by Brian Russel

As a lawyer who subscribes to a “strict constructionist” reading of the U.S. Constitution, it’s a rare day when Chief Justice John Roberts, Justice Antonin Scalia and Justice Samuel Alito all three see a case before the U.S. Supreme Court differently than I do. Wednesday, March 4, 2009 was such a day, and I believe that the majority, comprising the remaining six justices, got it right. The Court, in Wyeth v. Levine, held that consumers who suffer adverse side effects of pharmaceuticals can sue the manufacturers in state courts, allege the inadequacy of the drugs’ warning labels, and recover damages, even if those labels have been approved at the federal level. In other words, the courts of each individual state retain the power to find warning labels inadequate to protect their citizens even after the labels are approved by the federal Food and Drug Administration (FDA) for use across the United States. I agree, for both Constitutional and practical reasons.

The Constitutional rationale for my agreement with the majority in Wyeth v. Levine is rooted in my belief in states’ rights. Powers not specifically granted to the federal government by the Constitution are supposed to be reserved to the individual states, but over the past two centuries, the federal government has “progressively” usurped states’ rights in the name of regulating “interstate commerce,” which generally has been interpreted broadly enough to encompass just about anything the federal government has wanted to regulate. The regulation of interstate commerce is in fact one of the powers specifically assigned to the federal government in the Constitution, but in my view, states should be free to afford their citizens greater consumer protection than that which is provided by federal regulations, if they so choose. In other words, federal regulation should not preempt more restrictive pharmaceutical labeling standards at the state level.

The practical rationale for my agreement with the court’s ruling is rooted in my belief, as a psychologist, that I’m seeing psychotropic drugs in particular being prescribed to more and more Americans for more and more conditions and doing more harm than good in more and more cases. Lately, I’ve been writing and speaking a lot about the out-of-control hail of psychotropic pills pelting America’s children, and in my opinion, as both a lawyer and a psychologist, the only realistic hope of stemming that tide is a series of large jury verdicts across the country. That hope would’ve been diminished substantially had the Roberts-Scalia-Alito view prevailed in Wyeth v. Levine. The drug at the center of the Wyeth v. Levine ruling was not a psychotropic drug – it was the anti-nausea drug Phenergan, which caused an adult guitarist in Vermont to lose her arm after the drug was injected inadvertently into an artery instead of a vein, resulting in the onset of gangrene. Nevertheless, the same kinds of problems that I’ve identified with the marketing of psychotropic drugs for use in children – exaggerations of effectiveness, manipulations of the results of clinical trials, failures to disclose serious potential side-effects like suicidal ideation – are affecting adults with even greater frequency. For instance, it’s been widely reported that the maker of the antipsychotic Seroquel is alleged in recently-unsealed court documents to have minimized the risk of developing diabetes to adult patients taking that drug. Here again, I believe that the pharmaceutical industry’s highly-profitable practices can be modified by little else than money.

As I’ve consistently acknowledged, pharmaceutical companies aren’t 100% to blame. There are cultural factors in play as well, whereby consumers of psychotropic drugs bear some responsibility. Many self-absorbed adult Americans have bought into the cultural myth that they’re not only capable of but also entitled to complete, enduring happiness and are willing to turn to pharmaceuticals in their quest for that unrealistic utopia. Also, adults who are faced with mild to moderate psychological symptoms seem increasingly to want “quick fixes” for themselves as well as for their children in lieu of more time-and-effort-consuming treatment options like psychotherapy, consciously electing in many cases to mask symptoms medicinally rather than trying to learn to cope with and overcome them.

That notwithstanding, the major pharmaceutical companies are spending billions to market psychotropic drugs directly to adult consumers and for a seemingly ever-broadening range of symptoms. I recently saw a television commercial touting the psychotropic drug Abilify as a treatment for depression. Abilify, however, is primarily an antipsychotic, originally marketed to treat symptoms like hallucinations and delusions, not depression. In fact, after years of graduate training in psychology, including a year-long internship in the psychiatric ward of a hospital, followed by years of clinical practice, that commercial was the first I’d ever heard of using Abilify, or any drug in its class, as an antidepressant. But that didn’t stop the commercial from saying, “If an antidepressant alone isn’t enough… .” In fairness, I did some research and found that Abilify did get FDA approval at the end of 2007 for use as an adjunct (supplement) to treatment with conventional antidepressants, but here again, I think states should be free to enforce labeling standards tighter than the federal government’s (and by the way, that approval of Abilify for depression applied to adults only, not to kids, which of course doesn’t guarantee that some pediatricians won’t prescribe it anyway, “off-label”).

Shocking as it may be, when it comes to the regulation of pharmaceuticals, psychotropic and otherwise, the federal government doesn’t always get it right. That’s why it’s a good thing the Supreme Court did get it right in Wyeth v. Levine.

Brian Russell is a licensed psychologist, attorney at law and familiar national television pundit on psychological, legal and cultural issues. Email: drbrian@lawpsyc.com