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A selectively worded preamble to the recently passed new drug labeling guidelines is causing controversy among lawyers, Congress, and citizen watch groups. The “federal preemption” included in the guidelines scheduled for release in June, suggests that people adversely affected by drugs approved by the Food and Drug Administration, should not be allowed to sue drug makers at the state level.

A representative from the FDA responded to concerns by saying, “We think that if your company complies with the FDA processes, if you bring forward the benefits and risks of your drug, and let your information be judged through a process with highly trained scientists, you should not be second-guessed by state courts that don''t have the same scientific knowledge.”

Trial lawyers and members of Congress, however, were quick to notice the obvious implications of such a measure. Preventing consumers, who have been harmed by a particular drug from suing for damages at the state level, takes the focus away from the health and safety of the patient and turns it back towards the profit of the pharmaceutical company. State product liability laws are designed to protect consumers from faulty drugs and products and allow them to receive compensation for losses suffered.

“The fact that the drug industry can get the FDA to rewrite the rules so that CEOs can escape accountability for putting dangerous and deadly drugs on the market is the scariest example yet, of how much control these big companies have over our political process,” commented Ken Suggs, President of the Association of Trial Lawyers of America.

The preclusion of state lawsuits in cases of injury caused by medication would relieve pharmaceutical kingpins from liabilities such as the suspected 55,000 deaths caused by Merck and Co.''s, Vioxx.

Senator Ted Kennedy, in response to the controversy, stated that it was typical behavior of the Bush Administration, (who has been associated with several cases of insider court briefings in support of drug companies), to take a policy for health and safety improvement and turn it into another means of protecting pharmaceutical companies.

The motion to improve drug labeling began in 2000 in an effort to simplify important health and safety information for consumers and doctors. After much litigation and debate, the new labeling will become effective this summer for new drugs and those drugs approved within the last five years. The “highlight” section of drug labeling will aim to underline the most important health risks and safety information for the patients and healthcare professionals. Some believe however, while the new labeling may benefit a prescribing doctor, they will still be difficult to decipher for drug users.

Director of the Public Citizen''s Health Research Group, Sidney Wolfe stated, “It is time to end the double standard where doctors and other health professionals are informed by FDA-approved labeling, but patients are treated like second-class citizens, receiving whatever the out-of-control purveyors of patient information leaflets choose to dispense.”

While the disclaimer may be suggested in the preamble of new drug labeling, the National Conference of State Legislatures stated last week that the FDA was assuming authority that was not theirs.