Lawsuit Alleges Schering Overstated Claritin Effectiveness

A coalition of more than 50 health activist organizations has filed a class-action lawsuit against Schering-Plough alleging that it has improperly marketed its blockbuster allergy drug Claritin by overstating its effectiveness. According to the lawsuit, Schering and two advertising companies that produce Claritin direct-to-consumer materials have engaged in false advertising by asserting that all users will "enjoy complete relief from their allergy symptoms" when in fact studies have shown that the drug works only about 50% of the time. "Schering-Plough is essentially making a promise to American consumers that it knows it will break about half the time as it will keep," according to Thomas Sobol, the leading attorney for the Boston-based Prescription Access Litigation project (PAL), which announced the lawsuit yesterday at a press conference in Washington, DC. The lawsuit, filed yesterday in a New Jersey Superior Court, proposes that all individuals in the United States who have purchased any Claritin products since August of 1997 be considered a nationwide class against Schering, which is based in New Jersey.

The Growth of DTC
In August of 1997 the FDA loosened its restrictions on DTC advertising, first legalized in 1985, allowing drug companies to mention a particular drug in television ads along with the ailment it is intended to treat as well as easing requirements for listing side effects and risks. Since then, DTC advertising, especially on television, has proliferated, with Claritin being one of the most heavily marketed drugs. According to the lawsuit, Schering spent $111 million last year advertising Claritin, making it the second-most marketed U.S. drug. Since August 1997, Claritin has produced roughly $10 billion in sales. The scale of DTC -- total advertising expenditures by drug makers reached $2.3 billion in 2000, up from $51 million in 1991 -- has been criticized by many patient advocacy groups and physicians, who say that drug ads can encourage patients to request unnecessary or expensive treatments. The FDA announced earlier this year that it would review the 1997 DTC guidelines.

Claims and Requests
PAL's lawsuit claims that Schering's marketing has come at a price to American consumers of Claritin. The lawsuit alleges that Schering has violated the New Jersey Consumer Fraud Act by failing both to disclose the "meager efficacy" of Claritin and to provide "credible counterbalance" in its marketing, and that the company has misled consumers and created an "illegitimate demand" for the drug. Noting that Claritin is available at significantly less cost in other countries, including Canada (where it is sold over-the-counter), the lawsuit states that Schering has charged "unconscionable prices" for the drug. According to Sobol, PAL is seeking from Schering a refund "of some portion" of the money spent on Claritin by consumers and an injunction against the company's "misleading" advertising. "If a pharmaceutical company spends millions of dollars on direct-to-consumer advertising of prescription drugs, it should be held accountable to the same consumer protection rules ... that all other mass marketers and advertisers are held to," he said.

Ongoing Work on 'Unacceptable' Practices
PAL, a coalition created this year to target the high cost of prescription drugs, is making increasing use of class-action lawsuits against major pharmaceutical companies. The Claritin suit is the fourth major legal action taken by the coalition this year -- in April, it filed a series of lawsuits against Bristol-Myers Squibb Co. charging that the company illegally maintained a monopoly on the anti-anxiety drug BuSpar; the next month it filed lawsuits in state and federal courts alleging that AstraZeneca and the generic drug maker Barr Laboratories colluded to keep the price of the breast cancer drug tamoxifen high; and PAL has sued Schering earlier this year alleging that it entered into two anti-competitive agreements with other companies in order to keep generic versions of the potassium supplement K-Dur 20 off the market. According to Stephen Rosenfeld, a legal adviser to PAL, one of the coalition's objectives in bringing these lawsuits is to raise consumer awareness about the high price of prescription drugs. "Our goal ... is to try to win those lawsuits, but also to get the information out, particularly at the state and local level, that corporate behavior here is unacceptable."

Schering Responds
The pharmaceutical industry has been a steadfast supporter of DTC advertising, and a Schering spokesperson yesterday defended the company's marketing of Claritin. Denise Foy, noting that DTC ads are regulated by the FDA, said that Schering is "committed to full compliance" with DTC laws. While saying that Schering had not received a copy of the PAL complaint yet, Foy disputed the assertion that Claritin's success was primarily due to its marketing, noting that it is the best-selling antihistamine in the United States. "There's no amount of marketing that can sustain a drug that's not effective," she said (John Kastellec, Kaiser Daily Health Policy Report, 8/10).