United States District Court, M.D. Alabama, Northern Division
[Copyrighted Material Omitted]
For Deborah Garrison, Plaintiff: Samuel R Harris , III, LEAD ATTORNEY, PRO HAC VICE, Girardi Keese, Raleigh, NC; Annesley Hodges DeGaris, Cory, Watson, Crowder & DeGaris, Birmingham, AL; John Albert Girardi, PRO HAC VICE, Girardi & Keese, Los Angeles, CA; John J. Vecchione, PRO HAC VICE, Valad and Vecchione, PLLC, Fairfax, VA.
For Novartis Pharmaceuticals Corporation, a Delaware corporation, Defendant: Bruce J Berger, Patrick R. Harkins, Philip M. Busman, LEAD ATTORNEYS, PRO HAC VICE, Katharine Ruth Latimer, Robert Eric Johnston, PRO HAC VICE, Hollingsworth LLP, Washington, DC; Frederick George Helmsing , Jr., LEAD ATTORNEY, Edward Simmons Sledge , III, McDowell, Knight, Roedder & Sledge, L.L.C., Mobile, AL; Matthew J Malinowski, LEAD ATTORNEY, PRO HAC VICE, Washington DC; .
MEMORANDUM OPINION AND ORDER
W. Keith Watkins, CHIEF UNITED STATES DISTRICT JUDGE.
Before the court are Defendant Novartis Pharmaceuticals Corporation's motion for summary judgment (Docs. # 45, 46) and its motion to exclude certain testimony of Dr. Vishtasb Broumand (Doc. # 47). Each motion has been fully briefed, and the motion for summary judgment has been supplemented with additional authorities. ( See Docs. # 51, 53, 63, 67, 69 (motion for summary judgment); 60, 61 (motion to exclude Dr. Broumand).) Upon consideration of the parties' arguments, the evidence, and the relevant law, the court finds that the motions are due to be granted.
I. JURISDICTION AND VENUE
The court has subject-matter jurisdiction over this case pursuant to 28 U.S.C. § 1332(a). The parties do not contest personal jurisdiction or venue.
1. Aredia ® and Zometa ®
Ms. Garrison has suffered osteonecrosis, or bone death, of the jaw (" ONJ" ) which has rendered her permanently disfigured and caused enduring pain. She alleges two drugs, Aredia ® and Zometa ® , which were marketed, distributed, promoted, tested, labeled, and sold by Novartis, caused her injuries. Zometa ® is the successor drug of Aredia ® , and both are reported to increase the risk of developing ONJ. Both drugs are nitrogenous bisphosphonates that are prescribed by doctors for the management of metastatic disease to the bone and other degenerative bone conditions. Bisphosphonates are useful for the prevention of the loss of bone mass because they inhibit osteoclasts, the bone cells that re-absorb and destroy old bone tissue.
However, bisphosphonates can have devastating effects on the jaw. The jaw bone
is unique in that it is subject to heightened stress, and thus, it " remodels" -- i.e., replaces old bone with new bone -- at a faster than normal rate as compared to other bones. Bisphosphonates like Aredia ® and Zometa ® have an alleged " site preference" for high remodeling areas and thus impact those areas more markedly. The drugs can cause changes to both the lower and upper jaw bones (the mandible and maxilla, respectively). Patients who have been exposed to bisphosphonates can develop ONJ many years after receiving bisphosphonate therapy because the drugs have a long half-life in the bone. The same patients also have a particularly heightened risk for developing ONJ following oral surgery.
In her complaint, Ms. Garrison alleges that Novartis knew or should have known that bisphosphonate drugs could cause ONJ. She claims that as early as 1996, Novartis knew that ONJ had been reported in clinical trials and that by 2002, Novartis had learned from doctors and oral surgeons that some patients who had received bisphosphonate treatments were suffering with severe ONJ symptoms. Novartis did not begin to place warnings about ONJ on its drugs until September 2004, and it did not notify dental professionals of ONJ risks until May 2005. She claims that Novartis has continued to downplay the known risks of taking Aredia(r) and Zometa ® , has rebranded the drugs' names to conceal the negative connection to ONJ, and has misreported safety data to the Food and Drug Administration.
2. Ms. Garrison's Medical History
In 1998, a metastatic bone survey revealed osteopenic lesions and degenerative bone changes in Ms. Garrison's cervical spine. These changes in her spine required two different surgeries in 1999. Ms. Garrison received care from David Morrison, M.D., and later, Khalid Matin, M.D., both oncologists at Montgomery's Cancer Center. By September 2001, Dr. Morrison formally diagnosed Ms. Garrison with Stage 1a Dune-Salmon multiple myeloma, a bone cancer that causes bone lesions, bone pain, and bone deterioration.
Under Dr. Morrison's care, Ms. Garrison received intravenous infusions of Aredia ® from September 2001 until April 2002. At that time, Novartis offered no warnings of ONJ, and it is undisputed that Dr. Morrison did not convey the risk of ONJ to Ms. Garrison when he first prescribed bisphosphonate therapy. Dr. Morrison stopped the bisphosphonate therapy for a period of time because Ms. Garrison's cancer was in remission and the drug was not ameliorating her bone pain.
In September 2005, Ms. Garrison began taking intravenous Zometa ® treatments. By that time, Novartis had updated its warnings and had notified doctors of the reported risk of ONJ. Dr. Morrison claims that he communicated the risk of ONJ to Ms. Garrison in September 2005, ( see Morrison Dec., at ¶ ¶ 5-6 (Doc. # 46-1)), but Ms. Garrison denies that she was warned.
In 2009, Ms. Garrison experienced pain in her left jaw and a fever, and her symptoms worsened even though she took a
lengthy course of antibiotics. Ms. Garrison reports that she maintained regular dental hygiene and that her jaw pain was not caused by a lack of dental care. The jaw pain caused her to have difficulty eating and sleeping. In January 2009, Dr. Matin, who by that point had become Ms. Garrison's treating oncologist, discontinued the Zometa ® treatments because Ms. Garrison was considering oral surgery and Dr. Matin wanted to reduce the heightened risk of developing ONJ.
In April 2009, Ms. Garrison consulted Dr. David Roden, an oral maxillofacial surgeon at the University of Alabama at Birmingham (" UAB" ) Oral Surgery Clinic. Dr. Roden observed purulent discharge ( i.e., pus) and recommended extraction of fractured tooth # 20 on Ms. Garrison's left mandible. Purulent discharge is indicative of osteomyelitis, an inflammation of the bone caused by a bacterial infection. At that time, Dr. Roden did not observe any exposed necrotic bone, and Ms. Garrison's x-rays did not indicate ONJ. Ms. Garrison waited about a year before having tooth # 20 extracted by another dentist in Montgomery.
In July 2010, Ms. Garrison returned to UAB and saw Dr. Victor Szymela who discovered exposed necrotic bone in the left mandible at the extraction site. A CT scan taken on June 28, 2010, revealed " erosion of the left body of the mandible with periosteal new bone formation, suggesting chronic inflammation that is seen in ONJ." (Broumand Rep., at 4 (Doc. # 60-5, at 5).) Ms. Garrison has continued to have exposed necrotic bone and to endure pain in her jaw, which has been observed and treated by Dr. Szymela, Dr. Somsak Sittitavornwong, and Dr. Lisa Miller. Under their care, Ms. Garrison's jaw has failed to respond to multiple debridements, intravenous and/or oral antibiotics, and other conservative therapies. Dr. Miller, a board certified oral and maxillofacial surgeon, performed a biopsy of Ms. Garrison's jaw bone in January 2011, which revealed necrotic bone consistent with osteonecrosis. At that time, Dr. Miller diagnosed Ms. Garrison with bisphosphonate-related ONJ.
B. Procedural History
Ms. Garrison filed this suit in July 2011. Her complaint alleges strict liability (Count I), negligent manufacture (Count II), negligent failure to warn (Count III), and breach of implied warranty (Count V), and seeks compensatory and punitive damages and attorneys' fees and costs. The case remained stagnant for about fourteen months while the parties anticipated transfer by the Judicial Panel on Multidistrict Litigation to the Middle District of Tennessee. Once it later became clear that the JPML would not transfer the ...