with the complaint when Plaintiff’s counsel pleads every cause of action under the sun. It is perpetuated when defense counsel pleads every affirmative defense in the known universe (including our favorite, laches). Both are hoping, sometimes beyond hope, that when the issues are finally clarified, and both sides begin to determine what the case is actually about, they will have pled correctly.
Sometimes, though, it doesn’t work out that way. In Haynes v. Cyberonics, Inc., No. 1:09-CV-2700-JEC, 2011 WL 3903238 (N.D. Ga. Sept. 6, 2011), Plaintiff Cloys Haynes sued the manufacturer of a device called a Vagal Nerve Stimulator, which had been implanted in his neck to control epileptic seizures. He claimed that a few months after the device was implanted, he suffered various symptoms, including feelings of electric shock and tingling. He also alleged that he suffered permanent left side neurological damage and chronic pain in parts of his body, including his throat and ear. Ultimately, Plaintiff underwent surgery to remove the original device and replace it with a new, identical device. Problem for Plaintiff: During the surgery to replace the device, a diagnostic test was performed on the original nerve stimulator. It was found to be normal. No other testing was done.
Plaintiff’s original causes of action included strict liability, negligence, breach of warranty, punitive damages, and loss of consortium. Plaintiff later amended the Complaint to add a negligent manufacturing defect claim. He also sought attorneys fees for his troubles.
Just prior to the expiration of the discovery deadline, Plaintiff moved to have the case dismissed without prejudice. Not surprisingly, the defendant opposed the motion and filed a motion for summary judgment, as well. It also subsequently filed a motion to allow for supplemental briefing based on new preemption law in the 11th Circuit. That motion was granted by the Court.
The Defendant based its summary judgment motion on the doctrine of preemption and asserted that all of Plaintiff’s causes of action failed in the face of this super-defense. We’ve blogged about this defense before. It’s awesome. As the Court in this case noted, “[u]nder the doctrine of federal preemption, state laws that conflict with federal law are ‘without effect.'” The Court also provided a very nice articulation of the test used in such cases:
In Riegel v. Medtronic, Inc.,
the Supreme Court determined that this express preemption clause will bar common law claims arising from injuries caused by FDA-approved medical devices in many circumstances. Tracking the language of the statute, Riegel
set forth a two-pronged test for deciding whether state claims are preempted. First the district court must determine whether the federal Government has established requirements applicable to the device. If so, the court must then determine whether the plaintiff’s common-law claims are based upon state law requirements
(1) that are “different from, or in addition to”
the federal ones and (2) “that relate to safety and effectiveness.”
Plaintiff did not dispute that the nerve stimulator, as a Class III medical device, was subject to federal requirements for purposes of a preemption analysis. It also conceded that, as a result, his design claim was preempted. He didn’t concede, however, that preemption barred his other causes of action.
As to Plaintiff’s cause of action for manufacturing defect, a strict liability claim, the Court held that the claim was preempted:
Clearly, the FDA regulates the manufacturing practices of Class III medical devices. Further, a manufacturer could comply with all FDA regulations, but nevertheless produce a product containing an unintended flaw or abnormal condition. That being so, by holding a manufacturer liable under such circumstances, Georgia law would be in the position of imposing requirements “in addition to” federal law. Accordingly, [as] defendant argues, plaintiff’s strict liability manufacturing defect claim is therefore preempted.
Even if the claim were not preempted, the Court reasoned, Plaintiff had failed to provide any proof that the device was negligently manufactured. He also failed to provide evidence that the symptoms and/or injuries he suffered were caused by the device. (There’s that pesky lack of expert testimony thing again).
Plaintiff also argued that the device contained an inadequate warning, which is a design defect under Georgia law. An inadequate warning may amount to a design defect and permit the imposition of strict liability. However, because the FDA regulates content and appearance of prescription medical device labels, Georgia law would be imposing “requirements” that were “in addition to” federal regulations. As such, this claim was also preempted.
Plaintiff almost succeeded in surviving summary judgment on his negligent manufacturing defect claim. As the Court noted, a “negligent manufacturing claim would not be preempted to the extent it relied on an allegation that the particular device had not been manufactured in accordance with the FDA’s pre-market approval process.” However, although Plaintiff survived preemption on this claim, he failed to survive the summary judgment motion because he had failed to offer any evidence of any manufacturing defect claim. Oh, well.
The most interesting analysis in this case, however, centered on the issue of preemption in the context of a breach of warranty claim. The Court stated, “Riegel did not address a breach of express warranty claim. Nor has the Eleventh Circuit decided whether a breach of express warranty claim can be preempted by the MDA. Other federal courts remain divided over the issue.”
The Court held that preemption does apply in the context of a breach of warranty claim. Its reasoning follows:
In any event, the express representation claims in this case would interfere with the FDA’s pre-market approval regime. Plaintiffs claim that defendant expressly warranted the stimulator to be “safe, and generally fit for use as an implanted stimulator,” when in fact the device was not safe. In order to prove that defendant breached this warranty, plaintiff would need to show that the stimulator was not safe: a finding that would directly conflict with the FDA’s pr-emarket approval of the device as reasonably safe and effective. Moreover, if these warranties were made in materials approved by the FDA in the pre-market approval process, then allowing a claim to proceed under Georgia law would subject defendant to state duties above and beyond the federal requirements. Such a claim would fall within [the] preemption clause prohibiting state requirements that are in addition to, or different from, federal requirements.
Accordingly, the Court concluded that Plaintiff’s express warranty claim was also preempted.