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Kruszka v. Novartis Pharms. Corp.

United States District Court, D. Minnesota

May 12, 2014

Candice Kruszka and Alan Kruszka, Plaintiffs,
Novartis Pharmaceuticals Corporation, Defendant

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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, counsel 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, counsel for Defendant.

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DONOVAN W. FRANK, United States District Judge.


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.


I. General Background

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.)

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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.

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(Def. Exs., Ex. 32.)[3]

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 (" she is alive today" ).)

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.)

II. Plaintiffs' Expert Dr. Marx

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. (Doc. No. 71 (" Def. Marx Exs." ), Ex. 1 (" Marx Report" ) at ¶ 1.) 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 " bisphosphonate-induced osteonecrosis of the jaw" (" BIONJ" ). ( Id. ¶ 14.) Dr. Marx was initially designated by the MDL Steering Committee to address certain topics addressed in his 2008 expert report. In the MDL proceedings, Novartis's motions to exclude Dr. Marx's testimony were denied in part without further analysis. See In re Aredia & Zometa Prods. Liab. Litig., MDL No. 06-1760 (M.D. Tenn. Aug. 13, 2009).

III. Kruszka's Treating Physicians: Dr. Gertz and Dr. Juhlin

Dr. Morie Gertz (" Dr. Gertz" ) is the oncologist who ultimately took over management

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of Kruszka's treatment from Dr. Silberstein. (Doc. No. 154 (" Odette Causation Expert Aff." ) ¶ 3, Ex. 9 (" Gertz Dep." ) at 105.) His area of expertise is in hematology. ( Id. at 4.) Dr. Gertz has authored three articles on bisphosphonates and, based on his research and experience, his medical opinion is that bisphosphonates cause BRONJ. ( Id. at 6-9.) In treating patients, Dr. Gertz often discontinues bisphosphonates after a year or two for patients who have a " complete response" to myeloma treatment. ( Id. at 66-68, 86, 90.) Dr. Gertz also participated in the authoring of the Mayo Clinic revised guidelines for bisphosphonate use in 2006. (Odette Causation Expert Aff. ¶ 3, Ex. 6.) Dr. Gertz testified that he would have changed his treatment of Kruszka had he known the risks associated with bisphosphonates at the time. (Gertz Dep. at 91, 95, 113.) Dr. Gertz testified that Kruszka's ONJ was bisphosphonate related, but did not diagnose her as having BRONJ at the time of treatment. ( Id. at 96.)

Dr. Todd Michael Juhlin (" Dr. Juhlin" ) is an oral maxillofacial surgeon in Iowa. (Odette Causation Expert Aff. ¶ 3, Ex. 8 (" Juhlin Dep." ) at 3.) Dr. Juhlin treated Kruszka. ( Id.) Dr. Juhlin has treated approximately ten patients with ONJ and has also had patients with osteomyelitis. ( Id. at 23-26.) Dr. Juhlin observed Kruszka with exposed bone in her mouth for approximately eighteen months beginning in 2002 and again at a later date. ( Id. at 41-42, 51.) Dr. Juhlin diagnosed Kruszka with osteomyelitis and recommended extractions and debridement. ( Id. at 52-53.) Dr. Juhlin testified that he has changed his treatment of patients since treating Kruszka based on information related to bisphosphonates. ( Id. at 90, 93, 99.) Dr. Juhlin now believes Kruszka suffered from BRONJ. ( Id. at 99-100.)

IV. Plaintiffs' Expert Dr. Kraut

Dr. Richard Alan Kraut (" Dr. Kraut" ) is Plaintiffs' retained witness who has presented an expert report relating to issues of causation. ( See Doc. No. 102 (" Def. Causation Exs." ), Ex. 27 (" Kraut Report" ).) Dr. Kraut is board-certified in oral and maxillofacial surgery, oral medicine, and dental anesthesia. ( Id. ¶ A.) Dr. Kraut has worked in these areas for decades. ( Id. ) Dr. Kraut has published a study and a related article on patients taking bisphosphonates. ( Id.) Dr. Kraut reviewed Kruszka's medical and dental records in giving his expert opinion. ( Id. ¶ B.) Dr. Kraut states in his report that he performed a " thorough differential diagnosis" in developing his opinion. ( Id. )

V. Claims

Plaintiffs assert the following claims against Defendant: (1) strict liability; (2) negligence -- negligent manufacture; (3) negligence -- failure to warn; (4) breach of express warranty; (5) breach of implied warranty; [4] (7) loss of consortium; and (8) punitive damages. (Doc. No. 39, Am. Compl. ¶ ¶ 18-59.) In its motion, Defendant seeks summary judgment for the following: all liability relating to infusions after January 2002; for Plaintiffs' failure to warn claims; on the grounds that Plaintiffs have no admissible evidence of specific causation; for Plaintiffs' design defect and implied warranty claims; and for punitive damages. Defendant also seeks to exclude the testimony of Dr. Marx relating to six separate issues, and the causation-related testimony of Dr. Gertz, Dr. Juhlin, and Dr. Kraut.

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I. Motions to Exclude Expert Testimony

A. Legal Standard

Before accepting the testimony of an expert witness, the trial court is charged with a " gatekeeper" function of determining whether an opinion is based upon sound, reliable theory, or whether it constitutes rank speculation. Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 589-90, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993) (" Daubert " ). In Daubert, the United States Supreme Court imposed an obligation upon trial court judges to ensure that scientific testimony is not only relevant, but also reliable under the Federal Rules of Evidence. Id. at 579.

Proposed expert testimony must meet three prerequisites to be admissible under Federal Rule of Evidence 702. Lauzon v. Senco Prods., Inc., 270 F.3d 681, 686 (8th Cir. 2001). " First, evidence based on scientific, technical or other specialized knowledge must be useful to the fact-finder in deciding the ultimate issue of fact." Id. " [I]t is the responsibility of the trial judge to determine whether a particular expert has sufficient specialized knowledge to assist jurors in deciding the specific issues in the case." Wheeling Pitts. Steel Corp. v. Beelman River Terminals, Inc., 254 F.3d 706, 715 (8th Cir. 2001). Second, the proposed expert must be qualified. Id. Third, the proposed evidence must be reliable. Id. The proponent of the expert testimony bears the burden to prove its admissibility by a preponderance of the evidence. Daubert, 509 U.S. at 592 n.10.

In determining whether the proposed expert testimony is reliable, the Court can consider: (1) whether the theory or technique can be and has been tested; (2) whether the theory or technique has been subjected to peer review and publication; (3) the known rate of potential error; and (4) whether the theory has been generally accepted. Id. at 593-94. The purpose of these requirements " is to make certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field." Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 152, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999).

In Kumho Tire, the Supreme Court concluded that " the trial judge must have considerable leeway in deciding in a particular case how to go about determining whether particular expert testimony is reliable." Id. In other words, a trial court should consider the specific factors identified in Daubert where there are reasonable measures of the reliability of expert testimony. Id. The ...

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