By Aaron Reiss
By Angelica Leicht
By Dianna Wray
By Aaron Reiss
By Camilo Smith
By Craig Malisow
By Jeff Balke
By Angelica Leicht
Dark blue splotches stained Lisa Collins's newborn son's mouth as if he'd gotten messy with a lollipop.
Mom scrubbed Baby clean in the bathtub, but the blemishes would not go away.
The discoloration soon spread to Chase's tiny fingernail beds -- the sign doctors had warned about.
Midway through her pregnancy, doctors told the 27-year-old Friendswood resident to expect complications.
The same ultrasound that revealed she was having a boy also showed the fetus was missing part of his heart. A more detailed X-ray image taken a week later revealed an underdeveloped heart chamber.
Doctors predicted Chase would require surgery within two weeks after delivery, if he survived that long.
Nobody could explain why the baby had congenital heart defects. Neither the mother's nor the father's family had any history with such problems.
Months later Collins caught a TV news segment warning pregnant women against using antidepressants. Studies showed they may cause birth defects in developing fetuses.
Collins doesn't suffer from severe depression or any other mental illness. But six months before becoming pregnant, she complained to her general practitioner in Pearland of irritable bowel syndrome and at times feeling claustrophobic.
After becoming pregnant, Collins asked Snell if she should stop.
"She assured me it was perfectly safe," the mom says. "I trusted my doctor."
Collins popped the oval-shaped pills through the end of her first trimester.
On November 2, 2005, Collins had a cesarean delivery at St. Luke's Hospital. Nurses immediately rushed the baby to the neonatal intensive care unit. For two weeks Chase was hooked to a ventilator and fed through a tube.
"I was tripping over cords trying to hold my baby," Collins recalls.
Able to breathe on his own, he was allowed to go home.
Here he was, nearly three months old, doing fine. A happy, alert infant with a mop of black hair, he ate slowly but rarely fussed and already slept through the night.
Mom held out hope that the doctors were wrong.
Then Baby turned blue.
In March Collins sued GlaxoSmithKline, the pharmaceutical giant that manufactures Paxil. The suit alleges the London-based company concealed studies and manipulated statistics that revealed the drug's risks for pregnant women.
"We cannot discuss pending litigation around our products," says GlaxoSmithKline spokeswoman Gaile Renegar.
Snell is also named in the suit. The 35-year-old general practitioner, currently on sabbatical after giving birth to her own child, contends she did not know about the hazards until the U.S. Food and Drug Administration's advisory late last year.
Since December 2005, the FDA has issued three public health advisories concerning Paxil and the threat of congenital heart defects. The regulatory agency changed Paxil's pregnancy category from C to D, which indicates that there is "positive evidence of fetal risk."
In addition to heart defects, several medical studies published in the last year have shown antidepressants taken during pregnancy significantly increase the risk of potentially fatal lung conditions and abdominal wall defects in newborns.
The FDA has not approved Paxil or other similar drugs for pregnant women, though they are commonly prescribed to treat depression. More than 40,000 pregnant women in the United States take antidepressants, according to the American Medical Association.
Though it remains too early to know how many families may be affected, the potential result is a new generation of deformed children and guilt-ridden mothers not seen since the thousands of thalidomide babies born in the early '60s.
Antidepressants such as Paxil were widely touted as wonder drugs with no serious side effects when they entered the market nearly two decades ago. "Sunshine in a bottle," proponents called them. They have since become increasingly controversial, prompting thousands of lawsuits.
These suits have fallen into two main camps. One alleges the drugs are addictive and can produce severe withdrawal symptoms including hallucinations, extreme mania and electric-shock sensations. The other claims they may actually cause depression and trigger suicidal and homicidal behavior.
Collins's case is among the first of its kind and marks the start of a new trend in litigation against antidepressant makers.
Dallas-area residents Anthony and Matilda Vasquez have filed the only other similar lawsuit in Texas. Their two-year-old son, Adrian, has undergone three open-heart surgeries and has a pacemaker. The mom took Paxil during her entire pregnancy.
These cases may attract international attention; the Collins suit is the first in the country to already have a trial date, set for next summer.
The FDA approved Paxil to treat depression in 1992 as part of a new class of antidepressants called selective serotonin reuptake inhibitors, or SSRIs.
It has long been believed that SSRIs work by boosting serotonin levels, the brain chemical most closely associated with depression. Drug makers and several leading scientists say this helps normalize cell-to-cell communication in the brain, stabilizing the chemical imbalance thought to cause depression.