United States District Court, D. Oregon
For Plaintiff: JEFFREY A. BOWERSOX, Lake Oswego, OR; ROBERT G. GERMANY, Pittman, Germany, Roberts & Welsh, LLP, Jackson, MS; MELANIE H. MUHLSTOCK, Parker Waichman Alonso LLP, Port Washington, NY.
For Defendant: ANNE M. TALCOTT, MARGARET A. HOFFMANN, RYAN P. BOYLE, JEFFREY D. HERN, REBECCA A LINDEMANN, Schwabe Williamson & Wyatt, PC, Portland, OR; KATHARINE R. LATIMER, GREGORY SCOTT CHERNACK, JOHN KALAS, Hollingsworth LLP, Washington, DC.
OPINION AND ORDER
ANNA J. BROWN, United States District Judge.
This matter comes before the Court on Defendant Novartis Pharmaceuticals Corporation's Motion (#65) to Find that Punitive Damages Are Unavailable and/or to Apply New Jersey Law to the Issue of Punitive Damages. For the reasons that follow, the Court concludes New Jersey law applies to the issue of punitive damages, and, as a result, punitive damages are unavailable in this matter. Accordingly, the Court GRANTS Defendant's Motion.
Plaintiff Patricia Stromenger is an Oregon resident who was diagnosed with breast cancer in November 2001.
In January 2002 Plaintiff's cancer metastasized to her bones. Approximately one month later the Food and Drug Administration (FDA) approved the cancer drug Zometa as safe and effective to treat bone metastases from solid tumors.
In April 2002 Keith Lanier, M.D., Plaintiff's treating oncologist, began intravenously infusing Plaintiff with Zometa on a monthly basis in an effort to promote " reduction of cancer-related bone events, for accelerated bone healing and for possible survival prolongation."
In May 2002 after Plaintiff received a single dose of Zometa, Barry Taylor, D.D.S., extracted Plaintiff's root tip from tooth #28. Plaintiff's tooth #28 had been extracted previously from her right lower jaw.
In September 2002 Plaintiff was referred to Eric Dierks, D.D.S., an oral surgeon, for evaluation of Plaintiff's right lower jaw. Plaintiff advised Dr. Dierks that she had recently undergone a dental extraction and had developed an infection, which did not clear up after treatment with antibiotics. Plaintiff also reported her concern with ongoing swelling and drainage of her right mandible. Dr. Dierks diagnosed Plaintiff with acute osteomylitis of the jaw.
In August 2003 reports of osteonecrosis of the jaw (ONJ) in patients using bisphosphonates such as Zometa began to surface in medical literature. Also in August 2003 Defendant submitted a label change for Zometa to the FDA. Specifically, Defendant added the following paragraph to the " Adverse Reactions" section of the package insert:
Cases of osteonecrosis (primarily of the jaws) have been reported since market introduction. Osteonecrosis of the jaws has other well documented multiple risk factors. It is not possible to determine if these events are related to Zometa or other bisphosphonates, to concomitant drugs or other therapies ( e.g., chemotherapy, radiotherapy, corticosteroid), to patient's underlying disease, or to other co-morbid risk factors ( e.g., anemia, infection, pre-existing oral disease).
Def.'s Mem. in Support of Mot. (#32) for Summ. J., Ex. 13 at 3. The labeling revision was made available to the public in December 2003.
In January 2004 Dr. Dierks noted Plaintiff was " dealing with a Zometa related osteonecrosis [of the jaw] that has become secondarily infected."
In February 2004 Defendant updated the Zometa label to provide:
Osteonecrosis of the jaw (ONJ) has been reported in patients with cancer receiving treatment regimens including bisphosphonates. Many of these patients were also receiving chemotherapy and corticosteroids. The majority of reported cases have been associated with dental procedures such as tooth extraction. Many had signs of local infection including osteomylitis.
A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors ( e.g., cancer, chemotherapy, corticosteroids, poor oral hygiene).
While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/ risk assessment.
Def.'s Mem. in Support of Mot. (#32) for Summ. J., Ex. 16 at 12.
In March 2004 Dr. Lanier discontinued Plaintiff's monthly dose of Zometa based on Dr. Dierks's recommendation.
In April 2004 Plaintiff's gums had receded to the point that bone in her right mandible was exposed. In April 2004 Dr. Dierks removed the sequestrum (the piece of dead bone separated from the sound bone during the process of necrosis) in Plaintiff's jaw.
In May 2004 Dr. Dierks discussed with Plaintiff his " hope that she would go on to complete healing" because " the necrotic bone had been cleanly removed [in the April 2004 debridement]."
In June 2004 Plaintiff and Dr. Lanier discussed further bisphosphonate therapy. Dr. Lanier advised Plaintiff that she " needed to wait until she was completely healed and at that point [he] would reconsider reinstitution of bisphosphonate[s] . . . on a quarterly basis."
In September 2004 Plaintiff and Dr. Dierks " discussed the fact that Zometa related osteonecrosis has no known cure and the timeline for its resolution is also unknown."
In November 2004 Plaintiff consulted Dr. Lanier and asked " [a] number of questions . . . regarding bisphosphonate osteonecrosis."
In January 2006 Plaintiff saw a television commercial discussing actions filed by individuals who allegedly developed ONJ as a result of taking Zometa. Plaintiff called her family attorney about the Zometa issue because that " was the first time she suspected that there was something wrong with the drug that was connected to [her] condition." Plaintiff's family attorney referred her to attorneys more familiar with the Zometa litigation.
On August 29, 2006, Plaintiff brought an action against Defendant in the Superior Court of New Jersey seeking compensatory and punitive damages on the ground that Zometa caused her to develop ONJ. Plaintiff brought claims for (1) defective design, (2) failure to warn, (3) breach of implied warranty, and (4) negligence, all in violation of N.J.S.A. 2A:58C-1, et seq . Plaintiff also brought a claim for violation of the New Jersey Consumer Fraud Act (NJCFA), N.J.S.A. 56:8-1, et seq., and a claim for punitive damages under the New Jersey Punitive Damages Act, N.J.S.A. 2A:15-5.9 and N.J.S.A. 2A:58C-1, et seq .
On October 13, 2006, Defendant removed the matter to the United States District Court for the District of New Jersey on the basis of federal-question jurisdiction.
At some point the Judicial Panel on Multidistrict Litigation (MDL) transferred the action under 28 U.S.C. § 1407 to the United States District Court for the Middle District of Tennessee.
Following discovery and briefing of dispositive motions in the MDL court, the MDL panel remanded the matter to the United States District Court for the District of New Jersey.
In April 2012 the United States District Court for the District of New Jersey transferred the matter to this Court.
On June 27, 2012, Defendant filed a Motion for Summary Judgment on the grounds that " [u]nder the statute of limitations operative in Oregon at the time of plaintiff's injury, Oregon Revised Statute § 30.905, plaintiff's product liability suit was untimely. Even under the amended version of Oregon Revised Statute § 30.905, effective January 1, 2004, her suit was untimely."
On October 22, 2012, Magistrate Judge Dennis James Hubel issued Findings and Recommendation in which he recommended the Court deny Defendant's Motion for Summary Judgment. Defendant filed timely Objections.
On December 11, 2012, this matter was reassigned from Magistrate Judge Hubel to this Court.
On December 18, 2012, this Court issued an Order adopting the Findings and Recommendation and denying Defendant's Motion for Summary Judgment.
On February 22, 2013, Defendant filed a Motion to Find that Punitive Damages are Unavailable and/or to Apply New Jersey Law to the Issue of Punitive Damages.
On April 9, 2013, the Court heard oral argument on Defendant's Motion and took the matter under advisement.
I. New Jersey's choice-of-law rules apply to resolve the ...