United States: Mixed Treatment Of Clinical Trial Liability On Summary Judgment

Last Updated: August 30 2019
Article by Eric Alexander

A little knowledge is a dangerous thing. A jack of all trades is a master of none. These cutesy little phrases throw some derision toward one who possesses some knowledge in a bunch of areas. Representing drug and device companies in litigation can make a lawyer reject the negative interpretation of these phrases. We have learned a bit here and there on a wide range of topics, some of which we have actually retained through the fog of time. When a decision touches on a number of areas where we know something, whether from litigation or the real world, we hubristically expect to be able to make sense of it. Spedale v. Constellation Pharms., No. CV-17-00109-PHX-JJT, 2019 U.S. Dist. LEXIS 139010 (D. Ariz. Aug. 16, 2019), was like that. It involved rulings on the defendant's Daubert motion on plaintiff's liability and causation expert and summary judgment motion in a case brought by a participant in a clinical trial for a cancer drug against the sponsor under principally product liability theories. We know something about those issues in general and the specific allegations about what animal studies showed, how that allegedly should have affected the clinical trial documents and enrollment, and the plaintiff's alleged psychiatric injuries hit at least within the neighborhood of our bailiwick. Yet, the decision in Spedale did not make much sense to us, even focusing solely on the summary judgment ruling.

The basic facts are that plaintiff had been treated for multiple myeloma for six years at a prominent research institution. Early on in her care, she was diagnosed with mania related to one of the drugs in her treatment regimen, which resolved by adding another medication. Six years later, with her cancer worsening, she was offered the chance to participate in a clinical trial at the institution instead of switching to another marketed cancer drug. The clinical trial was a Phase 1 study proceeding under a sponsor-submitted IND, so it was relatively small, did not only include patients with multiple myeloma, and was set up to make clear to potential participants that little was known about how the experimental drug would work in humans. After a thorough informed consent process, the plaintiff was enrolled in the trial and began the study drug. Within three weeks, she was diagnosed with mania, which worsened and allegedly persisted for years after discontinuing the study drug. She and her husband—whose facts and claim we will ignore here—sued the sponsor of the clinical trial claiming that Arizona law provided relief for negligent misrepresentation, negligent drafting of the informed consent form, lack of informed consent, and strict liability in manufacture, design, and warnings for the drug. Plaintiff found an expert to say that the preclinical studies suggested a risk of mania not properly studied by the sponsor or disclosed in the informed consent document, that the sponsor inadequately warned the investigators, and that the study drug caused plaintiff's mania. The sponsor offered fact and expert evidence about its compliance with FDA requirements, the appropriateness of the study design, the completeness of the consent documents, and plaintiff's enrollment in and consent for the clinical trial by her treating physician and other investigators.

The challenges to the plaintiff's expert excluded some of his opinions, but left intact his core opinions about the sponsor's approved informed consent documents, its disclosures of risks to the investigators, and the causation of plaintiff's (recurrent) mania. This is where we get a bit confused by the things the court did not consider and the order in which it considered the things it did. It seems to us that a predicate question, especially for a court sitting in diversity and paying due attention to Erie restraint, should be "Does established Arizona law permit tort claims by a clinical trial participant against the sponsor of a clinical trial?" Another important question to ask might be "In the case of a study under an IND, can a plaintiff recover under state law based on the contention that documents approved by FDA were inadequate without running afoul of preemption?" One could also ask "For analysis of proximate cause for the informational claims for this prescription drug, what did the prescribing physician say about the impact of additional information on his treatment of this plaintiff?" Sadly and somewhat surprisingly, the court did not really ask any of these questions in ruling on summary judgment.

Instead, the court walked through the claims in order and it was a mixed bag, allowing more of the case to go forward than we think made sense. First up were plaintiff's purported negligence claims, framed as a whether the defendant provided the investigators with enough evidence about the risks and benefits of the study drug to allow for adequate informed consent. The court ruled, in a footnote, that factual allegation of an affirmative misrepresentation was unsupported because the approved informed consent documents did not claim the study drug was a treatment for multiple myeloma. The court characterized the claim not based on an affirmative representation as "negligent drafting." Rather than examine whether Arizona law imposed such a duty, the court looked to whether federal law imposed duties that relate to the safety of study participants—they do—and what certain federal courts had said about those duties. Neither of the two cases the court cited concerned Arizona law. One, from the District of Massachusetts in 2014 has already drawn our ire for making up a new duty. Without saying it was predicting Arizona law or considering appellate decisions (like the cases cited here), the court followed that case and concluded a breach of a duty to the investigator could breach a duty to the study participant. That put the cart before the horse, but it also made it easy to conclude that there was a genuine issue whether the sponsor had breached a duty to plaintiff because her expert opined that it "failed to 'monitor the site's activities and documents.'" Thus, a novel duty of "negligent drafting" could be satisfied with expert evidence of failure to monitor. This was almost as befuddling as the ruling that there was a genuine issue on proximate causes solely based on plaintiff's expert evidence of medical causation. If the breach was drafting consent documents or monitoring the site's activities, then proximate cause would require some evidence about how the investigators would not have enrolled plaintiff and/or given her the study drug. It does not seem that plaintiff had any of that evidence.

On plaintiff's claim for informed consent, the court again skipped the step of determining if Arizona recognized such a claim against a clinical trial sponsor, as opposed to a medical provider. Although not considered on the first claim, the court did consider the role of the learned intermediary doctrine, because this was a prescription drug and plaintiff's self-serving testimony that different warnings to her would have affected her decision to participate in the trial should not matter on a warnings claim. The court's reasoning for blowing past the learned intermediary doctrine and the lack of supporting evidence from the prescribing physician was as follows:

[I]f Defendant breached its duty of care to Ms. Spedale by failing to perform due diligence in the preclinical testing phase, the [informed consent documents] could also be deemed deficient for lack of material information. Because the fate of Plaintiffs' informed consent claim rises and falls with their negligent drafting claim, the Court denies summary judgment with respect to Plaintiffs' informed consent claim.

Given that the "negligent drafting claim" hinged on information provided to the learned intermediary, this hardly seems like a rationale for avoiding a consideration of the law and evidence.

Next up were strict liability claims for manufacturing defect and design defect. Here, the court actually considered Arizona law specific to the issues in the case. It quote an Arizona appellate decision that strict liability for sellers can "apply to those who manufacture and [s]upply products to consumers on an investigational basis." It also analyzed Arizona cases on the two potential tests for design defect and determined that the lower bar "consumer expectation test" would not apply "[b]ecause experimental drugs are being the ordinary consumer's knowledge and experience." With the standards set, the analysis was fairly easy because plaintiff did not have evidence that the drug she took was not what it was supposed to be or that its risks exceeded its benefits. Thus, the defendant was granted partial summary judgment on these claims.

The consideration of the strict liability failure to warn claim, however, reverted to form without addressing the issues missing in the denial of summary judgment on the negligent drafting and informed consent claims. Even though the court hypothesized that additional preclinical testing might have detected something, it leapt to "if that knowledge would have removed someone with Ms. Spedale's medical history from the participant population, Defendant is liable for the resulting informational defect" without evidence from the investigators supporting such a change.

Because this was Arizona, however, the defendant left with the prize of partial summary judgment on punitive damages. Arizona requires "clear and convincing evidence that the defendant engaged in aggravated and outrageous conduct with an evil mind." The conduct of which plaintiff complained was not outrageous. That part made sense to us.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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