Stevens v. Novartis Pharmaceuticals Corp.., DA 10–0029.

• Docket Nº: No. DA 10–0029.
• Citation: 2010 MT 282, 358 Mont. 474, 247 P.3d 244
• Case Date: December 30, 2010
• Court: United States State Supreme Court of Montana

358 Mont. 474
247 P.3d 244
2010 MT 282

Peggy L. STEVENS, Plaintiff, Cross–Appellant and Appellee,
v.
NOVARTIS PHARMACEUTICALS CORPORATION, Defendant and Appellant.

No. DA 10–0029.

Supreme Court of Montana.

Argued and Submitted Sept. 23, 2010.Decided Dec. 30, 2010.

[247 P.3d 247]

For Appellant: W. Carl Mendenhall; Worden Thane P.C.; Missoula, Montana, Joe G. Hollingsworth, Katharine R. Latimer; Hollingsworth LLP; Washington, District of Columbia, Rebecca Anne Womeldorf (argued); Washington, District of Columbia.For Appellee/Cross–Appellant: Terry N. Trieweiler (argued); Trieweiler Law Firm; Whitefish, Montana, James T. Towe; Towe Law Offices; Missoula, Montana, Robert G. Germany; Pittman, Germany, Roberts & Welsh, LLP; Jackson Mississippi, Bartlett T. Valad; Valad & Vecchione, PLLC; Fairfax, Virginia.Justice W. WILLIAM LEAPHART delivered the Opinion of the Court.

[358 Mont. 475] ¶ 1 A Missoula County jury returned a verdict awarding Peggy Stevens (Stevens) $3,200,000.00 in compensatory damages in Stevens' action for negligence against Novartis Pharmaceuticals Corporation (Novartis). Stevens alleged that Novartis failed to properly warn that its drug, Zometa, causes osteonecrosis of the jaw (ONJ) in patients who undergo dental surgery while taking the drug. The District Court denied Novartis' motions for summary judgment, ruled against Novartis on several evidentiary issues, and denied post-trial motions for judgment as a matter of law and for a new trial. Novartis appeals these rulings. Stevens cross-appeals, claiming that the trial court erred in denying Stevens permission to file an amended complaint, in dismissing a Novartis sales representative from the action, and in offsetting social security disability benefits against the jury award.

¶ 2 We affirm in part and reverse in part.

¶ 3 We consider the following issues on appeal:

¶ 4 1. Whether the District Court erred in denying Novartis' motion for summary judgment.

¶ 5 2. Whether the District Court erroneously instructed the jury as to Novartis' duty to warn.

¶ 6 3. Whether the District Court erred in refusing Novartis permission to amend its answer to include an apportionment defense.

[358 Mont. 476] ¶ 7 4. Whether the District Court erred in excluding statements in prior pleadings that were allegedly inconsistent with Novartis' liability.

¶ 8 5. Whether the District Court erred in admitting testimony regarding a change to Novartis' warning label.

¶ 9 6. Whether Novartis is entitled to judgment as a matter of law because Stevens failed to prove proximate causation.

¶ 10 7. Whether the District Court erred in refusing Stevens permission to amend her complaint to include a claim for punitive damages.

¶ 11 8. Whether the District Court erred in offsetting social security disability benefits against the general damages awarded by jury.

¶ 12 9. Whether the District Court erred in dismissing Stevens' negligence claims against Patrick Doyle, a sales representative for Novartis.

FACTUAL AND PROCEDURAL BACKGROUND

¶ 13 Peggy Stevens was diagnosed with follicular lymphoma in October 2000 by Dr. Judy Schmidt (Dr. Schmidt), a Missoula oncologist. At the time, Stevens served as the house supervisor at Community Medical Center, where she had been employed for nearly 20 years. In April 2002, Dr. Schmidt prescribed Novartis' drug Zometa to Stevens after finding lymphoma in Stevens' spine, pelvis and ribs. Zometa, like other drugs in the “bisphosphonate” family, is administered intravenously to cancer patients who are at risk of bone fractures and other bone-related problems due to cancer-weakened skeletal systems. Zometa works by attacking cells called “osteoclasts” that normally dissolve old bone, which has the result of hardening bones to make them more resilient. At the

[247 P.3d 248]

time Dr. Schmidt prescribed Zometa to Stevens in April 2002, the drug had only recently been approved by the Federal Drug Administration (FDA), and no serious reports of any negative side effects had arisen.

¶ 14 Experts soon began to take note, however, of the large number of ONJ patients who were also taking bisphosphonates. Several months after Stevens began taking Zometa, Dr. Robert Marx, a leading national expert, published an award-winning medical textbook which first mentioned the possible link between ONJ and bisphosphonates. Novartis responded in September 2003 by changing the Zometa label to include a mention of ONJ, stating that “cases of [ONJ], primarily of the jaws, have been reported since market introduction.” The label also [358 Mont. 477] stated, however, that ONJ has “other well-documented risk factors,” and “it is not possible to determine if [cases of ONJ] are related to Zometa.” The label pointed to chemotherapy and smoking as the more likely and more well-established causes of ONJ.

¶ 15 Dr. Marx continued to sound the alarm, writing of a “growing epidemic” of ONJ in bisphosphonate patients. In December 2003, Novartis convened an advisory panel on the subject in coordination with the American Society of Clinical Oncology. The panel included Dr. Marx and another expert, Dr. Salvatore Ruggiero, who had echoed Dr. Marx's reports of ONJ-bisphosphonate linkage. In March 2004, a second panel was convened at Novartis headquarters, again with Dr. Marx, Dr. Ruggiero, and other leading national figures present. A main goal of this second panel was to draft a “white paper” on the topic, which was eventually published in June 2004. The white paper was met with heavy criticism from Dr. Marx and others. They asserted that the paper failed to admit the clear causal relationship between bisphosphonates and ONJ, and that it misleadingly identified other factors such as chemotherapy and smoking as the more likely causes of ONJ in bisphosphonate patients. In the same month the paper was released, Novartis again changed its Zometa label, adding that the majority of reported cases of ONJ were “in cancer patients attendant to a dental procedure” and advising that “although causality cannot be determined, it is prudent to avoid dental surgery as recovery may be prolonged.”

¶ 16 Stevens continued visiting Guardian Oncology for treatment, although her relationship with Dr. Schmidt no longer included active consultation. Instead, Stevens interacted with the nursing staff and visiting physicians at the clinic. She began having pain in her jaw in August 2004, and was subsequently advised that her tooth was cracked and she would need to have surgery to remedy the problem. Stevens called Guardian Oncology on August 31, 2004, in connection with the upcoming dental procedure. She advised clinic staff and locum tenens physicians that she needed to have dental work done and was planning on having her tooth extracted (a much less expensive procedure than alternative possibilities such as root canal therapy and crown lengthening) in the near future. No concerns regarding ONJ were raised, and Stevens made an appointment with Dr. Eugene Morris, an oral surgeon, for the procedure. Dr. Morris was unaware that Stevens was taking Zometa, but testified that even if he had known, it would not have made a difference as he was unaware of the relationship between Zometa and ONJ until 2006. Dr. Morris [358 Mont. 478] performed the extraction on September 27, 2004.

¶ 17 Within days, Stevens began having additional pain at the extraction site. She went on an antibiotic regimen, but the pain failed to abate. Stevens reported the continuing problem to Dr. Schmidt, who ordered an MRI in early 2005. The MRI suggested that Stevens had contracted ONJ, which was confirmed by further testing. Stevens stopped taking Zometa around this time, although the drug was still present in her body as it has a half-life of over a decade. While Stevens' ONJ continued to develop into a serious problem, her cancer was in remission, as it has been ever since. In October 2006, exposed bone first became visible at the extraction site. In April 2007, Stevens took what was intended to be a temporary break from work, but could not return to work without pain medication. Because Community Hospital requires its employees to abstain from all narcotics while on duty, however,

[247 P.3d 249]

Stevens was forced to abandon her position. She has been out of work ever since. ONJ has no cure and is progressive, and thus Stevens' condition will only deteriorate as more of her jawbone dies. Like all ONJ patients, Stevens suffers from chronic pain and constant infection, and manages her condition with antiseptic mouthwash, antibiotics, and powerful narcotics for pain.

¶ 18 The growing recognition of a link between ONJ and bisphosphonates caused reverberations in the courtroom as well as the medical community. On September 15, 2005, three class action suits were filed against Novartis in federal court in Tennessee. In one of these suits, Susan Becker, et al. v. Novartis Pharms. Corp., No. 3:05–0719 (M.D.Tenn.), counsel for the named plaintiffs sought to represent a worldwide class of plaintiffs who contracted ONJ after using Zometa. The suit alleged failure to warn, among other claims, and sought damages for personal injuries. Class certification was eventually denied and claims were ordered severed on November 14, 2007. During the pendency of the suit, the linkage between bisphosphonates, dental surgery, and ONJ had become widely accepted. Novartis had long since sent a “Dear Doctor” letter to doctors regarding Zometa and other bisphosphonates, admitting that the ONJ-bisphosphonate link was no longer an unproven hypothesis, but rather an established medical conclusion.

¶ 19 In August 2007, Stevens brought an action against Dr. Schmidt and Dr. Morris before the Montana Medical Legal Panel (MMLP), alleging failure to warn of the risk of contracting ONJ as a result of dental surgery while on Zometa. Dr. Schmidt responded that she did not have knowledge of these risks, and Dr. Morris responded that [358 Mont. 479] there were no other feasible options...