This post is from the non-Reed Smith side of the blog.

Looking back on the blog, the last time we posted about the Pelvic Mesh MDL was this summer when we lauded a remand judge for not allowing plaintiffs to expand their expert reports to include opinions already excluded by the MDL judge. At that time we commented briefly on the uncertainty that accompanies remand. That decision was a positive post-remand development. Today’s decision is the flip side. Remand gone awry and unfortunately, affirmed by the Eleventh Circuit.

The decision is captioned Eghnayem v. Boston Scientific Corporation, 2017 U.S. App. LEXIS 20432 (11th Cir. Oct. 19, 2017) and is actually a consolidation of four plaintiffs’ cases. The cases all involve Florida residents and were consolidated and remanded from the MDL in the Southern District of West Virginia to the Southern District of Florida. Id. at *3. The remand court proceeded to try the 4 cases together over defendant’s objection. After almost identical multi-million dollar verdicts were entered for each plaintiff, defendant appealed.

The primary grounds on appeal were the improper consolidation of the cases for trial and the exclusion of evidence of FDA clearance. The Eleventh Circuit said both decisions by the district court were not an abuse of discretion. Interestingly while the court found limiting instructions were sufficient to overcome the prejudice of the multi-plaintiff trial, it also found that limiting instructions would not have cured the prejudice that would have resulted if the FDA clearance had been admitted into evidence. That’s a bit of plaintiffs getting to have their cake and eat it too.

We posit there is only one reason for consolidating trials of more than one plaintiff in a tort case not involving a common accident – to prejudice defendants. Plaintiffs argue consolidation saves time, but is there any proof to back that up? It certainly creates a host of appellate issues that clearly take more time. Plaintiffs in Eghnayem offered testimony from 25 witnesses at trial. Largely, testimony of individual plaintiffs and their individual physicians which have no relevance to the claims of the other plaintiffs. Id. at *7. Testimony that confuses juries with different plaintiff-specific facts and frankly invites juries to reach improper conclusions, such as all these people wouldn’t be suing unless something was wrong.

Defendant, of course, raised all these prejudicial concerns which the trial court and the appellate court believed could be swept away by “expressly instruct[ing the jury] to consider each plaintiff’s claims separately.” Id. at *12. How exactly a juror is supposed to do that is unknown and feels almost impossible. But the appellate court went even further and presumed that “even had the cases not been consolidated, the plaintiffs would likely have been able to submit evidence of other patients with similar injuries.” Id. at *15. Evidence of adverse events or clinical trial events may be admissible as to notice – but in a severely more limited way than when 4 distinct claims and injuries are litigated fully to the same jurors.

For example, one plaintiff had “graphic images” showing her removed mesh and the tissue that was removed along with it. The Eleventh Circuit concluded that sometimes graphic evidence is particularly helpful. Id. at *17-18. And it might well be – for that particular plaintiff. But to conclude that those images would have been admissible as to the other 3 plaintiffs borders on inconceivable.

What about evidence that post-dated some of the plaintiffs’ implantations. Where drug or device usage occurred at varying times, one of the many problems of consolidation is that defendants are deprived of the state of the art defense and exposed to improper admission of subsequent remedial measures. The result is a “perfect” plaintiff’s case being tried, with all plaintiffs able to rely on all evidence relevant to anybody, regardless of differences in time and place. The Eleventh Circuit agreed with defendant that post-implant evidence couldn’t go to notice in those cases, but it may be relevant for some other reason and therefore, limiting instructions over exclusion was the proper course. Id. at *19. But it is a course that wouldn’t be necessary if the cases were tried individually.

Finally, defendants argued that the similarity in the damage awards – almost identical – is evidence that the jury was confused; unable to distinguish between and among the plaintiffs. Given plaintiffs with “different medical histories, and different treating doctors; . . . prescribed the [mesh] at different times for different conditions; and claimed to suffer different injuries, after different lengths of exposure, resulting in different treatment courses,” id. at *6-7, the uniform result isn’t a mystery, it’s juror confusion leading to a formulaic verdict. The appellate court, however, found that “similar” injuries resulting in “similar” verdicts wasn’t unreasonable. Id. at *14. But that’s just buying into the flawed premise that these claims were similar enough to try together in the first place. With that as the starting place, it is no wonder the Eleventh Circuit found no abuse of discretion.

This case highlights several of the key reasons drug and device defendants fight against consolidated trials. If you want a more in depth discussion of the topic, including cites to rulings that agree with us, check out our post here.

There was one other significant issue on appeal. The district court excluded all evidence of the device’s 510k FDA clearance. This isn’t the first mesh case to reach this conclusion. See our post on the issue here discussing a post-remand case that made a better call by allowing the evidence albeit with a strong limiting instruction. While not perfect, that decision is certainly better than the Eleventh Circuit finding that 510k clearance “has no relevance to the state law claims.” Id. at *22. Or its decision that admitting the evidence would have been unnecessarily time-consuming and led to jury confusion on core issues. Id. at *23. We would disagree with those conclusions anyway but find them particular hard to swallow where the same court concluded that a multi-plaintiff trial wasn’t unduly prejudicial or confusing. We are in fact confused as to how a jury instruction regarding what the 510k process is and is not would not be curative, but a limiting instruction that the jury “may not even consider the fact that there’s more than one case being brought” alleviates the myriad of prejudices a multi-plaintiff trial visits upon defendants.

We confess, we can’t think of any good reason for admitting evidence concerning product risks that the plaintiff in a particular case never actually encountered – yet plaintiffs try it with a straight face all the time.  It’s another example of plaintiffs throwing mud against the wall to see if it will stick; anything to divert attention from a weak merits case concerning the injuries actually being claimed.

Sometimes plaintiffs argue that, even though they never encountered a particular risk, it was so severe and downright scary that if they had only been warned about that risk, they wouldn’t have used the product.  Trouble is, while that argument could be causal in a “but for” sense (assuming plaintiffs aren’t lying), it’s not causal in the legal, or proximate, sense.  One of the major tort treatises explains the difference:

More centrally, the injury suffered must be within the class of injury that the warning requirement was meant to avoid.  For example, the plaintiff, if properly warned that asbestos might cause cancer, might have ceased to work around asbestos.  A failure to give such a warning could result in liability if the plaintiff did develop cancer as a result of asbestos exposure.  But the failure to provide such a warning would not result in liability if the plaintiff, not being warned, kept her job and lost a hand in a job-related machine accident.  In that example, failure to warn would be a cause in fact – the plaintiff would have been elsewhere, not working at the machine, if a proper warning had been given – but it is not a proximate legal cause.  It is not, in other words, within the risk that a warning was designed to avoid.

Dan B. Dobbs, The Law of Torts, at 1018 (2001).

Federal appellate decisions similarly reject this sort of “causation” over and over, initially in cases involving non-prescription products.  Most commonly, asbestos plaintiffs have been precluded from introducing evidence of cancer when they had no such injury, or even a significant risk.  See O’Banion v. Owens Corning Fiberglass Corp., 968 F.2d 1011, 1013 (10th Cir. 1992) (“evidence of cancer is so prejudicial that in the absence of expert medical testimony that ‘a reasonable degree of medical certainty’ exists that the plaintiff will develop cancer, such evidence should be excluded”) (applying Oklahoma law); Smith v. A.C. & S, Inc., 843 F.2d 854, 859 (5th Cir. 1988) (cancer evidence in non-cancer case “is highly inflammatory and understandably incites the passions and fears of most reasonable individuals”) (applying Louisiana law); Jackson v. Johns-Manville Sales Corp., 750 F.2d 1314, 1321 (5th Cir. 1985) (same) (applying Mississippi law); In re Related Asbestos Cases, 543 F. Supp. 1152, 1160 (N.D. Cal. 1982) (excluding reference to cancer “in any cases in which the plaintiff has not contracted cancer”).

The same result has occurred in automotive product liability.  For example, in Kane v. Ford Motor Co., 450 F.2d 315 (3d Cir. 1971), the plaintiff started out claiming one type of brake defect in a car, but then shifted to a different defect claim at trial.  The Third Circuit affirmed exclusion of such evidence, because it was “irrelevant to appellant’s theory of the case.”  Id. at 316.  See Fields v. Volkswagen of America, Inc., 555 P.2d 48, 58 (Okla. 1976) (excluding recall where “the defect mentioned in the recall letter is not the defect claimed to have cause the [plaintiff’s injury]”); Johnson v. Ford Motor Co., 988 F.2d 573, 578-80 (5th Cir. 1993) (affirming exclusion of five other incidents that different car models and different claims of mechanical defect); Olson v. Ford Motor Co., 410 F. Supp. 2d 869, 873-75 (D.N.D. 2006) (excluding automotive recalls where the reason for recall differed from plaintiff’s alleged product defect); Jordan v. General Motors Corp., 624 F. Supp. 72, 77 (E.D. La. 1985) (same).

But we’re more interested in prescription medical product liability litigation.

In our sandbox, the New York Court of Appeals rejected failure to warn of risks the plaintiff had not suffered in Martin v. Hacker, 628 N.E.2d 1308 (N.Y. 1993), where the plaintiff claimed that a drug should have been contraindicated in patients with a history of depression – but personally had no history of depression.  “Since it is undisputed that [plaintiff] had no history of mental depression, we are not concerned with the adequacy of the Contraindications section of the insert.  Id. at 1313. See McFadden v. Haritatos, 448 N.Y.S.2d 79, 81 (N.Y.A.D. 1982) (“Since there was no showing” that plaintiff “had a history of that condition,” the allegedly inadequate warnings “are not applicable”).

Other state appellate courts agree.  A Texas appellate court in Ethicon Endo-Surgery, Inc. v. Meyer, 249 S.W.3d 513 (Tex. App. 2007), entered judgment n.o.v. on a warning claim, where the prescriber knew of the risk that the plaintiff encountered − rejecting allegations of inadequate warnings about diabetes (“[n]othing in the record suggests that [plaintiff] was diabetic”), and several general surgical risks (“[a]ssuming that the general . . . risk factors . . . could form the basis of an appropriate warning, there is no evidence that the lack of such a warning caused [plaintiff’s] injury”).  Id. at 519.

In King v. Danek Medical, Inc., 37 S.W.3d 429 (Tenn. App. 2000), one of Bexis’ Bone Screw cases, the plaintiffs’ expert attempted to opine about a condition that the plaintiffs did not have.  Same result:

[Plaintiffs’ expert] did not attempt to testify that either [plaintiff] developed [that condition] as the result of their implants. . . .  The theoretical possibility that some [products] of other manufacturers can cause various bone problems, without proof that it occurred to these plaintiffs because of the products of these defendants, cannot defeat summary judgment.

Id. at 446-47.

Likewise, in Peterson v. Parke Davis & Co., 705 P.2d 1001 (Colo. App. 1985), the court affirmed rejection of a proposed jury instruction that would have required the defendant to warn about every possible drug risk:

[T]he request for an instruction that [defendant] had a duty to warn of all known dangers was properly denied.  In a failure to warn case, the plaintiff has the burden of proving that the manufacturer gave inadequate warning of the danger which caused the injury.

Id. at 1004.

Here in Pennsylvania, plaintiffs tried warning claims about the risk of injuries they never suffered in both the breast implant and fen-phen mass torts – failing both times.  In fen-phen litigation, plaintiffs alleging primary pulmonary hypertension (“PPH”) were precluded from arguing that better warnings about valvular heart disease (“VHD”) (and vice versa) would have made a difference, even when a prescriber would not have been deterred by better warnings about the injury (PPH) the plaintiff actually had:

In these circumstances, the relationship between the legal wrong (the failure to disclose the risk of VHD) and the injury (PPH) is not directly correlative and is too remote for proximate causation.  Therefore, as a matter of law, there is no proximate, causal connection between [defendant’s] failure to disclose the risk of VHD and [plaintiff’s] specific injury.

Cochran v. Wyeth, Inc., 3 A.3d 673, 681 (Pa. Super. 2010); accord Owens v. Wyeth, 2009 WL 3244890, at ??? (C.P. Phila. Co. Aug. 17, 2009) (“the only warnings properly at issue in a failure to warn case are those relating to the condition to which the plaintiff alleges to have suffered”), aff’d mem., 6 A.3d 572 (table), 2010 WL 2965014, at *5-6 (Pa. Super. 2010) (adopting trial court’s reasoning).

Likewise, in breast implant litigation, the Pennsylvania mass tort court held that liability for inadequate warnings about risks not encountered was too broad to be permitted:

If I accept plaintiffs’ argument, the law will be permitting recovery for a risk that the plaintiff assumed because the plaintiff might have made a different decision as a result of knowing of other risks for which the plaintiff did not experience any harm.

In re Silicone Breast Implant Litigation, 64 D. & C. 4th 21, 25-26 (C.P. Allegheny Co. 2003).  Recovery for warnings about risks that never happened “would have a reach that extends far beyond the purposes for the [duty to warn] doctrine.”  Id. at 26.

The same has proven true with mass torts in other state courts.  In re NuvaRing Litigation, 2013 WL 1874321, at *23 (N.J. Super. Law Div. April 18, 2013) (“any failure to notify the FDA of increased [other] risks would not affect the adequacy of the warning with respect to the . . . cause of [plaintiff’s] death”); Hedrick v. Genentech Inc., 2011 WL 5902794, at ??? (Cal. Super. Oct. 20, 2011) (“liability should be limited when a plaintiff does not suffer the unwarned-of injury”) (applying Massachusetts law).

In federal court, the plaintiffs in Rivera v. Wyeth-Ayerst Laboratories, 283 F.3d 315, 321 (5th Cir. 2002) (applying Texas law), “never assert[ed] that they were part of a risk group that should have been warned.”  Id. at 321.  Their warning claims were therefore “absurd”:

To find causation, we would have to infer the absurd − for example, that an extra warning, though inapplicable to [the lead plaintiff], might have scared her and her doctor from [the drug].  Such reasoning is too speculative to establish Article III standing.

Id.

In Eck v. Parke, Davis & Co., 256 F.3d 1013 (10th Cir. 2001) (applying Oklahoma law), the plaintiff alleged that his prescriber “would have read and heeded a warning” about not to prescribe two drugs together.  Turns out that didn’t happen.  The other drug was prescribed later by somebody else.  The warning to the first prescriber had nothing to do with plaintiff’s eventual injury.  Therefore, no causation as a matter of law:

[I]t is undisputed that [plaintiff] did not ingest the [two drugs] concomitantly . . . until . . . his prescribing physician was [somebody else]. . . .  That [the first prescriber] might have heeded a warning. . .about possible adverse effects were he to prescribe [the two drugs together] is of no significance given the facts before us.

Id. at 1020.

In Mills v. United States, 764 F.2d 373 (5th Cir. 1985) (applying Louisiana law), the adverse reaction that the plaintiff suffered was the subject of thorough warnings – so plaintiff claimed that warnings about other conditions were inadequate.  The court held that, since, plaintiff didn’t have those injuries the alleged lack of warnings about them were irrelevant.

The question of the adequacy of the warnings must be confined to consideration of whether the warnings were sufficient to inform the plaintiff of the risk of the particular condition or disease which allegedly caused his injury or death. . . .  [A] determination that warnings were inadequate with respect to some other condition does not bear on our conclusion that [plaintiff] was adequately informed of the risk of severe allergic reaction to the swine flu vaccine.

Id. at 379.

Likewise, in Novak v. United States, 865 F.2d 718 (6th Cir. 1989) (applying Ohio law), the plaintiff lacked any scientific evidence that the product could cause her condition, and therefore claimed inadequate warnings about a different risk she never suffered.  Amazingly, the district court allowed the switch.  The court of appeals did not, and reversed:

There was, therefore, no reason for the defendant to make the references deemed important or vital by the district court, and there was no duty on the part of the defendant to warn about any of these conditions.  Particularly, the district court erred in finding the warning inadequate, negligent, and insufficient because it did not specifically caution those who may have experienced [the other condition].  It was not proven that [plaintiff] had actually suffered from [that condition]. . . .

Id. at 726.  See In re Avandia Marketing, Sales Practices & Products Liability Litigation, 639 Fed. Appx. 874, 879 n.8 (3d Cir. 2016) (expert opinion had “no impact” on causation when based on a study that “dealt with a population of which [plaintiff] was not a part”) (applying Pennsylvania law); Coursen v. A.H. Robins Co., 764 F.2d 1329, 1336 (9th Cir. 1985) (“collateral misconduct unrelated to the specific injury suffered by the plaintiffs” properly excluded) (applying Oregon law).

Numerous other cases have reached the same conclusion. In Stahl v. Novartis Pharmaceuticals Corp., 2000 WL 33915848 (E.D. La. Nov. 29, 2000), aff’d, 283 F.3d. 254 (5th Cir. 2002), the plaintiff’s prescriber knew all about the drug’s alleged risks that he suffered.  Id. at *4.  Thus, plaintiff alleged inadequate warnings about other more serious conditions that he didn’t have.  Summary judgment granted:

[T]his Court is unpersuaded by [plaintiff’s] complaints that the warnings did not warn of death, liver failure, and the need for transplant.  [Plaintiff] has not suffered any of those injuries and is, therefore, precluded from imposing a duty to warn regarding those injuries not suffered. . . .  [A] claimant cannot seek to impose a duty to warn on a manufacturer of damage not sustained.

Id. (citation and quotation marks omitted).  See also Vakil v. Merck & Co., 2016 WL 7175638, at *6 (D.N.J. Dec. 7, 2016) (“Defendants cannot be held accountable for failing to warn Plaintiff of a symptom he never experienced”); Guidry v. Janssen Pharmaceuticals, Inc., 2016 WL 633673, at *4 (E.D. La. Feb. 17, 2016) (“The only specific . . . that supports the plaintiff’s failure-to-warn claim is that the FDA issued a safety announcement warning [about] ketoacidosis. But the plaintiff does not allege (at least coherently) that she ever suffered from ketoacidosis”; warning claim dismissed); Stephens v. Teva Pharmaceuticals, U.S.A., Inc., 2013 WL 12149265, at *3 (N.D. Ala. Oct. 31, 2013) (“warnings for a wide range of conditions from which decedent did not allegedly suffer . . . would not have had any effect on him”; motion to dismiss granted); Austin v. Bayer Pharmaceuticals Corp., 2013 WL 5406589, at *7 (S.D. Miss. Sept. 25, 2013) (“Plaintiff failed to state a claim for the failure to warn of side effects which Plaintiff did not suffer”); Harris v. Eli Lilly & Co., 2012 WL 6732725, at *3 (N.D. Ohio Dec. 28, 2012) (“For a plaintiff to succeed on an inadequate warning claim, the risk about which the manufacturer allegedly failed to warn must be the same risk which harmed the plaintiff.”) (following Ohio Rev. Code §2307.76(A)(1)); Tolliver v. Bristol-Myers Squibb Co., 2012 WL 3074538, at *4 (N.D. Ohio July 30, 2012) (same); Mason v. Smithkline Beecham Corp., 2010 WL 2697173, at *5 n.3 (C.D. Ill. July 7, 2010) (“a warning is only inadequate if it fails to list risks or side effects that do occur”); Harrington v. Biomet, Inc., 2008 WL 2329132, at *6 (W.D. Okla. June 3, 2008) (“no evidence” that two allegedly inadequate warnings caused plaintiff’s alleged injuries; summary judgment granted); Hernandez v. Ciba-Geigy Corp. USA, 200 F.R.D. 285, 295 (S.D. Tex. 2001) (dismissing plaintiffs who “do not plead that the[ir] children suffered any injuries or side effects of which [defendant] allegedly failed to warn”) (applying Texas law).

We’ve observed many times that multi-district litigation all too often becomes a breeding ground for bogus claims, and warning claims asserting injuries that plaintiffs don’t actually have is no exception.  Plaintiffs in Pelvic Mesh litigation have repeatedly advanced similar bogus warning claims based on risks they had not encountered, and lost each time.  The MDL judge granted an in limine motion against such evidence in Tyree v. Boston Scientific Corp., 2014 WL 5445769 (S.D.W. Va. Oct. 22, 2014):

I agree that evidence of complications that no plaintiff experienced is irrelevant and lacking in probative value. For the claims that require evidence of injury (strict liability for failure to warn, strict liability for design defect, and negligence), only the injuries experienced by the complainant are relevant.  Strict liability . . . requires the plaintiff to show . . . that the defect was the probable cause of her injuries. . . .  [E]vidence that the [the product] causes injuries not experienced by the plaintiffs has little probative value.  Moreover, elaborating on injuries that the plaintiffs did not incur risks needless presentation of cumulative evidence.

Id. at *6 (citations and quotation marks omitted) (emphasis original).  Accord Hall v. Boston Scientific Corp., 2015 WL 856786, at *5 (S.D.W. Va. Feb. 27, 2015) (“Evidence of complications that the plaintiff has not experienced is irrelevant and lacking in probative value.  For the claims that require evidence of injury, only the injuries experienced by the complainant are relevant.”) (applying Wisconsin law); Eghnayem v. Boston Scientific Corp., 2014 WL 5465741, at *7 (W.D. Va. Oct. 28, 2014) (same) (applying Florida law); In re Ethicon Pelvic Repair Systems Products Liability Litigation, 2014 WL 505234, at *10 (S.D.W. Va. Feb. 5, 2014) (excluding purported cancer risk where plaintiff “does not have cancer or allege any injuries related to an increased risk of cancer”) (applying Texas law); In re Ethicon Pelvic Repair Systems Products Liability Litigation, 2014 WL 457544, at *2 (S.D.W. Va. Feb. 3, 2014) (“secondary infections were not ‘a fact in issue’ because [plaintiff] did not experience a secondary infection”) (applying Texas law).

Other MDL cases reaching the same result include:

In re Xarelto (Rivaroxaban) Products Liability Litigation, 2017 WL 1352860, at *4, 7 (E.D. La. April 13, 2017) (excluding expert testimony about cancer where “cancer was not an issue for either Plaintiff”) (defense testimony); Solomon v. Bristol-Myers Squibb Co., 916 F. Supp.2d 556, 564 (D.N.J. 2013) (“Plaintiff, however, did not suffer from transient ischemic stroke.  Thus, this study is irrelevant to Plaintiff’s claim”) (applying Texas law); Carr-Davis v. Bristol Myers-Squibb Co., 2013 WL 322616, at *5 (D.N.J. Jan. 28, 2013) (“because the studies are not relevant to Decedent’s condition, then the failure to inform the physicians of such findings cannot establish causation”) (applying Missouri law); Cooper v. Bristol-Myers Squibb Co., 2013 WL 85291, at *6 n.11 (D.N.J. Jan. 7, 2013) (plaintiff “does not link those potential warnings to his personal circumstances”) (applying Alabama law); Thrope v. Davol, Inc., 2011 WL 470613, at *32 (D.R.I. Feb. 4, 2011) (“[n]othing in [the surgeon’s] account indicates that he handled the [product] in a manner that [defendant] failed to warn against”; judgment as a matter of law granted) (applying North Carolina law); In re Fosamax Products Liability Litigation, 2010 WL 1257299, at *5 (S.D.N.Y. March 26, 2010) (“Plaintiff cannot establish proximate cause without evidence [of a] failure to warn of the specific risk that allegedly materialized”) (applying Florida law); In re Rezulin Products Liability Litigation, 331 F. Supp.2d 196, 200-01 (S.D.N.Y. 2004) (alleged inadequate warning about risk plaintiff did not suffer held “quite beside the point”; “95 percent of the patients who took [the drug] suffered no liver injury” so “there is no evidence from which a trier of fact reasonably could conclude that these plaintiffs’ treating physicians would not have prescribed Rezulin even if plaintiffs are right as to the warning concerning liver toxicity”); In re Rezulin Products Liability Litigation, 2004 WL 1802960, at *3 (S.D.N.Y. Aug. 13, 2004) (“these plaintiffs do not claim to have suffered any liver injury” so “that there may have been a breach of the duty to warn of liver toxicity for which patients suffering from liver dysfunction may recover does not avail these plaintiffs”) (footnotes omitted), vacated in part on other grounds, 2004 WL 2009445 (S.D.N.Y. Sept. 8, 2004) (applying Mississippi and Texas law); Greiner v. Medical Engineering Corp., 99 F. Supp.2d 759 (W.D. La. 2000) (breast implants; “[a] claimant cannot seek to impose a duty to warn on a manufacturer of damage not sustained”), aff’d, 243 F.3d 200 (5th Cir. 2001); In re Norplant Contraceptive Products Liability Litigation, 1997 WL 81094, at *1 (E.D. Tex. Feb. 21, 1997) (“whether the [product] warnings were not adequate with respect to an injury not alleged is not relevant to whether physicians were adequately warned of Plaintiffs’ alleged injuries”).

Punitive Damages

Finally, one other argument that plaintiffs sometime advance about alleged failures to warn of risks that they didn’t actually encounter is that such non-causal failures to warn are relevant to “punitive damages.”

We don’t think so, and this time the argument is constitutionally based. Evidence of inadequate warnings about risks not encountered by plaintiffs is solely relevant to injuries suffered (if at all) by persons other than the plaintiff who is before the court.  That’s a punitive damages no-no.

In considering punitive damages, the United States Supreme Court first held:

A defendant’s dissimilar acts, independent from the acts upon which liability was premised, may not serve as the basis for punitive damages. . . .  Due process does not permit courts, in the calculation of punitive damages, to adjudicate the merits of other parties’ hypothetical claims against a defendant under the guise of the reprehensibility analysis.”

State Farm Mutual Automobile Insurance Co. v. Campbell, 538 U.S. 408, 422-23 (2003).

A few years later, the Court decided that, “[t]o permit punishment for injuring a nonparty victim would add a near standardless dimension to the punitive damages equation.”  Philip Morris USA v. Williams, 549 U.S. 346, 354 (2007).  Williams therefore flatly declared it unconstitutional to base punitive damages on allegations of harm to absent third parties (such as other people suffering different injuries):

We did not previously hold explicitly that a jury may not punish for the harm caused others. But we do so hold now. . . .  [W]e believe the Due Process Clause prohibits a State’s inflicting punishment for harm caused strangers to the litigation.

Id. at 357.  Thus, “it is particularly important that States avoid procedure that unnecessarily deprives juries of proper legal guidance.  Id. at 355.  It is “constitutionally important” to insure that “the jury will ask the right question, not the wrong one.”  Id.

[W]here the risk of. . .misunderstanding is a significant one – because, for instance, of the sort of evidence that was introduced at trial or the kinds of argument the plaintiff made to the jury – a court, upon request, must protect against that risk.  Although the States have some flexibility. . ., federal constitutional law obligates them to provide some form of protection in appropriate cases.

Id. at 357 (emphasis added).

Admission of warning/risk evidence beyond that involving the plaintiff in question constitutes a state-law “procedure” doing the exact opposite of what the Supreme Court required in Williams.  With respect to punitive damages, such evidence is inherently suspect because by definition it places before the jury “injury . . . inflict[ed] upon those who are, essentially, strangers to the litigation.”  Id. at 353.

In Skibniewski v. American Home Products Corp., 2004 WL 5628157 (W.D. Mo. April 1, 2004), after State Farm, but before Williams, the court excluded evidence of “any alleged side effect or risk of the products at tissue other than the side effect or risks that allegedly harmed plaintiff” both generally, and in response to a punitive damages argument.  Id. at *12-13.

[F]ailure to warn of a medical condition plaintiff does not have cannot serve as the basis of a failure to warn claim and . . . evidence regarding injuries plaintiff does not have is irrelevant.  Because plaintiff does not have [certain conditions], evidence of these should be excluded.

Id. at *7. See Ray v. Allergan, Inc., 863 F. Supp.2d 552, 565 (E.D. Va. 2012) (punitive damages argument based on all persons taking a drug for a condition, regardless of injury, required new trial under Williams); Schilf v. Eli Lilly & Co., 2010 WL 3909909, at *6 (D.S.D. Sept. 30, 2010) (evidence about a different drug “are irrelevant to Plaintiffs’ claim for punitive damages” under Williams); In re Fosamax Products Liability Litigation, 647 F. Supp.2d 265, 284-85 (S.D.N.Y. 2009) (conduct occurring after a plaintiff’s injury cannot be used to support punitive damages under Williams); In re Prempro Products Liability Litigation, 2007 WL 4189510, at *3 (Mag. E.D. Ark. Nov. 15, 2007), adopted, 2007 WL 4189497 (E.D. Ark. Nov. 21, 2007) (under Williams evidence “will not be permitted to testify regarding [defendant’s] general badness or badness in the specific areas which are not connected to [plaintiff’s] injury”). See also Branham v. Ford Motor Co., 701 S.E.2d 5, 24 (S.C. 2010) (punitive damages theory that “invited the jury to punish [defendant] for all [product-related] deaths and injuries, rather than the “harm to [plaintiff],” was improper under Williams); Pedroza v. Lomas Auto Mall, Inc., 2009 WL 1300944, at *4-5 (D.N.M. April 2, 2009) (conduct occurring after a plaintiff’s injury cannot be used to support punitive damages under Williams) (non-product liability case); Berardi v. Village of Sauget, 2008 WL 2782925, at *5-6 (S.D. Ill. July 17, 2008) (other allegedly similar incidents could not be admitted to prove punitive damages) (non-product liability case).

So there you have it.  Evidence of alleged product defects, that did not give rise to the harm that the plaintiff actually encountered, should be irrelevant and inadmissible in product liability litigation, no matter what the rationale offered for their admissions.  Such evidence is a smoke screen and a side show offered when a plaintiff is trying to distract attention from a lousy liability case.

If you read the decision in Rossitto v. Hoffmann-LaRoche Inc., 2016 N.J. Super. Unpub. LEXIS 1714 (N.J. App. Div. Jul 22, 2016), we think you’ll agree with our calling it “strong” criticism of two trial rulings that the appellate court firmly believed led to undue prejudice of the defendant.  The $18 million verdict awarded to two of four plaintiffs in a joint trial was vacated and the case is being remanded for a new trial.  This is not the first Accutane plaintiff’s verdict to be vacated by New Jersey’s appellate division, but rather another notch in the demise of this litigation which has seen a turn in favor of defendant since coming under new management.  Indeed, a quick search of the DDL blog for Accutane will show how the tide has turned.

The Accutane litigation is primarily comprised of claims alleging that the manufacturer failed to adequately warn about the risk of inflammatory bowel disease (“IBD”).  Therefore, the drug’s label takes center stage.  Here, the plaintiffs both used the drug with its 1984 label that included a warning that “Accutane has been temporally associated with IBD.”  Id. at *8.  In May 2000, after plaintiffs had stopped using Accutane, the label was revised to remove the word “temporally” and to add information about persistent IBD symptoms.  Id. at *18.

Although only one of the plaintiffs was a New Jersey resident, the parties agreed that New Jersey law would apply to both.  Id. at *34.  So, New Jersey’s “super-presumption” applies – that is if the warning given has been approved by the FDA, there is a rebuttable presumption of adequacy.  Id. at *37.  Called a “super-presumption” because it is “virtually dispositive” on failure to warn, it can be overcome with evidence of intentional concealment of a known risk or “substantial evidence of economically-driven manipulation of the post-market regulatory process.”  Id. at *37-38.  Plaintiffs got to trial in these cases because the New Jersey courts have found that as to the 1984 label plaintiffs have put forth enough evidence from which a reasonable jury could conclude they had rebutted the presumption.  Id.  at *55-56 (citing prior Accutane decisions addressing this issue).   But it’s a strong presumption so we decided to take the time to remind you about it.

Continue Reading New Jersey Accutane Plaintiff Verdict Vacated – Appellate Division Strongly Criticizes Evidentiary Rulings

For years we’ve advocated about ediscovery for defendants – consisting mostly of material gathered from a plaintiff’s social media postings. OK, so let’s assume some degree of success. Defense-side ediscovery has generated some good stuff, and come trial, we want to get it admitted into evidence. Now what?

That’s the subject of today’s rather short post. Since we’re hardly the source of all useful information, we’d like to pass along a handy 4-page checklist for the admissibility of electronic evidence. It covers evidence in the form of: e-mail, internet website posts; text messages/tweets; computer stored information; animations and simulations; and digital photos. It has the following headings:

  1. Preliminary Rulings on Admissibility
  2. Is the Evidence Relevant?
  3. If Relevant, Is It Authentic?
  4. Is Evidence Hearsay?
  5. Original Writing Rule
  6. Practice Tips

It’s what it purports to be – a checklist – it doesn’t provide case law, but it’s the kind of thing that lends itself to use in trial, rather than pretrial, situations.

This nifty guide was prepared jointly by Hon. Paul W. Grimm and Kevin F. Brady of Redgrave LLP, so give credit where credit is due. We’ve been in touch with both of them, and they have graciously allowed us to disseminate their work.

How much is “enough?” Will we have enough money to retire someday? Did the Drug and Device Law College Sophomore study enough for her computer science midterm? Is there enough salt in the matzo ball soup? In the realm of summary judgment, we who represent defendants are painfully familiar with courts that dodge this question, allowing claims to proceed and avoiding the complicated issues of admissibility that determine whether a plaintiff has presented enough evidence to create a genuine issue of material fact.

Not so in United States of America ex rel. John King and Tammy Drummond, et. al. v. Solvay S.A., et al.. 2016 U.S. Dist. LEXIS 43133 (S.D. Tex. Mar. 31, 2016). In King, a False Claims Act case, the Relators claimed that the defendant promoted three drugs for off-label uses, and that the off-label promotion resulted in false claims being submitted for prescriptions paid for by government health care programs. King, 2016 U.S. Dist. LEXIS at *5. The defendants moved for summary judgment on these claims, arguing that the relators did not have any admissible evidence of false claims. Specifically, the defendants argued that the Relators relied on inadmissible Texas and New York claims data to create summary charts of supposed false claims and didn’t disclose who created the charts or explain how they were created. Further, the defendants objected to the Relators’ reliance on sales representatives’ “call notes,” arguing that the call notes contained hearsay and lacked foundation. Id. at *8-9.

New York Claims Data

The Relators claimed that the New York claims data was self-authenticating because it was produced in response to a subpoena. The court disagreed, holding, “. . .[W]hile certainly Relators’ assertion that the State of New York produced the New York Claims Data pursuant to a subpoena must be what was requested in the subpoena,” documents produced pursuant to a subpoena are not always self-authenticating. Id. at *13. In contrast to a case cited by the Relators, which involved documents that were going to be used against that producing party, the Relators, who sued on behalf of the State of New York, were using the documents to benefit New York. The court concluded that the New York claims data was not self-authenticating “simply because it was produced pursuant to a subpoena.” Id. at *13-14.

Continue Reading Summary Judgment for Defendants in FCA Action: No Admissible Evidence of False Claims

Happy Birthday, Eric Clapton. (Today is also the birthday of painters Goya and Van Gogh. Is there something about March 30 that breeds people who turn their blues into art?) Clapton has been around so long it is easy to take him for granted. He has built up a formidable body of musicianship. He is the only three-time inductee in the Rock and Roll Hall of Fame, for his solo work as well as his stints with the Yardbirds and Cream. We remember how, in the late 1960s, one of our sisters would scribble on her school notebooks that “Clapton is God.” That sister later married a very nice, very hip guy, who was also a Clapton fan. A couple of years ago Clapton’s autobiography came out. Our brother-in-law summarized the book thusly: “I made a lot of music, took a lot of drugs, caused a lot of damage to relationships and health, but in the end, everything was pretty cool.” Just so.

In the early 1990s, we were working at a law firm representing the Robert Stigwood Organization (RSO). You might remember RSO as the force behind the soundtracks for Grease and Saturday Night Fever. RSO also managed the careers of the Bee Gees, Andy Gibb, Yvonne Elliman, and Clapton. In our case, RSO, along with Eric Clapton, was being sued by Jim Gordon, the drummer in the short-lived rock group Derek and the Dominos. Gordon claimed he had been denied writing credit and money for the long piano coda in the all-time great song, “Layla.” By the time he filed the lawsuit, Gordon was a resident of the Atascadero Prison for the criminally insane. Somewhere along the way, Gordon had started hearing a voice. That voice told him to kill his mother. With a hammer and butcher knife. He obeyed that voice. Needless to say, the deposition of Gordon behind prison walls was odd. Earlier in the case, our firm sent a representative to London to meet with our co-defendant, Mr. Clapton. That assignment went to another associate – one who didn’t even like Clapton’s music that much – certainly not as much as we did. Our bitterness and envy were complete. We insisted that the lucky associate (a close friend of ours, but his musical tastes ran more toward c&w and happy pop than toward guitar gods) relay a message to Clapton that, of all the versions of “After Midnight,” the best was the slow one that ran on the Michelob beer commercials. Imagine our delight when we were told that after Clapton listened to that opinion, he paused thoughtfully, nodded, and gently assented: “Yes. That one is the most soulful.”

It would be hard to list all of the great songs that Clapton worked on, but here is a start:

  • “For Your Love” (with the Yardbirds. Clapton hated the poppy-ness of the song and left the group just before the song climbed the charts)
  • “White Room” (listen to that solo and try arguing that the Drug and Device Law Sister was wrong all those years ago about deifying Clapton – go ahead, we dare you!)
  • “Sunshine of Your Love”
  • “Badge” (written with George Harrison. On the track credits, the rhythm guitarist is listed as L’Angelo Misterioso- that’s Harrison, who couldn’t use his real name for legal reasons. Damn lawyers.)
  • “Crossroads”
  • While My Guitar Gently Weeps” (we read somewhere that John Lennon contemplated replacing Harrison with Clapton, but Clapton wasn’t interested in becoming a Beatle)
  • “Layla” (the title song of rock’s greatest double album. Like most of the songs on that magnum opus, it is about Clapton falling in love with Harrison’s wife, Patti Boyd. Ms. Boyd, by the way, was one of the screaming, predatory schoolgirls in the Hard Day’s Night movie)
  • “Why Does Love Got To Be So Sad”
  • “Bell Bottom Blues”
  • “I Shot The Sheriff” (Maybe the original version by Bob Marley is better, but Clapton’s is also superb)

[The founder of this blog wants us to include “Wonderful Tonight” on our list of Clapton favorites. Who are we to refuse? But who knew there was a softer side of Bexis?]

Another one of Clapton’s hits was “Cocaine.” And thus we have an introduction to today’s case, Tersigni v. Wyeth, 2016 U.S. App. LEXIS 5393 (1st Cir. March 23, 2016). Tersigni was a diet drug case, and the alleged injury was Primary Pulmonary Hypertension (PPH). PPH is a very bad disease. The claims were brought under Massachusetts law for negligent design and negligent failure to warn. The trial court dismissed the negligent design claim. The negligent failure to warn claim went to the jury, which returned a defense verdict. On appeal, the plaintiff raised these issues:

  • The negligent design defect claim should not have been dismissed
  • The court should not have admitted evidence at trial that the plaintiff had been incarcerated
  • The court should not have admitted evidence at trial of the plaintiff’s cocaine use

Continue Reading First Circuit Upholds Defense Verdict in Diet Drug Case

This post comes from the non-Reed Smith side of the blog.

It landed with a concussing thud that surprised no one. The $498 million verdict came last Thursday after weeks of evidence that included suicide, racism, tobacco pseudo-science, cancer, the proliferation of pelvic mesh litigation, Saddam Hussein, and alleged fraudulent practices in foreign countries. You might be wondering what type of case the jury was considering. That evidentiary line-up might make you think it was a wrongful death civil rights trial, or something worse. But it wasn’t. It was a Pinnacle hip implant trial. Really.

Before the verdict came, we were worried that something like this could happen. We wrote about it just as the jury was beginning deliberations. And then it happened, which should have been no surprise given the grouping of five separate plaintiffs for one bellwether trial and the noise that defendants were making about evidentiary rulings.

The question now is, what does it mean? Will it promote the ultimate resolution of the mass tort? Well, there’s little to suggest that it will. In fact, it seems more likely to do the opposite.

Continue Reading Trouble in Texas II

This post does not come from the Reed Smith side of the blog.

After two grueling months, the second bellwether trial in the Pinnacle Hip Implant MDL has gone to the jury.  The last time that happened—in 2014—the jury came back with a defense verdict.  It was a resounding and, to some, upset victory for the defense in a plaintiff-selected case in a Texas court against Texas plaintiffs’ lawyers.

But that was then.
Continue Reading Trouble in Texas?: The Latest Pinnacle Hip Implant Trial Goes to the Jury

This post comes from the non-Reed Smith side of this blog.

With some courts, the § 510(k) clearance of a medical device is not only insufficient to support preemption. It’s not probative enough to be discussed at trial.  The MDL court in the Boston Scientific Pelvic Repair System Products Liability Litigation is one such court, consistently excluding from trial evidence of 510(k) clearance of the pelvic mesh device.  According to a recent decision by one of the courts overseeing a trial on remand from the MDL, the MDL court read Medtronic v. Lohr to hold that § 510(k) clearance addresses only the device’s equivalence with an already marketed device, not safety.  Winebarger v. Boston Scientific Corp., 2015 U.S. Dist. LEXIS 126616, at *13-14 (W.D.N.C. Sept. 22, 20150) (describing the basis for the MDL court’s decision).

We’re not so convinced. The 510(k) process is not a complete abandonment of safety considerations.  And it certainly provides evidence of whether the manufacturer behaved reasonably.  Congress enacted the 510(k) process, in part, to enable quicker clearance for new devices that are equivalent to devices that have already been on the market and have accumulated some sort of safety and efficacy record.  Moreover, the 510(k) process is an inescapable reality for device manufacturers.  A discussion of the process, how it was followed, and the safety information that was provided or available through the marketing of equivalent devices is relevant to assessing the reasonableness of the manufacturer’s actions.  If plaintiffs want to minimize its importance, establish that it says nothing about safety, or show what the manufacturer failed to do, they are free to present such evidence.  The jury can then decide the relevance of this evidence.

Fortunately, the remand court, applying North Carolina law, got this right – sort of.  In North Carolina, a jury may consider the “extent to which the design or formulation [of the device] conformed to any applicable government standard.”  Winebarger, 2015 U.S. Dist. LEXIS, at *19 (quoting North Carolina’s Product Liability Act).  And so, unlike the MDL court, the remand court determined that evidence of § 510(k) clearance is admissible.  But introduction of that evidence will likely come with a fairly severe limiting instruction:

The fact that BSC followed the requisite 510(k) protocol – limited as it is – prior to marketing its Uphold device has minimal probative value regarding BSC’s efforts to adhere to FDA processes and procedure generally. . . .  Admissibility might depend upon a limiting instruction that 510(k) clearance is not to be considered as evidence that the FDA authorized the Uphold as safe and approved its intended use as such; that 510(k) clearance is not evidence that BSC satisfied any standard of care in designing the Uphold device.  For these reasons, the Court’s preliminary ruling on Plaintiff’s motion is that the 510(k) clearance process is admissible subject to a limiting instruction consistent with the terms of the instant Order.

Id. at *22-23.

Continue Reading Section 510(k) Clearance: While it Doesn’t Support Preemption, Is It Relevant Evidence at Trial?

It’s been one of those weeks and it’s only Tuesday.  So, we aren’t going to try to be clever or witty today (we know some of you are relieved).  Nor are we going for scholarly or particularly profound.  We’re just going to point you to an interesting decision that popped up on our radar today – Rheinfrank v. Abbott Laboratories, Inc., No. 1:13-cv-144, slip op. (S.D. Ohio ______). We previously posted on this case when the court took a sizeable bite out of plaintiff’s failure to warn claim and we refer you to that post for the details.  With an already much thinner case to take to trial, the court did some more trimming with these recent in limine rulings:
  • Preempted labeling issues are excluded.  For this one we definitely recommend you revisit our earlier post.  But the short
    of it is that the court dismissed plaintiff’s failure to warn of the risk of developmental delay as preempted based on “clear evidence” that the FDA would have rejected the inclusion of such a warning in the labeling.  Id. at 2-3.  So, evidence that defendant should have strengthened its warning to include developmental delay is irrelevant and inadmissible.  This includes any argument that defendant could have unilaterally changed the warning via the CBE process.  Id. at 4-5.  Plaintiffs are allowed to introduce evidence that defendant could have “suggested stronger language” for its warning, but not related to developmental delay.
  • Subsequent labels and label changes are excluded.  After plaintiff conceived her daughter, the Depakote label was changed three times.  The court ruled that both the labels and evidence of changes in those labels was irrelevant and unduly prejudicial. “If the jury is presented with labels after this timeframe, the jury may conclude that Abbott’s earlier labels were inadequate merely because the latter labels include expanded warnings not present in the 2003-2004 version.”  Id. at 5.
  • Subsequent medical information limited to causation.  Unfortunately, the court didn’t apply the same reasoning to medical or scientific information that post-dated the birth of plaintiff’s daughter.  On this the court found that it might be relevant to what defendant could have or should have known.  Id. at 14.  Doesn’t it really show what was knowable after the fact?  We think the same issues of jury confusion and undue prejudice that warranted exclusion of later labels should keep out later science.  The up side is the court limited introduction of post-injury science to only evidence that “can be linked to the causation issues in the case.”  Id. at 14.
  • Other off-label marketing and promotion excluded.  One of plaintiff’s allegations is that defendant promoted Depakote off-label to treat tonic-clonic seizures, her reason for use.  Id. at 8.  So defendant moved to exclude evidence of other alleged off-label marketing activities that plaintiff wanted to use as evidence of a “nationwide scheme.”  The court agreed with defendant that promotion related to conditions other than one at issue in the case was irrelevant.  Id. at 9.  That same reasoning applied to evidence related to defendant’s plea, settlement, and agreement reached in an entirely different case.  Id. at 8.  The other case was an enforcement action regarding alleged off-label promotion of other uses.  In addition to finding this evidence irrelevant, the court found the probative value was significantly outweighed by unfair prejudice, jury confusion, and wasting time.  Id. at 8-9.  The court also more generally excluded evidence of other lawsuits, claims or investigations.  Id. at 12.
  • Duty to conduct post-marketing studies excluded.  This sounds more like a summary judgment topic, but the in limine motion went to whether plaintiff could offer evidence that defendant had a duty to conduct a specific post-marketing safety analysis; in this case a pregnancy registry.  The court said no, but.  Here the but is that plaintiff’s experts could opine that creating a pregnancy registry was something defendant could have done, just not something it was required to do.  Id. at 10-11.
  • New FDA labeling requirements excluded.  In 2014, the FDA changed its requirements to remove the use-in-pregnancy ratings from all prescription drugs.  Since plaintiff used the drug when the ratings were required, evidence about the new regulations is irrelevant.  Id. at 14-15.
  • Plaintiff’s personal information is relevant.  Plaintiff moved to exclude various pieces of personal information from the trial.  For instance, plaintiff wanted to exclude that during her pregnancy she used phenobarbital, she smoked, and she was the victim of domestic abuse.  Id. at 20, 22.  The court ruled all were appropriate areas of cross-examination of plaintiff’s experts regarding alternative causation.  Plaintiff also wanted to exclude evidence of her medical history and specifically her use of Depakote through four prior pregnancies.  This evidence the court found was relevant to plaintiff’s knowledge of the risks of birth defects associated with Depakote.  Id. at 21.

Not all the rulings went in favor of defendant.  The court was more generous if it believed the evidence went to defendant’s knowledge during the relevant time period.  So, for instance, defendant’s motion to exclude foreign labeling was denied because it was relevant to what Abbott knew at that time.  Id. at 6-7.  For the same reason, the court was unwilling to exclude all promotional materials which defendant argued were irrelevant because the prescribing physician testified that she did not recall any sales representatives or any promotional activities.  Id. at 9-10.  See also id. at 19-20 (allowing evidence regarding off-label promotion of the condition for which plaintiff was prescribed).

The continued paring down of this case is good news and makes us hopeful that more good news is still to come.