Staying The Course In A Mississippi Drug Case

by Reed Smith
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Defense hacks. Homers. Biased. These are just a few of the labels we have applied to the authors of this Blog. While we recognize our leanings and strive to offer something more than just cheering a decision for the defense and jeering a decision for the plaintiff, we do see some cases as having an obvious right result, no matter how long it takes to get there. However, just because a case is from a “bad” jurisdiction does not mean that all the decisions will be bad. In Johnson & Johnson v. Fortenberry, No. 2015-CA-01369-SCT, 2017 Miss. LEXIS 421 (Miss. Oct. 19, 2017), the geriatric plaintiff was prescribed defendant’s antipsychotic medication for about two years before developing a mild oral tardive dyskinesia (something that had appeared with the second medication plaintiff had been on). This was the third medication that plaintiff took for her severe psychosis and it apparently worked well for her. Her prescribing physician was well aware of the risk of tardive dyskinesia with every antipsychotic at the time, considering that the medication had a lower risk of tardive dyskinesia and other extrapyramidal symptoms according to both the medical literature and defendant’s marketing materials. After pending for twelve years, the case went to trial in a notorious plaintiff-friendly jurisdiction before a similarly known judge. Plaintiff proceeded at trial on failure to warn and negligent misrepresentation theories and won a sizable compensatory verdict, although punitive damages did not go to the jury. An appeal and cross-appeal followed.

As we often do, we will focus on the parts of the decision that seem more relevant to us. First, the warnings claim. You may have already guessed that we think this should have been a slam dunk for the defense. You would be right. In addition to what we noted above about the prescriber’s knowledge and plaintiff’s medical course, the prescriber testified that specifically warned plaintiff and her daughter-caregiver (who later pursued the suit for plaintiff’s estate) of the risk of tardive dyskinesia and other extrapyramidal symptoms. Id. at *8. His awareness of the risk was consistent with the thorough warnings for tardive dyskinesia in the FDA-mandate class labeling for all antipsychotics, which he considered to be consistent with his understanding of the risk from other sources. Id. at **9-11. For plaintiff, the prescriber stood by his decision to prescribe the drug, noting “the psychotic symptoms which are terrible and unremitting and lead to very bad outcomes. And those are much more certain than the risks of possible side effects.” Id. at *19. Plaintiff attacked the class labeling as “cookie cutter” and the prescriber’s self-professed understanding of the risk as influenced by the marketing for the drug. Id. at **20-21.

The first question on appeal was whether the label itself was sufficient to warn of the risk of tardive dyskinesia. This was not a close call, as the “label unequivocally communicated the risk of tardive dyskinesia associated with the use of all antipsychotic drugs, including Risperdal.” Id. at *18. In addition, the prescriber “specifically testified that he considered the language of the Risperdal label adequate to warn him of the risk of tardive dyskinesia in Risperdal users at the time he prescribed it to Taylor.” Id. at **18-19. It does not appear that the plaintiff, despite an array of willing expert, had much to say about the adequacy of the label itself. This may have never featured in the trial court, but there would have been an obvious problem with saying that the defendant needed to change the class labeling to avoid liability—implied preemption. In this situation, the drug’s manufacturer could not have taken an independent action to change the already robust class labeling. That did not come up on appeal because the plaintiff argued that marketing undercut the actual content of the label. However, the Mississippi Products Liability Act limits the inquiry to the label itself and the Mississippi Supreme Court was unwilling to allow marketing evidence to be considered. Id. at **21-23. Thus, after fifteen years, an obviously flawed warnings claim—we have not even mentioned the obvious lack of proximate cause—went away.

The negligent misrepresentation claim was another matter, as marketing evidence counted. As an initial matter, the parties agreed that the focus on such a claim for a prescription drug was on the representations to the prescribing physician. From the summary of the evidence at trial, it does not appear that there was a specific representation ever made to the plaintiff’s prescriber that was proven to be false and relied upon in connection with plaintiff’s care. Instead, generic evidence purportedly showing that the manufacturer marketed the drug as having less of risk of tardive dyskinesia and other extrapyramidal symptoms than other drugs was not tied to the prescriber’s decisions with plaintiff. Id. at **26-32. There was no evidence that he saw any of the marketing pieces that plaintiff contended were misleading or acknowledged a specific representation that misled him.

Instead, plaintiff offered a less direct chain of purported proximate cause: 1) prescriber testimony that “I just remember the information about it, and I assume marketing as well as reading about it – I can’t always differentiate because I read journals and things, too – but all the information identified it as atypical and having fewer EPS side effects”; 2) his view from all sources was that the risk of tardive dyskinesia was lower with Risperdal than lower than with older antipsychotics; 3) that he probably would have prescribed another, unspecified medication if he believed the risk of tardive dyskinesia with Risperdal was actually equal to an older antipsychotic; and 4) expert testimony that plaintiff would not have developed tardive dyskinesia if she had been prescribed one of two other antipsychotic medications instead of switching to Risperdal. Id. at **26 & 33-37. For the court, this was enough to raise a jury question as to whether the marketing materials provided to the prescriber misrepresented “that the tardive dyskinesia risk was low and materially lower than the tardive dyskinesia risk from Haldol”—the drug plaintiff was initially prescribed, but not one of the drugs plaintiff’s expert said would have avoided her injury—whether the prescriber relied on such a misrepresentation, and whether it proximately caused plaintiff’s injury. Id. at **38-39.

Here are some problems with that analysis. For the same reason that an adequate pleading of a misrepresentation claim needs to include the who, what, where, and when of the representation, it is hard to see how a plaintiff can establish a misrepresentation without something more specific than what plaintiff offered here. Moreover, where the general representations to the prescriber were perceived as being consistent with what he understood from the medical literature and other sources, there does not seem to have been reliance on any misrepresentation. Any reliance also did not seem to result in the prescription to plaintiff, as the prescriber’s impression from medical literature also would have needed to have been different to affect the prescribing decision. Plaintiff’s evidence on proximate cause also did not seem to match up because the prescriber did not say he would have prescribed one of the two medications that plaintiff’s expert testified would have avoided her injury. That all does not sound like plaintiff established enough to get to a jury on a negligent misrepresentation claim, but, like we said, we might be a bit biased.

Part of why plaintiffs like misrepresentation claims is that they tend to be a better vehicle for punitive damages than failure to warn claims. Here, despite the broad evidence admitted on marketing, which plaintiff contended showed intent to justify punitive damages, the trial court did not let punitives go to the jury. Along the way, the court excluded the defendant’s guilty plea to allegations of improper marketing after plaintiff’s last prescription. Id. at *64. That is a correct decision, but still deserves some recognition. In Mississippi, the trial is supposed to evaluate all the evidence to see if a punitive damages claim should go to the jury. Id. at **65-66. Because the trial judge did that, the Mississippi Supreme Court affirmed. That deserves a little credit too.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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