An HB Law & Science Conference Report
Two major classes of drugs recently have been the subject of mass tort litigation for their alleged tendency to cause birth defects. The first group includes Topamax® and Topiramate, used to treat migraines, and the second comprises Zoloft® and the other Selective Serotonin Reuptake Inhibitor (SSRI) drugs, used to treat anxiety, depression and other psychological disorders. A panel of experienced attorneys spoke about the state of litigation surrounding these blockbuster drugs during a conference hosted by HB Litigation Conferences on June 22, 2011.
The Science of SSRIs
Zonies said that although SSRI drugs have been on the market for over 20 years, scientists are still unsure of how they achieve their desired effect. He said it is believed they help block the “reuptake” of the chemical serotonin in the brain, which is believed to, in turn, have an effect on the patient’s mood.
“There is still a question of whether or not these drugs actually work,” said Zonies. Certain studies have suggested that SSRIs are no more effective than placebo in altering a patient’s mood and that regular exercise may have more of a positive effect, he said.
Zonies said there is “no question” that Zoloft and SSRIs cross over from pregnant women to their unborn children. These drugs can cause a number of serious birth defects, such as “respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability and constant crying,” he said.
These conditions may be a direct toxic effect of the SSRI if the mother continued to take the drug through pregnancy, Zonies said, or may be caused by drug discontinuation syndrome.
He compared Zoloft and SSRIs to another reuptake inhibitor, cocaine. Although cocaine has some differences because it is a triple reuptake inhibitor, it has been shown to cause birth defects, Zonies said.
Statutes of Limitations
Cartmell said the Zoloft and SSRI cases are unique because most involve injuries to a minor child. He said many states will not begin to toll the statute of limitations until two or three years after the child has turned 18.
“These are a lot different than the cases we’re all involved in” brought by adults, he said. He said most of the time attorneys would not have an issue with statute of limitations regarding a minor’s claim “unless the case was from way back in the 90s when the drug was first on the market.” However, attorneys should be wary of how the statute might affect the claims brought by the parents, who are generally subject to the standard limitations period.
Cartmell said that the marketing of Zoloft by Pfizer Inc. will be a “strong element” in the litigation. “One of the real things that has shown up in our investigation is the energy that [Pfizer] put into marketing to women—directed to women, and directed to women of childbearing ages. There’s no question about that,” he said. Initial investigations have also shown that the company may have been “ghostwriting” the reports of studies on the drug in order to spin the data in its favor, Cartmell maintains. “What we found was that when the unfavorable results were coming out, those studies were being buried but the favorable studies were all being published,” he said.
Cautious Case Selection
The speakers agreed that plaintiffs who pursue Zoloft and SSRI cases should be highly selective in which ones they take to court. “There are a lot of people who are taking all cases that involve birth defects. And our friends from Paxil® [litigation] know that not every case that involves birth defects is a [provable] case,” Cartmell warned.
“You need to be thinking about all kinds of things in deciding whether a case is a case, and one of the big areas of concern is obviously genetics. Genetic testing is going to be a huge part of the cases. There is a background rate of birth defects and I think the literature shows it’s three to five percent of all live births include defects, so the defense is obviously going to focus on [that],” Cartmell predicted.
He also said that the defense is likely to focus on other risk factors, including whether the plaintiff smoked and whether other children in the family had birth defects.
Cartmell said that many attorneys had been waiting to see whether they would choose to pursue claims against companies that manufactured generic Zoloft until the U.S. Supreme Court ruled on PLIVA, Inc. v. Mensing, 180 L. Ed. 2d 580 (U.S. 2011); 2011 U.S. LEXIS 4793.
In a 5-4 decision, the Supreme Court ruled on June 23 that the claims against a generic drug manufacturer for failure to warn under state law were preempted by federal statutes and Food and Drug Administration regulations. The case was reversed and remanded to the Fifth and Eighth Circuits for further ruling consistent with the decision.