3/25/2013· Warnings & Labels
When Suing a Drug Company For Failure to Warn: Avoid Generics
I just came back from my phannacy where I picked up two prescriptions for my seasonal allergies. One was a name brand product and another was a generic.
Originally Published in The Goldhaber Warnings Report, April 2012
By: Gerald M. Goldhaber, Ph.D.
Tel: 212-379-6661
Email Dr. Goldhaber
Judge Leon stated in his ruling, which was very similar to his arguments from his temporary injunction issued last November, "The government's interest in advocating a message cannot and does not outweigh plaintiff's First Amendment right to not be the government's messenger." The Judge believes that the tobacco industry would prevail in a lawsuit, thus justifying his ruling last month. He continued, "The graphic images were neither designed to protect the consumer from confusion or deception, nor to increase consumer awareness of smoking risks; rather, they were crafted to evoke a strong emotional response calculated to provoke the viewer to quit or never start smoking. While the line between the constitutionally permissible dissemination of factual information and the impermissible expropriation of a company's advertising space for government advocacy can be frustratingly blurry, here the line seems quite clear." The Judge also very helpfully provided the government with some tips to curb tobacco use, such as increasing anti-smoking advertising, raising tobacco taxes, reducing the size and changing the content of the labels, etc. The FDA and the Justice Department declined to comment on the Judge's ruling, however, a lawyer representing Lorillard, Floyd Abrams, said he was pleased with the ruling, "the government is free to speak for itself, but it may not, except in the rarest circumstance, require others to mouth its position." Mathew L. Myers, a lawyer and President of the Campaign for Tobacco-Free Kids, an advocacy group, voiced his displeasure with Judge Leon's ruling, "It represents an inaccurate statement of the facts, is wrong on the science of the health impact of tobacco and uses the wrong legal standards. Other than that, he got it perfect." The Justice Department has appealed Judge Leon's preliminary injunction and oral arguments are set for this month in the United States Court of Appeals for the District of Columbia. Win or lose these appeals, the industry will probably continue to fight this FDA requirement until the U.S. Supreme Court hears the case. As I have disclosed before, I have testified on behalf of the tobacco industry in the 1980's and 1990's.
Feel free to pass this issue of the Goldhaber Warnings Report on to any friend or colleague.
Dr. Gerald M. Goldhaber, the President of Goldhaber Research Associates, LLC, is a nationally recognized expert in the fields of Political Polling and Warning Label Research. His clients include Fortune 500 companies, as well as educational and governmental organizations. He has conducted hundreds of surveys, including political polls for candidates running for U.S Congress, Senate, and President. Dr. Goldhaber also served as a consultant to President Reagan's Private Sector Survey for Cost Control.
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3/25/2013· Warnings & Labels
When Suing a Drug Company For Failure to Warn: Avoid Generics
I just came back from my phannacy where I picked up two prescriptions for my seasonal allergies. One was a name brand product and another was a generic.
6/19/2009· Warnings & Labels
Samples of Effective Product Warnings
The Goldhaber Warnings Report: In the last issue of this newsletter, I listed the major components found in most warnings along with making several suggestions that should help improve a warning’s conspicuousness and make it more likely to gain the attention of the product’s user at the time of use. The following is an example of a warning that
4/18/2014· Warnings & Labels
Warning: Failure To Ignore Myths About Flu May Cause Flu
According to news reported almost daily, we are and will continue to experience flu activity in the United States at record levels. Both the CDC and the Mayors of major cities such as Boston and New York have declared public health emergencies blaming the current raging flu epidemic. We all know the symptoms of the flu: aches and pains throughout the body; blocked or runny nose; chills and cold sweats, fever, fatigue or sore throat. Most medical experts agree that the quickest and safest way to prevent the flu is to get a flu shot and let the vaccine now on the market stop the epidemic spread of the flu. Sadly, as of this date, slightly more than 1/3 of our citizens got vaccinated.