Bock v. Novartis Pharmaceuticals Corp.

Citations: 137 F. Supp. 3d 802; 2015 U.S. Dist. LEXIS 136920; 2015 WL 5842097Docket: Civil Action No. 2:10-cv-1338

Court: District Court, W.D. Pennsylvania; October 7, 2015; Federal District Court

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Plaintiffs Bruce and Bonnie Bock, as representatives of William M. Bock's estate, have filed a lawsuit against Novartis Pharmaceuticals Corporation, claiming that Bock developed osteonecrosis of the jaw (ONJ) due to the use of Zometa, a medication manufactured by Novartis for managing metastatic bone cancer. Novartis has filed a Motion for Summary Judgment concerning the remaining Counts II and III of the Complaint. The Court has jurisdiction under 28 U.S.C. § 1382 and has granted the defendant's motion.

The case centers on Novartis' prescription drugs Aredia and Zometa, both FDA-approved for treating metastatic bone diseases but associated with an increased risk of ONJ. Plaintiffs assert that Novartis did not adequately warn Bock and his healthcare providers about this risk. Zometa was initially approved by the FDA in August 2001, and reports linking ONJ to Aredia and Zometa emerged in September 2003, prompting Novartis to revise the drug labeling to include warnings about ONJ and its potential risk factors. In September 2004, further revisions highlighted that ONJ cases were primarily associated with patients undergoing certain cancer treatments, including chemotherapy and corticosteroids, and noted that dental procedures could exacerbate the condition. The labeling emphasized the need for dental evaluations and cautioned against invasive dental work during bisphosphonate treatment, leaving management decisions to the discretion of healthcare providers based on individual patient assessments.

On September 24, 2004, Novartis issued a 'Dear Doctor' letter to oncologists and oral surgeons, updating them on new warnings regarding osteonecrosis of the jaw (ONJ) associated with the bisphosphonates Aredia and Zometa, particularly in the context of dental surgery. Both of Bock’s treating physicians, Dr. Mohammed Islam and Dr. Mounzer Agha, received this communication. On May 5, 2005, Novartis sent another letter to dentists highlighting the ONJ warnings and recommending dental examinations for cancer patients before starting intravenous bisphosphonate therapy, advising against invasive dental procedures during treatment due to the risk of exacerbating ONJ.

Bock was diagnosed with anemia, leukopenia, and hypercalcemia in August 2005, prompting Dr. Islam to initially prescribe Aredia. Dr. Islam acknowledged his practice of reviewing prescribing information and confirmed awareness of the ONJ risk associated with Aredia, stating that he likely discussed it with Bock. By September 2005, after diagnosing Bock with multiple myeloma, Dr. Islam switched Bock to Zometa, citing its shorter infusion time and effectiveness.

Bock’s care transitioned to hematologist Dr. Agha, who continued Zometa treatment due to Bock's spinal fractures. Dr. Agha, familiar with the ONJ risk from Novartis communications and case reports, characterized the occurrence as "very rare" and deemed the benefits of Zometa to outweigh the risks. In March 2006, Dr. Agha informed Bock about the ONJ risk linked to dental procedures and emphasized the need for prompt reporting of any dental issues, also discussing the potential use of prophylactic antibiotics.

Dr. Agha testified that he consistently informs patients about the risks and benefits of Zometa, allowing them to make their own treatment choices. He emphasized that the risk associated with Zometa is minimal compared to its significant benefits. During treatment, patient Bock continued taking Zometa until April 2009. Bock's oral surgeon, Dr. Kent Galey, acknowledged seeing Zometa on Bock's medication list but did not recall discussing its risks, specifically osteonecrosis of the jaw (ONJ), with him, though he believed he would have discussed it if aware. Dr. Galey performed several dental procedures on Bock, including extractions and debridements, and noted the extraction was necessary despite the associated risks. In May 2009, Dr. Michael Kail preliminarily diagnosed Bock with ONJ and discussed the risks of surgery with him, but Bock chose to proceed. Bock consented to further procedures into 2010 and passed away in July 2011. Both Dr. Agha and Dr. Islam confirmed they continue to prescribe Aredia and Zometa to patients with conditions similar to Bock's without changes to their practices regarding the potential risks of ONJ.

Summary judgment is granted under Federal Rule of Civil Procedure 56(c)(2) when there is no genuine issue of material fact and the movant is entitled to judgment as a matter of law. The opposing party cannot rely solely on allegations or denials but must present specific facts through affidavits or other means to demonstrate a genuine issue for trial. If the opposing party fails to respond appropriately, summary judgment may be entered against them. A material fact is defined as one that could influence the case's outcome under applicable law. The moving party initially bears the burden of showing the absence of evidence supporting the non-moving party's claims. Subsequently, the burden shifts to the non-movant to produce specific facts establishing a genuine issue for trial. This requires the non-movant to provide affirmative evidence that exceeds mere speculation yet does not need to meet the preponderance standard to counter a properly supported motion for summary judgment.

To establish a claim for negligent failure to warn under Pennsylvania law, a plaintiff must demonstrate that: (1) the defendant manufacturer owed a duty to the plaintiff; (2) the manufacturer breached that duty; and (3) the breach was the proximate cause of the plaintiff's injuries. Additionally, the plaintiff must show that the manufacturer was at fault. In cases involving prescription drugs, the learned intermediary doctrine applies, placing the duty of warning primarily on the manufacturer to inform the prescribing physician rather than the consumer. The manufacturer must provide adequate warnings to the physician about the drug's dangers, as it is the physician's responsibility to understand the drug's characteristics, safe dosages, and potential interactions with other medications. The physician must also inform the patient of any associated risks. In evaluating claims of inadequate warnings, the focus is on whether the manufacturer's warnings to physicians were sufficient. The critical issue in Novartis’ summary judgment motion is whether the alleged inadequacy of warnings for Aredia and Zometa caused Bock’s injuries. To prove proximate causation, the plaintiff must show that, had the prescribing doctor received a different warning, their prescribing behavior would have changed, thus preventing the injury. This requires compelling evidence to suggest that an adequate warning would have influenced the physician's decision, making the inquiry highly fact-specific and case-dependent.

Novartis argues for summary judgment by asserting that Bock has not provided evidence indicating that a different warning would have influenced his treatment or prevented his injury. Pennsylvania courts have previously granted summary judgment in similar cases due to a lack of proximate cause. In Demmler, the court ruled that the plaintiff did not demonstrate that a more explicit warning would have changed her drug usage as per her doctor’s instructions. Similarly, in Lineberger v. Wyeth, the court found no evidence that a different warning would have affected the physician's prescribing practices, as the physician stated that his decision would not have changed regardless of the warning. In Adams v. Wyeth, the plaintiff failed to prove that an adequate warning would have altered the prescribing habits of her doctor. Notably, Parkinson v. Novartis Pharm. Corp. also emphasized that if a physician would have prescribed the same medication regardless of the warning, the warning's inadequacy could not be deemed the proximate cause of injury. In contrast, courts have denied summary judgment when evidence shows that the prescribing physician was unaware of the risks associated with the drug and would have acted differently if informed. In Simon v. Wyeth Pharm. Inc., the physician acknowledged he would have warned the plaintiff about newly understood risks and adjusted his prescribing practices accordingly, leading the court to find that adequate labeling could have altered both the physician's practices and the plaintiff's use of the drug.

In Daniel v. Wyeth Pharm. Inc., the court upheld the denial of a motion for judgment notwithstanding the verdict regarding proximate cause, emphasizing the significance of physician and plaintiff testimonies. The prescribing physician indicated that a different warning about breast cancer risks associated with the drug would have influenced his discussions with the plaintiff. The plaintiff affirmed that had she been warned, she would have declined the drug. 

In Rowland v. Zometa, the first plaintiff, Rowland, testified that she would not have taken Zometa if informed about the risk of osteonecrosis of the jaw (ONJ). The court found a genuine issue of fact regarding proximate cause, as the physician might have advised her against the drug with a different warning label. 

The second plaintiff, Orr, had a physician who was unaware of ONJ risks but stated that with an adequate warning, he would have counseled Orr, allowing him to make an informed decision. Orr also indicated he would have refused Zometa had he been fully informed about the risks. The court noted that this testimony created a genuine issue of material fact regarding causation and injury prevention.

Conversely, for the final plaintiff, Machen, the physician could not confirm if he had warned about ONJ risks but had signed a form acknowledging these risks. The court observed that there was no evidence that Machen would have declined the drug even if informed. Expert testimony suggested that his ONJ could not have been prevented by prior dental evaluations, leading the court to conclude that Machen failed to demonstrate a triable issue regarding the influence of a different warning on his physician’s prescribing practices and his resulting injury.

A review of the case record indicates a lack of evidence preventing summary judgment as seen in Simon, Daniel, and Rowland. Bock's physicians were aware of the risks of osteonecrosis of the jaw (ONJ) when prescribing the drug, and both testified they discussed these risks with him, ensuring he could make an informed treatment decision. Dr. Agha documented a detailed conversation regarding the risks. Despite the risks, both physicians would still prescribe the drug due to its benefits. Bock's death in 2011 resulted in no testimony from him about the warnings or his potential decisions based on different information, a crucial element in the referenced cases. Notably, Bock consented to dental procedures that led to his ONJ, despite being warned of the risks, which aligns with prior case law supporting summary judgment. Bock contends that expert testimony is necessary regarding the warning labels, but the current motion focuses on proximate cause, not the warnings' adequacy. The evidence does not show that either physician would have changed their prescription approach or that Bock would have declined the drug given different warnings.

Bock asserts that summary judgment should not be granted due to evidence of a significant change in Dr. Agha’s prescribing practices, specifically regarding the use of Zometa before dental procedures. Bock cites Dr. Agha’s current practice of holding Zometa for a month prior to such procedures, arguing that this change may have prevented his injury. However, Dr. Agha’s deposition reveals that he followed similar practices in 2005, indicating that the guidance he provided then is consistent with his current approach. Dr. Agha affirmed that he would still recommend dental examinations before initiating bisphosphonate therapy and that his practice has not substantially changed since 2005.

Bock challenges the credibility of Dr. Agha’s and Dr. Islam’s testimonies but fails to present any contradictory evidence. The court emphasizes that a plaintiff cannot counter a well-supported summary judgment merely by questioning witness credibility without presenting opposing evidence. The court concludes that Bock has not demonstrated any material fact that could suggest his injuries were avoidable with a different warning, thus justifying the granting of summary judgment for the defendant. The motion is granted, with prior counts of Bock’s complaint already dismissed, leaving only Count III for consideration.