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We sometimes tire of reading cases, ours or others, base on the same old allegations about what the drug or device manufacturer allegedly did wrong.  It often seems that the plaintiff lawyers work from the same playbook, written, we suspect, by Velvet Jones.  So, we perk up somewhat when we see atypical allegations of liability. We also have a particular interest in cases related to clinical trials.  The cases sometimes involve alleged injuries from clinical trial drugs and attempts by plaintiffs to have different law applied than if they had used the drug in the typical setting for an approved/cleared prescription drug/device. Like this lousy case.    There are also cases, with which we have some personal familiarity, where the alleged injury suffered by the clinical trial patient are to his rights under the Declaration of Helsinki or some other collection of ethical precepts for clinical research.  Other times, a plaintiff seeks to keep getting a study drug that was once getting (for free) through a clinical trial.  Like here, where Bexis gives a good overview of such cases as of a year ago.

Cacchillo v. Insmed Inc., No. 1:10-CV-01199, 2013 U.S. Dist. LEXIS 21791 (N.D.N.Y. Feb. 19, 2013), presents the vigorous effort of a one-time clinical trial patient to continue on a study drug that was withdrawn from the market before she started the trial and was no longer manufactured by the time she brought suit.  The court, with respect and patience befitting the serious condition for which the plaintiff desperately sought the drug, explained in detail why plaintiff could not make out a prima facie case on any of her three remaining causes of action and granted summary judgment.  This followed:  1) rejection of a preliminary injunction seeking to require the defendant to assist in submitting a single patient IND to FDA and then providing the drug to plaintiff at cost; 2) affirmance of that denial on appeal to the second circuit, Cacchillo v. Insmed Inc., 638 F.3d 401 (2d Cir. 2011); 3) dismissal under 12(b)(6) of six of the nine causes of action that plaintiff asserted, including one on §1983; and 4) a few years of discovery with a number of depositions. In short, plaintiff was given every opportunity to come up with a supported argument why the defendant should be compelled to provide a drug she
thought helped her Myotonic Muscular Dystrophy Type 1 (MMD1), a progressive and debilitating condition that has no approved drug therapy.

The marketing course of defendant’s drug, IPLEX, was certainly unusual.  Even before IPLEX was approved by FDA for its initial indication of treating certain types of “growth failure” in children, defendant was sued for patent infringement. A year after approval, defendant lost that case and subsequently agreed to stop marketing the drug in connection with a March 2007 settlement.  It was permitted, however, to do clinical trials concerning MMD1 or Amyotrophic Lateral Sclerosis (ALS, f/k/a Lou Gehrig’s disease).  It appears that ALS was always considered a more promising indication and defendant sponsored some programs for ALS patients to get access. Two years after the settlement, defendant sold off the facility where it had made IPLEX.  By December 2011, the supplies of IPLEX were gone.  This is the temporal context of most of plaintiff’s attempts to get IPLEX, although she had sought to participate in a clinical trial for MMD1—but was too old to enroll–even before IPLEX was approved.

Without recounting all of the history set out by the Court, the plaintiff was highly motivated to get IPLEX and eventually enrolled in a six-month double-blind placebo controlled Phase IIB trial at Ohio State 600  miles from where she lived.  Of course, to get in the study, plaintiff had to sign a Consent Form.  The Consent Form, predictably, did not promise an indefinite supply of the study drug—as a placebo controlled trial, it could not even promise she would get active drug—and made clear that the study could be stopped at any time, among other things.  In a bit of candor that would make clinical researchers cringe, plaintiff planned to drop out of the study if she believed she was on placebo based on her progress.  It turns out that plaintiff was actually getting IPLEX (but had not been told she was at the time) and showed substantial improvement during the trial. Plaintiff was aware that the design of the study involved withdrawing the study drug “while results were being computed,” but made inquiries of the site investigator and staff as to opportunities to resume IPLEX after the study.  In response, plaintiff was relayed Defendant’s position—its closest to a relevant representation of various statements identified by plaintiff—shortly after ending the trial:  “there would be no ‘Compassionate use or open-label study that subjects from this phase 2 study could roll into’ but that continued access to IPLEX could be secured through the next phase of the study, should it go forward.”  Id. at *36.

While plaintiff was deteriorating off drug and hoping there would be Phase III trial in which she could enroll, she viewed a press release from defendant’s website that mentioned the study plaintiff had been in, noted that IPLEX was not “commercially available,” and provided information about availability through “compassionate use” by either a “treatment IND” or “single patient IND.”  For some reason there was not an actual copy of the full release presented to the Court, so the parties were left with a dispute about whether the discussion of “compassionate use” was clearly only for ALS patients, as defendant contended. A few months later—after defendant had sold its production facility—plaintiff learned the study she was in would not be continued due to lack of efficacy and that she had been on IPLEX.  Defendant also announced that “it was immediately ceasing the supply of IPLEX to any new patients, and that it would not be initiating any further clinical trials of IPLEX at that time.”  Id. at *43.  Plaintiff made a few requests directly and through Ohio State to defendant for IPLEX through “compassionate use,” but defendant declined.  So, plaintiff brought her suit a year later. Waiting a year to sue and seeking preliminary injunction does not quite add up, so maybe she had to shop around to find a lawyer who would take her case.

With this history, it should be clear where the Court was headed on summary judgment.  Was there a contract for defendant to keep providing plaintiff IPLEX? No, as whatever implied agreement existed had insufficiently definite terms to be enforceable and would have needed to be in writing under that Statute of Frauds we learned about in law school.  Had defendant defrauded plaintiff on whether she would get IPLEX through compassionate use after the trial ended?  No, as there was no evidence that any promises defendant ever made about its future conduct were “made with a then-existing intention not to perform” or that plaintiff reasonably relied on such a promise.  Was there a negligent misrepresentation?  No, as the only representations were about (uncertain) future events and conduct rather than about any present fact.  In all, a fairly black-letter analysis of the elements of these causes of action.  Basically, the plaintiff’s hope that she would keep getting a drug she thought helped her created no legal obligation on defendant.  The Court did not really need to get into the issue of whether defendant could have even complied with the relief that plaintiff sought since it had no more IPLEX and had nowhere to make more of it.

Two things struck us about this case and how its issues intersect with other claims.  First, the evidence was that the drug was not effective for MMD1 and, according to the clinical investigator who became plaintiff’s personal doctor, plaintiff’s improvement during the study may have been a placebo effect, leading her to conclude “she did not know whether [plaintiff] would have continued to improve if she had continued taking IPLEX.”  Id. at *49.  It seems to us, somewhat like the analysis for medical monitoring in states that recognize it or even regular future medical expenses in an injury case, the costs to be imposed on the defendant for future medical care for the plaintiff should come with some evidence that the care is medically necessary. We recognize that one cannot expect too much precision in predicting future response to an investigational drug, but it also seems strange to consider relief about future medical care without requiring medical evidence.  After all, plaintiff was off IPLEX for 45 months before summary judgment was granted, but which time the analysis of whether continuing IPLEX made medical sense had surely changed.  Second, we have posted many times about the fundamental problem with failure-to-withdraw theories and we recall the words of a plaintiff’s counsel in an argument on one of the first of our cases to espouse this theory that “nobody made [defendant] keep selling the drug even though it had been approved.” Well, the plaintiff here was basically tried to make the defendant manufacture and distribute a drug that had its NDA discontinued and was never approved for her indication.  So, the plaintiffs clearly think a drug manufacturer should be damned if it does or does not.  That is not exactly the approach that would encourage companies to try to develop drugs for rare diseases without currently-approved therapies. Encouraging spending to develop new drugs is not typically part of the plaintiff playbook, though, so we should not be surprised.