Even the most ordinary medicines can sometimes be extraordinarily hazardous. The birth control drug Norplant was linked to cases of severe menstrual bleeding. The migraine medication Imitrex was blamed for dangerous heart rhythms. Even antibiotics sometimes kill.
When powerful drugs are administered to millions, a few are bound to have a bad outcome. But this unlucky law of averages hasn’t 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 for Medicare prescription drug coverage. 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 will mean more big torts to follow.
There’s rarely any logic to the litigation. When something goes wrong, 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’s hard to tell if the medicine is really at fault, but that hasn’t stopped the legal blame game.
Accutane changed the lives of many of the five million teenagers who have taken it. It’s 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’s comparable to the general teenage suicide rate, according to the CDC.
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 The bowel drug Lotronex caused about 60 serious events in 300,000 prescriptions before it was withdrawn, and became the subject of costly litigation.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, couldn’t meet 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. 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, limiting the development of new medicines and driving up prices for everybody. Older patients already take a litany of medications, which makes them especially vulnerable to unpredictable drug reactions and rare but serious side effects.
That’s not to say elderly patients won’t benefit from easier access to life saving medicines. But putting these patients on the pills they need means we better prepare to tolerate more side effects or tolerate more lawsuits.
The only out from this dilemma will be if drug makers are given protection, by coupling the Medicare benefit to tough new product liability reform.
Republicans in Congress have already rolled product liability reform for drug makers into malpractice reform for doctors. The measure appears 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 morph 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 and a writer for the British Medical Journal.