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CIAO DATE: 12/03
More Drug Use Will Mean More Lawsuits
On The Issues
March 2003
Lawsuits over the side effects of new drugs have become so frequent that even aspirin would not meet the safety standards that patients now expect. Drugs can have unforeseen problems when administered to large and old populations, and the resulting lawsuits have been allowed to handcuff the pharmaceutical industry by limiting drug development and driving up drug prices. A solution to this problem would be to link the Medicare drug benefit to product liability reform.
Even the most ordinary medicines can sometimes be extraordinarily hazardous. The birth control drug Norplant was linked to cases of severe menstrual bleeding. Hytrin, when used to treat hypertension, can cause painfully long erections. The migraine medication Imitrex was blamed for dangerous heart rhythms. Even antibiotics sometimes kill.
Legal Blame Game
When powerful drugs are administered to millions, a few are bound to have a bad outcome. But this unlucky law of averages has not stopped the blame game. With all of these drugs, and many others, costly litigation followed rare adverse events.
Often the patients at greatest risk for suffering these kinds of rare side effects are old people. It is common medical convention that seniors experience fewer of the benefits and more of the side effects of new medications.
This is something trial lawyers know as well as doctors, and it must have some tort artists eager to see Medicare prescription drug coverage enacted. Anything that gets more old people on drugs is sure to cause a commensurate rise in the number of unpredictable side effects. Since it only takes a dozen lousy outcomes to trigger class-action suits against a drug maker, more Medicare recipients on new medications means more big torts will follow.
There is often scant logic to the class action litigation. When something goes bad, drug makers are blamed. Since jury pools have been softened by a relentless campaign against the drug industry, nervous companies rarely take chances. These suits are often settled quietly out of court, masking the real cost to the industry, which is roughly estimated in the billions.
Often the number of side effects a drug causes is so small that it is hard to tell if the medicine is really at fault, but that has not stopped the legal blame game. Accutane, which has changed the lives of many of the five million teenagers who have taken it, is one example. It is the only effective cure for nodular acne, a particularly disfiguring condition. Now lawyers are making hay of fewer than 100 reported suicides among teenagers taking the drug since its release by Roche in 1982. That is comparable to the general teenage suicide rate, according to the Centers for Disease Control and Prevention.
Unforeseen problems should be expected when narrowly indicated drugs are administered to populations larger, older, and more diverse than anticipated. The bowel drug Lotronex caused fewer than fifty serious events in 300,000 prescriptions before it was withdrawn, and became the subject of costly litigation. Even drugs like aspirin, which cause hundreds of deaths each year, could not meet the safety standards patients expect today.
All this has become a bonanza for lawyers, however, as our society becomes more accustomed to taking medications for a wider range of problems. Bayer is facing more than 8,000 lawsuits after Bayer's widely used cholesterol-lowering drug Baycol was withdrawn from the market after being linked to about 100 deaths.
At least 6,000 of those lawsuits, however, are being filed by people who did not suffer any side effects whatsoever. How much will these lawsuits eventually cost? Bayer has reportedly paid about $125 million to settle the first 500 cases.
Even products successfully defended in court, such as the popular morning-sickness drug Bendectin, can still be driven from the market by the oppressive cost of ensuing litigation. Companies withdraw products, keep others off the market, and restrict the scope of research and development into vulnerable areas such as pediatrics and women's health.
Wider use of more drugs by old people will only expose manufacturers to greater risks of litigation, limit the development of new medicines, and drive up prices for everybody. Older patients already tend to take several other medications, which makes them especially vulnerable to unpredictable drug reactions and rare but serious side effects.
That is not to say elderly patients will not benefit from easier access to lifesaving medicines. Patients who can derive small incremental benefits from new medications are sometimes priced away, even though the health gains could often justify the added cost. But putting these patients on the pills they need means we need to prepare to tolerate more side effects or tolerate more lawsuits.
Protecting Pharmaceuticals
Litigation should not be a cost of commerce when government puts itself in the business of pushing pills. Drug makers deserve to be protected by coupling the Medicare benefit with tough new product liability reform.
Republicans in Congress have already rolled product liability reform for drug makers into malpractice reform for doctors. Democrats say the measure is dead on arrival. The proper place for considering these new protections is inside the Medicare drug benefit.
Drug profits pay for research. Tort awards only pay for more litigation. Without product liability reform, prescription drug coverage will transform into a full employment act for the lawyers, limiting development of new drugs and driving up prices for everybody.
Scott Gottlieb, M.D., is a resident fellow at AEI.
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