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Certain carbon products are supposed to last forever.  Houses should last more than 14 years, but they will need significant upkeep along the way.  Well maintained cars can last more than 14 years, but we think most do not.  We have a hard time thinking of many electrical products that last more than 14 years of regular use without requiring upkeep and parts being replaced.  The batteries we buy certainly do not last long, regardless of the irregularity of their use.  In Mullan v. North Cascade Cardiology, No. 68513-9-1, 2013 Wash. App. LEXIS 1281 (Wash. Ct. App. May 28, 2013), we were struck by the notion that liability might attach to the manufacturer of a battery in a pacemaker if its voltage dropped by about 22% in 14 years of quite regular use.  We do not think the battery in our electric toothbrush keeps 78% of its charge in a day.  In the end, the plaintiff lost in Mullan for the reasons a plaintiff often loses—lack of proof on elements of her prima facie case and lack of diligence in trying to get proof—but it was an interesting case along the way.

The basic facts of Mullan involved a pacemaker implanted in a woman in May 1994 for a congenital heart condition—the opinion is vague on some medical details—and the woman’s death in October 2008 from an apparent arrhythmia, a month after a representative of the defendant manufacturer told a defendant cardiologist that faxed-in readings from the pacemaker indicated that its battery would need to be replaced in five to six months.  [For context, May 1994 was a month after the death of Washington’s own Kurt Cobain.  October 2008 was the month of the epic debate between Sarah Palin and Joe Biden.]  Upon explant the pacemaker’s battery’s voltage tested at below the replacement level—called “end of life” (EOL), perhaps not the best name here.  Defendant manufacturer also evaluated the explanted pacemaker and determined that it had not malfunctioned and had battery life above EOL. The discrepancy in battery voltage readings after explant was explained by the manufacturer by the difference between testing at room temperature and body temperature.  Plaintiff waited more than two years, until the motions for summary judgment were being argued, to ask to test the pacemaker and its battery.  Plaintiff did offer up declarations from an electrical engineer and a cardiologist in opposition to the motions, so there was not exactly a walk over.

Perhaps because of the lag from implant to injury, the plaintiff premised liability against the manufacturer only on negligently “providing current, accurate, and timely technical assistance to [the defendant cardiologist] with regard to the useful safe life of the battery.”  Id. at **4-5.  At least that was the allegation being considered on appeal.  We have seen a long lag from release of a product until the plaintiff’s use or injury create legal and practical barriers to recovery.  For instance, statutes of repose can be based on the “useful life” of the product or a set number of years from sale to suit.  The “state of the art” defense, the “alteration” defense, and the absence of a post-sale duty to warn in most places make it hard to sue 17 years after the sale of a drug or implant of a device (as happened here).  There may also be difficulties in getting basic or defect evidence so long after a product has been designed, manufactured, sold, and used.  Whatever the reason, the Mullan plaintiff focused on the “technical assistance” the defendant manufacturer in 2008, its only apparent relevant act or omission within a decade of the plaintiff’s injury.  Such liability, where plaintiff can muster better proof than in Mullan, could pose some real issues for drug and device manufacturers.  Manufacturers tend to be pretty careful about not practicing medicine and not interfering with the doctor-patient relationship that is the center of the learned intermediary doctrine.  At the same time, regulatory requirements and marketing realities can make manufacturers engage in a range of contact with health care providers and even patients (i.e., potential plaintiffs) that might fall under the banner of “technical assistance.”  The longer it is from initial sale until a request for technical assistance, the harder it is for the manufacturer to respond in an accurate and timely fashion, assuming the manufacturer is still around to field the request at all.  We can envision a range of potential pitfalls for the manufacturer.

Mullan, however, suffered from two of the most basic pitfalls for a product plaintiff:  no evidence of breach of duty and no evidence that any breach proximately caused the plaintiff’s injury.  Applying good, basic summary judgment law, the court found that the defendant manufacturer—relying largely on its own testing—had shifted the burden to plaintiff to come forward with real evidence on each element of her cause.  Her expert did not aver that plaintiff’s arrhythmia was caused by a battery failure or by the defendant manufacturer’s technical assistance a month before.  While plaintiff’s expert claimed the defendant manufacturer’s testing of the actual device was unreliable, they never did their own testing and were left with unsupported guesses about product failure and causation.  Id. at *7 (“reasonable hypotheses exist to explain why [plaintiff] died that cannot be tested without access to the pacemaker itself”).  This is where we applaud the Mullan courts, and some very sensible Washington state law, in rejecting the plaintiff’s attempt to delay consideration of summary judgment until she could get the pacemaker and have her experts test it.  We have seen some courts, in the name of fairness, give traction to such late requests, though maybe not as late as the oral argument on summary judgment like here.  The lack of a “good reason for the delay in obtaining the desired evidence’ here was more than enough reason to uphold the trial court’s exercise of discretion in rejecting the late request.  Id. at **11-12.  With that, the case against the manufacturer was gone and the court did not have to reach arguments on “federal pre-emption and the learned intermediary doctrine.”  The claims against the defendant cardiologist, nurse, and their practice fell on a similar lack of proof, although it does look like the plaintiffs’ experts actually did criticize their conduct leading up to plaintiff’s death.

The lack of proof on causation may have been due to plaintiff’s reliance on a logical fallacy:  1) pacemakers are intended to minimize the chance of an arrhythmia (although the approved indication here was surely more technical); 2) plaintiff had an arrhythmia long after the implantation of a pacemaker; therefore, 3) her pacemaker failed and caused an arrhythmia.  This same sort of fallacy plays out in other drug and device cases (e.g., unintended pregnancy suits against a contraceptive product, recurrent hernia after surgery with a hernia patch) with or without rigorous expert proof.  We are pleased to see that the courts in Mullan recognized the fallacy and that the plaintiff’s experts were honest enough to not try to opine that there was causation.  The court did not even have to reach the real causation question:  whether plaintiff could make the added leap—required by the age of the product and resulting focus on recent technical assistance—of proving that inadequate technical assistance caused the plaintiff’s arrhythmia.