The following is a guest post from Reed Smith’s Rachel Weil. As always, she takes full responsibility for the content of the post.
Dipping our toes into the blogosphere is intimidating, given the company in which we daily find ourselves. We can claim neither Bexis’s pinpoint command of all recorded jurisprudence nor McConnell’s encyclopedic recall of cinematic and literary history. (He knows law, too, for the record.) Plus, our life notably lacks the anecdote-generating adrenaline our colleagues’ adventures provide. (Bexis and Alexander are BOTH zip lining in exotic locales as we type this.) Our individual voiceprint is thus not self-evident, and it would be easy to wax overly precious in attempting to identify it. For the time being, we will content ourselves with reporting legal developments and will remain optimistic that a niche will fashion itself for us.
This initial foray will curry little favor, as we are charged with summarizing two recent decisions in the Pinnacle Hip Implant MDL, neither of which contains a shred of good news for defendants. In one day, the MDL judge issued an opinion denying all five dispositive motions filed by defendants in two individual cases (In In re: DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation, 2014 U.S. Dist. LEXIS 97743 (N.D. Tex. July 18, 2014)) and an opinion denying all six of defendants’ Daubert motions to exclude the testimony of plaintiffs’ experts. (2014 U.S. Dist. LEXIS 97798).
The Pinnacle implant is a metal-on-metal hip implant device, marketed to younger hip replacement patients because it lasts longer than other implant devices. Plaintiffs in both individual cases alleged that the metal-on-metal design of the articulating surfaces of the Pinnacle implant produced metallic ion debris, potentially causing an inflammatory reaction leading to bone and/or tissue necrosis and resulting in the need for revision surgery. Four corporate affiliates of manufacturing defendant DePuy Orthopaedics, Inc., collectively the “Johnson & Johnson Companies,” filed a motion to dismiss, arguing that the Court lacked personal jurisdiction over them, and a summary judgment motion to be decided if the Court denied the jurisdictional motion. DePuy filed motions under Montana law addressed to plaintiffs medical monitoring/future medical damages claims, their failure to warn/misrepresentation/omission claims, and their claims for intentional infliction of emotional distress, breach of implied warranty, and res ipsa loquitur. Finally, DePuy moved for summary judgment on plaintiffs’ design defect claims, arguing that these claims were preempted under Pliva v. Mensing. Some “lowlights” of the Court’s denials of all of these motions:
After denying the Johnson & Johnson Companies’ jurisdictional motion, the Court considered their motion for summary judgment, in which the entities argued that they couldn’t be liable to plaintiffs because none of them had ever manufactured or sold the Pinnacle device. With Conte-esque disregard for this bedrock principle, the Court denied the motion, invoking Section 876(b) of the Restatement (Second) of Torts, which “provides that a party is subject to liability for harm to a third person resulting from the tortious conduct of another if he knows the other’s conduct constitutes a breach of duty and gives substantial assistance to the other so to conduct himself.” 2014 U.S. Dist. LEXIS 97743 at *13. Pointing out that § 876 “has recently been applied to business organizations by the Montana Supreme Court, id., the Court held, “The summary judgment evidence in this case raises fact issues that the Johnson & Johnson Companies knew that DePuy was engaged in the manufacture and marketing of a defective product and that they provided assistance to DePuy in marketing that product.” Id.
DePuy’s Motions: Failure to Warn and Related Claims
Relying on Oakberg v. Zimmer, Inc. 211 Fed. Appx. 578 (9th Cir. 2006), DePuy advanced a “failure to read” argument in support of its motions addressed to plaintiffs’ warnings-related claims. DePuy argued that, because the implanting physician had not read the Instructions for Use (“IFU”) accompanying the Pinnacle device, plaintiffs could not meet their burdens of proving that he relied on the warnings and representations in the IFU or that the warnings and representations caused him to choose the Pinnacle device. The Court declined to follow Oakberg, noting that, while the doctor never read the IFU, he “had a close relationship with his DePuy salesman” and relied on him for information, and was exposed to DePuy’s statements through seminars, lectures, advertisements, and medical publications. The Court concluded “that a reasonable jury could determine that Dr. Allmacher relied upon DePuy’s misrepresentations and omissions concerning the Pinnacle device.” 2014 U.S. Dist. LEXIS 97743, at *22-23. (As you will see below, the Court’s rejection of the “failure to read” argument returned to doom one of defendants’ Daubert motions.)
Intentional Infliction of Emotional Distress
DePuy argued that it could not be liable to the plaintiffs for intentional infliction of emotional distress because plaintiffs could not “demonstrate that DePuy engaged in intentional conduct directed at them for the purpose of causing them emotional distress.” Id. at *26. The Court insisted that “intentional” didn’t really mean “intentional,” noting that Section 46(l) of the Restatement (Second) of Torts discusses emotional distress caused by either “intentional” or “reckless” conduct. And even though no Montana decision had ever addressed “reckless” infliction of emotional distress through conduct not directed specifically at the plaintiffs, one nine-year-old Tennessee state court decision had allowed such a claim. And even if Montana did require specific conduct directed at Plaintiffs, and even if there was no proof that DePuy’s conduct “may not have been directed specifically at [the individual plaintiffs],” it was certainly directed at people like them. Id. at *28-29. And so the Court found its way to denying summary judgment on plaintiff’s intentional infliction of emotional distress claims while acknowledging that there was no evidence of intentional infliction of emotional distress.
Finally and predictably, the Court denied DePuy’s preemption motion. The Pinnacle device is a Class II medical device, cleared for marketing under the FDA’s 510(k) process after the agency concluded that it was “substantially equivalent” to a predicate device. DePuy argued that plaintiffs’ state law design defect claims were preempted under Pliva v. Mensing because, under 510(k), DePuy could not have changed the design of the Pinnacle without FDA approval. Bypassing Mensing entirely and muddling both preemption law and DePuy’s argument, the Court held that, because the Pinnacle was a Class II medical device, not a generic prescription drug, any express preemption argument was foreclosed by Medtronic v. Lohr. DePuy, of course, did not advance an express preemption argument, and its impossibility preemption argument – an accurate statement of 510(k)’s constraints – deserved consideration it did not get.
DEFENDANTS’ DAUBERT MOTIONS
Defendants fared no better in their Daubert motions addressed to the testimony of plaintiffs’ experts. The Court foreshadowed its holdings in its prefatory comment that “[a] review of cases within the Fifth Circuit in which expert opinions have been deemed unreliable and inadmissible reveals extreme circumstances of unreliability that were well beyond, for example, whether the expert considered all potentially relevant literature.” 2014 U.S. Dist. LEXIS 97798 at *19. Apparently finding no such “extreme circumstances,” the Court found ways to deny all six motions. Among them:
Plaintiffs’ “Expert on the Truth of Marketing”
First, the Court considered DePuy’s motion to exclude the testimony of Dr. John Abramson, plaintiffs’ “expert on the truth of DePuy’s marketing.” DePuy sought to exclude five opinions in which Dr. Abramson argued that DePuy exaggerated the benefits and minimized the risk of Pinnacle implants in is marketing materials, as well as his opinion that DePuy “paid physician consultants millions of dollars in return for input into the design and marketing” of the Pinnacle devices. Id. at *20-21.
The Court rejected DePuy’s arguments that: 1) Dr. Abramson, a family practitioner, was not qualified to render opinions about orthopedics; 2) his opinions were nothing more than lengthy narratives and speculation about DePuy’s state of mind; and 3) his opinions about DePuy’s marketing efforts were not relevant. The Court held that Dr. Abramson’s opinions did not require expertise in orthopedics; rather, he was “more than qualified” to compare DePuy’s marketing messages with his interpretation of “what underlying scientific research actually showed,” id. at *23, “ due to his expertise in the area of the influence of marketing on medical decision” and his expertise “in research design and the interpretation of scientific data.” Id. The Court noted that Abramson had “written extensively about the integrity of information that doctors rely on in making clinical decisions,” and that he had left his clinical practice to conduct full-time research in this area” and had “written a book on this issue.” Id.
Acknowledging that Dr. Abramson’s report contained “narrative summaries in addition to his opinions,” the Court shoehorned these summaries into Fed. R. Civ. P. 26, holding that they functioned to articulate the bases of Dr. Abramson’s opinion, and that “[e]xpert narrative testimony is entirely permissible where [it] would assist the trier of fact in understanding” complicated, voluminous . . . . scientific or technical” documents forming the basis of the expert’s opinion, id. at 25-26, and that “the admission of Dr. Abramson’s alleged speculation and narrative testimony . . . is not properly the subject of this Court’s gatekeeping function under Daubert.” Id. at 26.
Finally, the Court brushed aside DePuy’s argument that Dr. Abramson’s testimony was not relevant given plaintiffs’ physician’s admission that he had not relied on any of DePuy’s advertising in deciding to use the Pinnacle device. With reasoning akin to its rejection of defendants “failure to read” summary judgment argument, the Court held that the physician had other sources of the information in DePuy’s materials – presentations by key opinion leaders, surgeon dinners, medical education seminars, and medical journals – so DePuy’s marketing messages “were conveyed” even if the physician never saw any of DePuy’s marketing materials.
We confess to puzzlement over this decision, even against the backdrop of the Court’s other decisions. How is Abramson’s opinion “scientific, technical or other specialized knowledge [that] will assist the trier of fact,” as required by Fed. R. Civ. P. 702? The Court states that Abramson’s testimony is “helpful to the fact finder (even an orthopedic surgeon) [??? – how is the orthopedic surgeon a fact finder?] because he is interpreting complex scientific data to assess the truth of DePuy’s marketing claims.” Id. at 23-24. We think this is a stretch, even for this Court.
Scott Bayley, C.P.A., Plaintiffs’ Punitive Damages Expert
In denying DePuy’s motion addressed to this expert, the Court held that this “punitive damages expert” was not a “punitive damages expert” at all. According to the Court, Bayley was not being offered “as an expert on the calculation of punitive damages,” properly the jury’s function, as defendants argued. Rather, the expert “analyze[d] the financial condition and net worth” of defendants, and calculated three different figures, by three different methods, representing “the amount that Defendants could afford to pay before being adversely affected.” Id. at *30. Rejecting defendants’ argument that these figures simply provided the jury a range of awards within which to choose, the Court concluded, “The admissibility of Mr. Bayley’s testimony on the basis that it invades the province of the jury is more appropriately a question to be determined in this Court’s discretion over the presentation of evidence at trial and not as part of the Court’s gatekeeping function under Daubert.” Id. at *31. Finally, the Court rejected the defendants’ argument that the expert’s testimony was not reliable, notwithstanding the expert’s admission that “there is no basis in accounting for considering dividends, materiality or credit ratings for calculating the largest punitive damages award a company could sustain,” reiterating that the expert was calculating defendants’ ability to pay and was not calculating “an amount of punitive damages.” Id.
Other Daubert Motions
The Court also denied DePuy’s motions addressed to: 1) Plaintiffs’ expert on metal corrosion (rejecting arguments that the expert was not qualified to testify about design or defect issues and used unreliable methodology to reach his conclusions. Id. at *33.); 2) Plaintiffs’ expert on the injuries allegedly caused by cobalt nanoparticles in the metal-on-metal wear debris produced by the Pinnacle (“DePuy’s criticism of Dr. Colvin is merely a battle of the experts and goes to the weight rather than the admissibility of her testimony. A difference of opinion in interpreting the literature is not grounds for a Daubert challenge. Id. at *39-40.); 3) Plaintiffs’ biostatistics expert (rejecting DePuy’s argument that the expert based his conclusion on the wrong data, holding that “the factual basis for an expert’s findings goes to the weight of his testimony, not the admissibility.” Id. at *42 ) (citations omitted); and 4) Plaintiff’s expert in “measuring manufactured components” (“DePuy’s disagreement about how Dr. Ziegert executed the steps in the process for measuring wear volume goes to the weight not the admissibility of this testimony.” Id. at *44.)
Apparently, the “gatekeeper” was on hiatus. All in all, a bad day for defendants, and for the application of law to facts, in the Northern District of Texas. We hope that we have better news to report next time.