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Contact Lens Solution - Frye Exclusion

By James M. Beck and Mark Herrmann

So sayeth the NY state court in In re Bausch & Lomb Contact Lens Solution Product Liability Litigation, slip op. (N.Y. Sup. July 15, 2009). This post is necessary skeletal, as Herrmann is on vacation and Bexis' firm is involved in this litigation.

The litigation had a problem, on the one hand the defendant's contact lens solution (when misused) was allegedly linked an increase in a particular bacterial (called Fusarium) infection. There were a bunch of studies and other investigations looking into that.

But plaintiffs' counsel's indiscriminate solicitation of clients resulted in a bunch of plaintiffs who didn't have Fusarium infections. They had various other infections that had never been linked to the defendant's product.

"Never" is not an exaggeration. In the words of the court:

Plaintiffs' experts have not cited a single case report, clinical study, epidemiological study, or published and peer reviewed article, concluding as they do, that [defendant's product] is capable of causing non-Fusarium infections.

Slip op. at 23.

So what did the plaintiffs' experts offer, in the absence of anything resembling scientific proof?
Extrapolation from Fusarium-related studies. In-vitro (in a test tube) studies, without even animal studies to support them. "[G]eneral theories that an increase in microbial load [assumed] can result in an increased risk of infection" - with no established threshold. No actual testing of the defendant's product, even though they had samples. Slip op. at 23-26.

The result - exclusion - was hardly surprising. Again, as the court stated:

[T]his exercise [plaintiffs' expert's causation opinions] is more a leap of faith than a scientifically reliable analysis. The end product is the very "junk science" that the court is required to exclude.

Slip op. at 24. There's more, but you'll need to read it yourself.

Full post as published by Drug and Device Law on July 16, 2009 (boomark / email).