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CHICAGO-More people who have been exposed to but not injured by allegedly dangerous drugs or medical products are attempting to recover the costs of future medical monitoring or surveillance, an attorney says.

Medical monitoring class-action lawsuits, which became popular in toxic tort litigation in the early 1980s and 1990s, are a "new phenomenon" in drug and medical product litigation and a "high risk potential" for manufacturers, said Thomas E. Sanner, an attorney in the Minneapolis office of Hinshaw & Culbertson.

Whereas the average group of individuals in a medical monitoring class involving a toxic tort ranges from 200 to 1,000 people, the class of plaintiffs in a drug liability medical monitoring case can run into the millions, according to Mr. Sanner.

This is due in part to courts allowing individuals to sue for medical monitoring costs without any physical injuries or signs of injuries.

One of the more recent and highly publicized class-action suits seeking unspecified amounts for medical monitoring as well as general and punitive damages involves Wyeth-Ayerst Laboratories, manufacturer of weight loss drugs Pondimin or fenfluramine hydrochloride and Redux, dexfenfluramine hydrochloride (BI, Sept. 29).

In September, the U.S. Food & Drug Administration released data showing that as many as 32% of 291 people tested developed heart-valve abnormalities after taking either drug in combination with phentermine.

That combination of drugs was prescribed to 18 million Americans last year.

It is the sheer number of potential plaintiffs that make medical monitoring claims involving drug and medical products a high-risk exposure for manufacturers, Mr. Sanner said during Hinshaw & Culbertson's ninth annual risk and insurance symposium recently held in Chicago.

"The simple size can be breathtakingly enormous," he noted.

"In the drug liability world, I've been involved in a number of medical monitoring claims where the class exceeded 10 million plaintiffs," he said.

Other questions and issues also arise, making medical monitoring lawsuits a difficult risk for risk managers to assess.

For example, courts have not specifically addressed the definition of the percentage or level of risk needed to justify a medical monitoring claim, Mr. Sanner said. How much does the risk have to increase from the normal risks associated with the drug? he asked.

"If I take diet pills, do I have a 10% increased risk of getting pulmonary hypertension?" he asked rhetorically.

In addition, the latency period of exposure to develop the disease is indefinite, he said.

"How many years do you have to test?" Mr. Sanner asked. "It's an open issue in the law today," he said.

Another contentious issue occurs when medical monitoring plaintiffs end up developing the alleged injuries.

If a company settles a medical monitoring claim and through the testing, an individual is diagnosed with the injury that another group sued and received damages for, can the individual come back and sue? Mr. Sanner asked.

Most states have a "split cause of action clause" that might restrict people who have recovered money from a medical monitoring claim from filing a second suit if the disease actually develops, he said.

However, a California court-the only court to address this issue with medical monitoring claims-ruled that the exclusion rules do not apply, according to Mr. Sanner.

"I don't know what the evolution of this will be, but it's a scary thought," he said.

One way that employers can fight medical monitoring claims is by picking a specific jurisdiction, Mr. Sanner suggested.

While a majority of courts today allow recovery of medical monitoring costs absent any physical injury, a few courts still hold that a plaintiff must be injured to sue, he said.

He also suggested drug and medical product manufacturers focus on alternative reasons behind the relationship between their products and the alleged injuries. There may be some other cause triggering the illness, he said.