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Webb City woman loses 'fen-phen' case
Jeff Lehr
Globe Staff Writer
1/24/2006 - A Jasper County jury sided with the manufacturer of the so-called "fen-phen" diet drugs on Monday and denied a Webb City woman with heart-valve disease any damages in her lawsuit against the company.
The jury returned to a Joplin courtroom with the verdict in favor of drug maker Wyeth just 45 minutes after beginning deliberations at the end of a two-week trial. The lawsuit was filed by Bonnie Weston, 56, a former teacher and school counselor who now works part time at Lafayette House in Joplin.
The verdict form in Wyeth's favor was signed by 10 of the 12 jurors. Nine jurors would have had to find in favor of Weston for her to prevail.
Harvey Kaplan, a Kansas City attorney representing Wyeth, said the verdict shows that the evidence was not there to support Weston's claims that two of the company's drugs caused her valvular heart disease, that her disease is significant enough to pose substantial danger to her health or that the company acted improperly before the Food and Drug Administration removed the two drugs from the U.S. market.
"In particular, the medical evidence just did not support the plaintiff's claims," Kaplan told the Globe after the verdict was rendered.
Weston took the diet drugs Pondimin, or fenfluramine, and Redux, or dexfenfluramine, between April 1995 and July 1996 in an effort to lose weight. She was diagnosed less than four years ago with valvular heart disease.
The FDA pulled the drugs from the market in 1997 after the Mayo Clinic issued a report suggesting a possible connection between use of the drugs and the development of valvular regurgitation in several of the clinic's patients. The FDA has since reported findings of abnormal echocardiograms in 30 percent of people who took the drugs.
A national, class-action lawsuit against Wyeth eventually led to the creation of the National Settlement Trust, a third-party, legal mechanism through which qualifying users of the drugs who have developed valvular heart problems may receive damages or payments for medical treatments.
Weston sued Wyeth as an "intermediate opt-out" of the class-action lawsuit, as others have chosen to do, and her case was tried separately.
Whether she has aortic regurgitation was not at issue in the trial. What caused the valvular heart disease she has and how severe it is were at issue.
G. Sean Jez, an attorney with a Houston firm representing Weston, reminded the jury during closing arguments Monday of evidence the plaintiff's attorneys had presented showing that just three months' use of the "fen-phen" drugs increased users' risk factor for valvular heart disease by 23 times. By comparison, smoking raises the risk factor for lung cancer nine to 10 times, Jez said.
He pointed to evidence that was presented that his client had never been diagnosed with valvular heart disease until after she had taken the defendant's products, and that there is a 95 percent chance that her disease was caused by the diet drugs.
Jez argued that Wyeth had received 86 reports of users of Pondimin who had developed valvular heart disease by the year Weston began taking the drug, and that the company did not report them to the FDA. He said the company did not even initiate a study because it was getting Pondimin's sister drug, Redux, approved for the market and did not want to jeopardize the sales it anticipated.
Kaplan countered Jez's argument by pitting the testimonies of the plaintiff's experts against that of her own treating cardiologist, Dr. Francis Corcoran of Joplin.
"Their job was to exaggerate her injury for the courtroom, even though her cardiologist had repeatedly told her she did not have serious valvular heart disease and was unlikely to ever require surgery," Kaplan argued.
'Fen-phen' use
Bonnie Weston took 1,100 doses of the diet drug Pondimin over the course of a little less than a year in 1995 and 1996, then took 30 tablets of its sister drug Redux in July 1996, according to testimony.
Weston on Monday lost her case that the drugs caused her to develop valvular heart disease and that the manufacturer should be held liable.
Viagra Helps COPD Patients Control Pulmonary Blood Pressure
WEDNESDAY, Oct. 25 (HealthDay News) -- The drug sildenafil, popularly known as Viagra, may help people with chronic obstructive pulmonary disease control the illness-related blood pressure spikes in the heart's pulmonary artery, a new study found.
The medication, in addition to its use as a popular treatment for impotence, has already been approved by the U.S. Food and Drug Administration for the treatment of the chronic version of such blood pressure spikes, known as pulmonary arterial hypertension (PAH). The drug has been marketed specifically for this purpose under the trade name Revatio. Another drug -- bosentan -- is also approved for similar purposes.
The new research suggests that sildenafil may help all chronic obstructive pulmonary disease (COPD) patients -- even those not diagnosed with full-blown PAH -- who experience potentially dangerous pulmonary arterial blood pressure increases both at rest and following exercise.
The research was led by Dr. Sebastiaan Holverda of the department of pulmonary medicine at VU University Medical Center in Amsterdam, the Netherlands. Holverda and his VU colleagues were to present their findings Wednesday at a Salt Lake City meeting organized by the journal Chest.
According to the American Lung Association, COPD is actually a catch-all for two lung diseases that often strike in tandem -- chronic bronchitis and emphysema. In both cases, airflow is obstructed, impeding normal breathing.
Smoking is the leading cause of COPD, responsible for between 80 percent and 90 percent of all cases in the United States. More than 11 million Americans are estimated to have the illness, and more than 122,000 die from it each year. Women appear to be slightly more at risk than men.
There's no known cure for the disease, and medications primarily take aim at symptom relief and slowing the progressive disability the illness brings.
Pulmonary hypertension -- the incurable condition of continuous high blood pressure in the pulmonary artery located in the right ventricle of the heart -- is one of many serious complications that can strike COPD patients. PAH causes the artery, which is responsible for delivering blood from the heart to the lungs, to work harder than normal. A weakening of the heart muscle can ensue over time, increasing the risk of heart failure and even death.
The Dutch researchers noted that pulmonary hypertension is typically mild to moderate among COPD patients but is particularly aggravated while exercising.
Faced with the combined COPD-PAH threat, the Dutch team explored the potential benefit of treating at-risk chronic obstructive pulmonary disease patients with sildenafil both while at rest and during exercise. The drug works by shifting the activity of an enzyme called phosphodiesterase, reducing arterial blood pressure by dilating the smooth muscle of blood vessels that line the lungs. As these vessels expand, blood flow increases, the researchers explained.
The study authors focused on 12 patients who had been diagnosed with chronic obstructive pulmonary disease and were suspected of having PAH. Throughout the study, right heart blood pressure was tracked among all 12 patients by inserting a thin plastic tube into the pulmonary artery -- a procedure known as cardiac catheterization. Cardiac blood pressure was measured at rest and just after all the patients cycled for three minutes.
Then, the study participants were given 50 milligrams of oral sildenafil; 45 minutes later, resting and post-exercise blood pressure readings were taken again.
Holverda and his colleagues found that half the patients had PAH. But, both non-PAH and PAH patients experienced significant cardiac blood pressure increases when exercising.
Sildenafil appeared to control such increases after exercise, reigning in pulmonary blood pressure to markedly lower levels -- higher than at rest, but lower than non-medicated post-exercise readings. And, the non-PAH patients appeared to experience pulmonary blood pressure reductions after taking the drug, both while resting and exercising.
The authors concluded that the drug may help COPD patients -- whether they have developed PAH or not -- quickly control their pulmonary blood pressure in some situations.
Dr. Bartolome R. Celli, chief of pulmonary care at St. Elizabeth's Medical Center in Boston, applauded the Dutch study but called for more research.
"Pulmonary arterial pressure -- when it is elevated -- is a poor prognostic sign and reducing its levels should be of help," he said. "However, more testing is needed to see if those changes in pulmonary arterial pressure are translated into better clinical outcomes and not into any unwanted side effects."
More information
To learn more about COPD, visit the American Lung Association.
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