We have not posted for a while—that day job can really get in the way sometimes—so we agreed to tackle the ridiculously long decision in Christiansen v. Wright Med. Tech. Inc., MDL No. 2329, 1:13-cv-297-WSD, 2015 U.S. Dist. LEXIS 115601 (N.D. Ga. Aug. 31, 2015), as a bit of penance. This act may be appropriate given the recent Day of Atonement and, much like long Yom Kippur services during a fast, the decision drags on, repeats itself, has some highs and lows, and maybe induces some confusion and a touch of a headache. While we are not looking for a scapegoat, some of the reasoning for why the issues were presented how they were presented and why they were decided is lost on the reader, at least this reader. (Much like the original meaning of Azazel, to where/whom the original scapegoat was to be sent by Aaron. Or maybe not at all like that.) As a combination Daubert and summary judgment order on a bellwether case from an MDL for a product, a metal-on-metal hip implant, for which there is considerable litigation on similar products made by other manufacturers, there will likely to attempts to extend various parts of this decision to other cases. So, we will resort to the dreaded use of subheadings in discussing it.
Background
Plaintiff had a left hip replacement in 1995 with a device that used a ceramic femoral ball, a polyethylene liner, and a metal acetabular shell. In 2006, plaintiff had her right hip replaced with the defendant’s product, which utilized a ball and cup each made of cobalt-chromium with no liner. In 2012, plaintiff started experiencing pain in her right hip and, within a week, had a revision surgery where the defendant’s product was explanted (and presumably something else was implanted). All three surgeries were done by Dr. Lynn Rasmussen, who happened to have been consulting with defendant on designing hip implants in between the second and third surgeries. In doing the third surgery, Dr. Rasmussen observed what he called “metallosis” (sometimes “metalosis” in the records and briefs), but did not send any explanted tissue or material for pathological evaluation. Plaintiff sued under a range of product liability theories based on the risk of “metallosis.” Thereafter, plaintiff named at least ten experts to weigh in on causation and defect in some form or other, most of whom relied to some degree on Dr. Rasmussen’s characterization of what he saw—and defendant filed a bunch of Daubert motions. Plaintiff filed a “motion for partial summary judgment” that preemption and the learned intermediary doctrine did not apply to her claims and, at the court’s request, the defendant filed a motion for summary judgment on all the claims that plaintiff did not drop. An affiliated defendant also filed for summary judgment on different grounds. There were some other motions we are ignoring, but everything was addressed in one big decision.
Daubert
One of the motions that defendant filed asked that none of the retained experts be allowed to rely on what Dr. Rasmussen said he saw in his third surgery because there was no pathology or test evidence from that surgery to show how the tissue had reacted to the implant. When we saw that there was a separate “Metallosis Motion,” we expected it would be a challenge to whether there is a defined clinical entity called “metallosis” that can be diagnosed just be looking at it, no matter how experienced the surgeon making the diagnosis is. That is not what the defendant did, though. It did not challenge whether there is something called metallosis or even that Dr. Rasmussen observed signs of metallosis in the tissue and fluid he encountered during the third surgery. Instead, at least as the court interpreted it, the defendant made a Rule 703 challenge to attempts to rely on what Dr. Rasmussen said he saw when no “corroborating information” was available in the medical records. Given Dr. Rasmussen’s experience and testimony that he had seen metallosis enough to know it when he saw it—perhaps channeling Justice Stewart on obscenity—for the court to brush aside the challenge.
Rasmussen’s observations, conclusions, and opinions are the kind of medically reliable evidence that medical experts would consider in reaching a conclusion about the medical condition or complications. That is, medical professionals and researchers often rely on the observations of treating physicians to reach diagnostic conclusions, decide on courses of treatment and opine on the commonality of disease and injury among patients to determine if there is a common course of disease or injury. The observations of an experience treating physician are especially reliable because they serve to record a patient’s medical history and often form the basis for a person’s treatment and health issues throughout the person’s life.
Id. at **25-26. This may seem pretty straightforward, but there should be a distinction between observations of something already described in medical literature as representing a known clinical entity and conclusions that a novel clinical entity has been observed based on the untestable ipse dixit of the physician. We see some danger in how this ruling may be extended, as we do for the court’s related conclusion that “Rasmussen’s observations, conclusions and opinions were not required to be corroborated by laboratory or other corroborating testing before other experts could reasonably rely upon them.” Id. at *31.
The various experts who relied on what Dr. Rasmussen said he saw and diagnosed mostly got to offer their causation opinions, but not necessarily other opinions that were challenged. Reconciling the various parts of this would require more effort than we have offered here.
First, a pathologist was allowed to offer a case-specific opinion on the pathological processes without having pathology slides. This was permitted because she relied on photographs of the explant, along with what Dr. Rasmussen and plaintiff said. Id. at **38-40.
Second, a medical toxicologist, who had also personally evaluated the explant, was not allowed to give a causation opinion because he was viewed as just parroting Dr. Rasmussen’s opinion. Id. at **44-46.
Third, a biomedical engineer was allowed to opine on causation because his inspection of the explant “articulated evidence that supported Rasmussen’s conclusion.” Id. at **49-50.
Fourth, a metallurgist, who reviewed case-specific information but did not offer case-specific opinions, was allowed to refer to “tissue discoloration” as “staining.”
Fifth, a mechanical engineer was allowed to opine on cause because he also relied on the biomedical engineer’s report.
Sixth, our old pal Dr. Parisian was not allowed make it sound like she had reached a causation opinion in the midst of offering her regulatory opinions—which is one of her little trial tricks—but no other aspect of her opinions was challenged.
Seventh, an orthopedic surgeon was allowed opine on cause without blood test results on plaintiff like he typically uses to diagnose metallosis.
An eighth expert, a master’s level materials science and biomedical engineer, used a novel method to estimate the “simulated wear volume” of femoral heads and compare it to the measure of wear on the explanted femoral heads from plaintiff and other patients. The expert’s method for estimating what cannot be measured was apparently part of his master’s thesis and, as such, his opinion had been peer reviewed to some extent. The court saw that other Daubert factors were not met, though—as they are often not for similar guesses made by experts in medical device cases who talk about what happens with implanted medical devices that do not get explanted. The expert could not compare actual “immeasurable wear” to his estimation and, as such, could not test his method or establish its error rate. Id. at *69.
A ninth expert, another metallurgist, was allowed to opine that plaintiff was injured because the metals selected for product were purportedly a poor choice for a prosthetic hip. Defendant’s challenge focused on the expert’s failure to do any evaluation of plaintiff’s explant or any tests to evaluate any aspect of his theory about how the metals behave in the body. He also relied on material data sheets—yes,those somewhat notorious documents about worker safety when handling raw materials—in forming his opinions. Specifically, he relied on the handling instructions in the data sheets for cobalt and chromium powder in opining that metals “must also be dangerous when used in metal alloy form in a medical device.” Id. at *77. Rather than directly address the silly use of the data sheets or the utter lack of testing, the court concluded that the totality of the information that the expert considered, including the other plaintiff expert reports (the excluded ones among them), provided a reliable basis for the opinion. Like we said, we would need to try hard to reconcile some of these rulings.
A tenth expert—why stop at nine?—was a biostatistician who tried to opine that studies showed that the revision rate was higher than a company report stated in 2010. In what some courts might have said was a matter for cross-examination, the court excluded these opinions (but apparently allowed others about the conduct of clinical trials) because the studies he chose as comparisons were inappropriate in considering other products and other end points and in cherry-picking lesser quality surveys over randomized controlled trials. These “fundamental shortcomings in Waller’s comparison analysis [] discredit[] the reliability of the opinion, and to admit it would risk confusing, and likely misleading, the jury.” Id. at *92.
Summary Judgment
Holding Company’s Motion
We have posted many times about attempts by plaintiffs to bring product liability claims against individuals or entities other than the company that designed, manufactured, and marketed the product. State law formulations of product liability theories overwhelmingly limit liability to the company we typically call “the manufacturer,” absent an unusual fact pattern. At first blush, one of the defendants here, Wright Medical Group (“WMG”), which called itself a “holding company,” would seem like the kind of defendant that should get out of the case. There were two reasons why that was not the case here. First, maybe because of the MDL dynamic of how claims and motions to dismiss are raised and maybe because Bauman came down after the defendants had answered initially but before the current amended complaint had been answered, lack of personal jurisdiction over the WMG had not been raised as a defense. That was waiver and serves as a reminder to re-evaluate template answer and answering practice periodically. It is unclear whether any of the complaints alleged enough to satisfy current standards for personal jurisdiction over WMG.
Second, as the court framed it, WMG based its summary judgment motion on the lack of evidence that it “committed the wrongful conduct that Plaintiff alleges cause her injury.” Id. at *99. It did not contend that Utah law—which applied here—imposed no duties on it that could give rise to product liability. As such, the analysis does not discuss the requirements of Utah law at all. Instead, it focuses on the competency of the affidavit claiming that WMG was not involved in the design, manufacture, sale and marketing of the product at issue. The affiant was deposed and admitted relying on outside counsel and the main defendant’s tax director rather than her own personal knowledge. This made the affidavit insufficient to shift the burden to plaintiff under Rule 56 to establish genuine issues of material fact—and provides additional reminders on the importance of selecting the right affiant and the corresponding risk of deposition. To top it off, general statements in SEC filings could be read as suggesting that WMG was involved in the medical device business directly as opposed to just through its subsidiaries. These statements, along with billing and inventory records, “facially support that WMG may have been involved in the manufacture, sale, or marketing of the Conserve hip replacement components.” Id. at *104 (emphasis added). If the burden had shifted through sufficient evidence with the motion, then this “may have been” evidence from plaintiff might not have been enough, but the burden had never shifted. So, motion denied.
Preemption
Defendant’s contention on preemption was that express preemption wiped out plaintiff’s design-based claims, not because the actual product had been approved through a PMA, but because the plaintiff’s theory implicated other PMA approvals. As the court recounted it, no type of preemption besides express was asserted and Riegel makes it clear that the express preemption provisions in the Medical Device Amendment to the FDCA require a PMA approval of the specific device. The actual language of 21 U.S.C. § 360k imposes preemption when the state law claim imposes a requirement that is “different from, or in addition to, any requirement applicable under this chapter to the device,” which is not the same as limiting preemption to requirements coming from the PMA approval of the specific device. Whether the PMA approval of the defendant’s related device could impose a “requirement applicable under this chapter to the device” at issue was not really analyzed. That may have been because the court considered the lack of the PMA submission for the device at issue to have “denied the FDA the opportunity” to evaluate the device, its safety, and its efficacy. Id. at *121 n.50. That sounds an awful lot like a Buckman issue, but, again, implied preemption was not addressed. As for the idea that the plaintiff’s theory that all metal-on-metal hip implants were defective created preemption because FDA had approved other metal-on-metal implants, the court read the complaint as being about the product at issue rather than the class of products. The court did not, however, look back at the opinions of plaintiff’s experts—the ones analyzed in the Daubert part of the decision—to see that their view of defect was often not product-specific. It can certainly be the case that evidence and argument offered in support of a broader claim should be precluded based on preemption. This has come up in various contexts—for instance, a plaintiff expert saying that the drug should have had a black box label—but it would logically apply to the basic choice of a material or broad design too. The court, however, did not go that deep here in denying the express preemption motion.
Comment K
The analysis of the Comment K defense did try to predict how Utah courts would apply the defense to medical device cases given the Utah Supreme Court’s adoption for prescription drugs and a Utah federal court’s refusal to apply it to medical devices. (We discussed the Utah federal court decision here.) Relying heavily on the old Oklahoma Supreme Court case-by-case decision in Tansy v. Dacomen Corp., 890 P.2d 881 (Okla. 1994), the court predicted a case-by-case application of Comment K for medical devices. It also adopted Tansy’s language that Comments K should only apply where the device is designed to be “as safe as the best available research and testing permits.” 2015 U.S. Dist. LEXIS 115601, *118. Because unspecified “record evidence establishes a genuine issue of material fact regarding whether the Conserve implant was made as safe as it could be made,” Comment K did not apply. This does not seem like the right analysis, as Comment K is typically asserted in the face of design and manufacturing defect allegations. The court also looked to the presence of allegations about “whether the product was properly marketed in light of the alleged misrepresentations Defendants’ representative made to Rasmussen” in connection with the well-known statement from Comment K about the need for a “proper warning.” Id. at **118-19. This statement, however, is about how Comment K does not prevent liability for failure to warn, as opposed to requiring proof of an adequate warning before design claims can be kicked.
Proximate Cause for Failure to Warn
Speaking of failure to warn, the defendant won that claim based on the basic reason that the implanter did not read the product’s label. Faced with clear record evidence that Dr. Rasmussen did not rely on anything in writing from the manufacturer and made up his own mind on risks and benefits, the court did an appropriate Erie analysis in predicting that Utah would follow the vast majority of jurisdictions that the learned intermediary’s failure to read the allegedly inadequate warning breaks the causal chain. A straightforward analysis and good result. Somewhat strangely, though, the court did not consider what Dr. Rasmussen was allegedly told by representatives as going to the failure to warn claims, which it implied had to be based solely on the written warnings. “Any allegedly false information provided by Defendants’ representatives to Rasmussen is relevant only to Plaintiff’s fraudulent and negligent misrepresentation claims, not Plaintiff’s failure to warn claim.” Id. at *127.
Misrepresentation
On those misrepresentation claims, which also included the concealment variant, there was no allegation that plaintiff herself received any information from the defendant directly or should have. Instead, the allegation was that Dr. Rasmussen received and relied on various oral representations—so much for how he “prefers to ‘educate himself’ on the product and review the studies and what went into the design,” id. at *125—about the low risk of metallosis, long lifespan, and good range of motion, which made it good for patients who were young and active. These representations were allegedly part of why Dr. Rasmussen recommended this product for plaintiff, which plaintiff accepted. Relying on Kansas device law and Utah drug law, the court determined that all versions of the misrepresentation claims could be based on what was and was not told to Dr. Rasmussen. While we generally agree that the learned intermediary doctrine should apply to all informational claims for a prescription medical product, however framed, the lines between failure to warn and misrepresentation claims appear to have been blurred here. The misrepresentation claims here were about affirmative representations on safety, efficacy, suitability, and lifespan and about nondisclosure of risks, which swallows up the failure to warn claims that plaintiff lost. The difference is that the misrepresentation claims sound in fraud and fraud . . .
Punitive Damages
. . . is a basis for punitive damages under Utah law. While Utah has a statutory prohibition on punitive damages for FDA-approved drugs absent proof of fraud on the FDA, it has nothing like that for devices. As such, the court did not see how public policy would preclude punitive damages for a 510(k) device with adequate written warnings but allegations that the manufacturer “defectively designed the device and misrepresented or concealed the risks involved in using the device.” Id. at *8140-41. So, the blurred lines on warnings and misrepresentation did affect the availability of punitive damages. That is it for this decision, but we expect that we will see some parts of it cited again.