Friday, August 16, 2013
On The Ball In The Old Dominion
There are several reasons we recommend taking a look at last week’s decision in Ball v. Takeda Pharmaceuticals America, Inc., 2013 WL 4040395 (E.D. Va. Aug. 8, 2013). One is that the case involves Stevens Johnson Syndrome, a rare but devastating idiosyncratic reaction which has become something of a litigation flavor du jour, with plaintiffs claiming that a great number of drugs cause this condition. After showing considerable patience (plaintiff filed 5 motions to amend), the court ruled that plaintiff finally struck out.
Most significantly, Ball was super in dismissing the plaintiff’s warning claim. The court held that the defendant’s warning about SJS/TENS was adequate as a matter of law – and dismissed the case:
The [relevant] label clearly identifies Stevens-Johnsons syndrome as a potential “adverse reaction” that could result from use of the prescription drug. Under Virginia law, a manufacturer is obligated to give a reasonable warning, not the best possible one. Courts have routinely held warnings adequate as a matter of law when they alert a party to the very injury for which the plaintiff seeks relief. [Defendant] disclosed Stevens-Johnson syndrome as a possible adverse reaction to [the drug] prior to plaintiff’s ingesting the drug. . . . The failure to disclose this risk is the sine qua non of the plaintiff's negligence and negligence per se claims to the extent they seek to hold [defendant] responsible for plaintiff's Stevens-Johnson syndrome. Those claims are dismissed, with prejudice.
Ball, 2013 WL 4040395, at *5 (citations omitted). A finding of adequacy as a matter of law is powerful, since warning claims are at the heart of prescription drug litigation. That this determination was made at the motion to dismiss stage, with the court taking notice of the label, is obviously even better. “A manufacturer does not insure its product’s safety, and need not supply an accident-proof product,” Id. at *6 (citation and quotation marks omitted).
In another notable ruling, Ball kicked out the consumer protection claim. Because drugs are regulated by the FDA, the plaintiff’s allegations were precluded by the “safe harbor” in the Virginia statute for federally regulated products:
The VCPA . . . does not apply to federally regulated products. . . . [The product] is an FDA-approved drug whose warning labels are extensively regulated by federal law. The drug’s warning label serves as the standard under which the FDA determines whether a product is safe and effective. . . . Since federal law regulates the very matters the plaintiff says violate the VCPA, the plaintiff's VCPA claim fails as a matter of law.
Ball, 2013 WL 4040395, at *9 (citation and quotation marks omitted). We’re always pleased to pass along FDA “safe harbor” dismissals of consumer fraud claims.
Ball also found the complaint to be foul under TwIqbal. As to design and manufacturing claims, the court held that “[t]he amended complaint does little more than provide a formulaic recitation of the elements.” 2013 WL 4040395, at *6. The plaintiff failed to plead any alternative design. Id. (“plaintiff never contends that [defendant] could have designed [the drug] differently before putting it into the stream of commerce, or that such a design is even feasible”). Nor did plaintiff plead anything suggesting a manufacturing defect. Id. “A bare allegation of a “defect” is no more than a legal conclusion.” Id. Ball also TwIqballed a negligence per se claim. “To establish negligence per se, the plaintiff must identify a specific statute or regulation violated by the defendant.” Id. at *7.
[Plaintiff] never identifies the particular regulation she believes [defendant] violated. . . . . Rather, [plaintiff] only vaguely refers to unnamed “guidelines” and “requirements” applicable to prescription drugs. This will not do. In a negligence per se claim, a plaintiff may not throw the kitchen sink of statutes and regulations at a defendant in the hope that someone will eventually figure out the particular statute or regulation the defendant violated.
Ball, 2013 WL 4040395, at *8. And that’s not all on the TwIqbal front. Ball also found the plaintiffs’ allegations about certain corporate affiliates of the manufacturer woefully deficient and TwIqballed them, too. Id. at *4 (merely alleging “dominion and control” not enough).
Not only that, Ball also bounced plaintiffs’ allegation of failure to test. There’s no such cause of action in Virginia. Id. at *7 (“[n]o court has yet accepted a ‘failure to test’ theory as a viable claim separate and apart from the three traditional product defect claims mentioned above”). “[U]nder Virginia law, [defendant] did not have a duty to conduct additional testing of its product beyond what was performed as part of the FDA approval process.” Id. (citing Torkie-Tork v. Wyeth, 757 F. Supp.2d 567, 572 (E.D. Va. 2010)).
Finally, the plaintiff failed to come up with an expert witness, despite first extending and then missing the deadline for submitting such a report (all those amended complaints took some time). Plaintiff’s excuse, that “[s]he cannot afford one,” was not “good cause” for still more extensions. 2013 WL 4040395, at *9. Although “cognizant of the need for an expert from day one, [plaintiff] remains − as she was before filing suit − without an expert witness.” Id. at *10. The opinion concludes with a detailed description of the perceived failings of plaintiff’s counsel, which we’ll omit. We’re reminded of Bill James’ terse description of the baseball prowess of Danny Ainge: “Dribble, dribble dribble….”