While Bexis was somewhere hiking on glaciers in New Zealand, the court in the Fosamax MDL litigation did an entirely expected thing – it denied class certification. As we’ve posted before, in virtually every prescription drug MDL somebody seeks to certify a class, and with almost as great regularity, that motion is denied. One of Bexis’ Vioxx pals (he’s not sure who, since it was sent by fax and cover page was removed – next time use PDF) at Hughes Hubbard passed it along, and when Bexis returned to reality, he shared.

Good thing, too.

The decision, now available electronically, is In re Fosamax Products Liability Litigation, 2008 WL 58890 (S.D.N.Y. Jan. 3, 2008). The Fosamax plaintiffs were a little more realistic (or less greedy) than many, and only sought certification of three individual state class actions, and only for (you guessed it) medical monitoring. To repeat what we asked in a prior post: When’s the last time you saw anybody sue for medical monitoring not in a class action?

This cautious approach didn’t help the Fosamax plaintiffs in the end – not at all. Even in a single-state class action, and even where no present injuries are alleged, there are just too many individualized issues to allow a class action in litigation involving use of a prescription drug.

Then again, with this particular drug we wonder just how many class members there would really be anyway, since the opinion points out that the injury risk is “only slightly higher than the risk of death by lightning strike.” 2008 WL 58890, at *4. How could that possibly be the sort of “significant” increased risk that medical monitoring claims require? But we digress. The issue in class certification is the plethora of individual issues arising from cases involving prescription drug use, not the doubtful merit of the underlying claims.

As with practically all drug use, dose/response is everything. Reaction to Fosamax apparently depends upon: (1) total dosage, (2) duration of use, (3) what disease the drug was prescribed to treat, (4) susceptibility to the mechanism by which the drug allegedly causes the condition in question, (5) how long it’s been since use of the drug has stopped, and (6) non-drug-related risk factors for the condition. 2008 WL 58890, at *4. In short, Fosamax is not that much different from any other drug alleged to cause any other condition.

All this is one reason why, “the class action device typically is not very useful in mass tort cases.” Id. at *7. Music to our ears, that kind of language is, since we’re old enough (we’re dating ourselves here) to remember the pre-Ortiz/Amchem days when plaintiffs actually argued that mass tort class actions were the “developing trend” or some such similar blather.

To back up its observation the court offers a footnote of 11 class action denials in prescription medical product cases. Id. at *7 n.8.

Hah! We listed 16 cases such class action denial opinions in our own post on the subject.

Hah back! The opinion indicates that one of the cases it cites contains citations to fifteen more similar class certification denials. Id.

Hah right back at you! None of our cases is older than 2002.

Hah, hah! That means the court is more thorough than you guys.

OK – you win.

We’ll try harder then. Before even getting to class certification criteria that overtly address individualized issues, the Fosamax court blows out the proposed classes because of the lousy, overbroad class definitions:

The proposed class definitions do not set any dosage or duration of use limitations on class membership. Nor do they attempt to screen out persons with unique risk factors. . . . Plaintiffs also fail to specify the duration of the proposed. . .monitoring program. Were the proposed class certified, the named plaintiffs would seek. . .monitoring for an indefinite period for anyone [in the three states].who took even a single tablet of Fosamax at any time. . . . The proposed class is uncertifiable for over-breadth alone.

Id. at *7. Go ahead, plaintiffs, amend. Then you’ll have to contend with the converse argument that the class isn’t manageable because it takes too much effort to determine who’s in the class. Precedent likewise establishes “that class membership is not feasibly ascertainable where it hinges on myriad medical factors individual to each class member.” Id. at *8.

We especially like the court’s typicality holding, because of its general applicability (for you non-lawyers “typicality” is one of four things that the Federal Rules require every type of class action to have). For typicality. it’s not enough – rather, it’s “an excessive level of abstraction,” id. at *9 – just to say that the plaintiff will prove the defendant’s “negligence.” Negligence depends upon the relevant state of the art, and the relevant state of the art changes over time. Thus different plaintiffs who took the drug (or used any other product, for that matter) at different times can’t be typical of each other:

Proof of negligence will require an assessment of the reasonableness of [defendant’s] actions or omissions in light of what it knew or should have known about the risk of [injury] at the particular time that each class member used Fosamax. What [defendant] knew or should have known about the risk. . .likely changed over time. . . . Those taking Fosamax at different times stand in different postures with respect to proving that defendant should have known about [the] risk [in question].

Id. at *9. Not only that, but product warnings change over time, too. Id.

It’s hard to think of any product liability case – and certainly no warning case – that could possibly be held “typical” under the Fosamax court’s analysis. And this is all without even getting to the “predominance”/“cohesiveness” issues of Rule 23(b).

And there’s more. The court goes through the various elements of medical monitoring – “significant” increased risk, monitoring being “reasonably necessary,” “proven” hazard (there is “no authority for the proposition that a pharmaceutical drug that currently enjoys FDA-approval can be proven to be inherently hazardous to all persons who have taken it”), even exposure to “greater than background levels” – and finds lack of typicality as to each of these aspects of medical monitoring. 2008 WL 58890, at *10-11. The bottom line:

 

Because each class member must offer highly individualized proof to establish most elements of a medical monitoring claim, the claims of the named plaintiffs, or any individual Fosamax user for that matter, are not typical of all other current and former users.

Id. at *11. Bingo. It’s difficult to think of any medical monitoring claim involving a consumer product that would qualify for class certification under the reasoning in Fosamax.

Why are we so interested in the typicality analysis? Well, one problem with medical monitoring is that a lot of plaintiffs try to label the monitoring remedy “equitable” – even though the claim seeks payment of money from defendants to plaintiffs like any run-of-the-mill damage case. Falsely equating “equitable” with “injunctive,” such plaintiffs argue for certification under a different section of the class action rule (Rule 23(b)(2)), for you lawyers) that doesn’t expressly require common issues to predominate. While the plaintiffs in Fosamax didn’t pull that stunt (see 2008 WL 58890, at *4 (seeking certification only under Rule 23(b)(3))), enough medical monitoring plaintiffs play this game that an analysis incorporating individualized issues into universally applicable elements of Rule 23(a) such as typicality is very useful.

The same typicality issues also preclude a finding that any class member (Fosamax user) is adequate to represent any other class member (Fosamax user) in class action litigation. 2008 WL 58890, at *11-12.

The court also conducts the usual predominance analysis under Rule 23(b)(3). Mostly it refers back to the individualized issues discussed in that typicality section of the opinion (fine with us), but the court adds that the medical monitoring claims would also be subject to individualized affirmative defenses. 2008 WL 58890, at *12. The court also mentions that plaintiffs have confined themselves to single states – but the discussion is more in the nature of “nice try, guys.” Application of different states’ laws are “but one factor among many” that cause individualized issues to predominate. Id. at *13.

The opinion’s superiority (that is, a (b)(3) class action must be the “superior” way to proceed) analysis is also notable. Plainly disbelieving the plaintiffs’ predictable spectre of innumerable small-dollar cases, the court frankly “finds that case-by-case adjudication of these claims would be superior to a class action.” Id. at *13. Individual class members would want to control their own medical monitoring – to have “a monitoring program that is tailored, under the advice of their own physicians, to their individual preferences and unique medical histories.” Id. Neither the FDA nor any medical society recommends monitoring of Fosamax users. Id. at *13-14. If the dollars are small, then plaintiffs simply should not sue until they can allege a significant loss:

There is no reason, however, why class members must limit the relief they seek to. . .monitoring. The class representatives themselves seek monetary damages for medical expenses already incurred, other side effects. . .and/or mental distress resulting from the increased risk. . . . Hundreds of other Fosamax users have already filed suit. . .seeking similar relief under many legal theories.

Id. at *13.

Even though another class certification denial in a prescription medical product liability case is in a lot of ways only making the rubble bounce, the Fosamax decision has enough unusual twists of its own to make it a well worthwhile read. Good work HHR.