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.
5/29/2012· Warnings & Labels
Semantics in Court: Providing Opinions on likely Meanings of Messages
My first expert witness case involved a man who was injured using a chinup bar designed to fit within a door frame. The bar has rubber suction cups at each end, and its length is adjusted by twisting its two sections together or apart for a telescoping effect.
3/6/2014· Warnings & Labels
Should Energy Drinks Have Warning Labels?
Earlier this month, the New York Times reported that the Food and Drug Administration (FDA) had received claims that the drink 5-Hour Energy may have led to 13 deaths and 33 hospitalizations in the last four years. 5-Hour Energy is a highly caffeinated energy shot sold by Michigan-based Living Essentials (a unit of Innovation Ventures) in 2-ounce packages equivalent to drinking about two cups of coffee.