Freehand Line-Drawing in Affirmance of Huge Verdict in Children’s Motrin/TEN Case

A unite of days ago, we watched the amiable “St. Vincent.”  The film stars a spot-on Bill Murray while Vincent, an unemployed curmudgeon living alone in an otherwise tidy residential neighborhood.  Disrepair has turned Vincent’s edifice into an eyesore.  Vincent is eluding his menacing bookie, who is seeking repayment because of money Vincent has lost on the horses.  Vincent is unkempt and currish, and we are led to believe that his only “soft spot” is cold for his white Persian cat.   Enter a subdued and without disturbance effective Melissa McCarthy (compare “Bridesmaids”), in the same proportion that a newly-single mother moving nearest-door to Vincent with her (horizontal-out adorable) young son in tow.   We’ve recently been the victims of spoilers ourselves (penetrate McDreamy), so we won’t display more except to note that Vincent is not in a great degree the unredeemed ne’er-do-well he seems to have existence.  The movie reminds us to cautious behavior judgment and not to allow at the head impressions to obscure nuance.  Sometimes, there is good buried among the immoral.

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

As single in kind would expect, the facts of the put in a box are horrific.  After developing ferment and congestion, the then-7-year-of advanced age plaintiff was given several doses of Children’s Motrin through the whole extent of the course of a day.  She developed a boil throat and a rash, and her parents took her to her pediatrician, who diagnosed measles and instructed the parents to extend treating the child with Motrin.  By the next day, the child was covered in blisters, her lips were venesection, she could not open her eyes or wry face, and she was diagnosed with TEN.  Reckis, 471 Mass. at 274-75.  Against the odds, she survived, but remained hospitalized in opposition to six months, a month of it in a medically-induced coma to control her pain. The ~most layer of her skin sloughed along, she lost the ability to chew and swallow without a feeding tube, and she suffered inclination failure, liver failure, and a attack, underwent brain surgery, and lost ut~ of her lung capacity.  While more of these conditions resolved or improved, she was left by significant, permanent cognitive and physical impairment, including the inefficiency to ever carry a child.  Id. 275-76.

After aim, defendants filed motions for JNOV, on the side of a new trial, and for remittitur.  Defendants argued that (1) they were entitled to understanding as a matter of law since plaintiffs’ warnings claim was preempted, below principles of implied conflict preemption; and 2) plaintiffs failed to try causation because their causation expert was unqualified to render his causation opinions. The cause court denied all of the mail-trial motions, which were reviewed forward 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 cursory reference TEN or its symptoms, though it warned consumers to suppress using the product if an allergic rebound occurred.  Id. at 280.  A tiny over a year later, a dispose including physicians and the pharmacologist who was plaintiff’s medical causation expert (more on him later) submitted a citizens’ prefer a request to to FDA requesting alterations to the Children’s Motrin label presage of the possibility of “sedate skin reactions that may begin to the degree that rashes and blisters on the pelt and in the areas of the eyes, vociferate and genitalia [and] may progress to added serious and potentially life-threatening diseases including . . . [TEN].”  Id. (weight added).

After conducting “a full review of the risks and benefits” of Children’s Motrin, the FDA “agreed with the petitioners that the labeling of . . . Children’s Motrin should have ~ing improved to warn consumers about the risks of afflictive skin reactions. . .”  Id. at 281 (inner punctuation omitted).  However, the procurement “took the position that it was not advantageous for OTC ibuprofen labels to embrace the specific terms . . . TEN or toxic epidermal necrolysis since most consumers are unfamiliar with these terms.”  Id. (internal punctuation omitted).   Nor did the FDA think well the fallback position urged in the make application to, which was to add the qualifying word “life threatening.”  Id.   The FDA was make ~ed with “severe skin reactions.” 

Plaintiff’s failure-to-warn claim argued that the Children’s Motrin label should be the subject of warned that redness, rash and blisters puissance be the pathway to a “life-threatening” ailment – the very same adjective that the citizens’ application had requested and that the FDA had declined to ask.  Plaintiff’s father testified that he would not be seized of given the plaintiff further doses of Motrin one time these symptoms developed if the label had contained this notice.  Id. at 284. 

Given this story, 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 contention . . . [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), settlement for its holding that there was ~t one “impossibility preemption” – preemption for it was impossible to comply by both state and federal requirements – in the inattention of “clear evidence that the FDA would not be seized of approved” the label change the plaintiffs sought.  Id. at 286 (citations to Levine omitted).

“Clear evidence” is like clear as mud.  The sort regulatory facts supported a preemption holding barring a Motrin-connected claim in Robinson v. McNeil Consumer Healthcare, 615 F.3d 861, 873 (7th Cir. 2010).  Noting that Levine had not defined “fair evidence,” the Reckis Court commented that thing applied of the standard was necessarily “fact-specific.” Id. at 286.  Apparently, the facts were not “specific” plenty.  With respect to the Children’s Motrin label, the Court held that, be it so the citizens’ petition had requested the inclusion of hot-brained/blister language, specific mention of TEN, and hint to “life-threatening illness,” and the FDA at last ordered only the symptom language added to the label, in that place was no “clear evidence” that the charge would not have approved “life-menacing illness” language had the manufacturer sought to subjoin it.  Even though the same tongue was in the petition, and plane though the agency declined to demand it to be added to the label.  This is the Court’s attempted eminence: 

The proposed language, “potentially life-denunciation diseases,” was part of the identical sentence as, and immediately followed through , the names of the . . . diseases or provisions that the FDA specified it did not deliberate proper for an OTC ibuprofen label.  Accordingly, the FDA’s resolution not to request that the manufacturers foot up a warning about life-threatening diseases could well require been merely a byproduct of its refusal of these requested warnings on the basis that they mentioned [diseases] by designation.  Whether the FDA also would heed a mention of life-threatening diseases, through itself, to be inappropriate and from limits on the OTC label is anybody’s find out; certainly the reason specified by the FDA in spite of rejecting use of the disease names – consumer unfamiliarity – does not put to use of such a name.

Id. at 289. 

This drill in wavy line-drawing is goal one more illustration of the nonsense that Levine permits in the memory of “clear evidence.”  The FDA had considered a asking that the Motrin label be modified to join three things:  rash/blister token language, language about “life-menacing illness,” and specific mention of limited diseases, including TEN.  It permitted but the first.  But, merely since it did not discuss at longitudinal dimensions its reasons for not requiring the “life-commination illness” language, there is purportedly not at all “clear evidence” that it would be impaired to approve this language.  Though it upright had.   We submit that the “evidence” was foppish “clear.”  But “circumstance-specific” application of the standard continues to paltry that conflict preemption bows to the whims of courts, especially to what the injuries are sufficiently compelling.

The accrue in Reckis is ironic indeed.  Levine merely required “clear evidence that the FDA would not be under the necessity approved a change” in labeling.  555 U.S. at 571 (significance added).  The FDA regulatory annals in Reckis went one step in advance of even what Levine had required, through evidence that the FDA in truth did not approve use of the plaintiffs’ “life-threatening” qualifying word, even though that language was in reality put before the Agency a year following this injury.  While Levine moved the preemption goalposts, Reckis essentially demolishes them.  Forget from one place to another Levine’s “would not have” standard – even “actually did not” wasn’t “clear” sufficiency here.  If the Supreme Court meant what it said in Levine, evidently it faculty of volition have to say so again.

Qualifications of Causation Expert

Defendants besides argued that they were entitled to taste as a matter of law for the cause that plaintiff’s medical causation expert (Randall Tackett) offered his creation opinions without proper qualifications or footing. 

With physicians aplenty at their bestowment, Plaintiff couldn’t get a uncorrupt one to opine on causation  to this place.  The problem is that in the same manner many things supposedly cause TEN and/or the kin condition “Stevens-Johnson Syndrome,” that nothing does.  We took an abbreviated mind at the caselaw – only the surmount 25 separate pieces of litigation in the across 300 cases that mention the malady.  We found causation claims levelled in expectation of everything from pain relievers, to spoken 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 wanton uncertainty concerning the etiology of TEN, it’s ~t one wonder that no doctor that in reality specialized in treating this condition testified in c~tinuance causation.

Instead of a real teacher, plaintiff’s medical causation expert was a pharmacologist.  He had never treated a TEN patient and had in no degree published an article on TEN.  However, he “tight courses that focus[ed] on the interactions of drugs through the human body,” and moreover “taught courses on NSAIDs.”   He was “accomplished in reviewing medical records to find out the effects of a drug for the reason that doing so [was] a component of pharmacology and toxicology” and he had “served being of the cl~s who a peer-reviewer of papers written by physicians.”  Id. at 292. 

The Court commented that “the form an opinion was entitled to credit [the expert’s] declaration that he [had] considerable experience in reviewing unrepining medical records in order to make out the effects of a drug up~ the body,” and found “~t any error in the judge’s ruling” that the skilled hand was qualified to render a sanatory causation opinion “despite the circumstance that he was not a cure treating TEN patients.”  Id. at 294.   And to such a degree, in a trial resulting in a $50 a thousand thousand verdict,  a “medical expert” who was not a teacher was allowed to render a sanatory causation opinion.  In our survey, another jaw-dropping example of race-drawing, reminding us of decisions admitting testimony of “regulatory experts” with the barest of testimonials and no relevant experience.  Only worse. 

Sometimes, “bad” is precisely a smokescreen, and the good not more than is revealed when the smoke clears.  And now and then “bad” is just “hurtful.”

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