Contributors
Peter McAllister: Lawyers open new front: Warning labels
01:00 AM EST on Wednesday, December 3, 2008

FAIRFIELD, Conn.
AS A PHYSICIAN, I spend my days in the examination room and not the courtroom. But, right now I’m watching intently as the Supreme Court considers Wyeth v. Levine, a case that could have a profound impact on what medicines are available to my patients. The court has just heard oral arguments for the case, which considers whether the Food and Drug Administration or state trial courts will determine the appropriate side-effect warning labels for drugs.
If the Supreme Court rules for the trial lawyers, the court may limit access to pharmaceuticals in same way that excessive litigation has cut patient access to physicians.
Nine out of ten obstetricians/gynecologists have been sued at least once, with an average of 2.6 claims per doctor, according to a 2006 survey by the American College of Obstetricians and Gynecologists. Many have stopped delivering babies as a result.
In highly litigious states like Connecticut, New Jersey and Pennsylvania, malpractice-insurance premiums have nearly tripled since 2000. An obstetrician in New Jersey pays $172,000 for insurance before he sees a single patient. As a result, young physicians simply can’t afford to enter this specialty.
And according to a 2003 American Hospital Association survey, 45 percent of hospitals reported a loss of physicians or reduced coverage in emergency departments owing to fear of lawsuits. Having chased so many physicians out of medicine, trial lawyers now have begun to limit the number of treatments available to patients by filing lawsuit after lawsuit against drug makers.
For example, Bendectin, a treatment for morning sickness, was voluntarily removed from the market in 1983 following lawsuits alleging that it caused birth defects. The Food and Drug Administration found the birth-defect claim to be bogus, but Bendectin stayed off the market thanks to the high cost of litigation. Hospital admission for morning sickness has since doubled.
Litigation makes it more difficult for patients to receive the treatments they need. By focusing on whether a drug’s label goes far enough to warn patients of any possible risk, lawyers force the FDA to constantly reevaluate warning labels, distracting the agency from its core mission of approving safe and effective drugs.
The resulting practice of over-warning — cramming information onto the drug’s label to warn of remote risks — doesn’t help anybody. Patients either ignore excess warnings or they overreact to them, discounting professional advice. And doctors often lament the lack of ease in locating the most relevant parts of a label. Warnings should make a physician’s practice easier, not harder.
Just look at what’s happened with some antidepressants. When the FDA imposed a “black box” warning that some antidepressants may increase the incidence of youth suicides, the number of prescriptions declined. Youth suicide rates increased.
The American Journal of Psychiatry has suggested that overzealous warnings may have contributed to the increase in suicides, because patients who needed the medicine were afraid to take it.
One important way to curb the negative influence of trial lawyers on patient access to quality health care is for the Supreme Court to affirm the principle of “pre-emption,” which states that federal law supersedes state law when there’s a conflict.
Pre-emption ensures that drug warnings are approved by expert FDA scientists instead of by state judges and juries with no expertise, or even worse, by lawyers with a financial interest in the verdict.
Without pre-emption, medical innovation is more difficult. If companies must navigate not only the lengthy FDA-approval process but also comply with 50 different state standards, they may conclude that research into new treatments isn’t worth the cost. That’s bad news for both doctors and patients waiting for more effective medicines.
A ruling in favor of pre-emption will strike a blow to the trial lawyers’ who profit from litigation at the expense of patient access to health care. As someone who has devoted his professional life to the well-being of patients, I hope the court decides wisely.
Peter McAllister, M.D., is a neurologist in Fairfield, Conn., and a clinical instructor in the Department of Neurology at Yale University. He is also the Northeast chairman of the Alliance for Patient Access.
We want to hear from you
More editorials
Most Viewed Yesterday
CCRI is spread too thin to train 21st-century work force, report finds
Agent: Bay in contact with other clubs, but still prefers Boston
PC Friars open with a 96-53 blowout of Bryant
Most active surveys
Did Bill Belichick make the right call on fourth-and-2?
What’s your customer service experience been like while shopping recently?
Do you agree that Marshon Brooks is destined for stardom at PC?
Will the Patriots end the Colts' chances of a perfect season?
Most e-mailed in the last 24 hours
Reader Reaction









You must be logged in to contribute. Log in | Register Now!
You are logged in as screenname | Log Out
You are logged in, but do not have a "screen" name. Create a Screen Name