Source: https://www.fdli.org/2019/05/in-re-depuy-orthopaedics-inc-pinnacle-hip-implant-products-liability-litigation/
Timestamp: 2020-07-02 16:11:55
Document Index: 790653334

Matched Legal Cases: ['§402', '§402', '§6', '§2', '§888', '§888', '§82']

In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation - Food and Drug Law Institute (FDLI)
James M. Beck[1]
Of all the recent federal multidistrict litigations involving FDA-regulated prescription medical products, few if any have garnered as much controversy as the In Re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation. The decision to use consolidated trials in Pinnacle Hip “bellwether” cases, virtually from the beginning, drew scathing criticism in a rare mandamus appeal, In re DePuy Orthopaedics, Inc., 870 F.3d 345 (5th Cir. 2017), where the court, although denying mandamus, found “grave error” in the manner in which this Multidistrict litigation (MDL) was being conducted. Id. at 351. Likewise, long delays in the availability of appellate review in MDL situations has prompted proposals to amend the federal rules to increase appealability.[2]
Given this history, the first actual appeal from the Pinnacle Hip MDL would have been significant, regardless of its context or content. However, the trial that produced this appeal was itself newsworthy: five plaintiffs received a verdict for the remarkable total of $502 million.[3] Less than one tenth of one percent − $500,000 − was for measurable “economic compensatory damages.”[4] Another $145 million was for pain and suffering (little under 30%), and the remaining $360 million was for punitive damages.[5] The punitive award, in particular, grossly exceeded what was legally permissible under controlling Texas law, and was reduced to under $10 million before any appeal was taken.[6]
The Fifth Circuit largely affirmed the lower court’s denial of judgment as a matter of law. In so doing it departed in a number of ways from established Texas law, primarily on design and warning-related issues.[7] The Fifth Circuit, however, also ordered a new trial in what must be one of the most significant rebukes of attorney trial misconduct in the Twenty-First Century.[8] For these results, particularly the latter, Pinnacle Hip makes this year’s list.
Discussion of the facts, holding and rationale
The “Pinnacle hip” implant, manufactured by Johnson & Johnson subsidiary DePuy Orthopaedics, is a so-called “metal-on-metal” total hip replacement medical device system.[9] The component targeted in the Pinnacle Hip litigation is the liner against which the rest of the implant rotates. This liner could be made from either ceramic, plastic, metal or plastic.[10] Ceramic came first, but rapidly gave way to metal and plastic. Plastic liners deteriorated more quickly and cause a condition called “osteloysis” that “dissolv[es] the surrounding bone,” whereas plaintiffs in the Pinnacle Hip litigation alleged that the metal version caused “instability and metallosis.”[11]
After the first, traditional single-plaintiff “bellwether” trial in Pinnacle Hip produced a defense verdict, the course of the MDL changed abruptly, with seven previously selected individual bellwethers abandoned in favor of multi-plaintiff trials.[12] “Five of those were consolidated, over defendants’ objection, for the second bellwether trial, which lasted nine weeks and forms the basis of these appeals and cross-appeal.”[13]
Judgment as a Matter of Law Issues
The defense challenged most aspects of the verdict as involving improper legal theories as a matter of law. On these issues defendants were mostly unsuccessful. Judgment as a matter of law is a difficult argument to win, because all evidence must be construed in favor of the verdict winner.[14]
Most notable were issues relating to design defect. Texas courts – including both the Texas Supreme Court and prior Fifth Circuit precedent − had held that Restatement (Second) of Torts §402A, comment k (1965), applied to prescription medical product liability cases without case-by-case analysis, thereby precluding strict liability-based design claims.[15] But none of these courts had addressed the issue in the specific context of medical devices. In a ruling that is virtually unique, the Fifth Circuit held that, although Texas courts have recognized so-called “blanket immunity” from design defect claims for prescription drugs, Texas law would nonetheless impose a different, more plaintiff-friendly “case-by-case” approach to medical devices.[16] This result is contrary to the Third Restatement, which treats drugs and devices identically for design liability purposes,[17] and is singular among appellate decisions in the United States. Other than Pinnacle Hip, whether a given jurisdiction applies comment k to all cases, on a case-by-case basis, or not at all, every other decision has construed it the same way to both drugs and medical devices.[18]
The defendant was also unsuccessful in arguing that the same product design that the defendant’s metal-on-metal implant was intended to replace – a “metal-on-plastic” implant – could not be an alternative design because it was really a “different product.”[19] That position accorded with the FDA’s device classifications, which treat metal-on-metal and metal-on-plastic hip implants as different products.[20] By statute, Texas law imposes an absolute alternative design requirement in design defect cases,[21] and the Fifth Circuit had strictly construed a similar Louisiana statute.[22] While Pinnacle Hip reaffirmed that similar-use products “fail[ing] to perform the discrete kinds of functions for which the alleged defective was designed” or with a “wide disparity in price” cannot be considered alternative designs,[23] it construed the trial record in plaintiffs’ favor and allowed, as an “alternative” design, a type of hip implant administratively deemed to be a different product. The trial evidence trumped the FDA because “several plaintiffs were advised” to include that type of implant.[24]
Concerning plaintiffs’ warning claims (denominated “marketing defects” in Texas), the most notable ruling in Pinnacle Hip was that plaintiffs were free to use “objective” evidence in support of proving causation under the learned intermediary rule.[25] In this context, “objective” evidence means employment of expert witnesses to opine about how a “reasonable physician” – as opposed to the plaintiff’s actual prescriber/surgeon – would react to the allegedly inadequate warning.[26] Pinnacle Hip again reached a result that preserved the plaintiffs’ warning claims.
At the threshold, the parties debate the relevance, under Texas law, of “objective evidence” − that is, evidence “that a different warning would have affected the decision of a reasonable doctor.” . . . Here, plaintiffs proffered objective evidence in [expert] testimony that, if the full risks of [metal-on metal implants] were known to physicians, “they would run to [a different product].”[27]
Unlike decisions in most other jurisdictions, Fifth Circuit and Texas precedent provide some basis for allowing experts to provide “reasonable physician” testimony.[28] However, that law was hardly uniform.[29] Once again, opting for the liability expanding option, the Fifth Circuit in Pinnacle Hip permitted such expert testimony.[30] Critically, however, the court refused to allow expert “reasonable physician” opinions to be decisive in no-evidence situations where a plaintiff otherwise would be unable to satisfy the burden of proof.
[A] jury might be allowed to presume a particular physician would respond “reasonably” to fuller disclosure. But that presumption must yield to contrary subjective testimony by the treating physician, and [plaintiffs’ precedent] fails to explain how objective evidence would apply to whether that doctor would have read or encountered the warning in the first instance.[31]
In Pinnacle Hip, plaintiffs had sufficient prescriber-specific evidence, according to the Fifth Circuit, to create a jury-submissible case on causation under the learned intermediary rule.[32] Thus, where future plaintiffs entirely lack testimony from prescribing physicians, Pinnacle Hip is not precedent that some expert’s opinion would be sufficient to avoid dismissal. Further, any “objective” testimony “must yield to contrary subjective testimony by the treating physician.”[33] Pinnacle Hip therefore permits plaintiffs to offer additional evidence in support of learned intermediary causation claims, but does not resurrect claims that otherwise would be dismissed for lack of any relevant prescriber testimony in the first place.[34]
The last of Pinnacle Hip’s significant legal rulings involved whether Texas could obtain personal jurisdiction over a non-resident holding company that did not itself make the products at issue. The defendant’s position was up against a rigorous “clear error” appellate standard.[35] Most trial courts, not bound by this standard, have granted jurisdictional motions concerning this same defendant.[36] Plaintiffs’ jurisdictional theory relied on Fifth Circuit precedent “embrac[ing the] more expansive” form of “stream of commerce” personal jurisdiction.[37] Recent Supreme Court precedent has impaired that jurisdictional theory, which relies on nothing more than a defendant being able to “anticipate” that its product might find its way into a state through the actions of third-party resellers,[38] and Texas precedent has since rejected the “expansive” view taken in Pinnacle Hip.[39]
New Trial Issues
Overall, two-plus years of consolidated trials in the Pinnacle Hip multidistrict litigation has produced over $1.7 billion in jury verdicts for plaintiffs.[40] In granting a new trial, the Fifth Circuit put a brake on that momentum. The unanimous decision was a rebuke to both “the district court’s evidentiary errors and [plaintiffs’ attorney Mark] Lanier’s deception.”[41]
The “evidentiary errors” were many and serious.[42] Pinnacle Hip felt the need to address only two of them as a sufficient basis to order a new trial. The first concerned plaintiffs’ effort to link the defendants to bribery involving Saddam Hussein.[43] The Fifth Circuit held that a deferred prosecution agreement, involving the actions of remotely related corporate affiliates not involved in manufacturing the Pinnacle Hip Implant device should never have been admitted. The defendants’ “testimony on their corporate culture and marketing practices” did not “open the door” for such remote and inflammatory rebuttal evidence.[44] Rather, “the rules of evidence do not simply evaporate when one party opens the door on an issue.”[45] Prior bad acts are not habit evidence, but plaintiffs sought to use them as such – telling the jury “[t]hat ought to be enough.”[46] To which the Fifth Circuit responded, “Indeed. [plaintiffs’ counsel] tainted the result by inviting the jury to infer guilt based on no more than prior bad acts. . . . That alone provides grounds for a new trial.”[47]
The second reversible evidentiary error in Pinnacle Hip involved insinuations of race discrimination – a hearsay resignation letter from an employee alleging racism.[48] Describing the trial as a “spectacle,” the Fifth Circuit concluded that plaintiffs’ use of that letter, particularly in closing argument, was “seriously distracting” and raised an issue “that defendants had no meaningful opportunity to rebut via cross-examination.”[49]
Rule 60 Misconduct
Even more serious than the “spectacle” created by repeated admission of improper and prejudicial evidence was the “deception” practiced by plaintiffs’ counsel regarding their payment of two supposed “non-retained” experts – something they falsely told both the jury and the court they had not done.[50] At trial, plaintiffs’ counsel claimed these experts were testifying without compensation, as compared to the supposed “bought testimony” of defense experts.[51] It was all fake. Prior to trial, plaintiffs’ counsel donated $10,000 to the alma mater of one of the experts; after trial counsel paid them an additional $65,000.[52]
In stark contrast to counsel’s trial description of these experts as “pro bono,” “the $10,000 check went unmentioned.”[53] “As between ‘real life’ and ‘bought testimony,’ [the jury] chose the former by a margin of $502 million. But that choice was a false one, manufactured entirely by Lanier.”[54] This deception richly deserved the sanction of vacating the judgment:
This is the rare case in which counsel’s deceptions were sufficiently obvious, egregious, and impactful to penetrate the layers of deference that would ordinarily shield against reversal. . . . Lanier’s failure to disclose the donation, and his repeated insistence that [the experts] had absolutely no pecuniary interest in testifying, were unequivocally deceptive . . . .
Lawyers cannot engage with a favorable expert, pay him “for his time,” then invite him to testify as a purportedly “non-retained” neutral party. That is deception, plain and simple. . . . We find, by the “clear and convincing” evidence of common sense, that Lanier misled the jury in creating the impression that [plaintiffs’ experts] had neither pecuniary incentive nor motive in testifying. Neither our double deference nor counsel’s specious reasoning can alter that conclusion.[55]
The Fifth Circuit’s Parthian shot was aimed at the lower court, rather than the plaintiffs. Sua sponte, since the defendants had not requested such relief, Pinnacle Hip noted the possibility of reassigning the entire MDL to a different judge “under this court’s supervisory power to reassign.[56]
Significantly more than forty percent of the entire federal civil docket now consists of cases in multidistrict litigation.[57] They are viewed by most federal judges, as well as by most attorneys who practice in them as vehicles for settlement, rather than adjudication. Settling multidistrict litigation requires forcing defendants to agree to pay large sums of money, leading to pressure tactics that rarely see the light of appellate review. They did, to some extent, come to light in Pinnacle Hip, and the Fifth Circuit made its displeasure clear. The same multidistrict litigation has produced more eye-popping verdicts in consolidated cases. Those verdicts are also on appeal to the Fifth Circuit.
In Pinnacle Hip, the Fifth Circuit got a firsthand look at such settlement tactics, and it did not like what it saw. It castigated the evidentiary rulings that turned an excessively long trial with an excessive number of plaintiffs into a “spectacle.” It did more than castigate the underhanded lawyering tricks induced by the need to win when the stakes became incredibly, and unnecessarily, high. After the judge handling the Pinnacle Hip multidistrict litigation ignored a previous warning by the Fifth Circuit[58] and proceeded with more multi-plaintiff “bellwether trials,” the Fifth Circuit responded with a stronger shot across the bow, reminding the judge handling multidistrict litigation that he can be replaced.[59] Plaintiffs would be well-advised to settle the Pinnacle Hip MDL for a reasonable amount – before the Fifth Circuit gets another crack at subsequent “spectacle” trials. Pinnacle Hip has telegraphed that the next result could involve house-cleaning. A reset to square zero does nobody any favors, but defendants are selling things that people want to buy, while the plaintiffs do not have a non-litigation cash stream.[60]
Thus, we would not be surprised if this decision turns out to be the last appeal from the Pinnacle Hip MDL to reach the Fifth Circuit.
The impact of Pinnacle Hip on substantive law is harder to gauge. Multidistrict litigation is often – as it was here – an excuse for resort to novel theories of liability. The Fifth Circuit’s forceful reiteration of conservative Erie prediction principles,[61] even if directed in this instance against defendants, should deter some multidistrict litigation shenanigans. Whether courts will continue to apply Restatement §402A, comment k in the same fashion to prescription drugs and medical devices will ultimately be decided in state courts,[62] and the weight of precedent remains heavily against doing so.
[1] James M. Beck, Senior Life Sciences Policy Analyst at Reed Smith LLP, specializes in complex personal injury and product liability litigation. He is also the founder of, and regular contributor to, the award-winning Drug and Device Law Blog.
[2] E.g., Lawyer’s for Civil Justice, “Ten Observations About The MDL/TPLF Subcommittee’s Examination into the Function of the Federal Rules of Civil Procedure in Casesconsolidated For Pretrial Proceedings,” at Item 6 (filed April 6, 2018), available at: https://www.uscourts.gov/file/24163/download.
[3] In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, 888 F.3d 753, 764 (5th Cir. 2018).
[6] Id. Plaintiffs cross-appealed this reduction, claiming the Texas punitive damages statute was unconstitutional. In a footnote the Fifth Circuit rejected that argument as “frivolous.” 888 F.3d at 787 n.72. Because a new trial was required on all claims, the Fifth Circuit did not address defendants’ punitive damages arguments. Thus the propriety of punitive damages-related “expert” testimony advocating an award that was illegal under Texas law was not addressed. See In re DePuy Orthopaedics, Inc., 2016 WL 6271474, at *8-9 (N.D. Tex. Jan. 5, 2016) (allowing such expert testimony).
[7] 888 F.3d at 765-83.
[8] Id. at 784-92.
[10] Id. at 764.
[11] Id. at 764, 768.
[12] Id. at 763.
[14] Id. at 765 (“JMOL is warranted only if a reasonable jury would not have a legally sufficient evidentiary basis to find for the nonmovant”).
[15] Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 165 (Tex. 2012) (applying comment k to prescription drug without case-by-case analysis); Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1273 (5th Cir. 1974) (applying comment k without case-by-case analysis to a vaccine; only warning-based claims viable); Gonzalez v. Bayer Healthcare Pharmaceuticals, Inc., 930 F. Supp.2d 808, 817-18 (S.D. Tex. 2013) (applying comment k to prescription drug without case-by-case analysis); Woodhouse v. Sanofi-Aventis United States LLC, 2011 WL 3666595, at *3-4 (W.D. Tex. June 23, 2011) (“comment k applies to products such as [defendant’s prescription drug]”); Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *3 (N.D. Tex. Nov. 15, 2007) (“Prescription drugs are not susceptible to a design defect claim where, as here, the drug is ‘accompanied by proper directions and warning.’”) (quoting comment k); Carter v. Tap Pharmaceuticals, Inc., 2004 WL 2550593, at *2 (W.D. Tex. Nov. 2, 2004) (“Under Texas law, all FDA-approved prescription drugs are unavoidably unsafe as a matter of law”); Hackett v. G.D. Searle & Co., 246 F. Supp.2d 591, 595 (W.D. Tex. 2002) (“under Texas law and comment k of the Restatement, Defendants can only be held strictly liable if the drug was not properly prepared or marketed or accompanied by proper warnings”).
[16] 888 F.3d at 772.
[17] Restatement (Third) of Torts, Products Liability §6(c) (1998). In several other contexts the Texas Supreme Court has favored the Third Restatement’s approach to product liability. Hernandez v. Tokai Corp., 2 S.W.3d 251, 257-58 (Tex. 1999); General Motors Corp. v. Sanchez, 997 S.W.2d 584, 592 (Tex. 1999); Hyundai Motor Co. v. Rodriguez, 995 S.W.2d 661, 666-67 (Tex. 1999); Uniroyal Goodrich Tire Co. v. Martinez, 977 S.W.2d 328, 335 (Tex. 1998).
[18] The writer’s 50-state survey of comment k law, undertaken in response to Pinnacle Hip found no other appellate decision treating comment k one way for medical devices and a different way to prescription drugs. See < https://www.druganddevicelawblog.com/2018/05/on-comment-k-and-medical-devices.html > (last visited March 11, 2019). See also Beck & Vale, Drug & Medical Device Product Liability Deskbook §2.02[2] at pp. 2.02-13 to -16 n.14 (Supp. 2017).
[19] 888 F.3d at 766-68.
[20] Compare 21 C.F.R. §888.3310 to §888.3340 (separate classifications for “metal/metal” and “metal/polymer” hip implants).
[21] Tex. Civ. Prac. & Rem. Code §82.005 (a)(1).
[22] Theriot v. Danek Medical, Inc., 168 F.3d 253, 255 (5th Cir. 1999).
[23] 888 F.3d at 766, 769.
[24] Id. at 769.
[25] Id. at 774-75.
[26] Id. at 774.
[28] See Centocor, 372 S.W.3d at 171 (mentioning that plaintiffs “presented no objective evidence” of prescriber attitudes but making no ruling), Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 812 (5th Cir. 1992) (allowing expert testimony on what a “reasonable” physician might have done under Mississippi law).
[29] See Ackermann v. Wyeth Pharmaceuticals, Inc., 526 F.3d 203, 212 (5th Cir. 2008) (suggesting that Thomas would not apply to Texas law).\
[30] 888 F.3d at 775 (“objective evidence is at least relevant”).
[32] Id. at 776 (pointing to a “mixed bag” prescriber testimony).
[34] This article does not address several less salient substantive rulings by the Fifth Circuit. See Id. at 769-71 (outdated 510(k) preemption argument); 773 (warning adequacy as a matter of law); 777 (statute of limitations); 781-83 (aiding and abetting, nonmanufacturer seller, negligent undertaking).
[35] Id. at 778.
[36] Fox v. Johnson & Johnson, 539 S.W.3d 48, 51 (Mo. App. 2017); Goldstein v. Johnson & Johnson, 2019 WL 289290, at *3 (S.D. Fla. Jan. 21, 2019); Jinright v. Johnson & Johnson, Inc., 2017 WL 3731317, at *5 (E.D. Mo. Aug. 30, 2017); New York City Asbestos Litigation, 2018 WL 3697135, at *2 (N.Y. Sup. Aug. 3, 2018); New York City Asbestos Litigation, 2018 WL 3636296, at *2-3 (N.Y. Sup. July 31, 2018).
[37] 888 F.3d at 778-79 (citing Choice Healthcare, Inc. v. Kaiser Foundation Health Plan, 615 F.3d 364, 373 (5th Cir. 2010)). The “more expansive” form of stream of commerce jurisdiction refers to Justice Brennan’s concurrence in Asahi Metal Industry Co. v. Superior Court of California, 480 U.S. 102 (1987). See 888 F.3d at 778.
[38] Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773, 1781-82 (2017). Following the BMS decision, other appellate courts have rejected expansive “stream of commerce” jurisdiction. E.g., Montgomery v. Airbus Helicopters, Inc., 414 P.3d 824, 834 (Okla. 2018); Venuti v. Continental Motors Inc., 414 P.3d 943, 951 (Utah App. 2018); Shuker v. Smith & Nephew, PLC, 885 F.3d 760, 780-81 (3d Cir. 2018) (applying Pennsylvania law).
[39] Michelin North America, Inc. v. De Santiago, ___ S.W.3d ___, 2018 WL 3654919, at *9 (Tex. App. Aug. 2, 2018) (following “narrower” “the stream-of-commerce-plus test”; disagreeing with Fifth Circuit precedent).
[40] In addition to the half-billion verdict at issue in Pinnacle Hip, a second consolidated trial in December 2016 resulted in a billion-dollar verdict, and another trial in November, 2017 produced a quarter-billion verdict. These other verdicts are also being appealed. See This Week in Orthopedics, December 7, 2016 < available at https://ryortho.com/breaking/1-billion-jury-award-in-3rd-pinnacle-trial/ >; < This Week in Orthopedics, Nov. 21, 2017 < available at https://ryortho.com/breaking/patients-win-3rd-pinnacle-hip-lawsuit-in-a-row/ >
[41] 888 F.3d at 763.
[42] Id. at 787 n.71 (listing a litany of other irrelevant and prejudicial evidence, with the admonition that “[t]he district court should weigh carefully the applicability of Rules 403 and 404(b)”).
[43] Id. at 784-87.
[44] Id. at 784.
[46] Id. at 785.
[48] Id. at 786-87.
[49] Id. at 787.
[50] Id. at 788-92.
[51] Id. at 789.
[52] Id. The defense was as fooled as the jury was. Defense counsel only discovered the deception in the course of expert discovery in a subsequent case. Id.
[55] Id. at 791-92 (footnotes omitted).
[56] Id. at 792 n.83 (citation and quotation marks omitted). The panel raised the prospect of such relief at oral argument, but defendants did not request this relief. Id.
[57] Bradt, “The Long Arm of Multidistrict Litigation,” 59(4) W&M L.R. 1165 (at abstract) (1918); Rules 4 MDLs: Calculating the Case, Lawyers for Civil Justice (Oct. 4, 2018), available at < https://www.rules4mdls.com/ >; Herrmann, “Above the Law” (June 12, 2017), available at < https://abovethelaw.com/2017/06/a-statistic-that-should-guide-large-litigation-firms/ >
[58] Depuy Orthopedic, 870 F.3d at 348 (“request[ing] the district court to vacate its ruling on waiver and to withdraw its order for a trial”).
[59] Pinnacle Hip, 888 F.3d at 792 n.83
[60] This is not to say that plaintiffs’ counsel could not take advantage of available third-party litigation financing, but writing off years of litigation before a friendly judge is not a profitable endeavor.
[61] “[I]t is not for us to adopt innovative theories of recovery or defense for Texas law, but simply to apply that law as it currently exists.” 888 F.3d at 772 n.22 (citation and quotation marks omitted).
[62] The issue is currently before the Utah Supreme Court on a certified question in a case called Burlingame.