Plaintiffs love sales representatives. They love to use them to try to keep cases in state court—naming them as non-diverse defendants. They love to try to use them to get around preemption—claiming a direct duty from the rep to the plaintiff. And they certainly love making sales representative statements and conduct a focal point of their cases. That’s because plaintiffs try to argue that liability attaches any time a sales rep makes a statement that is “inconsistent” with the label. Defining “inconsistency” liberally, plaintiffs try to use sales reps to get around the learned intermediary doctrine often without much more evidence than that the sales rep visited the prescribing doctor. In reality, however, failure to warn claims in prescription drug and device cases frequently are thwarted by knowledgeable physicians who apply their independent medical judgment in deciding whether a course of treatment is in the best interests of their patients. Therefore, if courts keep the attention on the physician, where it should be, the learned intermediary doctrine should relegate the role of the sale rep in most cases to the back burner.
That’s precisely what the court did in Gulledge v. Depuy Orthopaedics, Inc., 2023 U.S. Dist. LEXIS 187267 (S.D. Ala. Oct. 17, 2023). Taking its cue from both the Pinnacle Hip Implant MDL and a N.D. Illinois decision in another case remanded from that MDL, the court in Gulledge denied plaintiff’s request to depose the sales reps who were present in the operating room at the time of her implant surgery and her revision surgery.
First, while the case was in the MDL, plaintiffs generally requested permission to depose sales reps arguing that the reps who were in the operating room “would see where the device caused significant harm to the patient” and “hear the surgeon discuss his or her findings during the surgery.” Id. at *3. The MDL Special Master deferred the appropriateness of sales rep depositions until after the surgeons had been deposed. Id. at *4. A step in the right direction of keeping the doctors in the foreground of the analysis.
Second, this issue was raised in Baldwin v. DePuy Orthopaedics, Inc., 2023 U.S. Dist. LEXIS 54471 (N.D. Ill. Mar. 30, 2023), which we discussed here, where the court found that “the mere fact that the sale representatives were present for the implant surgeries” did not make their testimony relevant. Id. at *5. Rather, plaintiff needed to establish a “nexus between the sale representatives’ presence at the surgeries and the plaintiff’s claims.” Gulledge, at *10-11. Strike another note for keeping the attention appropriately on the healthcare providers.
Third, utilizing the decisions of the MDL and Baldwin, the Gulledge court looked at the testimony of plaintiff’s surgeons in this case: (i) sales reps have no clinical involvement in the operating room and are primarily there to make sure the medical devices are available during surgery; and (ii) the surgeons do their own “due diligence” which included reading publications, attending courses, and speaking to peers about the hip implants. So, plaintiff had no evidence that either of plaintiff’s surgeons actually relied on information from the sale reps. The surgeons’ testimony also made it clear that they were better positioned to testify about plaintiff’s condition or the condition of the implants—not the sales reps. Finally, the court noted that voluminous document discovery had taken place in the MDL where thousands of pages of marketing, sales, and product communications were produced. Adding that up, the court found the testimony of the sales reps would not be relevant.
This decision has multiple points of impact for this case and others like it. First, the evidence cited by the court in denying the depositions should also serve as the basis for summary judgment on failure to warn. If plaintiff’s surgeons did their own research and analysis and used their independent medical judgement in deciding to use the hip implant, plaintiff’s failure to warn claim should be barred by the learned intermediary doctrine. Second, defendants should be using Gulledge and Baldwin in MDLs to urge courts to do exactly what the Pinnacle Hip Implant Special Master did—defer sales rep depositions until after prescriber depositions—and to only allow sales rep depositions where plaintiff has the nexus evidence described above. In MDLs with hundreds or thousands of plaintiffs, just one or two sales rep depositions per case can be a significant time and resource drain on defendants. To what end if no reliance? The better course is to keep the focus where it ought to be, on the prescriber.