Rowland v. Novartis Pharms. Corp.

983 F.Supp.2d 615

Karen ROWLAND, Plaintiff,

v.NOVARTIS PHARMACEUTICALS CORP., Defendant.

George Machen and Stacy Machen, Plaintiffs,

v.Novartis Pharmaceuticals Corp., Defendant.

John Orr, Plaintiff,

v.Novartis Pharmaceuticals Corp., Defendant.

Civil Action Nos. 2:12–cv–01474, 2:12–cv–01476, 2:12–cv–01715.

United States District Court, W.D. Pennsylvania.

Nov. 22, 2013.

John J. Vecchione, Valad & Vecchione, PLLC, Fairfax, VA, Daniel E. Krauth, Joseph F. Butcher, Samantha Quinn, Zimmer Kunz P.L.L.C., Pittsburgh, PA, David K. Lietz, The Lietz Law Firm, Washington, DC, Daniel A. Osborn, Brown & Wood, Philip Jeremy Miller, Osborn Law, P.C., Russel Harrison Beatie, Jr., Russel Harrison Beatie, LLP, New York, NY, for Plaintiffs.

Constantine J. Passodelis, Jeffrey Cohen, Michael R. Lettrich, JonesPassodelis PLLC, Pittsburgh, PA, Ethan D. Stein, Diane E. Lifton, Gibbons P.C., New York, NY, Neil S. Bromberg, Donald W. Fowler, Joe Gregory Hollingsworth, Robert E. Johnston, Hollingsworth, L.L.P., Katharine Ruth Latimer, Washington, DC, Jacqueline Mecchella Bushwack, Rivkin Radler, LLP, Uniondale, NY, for Defendant.

OPINION

MARK R. HORNAK, District Judge.

Plaintiffs Karen Rowland (“Ms. Rowland”), George Machen (“Mr. Machen”), Stacy Machen (“Mrs. Machen”), and Michelle Pratt Orr (“Ms. Orr”) bring strict liability and negligence claims against the Defendant, Novartis Pharmaceuticals Corporation (“NPC”), alleging that they or their spouse developed a painful and permanently disfiguring condition as a result of using Defendant's prescription medication for the purpose of managing metastatic bone cancer. Pending before the Court are NPC's Motions to Preclude Punitive Damages, ECF Nos. 53 and 55, in which NPC requests that the Court grant summary judgment in its favor on claims for punitive damages by Ms. Rowland and the Machens. ¹

Having carefully considered the Plaintiffs' Complaints, ECF 2:12–cv–01476–MRH, No. 1 and ECF 2:12–cv–01474–MRH, No. 1, Defendant's Motions to Preclude Punitive Damages, ECF Nos. 53 and 55, Defendant's Briefs in Support, ECF Nos. 54 and 56, Plaintiffs' Brief in Opposition, ECF No. 84, and Defendant's Reply Brief, ECF No. 87, the Court concludes that Pennsylvania law applies to the claims of Ms. Rowland and the Machens for punitive damages and denies NPC's Motions.²

I. BACKGROUND

Ms. Rowland is a citizen of Pennsylvania, residing in Export, Pennsylvania. Rowland Compl. ¶ 2 (“RC”). Beginning in September 2004, Ms. Rowland was prescribed, purchased, and was infused with the drug Zometa after the breast cancer she had developed metastasized to her bones. ECF No. 54, at 3. Zometa is designed, manufactured, marketed, distributed, and sold by Defendant NPC, a Delaware corporation with its principal place of business in New Jersey. OC ¶¶ 4, 6. Zometa is a prescription medication for patients with cancer that has metastasized to their bones. ECF No. 54, at 3. The drug prevents cancer-related bone damage that can lead to paralysis and death. Id.Zometa has been approved by the United States Food and Drug Administration (“FDA”). RC ¶ 7. Ms. Rowland alleges that her use of Zometa caused her to develop osteonecrosis of the jaw (“ONJ”), a permanently disfiguring and painful condition that may result in complete loss of the jaw bone. RC ¶ 1.

Mr. and Mrs. Machen are citizens of Pennsylvania, residing in New Kensington, Pennsylvania. Machen Compl. ¶¶ 2–3 (“MC”). Beginning in July 2006, Mr. Machen was prescribed, purchased, and was infused with Zometa for treatment of his stage IVB Hodgkin's disease, which had metastasized to his bones. ECF No. 56, at 3. The Machens also allege that Mr. Machen's use of Zometa caused him to develop ONJ.

Ms. Orr has been substituted as a party in this action for her late husband, John Orr (“Mr. Orr”). ECF No. 47, at 2. Mr. Orr lost a long battle with cancer on October 8, 2012. ECF No. 43, at 1. At all times relevant to this action, Mr. and Mrs. Orr were citizens of Pennsylvania and residents of Bethel Park, Pennsylvania. Beginning in January 2003, Mr. Orr was prescribed, purchased, and was infused with Zometa as part of his treatment for Stage II multiple myeloma, which had metastasized to his bones. ECF No. 36, at 2. Like Ms. Rowland and Mr. and Mrs. Machen, Ms. Orr claims that her husband's use of Zometa caused him to develop ONJ. Orr Compl. ¶ 14 (“OC”).

Ms. Rowland and the Machens originally filed suit in the federal court for the District of Columbia. See RC, at 1 and MC, at 1. Mr. Orr initially filed suit in the federal court for the Southern District of New York. OC ¶ 1. All three cases were conditionally transferred to the Middle District of Tennessee for coordinated pretrial proceedings pursuant to 28 U.S.C. § 1407, and then transferred to the Western District of Pennsylvania. ECF Nos. 4, 9. The cases have been consolidated here for pretrial matters at 2;12–cv–01474–MRH.

Plaintiffs claim that in 2002 or before, NPC received information from doctors that patients who were treated with Zometa and Aredia—a “first generation” version of Zometa NPC also manufactures—had been diagnosed with ONJ. RC ¶ 13. Plaintiffs also claim that in clinical trials for Zometa, several subjects reported ONJ-like symptoms, but NPC ignored those test results. RC ¶ 10. Additionally, in 2004, a group of physicians published a report about patients being diagnosed with ONJ after being given Aredia and Zometa. RC ¶ 6. Despite this information, NPC allegedly did not warn physicians or the public about such side effects until September 2004 and has continued to market Zometa. RC ¶¶ 13–14. Plaintiffs further suggest that the dosage instructions on the Zometa label constituted an overdose, which contributed to the severity of their side effects. RC ¶¶ 16–20. On these claims, Plaintiffs bring five causes of action against NPC for strict liability, negligent manufacture, negligent failure to warn, breach of express warranty, and breach of implied warranty, and claim they are entitled to both compensatory and punitive damages.

NPC does not dispute that Pennsylvania law applies to the Plaintiffs' claims for compensatory damages. However, NPC argues that this Court should apply New Jersey law to the Plaintiff's punitive damages claims because NPC maintains its principal place of business in New Jersey, and the conduct that it maintains is most relevant to the punitive damages claims—NPC's corporate decisions regarding Zometa labeling, clinical trials, adverse event reporting, and marketing—occurred in New Jersey. It is not clear from the record where Zometa is manufactured, or where the labels for the drug are produced. Under New Jersey law, punitive damages may not be awarded in products liability actions involving FDA-approved drugs, unless a plaintiff shows that the defendant “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.” N.J. Stat. Ann. § 2A:58C–5c. NPC asserts that (1) New Jersey's relevant punitive damages statute is impliedly preempted by the United States Supreme Court's decision in Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) ( See McDarby v. Merck & Co., 401 N.J.Super. 10, 949 A.2d 223, 272–76 (N.J.Super.Ct.App.Div.2008)) ³, (2) punitive damages are not available in this case, and (3) the Court should grant summary judgment in its favor on the Plaintiffs' punitive damages claims.

Plaintiffs contend that because they are Pennsylvania residents, were prescribed Zometa and treated in Pennsylvania by Pennsylvania doctors, purchased Zometa in Pennsylvania, were infused with Zometa in Pennsylvania, and suffered the effects of ONJ here, allegedly as a result of taking Zometa, Pennsylvania law should also apply to their claims for punitive damages.⁴ They argue that the conduct engaged in by NPC that is most relevant to the issue of punitive damages occurred in Pennsylvania—NPC sought to do business in Pennsylvania and obtained permission to do so, marketed Zometa in Pennsylvania, sold Zometa here, and allegedly failed to properly warn Pennsylvania medical professionals of the potential side effects of Zometa. Plaintiffs also point to the fact that NPC's parent company, Novartis AG, is a Swiss company, and claim that Novartis AG actually made decisions regarding Zometa labeling in Switzerland, not in New Jersey. ECF 84–4.

II. STANDARDA. Summary Judgment

Summary judgment is appropriate when “there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(a); Celotex Corp. v. Catrett, 477 U.S. 317, 322–23, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). The parties must support their position by “citing to particular parts of materials in the record, including depositions, documents, electronically stored information, affidavits or declarations, stipulations (including those made for purposes of the motion only), admissions, interrogatory answers, or other materials.” Fed.R.Civ.P. 56(c)(1)(A). In other words, summary judgment may be granted only if there exists no genuine issue of material fact that would permit a reasonable jury to find for the nonmoving party. See Anderson v. Liberty Lobby, Inc. 477 U.S. 242, 250, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986).

In reviewing the evidence, the court draws all reasonable inferences in favor of the non-moving party. See Reeves v. Sanderson Plumbing Prods., Inc., 530 U.S. 133, 150, 120 S.Ct. 2097, 147 L.Ed.2d 105 (2000); Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587–88, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986); Huston v. Procter & Gamble Paper Prod. Corp., 568 F.3d 100, 104 (3d Cir.2009) (citations omitted). It is not the court's role to weigh the disputed evidence and decide which is more probative, or to make credibility determinations. See Anderson, 477 U.S. at 255, 106 S.Ct. 2505;Marino v. Indus. Crating Co., 358...