One of the best developments in drug and device law over the last 15 years has been the demise of
the class action. Although seen by plaintiffs and some commentators
as convenient devices that can be used to resolve large numbers of
claims in bunches, courts have generally come to understand that
class actions just don't work in cases involving drugs and
medical devices. The differences among the claims and the claimants
are just too numerous, making class actions all but uncertifiable
outside of the settlement context. (See our class certification
denial cheat sheets here and here.)
When class actions are filed against drug and medical device
manufacturer these days, they usually look like Plumlee v.
Pfizer, Inc., No. 13-CV-00414-LHK, 2014 LEXIS 23172 (N.D. Cal.
Feb. 21, 2014). A patient who had used both branded and generic
Zoloft filed a class action against the innovator manufacturer, but
not because there was anything allegedly wrong with the product or
because she had experienced any alleged side effect. The plaintiff
does not even appear to have alleged that the product failed to
work as well as it was supposed to. She allegedly took the medicine
for more than three years, which suggests to us that she was
benefiting from the therapy. Id. at **9-10.
So what was the plaintiff's beef? Well, she alleged that the
innovator manufacturer made numerous misrepresentations, basically
by allegedly overstating the effectiveness of the drug in the label
and in marketing. Our favorite allegation is that the manufacturer
marketed the product to doctors through sales representatives who
were "typically young attractive people." Id. at
**8-9. Perhaps the plaintiff is referring to the 2010 motion
picture Love & Other Drugs, which starred Hollywood
hunk Jake Gyllenhaal as a sales rep for the drug company that also
happens to be the defendant in this case. (The movie also presented
a cavalier and horribly insensitive portrayal of patients with
Parkinson's disease, but that's a topic for another day.)
We don't know what movies the plaintiff has seen, but we do
know that her objective was to recover the purchase price of the
drug for herself and other patients under California's Consumer
Legal Remedies Act, Unfair Competition Law, and False Advertising
Law. Id. at *17.
There are so many things wrong with this lawsuit, we hardly know
where to start. For one thing, we emphasize again that this
plaintiff did not allege any injury. For all we know, she got
exactly what she paid for, which makes us (and the defendant)
wonder how she had standing to sue at all. In addition, having just
read yesterday's post on statutory safe harbors
for consumer claims, we wonder whether this action falls into
California's safe harbor for "business practices which the
Legislature has expressly declared to be lawful in other
legislation," see Cel-Tech Communications, Inc. v. Los
Angeles Cellular Telephone Co., 973 P.2d 527, 542 (Cal. 1999).
Plaintiff was complaining about FDA-approved labeling, and although
we doubt that any safe harbor applies, maybe one should. We also
wonder how the plaintiff ever hoped to get a class certified.
Claims based on alleged misrepresentations, whether in the drug and
device context or not, present myriad individual issues, including
and particularly on causation. Did the prescriber review the label
or see any marketing? Would different information on the drug's
efficacy have made any impact? If the sales representative was
actually as young and attractive as Jake Gyllenhaal (or his
beautiful co-star Anne Hathaway), would the physician have been
more or less influenced by the purported sales pitch? Good luck
attempting to adjudicate these individual issues and countless
others on a classwide basis.
Thankfully, it looks like we may never know the answers to these
questions, because in the end, the undoing of the plaintiff's
complaint was the statute of limitations. The plaintiffs'
claims were subject to three-year and four-year statutes of
limitations, and the most interesting part of the order is the part
addressing when the plaintiff's claim accrued. This, again, was
a consumer action seeking a refund of the purchase price, so the
claim accrued when the plaintiff last purchased the product.
Plumlee, at **22-24. This makes sense to us and apparently
also to the plaintiff, who conceded that "her injury was
deception at the point of sale." Id. at *24
n.5.
It also makes sense that the district court rejected the
plaintiff's attempt to invoke the discovery rule to delay
accrual. California's discovery rule "postpones accrual of
a claim until 'the plaintiff discovers or has reason to
discovery the cause of action.'" Id. at *26
(citations omitted). Under this rule, the plaintiff bears
the burden of proving not only delayed discovery, but also that he
or she could not have discovery the claim with reasonable
diligence. As the district court held,
Id. at *26 (citations omitted). We are not completely convinced that discovery rules should exist at all. But if we must have discovery rules, this formulation is as good as any, particularly its allocation of a burden to specifically plead reasonable diligence.
The district court's application of the discovery rule was as good as it gets, too. The plaintiff claimed that she did not discover the alleged untruthfulness of the defendant's statements until years after she last purchased the drug. Id. at *28. But this is the age of TwIqbal plausibility, id., at *4, and that bare allegation did not meet the plaintiff's burden because she did not allege specifically the time and manner of her discovery. In other words, she failed to allege when and how she "learned" that clinical trials allegedly undermined the defendant's representations. Id. Plaintiff's allegations also did not meet her burden of reasonable diligence, and although the quote below is kind of long, it is worth reading because it provides a roadmap to responding to plaintiffs like this one:
Id. at **29-30 (emphasis in original, citations omitted). So, yes, the same tougher pleading rules can be used against plaintiffs trying to plead into discovery rules. This is about as direct a holding as you are ever going to see. It also correctly describes the standard of reasonable diligence, correctly assigns the burden to the plaintiff to plead specific facts, and correctly calls the plaintiff out for failing to meet that burden. Onto our TwIqbal cheat sheet this one goes.
The only problem we have with the order is that the court granted leave to amend. This class action has no legs, and hopefully the next motion to dismiss will put an end to the case for good. Plaintiff surely is between a rock and a hard place: She kept her allegations general and vague with the hope that omitting her specific facts would help her on class certification. But now the court has called her hand, and even if she is able to plead the specifics required for delayed discovery, the statute of limitations is the least of her problems. We don't know how this thriller ends, but we know how we would write the script if it were up to us. The End.
This article is presented for informational purposes only and is not intended to constitute legal advice.