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MoistureLoc Daubert Hearing

By James M. Beck and Mark Herrmann

It's Herrmann alone at the keyboard today, because Bexis's firm is involved in defending the Bausch & Lomb MoistureLoc cases.

You may well have read about the MoistureLoc cases in the popular press.

After reports about a specific eye infection -- Fusarium keratitis -- Bausch & Lomb decided to voluntarily withdraw from the market its ReNu MoistureLoc contact lens solution.

The predictable solicitation of clients then began, the usual collection of lawsuits was filed, the MDL was created . . . you know the drill.

Bausch & Lomb conducted a massive study and concluded that, under certain conditions simulating consumer noncompliance with the package insert, MoistureLoc could allow the formation of a polymer film on a contact lens that permitted some strains of Fusarium to survive and thrive despite later disinfection with MoistureLoc.

But no data suggested that any organism other than Fusarium could survive in the polymer film.

Moreover, Bausch & Lomb wasn't alone: Several academic researchers examined outbreaks of eye infections and found no association between non-Fusarium infections and the use of MoistureLoc while the product was being sold. And no other published scientific evidence -- not a clinical trial, not an epidemiological study, not a case series, not even a case report -- provided human data linking MoistureLoc with non-Fusarium infections.

Some of the MoistureLoc lawsuits were naturally filed on behalf of people who actually suffered from Fusarium keratitis. But not all plaintiffs' lawyers were that finicky when they signed up clients, so hundreds of lawsuits were filed on behalf of folks who suffered from a collection of other eye ailments, none of which were ever associated with the use of MoistureLoc.

We've now learned that two judges -- one federal and one state -- will be sitting together on the bench over the next couple of days, conducting a joint Daubert (for the federal cases) - Frye (for the New York state cases) hearing to determine whether plaintiffs' proof of general causation linking MoistureLoc to non-Fusarium conditions rises to the level of admissible evidence.

We are (or at least the one of us writing this post is) pretty far from the scientific evidence in this case, but we get the sense that this hearing would be a fine opportunity for two courts to separate the MoistureLoc wheat from the MoistureLoc chaff. If there's no credible evidence that MoistureLoc causes non-Fusarium infections, then the two courts could dismiss all of the non-Fusarium claims, which would (1) eliminate the risk that Bausch & Lomb would be held liable for injuries that its product did not cause, (2) end the presumably expensive discovery aimed at non-Fusarium infections, and (3) increase the likelihood of resolving the theoretically plausible claims by stripping away the risk posed by the unsupported claims.

We'll watch the reports on the upcoming hearing with interest, and we'll let you know as soon as we hear a result.

Full post as published by Drug and Device Law on June 03, 2009 (boomark / email).