Prescribing physicians at risk in Paxil lawsuits

As Vioxx verdicts trickle in across the country, product liability and personal injury attorneys are gearing up for the next wave of lawsuits that will determine whether a drug company knew its product was dangerous but kept the information quiet.

Lawyers are keeping a close eye on lawsuits against GlaxoSmithKline alleging that babies were born with anomalies because their mothers took the antidepressant Paxil during their pregnancies. They're waiting to see which of two strategies that have emerged among trial attorneys filing the cases are most successful.

Doctors also should watch the cases to see which strategy prevails, because the outcome will affect them. One strategy involves naming physicians as defendants for prescribing the drug; the other strategy most likely would not drag physicians into court.

Let's first take a look at the logic behind the cases that don't involve naming doctors.

Baum Hedlund, a national pharmaceutical products liability law firm with offices in Los Angeles, Philadelphia and Washington, D.C., filed its first lawsuit against GlaxoSmithKline, maker of Paxil, in late July in state court in Philadelphia, where the pharmaceutical company is based.

Texas resident Adrian Vasquez and his parents, Anthony and Matilda Vasquez, sued after Adrian was born in April 2004 with congenital heart defects that included D-transposition of the great arteries, ventricular septal defect, patent ductus arteriosus, double-outlet right ventricle and pulmonary stenosis, according to the complaint filed in the Court of Common Pleas, Trial Division, Philadelphia County.

The physician who prescribed Paxil to Matilda Vasquez is not a defendant in the lawsuit.

Karen Barth Menzies, the attorney representing the Vasquez family, said she tries to avoid suing physicians because drug companies mislead or misinform physicians.

She noted that in other lawsuits involving pharmaceutical companies she has obtained documents through discovery that outline talking points for sales representatives instructing them how to respond to a physician who asks about a recently published study involving the drug. The talking points, she said, are designed to downplay any risk and make the physician feel comfortable about prescribing.

"We have always been reluctant to bring a doctor into the lawsuit," Menzies said. "We've seen so many internal documents of pharmaceutical companies, documents in which they manipulate information. It's clear who the culprit is."

It is only in rare instances where it may not be clear, she said, that a doctor may be added as a defendant. For example, if there could have been some information about a drug's risks and she isn't sure whether the physician may have or should have known about the risks, the physician might be named as a defendant.

Menzies said the evidence in the Vasquez case will show that GSK didn't warn physicians about the risks associated with Paxil and, in fact, took steps to avoid warning them. The complaint alleges that GSK failed to disclose fully the results of tests and other information it had about the possibility of Paxil interfering with a fetus' proper development and that GSK negligently and carelessly failed to adequately warn the medical community, the general public and Matilda and Anthony Vasquez about the dangers of using Paxil during pregnancy.

Adding a doctor as a defendant

The allegations are similar to those in a lawsuit Houston personal injury attorney Robert Kwok filed earlier this year. But the prescribing physician is named in that lawsuit.

Lisa Collins Steele, of Brazoria County, Texas, where the lawsuit was filed, gave birth to her son, Chase, in early November 2005, after taking Paxil during her pregnancy. Chase was born with a ventricular defect that required several surgeries. Steele and her son are suing GlaxoSmithKline for fraud and negligent misrepresentation, alleging that Paxil caused her son's heart defects and that the drugmaker knew of the risk and failed to disclose it for several years.

Kwok said the physician's culpability is a contested issue in Steele's case, and he declined to discuss it or provide the physician's name because the doctor at some point could come under a protective order from the court.

"There is a fact issue with regard to whether the physician knew or should have known [the risks]," Kwok said. "The doctor is going to say that GSK should have told him."

While Kwok refused to elaborate on why Steele named her physician in her lawsuit, other experts noted that there are a variety of reasons why plaintiffs' lawyers sue a physician in pharmaceutical or medical device tort lawsuits.

Experts from a law firm that handles most of the mass tort defense work for the Texas Medical Liability Trust, the largest medical insurer in Texas, said that the reasons include:

• The "empty chair" defense, in which other defendants defend the lawsuit by shifting blame to absent parties.
• Venue and jurisdictional concerns that deal with the location and court in which the lawsuit might be tried.
• "Party control," meaning that plaintiffs wish to assert leverage over physicians to discourage them from disparaging either the plaintiff or the integrity of the plaintiff's lawsuit, or from siding with the named defendants.

Kwok chose to file his case in Texas because he wants a jury of Steele's peers. Menzies said her decision to sue GSK in Philadelphia, where the company is based, alleviated strategy concerns that necessitated naming the treating physician. Suing GSK in its home state also will make it more difficult for the drug company to try to move the lawsuit to federal court.

Menzies said she also chose state court because it moves more quickly.

Assessing what was communicated

Both lawsuits allege that GSK knew about the Paxil risks well before it agreed to change the drug's pregnancy warning from a C to D and add new data and recommendations to the warnings section of the prescribing information, at the request of the Food and Drug Administration.

The lawsuits allege that in 2003 GSK initiated retrospective analysis dating back to 1995 of women who had taken antidepressants in their first trimester and had given birth to children with congenital anomalies.

In September 2005, GSK sent out a letter informing U.S. physicians that studies showed a higher rate of "congenital malformations" associated with Paxil's use than with other antidepressants.

A representative for GlaxoSmithKline could not be reached.

The attorneys who work with the Texas Medical Liability Trust said they did not believe that prescribing physicians are valid parties in Paxil lawsuits but might be joined to a lawsuit over potential concerns regarding medical care. These concerns can include drug dosage, duration and monitoring.

In their experience, they said, these issues are sometimes raised by attorneys for pharmaceutical companies who "engage in ill-advised, and usually unsuccessful, defense based on shifting the responsibility" in the lawsuit to a third party.

Kwok estimated that there are about 50 lawsuits already filed against GSK around the country, and both he and Menzies expect to file more. The fate of their differing strategies is likely to be watched by other attorneys who decide to sue GSK. And as cases wind through the courts, physicians likely will get some idea of the chances they will be named as a defendant by watching to see which strategy seems to be prevailing.