1 Docket Entry 175, MDL No. 1785, C/A No. 2:06-77777-DCN (filed May 15, 2009).
2 Docket Entry 179, MDL No. 1785, C/A No. 2:06-77777-DCN (filed May 28, 2009).
For the reasons stated herein, the court need not reach Bausch & Lomb's motion to strike Dr. Cohen's
May 18, 2009 affidavit.
4 See 21 C.F.R. § 886.5928.
UNITED STATES DISTRICT COURT
DISTRICT OF SOUTH CAROLINA
In re Bausch & Lomb, Inc. Contact Lens
Solution Products Liability Litigation
This Order Relates to:
MDL No. 1785
Civil Action No. 2:06-MN-77777-DCN
ORDER AND OPINION
Before the court are defendant Bausch & Lomb Inc.'s (“Bausch & Lomb”) motions to
exclude the opinions of plaintiffs' expert Dr. Elisabeth Cohen related to Non-Fusarium
infections,1 and to strike the affidavit of Dr. Cohen dated May 18, 2009.2 In conjunction with
Justice Shirley Werner Kornreich of the Supreme Court of the State of New York – New York
County, a joint Frye/Daubert hearing was held in New York City on June 3 - 5, 2009. For the
reasons stated below, Bausch & Lomb's motion to exclude is granted.3
Beginning in 2004, Bausch & Lomb manufactured and distributed ReNu with
MoistureLoc ("MoistureLoc"), a multipurpose solution indicated for use in the daily cleaning
and disinfection of soft contact lenses. Like all contact-lens solutions, MoistureLoc was
classified as a medical device and was subject to the regulatory authority of the United States
Food and Drug Administration (“FDA”).4 Pursuant to FDA rules and regulations, MoistureLoc
2:06-mn-77777-DCN Date Filed 08/26/2009 Entry Number 209 Page 1 of 27
5 ISO 14729, Sec. 4.I. at 2.
met or exceeded all FDA requirements. The requisite data documenting MoistureLoc’s safety
and efficacy was submitted to the FDA in December 2003, and the FDA cleared MoistureLoc for
sale and distribution in the United States on May 19, 2004.
MoistureLoc's Disinfectant Efficacy
MoistureLoc was a unique, patented product that was developed