Can Paxil Cause Birth Defects?

Nothing appeared wrong with Lyam David-Kilker during the first seven weeks of his life. Born on Oct. 24, 2005, the second son of Michelle David and Miles Kilker, he resembled any other healthy, happy infant, and the couple returned home to suburban Philadelphia with their family’s newest member. But in early December they began noticing changes. Lyam’s energy and appetite diminished, and even at rest, he labored to breathe.

David took him back to the hospital for a checkup. The diagnosis proved devastating. He had two holes in his heart and an undeveloped aortic arch, a rare birth defect that prevents blood from reaching all areas of the body. He would require open-heart surgery to save his life. Almost as soon as she received the news, David formed a theory about what caused his condition. “I knew right away,” she says. “I knew it was the Paxil.”

A doctor prescribed the antidepressant a couple months before her pregnancy to alleviate mild anxiety and sporadic panic attacks, and continued to prescribe it during the pregnancy. Manufactured by the London-based pharmaceutical GlaxoSmithKline, the drug belongs to the class of antidepressants called selective serotonin reuptake inhibitors, or SSRIs, that includes Prozac and Zoloft, among others. By chance, shortly after learning of Lyam’s health problems, David heard about a TV ad aimed at mothers who took Paxil while pregnant and whose babies suffered from birth defects. The ad provided a phone number for a Texas law firm handling Paxil-related litigation. She called and explained her son’s condition; a couple of referrals brought her case to Sean Tracey, a plaintiff’s lawyer in Houston.

No mother would want to meet Tracey under the circumstances that led David to him. But if suing the world’s second-largest drug maker over allegations that Paxil causes birth defects is the preferred course, and if resolved to go to trial—the first of some 600 similar cases leveled against GlaxoSmithKline nationwide to reach that stage—any mother would wish Tracey represented her. Or so insists the 29-year-old David, a dance instructor and former dancer for the Philadelphia 76ers. “In court, Sean was my voice and the voice of my child,” she says. “He believes in what he’s doing.”

The month-long trial against Glaxo last fall drew international headlines and marked what Tracey calls “the most grueling experience of my career.” Founder of the Tracey Law Firm, the 45-year-old trial lawyer, who specializes in personal injury and wrongful death cases, has won his share of multimillion-dollar judgments against large companies, attracting national notice for his work in asbestos litigation. In 2007, he obtained a $5.2 million jury award against Foster Wheeler Corp., a New Jersey engineering firm, on behalf of survivors of a man who worked with the company’s equipment for years and later died of asbestos-related cancer. Three years earlier, Tracey helped secure a $10 million verdict against Ford Motor Co. for family members of a woman whose death they blamed on secondhand asbestos exposure.

But scrutiny of the Glaxo trial within legal circles and by the media surpassed that of any of Tracey’s previous cases. Plaintiff’s lawyers and reporters alike viewed the proceedings as a bellwether for the hundreds of other suits alleging a link between Paxil and birth defects. In the end, the jury awarded David $2.5 million, $1.3 million above what she sought. By a 10-2 margin, the panel identified the drug as the “factual cause” of her son’s condition and found that Glaxo “negligently failed” to alert her doctor to Paxil’s potential risks. The money will pay for past and ongoing medical care of 4-year-old Lyam, who underwent two heart surgeries during his six-month hospital stay and faces more operations as he grows. After intensive work with therapists, he shows cognitive and developmental abilities on par with children his age, and doctors are cautiously optimistic about his long-term health.

For Tracey, beyond the arcane science and dueling experts, the case followed a classic story line. “No matter how complex everybody tries to make things, this was about good guys and bad guys,” he says, his voice thick with Texas drawl. “Ultimately, what all this was about was what did they know, when did they know it and what did they do with the information they either had or should have had.”

Tracey had, in fact, filed the first such suit against Glaxo, a multinational corporation with annual revenues of more than $40 billion, in 2006. In that case, which reached a confidential settlement in 2008, he represented Lisa Collins, a Texas mother whose son needed open-heart surgery three months after he was born to repair congenital defects. She attributed his condition to the Paxil she took while pregnant to cope with occasional bouts of claustrophobia.

Plaintiff’s lawyers across the country followed Tracey’s cue, and as the number of cases mounted, he and his legal team pored over an estimated three million internal Glaxo documents obtained through discovery. The paper trail included memos from as far back as 1980 that suggested Paxil caused developmental malformations in the offspring of lab animals; a company review from 1998, six years after the Federal Drug Administration approved the antidepressant, that found “an alarmingly high number” of reports of birth defects linked to the drug; and a report showing Glaxo officials were “almost certain” that Paxil caused heart defects in the fetus of a woman who chose to abort her pregnancy in 2001 rather than give birth to an unhealthy baby. The episode occurred four years before the FDA asked the company to change Paxil’s label to caution pregnant mothers that the drug may lead to heart defects in infants.

Apart from Tracey and his fellow plaintiff’s lawyers involved in Paxil-related litigation, few knew what the Glaxo files held, including congressional investigators and federal regulators probing the side effects of antidepressants. “It was eye-opening to me,” he says. “I saw the internal workings and documents that Congress had never seen, that the FDA had never seen, that nobody had ever seen and nobody would have seen if Lisa Collins hadn’t filed her lawsuit.”

The documents remained under wraps owing to a protective order to which he consented to avert a prolonged fight over gaining access to the files. He admits the arrangement left him conflicted. “There’s always that tension between my personal desire to air the dirty laundry of the facts of the case because I think there are public health implications and my clients’ right to resolve the litigation and move on with their lives.”

He tempers the urge to overreach by remembering a quote from Jerome Facher as delivered by Robert Duvall, who played the famed Boston defense attorney in the 1998 film A Civil Action. “Now, the single greatest liability a lawyer can have is pride,” Facher tells a roomful of law school students. “Pride. Pride has lost more cases than lousy evidence, idiot witnesses and a hanging judge all put together. There is absolutely no place in a courtroom for pride.”

“I always try to keep that in mind,” says Tracey, a founding partner in a pair of Houston firms from 1995 to 2007, when he joined Dallas-based Waters & Kraus; he departed later that year to open the Tracey Law Firm. “The case is not about me, it’s about the client. Lawyers who get obsessed with the greater good—that’s how you can lose cases.”

It was another courtroom drama, Inherit the Wind, that started him thinking about a law career before he reached his teens. An Indianapolis native who grew up in Detroit, he saw the movie on TV at age 10 or 11, and by the time the credits rolled, he aspired to the Clarence Darrow ideal. “I wanted to be that guy because that was the guy who stood up against the rich and powerful for the nobodies of the world.”

Tracey graduated from South Texas College of Law in Houston in 1991, three years after earning his bachelor’s in philosophy a couple of miles away at the University of St. Thomas. And though he gravitated to the opposite side of the bar from his Inherit the Wind idol, when describing his clients as casualties of corporate negligence, he comes across as utterly Darrowian.

“You do get outraged, and the reason you get outraged is that none of these things had to happen,” says Tracey, who lives in the Houston suburb of Friendswood with his wife, Kari, and has a 25-year-old daughter. “Look, I get to move on with my life, and hopefully I do my clients some good and I leave them a little better off than they were when they walked in my door. But the struggle doesn’t end for them. It goes on and on and on.”

He traveled to the Philadelphia suburb of Bensalem to meet Michelle David and Lyam Kilker about a year before her trial against GlaxoSmithKline. Then as now, the youngster exhibits few outward signs of his ordeal, and doctors consider his recovery from open-heart surgery a success. But he will suffer from high-blood pressure and will begin to lack the stamina of most children his age as he grows up because of his weakened heart. He will need to make regular visits to a cardiologist for the rest of his life and require surgeries to replace the graft covering the holes in his heart. He speaks in what his mother calls a “raspy chipmunk voice” because of damage to his throat caused by ventilation tubes.

While declining to disclose whether Glaxo talked settlement with David, Tracey says, “There’s almost always an opportunity to settle cases before trial. But when Michelle found out what I knew, she was of the opinion that this story should be told.” David’s desire to air the case in front of a jury motivated her as much as the memory of what she and her son endured. “You’re at the hospital for six months holding his little hand, and every day you have no idea whether this is going to be his last day, whether this is going to be the last time you’re ever holding him,” she says. “That’s not a feeling you ever forget.”

The trial began in September 2009. Freed from the agreed protective order, Tracey disclosed the internal Glaxo documents he unearthed during the Collins case. The company, denying that Paxil contributes to birth defects, asserted that it complied with federal regulations in conducting clinical trials and sharing results with the FDA, and suggested Lyam’s condition could be tied to David smoking before she learned of her pregnancy. Meanwhile, outside the courtroom, news about the case added to Glaxo’s public relations woes amid deepening concerns over the antidepressant. Bloomberg reported last year that Glaxo has already shelled out nearly $1 billion to settle Paxil-related litigation, including claims linking the drug to birth defects, suicides and addiction problems, along with an array of suits brought by federal regulators over antitrust and fraud allegations.

Far from relishing the media’s presence, however, Tracey found himself unsettled by coverage of the case. “I’d never had the experience of articles being published during trial,” he says. “That’s where I felt an extraordinary amount of pressure. It seemed to me everybody in the free world was watching me to make sure I didn’t screw this up.”

Experts from each side dominated the trial, trading interpretations of Glaxo’s own reports and the science behind Paxil. Tracey also used the David case to expose the practice of “medical ghostwriting.” The term applies to drug makers paying respected physicians to lend their names to articles written by company consultants and subsequently published in medical journals. Trusting the publication and the author, doctors who read the articles treat them as credible and, in turn, reassure patients that a drug is safe. Testifying for the plaintiff, Dr. David Healy, a world-renowned psychiatrist from Ireland and author of Let Them Eat Prozac, explained that “the article will talk about the good aspects of the drug and will leave out the risky issues, which are probably the most important things for the practicing doctor to know.”

Tracey pulled 20-hour days throughout the trial—unaided by caffeine because, he quips, “I’m naturally crazy to begin with”—and went without sleep the night before giving his closing statement. “I got into the courtroom that day and told myself, ‘I only need about an hour and a half of energy, then I can go die.’” When jurors returned with a verdict after seven hours of deliberation, Tracey wanted to die again, given the conventional wisdom that the longer a jury stays out, the more likely it will find for the plaintiff. “My heart started beating about 180 beats a minute,” he says. “But then at the very end, right before the verdict was read, I just went calm, and for whatever reason I said, ‘We won the case.’”

In response to the jury’s $2.5 million award, Glaxo, which has appealed, released a statement claiming “the scientific evidence does not establish that exposure to Paxil during pregnancy caused [Lyam’s] condition.” Nonethess, the verdict has apparently resonated with the force of a class-action judgment. Tracey reveals that, since the David verdict, the drug maker has settled more than 30 other Paxil-related suits he had pending. Likewise, the fact that a second trial over similar allegations has yet to occur anywhere in the country suggests the company may have redoubled its efforts to resolve cases before they reach trial. Even so, he refuses to gloat, ever mindful of pride’s perils. “You have to keep perspective, and I actually feel privileged that I get the opportunity to help people.”