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Appeals court ruling allows patients to sue drug companies

Medicine backgroundIn a major victory for patients, the Arizona Court of Appeals ruled Thursday they can sue prescription drug companies for consumer fraud.

Shattering their own precedents, the judges acknowledged that such lawsuits have not been allowed before in Arizona under the presumption that the drug company’s only obligation is to provide the full list of complications and side effects to the doctors who are prescribing the drug. The premise was that patients do not need that information.

But Judge John Gemmill, writing for the unanimous court, said that rule no longer has validity because of how manufacturers now are marketing their products.

“Prescription medication is often advertised and sold to consumers in a manner similar to other consumer goods,” he said.

Gemmill acknowledged that patients cannot get these drugs absent a prescription written by a doctor. But he said this is no longer the one-way discussion it used to be.

“Consumers discuss medications with their medical providers and may express preferences based on advertising,” Gemmill wrote. And he said patients have to decide whether to buy and actually use a drug even after getting a prescription.

“As a result, consumers may be deceived through fraudulent misrepresentations in connection with the sale of prescription drugs jus as in the sale of traditional consumer goods,” the judge explained. And that, he said, means the state’s Consumer Fraud Act applies to the sale and advertising of prescription drugs.

“Consumers are regularly presented with advertisements for medications to treat a variety of symptoms, prompting them to ask, encourage, and even pressure their medical providers to prescribe these brand-name medications,” the judge wrote. And he said Internet sites and medical databases give consumers access to both manufacturer-provided and third-party information about drugs.

“A physician no longer is necessarily the consumer’s sole source of information about the effects, benefits, and risks of the medication he or she takes,” Gemmill wrote.

What all that means, the judge said, is a manufacturer should not be shielded from liability.

“Otherwise a consumer may be left without recourse against a manufacturer in a situation where an adequate warning to a prescribing physician is undermined or negated by the flawed or incomplete representations of the manufacturer to the consumer,” he said.

The case involves Solodyn, an oral antibiotic manufactured by Scottsdale-based Medicis Pharmaceutical Co.

In 2008, Amanda Watts, a minor at the time, got a prescription for the drug from a doctor to treat chronic acne. She used the drug for 20 weeks.

When she returned to the same doctor two years later, she got a new prescription for Solodyn and took it for another 20 weeks.

Before using the drug, she got two informational publications providing details. Neither disclosed any link between Solodyn use and the development of auto-immune disorders.

But the company, in information available to the doctor, warns of lupus-like dyndrome and autoimmune hepatitis from “long term” use of the drug. And that information tells doctors they should inform patients of symptoms that might develop which should cause them to immediately stop using the drug and seek medical help.

In late 2010 she was hospitalized with drug-induced lupus and drug-induced hepatitis, both of which she alleges are side effects of her use of Solodyn. While she has recovered by the hepatitis, doctors says eh may suffer from lupus the rest of her life.

A trial judge threw out her consumer fraud lawsuit. But Gemmill said that was wrong.

He said the Arizona law prohibits “any deception, deceptive or unfair act or practice, fraud, false promise or misrepresentation” in connection with “the sale or advertisement of any merchandise.” And Gemmill said prescription drugs are merchandise.

More to the point, he said it’s the kind of merchandise that is advertised and sold just like any other consumer good.

The court acknowledged that Watts’ physician had access to all the information. But Gemmill said that does not take the manufacturer off the hook given the marketing done directly to consumers.

There was no immediate response from the attorney for the drug company.

One comment

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