Even Doctors Agree That Lawsuits Help Drug Safety

The Food and Drug Administration is responsible for helping ensure that drugs prescribed by doctors are both safe and effective. In making this assessment, however, the FDA frequently must rely almost entirely on data from studies either performed directly by drug companies or funded by them. Since these are the very companies seeking approval of the drug, the data is suspect.

In a case now before the U.S. Supreme Court, Wyeth v. Levine, the drug companies are arguing that FDA approval of a drug (based on drug company data) should preempt any lawsuits challenging the safety of the drug. This position is so outrageous that even the editors of the most prestigious medical journal in the country, The New England Journal of Medicine, have filed a friend of the court brief to oppose the drug companies. These doctors recognize that documents and data which can only be discovered by plaintiffs’ lawyers in litigation with the drug companies are an essential source of information for the FDA in evaluating drug safety.

The FDA has only a very limited budget to perform investigations itself. If plaintiffs’ lawyers are precluded from ever bringing lawsuits once the FDA approves a drug, no matter how many people the defective drug might kill, then the American people would be deprived of an essential tool for ensuring the safety of drugs prescribed for their use.