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# States Use FDA WLs Against Drug Companies
- URL: https://www.fdaweb.com/states-use-fda-wls-against-drug-companies/
- Published: 2016-06-14T12:00:00.000Z
- Updated: 2026-09-14T21:09:25.000Z
- Author: David McFarland
- Tags: Drugs, FDA Policy/General, #legacy-id-D5135937

The Washington Legal Foundation says that many state attorneys general view drug companies as “their own private cash cow.” A [*Legal Opinion Letter*](http://www.wlf.org/upload/legalstudies/legalopinionletter/061016LOL%5FWeiner.pdf?ref=fdaweb.com) by two Arnold & Porter attorneys outlines a recent South Carolina Supreme Court decision against Janssen over its Risperdal marketing. In 2003, FDA required all drugs in Risperdal’s class to include a label warning about an increased risk of diabetes and other hormonal antibodies. The company added the warning, and later sent a “Dear Doctor” letter describing peer-reviewed research indicating that Risperdal is not associated with an increased risk of diabetes and presents a lower risk than some other drugs in the class.

FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC, now the Office of Prescription Drug Promotion) issued a Warning Letter to the company complaining that the Janssen letter to doctors was false or misleading. Although the company believed that the scientific data supported the statements, it issued a corrective letter and FDA took no further action.

However, the report says, a number of state attorneys general sued the company under their states’ unfair trade practices acts and initially won large verdicts that were reversed on appeal. In South Carolina, however, the state Supreme Court allowed a verdict against the company to stand, although it reduced the award from $327 million to $124 million.

The company asked the Supreme Court to hear the case, but the report says that the state court did a good job of making its decision appeal-proof and the high court refused to hear the case.

“As Janssen argued,” the WLF letter says, “when wielded against pharmaceutical manufacturers in this manner, this statute conflicts with FDA regulation. The South Carolina Supreme Court therefore should have found that federal law preempted the attorney general’s claim…. The mischief created by the South Carolina Supreme Court’s decision goes beyond vandalizing FDA regulation. In issuing its Dear Doctor letter in 2003, Janssen took a side in an ongoing and legitimate scientific debate about Risperdal and similar products. So long as Janssen’s statements were not false and misleading, it had a First Amendment right to make them. DDMAC’s and its successor’s overuse of the term ‘false and misleading’ in dealing with such communications is problematic in its own right. But allowing the stock phrase of a division or office in FDA to become a weapon in the hands of state attorneys general across the country intensifies the chill on legitimate and truthful commercial and scientific speech. It compounds the infringement on First Amendment rights.”