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Bausch & Lomb MoistureLoc MDL Daubert Ruling

By James M. Beck and Mark Herrmann

We try not to wear out our welcome with our subscribers by publishing multiple posts in a single day, but there's more breaking news that we feel compelled to report today. It's in the Bausch & Lomb ReNu with MoistureLoc MDL. (Herrmann is writing this one up alone, since Bexis's firm is involved in the litigation.)

As we reported in May: After reports about a specific eye infection -- Fusarium keratitis -- Bausch & Lomb decided to voluntarily withdraw from the market its ReNu with MoistureLoc contact lens solution.

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.

Some MoistureLoc lawsuits were filed on behalf of people who actually suffered from Fusarium keratitis. But 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.

Two judges -- one federal and one state -- sat together in June to conduct 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.

The New York state court judge, Justice Shirley Werner Kornreich, granted Bausch & Lomb's motion last month, as we dutifully reported here.

Yesterday, the federal MDL judge, Judge David C. Norton, followed suit. Judge Norton granted Bausch & Lomb's motion to exclude the opinions of plaintiffs' expert as to the non-Fusarium infections. Here's a link to In re Bausch & Lomb, Inc. Contact Lens Solution Prods. Liab. Litig., Case No. 2:06-MN-77777-DCN, MDL No. 1785 (D.S.C. Aug. 26, 2009).

Here's the money quote from the 27-page decision: "Plaintiffs have not identified, or even suggested, a threshold level of microbes necessary to actually cause an onset of non-Fusarium infection. While such a level is important in the abstract, it is critical in this litigation, since a very small minority of contact lens wearers get infection in light of the sizable majority of contact lens cases that are contaminated at any given time. Plaintiffs' theory assumes, without evidence, that any increase in microbial load causes infection. In the absence of a reliable evidentiary basis to connect any loss of efficacy/increase in the microbial load with causation in humans, plaintiffs' expert opinions amount to speculation . . . ." Id. at 20.

We are (or at least Herrmann is) pretty far removed from this action. But word on the street is that Bausch & Lomb has now resolved most of the Fusarium cases, and the two Daubert rulings resolve the "junk" cases. That leaves only clean-up work (and resolution of the economic damage claims) to put this one to bed.

Full post as published by Drug and Device Law on August 27, 2009 (boomark / email).