Scheinberg v. Merck & Co.
924 F. Supp. 2d 477
S.D.N.Y.2013Background
- MDL bellwether case involving Fosamax and ONJ claims against Merck; plaintiff sues for design defect, failure to warn, fraud, breach of express and implied warranty, and seeks punitive damages.
- Plaintiff alleges Merck knew of ONJ risk and failed to warn the medical community; evidence includes adverse event reports and later 2003-2005 data.
- Merck contends warnings were adequate, and that plaintiff cannot prove proximate causation or that the product was not minimally safe.
- Court applies New York law; Scheinberg used Fosamax 2000–2006 with a tooth extraction in 2006; expert Kraut links Fosamax to ONJ.
- Court addresses four motions: Merck SJ on all claims; preclusion of two Merck experts (Buch, Breiman); preclusion of Parisian testimony; plaintiff’s Daubert challenges to Gruber and Glickman.
- Court grants SJ on breach of warranty (express and fraudulent concealment/misrepresentation) and punitive damages; denial of SJ on design defect and failure to warn; partial grant/denial of Daubert motions by both sides.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Design defect feasibility requirement | Feasible alternative design includes packaging label and potential placebo use. | New York law requires a feasible design alternative; label changes considered. | Denies summary judgment on design defect. |
| Failure to warn proximate causation | Additional warnings or Dear Doctor letters could have altered treatment. | Warnings were sufficient; causation contested. | Question of proximate causation for warning remains for trial. |
| Breach of express/implied warranty | Plaintiff relied on Merck handouts; warranties existed. | Plaintiff’s deposition undermines express warranty; implied warranty shows Fosamax minimally safe. | Express warranty denied; implied warranty granted for limitations? (Note: Court granted SJ on express warranty; implied warranty SJ denied.) |
| Fraudulent misrepresentation and concealment | Merck concealed ONJ risk and misrepresented safety/effectiveness. | No evidence of false statements or concealment with proximate causation. | Summary judgment granted for Merck on fraud claims. |
| Punitive damages | Willful concealment and misrepresentation support punitive damages. | Insufficient evidence of intent or high probability of harm. | Punitive damages summary judgment in Merck's favor. |
Key Cases Cited
- Urena v. Biro Manufacturing Co., 114 F.3d 359 (2d Cir.1997) (feasible alternative design can be evidence for design defect)
- Daley v. McNeil Consumer Prods. Co., 164 F.Supp.2d 367 (S.D.N.Y.2001) (feasible design/alternative design concept in design defect)
- In re Fosamax Prods. Liab. Litig., 645 F.Supp.2d 164 (S.D.N.Y.2009) (context for failures to warn and regulatory considerations)
- Anderson v. Hedstrom Corp., 76 F.Supp.2d 422 (S.D.N.Y.1999) (heeding presumption in failure to warn analysis)
- Raskin v. The Wyatt Co., 125 F.3d 55 (2d Cir.1997) (policy/summary judgment considerations in expert testimony)
- Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (Supreme Court 1993) (gatekeeping reliability of expert testimony)
- Kumho Tire Co. v. Carmichael, 526 U.S. 137 (Supreme Court 1999) (Daubert-based admissibility extends to all expert testimony)
- Urena (duplicate) , 114 F.3d 359 (2d Cir.1997) (see above)