About BioMedic-Insure
For 18 years, BioMedic-Insure, a France-based insurance broker, has specialized in procuring insurance for clinical trials conducted in countries where coverage must be provided by an in-country underwriter. Throughout this time the BioMedic-Insure specialists have continually supported research aimed at saving lives and improving the quality of life by developing insurance solutions that satisfy mandatory insurance requirements.
The Clinical Trial and Resulting Claim
In 2002 a company conducted a 12-month, 80 subject study in France to determine the safety and efficacy of a new drug for the treatment of rheumatologic problems. Several years later in October 2006, an attorney presented a complaint on behalf of a participant in the rheumatologic study to the sponsoring company, the clinical testing hospital, and the clinical trial investigator. The complaint alleged that his client, a 42-year-old father with four children, suffered complications and side effects as a result of being a research study participant that were so severe that they prevented him from being gainfully employed. The complaint further alleged that the Patient Information Sheet (Informed Consent Document) failed to include proper warnings, and that there was insufficient follow-up conducted by the investigator and hospital.
The plaintiff's lawyer asked the company, the hospital and the investigator to: 1) acknowledge that his client had in fact received the new drug; 2) assist in determining whether there was a link between his client's medical problems/ disability and the drug; and 3) compensate his client for the damages including:
The policyholder contacted BioMedic-Insure, who in turn notified the insurance carrier and assisted in selecting a defense attorney versed in clinical-trial litigation. BioMedic-Insure personnel also initiated contact with the sponsor to obtain the rheumatologic drug study protocol, including any amendments, the Patient Information Sheet signed by the patient, a copy of the authorization of the ethics committee (the equivalent of the Institutional Review Board) and any medical documents pertaining to the plaintiff.
BioMedic-Insure claims investigation personnel made inquiries as to whether the sponsor had ever received prior notice of adverse health events from the plaintiff, whether the sponsor could determine which drug the patient received, what the sponsor's opinion regarding the claim was, and whether the sponsor had any available details of the drug pathology from medical experts. In essence, BioMedic-Insure pursued and collected the required documentation necessary to proceed to trial and collaborated with the insurance carrier and policyholder to assure that the expert medical witness for the defense was acceptable to each party. All of this was accomplished within 30 days and a local French court then assigned the case to a judge and established a deadline to bring the matter to a disposition.
In December 2006 the following parties appeared before the judge:
The outcome was as follows:
A few days after the hearing BioMedic-Insure contacted the insured (sponsor) and insurance company to inform them of the hearing results, recommended the parties accept the findings (i.e., make no challenge), and suggested the value of the claim should be in the range of 400.000 to 600.000 Euro.
The plaintiff requested 785.000 Euro and the claim was settled for 530.000 Euro. Although this was higher than is usually expected, the patient/participant's loss of professional opportunity (i.e. his inability to work) was a dominant factor in the final settlement.
Conclusion
The potential for severe claims arising out of clinical trials is not limited to studies conducted in the United States. However, a good business partner, in this case BioMedic-Insure, is necessary to successfully defend an insured. BioMedic-Insure does not determine the facts, nor can they try the case, but this case study demonstrates how an experienced partner controls the process and can help to facilitate a fair result.