AFL-CIO, Two California Senior Groups File Suit Against AstraZeneca Over Alleged Misleading Nexium Advertisements
AFL-CIO, the Congress of California Seniors and the California Alliance for Retired Americans on Monday filed suit in Los Angeles Superior Court against AstraZeneca over allegations that the company misled consumers with an advertising campaign for the acid reflux medication Nexium, the Associated Press reports. The lawsuit alleges that AstraZeneca violated California laws against unfair competition and false advertising.
In addition, the lawsuit alleges that AstraZeneca made misleading comparison tests between Nexium and Prilosec, an older acid reflux medication manufactured by the company, to convince physicians and patients to use Nexium, the more expensive treatment. According to the lawsuit, Nexium costs $4.09 per pill, compared with 46 cents per pill for Prilosec.
The lawsuit alleges that AstraZeneca sought to "shore up profits" before patent protection on Prilosec expired in 2001, at which time less-expensive generic versions of the medication would be available, the Associated Press reports (Associated Press, 10/18). The Nexium label, which FDA approved, lists the results of four comparative tests with Prilosec. In the results of two of the comparative tests, a 40-milligram dose of Nexium was described as more effective than a 20-milligram dose of Prilosec; the results of the two other tests were described as inconclusive (Elliott, New York Times, 10/19).
AstraZeneca has promoted the results of the comparative tests in ads, but according to the lawsuit, "comparable dosages would have shown little difference in effectiveness," the Associated Press reports (Associated Press, 10/19). Nexium, which FDA approved in 2001, had sales of about $3.3 billion last year (Baltimore Sun, 10/19). AstraZeneca in 2003 spent $257 million on ads to promote Nexium.
The lawsuit does not seek specific damages but asks AstraZeneca to make "restitution and/or disgorgement of all unlawful or illegal profits" obtained through Nexium sales and interest on such profits. The lawsuit also asks that AstraZeneca cover the legal costs of the plaintiffs (New York Times, 10/19).
Alex Sugerman-Brozan, director of Prescription Access Litigation, a coalition of almost 100 groups that AFL-CIO has joined, said, "The main innovation was that they put yellow stripes on their purple pill and charged consumers grossly inflated prices."
Gerry Shea, director of government relations for AFL-CIO, said that the increased cost of prescription drugs has contributed to higher health care costs, which has become a contract issue in negotiations with employers. Shea said, "Health care has been the most contentious issue in collective bargaining for the past two years. In every major negotiation, we have either seen cost-shifting of some kind or explicit trade-off of wages."
The lawsuit marks the first time that AFL-CIO has filed suit against a health care company, according to Shea (Associated Press, 10/18). Steve Berman of Hagens Berman, the law firm that filed the lawsuit, said that a direct-to-consumer ad campaign for Nexium "is not wrong because it's legal. What's wrong here is that it was deceptive." He called the Nexium ad campaign "a prime example of the abuse that has led to billions of dollars being spent unnecessarily by consumers" (New York Times, 10/19).
AstraZeneca officials said that they have not reviewed the lawsuit. However, AstraZeneca spokesperson Rachel Bloom-Baglin said that "there are clear differences" between Nexium and Prilosec. She added, "In clinical trials, Nexium has demonstrated better acid control and better healing of acid-related damage. Bottom line is that more patients have better acid control with Nexium than with other medications of its type" (Associated Press, 10/18).
Bloom-Baglin said, "Our promotion of Nexium is done in accordance with the FDA's standards," adding, "It helped people who wouldn't otherwise seek medical care for a chronic condition" (Reuters/Los Angeles Times, 10/19). Bloom-Baglin also said that the results of the comparative tests between Nexium and Prilosec were based on past studies with the dosages of each medication considered most effective (Associated Press, 10/18).
In addition, AstraZeneca spokesperson Jim Coyne said that the allegations in the lawsuit were "simply not supported by the facts." He added, "With respect to the advertising, from the time of launch to the present day we've advertised Nexium based on the strength of the data we have. All the statements we've made and continue to make about Nexium are supported by the data" (New York Times, 10/19).