Higher healthcare costs inevitably occur when manufacturers adjust to the out of control tort environment by pricing certain products they perceive as presenting particular liability concerns at a significant premium over others. Higher prices create pressures to reduce the use of approved products, contrary to FDA's objective of rational prescribing. More than ever before, rising costs threaten to price the benefits of modern technology out of the range of many of the patients who most need it. And these cost pressures are going to increase as our population continues to age and more treatment options become available. According to many experts, the differential cost of healthcare between the United States and Canada can be explained by product liability considerations. Higher prices create pressures to reduce the use of valuable, safe, and effective healthcare options. More cost results in less effective healthcare.

 

When the tort system threatened the development of lifesaving medical products in the past, we found creative solutions. Consider the disaster that faced childhood vaccines in the mid 1980s. Under the weight of litigation, prices for vaccines increased 10-fold, and the number of manufacturers dropped from about 20 to only 4 – and only 2 in the US. So Congress took most child vaccine litigation out of the tort system and created the well-respected Vaccine Compensation Fund. Today, it’s widely understood that vaccines are safer than ever not despite these fundamental litigation reforms – but because of them.

 

When public health is put before private gain, tort law and the lawyers who practice it play very important role in protecting and enhancing America’s health. Tort law, appropriately applied, helps patients get redress for truly negligent care. When product manufacturers provide fraudulent information to FDA, or deliberately withhold information about safety problems associated with their products, they should be held accountable. The dedicated members of our legal profession have always provided, and continue to provide, vital protection against those who would prey on consumers or intentionally try to pass off harmful products. The threat of litigation can be an important disincentive to many predatory behaviors.  

 

The problem is that the current liability system doesn’t reward lawyers who focus on these real public health concerns. Instead, the most experienced and well-financed law firms know that the biggest payouts regularly go to those who take advantage of the FDA’s best efforts to promote the safe and effective use of medications. More and more often, these “mass tort” firms specialize in taking a new product warning label or withdrawal decision by the FDA, and view it as a signal to go forward with all guns blazing. Their bullets, unfortunately but not unpredictably, hit multiple innocent targets and result in a wounded American healthcare system. 

 

One woman, speaking to a reporter for the Jackson Clarion-Ledger, summed it up this way: When she read that the drug Propulsid might cause harm, she stopped taking it and signed up for a lawsuit. “Actually, I didn't get hurt by Propulsid,” she told the newspaper. But because she had taken the drug, she said she thought she could join a class-action lawsuit “and I might get a couple of thousand dollars.” Less fairness results in more damages.

 

Labeling can and must be a valuable tool for improving and protecting America’s health. That’s the law. The FDA is concerned that current labeling practices are in direct counterpoint to the principle objective of current regulations, to facilitate a doctor’s ability to “rationally prescribe” any medical product approved by the FDA. Rational prescribing occurs when a healthcare professional orders an approved prescription drug or biological product in circumstances where the risk/benefit profile of the product is optimal. The FDA’s most potent weapon in the battle for accurate, timely, “rational,” prescribing is clear, approved labeling.

 

The FDA’s legal and legislative authority over labeling for prescription drugs and biological products is plenary. The Federal Food, Drug, and Cosmetic Act establishes mandatory and prohibited labeling content and manufacturers have no choice but to comply with these requirements. Less obvious, but equally important, is the principle that the Act also constitutes a “ceiling.” In other words, a manufacturer cannot add risk information to labeling unless the FDA has specifically granted its permission.

 

The act clearly gives the FDA the authority to decide whether or not a product, when used properly, is safe, effective, and properly labeled. A product, used as described in FDA-approved labeling, should be considered safe and effective throughout the United States. Preemption is a well-recognized doctrine of constitutional law derived from the supremacy clause and analyzed by the Supreme Court in several cases. Federal law preempts state law here because FDA intends for federal regulation to be exclusive and preemption does not exceed statutory or constitutional limitations.