It’s like a question you would ask on a law school exam, except that it’s too easy. Consider these facts: A patient is considering whether or not to have a medical device surgically implanted. The patient is given a “user guide” before their surgery which says the implant is warranted to be free of defects for one year. Before the surgery, the patient also talks with a sales representative for the medical device manufacturing company, who says that a critical part of the implant is “guaranteed to last at least ten years.” Six months after the surgery, the patient’s symptoms come back, and so they have a surgery to remove the device. The device is sent back to the manufacturer, which confirms the implant failed because the critical part was defective.

The patient sues the manufacturer. What result?

As every law student who took Contracts and every lawyer who passed the bar can tell you, the above is a classic example of a “breach of warranty.” The manufacturer issued a written warranty and their sales representative (who was the “Territorial Manager,” and thus management-level, too) “guaranteed” even more. The result should be summary judgment entered by the court in the plaintiff’s favor, because there’s no genuine dispute that the manufacturer failed to live up to its own written warranty (the existence of the oral guarantee, unless admitted by the representative, goes to the jury).

Alas, that’s not how it usually turns out, because we’re talking about medical devices, where we don’t apply any of the same legal rules that apply to you, me, or the vast majority of smaller businesses in America. Like with prescription drugs, the judicial activists on the Supreme Court have bent over backwards to shield medical device manufacturers from any responsibility for their actions, frequently twisting the words of Congress — sometimes outright inventing Congressional statutes that don’t exist, like in PLIVA, Inc. v. Mensing — to protect medical device and implant manufacturers.

What seems like a plain-as-day breach of warranty case thus turns into an almost insurmountable challenge when a medical device is involved. In Riegel v. Medtronic, Inc., 552 U.S. 312 (2008),

In 1996, Charles Riegel underwent angioplasty to dilate his coronary artery. During the procedure, Riegel’s doctor ultimately inserted the Evergreen Balloon Catheter into Riegel’s artery and inflated the device several times, up to a pressure of ten atmospheres. On the final inflation, the Evergreen Balloon Catheter burst, and Riegel began to rapidly deteriorate. He developed a complete heart block, lost consciousness, was intubated and placed on advanced life support, and was rushed to the operating room for emergency coronary bypass surgery. Riegel survived, but suffered severe and permanent personal injuries and disabilities.

If there’s anyone who deserves compensation, it’s someone who, while unconscious in surgery, is horribly injured by a defective medical product that exploded while being used properly. But that’s not how the Supreme Court saw it. 

As Justice Ginsburg explained in dissent, the majority of the court took a thirty-year-old provision of the Medical Device Amendments of 1976 that was designed to deal with varying state regulatory schemes that had popped up in the absence of federal guidance and stretched it into virtually immunity for all manufacturers of Class III medical devices. The only type of claim that we know for sure survives is a claim where the plaintiff alleges that a violation of the Food, Drug & Cosmetic Act caused their injuries — but thanks to Twombly & Iqbal, two more attacks launched by the Supreme Court against plaintiffs, many courts expect plaintiffs to win their case the moment it’s filed by alleging facts about that regulatory violation that would be known only by the medical device company.

The end result has been the dismissal of a wide swath of litigation over hopelessly dangerous and defective medical devices. As catalogued by a team of defense lawyers, dozens of cases over defective implants like pacemakers, cardiac defibrillator leads, insulin pumps, and pain medication pump and infusion systems have been dismissed before the manufacturers even denied the allegations against them — even while Medtronic, the biggest player in this field, was paying $23.5 million to settle claims “that it violated the False Claim Act by using physician payments related to post-market studies and device registries as kickbacks to induce doctors to implant the company’s pacemakers and defibrillators.” The Stryker Trident hip replacement plaintiffs have been hit particularly hard: despite a recall by the company admitting that, for years, it was producing contaminated devices at its New Jersey plant, the vast majority of these claims have been dismissed soon after being filed. Pre-emption’s going to be a big issue in the Infuse Bone Graft lawsuits, despite mountains of evidence indicating Medtronic paid researchers to conceal side effects and then deliberately marketed dangerous off label uses.

Which brings us back to the hypothetical at the beginning of this post. It’s not a hypothetical, it’s a very real case, Cline v. Advanced Neuromodulation Systems d/b/a St. Jude Medical Neuromodulation Division. The case involves an implantable pain management device, this time a implantable pulse generator that stimulates the nerves with electrical currents. As described above, despite the one-year written warranty and the ten-year oral guarantee from one of their sales managers, the battery in the implant failed after just six months. Based on Riegel, St. Jude Medical argued that the entire case should be dismissed, even assuming all the alleged facts were true, because:

[T]he FDA is the final arbiter of a Class III medical device’s safety and effectiveness, and the FDA acts as the sole authority on whether Defendant SJN’s device remains safe, effective, reliable, and in conformance with the performance standards for which it achieved premarket approval. See 21 U.S.C.A. § 360e. To allow the plaintiff to proceed on a breach of an express warranty theory would usurp the authority of the FDA to regulate this product and nullify the preemption principles set forth in Riegel. A plaintiff could simply argue that any defect is actionable as it violates the medical device’s “limited warranty”—even if given premarket approval.

Did the FDA give the plaintiff a one-year warranty? Did an FDA officer walk into the plaintiff’s consultation with his doctor and promise the implant’s battery was “guaranteed” for ten years? Did the FDA demand Medtronic do either of those things? Did the FDA tell St. Jude Medical, “feel free to say whatever you want to patients, it’s okay?”

Of course not. The FDA did nothing more than determine that the device’s premarket approval application “contain[ed] sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s),” and that “the proposed labeling is neither false nor misleading.” 21 USC 360e(d)(1)(A).

Thankfully, common sense prevailed — at least on the breach of warranty claim — and on Friday the United States District Court for the Northern District of Georgia denied the motion to dismiss on the basis of pre-emption, holding:

[T]he Limited Warranty does not implicate the FDA’s determination of either safety or effectiveness. Defendant’s representation that the Model 3788 will be free from defects for one year does not overlap with the FDA’s assessment of whether the Model 3788 is “safe” for implantation or “effective” for the treatment of chronic pain. … This express warranty does not guarantee that the Model 3788 relieves back pain, restores natural movement, delivers the best results, or any other claim of safety or effectiveness. Instead, the Limited Warranty simply establishes a brief period of time that Defendant guarantees the craftsmanship of the Model 3788, apart from any FDA standards. …

In sum, under [the statute], the FDA executes its statutory responsibility for evaluating the safety and effectiveness of a Class III device through expert investigation of the relevant data and literature. If a device is shown to work, the agency weighs the benefit against any risk associated with the device to determine whether the device can properly be marketed. If so, the FDA ensures that the label’s conditions of use do not detract from the effectiveness of the device by confusing consumers regarding its administration or usage. Guided by these statutes, it is clear that the Limited Warranty falls outside the scope of the “effectiveness” review performed by the FDA. As such, this express warranty claim does not require a factfinder to reach conclusions on the safety or effectiveness of the Model 3788 or its labeling. Therefore, the claim for breach of the warranty at issue here does not “relate to the safety or effectiveness of the device” under §360k(a). Moreover, this claim for breach of express warranty is not based on a coercive or regulatory state law “requirement” under the language of §360k(a). Rather, it is based on an obligation that Defendant has freely imposed on itself.

An excellent analysis, and one for all plaintiffs to keep in mind when a device fails. Congratulations to plaintiff’s lawyers Clark McGehee and William Lanham of Johnson & Ward for having the guts to take on a Class III medical device case and then ability to get it past Riegel.

Of course, if this were to become the law everywhere, there’s a good chance medical device companies will abandon warranties altogether while sending in their sales managers to orally mislead patients with “warranties” and “guarantees,” but we’ll have to cross that bridge when we come to it.