Williams v. Novartis Pharm. Corp.

15 F.Supp.3d 761

Allen WILLIAMS, as Executor of the Estate of Barbara Bowles, Plaintiff

v.NOVARTIS PHARMACEUTICALS CORP., Defendant.

Shirley Sheffer, et al., Plaintiffs

v.Novartis Pharmaceuticals Corp., Defendant.

Case Nos. 3:12–cv–145

3:12–cv–238.

United States District Court, S.D. Ohio, Western Division.

Signed April 21, 2014.

Charles Franklin Shane, David Carr Greer, Dayton, OH, John Julian Vecchione, Valad & Vecchione PLLC, Fairfax, VA, John J. Beins, Beins, Goldberg & Hennessey, LLP, Chevy Chase, MD, for Plaintiff.

Bruce J. Berger, Spriggs & Hollingsworth, Katharine R. Latimer, Philip M. Busman, Hollingsworth LLP, Washington, DC, Megan Beth Gramke, Ulmer & Berne, Cincinnati, OH, Rex A. Littrell, Columbus, OH, for Defendant.

DECISION AND ENTRY SUSTAINING NOVARTIS PHARMACEUTICALS CORPORATION'S MOTION TO FIND THAT PUNITIVE DAMAGES ARE UNAVAILABLE (DOC. # 69 IN CASE NO. 3:12–cv–145, and DOC. # 66 IN CASE NO. 3:12–cv–238)

WALTER H. RICE, District Judge.

This matter is currently before the Court on Defendant Novartis Pharmaceuticals Corporation's Motion to Find that Punitive Damages are Unavailable. (Doc. # 69 in Case No. 3:12–cv–145, and Doc. # 66 in Case No. 3:12–cv–238). Novartis has filed identical motions in both of the above-captioned products liability cases, which are set for trial later this year.

Plaintiffs allege that Novartis knew or should have known that its bisphosphonate drugs, Aredia ® and Zometa ®, cause osteonecrosis of the jaw, and failed to adequately warn patients and the medical community of this risk. In addition to compensatory damages, Plaintiffs seek punitive damages, alleging corporate misconduct. Novartis argues that New Jersey law applies and, because the drugs are FDA-approved, and because the FDA has made no finding of fraud or misrepresentation, punitive damages are not available. Plaintiffs argue that Ohio law applies, and that genuine issues of material fact preclude dismissal of the claims for punitive damages. For the reasons set forth below, the Court SUSTAINS Novartis's motions.

The parties agree that, because both of the above-captioned cases were originally filed in the United States District Court for the District of Columbia, the District of Columbia's choice-of-law rules apply. Ferens v. John Deere Co., 494 U.S. 516, 522–23, 110 S.Ct. 1274, 108 L.Ed.2d 443 (1990). The parties also agree that Ohio law governs Plaintiffs' claims with respect to the issues of liability and compensatory damages. “The issue of punitive damages is distinct from that of liability for the underlying claims, however, and choice of law for that issue must be analyzed separately.” Minebea Co., Ltd. v. Papst, 377 F.Supp.2d 34, 40 (D.D.C.2005).

Under the District of Columbia's choice-of-law rules, the court first determines whether there is a conflict among the laws of the states that have an interest in the issue to be adjudicated. A conflict exists if application of the laws would produce a different result. If there is a conflict, the court determines which law to apply by analyzing the competing “governmental interests” and determining which state has the most significant relationship to the issue. Estate of Doe v. Islamic Republic of Iran, 808 F.Supp.2d 1, 20 (D.D.C.2011) (quoting USA Waste of Md., Inc. v. Love, 954 A.2d 1027, 1032 (D.C.2008) ). In making this determination, courts generally consider four factors: “(a) the place where the injury occurred; (b) the place where the conduct causing the injury occurred; (c) the domicile, residence, nationality, place of incorporation and place of business of the parties; and (d) the place where the relationship is centered.” Washkoviak v. Student Loan Marketing Ass'n, 900 A.2d 168, 180 (D.C.2006) (citing Restatement (Second) of Conflict of Laws § 145(2)(a)-(2)(d) ).

The court also considers the “needs of the interstate and the international systems, the relevant policies of the forum, the relevant policies of other interested states, certainty, predictability and uniformity of result, and ease in the determination and application of the law to be applied.” Estate of Doe, 808 F.Supp.2d at 21 (citing Restatement (Second) of Conflict of Laws § 6(2) ). “As a general rule, the law of the forum governs, ‘unless the foreign state has a greater interest in the controversy.’ ” Id. (quoting Kaiser—Georgetown Cmty. Health Plan v. Stutsman, 491 A.2d 502, 509 (D.C.1985) ).

In this case, Ohio and New Jersey both have an interest in the question of whether punitive damages may be awarded. Ohio has an interest because Plaintiffs reside here and this is where the injuries occurred. New Jersey also has an interest because Novartis is headquartered there and that is where the alleged corporate misconduct occurred.

The relevant Ohio and New Jersey statutes governing punitive damages in pharmaceutical products liability cases are very similar, but not identical. The Ohio law provides, in relevant part:

(C) (1) Except as provided in division (C)(2) of this section, if a claimant alleges in a product liability claim that a drug or device caused harm to the claimant, the manufacturer of the drug or device shall not be liable for punitive or exemplary damages in connection with that product liability claim if the drug or device that allegedly caused the harm satisfies either of the following:

(a) It was manufactured and labeled in relevant and material respects in accordance with the terms of an approval or license issued by the federal food and drug administration under the “Federal Food, Drug, and Cosmetic Act,” 52 Stat. 1040 (1938), 21 U.S.C. 301 –392, as amended, or the “Public Health Service Act,” 58 Stat. 682 (1944), 42 U.S.C. 201 –300cc–15, as amended.

* * *

(2) Division (C)(1) of this section does not apply if the claimant establishes, by a preponderance of the evidence, that the manufacturer fraudulently and in violation of applicable regulations of the food and drug administration withheld from the food and drug administration information known to be material and relevant to the harm that the claimant allegedly suffered or misrepresented to the food and drug administration information of that type.

Ohio Rev.Code § 2307.80.

The New Jersey statute reads as follows:

Punitive damages shall not be awarded if a drug or device or food or food additive which caused the claimant's harm was subject to premarket approval or licensure by the federal Food and Drug Administration under the “Federal Food, Drug, and Cosmetic Act,” 52 Stat. 1040, 21 U.S.C. § 301 et seq. or the “Public Health Service Act,” 58 Stat. 682, 42 U.S.C. § 201 et seq. and was approved or licensed; or is generally recognized as safe and effective pursuant to conditions established by the federal Food and Drug Administration and applicable regulations, including packaging and labeling regulations. However, where the product manufacturer knowingly withheld or misrepresented information required to be submitted under the agency's regulations, which information was material and relevant to the harm in question, punitive damages may be awarded ...

N.J. Stat. Ann. § 2A:58C–5(c).

On their face, both statutes contain an exception, allowing for punitive damages in cases of “fraud-on-the-FDA.” Nevertheless, in Buckman Company v. Plaintiffs' Legal Committee, 531 U.S. 341, 347–48, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001), the Supreme Court held that a state law “fraud-on-the-FDA” claim implicates “the relationship between a federal agency and the entity it regulates,” and is impliedly preempted.

In reliance on Buckman, Ohio and New Jersey courts have both held that these statutory exceptions are impliedly preempted by the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq. In McDarby v. Merck & Co., Inc., 401 N.J.Super. 10, 949 A.2d 223, 276 (N.J.Super.Ct.App.Div.2008), the court found implied preemption because the “punitive damages provisions of N.J.S.A. 2A:58C–5 impinge upon federal statute and regulation.” Likewise, in Decker v. GE Healthcare, Inc. (In re Gadolinium–Based Contrast Agents Prods. Liab. Litig.), Nos. 1:08GD50000, 1:12GD50004, 2013 WL 587655 (N.D.Ohio Feb. 13, 2013), the court noted that to allow a court to make an independent finding of fraud “would lead to ‘inter-branch-meddling.’ ” Id. at *14 (citing Garcia v. Wyeth–Ayerst Labs., 385 F.3d 961, 966 (6th Cir.2004) ). See also Marsh v. Genentech, Inc., 693 F.3d 546, 550–51 (6th Cir.2012) (holding that similar exception under Michigan statute was impliedly preempted).¹ Therefore, the “fraud-on-the-FDA” exception is not available under either Ohio law or New Jersey law.

It is undisputed that the drugs in question were approved by the FDA. Whereas New Jersey law broadly prohibits an award of punitive damages if the drug is FDA-approved, Ohio grants immunity from punitive damages only if the drug was also “manufactured and labeled in relevant and material respects” in accordance with the terms of the FDA approval.

Citing Burdine v. Stryker Corporation, 766 F.Supp.2d 837, 838–39 (N.D.Ohio 2011), Plaintiffs argue that it is premature for the Court to decide whether the punitive damages claim should be dismissed, since there are genuine issues of material fact concerning whether Novartis complied with the relevant FDA manufacturing and labeling requirements.

In support of this argument, Plaintiffs state only that “[t]he testimony of Dr. [Suzanne] Parisian on this point raises a material question of fact.” Doc. # 72, PageID# 8689. Unfortunately, Plaintiffs fail to cite to any particular portion of Dr. Parisian's testimony. The Court is not obligated to dig through the record to determine whether there is a genuine issue of material fact therein.

A cursory review of the record suggests that Plaintiffs do not allege that Novartis failed to manufacture the drugs in accordance with the terms of the FDA approval, or that the labels on the drugs varied in any material way from the labels approved by the FDA. Rather, Plaintiffs' allegations appear to focus instead on...