We like Riegel preemption because the oscillations of state tort juries should not supplant FDA regulation of medical devices. We like Twombly and Iqbal because plaintiffs should plead sensible facts before turning on the million dollar discovery machine. We do not much like the parallel claim exception to Riegel because its origin is muddy, its application messy, and its effect nasty. We really do not like courts that fail to apply TwIqbal rigorously, because they are lazy and they treat litigation as an expensive game that necessarily culminates in settlement, however bereft of merit the case might be. Accordingly, we have often expressed our ardent dislike for the Seventh Circuit’s Bausch opinion, because it makes the parallel claim exception available to almost any plaintiff willing to insert the words “violation of FDA regulation” somewhere in the complaint, no matter how vague, empty, or nonsensical. And just as accordingly, we like any case that rejects Bausch or interprets it in a way that cabins its ruinous consequences. That is to say, we very much like the recent case of Smith v. St. Jude Medical et al., 2013 U.S. Distr. LEXIS 3622 (D. MD. March 14, 1013). But we do not like the facts of Smith much, because we have reached that stage of life where nothing upsets us so much as sad things happening to children. The facts of Smith are sad indeed.
The plaintiffs sued St. Jude and Lifewatch Services, Inc. after their three-year old daughter died of heart failure. Here are the plaintiffs' allegations:
- In late 2005, doctors implanted a St. Judge pacemaker in a baby girl. Because of the girl’s condition, the ventricular threshold for the pacemaker was higher than normal. That increased threshold meant that the expected battery life of the pacemaker was halved from four years down to two years. In late 2007, the doctor told the plaintiffs that the pacemaker would signal when the battery had reached a level of depletion and required replacing. The doctor assured the parents that once the signal occurred, there still would be plenty of battery life remaining to allow for replacement of the pacemaker without any danger.
- In November of 2008, the doctor told the plaintiffs that the pacemaker battery had a remaining useful life of about nine months. He also ordered monthly telephone interrogation of the pacemaker by Lifewatch, another defendant in the case.
- During a medical appointment on May 11, 1009, the doctor predicted that the battery replacement likely would occur in September. When the plaintiffs arrived home from this appointment, they received an urgent message from the doctor. He explained that he had forwarded the latest interrogation results to a St. Jude company representative. Based upon that conversation, the doctor now believed that the remaining battery life on the pacemaker was much shorter than he had thought. The doctor requested to see the girl in early June to schedule an elective battery replacement.
- Sadly, on May 27, 2009, the girl died following a cardiac incident. The plaintiffs pacemaker stopped working due to a dead battery.
We are about to get to the legal stuff, but it is hard not to linger on those facts for a bit, and grieve for the extinction of a young life and the despair of those parents.
The plaintiffs' lawsuit contained several legal theories. The plaintiffs claimed that St. Jude and Lifewatch acted negligently. They also asserted claims for breach of warranty and misrepresentation against St. Jude. The court ultimately granted St. Jude’s motion to dismiss after applying TwIqbal pleading standards and federal preemption. The court concluded that the plaintiff’s claims for negligent manufacturing and implied warranty “appear to lie squarely within the scope of claims found to be preempted in Riegel.” Smith, 2013 U.S. Dist. LEXIS 36227 at *9. In an effort to evade federal preemption, the plaintiffs' argued that they had established a parallel violation of federal regulations. The problem is that the complaint only hinted at such a violation in the vaguest terms. There was no specific allegation of a violation of FDA regulations in the complaint, other than a conclusory allegation that the pacemaker did not meet “FDA standards for reserve battery capacity.” Id. at *10. The complaint did not indicate what, if any, “FDA standards for reserve battery capacity” were in place. Id. Moreover, the plaintiffs alleged "no deviation from the prescribed PMA manufacturing process that would explain the alleged failure to meet the FDA standards." Id. Instead, Without any factual allegations in support, the plaintiffs allege “that the Defendant St. Jude had a duty that required the sales and servicing support technicians….to advise Dr. Salim that the St. Jude model 5380 had a history of premature battery failure.” The complaint is devoid of factual allegations supporting any such history. There is no allegation that the manufacturing of the pacemaker deviated in any way from the process approved by the FDA, other than the conclusory allegation that St. Jude negligently failed “to manufacture a pacemaker that met FDA specifications for reserve battery capacity.” The fact that the St. Jude pacemaker allegedly failed does not itself establish a deviation from the FDA-approved standards.
Not surprisingly, the plaintiffs’ lawyer sought refuge in Bausch, which is the appellate case that permitted the vaguest, most conclusory allegations to set up a parallel violation. But the Smith court distinguished Bausch, characterizing Bausch in such a way as to make it sound almost reasonable: “In Bausch, however, the plaintiff did not simply rely on conclusory allegations of a failure to comply with FDA requirements, but was able to cite to an FDA investigation into the approved device, an FDA product recall and a warning letter bearing a causal relationship to plaintiff’s alleged injuries, and to a factual statement by the FDA suggesting that the device in question had not been manufactured in accordance with regulatory standards.” Id. at *13.
The plaintiffs' other claims against St. Jude fared no better. The plaintiffs contended that St. Jude was liable for breach of express warranty and negligent misrepresentation arising out of information allegedly provided by a St. Jude representative to the doctor. But TwIqbal again compelled dismissal because the complaint did not include any "specific allegations regarding the content of what St. Jude may have communicated to the doctor." Id. at *14. The complaint merely alleged that St. Jude gave express and implied warranties that the pacemaker battery had several months of battery capacity left sufficient to allow replacement on an elective basis sometime after June 2, 2009. That allegation is insufficient for several reasons. To the extent the plaintiffs were complaining of communications between St. Jude and the doctor, the “learned intermediary” doctrine barred the claim. To the extent the plaintiffs alleged that the doctor “was acting as St. Jude’s agent in conveying information to them, they provide no factual allegations to support any agent/principal relationship." Id. at *16. Moreover, it "is implausible to suggest that a product manufacturer would ask a doctor to serve as its agent in communicating with that doctor’s own patients, where the law requires no such direct communication.” Id. In any event, "even assuming the St. Jude representative gave the doctor an estimate regarding battery capacity, the fact that an FDA-approved battery allegedly failed does not nothing to establish that St. Jude deviated from FDA-approved standards." Id. at *17. Further, St. Jude’s alleged representations to the doctor happened almost four years after implantation of the device. Such representations "could not, therefore, have been part of the 'basis of the bargain,' and no express warranty claim is viable." Id. at *18. Finally, the plaintiff’s complaint suggested that St. Jude had a duty to provide ongoing follow-up medical care and treatment to the baby girl. But, as in many states, Maryland imposes special requirement on medical malpractice claims. The plaintiffs defined St. Jude not as a “health care provider,” but as a “health care medical products manufacturing, sales, service, and consulting institution.” The plaintiffs did not adequately allege "facts to support any duty owed by St. Jude, a products manufacturer, to provide ongoing medical care." Id. at *19.
We have often heard that hard cases make bad law. Sometimes a sad case can make good law.