Duty To Supply

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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 TwIqbal.  Id. 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.

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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.

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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.

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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.

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“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…

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.

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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…

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 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

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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…