The Tale of Two Drug Trials: Paxil and Fosamax

By Adrianne E. Walvoord
Special to the Legal

In November, two trials involving claims again pharmaceutical drug giants created the perfect backdrop for our state versus federal court dichotomy.  The outcomes, unfortunately, didn’t help to bolster our cause…

Blyth v. GlaxoSmithKline  – a case claiming that GSK did not properly warn the public that its anti-depressant prescription drug, Paxil, caused serious birth defects in infants exposed to the drug prior to birth – began on Nov. 9 in the Philadelphia Court of Common Pleas . 

Less than a hundred miles north of Philadelphia, the trial of Graves v. Merck –  a case claiming that Merck did not properly warn the public that its osteoporosis prescription drug, Fosamax, caused osteonecrosis of the jaw – was underway in the U.S. District Court for the Southern District of New York.  For 10 days, the failure to warn trials raged on in different jurisdictions … 

The plaintiffs in both courts were equally sympathetic and undeniably experienced serious injuries:  Graves took Fosamax from 2001 to 2004 and thereafter developed a debilitating jaw condition known as osteonecrosis of the jaw (ONJ), which caused portions of her jaw to decay and die.  Graves’ condition ultimately required her to undergo surgery to have her jaw amputated in 2006.

Blyth, on the other hand, took Paxil from 2004 through 2005 and had a baby girl, Anna, in January 2006. At just five weeks old, Anna turned blue, was rushed to the hospital and diagnosed with heart defects. Anna underwent surgery at only five weeks old to fix a narrowing in her aorta and underwent an additional surgery at nine months.

Evidentiary rulings by both the state and federal judge greatly restricted the plaintiffs' ability to get in critical evidence:  In Philadelphia, Judge Gary Glazer decidedly ruled out any evidence dated after the time Blyth stopped taking Paxil despite references in these records to knowledge GSK obtained pre-2005.  In Manhattan, Judge John F. Keenan kept out one of plaintiff’s key expert witnesses. 

On Nov. 19, after several hours of deliberation, the jury in Graves found for Merck.  On Nov. 23, Glazer entered judgment in favor of GSK and dismissed the Blyth case halfway through the trial. 

Graves was the third Fosamax bellwether lawsuit to go to trial, and the second trial victory for Merck.  Estimates show that there are currently about 1,000 Fosamax jaw lawsuits pending against Merck.  In addition, there are hundreds of Fosamax femur fracture cases involving similar allegations against Merck pending in New Jersey. 

In the Paxil birth defect litigation, Blyth was the first case to go to trial since Oct. 13, 2009, when a jury awarded $2.5 million to the family of Lyam Kilker, a child born with a congenital heart defect caused by Paxil use during pregnancy.  Nearly 75 percent of the 600 Paxil birth defect cases filed in Philadelphia have settled since the Kilker case in 2009, and estimates reveal that GSK has spent over $1 billion to settle these suits.

Despite the parallel result in the most recent trials, one could (unscientifically) conclude that state court has provided greater to plaintiffs.  This supposition, of course, fails to take into account the merits of the cases and empirical data on the number of cases and settlement values but poses interesting food for thought … does the forum affect the outcome?

Adrianne E. Walvoord is an associate at Anapol Schwartz Weiss Cohan Feldman & Smalley handling pharmaceutical and medical device litigation involving complex medical, scientific, and legal issues.  She practices in federal court, as well Pennsylvania and New Jersey state courts. She also currently represents juveniles affected by the Luzerne County Juvenile Detention Center scandal. Contact her at awalvoord@anapolschwartz.com.

Comments

[scott g]

Regarding the Paxil birth defect claim, I can't believe the outcome of that case. The ruling should have been a quick and easy win for the family because considering she was taking Paxil and had her baby prior to the drug warning labels that were enforced by the FDA in 2006.

[paxil lawsuit]

August 22, 2006

The FDA approved the label warning changes to include the information that "Infants exposed to SSRI's in late pregnancy have an increased risk for persistent pulmonary hypertension of the newborn."
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Families whose children were born with birth defects, following their mothers' use of Paxil during pregnancy between 1992 and this label should ALL have rulings in their favor...