Back in the early days of the blog, when it was a Bexis/Herrmann operation, we wrote about the California Supreme Court decision that opened the floodgates to all that food litigation that now plagues that state − Farm Raised Salmon Cases, 175 P.3d 1170 (Cal. 2008). We explained how the court In Farm Raised
We continue to scratch our heads over consumer class actions seeking monetary compensation when the customers received exactly what they paid for. We see them from time to time in the pharmaceutical space, where patients claim monetary compensation even though the prescription drugs they used worked like they were supposed to with no adverse reactions.
We’ve always hated the concept of cy pres class action settlements. A cy pres distribution is an admission that, even without opposition, the plaintiffs cannot prove who was injured and by how much. Cy pres also takes money supposedly belonging to the injured class and give it to charities not injured by anyone, so the
We sometimes sit around trading stories about the dumbest lawsuits we have ever seen. Our personal favorite is a class action that the Drug and Device Law Spouse defended years ago seeking damages against a national shipping company because items sent by “Second Day Air” did not always go in an airplane. The packages arrived
If clients get sued by someone where physical or financial injury seems remote, unclear, or speculative, consider raising the defense of lack of standing. Courts are for resolving actual disputes among parties. As we said a little more than a month ago in another post on standing, courts are not debate halls. The standing
We recently read an editorial in The New York Times advocating lawsuits as a means of regulating an industry. Politicians are gripped by paralysis – so the argument goes – thus we must entrust the issue to litigators, smart judges, and good-hearted jurors. After all, hadn’t years of product liability litigation resulted in safer
Class actions hold our interest, even though we do not see them all that often anymore in the drug and medical device space. Maybe we are the rubbernecking motorists who can’t resist slowing down to gaze at someone else’s fender bender. Maybe we are the children at the zoo who rush to the reptile house
Just two days ago, Bexis lowered the boom on the Third Circuit’s recent decision in Cottrell v. Alcon Labs, ___ F.3d ___, 2017 WL 4657402 (3d Cir. Oct. 18, 2017). In a 2-1 decision, the Cottrell court permitted the plaintiffs to proceed on the notion that making eye drop drips bigger than they have
Last month we brought you word of an excellent result (preemption) in a ridiculous case − a class action claiming that the drops in eye-drops are too big. That decision was in accord with an earlier decision likewise dismissing such claims on preemption grounds. See Thompson v. Allergan USA, Inc., 993 F. Supp.2d 1007
We’re pleased to report the demise of a plaintiff’s firm’s attempt to punish the FDA for rejecting the firm’s attempt to force the agency to create evidence helpful to plaintiffs in litigation. The ploy began in 2012, when “a law firm that represents hundreds” of plaintiffs in prescription drug mass tort litigation “on a contingency fee basis” “filed a citizen petition with the [FDA].” Sheller, P.C. v. U.S. Dep’t of HHS, 119 F. Supp.3d 364, 368 (E.D. Pa. 2015). Plaintiff sought agency action that it could, in turn, parade before juries in the underlying mass tort, specifically: “that the FDA immediately revoke the [relevant] indication for the . . . [d]rugs” at issue or alternatively “require that labeling for those drugs include a black box warning based on the lack of sufficient data to prove their safety.” Id. In addition, the plaintiff law firm sought to enlist the FDA in evading a confidentiality order (originally agreed to by the law firm) that protected discovery which the defendant in the underlying litigation had provided. Id.
So far, so what? While annoying, attempts of this nature to embroil the FDA in mass tort prescription medical product litigation are part of the other side’s play book. (((Bexis))) recalls similar machinations during the Bone Screw litigation whereby the plaintiffs did everything they could (ultimately unsuccessfully) to prevent the Agency from adding to those products’ labeling previously off-label uses that had become the medical standard of care – because the Bone Screw plaintiffs’ litigation strategy was based on the procedures in question being off label.
The Bone Screw plaintiffs failed, 63 Fed. Reg. 40025-41 (FDA Jul. 27, 1998) – as did the law firm plaintiff in Sheller (119 F. Supp.3d at 368) – since the FDA normally has little patience for the junk science that the other side routinely peddles in mass tort litigation. The plaintiff law firm in Sheller would have been off not filing the petition at all, since according to plaintiff, “the FDA decision to deny its petition “has been used as the basis to assert federal preemption and other [defense] arguments against [plaintiff’s] clients in [mass-tort] litigation.” Id.
No kidding. That’s the down side this sort of litigation strategy. Attempts to involve the FDA in litigation have the risk that, if one loses, the FDA’s actions can create a positive narrative for the other side.
But plaintiffs believe in the doctrine of “heads I win; tails you lose.”
So in Sheller the plaintiff law firm attempted to gin up, from their failed strategy, a tort cause of action – not an administrative claim – against the FDA. Talk about a bootstrap. The plaintiff law firm was the one that involved the FDA in the first place. The bizarre theory of liability postulated that, if the FDA wouldn’t cooperate in creating pro-plaintiff evidence/themes in the underlying litigation, that required the plaintiff law firm to work harder and spend more money to come up with something that juries might believe. So the law firm sued the FDA to recover its purportedly increased litigation costs:
Plaintiff [claims] . . . that the FDA denial of [its] citizen petition increased [its] costs in litigating [because] . . . the defendant . . . has argued that the FDA’s denial of the Petition proves, as a matter of law, that the [drug’s] label is adequate. . . . Plaintiff argues that it must continue to expend resources in defending against that argument, and it faces the risk that a Court will accept it, lowering [plaintiff’s] contingent fee recovery.
Sheller, 119 F. Supp.3d at 369-70 (quotation marks omitted).
Continue Reading Bootstrapped Claim Against the FDA Gets the Boot