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.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

In association with
Related Topics
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions