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.