The Food and Drug Administration on Thursday said it is considering a lawsuit filed by the state of Florida against Pfizer Inc, which is manufacturing and selling Viagra.
The suit, filed in U. S. District Court in Florida, is an attempt to recover billions of dollars in damages from Pfizer for erectile dysfunction drugs that have been linked to deadly injuries and death in the United States. The FDA has long said Viagra, sold by Eli Lilly and Company, is the first drug to be approved for use in men. In recent years, however, doctors have increasingly switched patients from Viagra to sildenafil, the active ingredient in Viagra, because it may increase the risk of heart attacks.
In the suit, filed Thursday in U. District Court in Florida, the FDA said it has been considering the suit and will seek approval of a similar lawsuit filed by the state of Florida. It also asked the FDA to approve a similar lawsuit filed by the state of Connecticut, where prescription drugmaker Eli Lilly has been accused of promoting dangerous products over Viagra.
“The FDA’s approval of this drug could be a significant milestone in the battle to protect consumers who rely on Viagra,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to meeting its own legitimate and ethical responsibilities by approving prescription drugs.”
The suit claims that Pfizer has engaged in a dangerous practice by marketing Viagra in the United States, which is a significant safety issue for Pfizer. The suit seeks damages for the deaths of more than 11,000 men who had been diagnosed with erectile dysfunction.
The company says that by selling the drug without FDA approval, it is potentially harming its employees and the general public. It said it will take steps to protect patients from potentially dangerous side effects such as high blood pressure and vision problems.
Pfizer has said that it has been promoting the drug through a number of Web sites. It said it would review and comment on the suit and would update the FDA with updates to the information.
The suit was filed Thursday by the state of Florida. It seeks the FDA approval of a similar lawsuit filed in Connecticut. The suit also asks that the state provide evidence of the FDA’s findings in the matter.
According to court filings, Pfizer said it is not planning to make any payments for the suit. However, it is not clear how much the state will pay for it. The company is also notifying its patients that it will not be making any payments for the suit. If the company does not approve the lawsuit, it could be set aside by the FDA.
“We believe that the FDA has a responsibility to protect consumers,” said Amy Bermane, an associate with the National Federation of State Similarities and the acting director of the National Consumers League.
The suit was filed Friday in federal court in Manhattan, Connecticut, after a two-year investigation by U. District Judge Richard M. Schlesinger, whose firm had not disclosed the details of the case. The suit seeks to recover up to $2.3 billion in damages from the company, including $3.2 million in the potential amount of $25 million in the potential punitive damages.
The suit was filed by the state of Connecticut and is being filed in the U. District Court for the District of Columbia.
The suit alleges that in July 2007, Pfizer Inc. marketed a drug, Viagra, in a manner that may cause severe heart attacks. The FDA has said that the drug was being promoted in a manner that is not in line with the U. Food and Drug Administration’s recommendations.
In an emailed statement to The New York Times, the FDA said that it has made no recommendation on the suit. However, it has said that it will seek approval of the lawsuit as soon as possible. The FDA said that the suit does not directly address the FDA’s findings in relation to the drug.
The suit was filed Thursday in Florida and is filed in U. District Court in the same state.
A spokeswoman for Pfizer said the company has not announced what the suit is about. The company declined to provide a time or date of publication for the suit.
The suit alleges that in September 2007, the company marketed a new drug, sildenafil, for treatment of erectile dysfunction.
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