Abuse of medical system by lawyers hurts patients

The U.S. Supreme Court just heard arguments in Wyeth v. Levine, a case likely to have major effects on the legal framework governing the approval of pharmaceuticals. The court will essentially decide whether scientists at the U.S. Food and Drug Administration or local juries have the final word on drug labeling laws.

The case brings into focus a major problem facing America’s health-care system. Health-care providers and medical product manufacturers have adopted a risk-averse stance toward both the delivery of care and future medical innovation because of the threat of protracted and costly legal battles.

Unfortunately, this conservative posture works to the detriment of patients. For years, frivolous litigation has been driving up health-care costs, reducing patient access to life-saving medicines, suffocating physicians, and undermining medical research and investment.

Every medical treatment carries some degree of risk. When treating patients, physicians weigh the health benefits of a particular course of action against its potential side effects. The same goes for federal drug-safety regulators.

That process is imprecise. The human body is a tremendously complex system, and everyone’s personal physiology is unique. If a treatment doesn’t go exactly as planned, it’s usually not the result of malpractice or fraud on the part of the medical provider.

Of course, when health-care providers are negligent or commit fraud, they should be held accountable. That’s what the tort system is for. But trial lawyers have taken to using litigation irresponsibly —- filing as many lawsuits as possible, often targeted at the deepest pockets, regardless of merit, in hopes of landing big-money judgments or settlements.

This trend would only worsen if Wyeth loses its case before the Supreme Court.

Legally speaking, the Wyeth case is about the principle of “preemption,” which holds that federal regulations supersede state ones if they come into conflict. Wyeth argues that FDA approval of its products and the labels on them should protect it from certain product liability lawsuits.

Preemption does not protect companies from being sued for fraud, deception, or other forms of wrongdoing. Preemption only applies if a lawsuit puts a company in the impossible position of having to satisfy a federal agency whose requirements clearly conflict with the decision of a local jury.

Without preemption, the billion-dollar FDA drug-approval process would become almost meaningless. State legislatures and local juries would be free to second-guess FDA evaluations on everything from the costs and benefits associated with a drug to the text on an approved product’s label. Medical firms would find themselves on the defensive at every turn.

That may seem like an important check on medical companies and drug makers, but it has the unintended consequence of causing firms to change their research programs. Rather than take a chance on a risky —- but potentially groundbreaking —- treatment option, researchers will restrict themselves to safer “sure things.”

Frivolous litigation also causes medical firms to pull safe and effective products from the market.

For example, the number of American vaccine manufacturers has plummeted in recent years partly because of price pressures, but also because of an uptick in lawsuits claiming a link between the measles-mumps-rubella vaccine and autism. There is zero support for such a link in every major scientific study to date.

The tumultuous legal environment surrounding drugs and other medical products has contributed mightily to the rise of cumbersome bureaucracies in the provider community. Just as medical manufacturers are forced to take precautions in their research programs to defend against lawsuits, so too must hospitals and other health care providers.

Patients see this excess bureaucracy with every trip to the doctor’s office or pharmacy. Forms must be filled out in triplicate to satisfy the health-industrial complex —- and to keep the legal profession at bay.

Unsurprisingly, many patients have started sidestepping this burdensome system by turning to nonsanctioned channels, such as online pharmacies, for medical advice and treatments.

A 2007 FDA study examined 2,000 foreign drug packages shipped into the United States. Ninety percent were prescription drugs already available domestically. As FDA deputy commissioner Randall Lutter remarked on the finding, “many people are buying drugs online not to save money but to bypass the need for a prescription from their doctor.”

Such a development portends huge risks for the American public. Drugs from online outfits often come from unregulated or unproven distributors. Pills are often counterfeit or ineffective. A 2007 report from the online fraud expert MarkMonitor found that just four of the 3,160 online pharmacies it studied had attained the Verified Internet Pharmacy Practice Sites seal, the industry’s quality control standard.

Our tort system exists to ensure that wronged parties receive compensation and that fraudulent or negligent parties are punished. But abuse of the system by trial lawyers is driving safe drugs from the market and patients from mainstream medicine. The Supreme Court —- and eventually Congress —- must take a stand against these tort abuses for the sake of public health.

> Roger Bate is a resident fellow at the American Enterprise Institute and author of “Making a Killing: The Deadly Implications of the Counterfeit Drug Trade.”