Liability for Investigational Drugs That Work (Perhaps Too Well)

by Dechert LLP

On a number of occasions – more during the first couple of years of the blog than recently – we opposed causes of action that would impose liability on drug/device manufacturers for investigational drugs that worked, and indeed worked well. By that we mean claims by research subjects demanding one form or another of continued access to an investigational drug after the study the plaintiff was participating in had concluded. Thus, we were mortified by the prospect of some sort of “constitutional right of access” to investigational drugs at issue in the Abigail Alliance litigation, and relieved when the purported right was held not to exist.  See Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007) (en banc); CareToLive v. von Eshenbach, 525 F. Supp.2d 952 (S.D. Ohio 2007).  If such a right had been recognized, our clients would have inevitably been the next targets, since our clients make the drugs.

A little later, we offered our two cents worth when a district judge in the Gunvalson litigation entered an injunction ordering a drug company to continue supplying an investigational drug that was being discontinued.  Fortunately (from our point of view – particularly since the defendant hired Dechert for the appeal), the Third Circuit ultimately reversed.  See Gunvalson v. PTC Therapeutics Inc., 303 Fed. Appx. 128 (3d Cir. 2008).

Make no mistake about it, these are awfully sympathetic cases.  In every one of them the plaintiff has some incurable condition that is at worst fatal and at best debilitating.  There is no FDA-approved treatment that works worth a damn, and the investigational drug is – or is alleged to be – working miracles.  However, the degree of sympathy such plaintiffs warrant is why these causes of action are so potentially dangerous, for they target the very process of innovation itself..

Recently, we discovered another instance of a study subject suing to demand continuation of investigational therapy after the end of a clinical trial.  This case was actually decided earlier, in 2005, but never appeared in any of the online services.  We found it serendipitously, and once we did, sent it to Westlaw.  The case is Vinion v. Amgen Inc., 2005 WL 6763338 (D. Mont. Nov. 9, 2005).  The plaintiff in Vinion used an investigational biologic and concluded that it “was was effective in improving [his] symptoms.”  Id. at *1.  The company allegedly told the plaintiff’s doctor that it “would continue to provide the drug to that person on a ‘compassionate use basis’ after the study was concluded.”  Id. at *2.  Or so the doctor said.  The Vinion court assumed that statement to be true for purposes of summary judgment.

The only fly in the ointment?  Cost.  The product was supplied free of charge during the course of the study (as FDA regulations require), but once the study was completed, plaintiff ran afoul of his insurer’s death panel.  See Id. at *2 (“his insurance would not pay for it and he could not afford it on his own”).

So plaintiff in Vinion sued – the drugmaker, not his insurer – claiming an oral contract “that [he] would be provided the drugs free of charge forever.”  Id. at *1.

This is the kind of trouble that sponsors of clinical trials get into when they try to go beyond what the FDA requires.  A purported oral contract to supply investigational drugs was also alleged in Gunvalson.  So don’t expect clinical trial sponsors to be eager to go above and beyond their legal obligations.  Our litigation-happy society discourages it.  No good deed goes unpunished.

Anyway, enough editorializing.  What happened in Vinion?  The defendant received summary judgment because, while a promise to continue supplying the product existed – there had never been any promise made to supply the drug for free:

"The undisputed facts . . . reveal that Defendants never promised to provide Plaintiffs with free [product].  There were three participants at the meeting where Plaintiffs allege a promise was made – Dr. [X, the plaintiff’s doctor], Dr. [Y], and [Mr. Z].  Although Dr. [X] testified that Dr. [Y] promised to continue providing [the product] post-study, none of the three testified that they discussed [defendant] providing [it] free of charge after the study was complete. . . .  Dr. [X] testified that “the word free never came into the discussion at all. . . .  [The others] denied making a promise to provide [product] free of charge after the drug study. . . .  Dr. [X] also testified that . . . he assumed that any provision of [the product] after the study would be at no cost to Plaintiffs because Plaintiffs were unable to pay for the drug.  However, Dr. [X’s] assumption is not evidence of an enforceable promise."

 Vinion, 2005 WL 6763338, at *5-6.

To try to get around this testimony – indicating that plaintiff’s treater had simply been mistaken as to the terms of the defendant’s offer, plaintiff attempted to have his treater declared an “agent,” or failing that, an “ostensible agent” of the defendants because the treater was an investigator in the defendant’s study.  Fortunately (for the defendants), they had covered this point in their study documentation, specifying that the “relationship . . . is that of an independent contractor.”  Id. at *6.  Let that be a lesson – proper documentation can insulate study sponsors from liability for the mistakes of the investigators they recruit.  Other documentation (the study’s informed consent form) sank the plaintiff’s ostensible agency claim:

"[T]he documentary evidence demonstrates that Plaintiffs had actual notice that Dr. [X] was only authorized to convey answers to medical questions, not questions regarding Plaintiffs' rights as study subjects.  Whether Plaintiffs were entitled to receive the drug after the study was completed is a question regarding their rights as study subjects. Plaintiffs could not look to Dr. [X] for that information, but rather had been told to contact Defendants [or the institutional review board]."

Vinion, 2005 WL 6763338, at *6.  Documentation is important in clinical trials – in Vinion it prevented liability on an investigator's unilateral mistake.

It turns out (we didn’t know until later) that Vinion was affirmed.  See Vinion v. Amgen Inc., 272 Fed. Appx. 582 (9th Cir. 2008).  In the eyes of the Court of Appeals, proper documentation again was the key:

"The only contact between [defendants] and [plaintiff] was the consent agreement they signed at the beginning of the study.  The agreement says that the study is “under the direction” of [plaintiff’s] physician and says nothing to support a reasonable belief that [the treater] would be acting under the direction of the [defendants].  [Defendant’s] agreement with the physician specified that he was an “independent contractor,” and [defendants] did nothing that would give him the appearance of being their agent."

Id. at 583-84.

We thought we’d look for other cases where plaintiffs sought to force clinical trial sponsors to continue supplying investigational drugs after termination of such studies.  We knew of another case from our Abigail Alliance research.  See Abney v. Amgen, Inc., 443 F.3d 540, 548-51 (6th Cir. 2006) (rejecting any duty to continue supplying drug after study ended).  So we shepardized all the relevant cases we knew about and also searched for the term “compassionate use.”

We first found Cacchillo v. Insmed, Inc., 638 F.3d 401 (2d Cir. 2011), in which a participant in a clinical trial sued the defendant sponsor of a clinical trial for allegedly refusing to support the plaintiff’s “compassionate use” application to the FDA for continued access to the study drug after the study was concluded.  In addition to common-law claims, this plaintiff creatively asserted a civil rights claim under 42 U.S.C. §1983.  As in other cases, the plaintiff sought a preliminary injunction ordering the defendant to provide the discontinued drug for an indefinite period.  The Second Circuit rejected such relief, pointing out that the drug in question “is no longer produced, only limited stores of [it] remain and . . . all remaining [drug] has been committed to patients with amyotrophic lateral sclerosis.”  638 F.3d at 403.  The court refused to let a disappointed research subject use litigation to jump the queue:

"[Plaintiff] has not met her burden to show that she has a likelihood of success on the merits.  [Her] claims hinge on [defendant’s] alleged promise to support [her] compassionate use application.  Yet, [she] has no evidence that such an agreement existed beyond her own vague recollection. . . .  [Her] description of the alleged agreement is problematic for at least three reasons. First, [her] recollection of the contents of [defendant’s] website is belied by [defendant’s] exhibits showing that its website contained no such statements.  Second, [she] offers no theory of agency by which the clinical research coordinator’s alleged statement would be binding upon [defendant].  Third, [her] vague descriptions of the alleged agreement, without more, strongly suggest that [she] is not likely to establish that [defendant] agreed to support her compassionate use application even if, as happened in the present case, [defendant] concluded that the drug at stake is ineffective and better allocated to other patients."

Id. at 406.

However, despite the Second Circuit’s dim view of the plaintiff’s evidence, that District Court in the same case subsequently allowed some of the plaintiff’s claims to survive a motion to dismiss.  In Cacchillo v. Insmed Inc., ___ F. Supp.2d ___, 2011 WL 2600611 (N.D.N.Y. June 29, 2011), the plaintiff’s civil rights claims were dismissed, for lack of state action, along with claims for intentional infliction of emotional distress, assumed (Good Samaritan) duty, fiduciary duty, negligence, and unjust enrichment.  Id. at *11, 15-18. However, given the statements allegedly made on the defendant’s website (see if it will do that again), the district court held that claims for breach of implied contract, negligent misrepresentation, and fraud (!) survived dismissal for failure to state a claim.  Id. at *11-14.  As we said, these plaintiffs can be very sympathetic.

As support for dismissing the fiduciary duty claim, Cacchillo (district court) cited another interesting case, also involving a lawsuit demanding continuing post-study access to an investigational drug, Suthers v. Amgen Inc., 372 F. Supp.2d 416 (S.D.N.Y. 2005).  Suthers looks a lot like Gunvalson.  The plaintiffs were research subjects, and they sought an injunction to force the drug manufacturer (and study sponsor) to continue supplying a product they found effective after the study was concluded – because the data did not support overall safety or effectiveness.  Nope, the court held.  Once again the documentation – the patient consent form and the agreement between the study sponsor and its investigators – precluded the finding of any duty to supply investigational study medication indefinitely to particular study subjects, regardless of the outcome of the study as a whole.  372 F. Supp.2d at 424-25.  Nor, given the documentation, could they make their treating physician into an agent or apparent agent of the defendant.  Id. at 425.

Suthers also rejected liability on the basis of “promissory estoppel” – because there was no “unambiguous promise” to supply medication forever.  Nor was there a fiduciary duty owed between an FDA-regulated sponsor of a clinical trial and a study subject:

"Here, a therapeutic treatment was tested in a manner so that the tests would comply with FDA regulations.  To avoid the potential that a pharmaceutical company with a financial interest in the outcome would place participants at risk of needless harm, independent research institutions and their physicians conducted the clinical trials. . . .  The FDA tightly regulates how research trials are to be conducted. . . .  One provision of [an FDA regulation] anticipates that a study sponsor may seek the right to terminate a subject's participation without his consent.

The fiduciary duty envisioned by the plaintiffs would presumably mean that if it were in a study participant’s best interests to continue a clinical study, then the sponsoring company would be without power to terminate it without risking a finding of breach.  Such a standard provides no guidance on a host of issues, including how long the sponsor’s fiduciary duty would extend, whether the research institution would also have a duty to continue treating the study participant indefinitely, and whether the fiduciary obligations of the study's sponsor would survive the decision of the patient to cease his or her relationship with the research institution.

Here, the trial was consciously structured to foster the independence and objectivity of the research institutions and principal investigators conducting the study.  The independence ensures that the sponsoring company does not manipulate the study to the ultimate detriment of those who may someday use the treatment. . . .  [T]here is no basis in fact or law to impose a fiduciary duty running from the sponsor of an independent study to participants who it does not select, has not met, and about whom it may not know the details of their medical conditions.  The constraints upon the conduct of the sponsoring company include FDA regulations and the contractual commitments that it undertakes, as well as ethical constraints imposed internally and through the pressures of the marketplace."

372 F. Supp.2d at 427-29.  Now there’s a ruling that future study sponsors faced with similar claims can use.

In a subsequent opinion the court dismissed the remaining claims in Suthers, ruling:  (1) there was no contractual promise to provide the investigational drug “indefinitely” after the study was completed; (2) no implied covenant of “good faith” was violated; (3) no “clear and unambiguous” promise supported a claim for promissory estoppel; (4) again, that there was no fiduciary duty; (5) there was no Good Samaritan negligence liability; and (6) that clinical trials did not involve “sales” that could support a consumer protection claim.  Suthers v. Amgen Inc., 441 F. Supp.2d 478 (S.D.N.Y. 2006).

Other than a smattering of law review articles, CLE materials, and briefs, that appears to be all the caselaw involving claims that plaintiffs have some right to allegedly beneficial investigational products, even after the relevant clinical trial has ended. So far, at least, no plaintiff has been successful in using litigation to force a sponsor of a clinical trial to continue providing its investigational product to the plaintiff after the trial was completed.

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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