[Drug and Device Law] Definition of Insanity - Expecting Certification of a Personal Injury Class Action
Albert Einstein famously defined insanity as “doing the same thing over and over again and expecting different results.” We thought of that definition when we read Shepherd v. Vintage Pharmaceuticals, LLC, ___ F. Supp.3d ___, 2015 WL 6956767 (N.D. Ga. Nov. 4, 2015). Shepherd is – was – a personal injury class action. No personal injury class action has survived a contested appeal anywhere in the federal court system since the Supreme Court put the kibosh on such things with its decisions in Amchem Products, Inc. v. Windsor, 521 U.S. 591 (1997), and Ortiz v. Fibreboard Corp., 527 U.S. 815 (1999). That includes several dozen decisions involving prescription medical products, which are listed in our federal class action denial cheat sheet.
Shepherd was decided a month ago – an eternity in blog time – but whatever reason, the decision fell through the cracks and was not picked up by the services. In fact, we first learned about it from a story in the Legal Intelligencer (local Philly legal newspaper; behind a paywall) about a bunch of these plaintiffs abandoning ship following denial of class certification and becoming litigation tourists in Philadelphia. We have a PACER account and know how to use it, so before the day was out we had located the opinion and sent it to Westlaw.
As a class action, the pleaded facts were rather (or perhaps typically) overreaching. The manufacturer defendant, exercising extreme caution, recalled “eight different oral contraceptive products” all packaged by the same entity, after one improperly packaged blister pack was returned by a pharmacist in Iowa. 2015 WL 6956767, at *1. “Of the 507,966 blister packs that were returned in the recall, only 53 were improperly packaged in the reverse order.” Id. at *2. Plaintiffs claimed that 113 women became pregnant because of the error, but never proved a single case. Id. at *2. As the court pointedly observed, “[t]he Iowa package is the only known defective package received by a consumer.” Id. at *1.
Blatantly abusing Fed. R. Civ. P. 23, plaintiffs sought certification of no fewer than four subclasses, which together sought to include everybody, in the entire country, who ever bought or used (within the statute of limitations) any of the eight recalled brands of oral contraceptives:
Subclass A: Of those Class members as defined above, those persons who ingested none of the birth control pills and/or ingested the birth control pills and experienced no significant physical symptoms;
Subclass B: Of those Class members as defined above, those persons who experienced significant physical symptoms;
Subclass C: Of those Class members as defined above, those persons who became pregnant, and the pregnancy was not carried to term;
Subclass D: Of those Class members as defined above, those persons who became pregnant; and, the pregnancy resulted in the live birth of a baby.
Id. at *2.
Certification was denied to both the overall class and all of the four subclasses. The requirement that the class be ascertainable – that there be some reasonably easy way to tell who’s in it or not, was insurmountable. “A class is identifiable if its members can be ascertained by reference to objective criteria.” Id. at *4 (citation and quotation marks omitted). As mentioned above, not one of the 113 women who claimed pregnancy could establish that they actually used improperly packaged pills.
[T]he members of the proposed class and subclasses are not “ascertainable” because there is no way of knowing which consumers purchased or digested birth control pills that had been improperly packaged. . . . Plaintiffs have not proffered any means of identifying class members. Defendants’ records show only products sold to distributors and retailers, but not to individuals. Potential plaintiffs are unlikely to have retained sales receipts because of the small amount of money involved in the purchase. Thus, the only means of identifying purchasers would be through self-identification affidavits.
Id. The court refused to allow what amounted to a purely self-authenticating class definition – rejecting any method that “would amount to no more than ascertaining by potential class members’ say so.” Id. at *5 (citation and quotation marks omitted).
Nor could plaintiffs show, even apart from their unsupported ipse dixit as to sales and use, that they in fact received pills that were improperly packaged:
Even if this information could be obtained, it still would only identify consumers who had been sold “recalled” products. Significantly, the class definition . . . requires the consumer to be have been provided “defective” pills. . . . Plaintiffs have not proffered evidence to show that the blister packs they bought and consumed were improperly manufactured − or offered a plan for how potential class members could demonstrate that their products were defectively packaged.
Id. We’ve previously advocated amending Rule 23 to make the ascertainability requirement explicit. Shepherd is a paradygmatic example of why ascertainability is essential to prevent the certification of amorphous and exaggerated class actions consisting mostly of plaintiffs who have not been injured at all, while the rest of them can’t prove causation.
The proposed subclasses also flunked the other Rule 23 requirements. The class plaintiffs weren’t typical and their claims weren’t common because they weren’t even members of three of the four subclasses (which contained non-overlapping definitions). Id. at *6. Nor did common issues predominate:
[R]esolution of the claims of the putative classes and subclasses will require the Court to focus on the individual circumstances of each member of the class. It is not enough that each class member prove that Defendants sold a defective product. . . . Each plaintiff must show in an individualized manner which “physical symptoms” she suffered, her medical history, and whether her use of any allegedly defective product resulted in these physical symptoms or a pregnancy (as opposed to any other cause of pregnancy).
Id. at *7 (noting 1-5% background failure rates for oral contraceptives, depending on whether pills taken “correctly”). Differing state laws also doomed the nationwide aspect of the class. Id. at *7-9 (discussing variations in warranty, unjust enrichment, and consumer protection statutes). In particular, the various states treat “wrongful conception” suits (which at least 113 purportedly were) in greatly different fashions – from allowing them like other tort actions, to banning them outright for “public policy” reasons. Id. at *9.
Damages were also individualized, and not just in the personal injury subclasses. Even as to purely economic loss, “[t]o determine the value of what each plaintiff received, she will need to provide some evidence as to whether she received a defective blister pack or not. Plaintiffs have not offered any means of such a determination beyond self-identification.” Id. at *10. In addition, different pharmacies (and different plaintiffs) had different practices as to reimbursement for recalled products:
Even a “full reimbursement” model requires assessment of what each plaintiff paid for the recalled pills. . . . Plaintiffs do not offer any model whereby those damages could be ascertained. Even if the amount paid could be discerned, additional evidence would need to be taken on an individual basis to determine whether the plaintiff’s pharmacy offered reimbursement or replacement pills and if so, whether plaintiff did or did not take advantage of that offer, and why.
Id.
Albert Einstein’s special and general theories of relativity dramatically changed our conception of how the universe operates. For 100 years relativity has been confirmed by every test that science could devise, including tests that Einstein could hardly have imagined. Yet he never won the Nobel Prize for either relativity theory. Nor did the plaintiffs in Shepherd win any prizes for their class action, which failed every test known to class action jurisprudence.
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Posted By Bexis to Drug and Device Law at 12/03/2015 06:43:00 AM --
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