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Following More Than Just Money
- Mar 24, 2020
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by James M. Beck - Senior Life Sciences Policy Analyst
In our How Not To Create an “Exception” to the Learned Intermediary Rule post two years ago, we criticized a couple of Texas trial court cases for attempting to create a company compensation exception to the learned intermediary rule, that prior decisions had almost universally rejected. That post includes a comprehensive discussion of nationwide precedent that has considered the effects (mostly negligible) of a treating physician receiving financial payments (royalties, consulting fees, clinical trial recruitment fees, etc.) from the defendant in a prescription medical product liability case. We won’t repeat that here.
We are pleased to add Salinero v. Johnson & Johnson, ___ F. Supp.3d ___, 2019 WL 4316163 (S.D. Fla. Sept. 10, 2019), to that discussion. In one of the most thorough treatments of the issue to date, Salinero rejected an argument that the learned intermediary rule did not apply in a pelvic mesh case because the prescribing physician was allegedly “‘biased’ by his status as ‘Defendants’ long-time paid expert witness, consultant, corporate committee member, and . . . sales force lecturer, who happens to also have been [plaintiff’s] treating physician.” Id. at *7.
As the plaintiff’s argument suggests, her treating surgeon was a longtime user of the product and thoroughly familiar with its risks. As we’ve discussed in too many posts to mention, prior prescriber knowledge is fatal to warning claims because a claimed failure to warn somebody of what s/he already knows cannot be causal. To get around the learned intermediary rule, plaintiff attacked, not the prescriber’s knowledge or treatment, but his having been (well) compensated by the defendants.
Predictably, plaintiffs relied on the two Texas cases that we had criticized in our prior post. Salinero, 2019 WL 4316163, at *8 (citing and discussing In re Depuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation, 2016 WL 6268090 (N.D. Tex. Jan. 5, 2016), and Murthy v. Abbott Laboratories, 847 F. Supp.2d 958 (S.D. Tex. 2012)). Defendants, however, argued that the result was “wrongly decided” and “point[ed] to a litany of other cases where courts granted summary judgment on the grounds of the learned intermediary defense, despite the alleged bias of a learned intermediary who had been compensated by the defendant.” 2019 WL 4316163, at *9. We compared Salinero’s discussion of the defendant’s (id. at *9-10) cases with those in our post, and are pleased to report that we had them all.
The court rejected any purported exception to the learned intermediary rule for financial payments, and instead imposed on the plaintiff the obligation to come forward with actual evidence that the defendant should have expected its financial payments to influence the prescriber’s medical treatment, and thus should not have relied upon this particular physician, as the learned intermediary rule would otherwise permit: The Court predicts that the Florida Supreme Court would side with the weight of authority cited by Defendants . . . above. These cases do not stand for the proposition that these states’ learned intermediary doctrines always apply in suits against manufacturers of drugs or medical devices. Rather, the cases suggest that the learned intermediary doctrine may not apply if the manufacturer knew or reasonably should have known that the intermediary-physician would not be exercising his independent medical judgment, such that the manufacturer could not rely on the intermediary-physician to duly consider the provided warnings when prescribing treatment.
Id. at *10 (emphasis original). It agreed with us about the Texas cases, expressly “disagree[ing]” with Pinnacle Hip: to the extent it suggests that the mere fact of [a prescriber’s] having served as an expert witness for [a defendant], or the mere fact of [a prescriber’s] having received “thousands of dollars in Honorariums, reimbursements, royalties, and payments for speaking engagements and promotional speaking events” and having been identified as a “Key . . . Surgeon,” created a genuine dispute that those surgeons acted or reasonably could have been expected to act in a non-objective manner when choosing a course of treatment for the plaintiffs in that case.
Id. at *11.
More than just money, to avoid the learned intermediary rule, a plaintiff must come forward with “proof of non-objectivity – . . . proof of [the prescriber] being ‘so closely related’ to the manufacturer ‘that he could not exercise independent professional judgment.’” Id. (quoting Talley v. Danek Medical Inc., 179 F.3d 154, 163 (4th Cir. 1999)). Predictably, plaintiff in Salinero had no such thing.
Plaintiffs offer no evidence to suggest that Defendants knew or reasonably should have known that [the implanting surgeon] would not be exercising his independent medical judgment when he decided to implant [the device] in [plaintiff]. Plaintiffs cannot prevent the application of the learned intermediary doctrine here simply by pointing to [the implanter’s] history as an expert witness and consultant for Defendants. . . . [N]othing in [his] deposition ties his role as a consultant or expert witness to the . . . product specifically. Plaintiffs have not presented any evidence to suggest it was a foregone conclusion that [he] would prescribe [the device] to treat [plaintiff].
Id. Calumny and innuendo are not enough.
[T]here is no evidence beyond Plaintiffs’ conjecture and speculation to cast doubt on [the implanting surgeon’s] testimony that he believed that he was fully apprised of the risks of implanting [the device] . . . and still would have chosen to implant it in [plaintiff] anyway. As [the surgeon] testified, his decision to use [the device] in [plaintiff’s] surgery had nothing to do with any consulting or expert witness work he had done for Defendants.
The end result was predictable, which is why plaintiff tried so hard to get around the learned intermediary rule in the first place. Any surgeon experienced enough to serve as a defense expert in mass tort litigation will have a full and complete understanding of the risks of the products s/he uses – and that was true in Salinero. Id. (discussing at length the surgeon’s non-reliance on product labeling, prior knowledge of all relevant risks, and that no revised warning would have changed his decision to use the device).
JAMES M. BECK is Counsel resident in the Philadelphia office of ReedSmith. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale).
James handles complex personal injury and product liability litigation. He has overseen the development of legal defenses, master briefs, and dispositive motions in numerous multidistrict litigation matters and other mass torts. On the appellate side, he has drafted major appellate briefs in significant product liability and related matters, including numerous amicus curiae briefs.