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.

We have blogged before about the Mirena IUD litigation. Cases alleging injuries from device migration and uterine perforation were centralized in an MDL in the Southern District of New York, but, as we reported here, summary judgment was granted for the defendants in all of those cases when Daubert motions disposed of the plaintiffs’ causation experts.  There is another group of Mirena plaintiffs, this time alleging that Mirena caused them to develop idiopathic intracranial hypertension (“IIH”), a serious brain disorder marked by increased pressure in the brain and central nervous system.

Exactly one published study has ever linked Mirena to IIH. The lead author was Mahyar Etminan, Pharm. D. – much more about him in a minute.  You can read the Etminan article here. The Etminan article reported the results of two analyses:  an epidemiological study and an analysis of adverse events reported in the FAERs database.  The epidemiological study – that is to say, the unbiased statistics – did not demonstrate an increased risk of IIH associated with Mirena use when compared to combined oral contraceptives.  But the article reported that the FAERs analysis demonstrated a higher-than-expected proportion of IIH reports with Mirena as compared to all other products in the FAERS database.  (We’ve devoted an entire post (and cheat sheet) to why adverse event reporting doesn’t, and can’t, demonstrate causation.)

The Etminan article was published in 2015 and included a standard “no conflict of interest” statement. In the ensuing months, Mirena IIH plaintiffs in a half-dozen district courts disclosed their experts.  Among them was none other than Mahyar Etminan, who, it turns out, had been on plaintiffs’ payroll all along in a blatant conflict of interest not disclosed in his article.  Etminan, along with three other causation experts, cherry-picked the results of the FAERs analysis to allege a causal relationship between Mirena and IIH but never dealt with the conflicting epidemiological data from the same article.

And it gets even better.   In December 2016, Etminan executed an affidavit, which you can see here.  In it, Etminan explained that the methodology of the FAERs analysis was flawed and did not support its conclusion.  Specifically, in comparing the proportion of IIH reports among Mirena users with the proportion among non-users in his FAERs analysis, Etminan failed to limit the comparator groups to women of reproductive age.  Because women of reproductive age have a higher background incidence of IIH than other age groups, failing to limit the comparator groups to these women introduced a bias against the Mirena group.  When the analysis was re-done with the correct comparator groups, the affidavit explains, the results did not support a claim that Mirena increases the risk of IIH.

And so Etminan, the source of the only published study claiming that Mirena causes IIH, publicly renounced his published conclusions. (Earlier, when the flaws in the FAERs analysis came to light, Etminan withdrew from the seven cases in which he’d been named as an expert.)  We don’t know that we have ever seen anything like this in all of our days litigating mass torts.  And we love watching the collapse of a house of cards erected on a foundation of paid (and undisclosed) advocacy.

But the story isn’t over yet. None of plaintiffs’ other causation experts – all of whom also relied on Etminan’s published FAERs analysis – has yet withdrawn.  And, just days ago, IIH cases were centralized in an MDL in the Southern District of New York.  (Plaintiffs had sought such an MDL in 2014, but the JPML rejected that request.)  Regular blog readers are familiar with our views of many MDL plaintiffs and their lawyers, spawned during countless hours fighting hordes of meritless claims that MDL judges allow to remain pending.  By rights, with no evidence of causation, plaintiffs should be out of court.  And, certainly, some threshold determination of merit should precede the formation of an MDL.  But mass torts exist for the masses, who queue up for settlement handouts that don’t depend on meritorious claims.  Can the new IIH MDL proceed very far down the litigation path when the plaintiffs’ causation claim has been debunked by its primary supporter?  Back in November, we learned never to say never.  So stay tuned.

Doctors warn patients and decide which warnings to give. Manufacturers warn doctors and, if a particular doctor already knows a particular risk, it doesn’t even matter—in a court room, that is—whether the manufacturer warned the doctor. That is the interplay between the learned intermediary doctrine and the proximate causation element of a failure to warn claim.

And, in Tomaselli v. Zimmer, Inc., 2017 WL 1011492 (S.D.N.Y. Mar. 15, 2017), they came together to hand summary judgment to the defendant manufacturer and distributor. The doctor in Tomaselli surgically implanted a hip repair device into one of his patients to repair the patient’s greater trochanter, part of the femur bone near the hip. Later, one of the device’s cables unwound while inside the patient so that it was laying alongside her femur, causing her some level of pain. The doctor discovered this but, ultimately, recommended to the patient that it not be removed. Thereafter, the patient and her husband sued the manufacturer, the distributor and other defendants.

But they ran into a problem, something that usually isn’t a problem unless you’re in a court room asserting a failure to warn claim. The doctor was very experienced. He had performed more than 5,000 hip surgeries over the course of a 30-year career. He knew things. And one of the things he knew was that cables in hip repair devices can fail:

Based on his experience. . . Dr. Nercessian testified that cable breakage is “a known risk of any wire, any cable,” and that cables tend to break “[b]y reaching and exceeding the maximum fatigue strength of the metal.” Asked whether a cable implanted to repair a greater trochanter fracture may break if the fracture fails to fully heal—a so-called “nonunion”—Dr. Nercessian replied, “Definitely.”

Id. at *1 (citations omitted).

So this doctor knew the risk. That meant that, for purposes of the plaintiffs’ failure to warn claim, it didn’t matter whether the manufacturer had warned the doctor. He already knew. Moreover, this doctor chose, for whatever reason, not to warn this patient about that risk. That didn’t matter either. The doctor’s knowledge of that risk, whether he chose to convey it to his patient or not, cut off proximate causation. Here is the court laying out these principles under New York law:

Under the “informed intermediary” doctrine, a manufacturer “discharges its duty by providing the physician with sufficient information concerning the risks of the device.” Moreover, “where the treating physician is independently aware of potential adverse events, that knowledge is an intervening event relieving the manufacturer of any liability to a patient under the failure to warn theory.” “A physician’s existing awareness of a potential risk or side effect thus severs the causal chain between an allegedly inadequate warning and a plaintiff’s injury.”

Id. at *3 (citations omitted). And, finding no proximate causation, the court granted summary judgment to the manufacturer and distributor on plaintiffs’ failure to warn claim.

A couple of months ago, we reported on the magistrate’s report and recommendation in this case to grant summary judgment against all plaintiff’s claims, which included her failure to warn, design defect and warranty claims. At that time, we seriously doubted that plaintiff would object to the report and recommendation. It was so well-reasoned. You can read our discussion of that report, which was much more detailed, here. As it turns out, plaintiff did object, but only to the failure to warn recommendation. And, as it also turns out, we were right. The report and recommendation was well reasoned. With this decision, the district judge adopted the magistrate’s “thorough and well-reasoned Report in its entirety.”  Id. at *4.  And, now, we can be virtually certain that this is the last we will hear of this case.

 

We have posted several times in the last few years (like here, here, here, and here) about cases alleging birth defects from maternal SSRI use during pregnancy.  Perhaps because of the inherent sympathy for the plaintiff (offspring), it seems that plaintiffs in birth defect cases get extra chances to prove that have enough science to support their claims.  Science in this area is undoubtedly complicated.  For one thing, while ontogeny does not always recapitulate phylogeny, fetal development of placental mammals (of which humans are a relatively recently evolved species) varies, so extrapolation from animal studies on teratogenic effects is even harder than with studies of direct effects on animals.  For another, ethical considerations generally preclude prospective clinical trials designed to study teratogenic effects.  FDA’s treatment of drug labeling on the risks of teratogenic effects has reflected some of this dynamic.

Litigations pursuing birth defect claims seem to follow their own dynamic.  Despite the oft-cited caution from Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 319 (7th Cir. 1996), that “the courtroom is not the place for scientific guesswork, even of the inspired sort.  Law lags science; it does not lead it,” it often seems like cases are pursued before there is science to support them, particularly if specificity of drug, dosage, and injury is going to be required.  This may be due to the impact of statutes of limitations.  It may also be because some courts are lenient on admissibility of causation evidence and there can be years from filing a case a case until Daubert (or equivalent) motions are decided.  Another dynamic seems to be that the only proof as to whether the plaintiff’s mother took the drug during the relevant time can be her word, unless the plaintiff’s expert can argue that the birth defect can itself count as proof of exposure.  We also sometimes see that general causation can be a harder concept for courts to understand than it should be.

Looking through our particular lens, we see all of this in K.E. v. Glaxosmithkline LLC, No. 3:14-cv-1294(VAB), 2017 U.S. Dist. LEXIS 13705 (D. Conn. Feb. 1, 2017), a case that came to the correct result—causation opinions excluded—but took an overly charitable route in arriving there.  The case alleged that maternal use of the defendant’s SSRI during the first trimester of her pregnancy with plaintiff in 2001 caused him to develop a bicuspid aortic valve and accompanying regurgitation.  The plaintiff was diagnosed with a bicuspid aortic valve in September 2010 (after evaluation following his father’s diagnosis with his own heart condition), by which time the drug’s label had been revised to reflect the pregnancy category D—“adverse reaction data from investigational or marketing experience or studies [of the drug] in humans”—and the manufacturer had sent a dear healthcare provider letter describing the basis for the change. Id. at **16-18.  The purported prescribing physician testified that he would not have prescribed the drug to a patient whom he suspected was pregnant or recommended it for a pregnant woman based on the label as it was in 2001. Id. at **16-17.  We say “purported prescribing physician” because he denied prescribing the drug to plaintiff’s mother until after the plaintiff was born, which is what his records and pharmacy records—but not plaintiff’s mother’s testimony—showed. Id. at **9-12.  More on that later.  After the bicuspid valve diagnosis, plaintiff’s records suggested that his mother had used the drug during pregnancy and his mother—plaintiff was still a minor—thought that there was a relationship.  This was reinforced by a lawyer advertisement on television trolling for plaintiffs and she contracted and signed up with a law firm to pursue a lawsuit over plaintiff’s bicuspid aortic valve by September 2011. Id. at **18-19.  Even though the statute of limitations in Connecticut for claims like this was two years, plaintiff waited until late July 2014—close to four years after the diagnosis—to sue.  Within a year—pretty fast for such cases—the manufacturer moved to exclude plaintiff’s sole causation expert and for summary judgment on statute of limitations, lack of causation, and other problems with plaintiff’s proof.  The decision we are discussing followed more than eighteen months later.

Continue Reading Unreliable Expert Causation Evidence Ends Birth Defect Case

Last week’s Westlaw search (that’s one way we find the cases we discuss in the Blog) brought a blast from the past – a case almost three years old showed up discussing – and rejecting – expert testimony about so-called “regulatory causation.”  Since we’d only touched upon this type of expert opinion once, we thought we’d take a more in-depth look at this concept.

The first thing we discovered is that “regulatory causation” apparently was invented by the ubiquitous Suzanne Parisian, largely for use in the now-mostly-concluded Aredia/Zometa litigation.  That theory was an attempt to dumb down the usual common-law requirements for both causation (ordinarily “more likely than not”) and expert certainty (a “reasonable degree of medical” either “certainty” or “probability” depending on the jurisdiction).

As we described in more detail, here, the FDA, being a regulatory agency, is able to intervene prophylactically, before actual harm takes place, in order to prevent such harm.  Thus, the FDA is not bound by common-law causation or expert standards in deciding when a warning should appear on the label for a drug or device.  And the Agency doesn’t.  Instead, its regulations governing label changes state the new warnings should be added “as soon as there is reasonable evidence of a causal association [of a risk] with a drug; a causal relationship need not have been definitely established.”  21 C.F.R. §201.57(c)(6)(i).  That’s for drugs approved after mid-2001.  For some older drugs (without an update since 2001), the standard is similar, although the words vary:  “as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved.”  Id. §201.80(e).  See In re Incretin-Based Therapies Products Liability Litigation, 142 F. Supp.3d 1108, 1120 (S.D. Cal. 2015) (describing how these regulations work).  For medical devices, the equivalent standard is harder to locate, since the FDA’s “labeling” regulations for devices does not address when to change a label.  For PMA devices a standard of sorts – “reasonable evidence of a causal association” – in the CBE provisions applicable to such devices.  21 C.F.R. §814.39(d)(2)(i).

Continue Reading “Regulatory Causation” Roundup

For those of us who spend large chunks of our professional lives in mass tort MDLs, expressions like “settlement inventory” are ubiquitous. It is too easy to lose sight of the fact that these expressions put the rabbit in the hat, assuming that resourceful plaintiff lawyers will necessarily queue up for settlement payments at the end of the day and disregarding the fact that plaintiffs are supposed to be able to prove injury and causation before money changes hands.  And so we were especially pleased to read last week’s decisions in the Lipitor MDL, in which the  cautious and relentlessly thorough MDL  judge granted defendant Pfizer’s omnibus summary judgment motion, dismissing all but a single newly-filed case, because the plaintiffs could not meet their burden of proving that Lipitor caused their diabetes.  (There are two decisions relating to different dosages of Lipitor.  You can read them here and here.)

The Lipitor MDL, created in February 2014, centralized cases in which female plaintiffs alleged that Lipitor – prescribed in dosages of 10 mg., 20 mg., 40 mg., and 80 mg. – caused them to develop Type 2 diabetes.  In March and April of 2015, as trials of two bellwether cases approached, the plaintiffs served common expert disclosures of general causation experts, followed, in May and June, 2015, by specific causation expert disclosure in the two bellwether cases.  After full expert discovery, Pfizer moved to exclude all of these experts.  Ultimately, the court excluded the plaintiffs’ expert testimony on general causation with respect to Lipitor dosages of 10, 20, and 40 mg.  The court  also excluded the testimony of the bellwether plaintiffs’ specific causation experts, finding that the experts failed to rule out other possible causes of diabetes and relied impermissibly on temporal relationships, and granted summary judgment  for Pfizer on the claims of both bellwether plaintiffs.  (You can read our posts on these Daubert decisions here and here.)

However, the court left one general causation “window” open, based on one study finding that it was more likely than not that patients with certain characteristics who took 80 mg of Lipitor would not have developed diabetes in the absence of Lipitor. Thus, though neither of the bellwether plaintiffs had the requisite characteristics, it was possible that a plaintiff existed who took Lipitor at the 80 mg dosage and who could proffer a specific causation opinion that would survive Daubert.

Continue Reading Lipitor MDL Court Grants Pfizer’s Omnibus Summary Judgment Motion: No Evidence of Causation

This is a guest post from Michael Salimbene, an associate at Reed Smith.  It’s about learned intermediary causation, and the need for prescriber testimony.  Not infrequently, in mass torts with lots of solicited plaintiffs, the other side puts off doing anything, including preserving prescriber testimony, for as long as possible.  If the prescriber dies or disappears, plaintiffs don’t have any causation testimony, and since they bear the burden of proof, that’s a problem for them.  The guest post describes the latest example.  As always our guest poster deserves 100% of the credit (it’s not our work), and any blame, for what follows.

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This guest blogger lives just outside of Philadelphia. In this neck of the woods, the post-holiday, pre-Spring window is perhaps the most universally loathed time of year.  It’s filled with grey skies and frigid winds.  Partner in-office attendance, which tends to wane during the summer months and late December, hits its yearly high.  The all-important billable hour “clock” resets to 0.  Street corner sales of unlicensed Carson Wentz tee shirts have stalled, and playoff football will feature two of Philadelphia’s most hated rivals, the Giants and the Cowboys.  Your children, if anything like this guest blogger’s, will ignore the Frozen-themed electric car that “Santa” left (but took you 4 hours to assemble) in favor of a $6 pair of pink bunny slippers.  So for today’s post, in search of some good news, we travel to the Middle District of Georgia where the temperature hovers just above 60 degrees.  In a few short months, Northeasterners will also be enjoying warm skies and Georgia’s finest offering, The Masters.  Until then, we’ll have to make due with favorable warning-causation decisions like this one.

Today’s case comes to us from the Mentor Corp. Obtape Transobturator Sling Products Liability Litigation MDL in the Middle District of Georgia. In re Mentor Corp. ObTape Transobdurator Sling Prods. Liab. Litig., No. 4:13-cv-229, 2016 WL 4611572 (M.D. Ga. Sept. 2, 2016).  We’ve blogged about this MDL quite a bit (recently here, here, and here).  As were most plaintiffs in the ObTape litigation, this plaintiff’s prescribing surgeon treated her for a form of incontinence with the relevant device.  If you’ve watched daytime TV in the past 5 years, you’ll be familiar with the typical list of complaints that undergird vaginal mesh lawsuits:  mesh “erosion” or “extrusion” (movement of the mesh material into surrounding tissue); “dyspareunia” (painful intercourse); and the need to have additional surgery to correct mesh-related complications, to name a few.  Plaintiff never had her mesh removed, but alleged, among other things, that the product caused her to suffer from chronic pain.  So what makes this case different from the thousands of other mesh cases pending across the nation?  Plaintiff’s implanting physician died before he could testify in her case.

Continue Reading Guest Post – Failure to Warn Claim Dead on Arrival Without Testimony from Prescribing Physician

What follows is a guest post about a recent favorable decision in Canadian drug/device litigation.  Unlike in the USA, product liability class actions cases are often certified in Canada.  Thus, any pro-defense decision is good news indeed.  Robin Linley and Jessica Lam of Blake, Cassels & Graydon LLP in Toronto have been good enough to provide us what they call a “brief and selective summary” of Wise v. Abbott Laboratories Limited, No. CV-16-550747CP, 2016 ONSC 7275 slip op. (Ont. Super. Nov. 23, 2016), which in typical Canadian fashion, takes 85 pages to reach a result that our clients will like.  As always, our guest posters are 100% responsible for their content, and thus entitled to 100% of the credit or blame, as it may be, for what appears below.

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In a recent product liability class action decision, Wise v. Abbott Laboratories Limited, No. CV-16-550747CP, 2016 ONSC 7275 slip op. (Ont. Super. Nov. 23, 2016) (“Wise“), the Ontario Superior Court of Justice (“Court”) granted the defendants’ motion for summary judgment in advance of the certification motion, concluding that there was no genuine issue requiring a trial because there was insufficient evidence of general causation.  The decision highlights the potential for defendants to use summary judgment to resolve a class action before certification in appropriate cases.

The representative plaintiff brought a proposed class action against Abbott alleging that its testosterone replacement product, for the treatment of hypogonadism (testosterone deficiency) in men, caused serious cardiovascular (CV) events.  The plaintiff further alleged that the drug had no therapeutic benefit and that class members should be compensated for their economic losses incurred in purchasing the product. The plaintiffs also sought recovery from the defendant based on allegations of failure to warn and the novel claim of “waiver of tort”.

Abbott submitted that the plaintiff’s claims should be dismissed on the grounds that they could not prove general causation, which was a constituent element in all of the plaintiff’s product liability claims, and that ultimately, there was insufficient evidence of a “genuine issue requiring a trial”.

Continue Reading Guest Post – Ontario Court Decision Highlights Summary Judgment as a Potential Tool in Class Proceedings North of the Border

It is always nice to win a case, whether by motion or trial. But just in terms of pure exhilaration, it is hard to beat hearing the jury foreperson announce that, after a hard-fought trial, you win. But note that term “hard-fought.” Most trials really are hard. They really are expensive. They really are stressful. The road to even the most resoundingly wonderful verdict probably had a couple of nasty potholes. That was the case with Horrillo v. Cook Inc., 2016 U.S. App. LEXIS 21026 (11th Cir. Nov. 23, 2016). Prior to trial, there was at least one Daubert ruling that couldn’t have pleased the defense. Also, as reported by our friends in the Abnormal Use blog, there was a learned intermediary ruling that we do not like one bit. But all’s well that ends well, right?

In Horrillo, the plaintiff brought a product liability action on behalf of his deceased mother, who had undergone a surgery to clear her renal artery. The surgery went terribly wrong, as the patient sustained a stroke. The opinion also does not tell us whether the plaintiff ever sued the doctor. The surgeon used a stent manufactured by the defendant. That stent was designed for use in bile ducts, but the surgeon used it off-label in this case. That off-label use was apparently not all that uncommon. The plaintiff’s legal theories included negligence and negligent failure to warn, strict products liability and strict failure to warn, and breach of warranty. After a nearly four-week trial, the jury returned a verdict in favor of the defendant. The plaintiff then moved for a judgment notwithstanding the verdict, or, in the alternative, a new trial. The trial court denied those motions, and the plaintiff appealed to the 11th Circuit. Applying the appropriate standards of review, the 11th Circuit affirmed the trial court’s rulings and the defense verdict.

Continue Reading 11th Circuit Upholds Stent Defense Verdict

Bexis, who took some lumps in probably the worst Wisconsin product liability decision ever (he filed PLAC’s amicus brief in Thomas v. Mallett, 701 N.W.2d 523 (Wis. 2005)), just read what we believe is the best Wisconsin law decision ever – at least in the drug/medical device sandbox that we inhabit. The decision is In re Zimmer Nexgen Knee Implant Products Liability Litigation, 2016 WL 6135685 (N.D. Ill. Oct. 21, 2016) (since the caption is a mouthful, we’ll call it “ZNKI“).

Here’s why ZNKI is favorable on Wisconsin legal issues.

First, as our longstanding 50-state survey on the learned intermediary rule points out, Wisconsin is one of nine states in which only federal courts predicting state law have had occasion to adopt the learned intermediary rule.  Looking more closely at these nine, Wisconsin is one of only two states (South Dakota being the other) where only federal district courts have reached this holding.  What isn’t there, but is discussed in ZNKI, is that some courts have (without much reasoning) refused to predict Wisconsin’s adherence to the rule.  Refusing to dodge the issue, ZNKI forthrightly examines both Wisconsin precedent and the general state of the law and concludes that Wisconsin would join the nationwide learned intermediary consensus:

[F]ederal courts applying Wisconsin law have reached different conclusions about the doctrine’s applicability.  The vast majority of states, however, do employ some version of the doctrine.  In addition, this court’s research suggests that those courts that have declined to apply the doctrine under Wisconsin law have done so in cases involving prescription drugs, not medical devices, and those courts offer no reason to believe that the Wisconsin Supreme Court would not adopt this majority rule if presented with the issue.

In the context of . . . surgery, a patient must rely on the experience and judgment of his or her surgeon, who selects the appropriate implant and educates the patient about the particular risks − based on the patient’s particular circumstances and physiology. . . .  Given that context, and given the widespread acceptance of the doctrine throughout the country, the court believes it is likely that the Wisconsin Supreme Court would apply the learned intermediary doctrine in this case.

ZNKI, 2016 WL 6135685, at *19-20 (numerous citations omitted).  As we’ve pointed out recently, the learned intermediary rule is, if anything, enjoying a renaissance, with thirteen straight state high court adoptions since the infamous Karl case (since overruled by statute) was the only supreme court to go the other way.

Continue Reading Probably the Best Wisconsin Law Decision We’ve Ever Seen