Issues in Medical Products Liability
Christine, Brian, Risk Management
THE MEDICAL COMMUNITY is threatened by what Peter Huber has called the liability industry, said Roger Fine, vice president of administration at Johnson & Johnson, at the FOJP Service Corp.'s 10th Annual Conference on Medical Malpractice. "From the medical products manufacturer's point of view, the current system is a feeding frenzy. The system should be encouraging innovation, research and the development of new products and services for the betterment of humankind," he said. "Instead, the industry is spending time learning how to protect itself from the threat of lawsuits."
However, Alvin Gordon, an attorney with the law firm of Julien & Schlesinger, said that from the plaintiff's point of view, medical products manufacturers and health care providers often create the circumstances that expose them to the risk of liability. "Manufacturers have an obligation to know their product and warn the medical community and patients about any potential dangers," he said. "As a result, it's important for the manufacturer to keep on top of current knowledge about its product through medical literature, cases of adverse reactions and other means." And the greater the potential risks or hazards posed by a product, the more extensive are the efforts the manufacturer must take to inform the medical community about these dangers, declared Mr. Gordon.
THE ADVENT OF strict liability, which arose over the last few decades, has not resulted in the equitable and efficient liability system envisioned by its proponents, said Mr. Fine. "For medical products companies, the system has failed to spread the risk in the way that it was supposed to," he stated. "In fact, the system has scared away the insurance companies; the real insurers are the consumers and the patients." As an example of this failure, Mr. Fine cited his own company's difficulties in obtaining insurance. "For the past five years, Johnson & Johnson has been unable to obtain liability insurance at any price," he said. "Yet the whole rationale of the strict liability system was that we would be held strictly liable even if innocent because we would be in a position to ensure against the risk."
In regard to medical products, Mr. Fine said the liability system is hampering the development of new products. "The system is killing useful products and preventing new ones from reaching the market," he said. As an example, Mr. Fine mentioned that the highly effective DPT vaccine for whooping cough is no longer manufactured due to liability concerns.
In order to improve their results within the current system, Mr. Fine suggested that health care providers, medical products manufacturers and physicians all cooperate in the process. "We should stop pointing fingers at each other," he stated. "For example, physicians should stop automatically agreeing with the plaintiff that the warnings on a manufacturer's drugs are inadequate and should stop coming to the conclusion that a medical device was the cause of a particular problem when we don't really know for sure if this is the case."
Manufacturers' Obligations REGARDLESS OF whether or not one agrees with this assessment of the tort system and its relationship to the medical products industry, the medical community can nevertheless take proactive steps to protect itself from liability, said Mr. Gordon. For example, manufacturers must ensure that the warnings they provide for their drugs or products are comprehensive. "Manufacturers must warn against all known side effects, complications and contraindications for their drugs or products," he stated. "Often, this can be easily done, and can go a long way toward curtailing litigation. …