[Drug and Device Law] Nothing Helps With Post-Thanksgiving Indigestion Quite Like A Heaping Helping Of Express Preemption
OK, we made that up. It is not true at all. A complete lie, much like “The Dallas Cowboys are America’s Team.” Or “Eating turkey makes you sleepy because of its high tryptophan content.” Or “The pilgrims left England because of their desire to wear stylish hats.” Or “Lawyer advertising for drug and device cases serves an important role in improving medical care.” If you did your duty as an American yesterday and gorged yourself on an assortment of turkey, stuffing, tubers, cranberry compotes, pie, and football, then you may be feeling somewhat bloated today. You have many options to address that feeling, including taking a walk outside before returning to leftovers and more football. Reading this post about a recent express preemption decision will not help with indigestion, but it should not hurt either.
The opinion in Hesik v. Boston Scientific Corp., No. 1:12-cv-00014-JMC, 2014 U.S. Dist. LEXIS 156563 (D.S.C. Nov. 4, 2014), carved up the product liability claims asserted in connection with a Class III device, specifically a cardiac defibrillator. As our readers know, the Medical Device Amendments of 1976 served up express preemption for Class III devices—basically, those approved though a Pre-Market Application—as to state law requirements that are “different from, or in addition to” the FDA requirements. 21 U.S.C. §360k(a). This has been interpreted by the Supreme Court to bar product liability actions premised on claims that do not impose “parallel” duties on manufacturers. Riegel v. Medtronic, Inc., 552 U.S. 312 (2008); our numerous posts on the subject. A parallel claim is a “narrow exception to the rule of preemption” into which some courts strain to stuff plaintiff’s claims. We sometime post on how it grinds us that courts, particularly federal courts sitting in diversity, extend existing state law to allow a claim that would be predicted on non-compliance with an FDA requirement such that imposing liability would not add to the federal requirements on the manufacturer. Like here. We do not have that situation in Hesik, which (drum)sticks with South Carolina law as is. We do have a few twists on the typical arguments we see in cases like this, including that plaintiff had the giblets to move for summary judgment himself.
The plaintiff in Hesik suffered heart block and atrial fibrillation when defendant’s defibrillator allegedly failed within a year of its implantation to replace another, fried defibrillator. Defendant evaluated the defibrillator and found areas of blood, areas that were deformed and bubbly, and areas of heat damage—descriptions of many turkeys yesterday that are less desirable for defibrillators. Accordingly, the defendant dished out a $25,000 credit to the explanting hospital under its five-year vintage warranty and $2500 to the plaintiff under its Unreimbursed Medical Expense Program. Around the same time, the defendant issued a notice that some of its defibrillator models could fail because of a weakened bond between the header and case, which we assume is somewhere near the wishbone. Plaintiff mixed these facts with a sprinkling of citations to regulations and unrelated late-reported manufacturing changes and cooked up both an alleged irrefutable admission of product defect and parallel claims. Although such allegations might let the plaintiff squeeze past a motion to dismiss—as we assume Hesik did here—on summary judgment, the plaintiff needs some proof with his pudding. (As we know from The Wall, er, something about eating meat before pudding. They were speaking British and we are still on heels of an American holiday, so the details are unimportant.) The court sliced, diced, and chiffonaded—seriously, if you not chiffonading your leafy herbs, you are an amateur—the proof proffered for each cause of action and found three of four preempted. Negligent design and manufacturing and strict liability were trussed up and cooked in the same pot. Agreeing with Bass v. Stryker Corp., 669 F.3d 501, 515 (5th Cir. 2012), discussed here, that parallel claims could be premised on the failure of the device to conform to the PMA’s specifications, the court had to look at the evidence of non-conformance—something Bass did not do in the motion to dismiss context. A granular-level look was not a must, because “Plaintiff has failed to offer any evidence that creates a genuine issue of material fact as to how the Defibrillator deviated from the PMA’s specifications.” 2014 U.S. Dist. LEXIS 156563, *20. Implicit in the analysis—embreaded, if you will—was that proof of device failure does not equate to proof of nonconformance with the design and manufacturing specifications for the product made a requirement by PMA approval. Without the right evidence, plaintiff’s negligence and strict liability claims were toast.
Implied warranty claims often travel hand in oven mitt with design defect claims, such that some jurisdictions do not permit both in the same case. In South Carolina, implied warranty claims require proof that the product, as designed, was unreasonably dangerous to the user; finding the difference between this version of implied warranty and design defect claim is like distinguishing between a sweet potato and a yam after you mash them up and cook with brown sugar, cinnamon, butter, and perhaps a marshmallow or twenty. Here, plaintiff pressed that the implied warranty was breached because the product failed within a year. This was easily seen as an attempt to lard an additional requirement on the manufacturer of the defibrillator beyond what was already imposed by FDA. Plaintiff also tried to pour past preemption by asserting claims predicated on violations of federal regulations. We would have liked to see an appetizer of whether South Carolina had such a claim before the entrée of whether plaintiff had mustard the right proof. The regulations the plaintiff had cited—defining implantable pacemakers as Class III devices and stating that express preemption does not apply to “requirements of general applicability . . . such as general electrical codes, and the Uniform Commercial Code (warranty of fitness)”—could not be tied to plaintiff’s device and its alleged failure, so the analysis was cut short. “[W]here a plaintiff relies on nothing more than unsupported violations of general regulations in support of a parallel cause of action, preemption bars the claim.” Id. at *27 (citations skimmed off by bulb baster).
The icing on the cake would have been if the last claim had been preempted, but sometimes cake is better without icing. Here, the express warranty claim—permitted in South Carolina for “any affirmation of fact or promise,” even relayed indirectly to the buyer—was grounded in a voluntary act—the claim that the product would function without failure for five years or certain payments would be made to re-dress any failure. In the context of express preemption—as opposed to the mélange of implied preemption—voluntariness can mean no preemption. Nothing about the PMA process or other FDA requirements required the manufacture to sauce its defibrillator with a warranty, let alone the piquant one used here. Thus, the express warranty claim “presents no risk of interference with the federal medical device regulatory scheme, and the claim escapes express preemption” like some green bean casserole might escape your child’s mouth. Id. at *25. And, as with the vegetables left on the plate (or maybe table cloth), after the rest of the meal has been consumed, who are we to be greedy? * * *
As you may have surmised, we have not-so-cleverly imbedded a variety of food and drink terms throughout the post. In case, you need some further distraction before tackling the dishes from last night or whatever else you will be doing this morning, feel free to do our little word search. If you mark up the post in some efficient way and send your results to Bexis, then he will tally the results (like a scorecard of actual scores for once). The one who identifies the most will get a mention in a future post, which is almost as good as winning something. --
Posted By Eric Alexander to Drug and Device Law at 11/28/2014 08:04:00 AM --
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