United States: Heeding Presumption Only Goes So Far In Post-Sale Warning Case

Last Updated: December 19 2016
Article by Eric Alexander

Devoted as we are to the defense of manufacturers of prescription drugs and medical devices, we have often advocated for the full implication of the fundamental—to us, at least—requirements that warnings claims focus on the decision making of the learned intermediary and that proximate cause matters.  One implication is that heeding presumptions typically make little sense for claims about these products.  It is one thing to say that a plaintiff should be allowed to proceed with a warnings claim when a prescriber is truly unavailable to provide testimony—like by dying before the plaintiff knew he had a claim—and the alleged missing warning would have clearly contraindicated the plaintiff from receiving the prescription product.  In such a case, it might make sense to presume, absent contrary evidence, that the physician would have heeded the warning and not prescribed the product to the plaintiff.  In just about every other prescription drug and device case we can imagine, the heeding presumption does not make sense.

We feel the same way about a post-sale duty to warn.  Not only do such duties run contrary to the typical focus in warnings cases on the notice to the manufacturer of potential risks before the product leaves its control (or is prescribed to plaintiff), but the proximate cause inquiry can quickly become an exercise in layered speculation.  Cases acknowledging such a post-sale duty have typically involved situations where the seller had a continuing relationship with the purchaser, with an obvious route for relaying additional information about the product in a way that allows a jury to evaluate whether injury would have been avoided.  In prescription drug and device cases, there tends not to be any direct relationship at any time and the manufacturer does not know the names or addresses of patients using its products.  Over time, patients move, change their physicians, and even see physicians for reasons unrelated to the reason they were prescribed a drug or device in the past.  Over time, manufacturers also stop selling specific products or product lines and may even go out of business.  When it comes to drugs with alleged remote effects or devices that are implanted for many years, these real world considerations make potentially unlimited post-sale duties to warn a folly.  We could go on, but we will not.

When we saw that In re Mentor Corp. ObTape Transobdurator Sling Prods. Liab. Litig, No. 4:08-MD-2004, 2016 U.S. Dist. LEXIS 170330 (M.D. Ga. Dec. 9, 2016), looked at heeding presumption for an alleged breach of the post-sale duty to warn with a trans-vaginal mesh product, we were not hopeful.  When we read the order, we were pleasantly surprised.  The basic facts of the particular case are that the plaintiff's decedent had a suburethral sling implanted by one doctor in 2005 to treat stress urinary incontinence, apparently had some follow-up care in 2009 for recurrent incontinence, and later had the product explanted by another physician in 2013 after an unspecified erosion.  The only contested issue in the decision was whether the manufacturer was entitled to partial summary judgment on the portion of the warnings claim based on an alleged failure to warn the original doctor and plaintiff of an alleged risk of delayed infection at some point between the implant in 2005 and the care in 2009.  (Although a prior decision in the same case, Burch v. Mentor, No, 2:12-cv-279, 2015 WL 5722799 (M.D. Ga. Sept. 29, 2015), covered some of the same ground, we will pretend there was just one decision.)  The inquiry only really begins because Florida recognizes a narrow post-sale duty to warn.  As we suggested, the Florida case cited as establishing this duty did involve a continuing relationship—between a swimming pool pump manufacturer and its distributors, which in turn had relationships with pool owners—that made it quite different than the issues in Mentor.  Alleging a breach of a duty, of course, is not enough to survive summary judgment.

Lacking any evidence that the first doctor would have done anything different with an additional warning received post-implant, the plaintiff claimed proximate cause could just be presumed because Florida also had a limited heeding presumption. Id. at 4-5.  Looking at the same pool case's presumption "that the pool owner would have heeded a more stringent warning regarding the hazards of a pool pump and would have fixed the grate over the pump in time to avoid the plaintiff's injuries," the court presumed the first doctor "would have paid attention to an additional warning that ObTape may have a higher rate of infection than other slings" but not that he would have taken a specific action. Id. at 5.  Because the Mentor case involved "a complex decision regarding a medical device that had already been implanted," there still needed to be evidence as to what the doctor would have done had he paid attention to an additional warning. Id. Plaintiff had no such evidence to prove proximate causation.  "Absent a presumption that relies on pure speculation, no reasonable juror could conclude based on the present record that any post-implant failure to warn caused any of [decedent's] injuries." Id. at 6.  We suspect this same statement could be made for most urged applications of a heeding presumption to the decision of a physician to prescribe a particular product or treat a patient who already used a particular product.  Hearing that the risk of a particular complication is higher than had been understood does not necessarily change the physician's overall risk-benefit decision when it comes to prescribing.  Hearing the risk of a particular complication is higher than had been understood when the drug had been prescribed or device implanted does not necessarily change any aspect of treatment.  It certainly does not necessarily mean the physician will leap to removing an implanted device.  The call to "heeding" does not change any of this.

Having failed to show proximate cause through the physician, the plaintiff suggested that her decedent also should have received a post-implant warning directly from the manufacturer.  Rather than evaluating how a post-sale duty could make sense with a prescription medical device like this, the court kept it simple.  Florida's acceptance of the learned intermediary doctrine meant there was no duty to warn the decedent directly at any time. Id. There was also no evidence in the record about how the decedent would have behaved differently with different information, just speculation from her estate's representatives.  Again, this is clearly the right result, even if we would have liked to have seen a more direct knock about the purported post-sale duty to warn for a prescription medical device.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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