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Issues in medical products liability.

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.

Failing System

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." As an example, Mr. Gordon recommended that drug manufacturers put all the necessary warnings for their products in the package and in the Physician's Desk Reference; if it is discovered that adverse reactions or other hazards result from use of a particular drug, the manufacturer should then notify physicians about these dangers. "The scope of the warning is the key factor in a drug liability case," he said.

Medical manufacturers must also ensure that they conduct comprehensive, long-term tests for their products, stated Mr. Gordon. "If a company fails to conduct these long-term tests, then this failure creates the basis for liability." As an example of this problem, Mr. Gordon described a heart valve manufacturer that did not test its product adequately. "The manufacturer assumed that only patients in their 60s, 70s and 80s would use the product, so the testing was done only on people in those specific age groups," he said. However, the product failed when used in younger, more active individuals. As a result of their insufficient product testing, the company had thereby exposed itself to liability.

In the near future, lawsuits filed against medical manufacturers are likely to increase in number, said Richard Rubenstein, a partner with Wilson, Elser, Moskowitz, Edelman & Dicker. "Considering the ever-increasing complexity of medical devices, the number of lawsuits against manufacturers will continue to grow," he said. Mr. Rubenstein predicted that implantable drug delivery systems, which are a relatively new innovation, will raise perplexing exposure and liability issues. "These systems, which are essentially a hybrid between a drug and a device, will raise interesting questions as to which aspect of the product caused the patient's injuries, the drug or the delivery system."

In many liability cases, it is common for an injured or aggrieved patient to sue both the health care provider and the manufacturer, said Mr. Rubenstein. In many instances, he said that these suits result in a battle between the three parties. "Liability becomes the big issue in these cases," he stated. "For example, in a situation where the health care provider misuses the manufacturer's product, it will be difficult for the plaintiff and the health care provider to argue that the manufacturer should have provided a warning with respect to these uses." However, if the manufacturer knows or has reason to know of the unintended use of the device, then the surgeon or plaintiff can argue that the manufacturer should have warned of these risks. Mr. Rubenstein also pointed out that in this situation, the manufacturer's attorneys will then examine the health care provider's knowledge to determine if he or she knew of the risks associated with these applications. "If it can be shown that the health care provider knew of these risks, then the manufacturer can argue that there was no proximate causation between its lack of a warning and the patient's injuries."

In order to minimize their legal exposures, manufacturers and medical providers should undertake certain proactive measures, said Mr. Rubenstein. "First, health care providers should ensure that all personnel who use a medical device are fully trained in its operation." Where feasible, Mr. Rubenstein recommended that health care providers remain in contact with manufacturers to keep up-to-date on any changes in a product or recommendations regarding its use. He also suggested that health care providers ensure that all personnel who render diagnoses based on the data provided by a particular medical device be aware of the device's capabilities and limitations.
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Author:Christine, Brian
Publication:Risk Management
Date:Jan 1, 1993
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