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Kruszka v. Novartis Pharmaceuticals Corp.
Citations: 19 F. Supp. 3d 875; 2014 WL 1878771Docket: Civil No. 07-2793 (DWF/JJK)
Court: District Court, D. Minnesota; May 19, 2014; Federal District Court
The Court is addressing several motions in a case involving Plaintiffs Candice Kruszka and Alan Kruszka against Defendant Novartis Pharmaceuticals regarding claims that Kruszka developed osteonecrosis of the jaw (ONJ) due to the use of the drug Aredia, produced by Novartis. The motions include Novartis's request for summary judgment against the Kruszkas, as well as two motions to exclude expert testimony related to causation and the testimony of Dr. Robert Marx. The Court partially grants and partially denies these motions. Aredia, a bisphosphonate medication, is recognized for extending life and alleviating complications in patients with multiple myeloma, a serious form of blood cancer. Kruszka was diagnosed with multiple myeloma on June 15, 2000, after presenting with severe pain and other related complications. She began treatment with Aredia on the same day to protect her bones. Kruszka received over fifty doses of the drug until February 2005, while also undergoing chemotherapy. Following her treatment, she required a stem cell transplant in January 2001. A dental examination prior to the transplant revealed periodontal disease, leading to the extraction of an irreparable tooth due to the risk of ONJ. The medical records indicate that Kruszka's hospital used branded Aredia until 2002, after which generic versions became predominant. In September 2002, Kruszka sought dental treatment from Dr. Nettleton for pain in her lower left jaw following an extraction of Tooth 17, where exposed bone was noted. She was referred to oral surgeon Dr. Juhlin, who found no infection during her initial visit on September 19, 2002. Despite ongoing pain and multiple consultations, including an October 3 procedure where dead bone was removed and antibiotics prescribed, no signs of infection were identified by several doctors through November 2002. Dr. Juhlin extracted Tooth #21 on December 27, 2002, and confirmed the absence of infection during a follow-up on January 7, 2003. However, Kruszka reported persistent dental pain at Mayo Clinic in February 2003 and later returned to Dr. Nettleton with inconclusive findings in March. On March 17, she noted pain and bone fragments, leading to dietary restrictions and a recommendation for surgical exploration by Dr. Juhlin, who observed exposed bone without infection on March 18. Kruszka underwent a debridement procedure and Tooth 19 extraction on April 3, 2003, where she was diagnosed with chronic osteomyelitis. Pathological analysis confirmed inflammation and osteomyelitis in the bone. Following further complications, including facial swelling and an abscess in late April, she was referred to infectious disease specialist Dr. Terrell, who diagnosed osteomyelitis and prescribed a prolonged antibiotic regimen. By August 2003, Kruszka's condition was reportedly resolved, but by August 2004, she experienced numbness and other debilitating symptoms affecting her quality of life. Notably, she claimed these issues disrupted her speech, eating, and social activities. In May 2004, Dr. Gertz informed Kruszka about the association between bisphosphonate use and osteonecrosis of the jaw (ONJ), marking the first disclosure she received regarding this risk related to Aredia. Warnings about this association were first included in Aredia's FDA-approved labeling in September 2003, followed by further revisions in 2004 and mass communication efforts by Novartis to healthcare providers. Kruszka was alive as of November 2013, with no additional bone fractures until May 2008. Dr. Robert Marx, D.D.S., a board-certified oral and maxillofacial surgeon at the University of Miami School of Medicine, has extensive experience in bisphosphonate-related research and is one of the first to identify a link between bisphosphonates and osteonecrosis of the jaw (ONJ). He aims to provide expert testimony regarding bisphosphonate-induced osteonecrosis of the jaw (BIONJ) and was initially designated by the MDL Steering Committee for specific topics in his 2008 expert report. Previous motions by Novartis to exclude his testimony were partially denied without extensive analysis. Dr. Morie Gertz, an oncologist specializing in hematology, succeeded Dr. Silberstein in managing patient Kruszka's treatment. He has authored three articles on bisphosphonates and believes they cause bisphosphonate-related osteonecrosis of the jaw (BRONJ). Dr. Gertz often discontinues bisphosphonates in patients who respond completely to myeloma treatment and contributed to revised Mayo Clinic guidelines for bisphosphonate use. He indicated that he would have altered Kruszka's treatment if he had known the risks associated with bisphosphonates and acknowledged that her ONJ was related to these drugs, although he did not formally diagnose BRONJ at the time. Dr. Todd Michael Juhlin, an oral maxillofacial surgeon in Iowa, treated Kruszka and has experience with ONJ and osteomyelitis. He observed exposed bone in Kruszka's mouth for about eighteen months and diagnosed her with osteomyelitis, recommending extractions and debridement. Following his experience with Kruszka, Dr. Juhlin has modified his treatment approach concerning bisphosphonates and now believes she suffered from BRONJ. Dr. Richard Alan Kraut, a retained expert for the plaintiffs, is board-certified in oral and maxillofacial surgery, oral medicine, and dental anesthesia, with decades of experience and publications related to bisphosphonates. He reviewed Kruszka's medical and dental records and conducted a thorough differential diagnosis to support his expert opinion on causation. Plaintiffs bring several claims against the Defendant, including strict liability, negligence (both negligent manufacture and failure to warn), breach of express and implied warranty, loss of consortium, and punitive damages. The Defendant seeks summary judgment on various grounds: all liability for infusions after January 2002, failure to warn claims, lack of admissible evidence for specific causation, design defect and implied warranty claims, and punitive damages. Additionally, the Defendant aims to exclude testimony from Dr. Marx and causation-related testimony from Dr. Gertz, Dr. Juhlin, and Dr. Kraut. The legal standard for admitting expert testimony requires trial courts to act as gatekeepers, ensuring that the testimony is based on reliable and relevant scientific principles, as established in Daubert v. Merrell Dow Pharmaceuticals. Expert testimony must meet three criteria: it must be useful for fact-finding, the expert must be qualified, and the evidence must be reliable. The party presenting the expert testimony bears the burden of proving its admissibility. Factors for assessing reliability include whether the theory has been tested, subjected to peer review, the known error rate, and general acceptance within the field. The trial court has significant discretion in determining the reliability of expert testimony, focusing on whether it is based on scientifically valid reasoning. Generally, the factual basis of an expert opinion affects credibility rather than admissibility, with the opposing party allowed to challenge it during cross-examination. Testimony may only be excluded if it is fundamentally unsupported and offers no assistance to the jury. Defendant's motion seeks to exclude specific aspects of Dr. Robert Marx's expert testimony regarding oral surgery and bisphosphonates, citing Federal Rules of Evidence 401-403, 702, and the Daubert standard. The motion targets Dr. Marx's ability to: 1) opine on dose and duration; 2) discuss dental evaluation and treatment measures related to bisphosphonate-induced osteonecrosis of the jaw (BIONJ); 3) speculate on causation regarding patients in Zometa and Aredia trials; 4) draw general causation conclusions from unreviewed adverse event reports; 5) explain the biological mechanisms of bisphosphonates causing osteonecrosis; and 6) allege bad faith conduct by Novartis. Plaintiffs invoke the law of the case doctrine, arguing that prior rulings by the MDL court should remain binding. The Court acknowledges that while this doctrine is not automatic and can be discretionary, it typically promotes efficiency and respects prior rulings unless substantial changes warrant a departure. The MDL court had previously reviewed and upheld the reliability of Dr. Marx's testimony on issues related to dental screening, clinical trial patients with BIONJ, and causation, leading the Court to deny Defendant's motion concerning these topics. Regarding dose and duration, Defendant contends that Dr. Marx lacks the qualifications to testify due to his non-oncologist status and lack of prescription authority for Aredia and Zometa. However, the Court finds Dr. Marx qualified under Rule 702 as a certified oral maxillofacial surgeon with extensive experience and research in bisphosphonates and ONJ, thus affirming his competency to testify on these issues. Dr. Marx is deemed qualified to provide expert testimony on the dosage and duration of bisphosphonates based on his experience and research, particularly relating to his observations from a study involving 119 patients which indicated a correlation between increased dosage and severity of cases. His testimony must adhere to the standards of Rule 703 and the Federal Rules of Evidence, requiring a proper foundation for admissibility. However, Dr. Marx is not qualified to testify about the specific results or efficacy of varying doses, nor can he predict how changes in dosing schedules might influence the risk of osteonecrosis of the jaw (ONJ) or the drugs' efficacy. He lacks scientific evidence to support opinions that different doses could have prevented or reduced the risk of jaw disease in a specific case. Such opinions would necessitate extrapolation beyond his factual knowledge, creating an excessive analytical gap. Consequently, the Defendant's Daubert motion is partially granted, allowing Dr. Marx to testify on dose and duration grounded in specific studies, but restricting general opinions on altered dosage efficacy. Furthermore, despite challenges regarding his qualifications in bone biology and reliance on animal studies, Dr. Marx is recognized as competent to testify on the biological mechanisms through which bisphosphonates cause ONJ due to his extensive experience in treating and studying the condition. Defendant challenges the reliability of Dr. Marx's testimony, arguing his reliance on an animal study is inappropriate and that he neglects conflicting studies. However, these concerns pertain to the credibility and weight of his testimony rather than its admissibility. The court allows for cross-examination and the introduction of contrary expert evidence, affirming that any doubts about the utility of Dr. Marx's testimony should favor admissibility, provided the proper foundation is established. Consequently, the court denies Defendant's Daubert motion regarding Dr. Marx's testimony on the biological mechanisms linking bisphosphonates to osteonecrosis of the jaw (ONJ). Regarding the testimony related to Novartis's corporate conduct, both the court and parties agree that Dr. Marx cannot express opinions on Novartis's state of mind or intent but may testify as a fact witness based on his experiences with the company. Dr. Marx is permitted to discuss interactions that indicate when Novartis became aware of ONJ, and any future issues concerning his testimony on "bad faith" conduct will be addressed at trial. Defendant also seeks to exclude specific causation testimony from Plaintiffs' doctors, Dr. Gertz and Dr. Juhlin, and retained expert Dr. Kraut, citing Federal Rule of Evidence 702 and Daubert. Dr. Gertz is expected to testify that Aredia contributed to Mrs. Kruszka's ONJ, while Dr. Juhlin will assert that her ONJ was caused by Aredia use. Defendant argues that Drs. Gertz and Juhlin lack expertise in bisphosphonates or ONJ and have not provided specific causation opinions. Additionally, Defendant contends that Dr. Kraut's opinion is scientifically unreliable due to omissions regarding Kruszka's medical history. Dr. Gertz's testimony on specific causation regarding Kruszka's osteonecrosis of the jaw (ONJ) is challenged on two main grounds: his qualifications and the absence of a required differential diagnosis. Gertz, who was Kruszka's second treating oncologist, admits he lacks expertise in jaw conditions and did not treat Kruszka's jaw issues. Although he has authored articles on bisphosphonates and has experience prescribing them, the court finds that his testimony lacks scientific reliability as per Daubert standards. He fails to demonstrate that his opinion on Aredia's contribution to Kruszka's condition is based on any scientific methodology, relying instead on personal experience and literature review without having conducted a differential diagnosis or ruling out other causes. Consequently, he cannot reliably connect bisphosphonates to Kruszka's ONJ, although he may testify about his treatment-related opinions. Dr. Juhlin's testimony is similarly contested, primarily because he did not diagnose Kruszka with bisphosphonate-related osteonecrosis of the jaw (BRONJ) during her treatment, instead diagnosing her with osteomyelitis. Like Dr. Gertz, he also failed to conduct a differential diagnosis, affecting the reliability of his causation opinion. As Kruszka's oral maxillofacial surgeon, Juhlin does not demonstrate an independent determination of the cause of her ONJ. Dr. Juhlin, an experienced oral surgeon since the mid-nineties, has treated around seven to ten patients with osteonecrosis of the jaw (ONJ) but did not diagnose Kruszka with ONJ during her treatment. He was unaware of her use of Aredia at that time and only formed an opinion suggesting she likely had ONJ during his deposition. Plaintiffs aim to use his later-developed views as expert testimony, which does not meet the reliability standards set by Daubert and Rule 702; thus, he is barred from providing specific causation testimony related to bisphosphonates and Kruszka’s condition. However, he may testify about his treatment opinions and office procedures regarding bisphosphonates. In contrast, Dr. Kraut's specific causation testimony has been challenged by the Defendant based on claims of unreliable methodology. The Defendant argues that Dr. Kraut consistently concludes that bisphosphonates are the cause of ONJ without adequately ruling out other conditions, such as osteomyelitis. Despite these challenges, the Court finds that Dr. Kraut's testimony does not fall short of Rule 702 and Daubert standards. The Court emphasizes that reliable causation testimony is not required to exclude every alternative cause, and the presence of potential alternative causes affects the conclusion's accuracy rather than the methodology's soundness. Consequently, Dr. Kraut is permitted to provide his expert opinion on specific causation. The Defendant’s arguments primarily address the weight of Dr. Kraut's testimony rather than its admissibility. Defendant has the right to challenge Dr. Kraut's credibility through cross-examination, rebuttal witnesses, and contrary expert evidence, with the jury determining the weight of Dr. Kraut’s testimony. The Court favors the admissibility of Dr. Kraut’s testimony, pending proper foundational support, leading to the denial of Defendant's Daubert motion against him. Regarding summary judgment, it is appropriate when no material facts are disputed, and the moving party is entitled to judgment as a matter of law, viewed favorably toward the nonmoving party. The burden lies on the moving party to demonstrate the absence of genuine issues of material fact, while the nonmoving party must present specific facts to dispute the claim. Summary judgment is considered integral to the judicial process rather than a shortcut. In the context of generic pharmaceuticals, manufacturers of branded products are not liable for injuries caused by generic versions made by others, necessitating proof that the defendant supplied the product causing the injury. The Defendant argues that evidence from the pharmacy manager and sales records indicates that Plaintiff could not have received Aredia after January 2002, justifying summary judgment on liability for infusions received post-January 2002. The affidavit from Mercy’s Director of Pharmacy corroborates that Aredia was no longer purchased after that date, supporting the argument with market share data showing a decline in Aredia's usage as generics gained market dominance. Plaintiffs contend that Defendant is liable for injuries resulting from pamidronate infusions administered after 2002 due to challenges regarding the authenticity of Defendant's affidavit, the prescription of Aredia in Kruszka's medical records, and Aredia's lengthy half-life, which suggests it remained in Kruszka’s system post-administration. The Court finds that Novartis has adequately demonstrated no genuine issues of material fact concerning the drug supplies used for Kruszka's infusions, supported by supplier records indicating the sale of generic pamidronate starting in February 2002 and its market prevalence. However, the Court acknowledges a genuine issue of material fact exists regarding Aredia's half-life and its effects, allowing Plaintiffs to present evidence of liability for injuries post-2002 linked to Aredia's persistence in Kruszka's body. Summary judgment is partially granted for claims associated with injuries from generic pamidronates but denied for those related to Aredia's lingering effects. For failure to warn claims, Plaintiffs must establish that: 1) the defendant had a duty to warn; 2) the defendant breached this duty through inadequate or nonexistent warnings; and 3) such failures caused Plaintiffs’ damages. Minnesota law merges strict liability and negligence failure to warn claims into a single action. A manufacturer is obligated to exercise reasonable care to prevent exposing consumers to unreasonable risks associated with its products, with the duty pertaining only to the time of the product's sale. The existence of a duty to warn is a legal question, and under the learned-intermediary doctrine, the duty to warn applies to the prescribing physician, not the patient. If a duty is established, factual issues regarding the adequacy of the warning, breach, and causation are to be resolved by the fact finder, necessitating a direct causal link between the inadequate warning and the injury sustained. Plaintiffs must demonstrate that a proper warning from Defendant would have prevented Ms. Kruszka from taking Aredia, thereby avoiding her jaw condition. Defendant contends that they could not have anticipated the risk of osteonecrosis of the jaw (ONJ) since they first received reports of it in December 2002, after Ms. Kruszka's tooth extraction in January 2001. They also note that significant case reports linking bisphosphonates to ONJ were published only in 2003, leading to label changes by Novartis. Conversely, Plaintiffs argue that there are disputed facts indicating that Defendant might have been aware of ONJ risks associated with Aredia, citing various clinical trials and reports from physicians that suggested a potential connection. It's established that pharmaceutical manufacturers have a duty to warn about known dangers or dangers they should know, as supported by case law. The Court recognizes that whether Novartis had adequate knowledge and provided sufficient warnings is a matter for a jury to decide. Plaintiffs have presented evidence, including a 1981 study on rats, reports of ONJ cases during clinical trials, and indications that physicians communicated concerns about bisphosphonates to Novartis. Additionally, the MDL Court previously found genuine issues of material fact regarding general causation and warning adequacy in related litigation. The Court concludes that there is sufficient evidence to suggest a genuine issue regarding what Novartis knew or should have known during the relevant time and whether adequate warnings could have altered Kruszka's treatment. Plaintiffs provide several pieces of evidence suggesting that Dr. Silberstein may have altered his treatment approach regarding bisphosphonates due to concerns about osteonecrosis of the jaw (ONJ). Specifically, they assert that he might have reduced the treatment duration, changed dosages, conducted thorough examinations related to ONJ, and increased collaboration with dental professionals. Dr. Silberstein acknowledged the possibility of stopping or withholding bisphosphonates in the presence of dental issues. Additionally, Dr. Juhlin, who treated Kruszka, now inquires about bisphosphonate use before surgeries and tends to perform fewer procedures on patients with such a history. He indicated that he might have opted for observation rather than immediate surgery for Kruszka. The court notes that if even one treating physician would have acted differently with full awareness of the ONJ risks, the plaintiffs can survive summary judgment. The defendant's argument that Kruszka would have continued treatment with Aredia regardless of warnings does not establish a lack of genuine material fact, especially in contrast to other cases where doctors continued treatments despite known risks. The plaintiffs have provided sufficient evidence regarding duty, breach, and causation to proceed with their failure to warn claim, leading to the denial of summary judgment. Specific causation linking Aredia to Kruszka's jaw condition requires expert testimony due to its complexity, which the court allows from Dr. Kraut, thus creating a factual question for the jury. Regarding claims of design defect and breach of implied warranty, the plaintiffs argue that Aredia was unsafe for its intended use and lacked merchantable quality, as it poses significant risks of injury. Under Minnesota law, this claim is presented in the context of the implied warranty of merchantability. Strict liability has preempted implied warranty claims in personal injury cases, leading to the dismissal of Plaintiffs’ breach of implied warranty claim, as it is subsumed by their strict liability claims. The Court found that this legal issue does not warrant a jury's consideration. For the negligent design defect claim to survive summary judgment, Plaintiffs must show: (1) the product was in a defective condition unreasonably dangerous for its intended use, (2) the defect existed when the product left the defendant's control, and (3) the defect was the proximate cause of the injury. The "reasonable care balancing test" evaluates whether the manufacturer took adequate care to avoid unreasonable risk of harm, considering both intended and foreseeable unintended uses of the product. While evidence of a feasible safer alternative design is relevant, it is not a requisite element for a design defect case. To submit the claim to a jury, the Court must weigh the likelihood and severity of potential harm against the burden of precautionary measures. Plaintiffs allege the design failure includes the Defendant's lack of testing for osteonecrosis of the jaw (ONJ) in trial subjects and argue that a lower dose and duration of the drug could have been feasible. They reference updated guidelines from Mayo in 2006 as supporting evidence. Conversely, the Defendant contends that Plaintiffs failed to provide evidence of a feasible alternative design, rendering their claim legally insufficient. The contested issues of dosage and duration alone do not establish a genuine material fact for a design defect claim, and Plaintiffs must demonstrate that Aredia was unreasonably dangerous under the reasonable care balancing test. They present a 2003 email from Novartis regarding alternative dosages for Zometa as part of their evidence. The email cited does not adequately address the "reasonable care balancing test," as it fails to demonstrate that an alternative dose of Aredia could minimize the risk of osteonecrosis of the jaw (ONJ) without diminishing Aredia's efficacy. Plaintiffs reference revised Mayo guidelines from 2006, but these revisions do not resolve key issues such as Novartis’s degree of care, the presence of an unreasonable risk of harm, or whether recommending lower dosages was feasible at the time or would prevent jaw conditions. The assertion that doctors should have been instructed to examine patients’ mouths is insufficient to establish that Aredia was unreasonably defective or that the defect could have been reasonably remedied, especially in the absence of expert testimony to support claims regarding dosage and duration. The court concludes that the evidence does not permit a reasonable jury to find in favor of the plaintiffs on the design defect claim, leading to the dismissal of this claim and the granting of summary judgment for the defendant. Regarding punitive damages, a plaintiff must demonstrate that the defendant acted with knowledge of facts indicating a high probability of injury and did so with conscious disregard or indifference. This indifference must be characterized as malicious. Punitive damages are considered an extraordinary remedy, requiring proof by clear-and-convincing evidence. At the summary judgment stage, the court must determine if a jury could reasonably find that the plaintiff met the burden of proof required for punitive damages under Minnesota law. Plaintiffs have demonstrated sufficient specific facts that create a genuine issue for trial regarding the Defendant's disregard for patient safety concerning Aredia. Evidence presented indicates that the Defendant was aware of concerns linking bisphosphonates to osteonecrosis of the jaw (ONJ) before such warnings were included in medical communications. The presence of some evidence post-2002 does not undermine its relevance, as the jury will determine its weight. The Court finds this case aligns with other MDL cases permitting punitive damages claims and thus denies the Defendant’s motion for summary judgment concerning punitive damages. Regarding the Defendant’s Motion for Summary Judgment, the Court grants it in part and denies it in part: 1. Liability for infusions post-January 2002 is partially granted concerning generic drugs but denied regarding Aredia's half-life effects. 2. The motion is denied for failure to warn claims. 3. The motion is granted for design defect and implied warranty claims. 4. The motion is denied for punitive damages claims. The Defendant’s Motion to Exclude Expert Testimony is also granted in part and denied in part: 1. The motions regarding specific causation testimony from Dr. Gertz and Dr. Juhlin are granted. 2. The motion for Dr. Kraut's testimony is denied. 3. For Dr. Robert Marx, the motion is denied concerning pre-dental screening and causation but granted regarding testimony on dose and duration based on specific studies while denying the opinion on efficacy changes. Dr. Marx's testimony regarding "bad conduct" has led to the granting of the defendant's motion. Novartis produces both Aredia and Zometa, bisphosphonates used in cancer treatment, although Kruszka did not receive Zometa. The causal link between osteomyelitis, osteonecrosis of the jaw (ONJ), and bisphosphonate use remains contested; however, there is some consensus on an association between bisphosphonates and ONJ. The plaintiffs, Kruszka and her husband, have withdrawn claims related to the Consumer Fraud Act and manufacturing. They have also agreed not to present testimony concerning Novartis' or the FDA's state of mind, intent, or motives, nor criticisms of Aredia and Zometa's clinical trials. The Court retains the authority to address issues related to reports not reviewed by Dr. Marx during the trial, including matters under Federal Rules of Evidence 703 and 104, despite recent legal uncertainties in the Eighth Circuit. In Fullington v. Pfizer, Inc., Judge Murphy highlighted that recent Supreme Court rulings have diminished the authority of generic manufacturers regarding product safety and labeling, placing greater responsibility on brand manufacturers. This shift could impact the relationship between brand manufacturers and generic drugs, as brand manufacturers are now solely responsible for labeling content. The defendant must establish a proper foundation for Dr. Marx's testimony at trial. Under Minnesota law, the plaintiffs' failure to warn claims based on strict liability and negligence merge into a single cause of action, allowing the plaintiff to present the case to the jury on one theory. Although the Court permits certain testimony from Dr. Marx regarding dose and duration, the plaintiffs have not substantiated this testimony in their briefs, and it does not create genuine issues of material fact regarding design defects.