Friday, October 09, 2015

Three Strikes and Out of Court for Breast Implant Opt-Out

Over the weekend, we watched one of our favorite “chick flicks,” a holiday-themed montage entitled “Love, Actually.”  One of our favorite characters, played by the ever-brilliant Bill Nighy, is an over-the-hill former pop star who resorts to superimposing cheesy holiday lyrics on a familiar melody in an (ultimately successful) attempt to manufacture one last comeback.  A disc jockey, hearing this effort for the first time, exclaims, “How the mighty have fallen!”  This crossed our mind as we read today’s case, a decision on Daubert motions in a leftover breast implant case.

Twenty-some years ago, we cut our Drug and Device teeth on breast implant litigation, arguing motions in the infant Mass Tort Program in Philadelphia  Back then, the high-profile litigation, involving claims that breast implants caused serious auto-immune diseases in recipients, commanded high levels of attention and resources and produced some landmark verdicts.  Now, with the vast bulk of the litigation long settled, key defendants in bankruptcy, and many of plaintiff’s claims resoundingly debunked, all that remains are isolated opt-outs, like In re Dow Corning, Corp., Ezra v. DCC Litigation Facility, Inc., 2015 WL 5737997 ( E.D. Mich. Sept. 30, 2015), a primer on Daubert’s raison d’etre.
Plaintiff in Ezra claimed that her silicone gel implants caused

muscle aches and pains all over her body; metallic taste in the mouth; chronic problems with diarrhea; dizziness/vertigo problems; chronic low-grade fevers; frequent yeast infections; chronic fatigue; severe headaches; loss of taste and smell; memory loss and loss of concentration; frequent gastrointestinal problems; sinus problems with ear aches; difficulty swallowing; problems with choking; easily bruised with slow healing of bruises and cuts; spider veins on legs and feet; coldness of hands, fingers, feet, toes and face; muscle spasms; problems with rashes; tingling and numbness in extremities; difficulty breathing; unexplained dental problems; excessive hair loss; as well as emotional, physical and financial losses.

Ezra, 2015 WL 5737997, at *1.   She proffered the testimony of three causation experts, and defendant moved to exclude all three. 

The first, retained one week before the expert deadline “only after a plaintiff in a companion case located him through Internet searches,” id. at *3, was according to Defendant, “a part-time internal medicine doctor who has divided his workload into four roughly equal parts: internal medicine practice; prescribing the synthetic opiate Suboxene to drug users; conducting social security exams and drafting reports; and testifying as a paid expert witness in a wide range of cases, many involving drug and alcohol intoxication issues.” Id.  Thus, according to Defendant, the expert was not qualified to render opinions on breast implants or autoimmune diseases.  Moreover, Defendant argued, the expert’s opinion that “silicone could cause disease in certain genetically predisposed persons,” id., was pure ipse dixit and was not the result of any reliable methodology.  Defendant pointed out that the expert’s report contained “no discussion of autoimmune disease, no independent analysis regarding how or why plaintiff's conditions constitute autoimmune diseases and no reference to any texts, treatises, or authorities regarding autoimmune diseases, . . . [and that he admitted]  to performing no research on the issues of whether silicones are capable of causing rheumatoid arthritis or any other type of autoimmune disease or symptoms and has not published any papers on the topic.”  Id.

In opposition, Plaintiff argued that the expert had “extensive 35-year-experience as a physician,” id., and, though he had “conducted no research studies on the issue of silicone and autoimmune disease,” this did not bar him from testifying at trial.  Id. 

The court agreed – resoundingly – with the defendant, holding that the expert: 1) was not qualified to offer his opinions (“Other than his deposition testimony that he has diagnosed people with autoimmune diseases, he has not established his knowledge or training as to autoimmune disease, specifically whether breast implants or silicone gel causes such diseases.”); 2) employed no reliable methodology (“There was no causation analysis in [the expert’s] report, other than a summary of [plaintiff’s ] medical history.”); and 3) would not assist the trier of fact, since, again, it lacked any causation analysis.  Id. at 4.   As such, the court excluded the expert’s testimony in its entirety.

Plaintiff’s other experts fared no better.  Her rheumatologist submitted a “one-page report, competed within two hours,” in which, defendant argued, he rendered opinions that were “contrary to the scientific evidence widely endorsed by the medical and scientific communities [and] based on possibilities, not probabilities.”  Id.  Moreover, as defendant pointed out, the expert “merely assumed, without more, that [the plaintiff] was exposed to silicone gel manufactured by Dow Corning.”  Accordingly, defendant argued, the expert’s opinions lacked reliable methodology and were based on a theory that was pure speculation.”  Id. at *5.  The court agreed, holding that the expert lacked any specialized knowledge in the relevant area of rheumatology, that he “admitted that his report does not set forth any methodology or any analysis or reasoning” and that he simply read the medical records and provided his conclusions, that his opinion could not help the trier of fact “since he cites no support for his opinion.”  Id. at *5-6.  Two down, one to go.

Plaintiff’s third expert, apparently a chemist or “materials science” type (the opinion doesn’t specify) whom courts had “routinely excluded . . . in breast implant litigation,” testified that breast implants “have injurious potential and they degrade and injure.”  Id. at *6.  The court found that, while the expert was “specialized in the field related to chemical properties of silicone gel,” he could not testify about medical causation because, with no medical training, “he would be merely speculating.”   Id.  Strike three.  And, with all of plaintiff’s causation experts excluded, the court granted summary judgment for the defendant. 

For a plaintiff considering opting out of a global settlement, Ezra should serve as a cautionary tale.  Those of us who spend our days representing defendants in mass tort litigation are all too aware that bottom-feeding plaintiffs’ lawyers fill court dockets with cases that lack all merit then wait patiently to be swept along on the settlement train.  But there is safety in numbers.  And “lone holdout” status increases the odds that a court will slam the gates on experts who blatantly fail to meet Daubert’s admissibility standards.  A good (if obvious) decision, and now onto weekend movie time!

Thursday, October 08, 2015

Heedless Heeding Presumptions – How New York Law Became a Morass

Ever since this blog started, we’ve made plain that we have no use for the so-called “heeding presumption.”  This presumption posits that, because under Restatement §402A, comment j, a defendant providing an adequate warning can presume it will be heeded, a plaintiff should also be able to presume that an adequate warning, had it been granted, would have been heeded.  That’s false equivalence if we’ve ever seen it.  A defendant to such a warning claim needs no heeding presumption, since it wins on adequacy without ever getting to causation.  The comment j discussion really involves design defects (about which more below).  Plaintiffs, on the other hand, are getting a burden of proof shift on warning causation that simply has no basis in reality.  People disregard adequate warnings all the time.

So we fight the heeding presumption whenever it comes up.  Some states have good law on the issue.  N.C. G.S.A. §99B-5(a); Wis. Stat. §895.047(1)(e); Ford Motor Co. v. Boomer, 736 S.E.2d 724, 733 (Va. 2013); Rivera v. Philip Morris, Inc., 209 P.3d 271, 274 (Nev. 2009); Leaf v. Goodyear Tire & Rubber Co., 590 N.W.2d 525, 528-29 (Iowa 1999); Riley v. American Honda Motor Co., 856 P.2d 196, 199-200 (Mont. 1993); Deere & Co. v. Grose, 586 So. 2d 196, 198 (Ala. 1991); Huitt v. Southern California Gas Co., 116 Cal. Rptr.3d 453, 467-68 (Cal. App. 2010); Harris v. International Truck & Engine Corp., 912 So. 2d 1101, 1109 (Miss. App. 2005); McPike v. Enciso’s Cocina Mejicana, Inc., 762 P.2d 315, 319 (Or. App. 1988); DeJesus v. Craftsman Machinery Co., 548 A.2d 736 (Conn. App. 1988); Muilenberg v. Upjohn Co., 320 N.W.2d 358, 366 (Mich. App. 1982); Potthoff v. Alms, 583 P.2d 309, 311 (Colo. App. 1978); Payne v. Novartis Pharmaceuticals Corp., 767 F.3d 526 (6th Cir. 2014) (applying Tennessee law); Tuttle v. Lorillard Tobacco Co., 377 F.3d 917, 925 (8th Cir. 2004) (applying Minnesota law); Wilson v. Bradlees of New England, Inc., 250 F.3d 10 (1st Cir. 2001) (applying New Hampshire law); Christopher v. Cutter Laboratories, 53 F.3d 1184, 1192-93 (11th Cir. 1995) (applying Florida law); Odom v. G.D. Searle & Co., 979 F.2d 1001, 1003 (4th Cir. 1992) (applying South Carolina law); Muzichuck v. Forest Laboratories, Inc., 2015 WL 235226, at *13 (N.D.W. Va. Jan. 16, 2015); Luttrell v. Novartis Pharmaceuticals Corp., 894 F. Supp.2d 1324, 1345 n.16 (E.D. Wash. 2012).

Almost as many states are adverse.  House v. Armour, Inc., 929 P.2d 340, 347 (Utah 1996); Coffman v. Keene Corp., 628 A.2d 710, 717-19 (N.J. 1993); Eagle-Picher Industries, Inc. v. Balbos, 604 A.2d 445, 468-69 (Md. 1992); Bushong v. Garman Co., 843 S.W.2d 807, 811 (Ark. 1992); Arnold v. Ingersoll-Rand Co., 834 S.W.2d 192, 194 (Mo. 1992); Butz v. Werner, 438 N.W.2d 509, 517 (N.D. 1989); Harlow v. Chin, 545 N.E.2d 602, 606 (Mass. 1989); Bloxom v. Bloxom, 512 So.2d 839, 850 (La. 1987); Payne v. Soft Sheen Products, Inc., 486 A.2d 712, 725 (D.C. 1985); Wooderson v. Ortho Pharmaceutical Corp., 681 P.2d 1038, 1057-58 (Kan. 1984); Seley v. G.D. Searle Co., 423 N.E.2d 831, 838 (Ohio 1981); Menard v. Newhall, 373 A.2d 505, 506 (Vt. 1977); Cunningham v. Charles Pfizer & Co., 532 P.2d 1377, 1382 (Okla. 1974); Dole Food Co. v. North Carolina Foam Industries, Inc., 935 P.2d 876, 883 (Ariz. App. 1996); Ortho Pharmaceutical Corp. v. Chapman, 388 N.E.2d 541, 555 (Ind. App. 1979).

Since the turn of the century, our team has a definite edge (more on why that is so, below, as well).

A few states, like Pennsylvania, and Texas, are somewhere in the middle – allowing a heeding presumption in some product liability situations, but not for cases involving prescription medical products.  Compare Coward v. Owens-Corning Fiberglas Corp., 729 A.2d 614, 620-21 (Pa. Super. 1999), with Lineberger v. Wyeth, 894 A.2d 141, 145, 149-50 (Pa. Super. 2006); and Technical Chemical Co. v. Jacobs, 480 S.W.2d 602, 606 (Tex. 1972), with Ackermann v. Wyeth Pharmaceuticals, 526 F.3d 203, 212-13 (5th Cir. 2008) (applying Texas law).

And then there’s New York, where the law can charitably be described as a morass.  So how did the law of the Empire State crumble into quicksand?

Well, it’s not a problem with basic warning law.  The New York Court of Appeals is fine on the burden of proof in warning cases generally.  The black letter law, in New York as in most places, is that “[i]n order to prevail at trial in a negligence case, a plaintiff must establish by a preponderance of the evidence that the defendant’s negligence was a proximate cause of plaintiff’s injuries.”  Burgos v. Aqueduct Realty Corp., 706 N.E.2d 1163, 1165 (N.Y. 1998).  “The burden of proof to establish causal negligence is upon the plaintiff.”  Hirsh v. State, 168 N.E.2d 372, 373 (N.Y. 1960).  “It is well settled that a plaintiff must generally show that the defendant’s negligence was a substantial factor in producing the injury to satisfy the burden of proving a prima facie case.”  Wild v. Catholic Health System, 991 N.E.2d 704, 706 (N.Y. 2013).  What’s more, there’s no difference between negligence and strict liability in New York, insofar as warnings are concerned.  “New York views negligence and strict liability claims as equivalent.”  Martin v. Hacker, 628 N.E.2d 1308, 1311 n.1 (N.Y. 1993).

In a bunch of cases, the New York intermediate appellate courts have followed this traditional burden of proof in product liability litigation warning cases.  “[I]n any products liability case, the plaintiff in an action premised on inadequate warnings must prove causation.”  Estrada v. Berkel Inc., 789 N.Y.S.2d 172, 174 (N.Y.A.D. 2005).  “[A] plaintiff whose claim is based on inadequate warnings must prove . . . that if adequate warnings had been provided, the product would not have been misused.”  Banks v. Makita U.S.A., 641 N.Y.S.2d 875, 877 (N.Y.A.D. 1996).  “Plaintiffs had the burden to show that had a different warning been given, this patient would not have used the product that caused her injury.”  Mulhall v. Hannafin, 841 N.Y.S.2d 282, 287 (N.Y.A.D.  2007).  In Reis v. Volvo Cars, Inc., 901 N.Y.S.2d 10 (N.Y.A.D. 2010), the court held that the plaintiff’s “failure to warn claims should have been dismissed because . . . there is no proof in the record that [plaintiff] would have read and heeded a warning had one been given.”  Id. at 13.  Reis followed Sosna v. American Home Products, 748 N.Y.S.2d 548 (N.Y.A.D.  2002), a prescription drug case holding that:

Contrary to plaintiff’s argument, in this state, it remains plaintiff’s burden to prove that defendant’s failure to warn was a proximate cause of his injury and this burden includes adducing proof that the user of a product would have read and heeded a warning had one been given.

Id. at 549.  Accord Santos v. Ford Motor Co., 893 N.Y.S.2d 537, 538 (N.Y.A.D. 2010) (quoting and following Sosna).  See also Menna v. Walmart, 975 N.Y.S.2d 710 (table), 2013 WL 3958247, at *2 (N.Y. Sup. 2013) (plaintiff “must adduce proof that he or she would have read and heeded a warning had one been given”); Zapata v. Ingersoll Rand Co., 959 N.Y.S.2d 93 (table), 2012 WL 3553111, at *11 (N.Y. Sup. 2012) (“under well settled law, to prove proximate cause, a plaintiff has the obligation to adduce proof that had a warning been provided, he or she would have read the warning and heeded it”); Granata v. Sub-Zero Freezer Co., 819 N.Y.S.2d 210 (table), 2006 WL 1358468, at *5 (N.Y. Sup. 2006) (quoting Sosna), aff’d, 841 N.Y.S.2d 469 (N.Y.A.D. 2007); Power v. Crown Controls Corp., 568 N.Y.S.2d 674, 675 (N.Y. Sup. 1990) (“the injured plaintiff must, of course, prove that the inadequacy of the warning was a proximate cause of his injuries”).

Traditional causation also finds support in federal decisions applying New York law.  “A plaintiff proceeding under a failure-to-warn theory in New York must demonstrate that the failure to warn adequately of the dangers of a product was a proximate cause of his or her injuries.”  Bravman v. Baxter Healthcare Corp., 984 F.2d 71, 75 (2d Cir. 1993).

In a failure-to-warn action, a plaintiff bears the burden to prove that defendant’s failure to warn was a proximate cause of his injury and this burden includes adducing proof that the user of a product would have read and heeded a warning had one been given.  In the case of prescription medications, where warnings are directed to prescribing physicians, a plaintiff must demonstrate that had a different, more accurate warnings been given, his physician would not have prescribed the drug in the same manner.

Alston v. Caraco Pharmaceutical, Inc., 670 F. Supp.2d 279, 285 (S.D.N.Y. 2009) (citing Sosna).  Accord McDowell v. Eli Lilly & Co., 58 F. Supp.3d 391, 408 (S.D.N.Y. 2014) (“a plaintiff must demonstrate” that “a different, more accurate warning” would have “changed” the decision to use the product); Hayes v. New York, 2013 WL 5278879, at *15 (N.D.N.Y. Sept. 18, 2013) (“Plaintiff has failed to offer any evidence that even if a different warning had been issued, the user of the product . . . would have read and heeded that warning”); Cuntan v. Hitachi KOKI USA, Ltd., 2009 WL 3334364, at *17 (E.D.N.Y. Oct. 15, 2009) (plaintiff’s burden of proving causation in a warning case “is well settled” law); In re Aredia & Zometa Products Liability Litigation, 2009 WL 2496873, at *2 (M.D. Tenn. Aug. 13, 2009) (“[i]t remains Plaintiff’s burden to prove that defendant’s failure to warn was a proximate cause of her injury, and this burden includes adducing proof that the user of a product would have read and heeded a warning”) (applying New York law).

Still, numerous New York cases have gone south on the heeding presumption.  Union Carbide Co. v. Affiliated FM Inssurance Co., 955 N.Y.S.2d 572, 575 (N.Y.A.D. 2012) (“New York law presumes that users will heed warnings provided with a product”); Power v. Crown Controls Co., 568 N.Y.S.2d 674, 675 (N.Y. Sup. 1990) (“the presumption that a user would have heeded warnings can be rebutted by proof that an adequate warning would have been futile”); Adesina v. Aladan Co., 438 F. Supp.2d 329, 338 (S.D.N.Y., 2006) (“[f]ailure to warn law includes a presumption that ‘a user would have heeded warnings if they had been given, and that the injury would not have occurred’”) (quoting G.E. Capital Co. v. A.O. Smith Co., 2003 WL 21498901 at *5 (S.D.N.Y. 2003)); Henry v Rehab Plus Inc., 404 F. Supp.2d 435, 442 (E.D.N.Y. 2005) (“[i]n New York there is a presumption that a user would have heeded warnings if they had been provided and that the injury would not have occurred”); Santoro v. Donnelly, 340 F. Supp.2d 464, 486 (S.D.N.Y. 2004) (same); Anderson v. Hedstrom Co., 76 F. Supp.2d 422, 441 (S.D.N.Y. 1999) (“New York [follows] a presumption that a user would have heeded warnings if they had been provided, and that the injury would not have occurred”).

What created this split?  We think two things did – and one thing did not.

First, the “did not.”  We can say with some confidence that, unlike most other states, the culprit in New York was not Restatement §402A, comment j.  That’s because New York has never recognized comment j.  The New York Court of Appeals has cited comment j a grand total of one time:  thirty years ago, in a dissent, on a different issue.  See Schumacher v. Richards Shear Co., N.E.2d 195, 202 (N.Y. 1983) (comment j cited concerning a “duty to become and remain aware of . . .  technical developments”) (Jasen, J., dissenting).  Instead of comment j – or §402A strict liability generally – as we’ve already mentioned, in warning cases, New York law treats negligence and strict liability claims as “equivalent.”  Martin, 628 N.E.2d at 1311 n.1.  The relevant tests negligent warnings are found in Restatement (Second) of Torts §388 (1965), which (in stark contrast to §402A, comment j) the Court of Appeals has cited repeatedly, if not particularly recently.  E.g., Sukljian v. Charles Ross & Son Co., 503 N.E.2d 1358, 1362 (N.Y. 1986); Cover v. Cohen, 473 N.Y.S.2d 378, 385-85 (N.Y. 1984); Robinson v. Reed-Prentice, 403 N.E.2d 440, 446-47 (N.Y. 1980).  Notably, neither Restatement §388, nor any of its comments, contains language suggesting a presumption, assumption, or anything of the sort with respect to the reading and heeding of warnings.  Also notably, none of the New York cases relying on a heeding presumption have even suggested that it also applies in negligence, which the logic of Martin would require, if such a presumption actually existed.

Nor is the comment j language from which the heeding presumption originally arose even valid any longer.  Instead, that part of comment j has been expressly repudiated by the American Law Institute (“ALI”) itself.  The ALI, in its more recent Third Restatement of Torts, explicitly rejected the position that products with open and obvious design defects are not “defective” in design because users could be presumed to read and heed adequate warnings of their risks:

The fact that a risk is obvious or generally known often serves the same function as a warning.  However, obviousness of risk does not necessarily obviate a duty to provide a safer design.  Just as warnings may be ignored, so may obvious or generally known risks be ignored, leaving a residuum of risk great enough to require adopting a safer design.

Restatement (Third) of Torts, Products Liability §2, comment l (1998).  It’s no surprise that after the Third Restatement, judicial acceptance of the heeding presumption has essentially ground to a halt outside of those states that had already used comment j to create it.

Comment l’s design-related recognition that “warnings may be ignored” by consumers, as recognized and discussed by the drafters of the Third Restatement, is antithetical to any heeding presumption:

Much of the problem was created by unfortunate language in the Restatement, Second, of Torts § 402A, Comment j. . . .  The Comment j presumption embodies the behavioral assumption that “reasonable” users can be expected to receive, correctly interpret, and obey every comprehensible warning accompanying every product they use or encounter. . . .  [A]lmost all products present substantial risks if improperly manufactured, designed, or used. . . .  People would have to read, understand, remember, and follow innumerable product warnings to protect themselves from all product-related risks they may confront.  Moreover, . . . people must devote some of their limited time and attention to many other types of choices. . . .  [W]arnings should only be used as a supplement to a design that already embodies reasonable safety and not as a substitute for it.

Comment j of the Restatement, Second, is inconsistent with the judicial abandonment of the patent danger rule and with those cases that take the position that a warning will not absolve the manufacturer from the duty to design against dangers when a reasonable, safer design could have been adopted.

Restatement (Third) of Torts, Products Liability §2, Reporters’ Note to comment l, at p. 101 (1998) (emphasis added).  And what do the Third Restatement’s drafters cite for this proposition?  New York law – specifically the abolition of the “patent danger” rule in Micallef v. Miehle Co., 348 N.E.2d 571, 578 (N.Y. 1976) (“the patent-danger doctrine should not, in and of itself, prevent a plaintiff from establishing his case”).  Thus, a comment-j-based heeding presumption would be uniquely antithetical to New York law, not only as to causation in inadequate warning cases, but also with respect to design defects and patent risks.

Now for the “dids.”  In our view the culprits in the creation of the New York heeding presumption morass are, first, the failure of certain courts to appreciate the differences between differing kinds of warning defects; and second one grotesquely distorted prediction of New York law by the Second Circuit – ironically at almost precisely the same time that the Third Restatement was kicking out the comment j jams from the heeding presumption.  See Liriano v. Hobart Corp., 170 F.3d 264 (2d Cir. 1999).

Warning claims can be divided (as can many things, such as New York resident presidential candidates) between substance and optics.  While the law recognizes claims that turn on the conspicuity of warnings, as opposed to their substance, see Martin, 628 N.E.2d at 1312, this type of claim is uncommon compared to allegations that the content of product warnings was absent or inadequate.  Martin, for one, spent one sentence on non-informational warning claims and several paragraphs on informational ones.  Id. at 1311-13.  In conspicuity cases, warning prominence bears directly on causation, and is a way around the otherwise dispositive defense that the actor didn’t read the warning.  Most warning cases, including almost all drug/device warnings (since boxed warning claims are preempted) turn instead on what product warnings actually say.

This distinction was discussed in Johnson v. Johnson Chemical Co., 588 N.Y.S.2d 607 (N.Y.A.D. 1992).  The general rule “in any products liability case, [is that] the plaintiff in an action premised on inadequate warnings must prove causation,” and a plaintiff in a product misuse case can recover only if “he proves that, [with] adequate warnings . . . the product in question would not have been misused.”  Id. at 611.  In a warning “prominence” case, however, that “argument loses its persuasive force”:

A second factor to be considered is the prominence with which such language is displayed. . . .  A consumer such as [plaintiff] who, by her own admission, tends to ignore one sort of label, might pay heed to a different, more prominent or more dramatic label.

Id. (factual examples omitted).

One of the cases Johnson cited, id. at 611-12, is Baker v. St. Agnes Hospital, 421 N.Y.S.2d 81 (N.Y.A.D. 1979), another conspicuity case.  In Baker, a drug case, the plaintiff’s problem was that the substantively adequate warning was typically removed by pharmacists before prescribing physicians received it – a variant of the physician failure to read defense.  The court in Baker let plaintiff get away with an argument that other methods (such as “Dear Doctor” letters) would have been a “more effective means of communicating its warning.”  Id. at 86.  See also LaPaglia v. Sears Roebuck & Co., 531 N.Y.S.2d 623, 628 (N.Y.A.D. 1988) (ignored warning should have been more “prominent”); Hoffman-Rattet v. Ortho Pharmaceutical Corp., 516 N.Y.S.2d 856, 861 (N.Y. Sup. 1987) (product had “allegedly inadequately conveyed updated warnings”); Monell v. Scooter Store, Ltd., 895 F. Supp. 2d 398, 414 (N.D.N.Y. 2012) (“location of the warning was insufficient”); Derienzo v. Trek Bicycle Corp., 376 F. Supp.2d 537, 568-69 (S.D.N.Y. 2005) (warning allegedly “inconspicuous”); Santoro, 340 F. Supp. 2d at 490 (product should have had an “exterior warning”); Anderson v. Hedstrom Corp., 76 F. Supp.2d 422, 441-43 (S.D.N.Y. 1999) (warning should have been “in bold letters on the [product] itself”).  Conspicuity cases, cabined by the language of actually-given warnings, involve none of the rank speculation created by assuming that any allegedly “adequate” language, conveyed at unknown times in unknown ways, would have been heeded.  Indeed,  most conspicuity cases, like Johnson and Baker, do not purport to shift the burden of proof, and thus aren’t really heeding presumption cases at all.

Second, and particularly in federal courts, cases attempting to apply New York law are bedeviled by ill-chosen language in Liriano.  The plaintiff’s case in Liriano lacked any evidence that a warning would have altered the his conduct (sticking his hand in an unguarded meat grinder), but the jury nevertheless returned a plaintiff’s verdict.  Second Circuit also shrugged off the absence of warning causation evidence, with the comment that the traditional burden of proof “rested on a false premise.”  170 F.3d at 271.  Instead, Liriano discovered a factual “inference” that “shift[ed]” the burden of proof:

[Plaintiff] does not bear that burden.  When a defendant’s negligent act is deemed wrongful precisely because it has a strong propensity to cause the type of injury that ensued, that very causal tendency is evidence enough to establish a prima facie case of cause-in-fact.  The burden then shifts to the defendant to come forward with evidence that its negligence was not such a but-for cause.  [Where] . . . the kind of negligence that the jury attributed to the defendant tends to cause exactly the kind of injury that the plaintiff suffered . . ., rather than requiring the plaintiff to bring in more evidence to demonstrate that his case is of the ordinary kind, the law presumes normality and requires the defendant to adduce evidence that the case is an exception.  Accordingly, in a case like this, it is up to the defendant to bring in evidence tending to rebut the strong inference, arising from the accident, that the defendant’s negligence was in fact a but-for cause of the plaintiff’s injury.

Id. at  271 (emphasis added).

Liriano did not mention, let alone discuss, New York Court of Appeals decisions such as Burgos and Hirsh stating that plaintiffs always bears the burden of proving causation in warning cases.  Instead, the Second Circuit cited, as supposed precedent for “shifting” the burden of proof on causation in product liability warning cases, Martin v. Herzog, 126 N.E. 814 (N.Y. 1920), an ancient negligence case involving an accident allegedly caused by nonuse of headlights on a horse-drawn buggy being driven at night.  Liriano did not mention, however, that Martin was a contributory negligence case.  The occupants of the buggy − proceeding without lights after dark − were the plaintiffs, so the burden of proving their negligence rested on the defendant.  126 N.E. at 814.  Martin was thus inapposite to a plaintiff’s burden of proof in routine product liability cases.  The “inference” mentioned in Martin, 126 N.E. at 816, satisfied the defendant’s pre-existing burden of establishing the affirmative defense of contributory negligence.  It did not “shift” that burden in any way.  But even if Liriano had been about contributory negligence, the Second Circuit got it wrong.  “The rule [in contributory negligence cases] does not entitle the jury to presume plaintiff exercised due care at the time of the accident nor does it shift the burden of proof:  plaintiff must still establish a prima facie case.”  Sawyer v. Dreis & Krump Manufacturing Co., 502 N.Y.S.2d 696, 699 (N.Y. 1986).

In suggesting that an “inference” could reverse the ordinary burden of proof, Liriano seriously misread New York law.  Indeed, the New York Court of Appeals has repeatedly complained about precisely this type of holding. “[T]he indiscriminate use of the terms ‘presumption’ and ‘inference’ [has] caused procedural problems.”  Morejon v. Rais Construction Co., 851 N.E.2d 1143, 1146 (N.Y. 2006).  “[A]n ‘inference’ and a ‘presumption’ are not identical in scope or effect.”  George Foltis, Inc. v. City of New York, 38 N.E.2d 455, 462 (N.Y. 1941).

[A] “presumption” is a rule of law attaching definite probative value to a specific fact, as distinguished from an “inference,” which is a permissive conclusion by a trier of the fact, unaided by any rule or theory of law directly applicable.

People v. Hildebrandt, 126 N.E.2d 377, 378 (N.Y. 1955).  Inferences do not shift the burden of proof.  “Permissible inferences, based on specified underlying facts . . . must first be proved before the inference may be drawn.”  People v. Leyva, 341 N.E.2d 546, 552 n.3 (N.Y. 1975).  Most recently, in Zamora v. New York Neurologic Assocs., 970 N.E.2d 823 (N.Y. 2012), that court rejected a supposed causation “presumption” in a workers’ compensation case, holding that the lower court improperly “created a presumption out of an inference” that “would shift the burden of proof,” something for which “[t]here is no precedent in our decisions.”  Id. at 826.

Liriano isn’t even consistent with prior Second Circuit precedent, which recognized that what the plaintiff was trying to pass off as a “heeding presumption” was really nothing more than a permissible jury inference:

[Plaintiff] somewhat misstates the matter by asserting that New York recognizes a “heeding presumption,” but she is correct in contending that in some circumstances, New York permits the trier to infer that a warning would have been heeded and thereby to conclude that the absence of a warning that was reasonably required to be given was a proximate cause of an injury.  Appellee cites no New York decision that refers to a “presumption” of heeding.

Raney v. Owens-Illinois, Inc., 897 F.2d 94, 95 (2d Cir. 1990) (applying New York law); see Topliff v. Wal-Mart Stores E. LP, 2007 WL 911891, at *43 (N.D.N.Y. March 22, 2007) (given Raney, court was “skeptical” of Plaintiff’s characterization of the failure-to-warn law in New York as providing a “presum[ption] that a user would have heeded the warnings if they had been given”).

All those New York federal cases we cited above, which purport to recognize a general heeding presumption, are ultimately dependent upon the erroneous Liriano decision.  They either follow Liriano directly, or else cases such as Anderson, 76 F. Supp.2d at 441-43, that, in turn, relied extensively on Liriano.  See Adesina, 438 F. Supp.2d at 338 (citing Liriano); Santoro, 340 F. Supp.2d at 490 nn. 153-54 (citing Anderson); G.E. Capital, 2003 WL 21498901, at *5 (same); cf. Henry, 404 F. Supp.2d  442 (not citing any New York precedent).

Thus, the current muddle in New York law concerning the heeding presumption is a product of a result-oriented Second Circuit opinion trying to stretch New York law in violation of basic Erie principles.  See, e.g., Travelers Insurance Co. v. Carpenter, 411 F.3d 323, 329 (2d Cir. 2005).  “[E]mbrac[ing] the exhilarating opportunity of anticipating a doctrine which may be in the womb of time, but whose birth is distant” is not the business of federal courts in diversity cases.  Spector Motor Service v. Walsh, 139 F.2d 809, 823 (2d Cir. 1943) (Learned Hand dissenting), vacated, 323 U.S. 101 (1944).  That has combined with an unfortunate tendency of some courts to ignore the difference between warning cases based on substance and those based on conspicuity.  Whatever, the reason, such woolly-headedness does not extend to New York’s highest court, which has firmly stuck to the traditional burden of proof in warning causation cases.  Given the size of the mess that the lower courts have created on this topic, it will probably require the New York Court of Appeals to clean it up.

Wednesday, October 07, 2015

No Error With Comment k Jury Instruction

            As drug and device lawyers we live in a comment k dominated world.  When we say comment k on this blog, everyone knows what we mean.  We aren’t talking about a scientific discovery regarding potassium.  We aren’t reviewing a new flavor of k-cup for the Keurig.  We aren’t posting about breakfast cereals.  And we definitely are not passing comment on the Kardashians, Kobe, Keanu, or K-Fed. 

            But just in case you need a refresher, here is the comment k that concerns us:

Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. . . . Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. . . .  The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.

Restatement (Second) of Torts §402A, comment k (1965) (emphasis added).  As you can see from the highlighted language, comment k recognizes that some products – drugs and medical devices in particular – are “unavoidably unsafe” and therefore not defective if properly prepared and accompanied by an adequate warning.  Most courts to have considered the issue have interpreted comment k to mean that manufacturers do not face strict liability for properly manufactured prescription drugs that are accompanied by adequate warnings.  That is true in Washington.  Young v. Key Pharmaceuticals, Inc., 922 P.2d 59, 63 (Wash. 1996) (under comment k, a prescription drug manufacturer is liable “only if it failed to warn of a defect of which it either knew or should have known . . . it is liable in negligence and not in strict liability”). 

            That is the background against which our case for today is set.  In Payne v. Paugh, 2015 Wash. App. LEXIS 2276 (Wash. Ct. App. Sept. 28, 2015), plaintiff appealed from a jury verdict in favor of Medtronic, the manufacturer of the endotracheal tube used during her tracheal laser surgery.  On appeal, plaintiff claimed that the trial court erred in giving the jury only the comment k negligence instruction and that it should have included a strict liability instruction as well.  Id. at *20-21. 

            It is important to note that at no time before, during or after trial did plaintiff challenge that the comment k negligence standard applied to the design defect claim against Medtronic.  Id. at *8 (confirmed at summary judgment stage); *10-11 (agreed to pre-trial instructions); *41-42 (proposing strict liability instruction as supplement to negligence instruction).   So the instruction that all parties concede was properly given was:

   As to the plaintiff's claim against the Medtronic Defendants, a medical device manufacturer has a duty to use reasonable care to design medical devices that are reasonably safe. "Reasonable care" means the care that a reasonably prudent medical device manufacturer would exercise in the same or similar circumstances. A failure to use reasonable care is negligence.
The question of whether a medical device manufacturer exercised reasonable care is to be determined by what the manufacturer knew or reasonably should have known at the time the device left its control.
In determining what a medical device manufacturer reasonably should have known in regard to designing its device, you should consider the following:
A medical device manufacturer has a duty to use reasonable care to test, analyze, and inspect the products it sells, and is presumed to know what such tests would have revealed.
A medical device manufacturer has a duty to use reasonable care to keep abreast of scientific knowledge, discoveries, advances, and research in the field, and is presumed to know what is imparted thereby.

Id. at *41-42.  Plaintiff’s post-trial argument was that the above jury instruction advises that a manufacturer must use “reasonable care” to design a device that is “reasonably safe,” but then only defines what the jury should consider in determining “reasonable care.”   Plaintiff argued that the definition of “reasonably safe” should come from the strict liability instructions.  Id. at *20-21.  Aha!  So, plaintiff is giving lip service to comment k, but really is asking the court to expand the doctrine to include the more liberal and jury-friendly strict liability standards.  In Washington the strict liability standards for determining whether a product is “not reasonably safe” include both the risk-utility test -- whether a product's risks outweigh the intended benefits -- and the even worse, more subjective consumer-expectation test – whether the device functioned as safely as a reasonable consumer would expect.  Id. at *37-39. 

            Those are standards used to determine whether a product is “not reasonably safe.”  But that is not a decision that needs to be made in a comment k case.  Washington, like so many other states, has already determined that drugs and medical devices are “unavoidably unsafe.  The only question that remains is whether the manufacturer took reasonable care to warn of the known risks that make the product “unavoidably unsafe” in the first place.  Plaintiffs are trying to add on a standard for the jury to decide a question which has already been decided as a matter of law.

            The Washington Court of Appeals agreed that the comment k instruction that was given properly and completely described the duty of a manufacturer of unavoidably unsafe products: 

Under the WPLA and case law, the risk utility and consumer expectations tests are used to determine whether a manufacturer is strictly liable and do not apply to a negligence design defect claim under comment k. And contrary to the assertion of [plaintiff], the Comment K Negligence Instruction addresses the factors the jury should consider in determining whether a medical device manufacturer used reasonable care to design a medical device that is reasonably safe.

Id. at *44. 

            We applaud the appellate court for adhering to the original interpretation of comment k and keeping the focus on the warnings.  Allowing either the risk-utility or the consumer expectation test to creep into prescription drug and device cases is very dangerous.  Permitting the former in the context of an FDA-approved drug or device is tantamount to allowing a jury to toss away the FDA’s conclusion in approving the product that its benefits outweigh its risks.  As for the consumer-expectation test, drugs and medical devices are the epitome of “complex” products as to which an “ordinary consumer” would have no expectations.  That is precisely why plaintiffs are limited to warning defect claims in these cases. 

            Back to other interesting k comments, did you know that potassium is the seventh-most abundant element in the Earth's crust?  Or that Special K has a limited autumn edition flavor --Apple Cinnamon Crunch?   

Tuesday, October 06, 2015

Cymbalta Judge Severs Claims and Smacks Down Plaintiff Lawyers’ Self-Created "Quagmire"

Ninety-nine years ago tomorrow Georgia Tech administered the most lop-sided beat-down in college football history, edging Cumberland University 222-0.  (By the way, who was the head coach of Georgia Tech who presided over that delightful display of sportsmanship?  Find the answer below.)  Today we blog about a legal beat-down, though in this case it is the plaintiff-losers - actually, the plaintiff lawyers - who were the bad sports.  The case involves a firm client, though we were not involved.  There is still an open issue remaining regarding transfer, so we will do our best to resist spiking the ball.  Instead, we will simply gather in the victory formation as we report the court's holding as if we were writing a box-score, sans razzle and dazzle.


The case is Hill v. Eli Lilly & Co., 2015 U.S. Dist. LEXIS 130934 (S.D. Indiana Sept. 29, 2015), and is another step in the saga of Cymbalta plaintiff lawyers who keep pushing the litigation up a hill in an effort to create a class action, mass action, MDL, or whatever will allow them to park as many meritless cases in one place, only to have that litigation roll back down the hill, resulting in crushed toes, directed verdicts, and jury findings of no liability.  The judge in the Hill case saw through the plaintiff shenanigans and granted a motion to sever plaintiffs who had been joined in a transparent and meritless effort to create a mini-MDL.  
Before granting the motion to sever, the judge supplied a bit of background, so we will, too.  Plaintiffs’ counsel, often the very same lawyers, have been filing Cymbalta cases around the country.  There are various claims, but the central allegation is that the warnings regarding withdrawal symptoms were inadequate.  Plaintiffs tried to certify a class in C.D. Cal.  They failed.  Plaintiffs petitioned for creation of a Multi-district Litigation.  They failed.  Plaintiffs' counsel then filed six Cymbalta lawsuit in S.D. Indiana, all but one involving multiple plaintiffs from different states.  Other plaintiffs' counsel pursued the same strategy.  Some plaintiffs who had filed their cases in other federal districts moved to transfer those cases to S.D. Indiana, mostly, though not always, without success.  Then plaintiffs' counsel showed their hand by again seeking creation of an MDL, this time in S.D. Indiana.  If at first you don't succeed, file, file again.


The Hill case included six plaintiffs.  They hailed from South Carolina, Kentucky, Texas, Alabama, Tennessee, and Idaho.  They all took Cymbalta and claimed injuries, but after that their facts were different.  The defendant moved to sever these claims into separate actions and also moved to transfer the cases to the plaintiffs' home states.  Federal Rule of Civil Procedure 20 allows joinder of parties when their claims arise out of the same transaction or occurrence and when there are common questions of fact and law.  Rule 21 governs a motion to sever the different plaintiff claims.  In addition to the issues of whether the claims involve the same transaction/occurrence and common questions of fact/law, severance depends on whether severance would further or hinder judicial  economy, would avoid prejudice, and whether different witnesses and documentary proof would be required for the separate claims.  Remarkably, every factor favored severance.  It might not be 222-0, but it certainly was not a close call.


The court's key holding was that each plaintiff's usage of Cymbalta was a separate transaction.  The plaintiffs argued that all of the cases arose from the same transaction, namely the development of Cymbalta, but that position was "simplistic" and, more to the point, wrong.  The claims were necessarily highly individualized, turning on what their doctors knew, said, and decided.  The Hill court had no difficulty siding with the "consistent reluctance of federal courts to treat products liability claims as arising from the same transaction or occurrence merely because they relate to the same medicine or medical device."  On this basis alone - that the claims arose from separate transactions - severance was warranted.  But the Hill court piled on the points by showing how all the other factors supported severance.  The different plaintiffs' claims depended on different facts pertaining to why they took the medicine, when they took it, what happened, etc.  Those plaintiffs also brought their claims under different state laws.  Further, the particularity of the factual and legal issues in the different plaintiffs' claims suggested that uniform treatment of them was highly unlikely.  So much for the implication that joinder would serve judicial economy.  Then the court flagged the plaintiffs’ lawyers for chutzpah: 


The Court also recognizes that keeping Plaintiffs' claims joined will have little to no positive impact on each Plaintiff, but will be much more convenient for Plaintiffs' counsel. Indeed, Plaintiffs' counsel notes they have filed “hundreds” of Cymbalta-related cases around the country, that there are “thousands of cases within the pipeline,” and the Plaintiffs face a “logistical quagmire.”  But it is really Plaintiffs' counsel that faces a “logistical quagmire,” and it is a quagmire of counsel's own making.  (emphasis in original)



At this point, the plaintiffs' counsel must have started wishing that the defendant's motion to transfer the cases to the home jurisdictions would be granted. 


The Hill court also saw severance as making more sense in terms of avoiding prejudice to the defendant.  Finally, while common, company-oriented discovery was largely done, plaintiff-specific discovery remained, and remained in scattered jurisdictions.  In short, it made no sense to keep the different plaintiffs together in one case.  Accordingly, the court granted the severance motion and ordered the cases to be refiled separately, with every plaintiff save the first required to pay a separate $400.00 filing fee.  (That last point always bothers plaintiffs' counsel quite a lot.  Consequently, we like it.)


The Hill court punted on the transfer motion, noting that the arguments on that issue were premised on the cases being kept together.  Now that the cases were to be severed, it was time to wait and see.  Thus, the court denied the defendant's transfer motion, but without prejudice.  We cannot imagine that the plaintiffs' counsel regards that as anything resembling a win.  We do not know whether this case - sorry, whether these cases -  are in the third quarter, fourth quarter, or final two minutes, but we are confident that the plaintiffs are losing big-time.


(And who was that Georgia Tech coach who ran up the score so brutally?   None other than John Heisman, whose name adorns college football's most hallowed trophy.  Heisman also graduated from the University of Pennsylvania Law School, where we teach a class.  And, yes, we definitely teach our students to run up the score.)


(We cannot leave off without citing another piece of college football beat-down history.  Only once in the last 50 years has a college team scored 100 points against a major program.  That was the Houston Cougars, who on November 23, 1968 prevailed over Tulsa 100-6.  On the roster for the losing Tulsa squad was a fellow who later became a successful jury consultant and even more successful TV celebrity:  Dr. Phil.  He has referred to this particular game as a lesson in adversity.  The triumphant Cougars squad had several folks who went on to achieve success in various fields.  For example, Wade Phillips was a linebacker on that team, and he has had a long, fine career as an NFL coach.  It is important to understand that the Cougars did not try to embarrass Tulsa, at least not too much.  The starters were benched after things got out of hand, but the substitutes kept scoring.  One defensive back was put in as a receiver, and even he managed to reel in a touchdown pass.  That was Larry Gatlin, who attained stardom, not on the professional gridiron, but on the country music stage.  Gatlin caught that td pass from the back-up quarterback.  The starter had been pulled.  Perhaps you have heard of that starting quarterback.  His name is still on a number of school records, which is remarkable considering the amazing list of quarterbacks who came out of the Cougars’ program.  Anyway, he would later become one of the most formidable plaintiff attorneys in the country.  At least once or twice, we have felt like he thumped us by 100 points.   His modesty keeps us from naming him, though it is easy enough for you to look it up.) 



Monday, October 05, 2015

Another Decision Applying Bartlett Preemption to All Drugs

Just last month we collected all the favorable precedent applying impossibility preemption under Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), to innovator drugs – although the precise subject of that post was preemption of design defect claims involving §510(k) medical devices.  We were aware of four such rulings, all in the last year or so:  Yates v. Ortho-McNeil Pharmaceutical, Inc., 76 F. Supp.3d 680, 686-88 (N.D. Ohio 2015); Shah v. Forest Laboratories, Inc., 2015 WL 3396813, at *5 (N.D. Ill. May 26, 2015); Booker v. Johnson & Johnson, 54 F. Supp.3d 868, 874-75 (N.D. Ohio 2014); Amos v. Biogen Idec, Inc., 28 F. Supp.3d 164, 168-69 (W.D.N.Y. 2014).

We think the argument that Bartlett intended for implied impossibility preemption extend to all drugs – generic and innovator – is painfully obvious.  The Court in Bartlett went out of its way to state, “[o]nce a drug − whether generic or brand-name − is approved, the manufacturer is prohibited from making any major changes to the ‘qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications.’”  133 S. Ct. at 2471 (quoting 21 C.F.R. §314.70(b)(2)(i)) (emphasis added).  After all, why else would the Court have specifically mentioned “brand name” drugs if not to indicate that the same preemptive logic included them?

Yet another court has now agreed.  Readers may recall that not too long ago we posted about a 95% favorable opinion in Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015).  In that opinion, as we discussed, the court granted summary judgment against design defect claims on the ground that plaintiffs had no alternative design as required by Ohio law.  Id. at *27-28.  Well, the plaintiffs sought reconsideration, and in a classic case of “be careful what you ask for,” received it.  See Rheinfrank v. Abbott Laboratories, Inc., No. 1:13-cv-144, slip op. (S.D. Ohio Oct. 2, 2015).  Rather than parse through the plaintiffs’ attempt to obfuscate the facts concerning the basis (or lack thereof) for the design defect claim, the court instead held that claim preempted, a defense argument that had not been reached the first time around:

[E]ven if the Court did misconstrue Plaintiffs’ burden of coming forward with evidence of an alternative design, there is no error in outcome.  As noted above, the Court did not fully consider Defendants’ preemption argument in ruling on the design defect claim. . . .

In their motion for summary judgment, Defendants argued that Plaintiffs’ suggestion that [the manufacturer] could tweak the Depakote molecule to make it safer . . . is preempted under Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466, 2471 (2013).  The Supreme Court in Bartlett held that . . . “state-law design defect claims . . . that place a duty on manufacturers to render a drug safer by either altering its composition or altering its labeling are in conflict with federal laws that prohibit manufacturers from unilaterally altering drug composition or labeling.  Id. at 2479.  Creating an alternative design would require changing the composition of an FDA-approved drug, which is prohibited by federal law.  ida 2479.  Creating an alternative design would require changing the composition of an FDA-approved drug, which is prohibited by federal law.  Id. at 2479.

Although Plaintiffs argue this holding is limited to generic drugs and does not extend to brand drugs, the language of Bartlett is not so restrictive.  The Court adopts the reasoning . . . in Yates v. Ortho-McNeil Pharmaceutical Inc.:

[block quote and citation from Yates omitted – you can read all about Yates here]

Rheinfrank, slip op. at 8-9.

So now there are five decisions holding innovator drug design defect claims preempted under Bartlett.  Here’s hoping that many more follow, and that we bloggers find out about them as quickly as we learned of Rheinfrank.