Under Fed. R. Evid. 9(b), “[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.” In our sphere, federal courts are quite variable in how they apply this standard when deciding 12(b)(6) motions. In particular, MDLs seem to have an unfortunate habit of allowing general allegations to support fraudulent misrepresentation claims and other claims based on alleged fraud or mistake. The lenient courts tend to say things like “without discovery, plaintiffs cannot know enough to plead with particularity” and “the inferences go to the plaintiff at this stage.” Later, though, when the defendants have spent time and money on discovery and teed up a summary judgment motion, do courts require that plaintiffs have adduced evidence establishing the specific “who, what, when, and where” of any alleged misrepresentation? In our experience, not often enough. Instead, some courts let this combination of vague evidence suffice at the summary judgment phase: 1) the prescriber generally saw and considered what sales representatives said about a medical product, 2) no sales representative ever disclosed the existence of some alleged risk that the manufacturer never thought was reasonably associated with the use of the product, and 3) the prescriber would have considered evidence about this alleged risk if some sales representative had provided it to her. We do not think this evidence should be enough to establish the prima facie case for any claim, but it certainly does not establish particular circumstances for any misrepresentation, whether affirmative or by omission.
The BHR MDL has gotten a lot wrong, particular on preemption, but we think it got this issue right, at least for one case. By way of brief recap, decisions from the In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Prods. Liab. Litig., MDL No. 2775, have graced our bottom ten list twice in the last four years. (Here and here.) This MDL concerns a PMA device, so parallel claims only fly if state law provides for them in the first place, they are consistent with FDCA requirements, and they are not inconsistent with Buckman. The BHR court botched that analysis more than once (here and here), including in connection with rulings on expert opinions. When it has come to summary judgment, however, the results have improved (like here, here, and here), although that may have had more to do with the overall weakness of the claims being asserted. When the court denied a plaintiff motion for a new trial after a defense verdict, we found the reasoning a bit shaky and the leeway plaintiff had received along the way excessive.
Here, though, we give credit where it is due. The BHR court dug in to an extent many MDL court do not in granting summary judgment in In re BHR (Hand v. Smith & Nephew), No. 1:17-cv-2775, 2022 WL 1556099 (D. Md. May 17, 2022). In Hand, the court tackled a range of issues, but the part that stands out to us is the treatment of the misrepresentation-based claims, even with the court’s unwieldy preemption rulings in the way. The basic facts of Hand are that the plaintiff had a BHR system implanted in her left hip following pain there for close to three years that progressed to her being “significantly disabled,” four prior surgeries in her right hip, and extensive consultation on the risks, benefits, and alternatives. The BHR surgery maintained more of her femur compared to a total hip replacement. After attending a patient education class, seeking a second opinion, being warned that she was at increased risk for revision as a woman, and being warned of a risk of metal ions accumulating in her blood, she went forward with the BHR implant in her left hip on June 25, 2007. About six years later, she reported new pain in her right hip and was diagnosed with increased metal ions in her blood. About three and a half years after that, she complained of new pain in her left hip, was worked up, and had a left hip revision surgery in December 2016. She sued a month later, asserting a range of claims, some of which were knocked out by MDL-wide rulings.
After more than five years on the docket, the defendant had its motion for summary judgment heard. The first issue, somewhat ironically, was whether the plaintiff’s express warranty claim was time-barred. We will not dwell on this too long as it related to a quirk of Illinois law, which provides a four year statute running from the delivery of the good or service at issue unless there is an explicit promise of future performance. Here, plaintiff tried to turn a statement in a patient guide about a study reporting “survivorship [i.e., no re-operation] of 98.4 percent at the five-year mark, which is comparable with the survivorship of a traditional total hip replacement in the under-60 age group” into such a promise. Id. at *5. The court disagreed, citing the guide’s immediately prior statement that “[i]t is impossible to say how long your implant will last because so many factors play into the lifespan of an implant.” Id. Her negligence claims, however, were not barred by the two-year statute of limitations even though she had the following three and half years before she sued: right hip pain, a related diagnosis of increased metal ions, and a documented concern about revision of her left hip BHR based on the warnings she had received before implant. “But knowing that her metal ion levels were attributable to her implant is not the same as knowing her metal ion levels were caused by another’s negligent conduct, as Illinois law required to start the clock on her lawsuit.” Id. at *6. Were we dwelling on preliminary matters, we might question that reasoning.
Moving on to the meat, though, we see the impact of the preemption and summary judgment rulings addressed in our prior posts on this MDL: “These alleged misrepresentations must be inconsistent with the FDA label at the time of Hand’s surgery (and this not shielded by the court’s earlier preemption rulings), and they must be false or misleading by omission.” Id. at *7 (citing the case discussed here). They also had to have been made between the May 2006 PMA approval and the June 2007 implant, and been relied upon by the implanting surgeon or the plaintiff. (We think only statements to the learned intermediary, the implanting surgeon, and the surgeon’s reliance should count, but we can set that aside for now.) Plaintiff offered four communications that were allegedly misrepresentations by omission of information about an increased revision risk in women. As we said, we do appreciate the court’s dive into the details of the alleged misrepresentations and whether plaintiff’s evidence connected the dots, but there was a basic fact that should have knocked them all out even without preemption: the implanting surgeon warned plaintiff of an increased revision risk in women before she consented to and had the BHR implant. The surgeon clearly did not rely on any representation to conclude there was no such increased risk or that it was not worth mentioning.
The first communication up was the patient guide, which allegedly misled plaintiff and the implanting physician. (In addition to thinking the focus should be solely on the physician, we think alleged misrepresentations in an FDA-approved medication guide would run smack into preemption except in special circumstances.) The language quoted above from the SOL analysis was alleged to misrepresent the revision risk, particularly because it did not break out the risk by each possible subgroup. But it was consistent with the rate in the approved IFU at the time and plaintiff had no evidence that she or her doctor relied on the undifferentiated rate. Id. at *8-9. As noted, the doctor knew about a higher risk in women, he told plaintiff about it, and plaintiff relied on what he told her in deciding to receive a BHR implant. Plaintiff offered back-up arguments that the patient guide did not identify a design feature that allegedly caused increased revisions, did not warn about the risk of metal ions, and minimized the complexity and trauma of revising a BHR implant compared to a total hip replacement. These were all dead ends. For the design issues, there was no evidence supporting a connection to revision rates until about eight years after the implant and plaintiff did not rely on this part of the guide. Id. at *9. For the metal ion claim, the guide’s information on this risk was consistent with the IFU and evidence at the time, and plaintiff relied on her doctor, who warned her about this. Id. at *10. The language comparing the revision of a BHR versus a revision of a total hip replacement was again consistent with the IFU, and plaintiff did not rely on this section of the guide. Id. We do not need to get way down in the weeds to convey the benefit of the court doing so when it evaluated evidence offered in support of a fraudulent misrepresentation claim.
The evaluation of the other three communications was similar. Plaintiff claimed the implanter was misled during a November 2006 BHR training course he attended in England. “But the record does not include information about the content of that training session beyond Hand’s assertions that it was the same as all other Smith & Nephew BHR training sessions.” Id. Her expert did not opine on the session and the implanter testified that he relied mostly on published studies, among a range of information. Many courts might have credited this vague evidence, but this court held that “Hand has failed to generate a record with enough information about the November 2006 training to support a genuine dispute over alleged misrepresentations by Smith & Nephew.” Id. at 11. The requirement in Fed. R. Civ. P. 56(c)(1)(A) that plaintiffs in this posture support their positions by “citing to particular parts of materials in the record” is supposed to operate like this.
Plaintiff also claimed there might have been some misrepresentation to the implanter from the sales representatives who delivered the BHR components to him in connection with two prior implants in women. Again, plaintiff offered general evidence about sales representatives and physician expectations, but “the record contains no information about those two possible sales representative conversations predating Hand’s implantation, and Hand’s argument about misrepresentations during those encounters is entirely speculative.” Id. Plaintiff’s last alleged misrepresentation was a June 2007 email inviting the implanter to consult on a possible next generation BHR, “although the design has excellent results.” Again, there was no evidence to suggest the email deceived the implanter about anything and certainly not about the increased risk of revision in women that “he already knew existed.” Id. at *12. So, all of plaintiff’s alleged misrepresentations failed.
She also offered three negligence claims, each of which was decided in the context of the somewhat wacky prior preemption rulings. On negligent failure to warn, claims relating to warning the plaintiff and implanter were preempted, but plaintiff had a chance to prove a claim based on failing to notify FDA of study data or MDRs between approval and the implant date. However, the study data plaintiff identified were public, and the implanter did not review the MAUDE database. “Together, these observations undermine the theory that Smith & Nephew’s alleged failure to warn the FDA about the Australian Registry’s annual reports was either the legal cause or the cause in fact of the Hand’s injuries.” Id. at *13. No proximate cause.
Next up was a “negligence per se” claim, which the court generously construed as a claim for common law negligence based on Illinois law according a favorable presumption where there has been a violation of a statute “designed to protect human life or property.” Given the court’s prior rulings, the plaintiff could not rely on violations of the FDCA—we agree with that—so she offered up three state statutes: express warranty, manufacturing defect, and “strict product liability.” Id. at *14. We see more direct responses to this legerdemain—that Illinois does not have negligence per se, and the statutory presumption cannot be based on law creating civil tort claims—but the court took each in turn. The work was brief, though, because plaintiff had already lost her claims based on each of those three statutes, one earlier in this ruling and the other two in a ruling on motion to dismiss back on 2018.
Plaintiff’s last gasp was a so-called negligent failure to train claim. The court had previously found this to be preempted unless it was premised on a failure to comply with the federal requirements. That exception should not exist because Illinois does not impose an independent duty to train surgeons on the use of a prescription medical device and because Buckman preempts claims premised on violation of a purely federal requirement, but plaintiff had no evidence of any deviation anyway. So, plaintiff lost that claim too, allowing for the derivative claims for punitive damages and loss of consortium to be dismissed. Much like the overall path of the BHR MDL, better rulings on global issues would have made for a cleaner decision. However, when the plaintiffs have failed to muster the evidence they need and the court drills down on what really has to be proven to support misrepresentation and warnings claims, the result ends up the same.