The Court of Appeal of the State of California Second District Division Five (“California Appellate Court”) held in its unpublished opinion filed on January 3, 2018 that a pharmaceutical company conducting a trial of a new drug owed no duty to a study participant to intervene in his medical care related to his preexisting heart disease.
The defendant, Janssen Research & Development, LLC, obtained FDA approval for a proposed drug trial to analyze the safety and efficacy of a long-acting injectable formulation of its antipsychotic drug, Risperidone. The study’s principal physician/investigator for the drug trial invited the plaintiff’s 17-year-old son, who was diagnosed with schizophrenia in 2004 and was prescribed the antipsychotic drug, Seroquel, to participate in the drug trial.
The plaintiff’s son had blood testing and a screening EKG on February 19, 2009, which the drug trial’s physician reviewed on February 20, 2009 and February 21, 2009, respectively. The EKG was abnormal due to sinus tachycardia; old myocardial infarction and non-specific T wave abnormalities possibly secondary to heart disease. The blood test revealed slightly elevated liver enzymes. Nonetheless, the trial physician concluded the results were not clinically significant and, based on the patient’s otherwise normal physical examination and denial of a family history of cardiac disease, admitted him to the study.
On February 23, 2009, the plaintiff’s son was injected with a non-therapeutic one-milligram dose of the study drug to test for adverse reactions to any of its ingredients. Within two hours of receiving the test dose, the plaintiff’s son had a second EKG that indicated his cardiac condition had worsened. A second blood test indicated that the plaintiff’s son’s liver enzyme levels were much higher than they had been on February 19, 2009. To rule out laboratory error, the trial physician ordered a retest that confirmed that the plaintiff’s son’s liver enzymes had risen alarmingly. The trial physician transferred the plaintiff’s son to a hospital where he was diagnosed with cardiomyopathy, pneumonia, failing liver function, and altered mental state. The plaintiff’s son died on February 26, 2009. His cause of death was dilated cardiomyopathy in conjunction with other factors, including multiple organ failures and pneumonia.
The plaintiff alleged that defendant Janssen Research & Development, LLC (“JRD”), which had received the EKG and blood test results, did nothing to intervene in his care; JRD failed to intervene in the decision to administer the one-milligram test dose; and, that dose was a substantial factor in the plaintiff’s son’s death.
The jury was presented with a special verdict form that asked whether the trial physician and JRD were negligent and, if so, whether the negligence of either was a substantial factor in causing the death of the plaintiff’s son. The jury answered these questions in the affirmative and awarded the plaintiff $3 million in general damages and $5 million in future damages, assessing the percentages of fault at 70% for JRD and 30% for the trial physician. Based on the jury’s verdict, the trial court entered a judgment against JRD in the amount of $5.6 million. JRD appealed.
The California Appellate Court concluded that as a matter of law JRD undertook a general duty not to harm the plaintiff’s son as part of the clinical study, which duty encompassed administration of the test dose (although FDA regulations impose on study sponsors a general duty to monitor the progress of their studies to ensure compliance with study protocols and the health and safety of participants, that duty is intended to protect participants generally from foreseeable harm caused by the drug studies themselves, including participants’ adverse reactions to study medications). The California Appellate Court held as a matter of law that the scope of that duty did not extend to diagnosing or treating the plaintiff’s son’s preexisting heart disease or intervening in his medical care and the medical decisions related to that condition (it is not foreseeable to a study sponsor that study physicians with the primary responsibility for participants’ health and safety will fail to recognize, diagnose, and properly treat preexisting, life-threatening conditions that first manifest during drug studies).
The California Appellate Court concluded: “Here, defendant undertook the general duty to ensure study participants’ health and safety during the study. That undertaking did not extend to protecting participants from unforeseeable medical malpractice by study physicians in response to undiagnosed, life-threatening conditions … JRD’s undertaking as the drug study sponsor cannot reasonably be construed to include a “guarantee of safety” from any and all acts of medical malpractice by physicians who bear the primary responsibility for safeguarding the health of study participants … The delay in diagnosing and treating [the plaintiff’s son’s] serious cardiac disease was not a foreseeable risk that would support an expanded scope of the general duty of care owed by defendant not to harm study participants … It is not reasonably foreseeable to a drug study sponsor that the response by study physicians—who, as the trial court found, are primarily responsible for the health and safety of participants while enrolled in drug studies—to a patient/participant’s preexisting and undiagnosed disease, unrelated to the clinical trial, would fall below the standard of care for a medical practitioner … In this case, the study physicians, not defendant, voluntarily assumed the primary responsibility for [the plaintiff’s son’s] health and safety during the study, including the responsibility to competently diagnose and treat any preexisting, life-threatening diseases.”
Source Liu v. Janssen Research & Development, LLC, B269318
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