Here comes the judge - More lawsuits target R.Ph.s as they take on more responsibility and courts expect more from them - Drug Topics

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Here comes the judge
More lawsuits target R.Ph.s as they take on more responsibility and courts expect more from them


Drug Topics


What do the Kansas City pharmacist Robert Courtney, Doc's Pharmacy in Walnut Creek, Calif., and Vioxx (rofecoxib, Merck) have in common? All involve pharmaceuticals, pharmacies, claims of harm to patients—and lawsuits against pharmacists.

Courtney was hit with a $2.2 billion civil judgment and a 30-year prison term in 2002 after admitting he had diluted cancer chemotherapy products since at least 1992. Injections of betamethasone compounded at Doc's Pharmacy killed three patients in 2001. Vioxx was taken off the market last September amidst charges that Merck systematically ignored safety data linking the drug to increased risk of cardiac events.

Plaintiffs' attorneys are taking all three cases—and thousands more—all the way to the bank. When it comes to product liability and malpractice cases, pharmacists are no longer innocent bystanders even when they do nothing wrong.

"We are not suggesting that Walgreen's or individual pharmacists [who dispensed Vioxx] engaged in malpractice, fraud, or misrepresentation," said Madison McClellan, a Stuart, Fla., attorney representing 49-year-old Mark Tomlin, who suffered heart failure while taking Vioxx for neck pain. Tomlin filed suit against Walgreen's and Merck in early December. "The issue here is with the manufacturer," McClellan said. "But under Florida product liability law, the distributor has a duty to ensure that every product is not unreasonably dangerous. The distributor bears a burden here."

Walgreen's does not comment on pending litigation, but Wayne State University pharmacy practice professor Jesse Vivian is not surprised by the Florida suit. Lawsuits are filed as much for tactical reasons as for cause. In product liability cases, he explained, it is common for attorneys to file cases against distributors in state court. The goal is to have the case heard at the state level, which is seen as more sympathetic to individuals than the federal courts.

There is also what Vivian calls the shotgun effect. "The plaintiff shotguns everybody in sight. All it takes is hitting one defendant with deep pockets, so you sue the drugmaker, the pharmacist, the pharmacy, the wholesaler, the physician—anybody and everybody you can imagine might have the slightest connection. All it takes is one of them paying to make it worthwhile."

Increasingly, that anybody includes pharmacists. It is not that pharmacists' stature or public image is eroding, Vivian said. It is more a change in the way pharmacy and law are practiced. Pharmacists used to be drug distributors. As such, their liability was limited to mechanical errors, dispensing the wrong drug, the wrong dose, or the wrong label. But as pharmacists expand their scope of practice to include counseling, utilization review, prescribing protocols, immunizations, and other services, they are also expanding their liability exposure.

"If you look to intellectual issues such as allergies, interactions, or how to use drugs, more and more of these cases are coming up each year," Vivian said. "The trend is increasing scope of practice and increasing scope of liability. The number of cases is growing."

Pharmacy insurers see the same trends. Liability claims are increasing faster than the number of pharmacy liability policies. Loss ratios, the ratio of claims insurance companies are called upon to pay compared with the size of the population that they insure, are increasing. The cost of liability coverage for pharmacists is nowhere near the levels paid by specialty physicians (see sidebar), but pharmacy rates are likely to rise over the next few years.

"We are seeing more claims, even taking into account our own growth," said Kenneth Baker, senior VP and general counsel of Pharmacists Mutual Insurance Co., the only insurance firm in the nation that specializes in covering pharmacists and pharmacies. "Claims are of higher dollar value," he said. "The margin between what is being paid and what is being collected is shrinking. We are looking at ways to control losses."

Translation: Insurers can lower their risk by introducing tougher standards and covering fewer pharmacists, by reducing coverage, or by raising rates.


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