The big shift in thinking about antidepressant use in pregnancy began in late 2005, when the FDA warned that Paxil “increases the risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy,” and demanded GlaxoSmithKline to change Paxil from a “Category C” drug to a “Category D” drug, i.e. a drug known to produce birth defects or injure fetuses.
In February 2006, the landmark “Selective Serotonin-Reuptake Inhibitors and Risk of Persistent Pulmonary Hypertension of the Newborn (PPHN)” study was published in the New England Journal of Medicine, showing that Prozac use in the third trimester of pregnancy increased the risk of PPHN. That study prompted the first formal SSRI FDA warning in July 2006 across the board for Celexa, Lexapro, Paxil, Prozac and Zoloft. In 2009, the British Medical Journal showed Prozac, Celexa, Paxil and Zoloft were all associated with an increased risk of congenital heart defects, particularly if a pregnant woman used more than one. In January 2012, the British Medical Journal reviewed over 30,000 pregnancies involving SSRI use and found the risk of PPHN was doubled when the baby’s mother used an SSRI. Just a week ago, the Archives of General Psychiatry published a study concluding that pregnant mothers treated with SSRIs had higher rates of premature birth and delayed infant head growth.
The risk is there, and the body of scientific research is growing, but many patients still don’t know the risks of using SSRIs in pregnancy, and today more than 5% of pregnant women take antidepressants. Other than changing the birth defect risk category of Paxil, though, the FDA hasn’t done anything to fix the situation. In December 2011 the FDA issued a drug safety communication that frustratingly said “it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN.” Zoloft, Lexapro, Celexa, and Prozac are still listed as a Category C drugs, and none of them warn patients or doctors about the risk. Buried in the fine print of Prozac’s warning label there’s a reference to PPHN and congenital heart defects, but then the risk is dismissed: “There are no adequate and well-controlled clinical studies on the use of fluoxetine in pregnant women.” Zoloft’s warning label doesn’t even mention the possibility of birth defects except through a vague reference to studies of pregnant rats.
All told, birth defect lawyers have probably done more to educate the public about the dangers of SSRI use in pregnancy by way of television ads than the FDA has. Which brings me to the core of this post: the increasing role of the First Amendment in drug liability lawsuits.
Drug manufacturer defense lawyers have been trying for years to use the First Amendment to destroy FDA regulation of off-label marketing. In their view, drug companies should have free reign to market prescription drugs however they want — even for uses that aren’t approved by the FDA, even with claims that aren’t supported by the medicine or the science. The five anti-consumer Justices on the U.S. Supreme Court gave them some hope with Sorrell v. IMS Health, Inc., 131 S. Ct. 2653 (2011), which astonishingly used the First Amendment to invalidate a state law prohibiting pharmaceutical companies from using confidential prescribing records to target individual doctors for high-pressure marketing.
Coming back to SSRIs, when a patient is prescribed an antidepressant, they are given the medicine and then some form of ‘patient education monograph’ — a package insert, a warning label, a brochure, et cetera — that explains how to take the medication and what the risks are. For Zoloft, although manufactured by Pfizer, most of the informational materials included with it are actually written and published by Wolters Kluwer Health. The various pharmacy companies (like Walgreen’s and CVS) have their own duties under state licensing laws to counsel patients, so they hire companies like Wolters Kluwer Health to write up patient-oriented guides to give out with the medications.
There are about 60 Zoloft birth defect lawsuits that have been filed so far, and to my knowledge the overwhelming majority of them name both Pfizer and Wolters Kluwer Health as defendants. Wolters Kluwer Health, after all, supposedly researched and thought about what went into those patient education monographs — and for Zoloft it deleted even the minimal references to studies of pregnant rats that were in the fine print provided by Pfizer. The WKH materials said nothing at all about anything relating to birth defects.
WKH has filed motions to have all of the birth defect lawsuits dismissed for a variety of reasons, including an argument that “publishers, like WKH, are entitled to full First Amendment protection, which precludes liability for non-defamatory information that is alleged to be negligent.” (You can read their brief here: WKH Brief.)
As a matter of law, as explained by the Plaintiffs’ Brief, WKH’s argument is just plain wrong: “There can be no constitutional objection to the suppression of commercial messages that do not accurately inform the public about lawful activity.” Central Hudson Gas & Elec. Corp. v. Public Serv. Comm. Of New York, 447 U.S. 557, 562, 100 S.Ct. 2343 (U.S. 1980). (I’ll leave to another day how, unlike in that case, there’s no “suppression” here — WKH can continue to print whatever it wants, the question is if it’s responsible when it provides inaccurate or false information.)
But there’s a deeper issue here. Our legal system has moved so far in favor of protecting monied interests that a medical and scientific publishing company that makes nearly $400 million in profit annually thinks it has a good shot at using the First Amendment — which was enacted to guard against criminal penalties and prohibitions on political speech by individuals — to dismiss a negligence lawsuit before the lawsuit can even get started. It’s like medical device companies trying to get complete legal immunity from any claims — a move prompted by the DePuy hip recall and transvaginal mesh erosion travesties that have injured hundreds of thousands of patients — or drug companies arguing that strict liability should be eliminated for them alone.
Normally, when someone says they shouldn’t ever be held responsible for the damage they cause, we immediately wonder why. What have they done? What are they planning to do? Why can’t they be held to the same rules the rest of us have followed since pre-school? But our legal debate has become so distorted, and the corporate interests so powerful, that the First Amendment is now routinely used to protect wealthy interests trying to increase their influence and power — exactly what the Framers wanted to avoid.
In time we hope the pendulum will swing the other way, and the First Amendment will return to its roots of protecting free speech on the topics that really matter, rather than serving as a mere tool by which politically connected interests can keep their market position. But how many people will have to suffer without any legal recourse before that time?