Photo of Eric Alexander

“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.