Kruszka v. Novartis Pharm. Corp.
| Decision Date | 12 May 2014 |
| Docket Number | Civil No. 07–2793 DWF/JJK. |
| Citation | 19 F.Supp.3d 875 |
| Parties | Candice KRUSZKA and Alan Kruszka, Plaintiffs, v. NOVARTIS PHARMACEUTICALS CORPORATION, Defendant. |
| Court | U.S. District Court — District of Minnesota |
John A. Girardi, Esq., and Molly B. Weber, Esq., Girardi & Keese, John J. Vecchione, Esq., Valad & Vecchione PLLC, Yvonne M. Flaherty, Esq., Elizabeth R. Odette, Esq., and Robert K. Shelquist, Esq., Lockridge, Grindal, Nauen, PLLP, for Plaintiffs.
Donald R. McMinn, Esq., Katharine R. Latimer, Esq., and Peter J. Skalaban, Jr., Esq., Hollingsworth LLP, Amy R. Fiterman, Esq., Christine R.M. Kain, Esq., Demoya R. Gordon, Esq., James A. O'Neal, Esq., Joseph M. Price, Esq., Linda S. Svitak, Esq., and M. Joseph Winebrenner, Esq., Faegre Baker Daniels LLP, for Defendant.
This matter is before the Court on the following motions: (1) Defendant Novartis Pharmaceuticals, Corporation's (“Novartis” or “Defendant”) Motion for Summary Judgment (Doc. No. 116) against Plaintiffs Candice Kruszka (“Kruszka” or “Plaintiff”) and her husband Alan Kruszka (“Mr. Kruszka”) for claims that Kruszka suffered osteonecrosis of the jaw (“ONJ ”) (or dead jaw bone) as a result of using Novartis's product Aredia ®; (2) Novartis's Motion to Exclude Expert Testimony (Causation Testimony) of Plaintiffs' Case–Specific Retained and Non–Retained Expert Witnesses (Doc. No. 94); and (3) Novartis's Motion to Exclude Expert Testimony of Plaintiffs' Expert Dr. Robert Marx (Doc. No. 61). For the reasons set forth below, the Court grants in part and denies in part the motions.
Aredia ® (“Aredia ”) is produced and marketed by Novartis.1 Aredia is recognized to extend life, reduce skeletal complications and reduce pain for patients with multiple myeloma, a form of blood cancer. (Doc. No. 119 (“Def. Exs.”), Ex. 5.) Aredia is part of a class of medications that are known as bisphosphonates, and can be administered intravenously. (Id., Ex. 4.) The primary active ingredient of Aredia is pamidronate disodium (“pamidronate ”). (Id. ) Aredia received FDA approval in 1991 for treating hypercalcemia of malignancy, in 1995 for treating multiple myeloma, and in 1996 for treating bone metastases of breast cancer. (Id., Exs. 8–9.) A generic version of pamidronate was first approved by the FDA in 2001, and others followed. (Id., Ex. 10.)
On June 13, 2000, Kruszka, who was fifty-one years old,2 presented to her doctor with severe back and hip pain and was unable to sit up or walk. (Id., Exs. 13–15.) During her hospital stay, on June 15, 2000, she was diagnosed with blood cancer in the form of multiple myeloma which resulted in hypercalcemia, a compression fracture in her spine, and “lytic” lesions in her skull, spine, and bones. (Id., Exs. 13 & 16 (“Silberstein Dep.”) at 55–58.) Her oncologist, Dr. Silberstein, found multiple areas of holes in her bones. (Silberstein Dep. at 57.) During her hospital stay in June 2000, she also suffered an additional fracture in her shoulder due to the brittleness of her bones. (Def. Exs., Ex. 18 (“Kruszka Dep.”) at 119.) Multiple myeloma patients' survival rate is approximately six months where no treatment is received. (Def. Exs., Ex. 3.) Kruszka was told she could expect to live six weeks without treatment (Kruszka Dep. at 115–16; Silberstein Dep. at 60–61). On June 15, 2000, Doctor Silberstein immediately prescribed Kruszka Aredia at the Mercy Cancer Center—North Iowa (“Mercy”) to protect against bone damage. (Silberstein Dep. at 58–59, 63–65; Def. Exs., Ex. 19.) Kruszka was also treated with chemotherapy consisting of vincristine, adriamycin, and dexamethasone (VAD) at the time of her diagnosis. (Def. Exs., Ex. 20.)
Kruszka ultimately received just over fifty doses of pamidronates, with her final dose on February 9, 2005. (See Doc. No. 158 (“Odette Aff.”) ¶ 3, Ex. 7; Def. Exs., Ex. 41.)
Plaintiff's medical records indicate infusions of Aredia. (Def. Exs., Ex. 41.) Sales reports from Mercy indicate that Mercy purchased branded Aredia until January 18, 2002, after which Mercy only purchased and sold generic pamidronate products. (Id., Ex. 12 (“Osland Aff.”) ¶¶ 6–9.) Generic drugs dominated the pamidronate market beginning in 2002. (Id., Ex. 11 (“Chee Decl.”) ¶¶ E, F.)
In January 2001, almost a year after Kruszka started Aredia and VAD therapy, she required a stem cell transplant. (Kruszka Dep. 114; Def. Exs., Ex. 21.) On January 24, 2001, prior to the transplant, Kruszka underwent a dental examination. (Def. Exs., Ex. 22.) The oral surgeon, Dr. Keller, noted periodontal disease and determined that Tooth # 17 needed to be extracted because it was non-restorable and due to risks of ONJ. (Id., Exs. 22, 23.) On the same day, Dr. Keller extracted Tooth # 17. (Id. ) Four days after the extraction, Kruszka was placed on Melphalan chemotherapy and then a day later underwent the stem cell transplant. (Id., Ex. 26.)
In September 2002, Kruszka presented to her dentist Dr. Nettleton for pain in her lower left jaw and reported that the area had not healed properly following the Tooth # 17 extraction. (Id., Ex. 28; Kruszka Dep. at 160–62.) Dr. Nettleton observed exposed bone in the lower left mandible area, and referred Kruszka to an oral and maxillofacial surgeon, Dr. Juhlin. (Def. Exs., Ex. 28.) During her September 19, 2002 visit, Dr. Juhlin did not observe any infection in the area. (Odette Aff. ¶ 3, Ex. 10.) Kruszka reported continued pain to Dr. Nettleton. (Id., Ex. 9.) On October 3, 2002, Dr. Juhlin removed dead bone from the area and placed Kruszka on antibiotics. (Def. Exs., Ex. 29.) Continuing through October and November 2002, Kruszka continued to visit doctors for her pain, and each doctor concluded that she did not show a sign of infection. (Odette Aff. ¶ 3, Exs. 8, 10.)
On December 27, 2002, Dr. Juhlin extracted Kruszka's Tooth # 21. (Id., Ex. 10.) On January 7, 2003, at her follow-up visit, Dr. Juhlin recorded no sign of infection. (Id. ) Kruszka reported continued dental pain in February 2003 at Mayo Clinic (“Mayo”). (Id., Ex. 8.)
On March 12, 2003, Kruszka returned to Dr. Nettleton's office, and staff was not able to make any conclusions regarding her condition. (Id., Ex. 9; Kruszka Dep. at 46.) On March 17, 2003, Kruszka reported pain and bone fragments protruding through her gum to Dr. Juhlin. (Odette Aff. ¶ 3, Ex. 10.) On March 18, 2003, Kruszka was observed at Mayo and was instructed to take on a non-chew diet and to limit mouth opening. (Id., Ex. 8.) That same day, Dr. Juhlin observed exposed bone, no signs of infection, and recommended a surgical exploration and mandibular debridement procedure for her pain. (Id., Ex. 10.)
On April 3, 2003, Kruszka underwent a debridement procedure and extraction of Tooth # 19. (Def. Exs., Ex. 30; Odette Aff. ¶ 3, Ex. 10.) At that visit, Dr. Juhlin diagnosed Kruszka with chronic osteomyelitis (infection in the bone). (Def. Exs., Ex. 30; Odette Aff. ¶ 3, Ex. 10.) Dr. Juhlin submitted a specimen of the dead bone for pathological analysis. (Def. Exs., Ex. 30; Odette Aff. ¶ 3, Ex. 10.) The pathologist found inflammation within the bone marrow and “confirm[ed] the presen[ce] of osteomyelitis ” in the bone.
On April 28, 2003, Kruszka returned to Dr. Juhlin with facial swelling and had an abscess in her left mandible drained. (Id., Ex. 33.) Dr. Juhlin then referred Kruszka to an infectious disease specialist, Dr. Terrell, at Mayo to treat her jaw problems. (Id., Ex. 34.) Dr. Terrell diagnosed Kruszka with osteomyelitis and prescribed Kruszka a prolonged (more than six month) course of four different antibiotics after determining that her prior treatments were “suboptimal.” (Id., Exs. 36 & 37 (“Terrell Dep.”) at 26–27, 31–34.)
On August 27, 2003, Dr. Juhlin again removed dead bone from the area. (Def. Exs., Ex. 38.) At that time, Kruszka's condition was generally resolved. (Kruszka Dep. at 172–75, 237–39.) In August 2004, however, Kruszka complained of numbness in her jaw, chin, and lip resulting in difficulty swallowing and chewing, a “deformed face,” and other issues. (Odette Aff. ¶ 3, Ex. 11; Kruzska Dep. at 53, 72, 171–72, 175–78.) Kruszka alleges the damage to her face and jaw has changed her life dramatically, including her speech, eating, social interactions, and she alleges she had to give up her church choir. (Kruszka Dep. at 53–54, 192–93, 223–24.) Kruszka did not suffer additional bone fractures until May 2008, and as of November 2013, was still alive. (Def. Exs., Ex. 42; see Doc. No. 118 at 12 ().)
With respect to Aredia, in May 2004, Dr. Gertz, an oncologist who treated Kruszka, gave her information regarding an association between bisphosphonate use and the development of ONJ ; that was the first time she received this type of information on Aredia. (Def. Exs., Ex. 40.)
Novartis first started providing warnings relating to an association between bisphosphonate use and ONJ in its FDA-approved labeling of Aredia and Zometa in September 2003. (Id., Exs. 62 & 63.) Novartis revised the label a second time in 2004 to include precautions relating to dental procedures. (See id., Exs. 66 & 67.) Novartis also sent thousands of “Dear Doctor” letters on these issues in September 2004. (Id., Ex. 68.)
Dr. Robert Marx, D.D.S. (“Dr. Marx”) is a board-certified oral and maxillofacial surgeon at the University of Miami School of Medicine and has practiced in the area for decades. He is involved in research and a number of publications relating to bisphosphonates and ONJ. (Id. ¶¶ 5, 10.) He is one of the first medical professionals to have explored a connection between bisphosphonates and ONJ. (Id. ¶ 10.) In this case, and a number of other related cases, Dr. Marx seeks to provide (or has provided) his expert opinion with respect to what is called ...
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