In a scene reminiscent of the movie Mr. Smith Goes to Washington, attorney Mark Lanier dramatically introduced the largest single exhibit ever presented in a trial in Brazoria County.
As assistants rolled in carts piled high with brown boxes Tuesday, Lanier started stacking up what he said were 157 boxes of documents he said pharmaceutical giant Merck & Co. Inc. “dumped” on the U.S. Food and Drug Administration.
The action came in the second week of testimony in a trial in which Lanier claims Merck’s popular painkiller Vioxx caused the 2001 death of 59-year-old Robert Ernst.
The cartloads of documents, he said, are copies of the ones Merck filed with the FDA to get approval for the drug in 1999.
In the 1939 film, James Stewart, as freshman U.S. Sen. Jefferson Smith, gives a passionate speech on the floor of the Senate as a parade of pages haul in bags of letters from young constituents.
Lanier, who is 44, said he’s never seen the movie.
Lanier has claimed during the trial that Merck buried FDA researchers in documents and hid study results that would show Vioxx in a bad light.
Merck head epidemiologist Nancy Santanello, who was on the witness stand at the time, protested that Merck filed the documents in electronic form so that FDA investigators could search for any information they wanted to look up.
Included were all the reports gathered on each of at least 10,000 patients who took part in clinical studies before Vioxx was approved.
She said Merck gave the FDA all of the study data they had, so that investigators could look up any part of any study. “If they had a question on any patient, they could search the data base for that individual patient,” she said.
Lanier stopped stacking the boxes after Merck attorney Gerry Lowry complained that she could no longer see the jury.
Lanier told state district Judge Ben Hardin that he wasn’t sure exactly where to put the boxes, which were on carts lining the hallway outside the courtroom.
“I’m going to let you work that out with the district clerk’s office,” said Hardin, who was chuckling.
“I wish they’d just filed the discs,” Chief Deputy District Clerk Nate Moore Sr. said. “I don’t know where we’re going to put them,” he said.
Moore said he was sure no single exhibit this big had ever been filed in his 11 years at the clerk’s office. “I guess we’ll just put them back in a storeroom,” he said.
His office has to keep all the exhibits for six months after a trial is over, Moore said.
Attorneys later said the documents may eventually be submitted on computer discs, but for the time being the boxes were stacked in the hallway outside the courtroom. It took four trucks to haul the documents to the courthouse.
Merck attorney Jonathan Skidmore said all of the data from the 157 boxes fit on three DVD and one CD discs.
“We’re not ashamed of the data we sent the FDA,” Skidmore said. “We’re proud of it.”
Merck has contended that Vioxx was the most tested drug ever put on the American market.
Lanier also handed jurors a printed time-line that caused defense attorneys to object.
On it he had “Merck Suspected” outlined in yellow and “Merck Knew” outlined in red, contending that Merck suspected Vioxx caused increase heart problems for patients through mid-2000 and knew it did from then until September, 2004, when it was pulled off the market.
Hardin said “Merck Suspected,” and “Merck Knew,” had to be taken off before the timeline if given to the jury.
Hardin sent the jury home for the day about 11 a.m. so he and the lawyers could discuss the exhibits in the case.
Tuesday afternoon the lawyers met in a closed session to take the deposition of Dr. Maria Araneta who conducted an autopsy on Ernst. That autopsy showed Ernst died of arrythmia.
Merck claims Vioxx couldn’t have caused Ernst’s death because he died of an arrythmia. The study that caused Merck to withdraw the drug showed an increased danger of heart attack or stroke, not arrythmia.
Araneta is expected to testify that Ernst could have had a heart attack, but that the damage from it wouldn’t have shown in his autopsy because he died so quickly.
Although both sides had listed Araneta as a potential witness, neither side had deposed her in preparation for the trial.
Lanier flew her in from Abu Dhabi, where she now lives and works.
He had hoped to use her as a surprise witness Tuesday, but Merck attorneys objected because she had not been added to the witness list in time for the discovery phase of the case.
Her deposition was videotaped in case she has to return to Abu Dhabi before she can testify.
When Lowry asked Hardin if Santanello, who had been on the witness stand for all or part of six days during the trial, could be excused for the day, the judge quipped.
“Yes, she can be excused. Tell her to take a trip to Galveston, tell her to go to the beach.”
Santanello is expected to be back on the witness stand today. The trial was originally scheduled to last five weeks, but now the attorneys involved are saying they doubt it can be finished that soon.