Ever since we first waded into the issue of “duty to supply” back in 2007 in connection with the litigation that produced Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007), we’ve criticized cases that, either actually or potentially, seek to impose liability – not for defective products – but for failure to supply as much of a non-defective drug as has been prescribed for the plaintiff.  Today, we’re updating that discussion with a recent development, the affirmance of the decision that rejected the concept of “duty to supply” in 22 states.  We blogged about that decision in the district court here.  Plaintiffs thereafter appealed, but dropped their claims asserting a “free-standing duty to supply the market.”  What’s left are described as “acceleration” (that progression of the disease allegedly worsened”) and “contaminant” (related to the production difficulties) claims.

This decision is Hochendoner v. Genzyme Corp., Nos. 15-1446, -1447, slip op. (1st Cir. May 23, 2016).  The allegations in Hochendoner were that production difficulties led to a shortage of the only FDA-approved treatment for Fabry Disease, a progressive condition that is eventually fatal if untreated.  Slip op. at 3-5.  The shortage (which lasted several years) led to rationing, and in response to rationing a bunch of Fabre sufferers tried to sue.  For more details, see our prior post.  Except for one plaintiff, none of them alleged that there was anything wrong with the product they actually received – only that they didn’t receive enough of it, and as a result their pre-existing Fabre Disease symptoms recurred and/or progressed.

The First Circuit affirmed, albeit on different grounds – standing . Although not addressed in the District Court, standing is a “prerequisite” to subject matter jurisdiction, and cannot be waived.  Slip op. at 8.  An interesting procedural point that the court confirmed is that a “plaintiff bears the burden of establishing sufficient factual matter to plausibly demonstrate his standing to bring the action” under TwIqbalId. at 10.  In Hochendoner all but one of the plaintiffs alleged no particularized injury (no doubt because the litigation was a putative class action, and anything particularized is likely to preclude class certification).  Simply being required to take a reduced dose of a drug didn’t come close to actual, particularized injury:

Utterly absent, however, is any allegation linking the alleged acceleration and contaminant injuries to any specific plaintiff. This gap is most apparent with respect to the contaminant theory.  There is simply no assertion at any point in the complaints that any specific plaintiff took or received a dose contaminated with particulate matter.  Rather, the allegation is only that [defendant] produced a batch of [the drug] contaminated with particulate matter − not that contaminated doses were ever shipped or administered to any named Fabry patients.

Continue Reading New Duty To Supply Decision

Since the inception of the blog we’ve taken interest in “flip side” lawsuits in which a plaintiff sues one of our manufacturer clients making allegations diametrically opposed to what we  usually see in product liability litigation – that, far from being injurious or “defective” − our client’s product is so valuable that the plaintiff can’t do without it, and is suing because of some threat to his/her supply of that product.

The first time we commented on such suits, the plaintiffs were suing the government, claiming a constitutional right to try investigational drugs.  We opposed that, knowing that, were such a right recognized, our clients would be the next targets of such constitutionally empowered plaintiffs, because our clients, not  the government, had the drugs in question.  The courts ultimately said “no,” see Abigail Alliance v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007), but the lawsuits followed anyway.  Most of these cases involved desperately ill people grasping at investigational straws because there was no cure (or even reliable treatment) for their conditions (muscular dystrophy, multiple sclerosis, and similarly devastating and fatal conditions).  We summed this kind of litigation up recently in reviewing the first comprehensive law review article on the subject.

Continue Reading Still No Duty To Supply Drugs – In 22 States

Ever since we rejected the concept of a constitutional “life interest” creating a right to use investigational, or even experimental, drugs in connection with the Abigail Alliance litigation back in 2007, we’ve been interested in what can be called “duty to supply” cases.  Our beef with the postulated constitutional right was that, if such a right were recognized, the next lawsuit would be against a pharmaceutical company to “enforce” that right.

Well, even without a right, precisely such a “duty to supply” claim was made in a case called Gunvalson, which because it was in our back yard, we covered extensively.  Our ex-colleague and co-founder, Mark Herrmann, even filed an amicus brief in Gunvalson, successfully urging the Third Circuit to reverse an order that would have required a manufacturer to supply an investigational drug outside of its investigation.

There have been a few more such suits, all thankfully unsuccessful.  In this post, we want to let any of our readers who share our eclectic interest in this topic know that the best law review article that we’ve ever seen on this topic has recently been published.  Here’s a link.  See William M. Janssen, “A ‘Duty’ to Continue Selling Medicines,” 40 Am. J.L. & Med. 330 (2014).  Free copies can also be obtained at the SSRN site here.  The article is comprehensive, indeed “comprehensive” doesn’t do it justice.  We’ve looked through it, and it discusses every major case on this topic.  It definitely goes far beyond the
usual function of law review articles of filling much needed gaps in the literature.

Continue Reading New Law Review Article About Duty To Supply Issues

Since the beginning of 2014, five states that we know of have enacted what is called “Right to Try” statutes.  See Ariz. R.S.A. §36-1311 to -1314; Colo. R.S.A. §§25-45-101 to -108; La. R.S. §1300.381-386; Mich. C.L.A. §§16221, 26451; V.A. Mo. S. §191.480.  “Right to Try” (a play on right to die) legislation addresses a serious subject as to which there is no easy answer.  There are still a lot of incurable diseases out there.  When somebody is afflicted with such a disease, all established treatments have failed, and that person is facing certain death, can that person have access to unapproved drugs – those that are still “investigational”  in FDA parlance – on the theory that s/he has nothing to lose?

We’ve been interested in the issue of what is sometimes referred to “compassionate use” of unapproved products still in the pipeline ever since the we blogged on the Abigail Alliance litigation back in 2007.  For those of you not reading us then, we praised the D.C. Circuit’s rejection of any constitutional right for terminally–ill patients to demand access to investigational drugs.  Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695, 710-11 (D.C. Cir. 2007).

We did that because the next step, after establishing such a constitutional right as against the FDA, would have been to file suit against our clients (the government usually doesn’t have the drugs, the manufacturers do) to “enforce” that right by demanding that drug companies supply them with the unapproved drugs they sought.  Sure enough, that’s happened, too, even without the purported constitutional right.  We discussed a number of such cases (all, thankfully unsuccessful) here.

Continue Reading On “Right To Try” Legislation

“Necessity is the mother of invention.”  “Desperate times call for desperate measures.”  “Bad facts make bad law.”  We see two of three of these adages play out in Carik v. U.S. Dept. of Health and Human Services, No. 12-272 (BAH), 2013 U.S. Dist. LEXIS 168714 (D.D.C. Nov. 27, 2013). To the great credit of the judge, who generally followed “Patience is a virtue” in dismissing an 89 page complaint against FDA, NIH, DHHS, and their respective top officials, bad facts did not make bad law here.  As our title suggests—clearly, this would be the worst cover of the Rolling Stones’ “You can’t always get what you want” ever—this case was an attempt by plaintiffs to make the government force two drug manufacturers produce more of two drugs that plaintiffs wanted to take.

What is not apparent from the Carik decision is that that at least some of these same twenty-five plaintiffs had already failed in their efforts with direct lawsuits against these manufacturers.  As detailed here
and here, two other district courts previously found no duty to supply these plaintiffs in particular or the market in general with approved drugs.  (The plaintiff from Lacognata was clearly also in Carik, but we cannot tell if the plaintiff from Schubert was one of the twelve named or thirteen unnamed plaintiffs in Carik.)  These results were consistent with decisions in clinical trial and experimental use cases, where patients have much closer relationships with manufacturers, rejecting a right to continue taking a drug after the manufacturer stops offering it (for free or otherwise).  Driven, we are sure, by desperation and what they viewed as necessity for their own long-term health, the Carik plaintiffs came up with the idea of suing all parts of the government they could think of having anything to do with the two drugs at issue.

Successfully suing the government is hard to do.  Successfully suing the government as a back-up to an unsuccessful suit against private parties is harder still.  So, it should not be too surprising that the plaintiffs in Carik failed.  Still, it is an interesting and potentially useful decision.

Each of the drugs at issue is the only drug approved for its particular indication and had a history of shortages based on manufacturing and/or compliance issues.  Id. at **3-4.  Plaintiffs and defendants agreed that these shortages were caused by the actions and inactions of the non-party manufacturers.  Id. at *2.  Yet, plaintiffs offered a long “mix[ of] facts, legal arguments, and political and social theory, often in the same paragraph,” in an attempt to cobble together some legal basis to require the government defendants to do something to alleviate the problem.  Id.  Typically, such vague complaints addressed in this blog are dealt with under 12(b)(6) and TwIqbal.  Here, defendants’ motion to dismiss for lack of standing under 12(b)(1) took care of the case without the court having to consider whether claims upon which relief could be granted had been stated.

Before bringing their suit, the Carik plaintiffs had petitioned NIH in 2010 to “march-in” on the patent for one of the drugs to allow it to be developed by others; something called the Bayh-Dole Act apparently creates such an exception to traditional patent protection when federal funding helped develop the technology, which was apparently the case with one of the drugs here.  Id. at **13-15.  Even though NIH noted that the requested intervention would not solve the drug shortage, it directed the patent holder to report on the status of the drug’s availability.  According to the patent holder, nobody had requested a license for the drug and the drug shortage was over by early 2013—after the suit was filed—so NIH closed its march-in case.  More on this later.

The lead plaintiff had also submitted a citizen petition to FDA in early 2011 asking that it “allocate full doses of [the drug] to U.S. citizens under its consent decree with [the manufacturer].”  Id. at **15-16.  The FDA does not manufacture drugs or keep stores of them for distribution, so we do not how this petition could ever be granted.  As FDA often does with citizen petitions, it merely responded to this petition with the statement that it would take more time to analyze the complex issues presented.  So, the petition was still pending when the case was filed.

It was unclear from the court’s presentation of plaintiffs’ contentions whether the propriety of the actions by NIH and FDA on the respective petitions was being challenged.  We suspect that they were not because there were no petitions on the second drug in the case and there would not have been pre-suit exhaustion of administrative remedies.  Instead, it looks like the plaintiffs were pursuing multiple avenues simultaneously, including the cases against the manufacturers in other courts.  The causes of action asserted against the government—and the patent holder, who was later dropped—could hardly have been more vague:  Violations of the Fifth and Tenth Amendments, violations of the Patent Clause, violations of the doctrine of separation of powers, and violations of the FDCA.  Id. at *16.  We cannot recall ever seeing a suit based on a violation of a doctrine.   Because the decision was based on lack of standing, the applicability of cases against manufacturers and other private defendants was somewhat limited.

According to Supreme Court cases like Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992), standing requires (a) an injury in fact, (b) causation between the injury and the defendant’s conduct, and (c) the ability for the court to redress the issue. The court never got to the third element, but it seems to us that this was a no-brainer by the time of the motion to dismiss.  For the drug at issue for twenty-four of the plaintiffs, “the drug shortage was over.”  No damages were sought.  The only relief sought was to do something to end the shortage.  So, there was no possibility of redress short of use of a WABAC Machine.  (There is apparently a movie coming out based on “Peabody’s Improbable History,” itself a sideshow within “The Rocky and Bullwinkle Show,” which suggests there are no new ideas in children’s movies.)  For the drug used by the remaining plaintiff, whose claims probably did not belong in this case anyway, there was nothing suggesting any possibility of redress even though the shortage had not ended.  The shortage was related to the manufacturer shifting from one plant to another.  The FDA can delay or prevent manufacturing a particular drug at a plant, but nobody claims it has authority to order manufacturing to occur.

As it was, twenty four of the plaintiffs had not alleged an injury in fact, or even the “imminent or certainly impending injury” that suffices in the standing context.  As should be the case for product liability cases, mere possibility of adverse effects from taking less or weaker doses of the drug because of the shortages was not enough.  2013 U.S. Dist. LEXIS 168714, **24-28.

The remaining plaintiff, however, claimed that the shortages of her drug had injured her eyesight and put her at imminent risk for irreversible damage, which was enough for the first element.  The court also rejected, with detailed analysis we will not repeat here, the idea that the vague constitutional injuries alleged by all the plaintiffs constituted cognizable injuries in fact.  The arguments from plaintiffs were so wacky that the court’s analysis would be unlikely to come up in cases against drug companies.

None of the plaintiffs could satisfy the causation element of standing.  They argued that the government defendants had a duty to alleviate the drug shortages and that the manufacturers were somehow acting as agents of the government.  As to the former argument, “[t]here is, quite simply, no statutory basis for the defendants to have taken the action plaintiffs alleged they should have taken, let alone a duty to do so.”  Id. at *46.  As to the latter argument, there actually are standards from the Supreme Court for when actions of private entities can be attributed to the government.  Plaintiffs did not allege the defendants “exercised coercive power or has provided such significant encouragement, either overt or covert, that the choice [of the private parties] must in law be deemed to that of the [government].”  Id. at **50-51 (quoting S.F. Arts & Athletics, Inc. v. U.S. Olympic Comm., 483 U.S. 522, 546 (1987)).  So much for standing.

These were clearly correct decisions on the facts presented.  One might claim that decisions like these affirming that drug manufacturers act independent of FDA run contrary to the conflict preemption arguments we make for such manufacturers, but we do not see it that way.  The FDA’s regulatory scheme delineates various powers, rights and duties.  Decisions that recognize what FDA has no authority or duty to do can be as important as decisions that recognize what a drug manufacturer has no authority or duty to do, like make labeling changes that FDA has already rejected.  We know courts would never make up fictional powers just to get to a certain result.

We have another case in which a plaintiff claimed that a pharmaceutical company is under a duty to supply its drug.  We blogged about the other one here.  These cases are interesting.  They tend to illustrate how, in litigation, you can claim almost anything.  In Bartlett, for instance, the plaintiff claimed that a company should stop selling its drug to avoid liability.  In these cases, it’s the opposite.  The defendant must sell its drug to avoid liability.  It’s no wonder
that in all these cases the plaintiffs have lost.

In this recent case, Schubert v. Genzyme Corp., Case No. 2:12CV587DAK (D. Ut. Sept. 4, 2013), the defendant, Genzyme, manufactured a drug called Fabrazyme, an enzyme replacement that is used by patients who have difficulty metabolizing their lipids.  Genzyme experienced a shortage of the drug after it found a virus contamination at its manufacturing facility.  So Genzyme rationed its supply to the market.  The plaintiff’s husband received only about 70% of his ordinary dose and eventually died.  Slip Op. at 2-3.  Afterward, plaintiff sued and claimed that the defendant failed to use reasonable care to ensure an adequate supply of Fabrazyme.

Unfortunate as the circumstances of this and other cases like it may be, the court reached the only conclusion it could.  Genzyme was under no affirmative duty to supply the drug.  While Utah, like many jurisdictions, will at times impose a duty and perhaps liability upon a defendant who has acted and brought about certain consequences (called malfeasance), it will not do so for a mere failure to act (nonfeasance) absent some sort of special relationship.  And plaintiff’s negligence claim, at bottom, was about a failure to act, whether she claimed that Genzyme didn’t supply the drug at all or didn’t supply enough:

[T]he court finds no distinction between the duty of a company that exits the market altogether and a company that does not supply enough product to meet full market demand.  In both instances, the harm is the shortage of the medication and it is an act of nonfeasance.  Genzyme should not be penalized for producing as much of the product as it could.

Slip Op. at 9-10.

Continue Reading Schubert v. Genzyme Corp.: Drug Manufacturers Are under No Affirmative Duty to Sell Their Drugs

Remember that weird case where the plaintiff was suing because the defendant removed a drug he liked from the market?  Well, it was affirmed the other day, by the Eleventh Circuit.  See Lacognata v. Hospira, Inc., No. 12-14078, slip op. (11th Cir. June 7, 2013) (unpublished).  The affirmance isn’t much – all of one paragraph – but it expressly affirms “for the reasons stated in the district court’s order.”   As we discussed in our previous post, there were some interesting propositions, mostly about Florida law, in that district court opinion, which have now received the blessing of the relevant court of appeals.  Could be useful.

               We sometimes tire of reading cases, ours or others, based
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.

We couldn’t make this stuff up, folks.

Here’s the description of the basis of the lawsuit in Lacognata v. Hospira, Inc., 2012 U.S. Dist. Lexis 102707 (M.D. Fla. July 2, 2012):

Plaintiff . . . brings this action individually and on behalf of all others similarly situated based on [defendant’s] failure to provide Plaintiff [a prescription drug]. . . . Plaintiff alleges that [defendant] is the sole supplier of [the drug]. . . . Plaintiff alleges that prior to November 2010, [defendant] was able to manufacture enough [drug] to meet market demand. But subsequently, [defendant] ceased shipping [drug] to the market. . . . Plaintiff alleges that “[b]y withdrawing access to [the drug], [defendant] through its own negligence and reckless disregard for human life and health created a global shortage which led directly to patients’ otherwise preventable injuries.”

Id. at *1-2 (we’re not 100% sure the product is a “drug” but that’s what the court calls it, so we will, too).

That’s right, the defendant is being sued for negligent withdrawal (there’s no mention of a recall or other adverse FDA action) of a prescription medical product from the market − not by somebody who was injured by any defect in the product, but by somebody who wanted to keep taking it.

Talk about a candidate for Rule 11.

Plaintiff Lacognata alleged:  (1) negligence; (2) negligence per se (for allegedly violating the FDCA); (3) tortious interference with her physician/patient relationship; and (4) breach of an “implied contract.”  Id. at *3.

We’ve never seen this sort of claim before outside of the context of the discontinuation of an FDA-regulated investigational clinical trial.  Even in that context, we’ve argued against setting dangerous precedents that would create some sort of ongoing duty to supply products.

Fortunately, the court threw the Lacognata case out, finding it “simply unprecedented.”  2012 U.S. Dist. Lexis 102707, at *9.  Negligence was the broadest cause of action, and thus the most interesting.  The court analogized to the general proposition that there’s no general duty to rescue:  “that the actor realizes or should realize that action on his part is necessary for another’s aid or protection does not of itself impose upon him a duty to take such action.”  Id. at *4-5 (citation and quotation marks omitted).  The court fully recognized that the duty plaintiff was arguing for was both unprecedented and unbounded − citing our favorite Erie v. Tompkins principle:

Plaintiff’s negligence claim fails as a matter of law.  There is no authority that supports Plaintiff’s argument that a drug manufacturer, like [defendant], has a duty to continue supplying a patient with a drug that it knows the patient relies upon for his or her medical health.  It is not this Court’s role to dramatically expand Florida law as Plaintiff seeks.

2012 U.S. Dist. Lexis 102707, at *5.  We have to say, this Erie rule comes in handy in all sorts of situations.

With respect to negligence per se, we’re not at all sure how the defendant supposedly violated 21 C.F.R. §314.161 (relating to voluntary drug withdrawals), since as the court observed, a voluntary drug withdrawal does not require FDA approval.  Lacognata, 2012 U.S. Dist. Lexis 102707, at *6.  The court didn’t have to deal with the substance of the plaintiff’s claim because negligence per se went down thanks to a proposition we established in Florida during the Bone Screw litigation − there’s no negligence per se because the legislature (here, Congress) did not intend that the FDCA be privately enforced:

Florida law does not recognize a claim for negligence per se based on an alleged violation of the Food, Drug and Cosmetic Act (“FDCA”), or the FDA’s implementing regulations. . . .  Florida law does not recognize a claim based upon a theory of negligence per se for an alleged violation of this particular federal regulation.

Id. (the oldest supporting citation, Blinn v. Smith & Nephew, is a Bone Screw case).

The court next found that withdrawal of a prescribed drug was not a “tortious interference” with the physician/patient relationship of every patient who was being prescribed that drug at the time of its withdrawal:

[T]here is no authority for the proposition that a manufacturer commits an “intentional and unjustified” interference with the physician/patient relationship by failing to supply sufficient quantities of a medication prescribed during the course of that relationship.

Lacognata, 2012 U.S. Dist. Lexis 102707, at *7.

Last (and probably least) was plaintiff’s “implied contract” claim.  This was based on the defendant’s alleged promise to keep the withdrawn drug “on backorder.”  This supposed promise (on motion to dismiss the court assumed it was made) lacked both specificity (“hardly amounts to a promise with definite terms”) and reliance:

Plaintiff does not allege that she changed her position to her detriment based on the representation. For example, Plaintiff does not allege that she gave up the opportunity to utilize other treatment options in reliance on [defendant’s] alleged promise.

Id. at *9.

Sometimes general propositions stated in weird cases can come in handy in odd ways.  Thus, readers may want to make a note of the Lacognata court’s summary of its position − “[A drug supplier] did not have a duty to supply Plaintiff with the drug and it did not have a duty to supply the market generally.”  Id.

And here’s another one.  In re Diet Drugs Products Liability Litigation,  2012 WL 1172164 (E.D. Pa. April 9, 2012).  The plaintiffs in Diet Drugs were “physicians who operated weight-loss clinics or other facilities where they prescribed the diet drugs” and who allegedly lost money when they were withdrawn from the market.  Id. at *1.  They lost, too, for essentially the same reason.  Like the patient in Lacognata, doctors who prescribe drugs “simply have no legally protected interest in [the defendant’s] continuing to manufacture and sell the drugs in issue.”  Id.

Moreover, in Diet Drug, since the former prescribers could allege no personal injury at all, their lost profit claims were barred by the economic loss rule.  Id. at *2-3.

Since Mensing we’ve had to deal with a flood of overreaching arguments by plaintiffs (and one off-the-reservation court) that this or that defendant had some sort of “duty” to withdraw this or that drug from the market even though the FDA had, in every case, approved the relevant product.  Thus, it’s beyond ironic that a manufacturer might also be sued for doing just that − voluntarily withdrawing a drug from the market.  So far, we’re pleased to say, at least one court has not appreciated the irony.

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.