Direct to Consumer Advertising of Cypher Stent Draws Heavy Criticism and Points to Need for Legislation By SEO Admin on May 28, 2008

For several years the U.S. Food and Drug Administration has been reviewing a set of guidelines proposed in 2004 for advertising medical devices. Now, a television advertisement for a heart stent, metal mesh devices that are used to prop open arteries after they have been cleared of blockages, has been scrutinized and attacked in an op-ed article for failing to adequately warn consumers about the potential dangers of receiving a stent, including a ruptured coronary artery. The ad does warn of heart attack and stroke. The ad for the Cypher stent, made by the Cordis subsidiary of Johnson & Johnson, was the first to market a stent directly to consumers on television and uses the tag line life wide open. Similar ad campaigns have promoted hip and knee implants, including one featuring the golfer Jack Nicklaus, who underwent a hip replacement in 1999 using a device made by Stryker. According to the article by cardiologists Dr. William E. Boden and Dr. George A. Diamond published by The New England Journal of Medicine, the advertisement promotes the products potential benefits but seems to play down the medical risks and should be reviewed by federal regulators. The ad does, however, mention some adverse events that can occur after a stent implant, including heart attack and stroke. Dr. Boden and Dr. Diamond observe, The notion that television viewers inspired by such an ad would go to their physicians and request not only a stent but a specific brand and model of stent is frightening, if not utterly absurd. In 2007 ad spending for medical devices was $200 million, according to TNS Media Intelligence, an advertising research firm. The United States is one of the few industrialized countries that permit such advertising directly to consumers, although recent law and developments indicate that such advertising is about to be more closely monitored. During a recent Congressional hearing on drug advertising, the chairman of the House Energy and Commerce Committee, John D. Dingell, said the committee had found some ads appear to be misleading and others deceptive. The chairman of the House subcommittee investigating drug advertising, Representative Bart Stupak, said that Congress should consider banning drug ads aimed directly at consumers. Section 906 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which went into effect on March 25, 2008, mandates that published direct-to-consumer advertisements for prescription drugs include the following statement printed in conspicuous text: "You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088." There is no such requirement for television ads or for ads for medical devices. The FDAs Division of Drug Marketing, Advertising, and Communications (DDMAC) employs reviewers who have responsibility for reviewing prescription drug advertising and promotional labeling to ensure that the information contained in these promotional materials is not false or misleading. One would hope that the FDA is more honest about enforcing its mission than the U.S. Federal Aviation Administration (FAA) is, as evidenced in recent accusations that the airlines and not the traveling public were considered the FAAs customers.

Related to This

Levine & Slavit, PLLC Logo

Levine & Slavit, PLLC

The law firm of Levine & Slavit, PLLC has served clients in Long Island and the Greater New York City-area since 1957. We are a team of personal injury and wrongful death lawyers who work tirelessly for victims' rights. Our team is licensed and affiliated with the:

  • New York State Bar Association
  • New Jersey Board of Bar Examiners
  • Florida Board of Bar Examiners
  • U.S. District Court Eastern District of New York
  • U.S. District Court Southern District of New York

Please contact our practice online for a free consultation or call (212) 687-2777 to speak to an attorney today. 

Contact Us Today

Rate, Review & Explore

Social Accounts Sprite
Google map image of our location in 60 E 42nd St Ste 2101 New York, NY

Manhattan Office

60 E 42nd St
Ste 2101
New York, NY 10165

Open Today 8:30am - 5:00pm

By Appointment Only

Google map image of our location in 350 Willis Ave Ste 100 Long Island, NY

Mineola Office

350 Willis Ave
Ste 100
Long Island, NY 11501

Open Today 9:00am - 5:00pm

By Appointment Only

(212) 687-2777 Send a message