Parker Waichman LLP

Glaxo Accused Paxil Birth Defect Risks

  Glaxo Accused Of Ignoring Paxil Birth Defect Risks. Last week we wrote that drug maker GlaxoSmithKline Plc was scheduled to defend itself in a Philadelphia court this week over allegations its blockbuster antidepressant Paxil, (generic: paroxetine) can lead to birth defects when taken by pregnant woman. Bloomberg.com described the lawsuit as a “test case” […]

Paxil Birth Defect Risks

 

Glaxo Accused Of Ignoring Paxil Birth Defect Risks. Last week we wrote that drug maker GlaxoSmithKline Plc was scheduled to defend itself in a Philadelphia court this week over allegations its blockbuster antidepressant Paxil, (generic: paroxetine) can lead to birth defects when taken by pregnant woman. Bloomberg.com described the lawsuit as a “test case” for some 600 other similar cases.

According to Philly.com, at the start of that trial this week, a plaintiff’s attorney claimed Glaxo  ignored information that Paxil caused birth defects. The lawyer represents a mother who said her three-year-old son is suffering from cardiac issues because she took Paxil while pregnant. The attorney also told the jury that Glaxo advised its scientists to not reveal any potential risks Paxil presented to pregnant women, Philly.com said.

Patients and their parents claim that internal Glaxo documents show the drug maker neglected to publicize warnings about Paxil’s risks until it was compelled to do so by the U.S. Food and Drug Administration (FDA) in 2005, said Bloomberg.com, last week. Paxil was approved by the agency in 1992.

Although Glaxo argued that its drug did not cause the boy’s heart problems

Although Glaxo argued that its drug did not cause the boy’s heart problems, the woman’s lawyer noted that in initial testing, when rats received Paxil, their pups did not live more than four days. Plaintiff attorneys claim Glaxo’s paperwork prove it was aware Paxil could increase birth defect risks as far back as 1980 and that it did not fully research Paxil before—and after—release to market, said Bloomberg.com, previously.

The attorney pointed out that going back to the late 1980s, a Glaxo scientist stated that, “there remains the possibility that Paxil could cause birth defects at higher doses,” reported Philly.com. According to the attorney, for two decades, Glaxo allegedly neglected to understand what caused the rat pups, whose mothers took Paxil when pregnant, to die, said Philly.com. “There remains the possibility that this compound could be teratogenic at higher dose levels. A teratogenic agent is one that causes malformations of an embryo or fetus,” wrote company scientist John Baldwin in a 1980 memorandum, quoted Bloomberg.com.

According to the FDA, in late 2005 it sent an alert to physicians about early studies suggesting Paxil could be a contributor to heart defects in babies when taken by expectant mothers in the first trimester, said Bloomberg.com, previously. The government asked Glaxo to update medication information warning on birth defects.

attorney for Glaxo argued

An attorney for Glaxo argued that while the boy was hospitalized for months following his birth and underwent cardiac surgeries that today, he “has no cardiac symptoms … is at preschool and runs and walks like a 4-year-old should,” quoted Philly.com. The boy’s attorney argued that the boy will need more cardiac surgery.

Glaxo received reports of 50 miscarriages or intrauterine deaths by 1997, with its own scientists describing the amount of cases as an “alarming finding,” words omitted in the final report provided to the FDA, despite that it was mandated to include such information, reported Philly.com, citing the plaintiff attorney.

Worse, Bonnie Rossello, an executive at Glaxo, wrote in a 1997 memo that should animal studies be conducted, the drug maker could “bury” any negative findings, added Philly.com.

Need Legal Help Regarding Paxil Birth Defect Risks?

The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
They got right on my case. Wasted no time and fought/won the decision to continue with my therapy after the insurance company wanted to terminate it. Even the insurance company knew from my medical records that I needed to continue. My nurse Ms. Joanne Stevens is very concerned about my condition and treatment and assured that I would continue. I am very familiar with this law firm. They are like human pitbulls when they latch onto a wrong door. Humph!!! I'm glad they're on my side.
JANICE Peters-Rowe
5 years ago
5 Star Reviews 150
To the employees Ana, Jorge & Jillian. I am very thankful for the effort that they did all this time in my case, they are helpful people and they take their job seriously. Thank You regards Jose Aguaiza.
franklin orlando
8 months ago
5 Star Reviews 150
Parker Waichman has been so much help with my case over the past few years. It has finally come to an end with a positive outcome. I would also like to thank Benita Rollis, who personally kept me up to date every step along the way. She was able to answer every question I had and always replied in a very timely and professional matter. I cant thank your firm enough. All I can say is thank you from me and my entire family.
Ed McKenna
2 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038