United States: Guest Post – Failure To Warn Claim Dead On Arrival Without Testimony From Prescribing Physician

Last Updated: January 9 2017
Article by James Beck

This is a guest post from Michael Salimbene, an associate at Reed Smith. It's about learned intermediary causation, and the need for prescriber testimony. Not infrequently, in mass torts with lots of solicited plaintiffs, the other side puts off doing anything, including preserving prescriber testimony, for as long as possible. If the prescriber dies or disappears, plaintiffs don't have any causation testimony, and since they bear the burden of proof, that's a problem for them. The guest post describes the latest example. As always our guest poster deserves 100% of the credit (it's not our work), and any blame, for what follows.


This guest blogger lives just outside of Philadelphia. In this neck of the woods, the post-holiday, pre-Spring window is perhaps the most universally loathed time of year. It's filled with grey skies and frigid winds. Partner in-office attendance, which tends to wane during the summer months and late December, hits its yearly high. The all-important billable hour "clock" resets to 0. Street corner sales of unlicensed Carson Wentz tee shirts have stalled, and playoff football will feature two of Philadelphia's most hated rivals, the Giants and the Cowboys. Your children, if anything like this guest blogger's, will ignore the Frozen-themed electric car that "Santa" left (but took you 4 hours to assemble) in favor of a $6 pair of pink bunny slippers. So for today's post, in search of some good news, we travel to the Middle District of Georgia where the temperature hovers just above 60 degrees. In a few short months, Northeasterners will also be enjoying warm skies and Georgia's finest offering, The Masters. Until then, we'll have to make due with favorable warning-causation decisions like this one.

Today's case comes to us from the Mentor Corp. Obtape Transobturator Sling Products Liability Litigation MDL in the Middle District of Georgia. In re Mentor Corp. ObTape Transobdurator Sling Prods. Liab. Litig., No. 4:13-cv-229, 2016 WL 4611572 (M.D. Ga. Sept. 2, 2016). We've blogged about this MDL quite a bit ( recently here, here, and here). As were most plaintiffs in the ObTape litigation, this plaintiff's prescribing surgeon treated her for a form of incontinence with the relevant device. If you've watched daytime TV in the past 5 years, you'll be familiar with the typical list of complaints that undergird vaginal mesh lawsuits: mesh "erosion" or "extrusion" (movement of the mesh material into surrounding tissue); "dyspareunia" (painful intercourse); and the need to have additional surgery to correct mesh-related complications, to name a few. Plaintiff never had her mesh removed, but alleged, among other things, that the product caused her to suffer from chronic pain. So what makes this case different from the thousands of other mesh cases pending across the nation? Plaintiff's implanting physician died before he could testify in her case.

Defendant moved for partial summary judgment, and, because Plaintiff abandoned all her other theories attacked by the motion, the only issue the Court needed to resolve was Plaintiff's claim for strict liability failure to warn. Nobody disputed that the law of Plaintiff's home state, Texas, applied.

Like just about everywhere else, Texas follows the learned intermediary doctrine, which "requires a prescription medical device manufacturer to provide an adequate warning about the device's risks to the prescribing physician and not to the patient directly. Id. at *2 (citing Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 157 (Tex. 2012)). Under Texas law, a plaintiff must prove both that defendant failed to provide an adequate warning regarding the product at issue and that the inadequate warning caused the plaintiff's injury. Stated differently, to prevail on her failure to warn claim, Plaintiff had to establish that her prescribing physician "would have acted differently had [Defendant] provided a different warning" about the product. Id.

And that's where things got tricky for Plaintiff. Because her implanting surgeon was deceased, securing direct testimony regarding the effect of an alternative warning was out the window. By "direct testimony," we mean the questions that seem to make up the bulk of plaintiff lawyer's deposition outlines, which go something like this: "Wouldn't you like to have known if [evil defendant company] knew [insert bad thing that could purportedly happen based on unseemly internal company emails that won't be shown to the witness because they may not even exist]?" As a result, Plaintiff was forced to trot out a two-pronged strategy that involved (1) the heeding presumption ( which we've covered a fair amount) and (2) her expert "filling-in-the-blanks." Neither worked.

First, the Court made short work of the heeding presumption, noting that the Fifth Circuit Court of Appeals "has expressed doubt that Texas courts would hold that this presumption applies in cases involving prescription drugs or devices." Id. (citing Ackermann v. Wyeth Pharm., 526 F.3d 203, 212 (5th Cir. 2008)) ("[N]either Texas nor federal courts applying Texas law have applied the read-and-heed presumption to pharmaceutical cases involving learned intermediaries"). Even if Texas did follow the heeding presumption in medical device cases, "it would simply permit the Court to presume that [Plaintiff's implanting surgeon] would have considered [the product's] [purported] risks . . . in determining which product to select for [Plaintiff]. The presumption does not, however, permit the Court to speculate about how [Plaintiff's implanting surgeon] would have weighed the additional warnings." Id. at *3.

Second, with the Court unwilling to speculate, welcome to the fold an expert witness, who was perfectly content to "opine" (cough...speculate) that: "(1) [Plaintiff's implanting surgeon] likely did not know that [the product] had certain risks that were not disclosed in the product insert data sheet, and (2) a reasonable physician in [Plaintiff's implanting surgeon's] position would have told his patients about all of these additional risks had he known of them." Id. But these opinions missed the mark. Under Texas law, it does not matter what a "reasonable" physician would do. Causation is not determined in the abstract. Rather, Plaintiff must demonstrate that a different warning would have caused the plaintiff's own doctors to stop prescribing the product at issue. Id. (citing Centocor, 372 S.W.3d at 172-73). Plaintiff had no such evidence. Moreover, Plaintiff lacked evidence that, if presented with an "adequate" warning, she herself would have done something different (i.e., withheld consent to surgery). Id. Exactly what that might be, the Court did not explain.

Plaintiff's expert therefore crawled further out on the causal limb to offer the opinion that Plaintiff's implanting surgeon "[m]ore likely than not ... would have altered his clinical practice in treating [Plaintiff's medical condition]" if he had received additional warnings about Defendant's product "in that he would have not offered [the product] as option to [Plaintiff], would have offered additional options to [Plaintiff] and/or would have relayed additional safety information from [the company to Plaintiff]." Id. This opinion would be more credible coming from Miss Cleo than an OBGYN. The Court seemed to agree.

[An expert] cannot offer an expert opinion unless it is based on "sufficient facts or data," Fed. R. Evid. 702(b), and [Plaintiff] did not point to anything in the present record to suggest that [her expert's] opinion on this point is supported by any facts or data about [Plaintiff's implanting surgeon's] practices, including how [he] evaluated the risks and benefits of the products he implanted in his patients.

Id. And with that, the Court granted Defendant summary judgment on Plaintiff's strict liability failure to warn claim.

We think this is a fair result. Plaintiff bore the burden of proof, and her complaint was filed eight years after the implant surgery in question. A tardy plaintiff bears the risk that sources of evidence will disappear in the interim. This is a recurring issue. One of this year's top 10 decisions, "Accutane I," dealt with this issue, and held under the laws of 35 jurisdictions that warning causation under the learned intermediary rule necessarily fails where the death or disappearance of the actual prescriber precludes the affirmative testimony necessary to satisfy a plaintiff's burden of proof. Accutane I was discussed here. A couple years ago, the blog published a " little list" of decisions that, like the one here, refuse to allow plaintiffs to shirk their causation burden where, for whatever reason, a prescribing doctor's testimony was not obtained. Texas was the first state discussed in that list, and this case adds to a growing body of favorable law. Moreover, the ObTape MDL has been a solid contributor to this body law. Today's post comes on the heels of an ObTape decision we blogged about that reached the same conclusion under Florida law.

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

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James Beck
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