Research Liability and Coverage

OMIC’s policy covers insureds for claims based on injuries arising from direct patient treatment by the insured or someone for whose actions the insured is liable. This includes injuries to patient-subjects in a clinical research setting as long as the research was conducted under and in accordance with an American IRB-approved protocol. In research-related claims, there are often multiple defendants and various theories of liability alleged. In order to understand how OMIC’s coverage would apply to such claims, here are some real world examples.

In the wake of the Office for Human Research Protection’s (OHRP’s) criticisms of the SUPPORT study (see the Lead article for details), law firms put out feelers to attract SUPPORT participants for potential lawsuits, offering to evaluate their cases. There was a large pool of potential plaintiffs; 1,300 infants had participated in the study. By April 2013, at least one lawsuit, Looney v. Moore, a class action, was filed against the IRB members at the University of Alabama at Birmingham, the lead site in the study, as well as the principal investigator (PI) and the manufacturer of the pulse oximeters used in the study. While the plaintiffs had made medical malpractice allegations against all of the defendants except the manufacturer, they ended up dropping these specific “medmal type” allegations. The remaining allegations are negligence, negligence per se, and lack of informed consent against the IRB members; negligence, breach of fiduciary duty, and lack of informed consent against the PI; and products liability and negligence against the pulse oximeter manufacturer. The case has yet to proceed to trial. Because OMIC’s policy does not cover insureds for their work on IRBs or manufacturing liability, we will examine more closely the allegations against the PI. This is a hypothetical coverage analysis as OMIC does not insure any defendants in this case.

The negligence allegations against the PI focus on his negligence in designing an “unethical and flawed” experiment that targeted vulnerable people in violation of state and federal standards and failing to ensure the informed consent form disclosed all risks and details of the “experiment” in order for subjects to make an informed decision whether to participate. The breach of fiduciary duty count states that the PI had both a researcher-subject and physician-patient relationship with the infants. In these relationships, he had a duty to disclose all information material to the decision to give consent. The specific lack of informed consent allegation states the PI did not prepare the informed consent form in compliance with legal and ethical norms and the subjects would not have participated had they been fully informed. As you can see, the crux of the case against the PI is the failure to obtain informed consent. While the plaintiffs dropped the allegations of negligence in the diagnosis, treatment, care and monitoring of the patients, the informed consent deficiencies coupled with injury to the plaintiffs would likely trigger medical professional liability coverage. However, if there was no physician-patient relationship and an insured was sued for designing a flawed informed consent form that was used by other researchers, there would be no direct patient treatment and therefore no coverage.

Another insured was faced with a research based claim when a patient-subject experienced a retinal tear after globe perforation (see the Lead article for more details). What protected the insured, in addition to adhering to the study protocol, properly managing the adverse event, and maintaining insurance with OMIC, was having in place an indemnification agreement with the study sponsor. Such agreements place the burden of defending the researcher and paying damages to the claimant on the sponsor. They should state that the sponsor will defend, indemnify, and hold the researcher harmless. The protection should extend to the research institute, owners, officers, directors, physicians, employees, and agents as appropriate. They should relieve the researcher of responsibility for any liability or loss arising from any claims, demands, suits, actions, or judgments. Sponsors will likely want to limit the indemnification to claims resulting from adverse effects of their products and exclude indemnification for negligence, malpractice, gross negligence, or willful conduct of the researcher, including failure to comply with applicable laws or the terms of the study protocol. They may also want to retain the right to settle the claim or take it to trial. You should consult with an attorney in order to secure the most advantageous terms. (OMIC will work with the sponsor to apportion coverage based on the agreement and the insured’s policy provisions.) The sponsor may also want you to indemnify them for your negligence or misconduct. Remember that your OMIC policy excludes such contractual liability. OMIC will defend and indemnify you, but not a third party, for claims based on your professional services.