You're Safe in Mass Tort Litigation…for Now

The current health care environment is an interesting one, as drug litigation headlines run parallel to a barrage of media advertisements for prescription drugs and medical devices. Patients are paying more attention to television, newspaper, and magazine ads; asking more questions; and requesting specific drugs. For the average physician, the situation is creating a new triumvirate in medical care: the doctor, the patient, and the product manufacturer. The manufacturer has now entered the medical treatment picture, not only providing physicians with treatment options but also giving them concern over liability.

Immunity Not Guaranteed

What is the real net effect of these lawsuits on the medical community? As a general trend in current litigation, physicians who prescribed "defendant" medications continue to stay out of the spotlight. As seen with the majority of the most recent cases pending, so far treating doctors are not being named as direct defendants, but the vulnerability is still there.

Defense attorney John Zen Jackson offers cautious optimism for physicians. "Physicians have an inherent edge in that it is typically easier to present them as caring, competent, and credible human beings. While physicians have long been 'target defendants,' they are not burdened with the profits-over-patients motive that has often plagued the pharmaceutical manufacturers," Jackson says. But he cautions, "One must not be caught believing that noninclusion of physician-defendants is a fixed norm."

Constant Vigilance

The most important step physicians can take in protecting themselves from the liabilities associated with drug safety issues is to stay abreast of significant research studies on drug side effects and interactions. Of course, this is only possible when there is adequate information available. According to a recent government report, drug companies have yet to even begin nearly two of three of the follow-up studies they agreed to undertake once their medicines were on the market. The second step physicians need to undertake after thoroughly researching and evaluating the safety risks associated with a particular drug is to adequately communicate these risks to their patients. Doctors know that when they prescribe drugs, their knowledge concerning the medication is generally far superior to the patient’s, and therefore, patients rely heavily on the doctor’s judgment.

Keeping a Paper Trail

Before a doctor prescribes a pharmaceutical to a patient, they are duty-bound to tell the patient of the drug's risks and to present all other alternatives to the drug so that the patient is capable of making an informed decision when determining whether or not to take the drug. The decision to prescribe a particular drug should be an individual one, based on the situation of each patient, particularly when it comes to drugs on the market with questionable risks. Upon prescribing a particular drug to a patient, it is crucial that the physician document any informed consent discussions. This includes all discussions held regarding risks, side effects, possible interactions with other drugs, and any other alternatives discussed.

Jackson notes, "Documentation of these discussions is a powerful prophylaxis when the chart is subjected to a plaintiff lawyer's review for potential defendants. Physicians should also consider maintaining some archival source of information that was and became available regarding the medical products and devices used in the practice. The existence of these data can be helpful in advancing a defense—if the lawsuit is not avoided in its entirety," he says. The role of a physician in the future of mass tort litigations is not carved in stone, so extra precautions must be taken as protection in case they get caught in the spotlight.

The Bottom Line

• Be well-versed in the significant research studies on drug side effects and interactions.
• Always thoroughly communicate to your patients the risks and side effects associated with the drugs you prescribe them.
• Document any informed consent discussions.

Robert B. Goley is vice president of claims administration and risk management at MDAdvantage. Previously, he served as vice president of claims at New Jersey State Medical Underwriters, Inc. Mr. Goley has nearly 25 years of experience in physician and hospital professional liability. He welcomes questions or comments at 888-355-5551, or info@mdanj.com. MDAdvantage specializes in helping New Jersey physicians minimize risk. For more information, visit www.md advantageonline.com. Janet S. Puro, assistant vice president of business development and corporate communications of MDAdvantage Insurance Co of New Jersey, also contributed to this article.