HoustonChronicle.com -- http://www.HoustonChronicle.com | Section: Health & Medicine

July 4, 2005, 10:04AM

Widow's suit against Vioxx maker to set tone for rest

Thousands of cases against the drug giant Merck hinge on this first trial

Copyright 2005 Houston Chronicle



Lawsuits involving Vioxx pending against Merck & Co. Inc.:
•907 federal cases combined in litigation in New Orleans
•More than 700 cases pending in other federal courts
•More than 1,900 cases pending in a coordinated proceeding in New Jersey
•More than 170 cases involving more than 1,000 plaintiffs pending in California state courts
•More than 170 cases pending in other state courts — including more than 50 in Texas
•At least 118 class actions pending in state and federal courts
Source: Merck &. Co. Inc.

ANGLETON - Carol Ernst blames pharmaceutical giant Merck & Co. Inc. for the 2001 death of the most wonderful man she ever knew, her husband, Robert Ernst.

Her lawsuit against the company is set for trial in Angleton July 11, the first of thousands across the country involving the pain-killer drug Vioxx to go to court.

Merck contends that its once-popular drug, which it withdrew from the market in September — had nothing to do with Ernst's death.

Millions, possibly billions, of dollars will be riding on the outcome of this and other cases headed to court.

"I think you can expect to see a courtroom full of laptops," said Texas Tech Law School professor Wesley Cochran. He said representatives of dozens of law firms will want to be on hand to take notes about every aspect of the proceedings.

State District Judge Ben Hardin has scheduled the trial for the biggest courtroom in the Angleton courthouse. He has asked for an unusually large panel of 100 prospective jurors.

The trial is expected to last three to five weeks.

If Carol Ernst wins, Cochran predicted, even more plaintiffs will file lawsuits against Merck. If Merck wins, it will give the company ammunition to fight other lawsuits, he said.

"I just want Merck to admit that they were wrong," said Ernst, a soft-spoken, 60-year-old from the north Texas town of Keene, 30 miles from Fort Worth.

"A sudden death is a tragedy for any family," said Merck attorney Jonathan Skidmore, "but Merck did not cause Mr. Ernst's death."

In briefs filed in Hardin's court, Merck said it withdrew Vioxx from the market in 2004 after studies showed that people taking the drug for more than 18 months suffered increased risk of myocardial infarction — heart attacks.

Ernst, who was 59 when he died, took the drug for less than seven months and died not of a heart attack, but from cardiac arrhythmia, Merck said in a court brief.

Even if Ernst had suffered a heart attack, research showed that there was no increased risk of heart attack until the drug had been taken for more than 18 months, Merck said.

Merck says the company, based in Whitehouse Station, N.J., believed Vioxx was safe. Merck Vice President Dennis Erb told Congress in May that the company quickly disclosed studies that first raised the possibility of heart repercussions, including the one that led to the drug's withdrawal.

"We believed wholeheartedly in the safety of Vioxx and that Vioxx was an important treatment option," Erb said, noting that his father took the drug.

"The nature of Mr. Ernst's death simply does not implicate the underlying scientific controversy," Merck said in a court brief.

A man full of life

Merck lawyers have not said whether Erb or any other past or present Merck executives will testify during the trial. Skidmore said the testimony and evidence Merck presents depends upon what testimony and evidence the plaintiff presents.

Ernst was not a typical 59-year-old man, his widow said.

A native of St. Louis, he had managed pizza restaurants for several years, but had dropped out of stressful corporate life to work at a local Wal-Mart and teach aerobics. He had two grown children from an earlier marriage.

She was a single mother of three, working as a social worker and going to college when her daughter introduced her to Ernst.

"I thought my life was complete," she said. "I wasn't looking for a man. I had my kids, my job and school, I didn't think I needed anything more."

Robert Ernst changed her mind.

He was fit and full of energy. He always seemed to see and look for the beauty in life. He had honed his body to run marathon races and triathlons.

They went to flower shows and took rides in the country to see wildflowers and visit crafts fairs. They dated for a couple of years and were married a little less than a year before he died.

They bought a tandem bicycle that another couple had once ridden across the country. "He liked riding that bicycle because that was something we could do together," she said.

A call to 911

Eight days before he died on May 6, 2001, they competed in a 62-mile ride up and down the hills around Tyler.

He was so in tune with his body, she said, that he could pretty much tell what his heart rate was without taking his pulse. The night he died he commented that he thought his pulse rate was unusually low.

Not long after they went to sleep she woke up hearing him making strange sounds. When she couldn't wake him up, she called 911.

"I just knew that they would fix it, whatever was wrong, and that they'd come out and tell me that he was fine," she said.

In the months following his death, she said she learned more and more about Vioxx and became convinced that it had caused her husband's death.

After talking to several attorneys, she eventually found Mark Lanier in Houston, who filed the lawsuit in Brazoria County in 2002.

Lanier said the lawsuit originally included a doctor and a research clinic in Lake Jackson that took part in some of the Vioxx studies. Lanier said he eventually dropped the doctor and the clinic from the case, but by then the case was already set in Angleton.

Vioxx was the only medicine Robert Ernst was taking, his widow said. He found it easier to take one Vioxx a day for pain in his hands rather than several ibuprofen, she said.

Vioxx, known generically as rofecoxib, is what is called a COX-2 inhibitor because it blocks the body's production of a form of an enzyme called cyclooxygenase. That enzyme stimulates chemicals that promote pain and inflammation.

Lanier claims Merck rushed Vioxx through Federal Drug Administration approval to compete with Pfizer's Celebrex and Bextra, two other COX-2 inhibitors, for what would be a very lucrative market.

The FDA asked Pfizer to withdraw Bextra in April, but allowed Celebrex to be used pending more studies, saying its benefits outweighed the risks.

Studies show dangers

The FDA first approved Vioxx for use in May 1999, for certain types of arthritis and pain management.

By 2003, the yearly worldwide sales of Vioxx were $2.5 billion and about 20 million people were taking the drug when it was withdrawn.

Merck contends that several clinical studies showed that the drug had no bad side effects.

When a longer-term study showed increased incidents of heart attacks in patients using the drug for more than 18 months, Merck shut down the tests and withdrew Vioxx from the market in September.

Lanier said Merck's seeking to get credit for voluntarily withdrawing Vioxx is "like Saddam Hussein surrendering and turning over his gun and wanting credit for handing over his gun."

He claims the company long knew that people suffered increased heart problems after taking Vioxx for as little as two weeks, and deliberately withheld that information.

But Merck contends the company has always revealed the results of any studies it knew about.

"There were no secret studies," Merck attorney Skidmore said.

"We are going to defend these lawsuits one at a time," Skidmore said.

Vioxx cases may keep lawyers busy for a long time.

Merck recently asked the Texas Supreme Court to combine parts of about 50 other cases pending in Texas.

On Thursday Texas Attorney General Greg Abbott filed a lawsuit against Merck seeking $168 million in damages for the 700,000 Vioxx prescriptions paid for by the Texas Medicaid program.

"Merck took extreme measures to get this drug approved for widespread use, including for Medicaid patients, without the proper respect for good science and the concerns of peers," Abbott said.


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