Opening arguments are underway in the Metro East's first Vioxx trial.Does Vioxx significantly increase the risks for heart attack?
Plaintiff's attorney Andy D. Birchfield, Jr. of Beasley, Allen, Crow, Methvin, Portis & Miles in Montgomery, Ala., told the jury that he will introduce evidence that Vioxx caused heart attacks.
"Merck worked hard to keep the truth quiet," Birchfield said. He told the jury that there are multiple studies that show Vioxx can cause heart attacks.
Frank Schwaller of Granite City filed suit in 2005, alleging that Vioxx caused or significantly contributed to the death of his 52-year-old wife who died suddenly from a heart attack after using the arthritis pain-reliever.
He claims Vioxx was defectively designed, inadequately tested, dangerous to human health, and lacked proper warnings, which subjected users to risks of heart attacks, strokes and other illnesses.
Birchfield talked for close to two hours during his opening. He repeatedly told the jury that Merck "oversold and under-warned" when it came to Vioxx.
He told jurors that there are three questions they need to consider:
Did Merck fail to adequately warn doctors about the dangers of Vioxx? and;
Was Vioxx a contributing factor in Patricia Schwaller's heart attack and death?
Birchfield conceded that Merck was a good company and has done some good things, but said that they veered off course with Vioxx.
He said in 1994, Merck brought in a "business man" CEO instead of a scientist or doctor and he changed Merck from a science-based operation to a sales-based one.
Birchfield said that Vioxx was rushed to the market because Merck was losing patents on six medications and that sales would be down.
"They needed a revenue replacement, and Vioxx is a lifetime drug, it does not cure," he said.
Birchfield also said Merck was in a race with Pfizer to be the first to introduce a Cyclo-Oxygenase-2 (cox2) inhibitor because of the serious financial implications that come with being first.
He said a study conducted by Merck showed a $611 million difference between being first and second to the market.
Birchfield also showed jurors an email in which a Merck employee calls the FDA "bastards" because the FDA proposed a label that Merck did not like.
He also said that Merck silenced doctors who thought Vioxx could cause a heart attack by offering grant money or threatened them.
Birchfield also said that Merck trained its sales reps to avoid telling doctors that Vioxx could cause heart attacks. He showed jurors two manuals that Merck gave to sales reps with titles "Victory, in it to win" and "Dodgeball."
"Merck sales reps were trained to dodge questions," he said.
Birchfield also said that as soon as results of a study came back showing that people with risk factors for heart attacks could experience one while taking Vioxx, they placed that information in the "precautions" section of the label instead of on the warning section.
"Patty Schwaller should not have been taking Vioxx and it took the love of Frank Schwaller's life," Birchfield said as he ended his opening arguments.
Merck attorney Dan Ball of Bryan Cave only got 20 minutes into his opening before the proceedings adjourned for the day.
Ball said that there was no doubt that Patty Schwaller was a loyal wife and dedicated mother and her death was a tragedy and a loss to the family.
"This case is not about a loss," Ball said. "This case is about whether it is fair and right to blame Merck for this tragedy."
He said Merck has no desire to be in the courtroom talking about Patty Schwaller's health and family issues, but it must stand up to the allegations.
"These are serious accusations and we will not take them lightly," Ball said.
Ball said that every 60 seconds a woman dies of heart disease and it is the number one killer in women.
He said that heart disease kills more women than the next four causes of death combined.
He said that Patty Schwaller struggled with her weight for the past 20 years where it ranged from 250-300 pounds. She was five foot two inches tall.
Ball said Schwaller had high blood pressure, was a diabetic, had high triglycerides, had a family history of heart disease and took medication for depression and stress.
He also said that Merck could not do anything without the FDA's approval and that federal regulators approved Vioxx on four different occasions.
Ball also said Merck did 101 total studies on Vioxx and always exceeded FDA standards when testing Vioxx.
He also countered Birchfield's claim that Merck needed a revenue replacement, telling jurors that since the middle 1990s Merck introduced 20 new products.
He also told jurors that Pfizer beat them in the Cox-2 market by introducing Celebrex before Merck could get FDA approval for Vioxx.
Ball also told jurors that Merck has given plaintiffs 21 million documents and emails during discovery and the plaintiff's team is taking bits and pieces of emails and documents completely out of context to "weave" a story.
He said if he compiled a video of Albert Pujols doing nothing but striking out with the bases loaded and showing that to people you would think he was a bad ball player.
He will resume Thursday morning.