A couple of days ago, we watched the lovely “St. Vincent.”  The film stars a spot-on Bill Murray as Vincent, an unemployed curmudgeon living alone in an otherwise tidy residential neighborhood.  Disrepair has turned Vincent’s house into an eyesore.  Vincent is eluding his threatening bookie, who is seeking repayment for money Vincent has lost on the horses. Vincent is unkempt and rude, and we are led to believe that his only “soft spot” is reserved for his white Persian cat.   Enter a subdued and quietly effective Melissa McCarthy (compare“Bridesmaids”), as a newly-single mother moving next-door to Vincent with her (flat-out adorable) young son in tow.   We’ve recently been the victims of spoilers ourselves (see McDreamy), so we won’t reveal more except to note that Vincent is not quite the unredeemed ne’er-do-well he seems to be.  The movie reminds us to reserve judgment and not to allow initial impressions to obscure nuance.  Sometimes, there is good buried among the bad.  

Such is not the case for Reckis v. Johnson & Johnson, 471 Mass. 272, 2015 Mass. LEXIS 169 (Mass. April 17, 2015).  There are few, if any, silver linings in this Massachusetts Supreme Court decision affirming an eye-popping jury award of $50 million in compensatory damages to a child whose devastating toxic epidermal necrolysis ("TEN") was allegedly caused by Children’s Motrin.  The Court also affirmed loss-of-consortium awards of $6.5 million to each of the child’s parents.

As one would expect, the facts of the case are horrific.  After developing fever and congestion, the then-7-year-old plaintiff was given several doses of Children’s Motrin over the course of a day.  She developed a sore throat and a rash, and her parents took her to her pediatrician, who diagnosed measles and instructed the parents to continue treating the child with Motrin. By the next day, the child was covered in blisters, her lips were bleeding, she could not open her eyes or mouth, and she was diagnosed with TEN.  Reckis, 471 Mass. at 274-75.  Against the odds, she survived, but remained hospitalized for six months, a month of it in a medically-induced coma to control her pain. The top layer of her skin sloughed off, she lost the ability to eat without a feeding tube, and she suffered heart failure, liver failure, and a stroke, underwent brain surgery, and lost most of her lung capacity.  While some of these conditions resolved or improved, she was left with significant, permanent cognitive and physical impairment, including the inability to ever carry a child. Id. 275-76.

After trial, defendants filed motions for JNOV, for a new trial, and for remittitur.  Defendants argued that (1) they were entitled to judgment as a matter of law because plaintiffs’ warnings claim was preempted, under principles of implied conflict preemption; and 2) plaintiffs failed to prove causation because their causation expert was unqualified to render his causation opinions. The trial court denied all of the post-trial motions, which were reviewed on appeal by the Massachusetts Supreme Judicial Court.  Id. at 274.

Preemption

At the time Children’s Motrin was administered to the plaintiff, the warnings section of its label did not mention TEN or its symptoms, though it warned consumers to stop using the product if an allergic reaction occurred.  Id. at 280.  A little over a year later, a group including physicians and the pharmacologist who was plaintiff’s medical causation expert (more on him later) submitted a citizens’ petition to FDA requesting alterations to the Children’s Motrin label warning of the possibility of “serious skin reactions that may begin as rashes and blisters on the skin and in the areas of the eyes, mouth and genitalia [and] may progress to more serious and potentially life-threatening diseases including . . . [TEN].”  Id. (emphasis added).

After conducting “a comprehensive review of the risks and benefits” of Children’s Motrin, the FDA “agreed with the petitioners that the labeling of . . . Children’s Motrin should be improved to warn consumers about the risks of severe skin reactions. . .”  Id. at 281 (internal punctuation omitted). However, the agency “took the position that it was not useful for OTC ibuprofen labels to include the specific terms . . . TEN or toxic epidermal necrolysis because most consumers are unfamiliar with these terms.”  Id. (internal punctuation omitted).  Nor did the FDA approve the fallback position urged in the petition, which was to add the adjective “life threatening.”  Id.  The FDA was content with “severe skin reactions.” 

Plaintiff’s failure-to-warn claim argued that the Children’s Motrin label should have warned that redness, rash and blisters might be the pathway to a “life-threatening” disease – the very same adjective that the citizens’ petition had requested and that the FDA had declined to require.  Plaintiff’s father testified that he would not have given the plaintiff further doses of Motrin once these symptoms developed if the label had contained this warning.  Id. at 284. 

Given this history, one can see why the defendants argued that this was “a classic case of conflict preemption, in that the warning the plaintiffs [said] would have made a difference . . . [was] one that the FDA had expressly rejected.” Id. at 283.  The Court disagreed, citing SCOTUS’s Wyeth v. Levine, 555 U.S. 555 (2009), decision for its holding that there was no “impossibility preemption” – preemption because it was impossible to comply with both state and federal requirements – in the absence of “clear evidence that the FDA would not have approved” the label change the plaintiffs sought.  Id. at 286 (citations to Levineomitted).

“Clear evidence” is as clear as mud.  The same regulatory facts supported a preemption holding barring a Motrin-related claim inRobinson v. McNeil Consumer Healthcare, 615 F.3d 861, 873 (7th Cir. 2010).  Noting that Levine had not defined “clear evidence,” the Reckis Court commented that application of the standard was necessarily “fact-specific.” Id. at 286.  Apparently, the facts were not “specific” enough.  With respect to the Children’s Motrin label, the Court held that, although the citizens’ petition had requested the inclusion of rash/blister language, specific mention of TEN, and allusion to “life-threatening illness,” and the FDA ultimately ordered only the symptom language added to the label, there was no “clear evidence” that the agency would not have approved “life-threatening illness” language had the manufacturer sought to add it.  Even though the same language was in the petition, and even though the agency declined to require it to be added to the label.  This is the Court’s attempted distinction: 

The proposed language, “potentially life-threatening diseases,” was part of the same sentence as, and immediately followed by, the names of the . . . diseases or conditions that the FDA specified it did not think proper for an OTC ibuprofen label. Accordingly, the FDA’s decision not to request that the manufacturers add a warning about life-threatening diseases could well have been merely a byproduct of its rejection of these requested warnings on the basis that they mentioned [diseases] by name.  Whether the FDA also would consider a mention of life-threatening diseases, by itself, to be inappropriate and off limits on the OTC label is anybody’s guess; certainly the reason specified by the FDA for rejecting use of the disease names – consumer unfamiliarity – does not apply to use of such a phrase.

Id. at 289. 

This exercise in wavy line-drawing is but one more illustration of the folly that Levine permits in the name of “clear evidence.”  The FDA had considered a request that the Motrin label be modified to add three things:  rash/blister symptom language, language about “life-threatening illness,” and specific mention of specific diseases, including TEN.  It permitted only the first.  But, merely because it did not discuss at length its reasons for not requiring the “life-threatening illness” language, there is purportedly no “clear evidence” that it would decline to approve this language. Though it just had.   We submit that the “evidence” was pretty “clear.”  But “fact-specific” application of the standard continues to mean that conflict preemption bows to the whims of courts, especially where the injuries are sufficiently compelling.

The result in Reckis is ironic indeed.  Levine only required “clear evidence that the FDA would not have approved a change” in labeling.  555 U.S. at 571 (emphasis added).  The FDA regulatory history in Reckis went one step beyond even what Levine had required, with evidence that the FDA in fact did not approve use of the plaintiffs’ “life-threatening” adjective, even though that language was actually put before the Agency a year after this injury.  While Levine moved the preemption goalposts, Reckisessentially demolishes them.  Forget about Levine’s “would not have” standard – even “actually did not” wasn’t “clear” enough here.  If the Supreme Court meant what it said in Levine, evidently it will have to say so again.

Qualifications of Causation Expert

Defendants also argued that they were entitled to judgment as a matter of law because plaintiff’s medical causation expert (Randall Tackett) offered his causation opinions without proper qualifications or foundation. 

With physicians aplenty at their disposal, Plaintiff couldn’t get a single one to opine on causation  here.  The problem is that so many things supposedly cause TEN and/or the related condition “Stevens-Johnson Syndrome,” that nothing does.  We took an abbreviated look at the caselaw – only the top 25 separate pieces of litigation in the over 300 cases that mention the disease.  We found causation claims levelled against everything from pain relievers, to oral contraceptives, to antibiotics.  Bartlett v. Mut. Pharm. Co., 133 S. Ct. 2466 (2013) (suldinac); Ball v. Takeda Pharm. Am., Inc., 587 F. Appx. 78 (4th Cir. 2014) (Dexilant);Brown v. Roche Labs., Inc., 567 F. Appx. 860, (11th Cir. 2014) (Rocephin); Lofton v. McNeil Consumer & Specialty Pharm., 672 F.3d 372 (5th Cir. 2012) (ibuprofen); Crisostomo v. Stanley, 857 F.2d 1146 (7th Cir. 1988) (Zyloprim); Vitatoe v. Mylan Pharm., Inc., 696 F. Supp.2d 599 (N.D.W. Va. 2010) (phenytoin); Gomez v. Pfizer, Inc., 675 F. Supp. 2d 1159 (S.D. Fla. 2009) (multiple, including Zoloft); Taylor v. Merck & Co., 2009 WL 3429685 (W.D. Tenn. Oct. 16, 2009) (Indocin); Hall v. Merck, Sharp & Dohme, 774 F. Supp. 604 (D. Kan. 1991) (Dolobid); Shinn v. St. James Mercy Hosp., 675 F. Supp. 94 (W.D.N.Y. 1987), aff'd, 1988 WL 49763 (2d Cir. 1988) (multiple, including Phenobarbital); Fusco v. Shannon, 89 A.3d 1156 (Md. 2014) (Amifostine); Jones v. Detroit Med. Ctr., 806 N.W.2d 304 (Mich. 2011) (carbamazepine); Larkin v. Pfizer, Inc., 153 S.W.3d 758 (Ky. 2004) (Zithromax ); Griggs v. Combe, Inc., 456 So. 2d 790 (Ala. 1984) Vagisil); Chamblin v. K-Mart Corp., 612 S.E.2d 25 (Ga. App. 2005) (Daypro); Kurer v. Parke, Davis & Co., 679 N.W.2d 867 (Wis. App. 2004) (loestrin);Parker v. Harper, 803 So. 2d 76 (La. App. 2001) (Dilantin);Jordan v. Ryan, 684 So. 2d 1030 (La. App. 1996) (erythromycin). Given the rampant uncertainty concerning the etiology of TEN, it’s no wonder that no doctor that actually specialized in treating this condition testified on causation.

Instead of a real doctor, plaintiff’s medical causation expert was a pharmacologist.  He had never treated a TEN patient and had never published an article on TEN.  However, he “taught courses that focus[ed] on the interactions of drugs with the human body,” and also “taught courses on NSAIDs.”   He was “experienced in reviewing medical records to determine the effects of a drug because doing so [was] a component of pharmacology and toxicology” and he had “served as a peer-reviewer of papers written by physicians.”  Id. at 292. 

The Court commented that “the judge was entitled to credit [the expert’s] testimony that he [had] considerable experience in reviewing patient medical records in order to determine the effects of a drug on the body,” and found “no error in the judge’s ruling” that the expert was qualified to render a medical causation opinion “despite the fact that he was not a physician treating TEN patients.”  Id. at 294.   And so, in a trial resulting in a $50 million verdict,  a “medical expert” who was not a doctor was allowed to render a medical causation opinion.  In our view, another jaw-dropping example of line-drawing, reminding us of decisions admitting testimony of “regulatory experts” with the barest of credentials and no relevant experience.  Only worse. 

Sometimes, “bad” is just a smokescreen, and the good within is revealed when the smoke clears.  And sometimes “bad” is just “bad.”