Suzanne Crews v. Mentor Corporation, 4:08-cv-05000

This MDL in the M.D. Ga. concerns Mentor's ObTape Transobturator Sling with Phase I non-Georgia plaintiffs alleging design defect, manufacturing defect, failure to warn, and failure to recall.
Fraud-on-the-FDA claims are alleged but the court finds them abandoned and grants summary judgment on them.
Plaintiffs Erin Oliver, Amber Suriani, and Deirdre Thompson received ObTape implants and suffered complications including infection, erosion, abscesses, and multiple removal procedures.
Treating physicians testified they were not aware of ObTape's increased risks and would not have used it if informed; doctors read or discussed Mentor materials/PIDS with varying levels of engagement.
The court previously addressed Phase I Georgia plaintiffs and, for design, manufacturing, and failure-to-warn, concluded genuine issues of material fact remain; it denies summary judgment on those claims while granting on certain non-merits-based claims.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Fraud-on-the-FDA preemption	Plaintiffs deny asserting fraud-on-FDA claims here.	Mentor contends such claims exist and are preempted.	Fraud-on-the-FDA claims abandoned; no relief on that theory.
Design defect under mixed-law framework	ObTape's design posed undue risk outweighing benefits.	Design risk/benefit factors do not show defect as a matter of law.	Genuine issues remain; design defect claims not barred at summary judgment.
Manufacturing defect viability	ObTape manufactured inconsistently with design specifications.	Manufacturing conformity disputed but some evidence supports no conclusive defect.	Genuine issues remain; manufacturing defect claims survive summary judgment.
Failure-to-warn adequacy	Warnings did not address ObTape's higher risks; doctors were not adequately warned.	Adequate warnings were given to physicians under learned intermediary doctrine.	Issues of fact remain; cannot grant summary judgment on warnings.
Failure to recall viability	Failure to act after distribution and potential recall-like actions were improper.	Ramirez controls and FDA actions dictate absence of recall duty in this context.	Ramirez does not bar recall claim; summary judgment denied as to recall.

In re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., 711 F. Supp. 2d 1354 (M.D. Ga. 2010) (court's prior discussion on Phase I Georgia plaintiffs' claims; used as reference for related issues)
Carlin v. Superior Court, 920 P.2d 1347 (Cal. 1996) (learned intermediary doctrine; physician warnings duty)
Ramirez v. Plough, Inc., 863 P.2d 167 (Cal. 1993) (FDA action not dispositive where warnings omitted; recall context)
Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (Sup. Ct. 1986) (summary judgment standard: genuine issues of material fact)
Hufft v. Horowitz, 5 Cal. Rptr. 2d 377 (Cal. Ct. App. 1992) (California risk/benefit design defect factors)