SOUTH BEDMINSTER, N.J. -- What will happen tomorrow when a person today fills a prescription at the local pharmacy and the drug turns out to be a counterfeit? Pharmacy retailers already have faced the issue and present examples of an emerging area of case law based on potential liability for manufacturers and distributors of prescription drugs.
John Gilbert Jr., a former attorney for the Drug Enforcement Agency and now a principal at a boutique law firm specializing in food and drug law, presented some of the first legal cases to address liability issues surrounding counterfeit drugs at last month's thought leadership conference sponsored by BuzzeoPDMA, a division of Dendrite.
Gilbert, with the law firm Hyman, Phelps & McNamara, said that in the case against one major chain, a consumer tried to bring a class-action suit against it and its distributor, alleging they sold counterfeit Lipitor. The court found that the consumer, or plaintiff, had not suffered and was not likely to suffer any actual harm, which would be required to make the case.
"It may be a bit of an anomaly, but it's interesting to see how these cases are going to start being brought and what the courts are going to look at as far as whether they are going to establish liability here, said Gilbert. "And this particular court said, You tell me this is a counterfeit drug, and it may be, but we don't see any harm. The court to me was saying to look at the traditional situations where you file injunctive relief or try to get a temporary restraining order--that area of law means you have to show harm. And the court is going to apply those traditional legal elements to those cases.
Citing another case that concerns a 16-year-old patient who was prescribed Epogen after an emergency liver transplant, Gilbert said the patient received a counterfeit drug from another drug chain. Amgen, the maker of Epogen, has been dismissed from the case. Upon its decision, however, the case will be one of the first to define potential liability of manufacturers, distributors and pharmacies for injuries from counterfeit drugs.
"As far as I know, currently the case is still going forward against the wholesaler and the pharmacy as far as trying to determine liability," Gilbert said.
He also offered details on a third case that holds future ramifications. The case concerned Pfizer, which filed suit against several drug distributors, claiming that its drugs had been counterfeited by the distributors or the distributors had sold counterfeit versions of its drugs.
In that case, the U.S. Food and Drug Administration intervened because it had a criminal investigation under way and was concerned about a civil case spilling out information and hurting the FDA's case.
"This is an illustration that, as companies are trying to move forward bringing their own lawsuits, there are going to be issues as to where the cases are if you have a group like the FDA or DEA involved in an investigation," said Gilbert. "Government would welcome manufacturers taking on the expense of pursuing this, but at the same time, the feds have never liked it when private industry gets involved in their investigations."
COPYRIGHT 2005 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2005 Gale Group