In Wyeth v. Levine, the Supreme Court will determine whether tort litigation against drug manufacturers is and should be preempted. A holding for Wyeth could mean that parties injured by FDA-approved pharmaceuticals no longer could sue drug makers for failure to warn about risks associated with their products. Potential plaintiffs no longer would have access to litigation to compel the release of truthful information about drug risk. This case pits the power of big business against the legal rights of injured parties. Even more significantly, Wyeth v. Levine has deep implications for public health. The case will decide the fate of a critical safeguard of our personal well-being: information.
Wyeth v. Levine will determine whether patients and doctors have access to all necessary information about FDA-approved, marketed drugs. A crucial source of information about drug risk historically has been personal injury litigation. Take Vioxx, for example, a widely used pain medication manufactured by Merck. Only through documents discovered in litigation did we learn that Merck executives misled the FDA and the public about company-known risks of Vioxx in order to protect the value of their blockbuster drug. If disclosed earlier, vital risk information discovered in litigation might have saved thousands of lives.
Not surprisingly, Wyeth wants to prevent similar information-seeking litigation against drug manufacturers like itself. Wyeth, with support from the federal government, argues that FDA makes its own risk-benefit assessments before approving drugs to enter the market, and that post-marketing litigation would undermine the FDA’s determinations, subjecting companies to multiple decisions about drug safety and efficacy. Unfortunately, however, as is evident in the example of Vioxx and uncounted other drugs, decisions the FDA makes at the stage of pre-approval review are inadequate to protect the public. Post-approval information about marketed drugs is necessary to safeguard the health and well-being of patients considering medical treatments. A decision for Wyeth would block access to the best method currently available for generating that information: tort litigation. Now that is a dangerous side effect.
At all stages in a drug’s life cycle, the FDA relies on the manufacturer applying for approval to provide the information on a proposed drug. In the early stages of drug review, the FDA is given safety and efficacy data on the drug’s performance in clinical trials. The outcome of the drug approval process hinges on the integrity of the applicant supplying that information. Based on that early stage data, the FDA makes the best decision it can about drug approval and labeling.
Even when based on complete information, however, pre-approval review is no assurance that a drug will turn out to be safe in broad-scale use. Pre-approval clinical testing does not generate information of the scope necessary to predict the safety of a drug once it has entered the marketplace. Clinical trials test the safety and efficacy of drugs on a population limited both in size and diversity. A serious adverse event that occurs in one out of 10,000 patients, for example, or only after long-term use, may not be detected in a trial of 2,000 subjects that lasts only 3 years.
For these reasons, at the time of marketing approval, the FDA does not have the breadth of information it would need to adequately warn the public about risks of the nearly one hundred new drugs approved each year. Likewise, according to the Institute of Medicine, the agency does not have sufficient resources to study the large-scale use of the thousands of FDA-regulated drugs currently on the market.
As a result, the FDA does not and cannot generate the necessary information about drugs made available to the public. FDA regulations require that manufacturers submit post-approval adverse event reports to the FDA. The agency, lacking adequate resources for post-marketing surveillance, must rely on manufacturer information to learn about the consequences of scaled up drug use. The public thus receives drug-related health information that has been filtered through those who most stand to gain by suppression and omission of risk and adverse affects data. In other words, our access to truthful information is most at risk when we are most vulnerable – when drugs are in the marketplace and FDA is dependant on manufacturers’ disclosures to monitor and warn about drug safety.
It is no surprise that manufacturers have the greatest incentive to manipulate data and the least incentive to release information that might harm drug value when medicines are on the market and available to consumers. Sadly, there are many examples of manufacturers withholding information and knowingly misleading the FDA and the public in order to protect a drug’s financial viability (e.g. AHP (Pondimin, Redux), Bayer (Baycol, Trasylol), and Johnson & Johnson (Ortho Evra)). Thousands of people have been harmed by drugs with dangers known to manufacturers before potentially life-saving information was released through litigation.
The FDA’s ability to protect the public’s health depends, at all stages, on the flow of accurate, scientific information from pharmaceutical companies to the FDA, and from the FDA to the public. If manufacturers withhold information, manipulate data, or release misinformation, the system fails. Unfortunately, manufacturers have used all of these tactics in order to boost sales of their drugs. Manufacturers have the latitude to design the collection and presentation of data in order to cast results in the most favorable light. History reflects that drug companies withhold from the FDA, doctors, and patients information that might negatively affect warning labels and resulting market value. Manufacturers’ practices time and again leave the public medically vulnerable.
Preserving the option of tort litigation maintains the best means currently available to compel disclosure of information upon which the FDA and consumers can act. Those who have been hurt by manufacturers’ omissions should not be barred from seeking accurate information in a court of law. For the patients who have not yet suffered adverse events, access to information will certainly clarify their risks and could save lives. Litigation may be the only way to protect and enforce that access.
The federal government’s complicity in blocking access to the courts tips the balance of fairness and safety unjustifiably to the benefit of the drug companies. A Supreme Court decision in favor of Plaintiff Levine would preserve a critical source of knowledge essential to protecting the public’s well-being. Watch the Court; your health may depend on it.