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In re Depuy Orthopaedics, Incorporated, Pinnacle hip Implant Product Liability Litigation

United States Court of Appeals, Fifth Circuit

April 25, 2018

IN RE: DEPUY ORTHOPAEDICS, INCORPORATED, PINNACLE HIP IMPLANT PRODUCT LIABILITY LITIGATION
v.
DEPUY ORTHOPAEDICS, INCORPORATED; JOHNSON & JOHNSON, Defendants-Appellants Cross-Appellees. JAY CHRISTOPHER, Plaintiff-Appellee Cross-Appellant, JACQUELINE CHRISTOPHER, Plaintiff-Appellee, RICHARD KLUSMANN, Plaintiff-Appellee Cross-Appellant, SUSAN KLUSMANN, Plaintiff-Appellee,
v.
DEPUY ORTHOPAEDICS, INCORPORATED; JOHNSON & JOHNSON, Defendants-Appellants Cross-Appellees. DONALD GREER, Plaintiff-Appellee Cross-Appellant,
v.
DEPUY ORTHOPAEDICS, INCORPORATED; JOHNSON & JOHNSON, Defendants-Appellants Cross-Appellees. ROBERT PETERSON, Plaintiff-Appellee Cross-Appellant, KAREN PETERSON, Plaintiff-Appellee,
v.
DEPUY ORTHOPAEDICS, INCORPORATED; JOHNSON & JOHNSON, Defendants-Appellants Cross-Appellees. MARGARET AOKI, Plaintiff-Appellee Cross-Appellant,
v.
DEPUY ORTHOPAEDICS, INCORPORATED; JOHNSON & JOHNSON, Defendants-Appellants Cross-Appellees. MARGARET AOKI, Plaintiff-Appellee,
v.
DEPUY ORTHOPAEDICS, INCORPORATED; JOHNSON & JOHNSON, Defendants-Appellants. JAY CHRISTOPHER; JACQUELINE CHRISTOPHER, Plaintiffs-Appellees,
v.
DEPUY ORTHOPAEDICS, INCORPORATED; JOHNSON&JOHNSON, Defendants-Appellants. DONALDGREER, Plaintiff-Appellee,
v.
DEPUY ORTHOPAEDICS, INCORPORATED; JOHNSON & JOHNSON, Defendants-Appellants. RICHARD KLUSMANN;SUSANKLUSMANN, Plaintiffs-Appellees,
v.
DEPUY ORTHOPAEDICS, INCORPORATED; JOHNSON & JOHNSON, Defendants-Appellants. ROBERT PETERSON;KAREN PETERSON, Plaintiffs-Appellees,
v.
DEPUY ORTHOPAEDICS, INCORPORATED; JOHNSON & JOHNSON, Defendants-Appellants.

          Appeals from the United States District Court for the Northern District of Texas

          Before SMITH, BARKSDALE, and HIGGINSON, Circuit Judges.

          JERRY E. SMITH, CIRCUIT JUDGE:

         These appeals and cross-appeal are from the second in a series of bellwether trials from the Pinnacle Hip multidistrict litigation ("MDL"), in which several thousand plaintiffs claim injuries from Pinnacle hips manufactured and sold by DePuy Orthopaedics, Incorporated ("DePuy").[1] The five plaintiffs in this consolidated action-Margaret Aoki, Jay Christopher, Donald Greer, Richard Klusmann, and Robert Peterson[2]-received Pinnacle's metal-on-metal ("MoM") design, suffered complications, and required revision surgery. They sued DePuy and its parent corporation, Johnson & Johnson ("J&J"), [3] and secured a half-billion-dollar jury verdict. Defendants' various post-trial motions-for judgment as a matter of law ("JMOL"), dismissal of claims against J&J for lack of personal jurisdiction, and a mistrial-were denied. Defendants renew all three lines of argument on appeal, attacking the verdict on nearly twenty independent bases. Plaintiffs cross-appeal, claiming Texas's exemplary-damages cap violates the state and federal constitutions. In a companion appeal, defendants appeal the denial of relief from judgment under Federal Rule of Civil Procedure 60(b)(3) on the ground that plaintiffs' counsel, Mark Lanier, concealed payment arrangements with two key expert witnesses.

         Disposing of the two sets of appeals together, [4] we conclude that only a few of plaintiffs' claims fail as a matter of law but that the district court's evidentiary errors and Lanier's deceptions furnish independent grounds for a new trial. Hence, we reverse in part, vacate the judgment and the order denying Rule 60(b)(3) relief, and remand.

         I. Background

         In 2011, the Judicial Panel on MDL ordered centralization of pretrial proceedings in the Northern District of Texas for cases involving the Pinnacle Acetabular Cup System hip implants. The parties agreed to a protocol for bellwether trials and, together, identified a pool of eight cases from which to select the candidates. The first bellwether trial lasted two months and ended in a jury verdict for J&J and DePuy (jointly "defendants"). The district court then jettisoned the seven remaining cases and ordered the parties to prepare ten new ones for trial. 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.

         At trial, plaintiffs claimed DePuy defectively designed and marketed its MoM implant and that J&J was liable, as a "nonmanufacturer seller, " for aiding and abetting and for negligent undertaking. At the heart of the claims lay the contested science of modern hip prosthetics, and we begin with the narrow points of agreement. As outlined in both sides' briefs, prosthetic hips are designed to replicate the hip's ball-and-socket function and typically consist of four components: a stem inserted into the femur, a femoral head attached to the stem (the hip "ball"), a cup implanted into the hip socket (the acetabulum), and a metal liner that fits into the cup and against which the ball articulates.

         The liner can be made from metal, polyethylene, or ceramic. The product at issue is Pinnacle's MoM design, in which both head and liner (Ultamet) are made of metal. Plaintiffs received the Ultamet but, several years later, required revision to metal-on-plastic ("MoP") or metal-on-ceramic designs.

         The briefs and trial transcripts present competing histories on hip-implant technology. Both sides agree the story begins in the 1960s with "first-generation" MoMs, the earliest models to achieve widespread use. The parties further agree that these early MoMs carried certain health risks and were quickly displaced by Sir John Charnley's metal-on-plastic ("MoP") design, long described as the industry's "gold standard."

         Here, we reach a fork. Defendants suggest that, in the 1990s, MoP was viewed as the industry's "weak link" because of its tendency to cause osteolysis, bone loss in the area surrounding the implant. When the metal ball articulates against the plastic liner, it generates debris from plastic wear that can cause dissolving of the surrounding bone, which, in turn, can require revision surgery. Defendants, along with several other manufacturers, promoted MoMs in the early 2000s to address this Achilles' heel and offer high-activity patients an alternative that would wear out more slowly than plastic.

         Plaintiffs meanwhile tell a less rosy story. They claim defendants hastily reintroduced Ultamet to market, without conducting any clinical tests, for the sole purpose of increasing market share. Medical science had long discovered that plastic-wear debris, and the attendant risk of osteolysis, could be reduced considerably if the plastic liner was "cross-linked, " that is, sterilized through radiation. Yet, the theory goes, defendants lured surgeons away from cross-linked plastic's proven success through an intricate misinformation campaign of false advertisements and DePuy-authored academic papers.

         On the core issue of marketing and design, the parties waged a war of the experts. Plaintiffs elicited testimony from engineers and medical scientists that Ultamet's MoM design was a producing cause of their injuries and that cross-linked MoP was a safer alternative. They also offered evidence that defendants, before bringing the product to market, were made aware of the considerable, and arguably unjustifiable, risks of MoM. Defendants' experts countered that, although MoP might be better suited to older patients, the risk-benefit calculus for younger, more active patients might still favor MoM. Defendants further maintained they had always been forthcoming with treating physicians about this risk calculus. The district court admitted several pieces of inflammatory character evidence against defendants-including claims of race discrimination and bribes to Saddam Hussein's Iraqi "regime"- reasoning the defendants had "opened the door" by repeatedly presenting themselves as "wonderful people doing wonderful things."

         The jury found for plaintiffs on the five above-mentioned causes of action and returned a $502 million verdict. It awarded just $500, 000 in economic compensatory damages and $141.5 million in non-economic compensatory damages, and DePuy and J&J were assessed exemplary damages of $120 million and $240 million, respectively. The defendants made numerous post-trial motions-for JMOL on all claims, for dismissal on jurisdictional grounds, and for mistrial. All were denied, save the request that the court apply Texas's statutory exemplary-damages cap, which reduced the $360 million to $9.6 million. Defendants appeal the judgment, and plaintiffs cross-appeal application of the cap.

         In a companion appeal, defendants request relief from judgment under Federal Rule of Civil Procedure 60(b)(3), based on plaintiffs' counsel's failure to disclose payments to two purportedly "nonretained" experts-Dr. Bernard Morrey ("Morrey Sr.") and Dr. Matthew Morrey ("Morrey Jr."). In preparation for the third bellwether trial, defendants discovered that before the second trial, plaintiffs' counsel Mark Lanier had made a $10, 000 donation to a charity of Morrey Sr.'s choosing, that Morrey Jr. had expected to be paid when testifying, and that the doctors had received post-trial payments totaling $65, 000. Defendants moved for relief, the court denied the motion, and defendants again appeal.

         II. Claims Against DePuy

         JMOL is warranted only if "a reasonable jury would not have a legally sufficient evidentiary basis" to find for the nonmovant. Fed.R.Civ.P. 50(a)-(1)(B). We review the denial of JMOL de novo, applying "the same standard . . . the district court used in first passing on the motion." Nobach v. Woodland Vill. Nursing Ctr., 799 F.3d 374, 377 (5th Cir. 2015) (quotations omitted). DePuy claims plaintiffs' design and marketing claims fail categorically and that Klusmann's and Greer's claims are barred by the relevant statute of limitations.[5]

         A. Design Defect

         To establish a design defect, plaintiffs had to prove that "(1) the product was defectively designed so as to render it unreasonably dangerous; (2) a safer alternative design existed; and (3) the defect was a producing cause of the injury for which the plaintiff seeks recovery." Casey v. Toyota Motor Eng'g & Mfg. N.A., 770 F.3d 322, 330 (5th Cir. 2014) (citations omitted). Texas law defines a safer alternative design as one that "would have prevented or significantly reduced the risk of the claimant's personal injury . . . without substantially impairing the product's utility."[6] Consistent with this risk-utility framework, a plaintiff "must show the safety benefits from [the] proposed design are foreseeably greater than the resulting costs, including any diminished usefulness or diminished safety." Casey, 770 F.3d at 331 (quoting Hodges v. Mack Trucks, Inc., 474 F.3d 188, 196 (5th Cir. 2006)). The Texas Supreme Court and intermediate courts have held that a "substantially different product" cannot constitute a safer alternative design.[7]

         Defendants seek JMOL on three accounts: (1) MoP is a different product, not an alternative MoM design, (2) plaintiffs' design-defect theory is preempted because it conflicts with the goals enshrined in relevant Food and Drug Administration ("FDA") regulations, and (3) medical-device liability is foreclosed by comment k to Restatement (Second) of Torts § 402A. Defendants fail on all three.

         1.

         Defendants' first contention-that MoP is a different product from MoM-implicates thorny questions of identity and definition, practically impossible to settle in the abstract.[8] In select instances, nonidentity will be obvious: For example, a proposal to add two additional wheels to a motorcycle or to "fully enclos[e] the cab" of a convertible. Caterpillar, 911 S.W.2d at 385. But this case does not lend itself to such straightforward resolution, as the parties dispute how to characterize the relevant product: Is it a "high-stability, low-wear" implant, of which MoP and MoM are merely two alternative iterations? Or is it the discrete MoM design, in which case MoP is a completely different beast? Hewing carefully to guidance provided by Texas courts, we conclude, based on the record, that MoP is a viable alternative design to MoM.

         The alternative-design/different-product distinction emerges from two Texas cases, both distinguishable from the present. In Caterpillar, the Texas Supreme Court considered whether a front-end loader with a removable rollover-protection structure ("ROPS") was defectively designed. Id. at 383-85. The court rejected the plaintiff's proposed alternative-in which the ROPS was rendered non-removable-because the non-removable structure would thwart the ROPS's "intended" function of enabling access to "low clearance areas." Id. at 384-85. The court refused to "impose liability in such a way as to eliminate whole categories of useful products from the market." Id. at 385 (emphasis added).

         In Brockert, 287 S.W.3d at 769, the Texas Court of Appeals applied this principle in the pharmaceutical context to conclude that an estrogen-only drug was not a safer alternative design to Prempro, a combination of estrogen and progestin, despite that both served "the same general purpose" of treating menopausal symptoms, id. The plaintiff claimed her estrogen-only alternative eliminated the risk of breast cancer introduced by Prempro. Id. The court rejected the argument, explaining that progestin helped "reduce the incidence of endometrial hyperplasia, " id. at 770, and that the plaintiff had failed to "explain how Prempro could have been modified or improved" without compromising that function, id. at 771. Thus plaintiff's theory was rejected as a "categorical attack" on the relevant product. Id.

         Doctrinally, it is notable that both Caterpillar and Brockert rejected a plaintiff's proposed alternative for failing to perform the discrete kinds of functions for which the alleged defective was designed-e.g., accessing low clearance areas or reducing incidence of endometrial hyperplasia. But neither case clearly supports the proposition that a slight difference in degree-that is, that the alternative does all of the things for which the allegedly defective product was designed, but does not do one of them quite as well-automatically renders the plaintiff's proposed alternative an entirely different product. Though this kind/degree distinction cannot dispel the underlying problem of characterization, [9] it finds direct support in the above caselaw and coheres with the overall structure of Texas design-defect law.

         Texas's risk-utility test plainly contemplates that a proposed alternative design might reduce a product's utility-that is, its capacity to perform a function for which it was designed-without rendering the alternative an entirely different product.[10] If any distinction in degree rendered the proposed alternative a different product as a matter of law, that would effectively moot the substantive balancing test for liability. Where the distinction is one of degree only, the risk-utility framework provides the proper mode of analysis.

         Defendants claim to have identified two relevant functional distinctions between MoM and MoP: (a) Metal is more durable than plastic and, therefore, more suitable to younger patients "who often seek not just pain relief but also the ability to resume an active lifestyle"; and (b) metal remedies osteolysis by "eliminat[ing] plastic debris entirely." Neither purported distinction, however, shows MoP to be an "entirely different product" under the above, proper framework. See Brockert, 287 S.W.3d at 770. To the first: Durability is a distinction in degree rather than kind. All hip implants-plastic, metal, or ceramic-are designed with the twin goals of minimizing wear debris and affording maximal longevity. Defendants' own promotional materials characterize both their MoP (AltrX LD) and their MoM (Ultamet XL) as "high stability, low wear" hip implants; they never suggest the latter enables the implantee to perform discrete tasks otherwise impossible with the former. Brockert and Caterpillar are thus distinguishable.

         The question then is whether plastic substantially impairs the hip implant's utility along the durability axis. See Bell Helicopter, 594 S.W.2d at 529. And though defendants presented evidence that metal was an "attractive option" for younger patients, plaintiffs presented contrary evidence that cross-linked plastic was preferable "a hundred times out of a hundred" and that it outperformed metal along the survivorship dimension by a wide margin. On this evidentiary record, we cannot conclude, as a matter of law, that MoP substantially impairs the implant's utility in terms of stability and rate of wear.

         As for reduction of osteolysis, plaintiffs rightly observe that cross-linked polyethylene was intended to do the same thing. The question then is whether the risk of osteolysis from cross-linked MoP substantially reduces MoM's utility, and the record says not. A DePuy executive conceded that MoM, too, can cause osteolysis, and DePuy seems to have known, when it sold Ultamet, that cross-linked plastic significantly reduced the relevant risk.[11] Thus, defendants have not identified a sufficiently discrete functional advantage to prove MoP is fundamentally a different product.

         At oral argument, defendants suggested the different-product/alternative-design question should be decided from the ex ante perspective, when DePuy believed MoM would eliminate osteolysis and substantially outperform plastic. That those marginal benefits may have failed fully to materialize is ostensibly irrelevant to the inquiry. But defendants cite no cases for this contestable proposition[12]; and regardless, its application here would require the equally contestable factual assumption that defendants did not, and could not, reasonably foresee the risks of instability and metallosis that, according to plaintiffs, dwarf MoM's purported benefits. Plaintiffs presented evidence that defendants knew, even before December 2004 (the earliest date on which any plaintiff received his or her implant) that cross-linked MoP meaningfully addressed the osteolysis risk and that MoM carried potentially catastrophic risks of failure. Thus, the jury could reasonably conclude, even under defendants' ex ante framing, that plaintiffs had identified a viable alternative design.[13]

         Defendants draw our attention to several other cases applying the alternative-design/different-product distinction, but none disturbs the above conclusion. First is Theriot v. Danek Medical, Inc., 168 F.3d 253 (5th Cir. 1999), in which the plaintiff alleged a design defect in pedicle screws used for spinal stability. The plaintiff identified "external neck braces or internal systems that use hooks or wires" as potential alternative designs, id. at 255, and, applying Louisiana law, we rejected that theory as "tak[ing] issue with the choice of treatment [i.e., the use of pedicle screws] made by Theriot's physician, not with a specific fault of the pedicle screw sold by [the defendant], " id. As the facts of that case make clear, Theriot's proposed alternatives were obviously of a different categorical and structural ilk. Any analogy from that case to this one flatly begs the underlying issue of characterization.[14]

         Defendants also cite Hosford v. BRK Brands, Inc., 223 So.3d 199 (Ala. 2016), holding that ionization smoke alarms and dual-sensor smoke alarms are different products. The plaintiffs argued ionization alarms were defective because they "fail to provide adequate warning" of a fire that "begins as . . . slow [and] smoldering, " id. at 204, and they identified the "more expensive" dual-sensor alarms, which incorporate both ionization and "photoelectric technology, " as a safer alternative, id. Applying Brockert and Caterpillar, the court deemed them two different products, based primarily on the wide disparity in price. Id. at 207. That court feared liability would drive the "less expensive [option] from the market . . .[, ] result[ing] in no smoke alarm being present" in homes like the plaintiffs'. Id.

         Here, that empirical judgment is obviously inapposite, given that several plaintiffs were revised to the very alternative they propose. None of defendants' cases counsels reversal on our facts.

         2.

         Defendants suggest the design-defect claims are preempted because they "stand[] as an obstacle to the accomplishment and execution of the full purposes and objectives" reflected in the MoM-related regulations of the FDA. See Hines v. Davidowitz, 312 U.S. 52, 67 (1941). Defendants' obstacle-preemption theory fails at two levels, misconstruing both the FDA's objectives with respect to MoMs and the alleged state-law obstacle in its path.

         We begin with the federal objective. Before 1976, the Federal Food, Drug, and Cosmetic Act left "the introduction of new medical devices . . . largely for the States to supervise." Riegel v. Medtronic, Inc., 552 U.S. 312, 315 (2008). Congress stepped in with the Medical Device Amendments of 1976 (MDA) and imposed, for the first time, "a regime of detailed federal oversight, " which authorized the FDA to regulate medical devices under a three-tiered, risk-based classification scheme. Id. at 316. Devices classified as class I or II can be made reasonably safe through compliance with FDA's "general controls" or "special controls, " whereas class III is reserved for cases in which "insufficient information exists to determine" whether general or special controls can ensure the product's "safety and effectiveness." 21 U.S.C. § 360c(a)(1)(A)-(C). In addition, Congress granted the FDA discretionary authority to ban outright any product that "present[s] . . . an unreasonable and substantial risk of illness or injury." Id. § 360f(a)(1); see generally Riegel, 552 U.S. at 315-17.

         Before class III devices can be brought to market, they generally must survive the FDA's rigorous premarket approval ("PMA") process, designed to ensure a device's "safety and effectiveness." 21 U.S.C. § 360e(d)(1)(A). That process is "quite time consuming, " requiring "an average of 1, 200 hours [for] each submission." Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 344- 45 (2001) (quotation omitted). The statute carves out an exception for "predicate" devices that were on the market before 1976, which can remain in circulation "until the FDA initiates and completes the PMA process." Id. at 345; see also 21 U.S.C. § 360e(b)(1)(A). And "to avoid the potentially monopolistic consequences of th[e] . . . exception, " the MDA also exempts any "substantial equivalents" of these predicate devices. See Buckman, 531 U.S. at 345; 21 U.S.C. § 360e(b)(1)(B). These equivalents enter the market through what is known as the "510(k) process, " which requires an applicant to show that the device either "has the same technological characteristics as the predicate device" or "is as safe and effective as a legally marketed device." 21 U.S.C. § 360c(i)(1)(A)(i)-(ii).

         The 510(k) process does not "denote official approval of the device"; to create a contrary "impression . . . constitutes misbranding." 21 C.F.R. § 807.97. The process "provide[s] little protection to the public" because it is "focused on equivalence, not safety." Medtronic, Inc. v. Lohr, 518 U.S. 470, 493 (1996) (quotations omitted). More recently, however, the agency has clarified, in guidance documents, that "principles of safety and effectiveness underlie the substantial equivalence determination in every 510(k) review."[15]

         The MDA contains an express-preemption provision that prohibits states from "establish[ing] . . . any requirement[] (1) which is different from, or in addition to any [MDA] requirement applicable . . . to the device, and (2) which relates to [its] safety or effectiveness." 21 U.S.C. § 360k(a). The clause covers class III, PMA products, Riegel, 552 U.S. at 322-23, but not 510(k)-approved products, id. at 322; Lohr, 518 U.S. at 493-94.

         As relevant here, MoMs were sold before 1976 and have traditionally been treated as pre-amendment class III devices that can be brought to market through the 510(k) process. Ultamet followed that route in December 2000, when defendants characterized the product as a substantial equivalent of Ultima, one of J&J's eventually recalled MoMs. In 2013, shortly after the FDA issued a proposed order requiring that all MoMs receive PMA, defendants chose to remove Ultamet from the market. The FDA finalized its order three years later and has not since granted PMA to any MoMs having a structure resembling Ultamet's.[16]

         Defendants suggest plaintiffs' theory of liability-that MoMs are "categorically defective"-flouts the FDA's considered judgment that MoMs should not be banned outright but rather regulated, and should remain available, as class III medical devices. That theory fails at two levels.

         First, plaintiffs' burden was to show only that Ultamet was defective, not that all MoMs were. And because Ultamet was off the market before the trial, the verdict cannot have thwarted the FDA's objectives in that narrow respect. Defendants reply that plaintiffs' only colorable theory at trial covered the MoM interface writ large. Maybe so, but defendants' position assumes, without any support, that our obstacle-preemption inquiry looks through the verdict and judgment to the arguments that lie beneath them. This seems unlikely, as it is the judgment, and not the parties' assertions, that carries binding effect and the attendant power to disrupt the federal regulatory scheme.[17]

         But even under defendants' look-through inquiry, it is not the case that plaintiffs' theory reached all possible MoMs. All would agree that, despite the sweeping language with which plaintiffs presented their case, their claims were impliedly limited to presently available technologies and the adverse health effects they allegedly engender.[18]

         This seemingly pedantic point is fatal to defendants' preemption argument. The FDA effectively withdrew all MoMs from the market with its February 2016 final rule and left open a single door in the form of PMA. Arguably, the final rule contemplates the possibility that every MoM then on the market would (and perhaps should) fail PMA. That the FDA chose not to ban MoMs as a class proves no more than that it wished to give manufacturers an opportunity to create MoMs not contemplated by plaintiffs' theory of liability. Unless and until the FDA actually grants PMA to an extant MoM that carries the risks that made Ultamet defective, defendants cannot prove that even plaintiffs' theory of liability obstructs the FDA's regulatory objectives.

         3.

         Defendants assert plaintiffs' claims are foreclosed by comment k to Restatement (Second) of Torts § 402A:

k. Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. . . . Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like . . . .

Restatement (Second) of Torts § 402A, cmt. k. The Texas Supreme Court has incorporated § 402A into its common law, New Tex. Auto Auction Servs. v. Gomez de Hernandez, 249 S.W.3d 400, 403 (Tex. 2008), and has considered comment k in the prescription-drug context, Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 165 (Tex. 2012). But it has never expressly extended the immunity rule to medical implants, let alone 510(k)-cleared devices, on either a categorical or a product-by-product basis.[19]

         Jurisdictions are split on whether medical devices enjoy blanket immunity, [20] with the majority of courts favoring the case-by-case method-ology.[21] Defendants ask that we deviate from that trend and foreclose all implant-based litigation, based on the conjecture that Texas courts might one day redraw liability boundaries in their favor. But defendants present scant predictive indicia from Texas to that effect, and we decline to step so far ahead of Texas courts, and against the majority view, in foreclosing broad avenues to suit.[22] Comment k does not bar plaintiffs' claims.

         B. Marketing Defect

         To prevail on their marketing-defect claims, plaintiffs had to show (a) "the warning was defective" and (b) the defect "was a producing cause of the injury." Ackermann v. Wyeth Pharm., 526 F.3d 203, 208 (5th Cir. 2008) (citation omitted). Defendants seek JMOL on three grounds: The relevant warnings were adequate as a matter of law, plaintiffs presented no properly designated warning expert, and they failed to prove causation. We conclude that defendants are entitled to JMOL for want of causation, but only as to Greer's and Peterson's marketing-defect claims.

         1.

         The adequacy of a warning is generally a question of fact. "However, if a warning specifically mentions the circumstances complained of, then the warning is adequate as a matter of law." Seifried v. Hygenic Corp., 410 S.W.3d 427, 433 (Tex. App.-Houston [1st Dist.] 2013, no pet.) (citations omitted). Defendants claim this is such a case.

         By defendants' description, plaintiffs all "experienced corrosion and friction wear from their hip implants" and "suffered adverse reactions to that debris." Defendants claim specifically to have warned of these circumstances in the two "Instructions for Use" pamphlets (IFUs) inserted into their acetab-ular cup and metal liner packages. The cup's IFU warns that "[t]issue reactions, osteolysis, and/or implant loosening caused by metallic corrosion, allergic reactions, or the accumulation of polyethylene or metal wear debris or loose cement particles" are among "the most frequently encountered adverse events . . . in hip arthroplasty." The liner's IFU additionally warns of "[s]ubclinical nerve damage . . . associated with surgical trauma, " "subluxation resulting from importer position and/or muscle and fibrous tissue laxity, " "[h]istological reactions [from] exposure to a foreign material, " "higher ion release" where "bone cement is not used, " and the "potential for release of metallic debris into the joint space." Defendants maintain these warnings reach all of plaintiffs' purported conditions and were therefore adequate as a matter of law.

         But in determining whether warnings are adequate as a matter of law, Texas courts subject them to a demanding standard of specificity. In Jordan v. Geigy Pharmaceuticals, 848 S.W.2d 176, 182 (Tex. App.-Fort Worth 1992, no writ), where the plaintiff suffered renal failure from an anti-inflammatory, the court reversed a summary judgment for the defendant on the plaintiff's failure-to-warn claim. It held that the warning at issue-which described "renal pathology in long-term administration to animals" and "overt renal failure . . . typically followed by recovery to the pretreatment state"-did not sufficiently address "irreversible renal failure" or "acute renal failure, " both suffered by the plaintiff. Id. at 181-82. Plaintiffs' position here is at least as compelling.

         As for the cup IFU, it was drafted before the Ultamet liner was ever created, and it addresses only general adverse events relevant to all hip arthro-plasty. Assuming Ultamet is defective for the reasons plaintiffs allege, the warning fails to put surgeons on notice as to the distinctive risks that arise from MoM-"metallosis, " "pseudotumors, " and "tissue necrosis"-or the magnitude of those risks. The liner IFU fairs no better: It fails squarely to address "metal wear debris" that occurs when the metal ball articulates against the metal liner, the underlying cause of plaintiffs' injuries. And, taken in context, its warnings about nerve damage, dislocation, and ion release concern complications not at issue in this case-e.g., surgical trauma and the implant's adaptation to the bone.

         Not until after the FDA issued its proposed rule in 2013 did defendants specifically warn about the metallosis, pseudotumors, and tissue necrosis-the sorts of conditions that plaintiffs maintained caused their revision surgery. In short, though defendants' IFUs identified metal debris generally, a reasonable jury could conclude that the warning failed to describe with reasonable specificity the source of the wear-debris problem, the conditions to which it gives rise, and the magnitude of the risk. Texas law requires a closer match than these defendants can show.

         2.

         Defendants alternatively suggest plaintiffs failed to provide expert testimony that the device was defectively marketed. They note that Morrey Jr., plaintiffs' only expert to testify on the allegedly inadequate warning, was never designated as an expert on warnings per se[23] and never testified directly on the contents of Ultamet's IFUs. Both claims are unpersuasive. To the first: Plaintiffs designated Morrey Jr. as their warnings expert before trial, and as the surgeon-intermediary tasked with interpreting and applying the warning, he was likely equipped to assess its adequacy. To the second: Plaintiffs' counsel read excerpts from warnings included in an FDA study in 2000 but later excised from the IFUs. Morrey Jr. replied that physicians "should have been made aware of those things, because those are the same risks that you're going to tell your patient when you're counseling them." This was sufficient to allow a reasonable jury to conclude the IFUs' warnings were inadequate.

         3.

         Defendants claim plaintiffs failed to show the inadequate warning actually caused their physicians to select Ultamet. Under the learned-intermediary ("LI") doctrine, which Texas applies in "medical products liability actions, "[24] "the manufacturer . . . satisfies its duty to warn the end user of its product's potential risks by providing an adequate warning to a 'learned intermediary, ' who then assumes the duty to pass on the necessary warnings to the end user." Centocor, 372 S.W.3d at 142. Where the LI doctrine applies, plaintiffs must show that, but for the inadequate warning, their doctors would have recommended different treatment, see Ackermann, 526 F.3d at 208, 214, or provided additional warnings that would have led plaintiffs to withhold consent, McNeil v. Wyeth, 462 F.3d 364, 373 (5th Cir. 2006).[25] The issue is generally a fact question, but "[w]hen the prescribing physician is aware of the product's risks and decides to use it anyway, any inadequacy [in] the product's warning, as a matter of law, is not the producing cause of the patient's injuries." Centocor, 372 S.W.3d at 170.

         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." Id. at 171. The Texas Supreme Court referenced "objective evidence" just once, in Centocor, noting that the plaintiffs not only "lack[ed] subjective evidence [about what the particular physician would have done] but presented no objective evidence that a different warning would have affected the decision of a reasonable doctor to prescribe [the relevant drug] for [plaintiff's] condition." Id. (emphasis added). Here, plaintiffs proffered objective evidence in Morrey Jr.'s testimony that, if the full risks of MoM were known to physicians, "they would run to polyethylene."

         At least one federal district court has dismissed Centocor's language as dictum[26]-but that is error. As our caselaw makes plain, non-binding language from the state supreme court is the second- or third-best predictive indicium of how that court might decide an underdetermined legal question. Centennial, 149 F.3d at 382. Though the dictum here is weak-the court was emphasizing how thoroughly the Centocor plaintiffs had failed to make their case, Centocor, 372 S.W.3d at 171, rather than affirmatively describing the types of proof that might sustain plaintiffs' burden-it suggests objective evidence is at least relevant to the inquiry.

         Relevance, however, does not imply sufficiency. In the LI context, causation entails two distinct factual predicates: first, that the doctor would have read or encountered the adequate warning[27]; and second that the adequate warning would have altered his treatment decision for, or risk-related disclosures to, the patient.[28] Centocor addressed only the latter, suggesting 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, [29] and Centocor fails to explain how objective evidence would apply to whether that doctor would have read or encountered the warning in the first instance.[30] When considered for the limited purpose intimated in Centocor, objective evidence would have little bearing on any of plaintiffs' claims.

         Take Greer and Peterson. Their treating physicians, Goletz and Schoch, did not testify, and plaintiffs offer no record evidence suggesting the two actually read or encountered defendants' inadequate warnings. On appeal, plaintiffs cite only their own statements for support: Greer testified Goletz told him his "[MoM] would not wear, [and] would last [his] lifetime, " and according to Peterson, Schoch said the same "because [Peterson's MoM] wouldn't have any plastic to wear out." But these snippets say nothing of how the doctors came to hold their respective views. Did Schoch and Goletz rely upon defendants' representations in choosing Ultamet, or did they learn of MoM's purported advantages by some other means? If the latter, how would better disclosure have reached the doctors? Not even "objective evidence" can fill these discrete evidentiary voids. The jury was left to guess, and plaintiffs' claims fail as a result. See Pustejovsky, 623 F.3d at 277.

         Aoki's and Klusmann's claims are more complex, given that the testimony from their treating physician, Heinrich, contains somewhat mixed signals. On the one hand, Heinrich claimed he was aware of the "risk of ions attacking the tissue and the bone and getting in the blood" when he chose to implant both patients with MoM. See Centocor, 372 S.W.3d at 169-71. And yet, his testimony also suggests defendants' omissions and misrepresentations played some part in his treatment decisions of both patients.

         In Aoki's case, Heinrich testified he used aSphere, Pinnacle's metal femoral head, because DePuy's "simulator data" suggested it "minimize[d] th[e] wear-in phase"-the immediate post-operative period in which articulation causes "an increased release of ions"-relative to alternative metal head designs. Heinrich "asked" "DePuy people" about "aSphere" and "made the decision" to use the product "based on" their representations. Meanwhile, plaintiffs presented Heinrich with emails suggesting DePuy knew its claims about aSphere were untrue, a deception Heinrich seemed to know nothing about. Heinrich also acknowledged more generally that "J&J[/]DePuy" said nothing of the increased "problems" with MoMs in "2008, 2009, maybe even in 2010."

         Klusmann's case presents a similarly mixed bag. He received bilateral MoM implants in 2004 and 2005 and began to experience intermittent pain as early as 2006. Heinrich consistently treated Klusmann with "conservative care" until 2011, when he first recommended revision. In explaining that delay, Heinrich testified that "doing things like checking ion levels and things of that nature" was less common then. Plaintiffs' counsel then read a letter from a DePuy physician criticizing MoMs for their potentially "catastrophic complications" and detailing the proper post-operative detection procedures. He then asked Heinrich, "[I]f DePuy had sent you this information-it certainly would have changed the way you were treating Mr. Klusmann, wouldn't it?" Heinrich offered a qualified replied: "To a certain degree. The only thing I would say is that he put in here that once he has ruled out other issues like back problems, loose implants, tendinitis, then he goes on to this workup. And so from that standpoint, yes, I agree." At the least, this testimony suggests DePuy's omission altered the course of Klusmann's post-operative care.

         To summarize: Though Heinrich had general awareness of the possibility that metal wear debris could cause adverse tissue reactions, he seems to have been unaware of (a) the magnitude of the risk, (b) the proper postoperative procedures to be followed with MoM patients who experience pain (Klusmann), and (c) DePuy's misstatements about aSphere's wear-related advantages (Aoki). Additionally, Heinrich relied on disclosures by DePuy's representatives in making his treatment decisions. A reasonable jury could discern causation on two bases. First, Heinrich's mixed messages may have been too equivocal to rebut plaintiffs' objective evidence, cf. Centocor, 372 S.W.3d at 169; and second, the subjective testimony itself-which included evidence of both deception and reliance-likely permitted an inference of causation. Either way, there is nothing unreasonable in the causation findings as to Aoki and Klusmann.

         Christopher's case is the most straightforward of the lot. Kearns, his treating physician, testified, "The metal liner, according to the data supplied by the company, through publication and representatives, [could] last much longer than all the other product liners available at the time." Kearns claimed he "got [his] information from" "a DePuy consensus panel, " a "brochure that [his] DePuy representative gave [him], " "word of mouth, from [his] partners, and from the literature . . . scientific journals." Yet, he was "never told" that the newer MoM designs were "unpredictable" and could lead to "a sudden catastrophic breakdown of the bearing." Defendants stress that Kearns never read the Ultamet's IFUs, but that concession, by itself, is not fatal. For Kearns's testimony makes clear he relied on DePuy to apprise him of the risks, and it plausibly suggests he would have learned of Ultamet's risks by other means. Cf. Pustejovsky, 623 F.3d at 277. Christopher's claim easily succeeds.

         In short, defendants were entitled to JMOL on marketing-defect claims by Greer and Peterson. That is not so ...


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