Houston more than 1,000 personal injury lawsuits filed in Texas over the once-popular pain medication Vioxx were put on hold Friday after a judge ruled the drug's manufacturer had given adequate warnings about the drug.
State District Judge Randy Wilson, based in Harris County, granted a motion by Merck & Co. Inc., the drug’s manufacturer, to dismiss part of a lawsuit filed by Ruby Ledbetter.
Merck’s attorneys argued a 2003 Texas law prevents Ledbetter from claiming she wasn’t properly warned about Vioxx.
The law, passed as part of tort reform efforts, says a drug manufacturer is not liable in allegations it failed to provide sufficient warnings about its product if the drug in question came with warnings approved by the Food and Drug Administration.
Friday’s ruling put Ledbetter’s case, which was set to go to trial in May, on hold. But Travis Sales, one of Merck’s attorneys, and Tommy Fibich, one of Ledbetter’s attorneys, both said Wilson had previously told lawyers in the case that such a decision would put all Texas cases on hold until
appeals courts rule on the issue.
Wilson, who is presiding over all Vioxx lawsuits filed in Texas, said in his ruling that virtually all the Texas cases allege that Merck failed to provide an adequate warning.
“The court got it right,” Sales said. “It goes to the heart of what Merck has always said. Merck gave proper information to the FDA and the FDA made proper labeling decisions based on what was there at the time.”
Fibich said although the judge ordered an expedited appeal in the case, he thinks that process could still take up to two years to complete.
“Meanwhile all those Texas cases will sit there and nobody is going to get their day in court,” he said.
Vioxx, an arthritis pain reliever, was pulled from the market in September 2004, when a study showed it could double the risk of heart attack or stroke if taken more than 18 months.
White House Station, N.J.-based Merck said it now faces 27,250 personal injury lawsuits over Vioxx, including 45,700 plaintiff groups.
The company is sticking by its plan of defending each of thousands of claims over Vioxx rather than settling the suits.
Wilson said in his ruling that for Ledbetter to win her case under Texas law, she would have to show that Merck had withheld or misrepresented information required by the FDA when it approved the drug or that such information was related to her injury.
Wilson said the FDA had not made any determination that Merck withheld or misrepresented information concerning Vioxx.
“Given the extent of federal regulation, and the extent to which the FDA is empowered to investigate and regulate drug manufacturers who fail to provide required information, permitting a Texas jury or judge to make the same inquiry would impinge on a uniquely federal issue,” Wilson wrote in his 11-page ruling.
Sales said federal law pre-empts part of the Texas statute from 2003.
“We think the court looked at this very carefully,” Sales said. “Texas courts should not be second guessing the FDA on these issues.”
Ledbetter, a 62-year-old woman from Elmendorf, just southeast of San Antonio, suffered a heart attack in May 2004.
“We think the court has made an erroneous ruling,” Fibich said. “The effect of his ruling is that it immunizes manufacturers that lie and mislead the FDA.”
Fibich said even if appeals courts uphold the judge’s ruling, his client and other plaintiffs have two other claims against Merck they can still try to prove in court: negligence and product design.
“I think they are all three good claims,” he said. “If I had to pick just one, it would be the failure to warn claim. But in all the cases where plaintiffs have prevailed against Merck, juries have found in favor of the product design and negligence claims.”
Fibich said the case will probably go all the way up to the Texas Supreme Court and he is looking at whether he can file any appeals in federal court.
In previous Texas Vioxx trials, a jury in 2006 awarded $32 million to the family of Leonel Garza, who died in 2001. The award was reduced to $8.7 million by state caps on noneconomic damages.
In 2005, a jury in Angleton awarded nearly $254 million to the widow of 59-year-old Robert Ernst, who also died 2001. That award was reduced to about $26 million.
The cases of Garza and Ernst would not have been affected by the 2003 Texas law because they filed their lawsuits before then.