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Plaintiff Lawyers Say More Fen-Phen Cases Are On The Way
Law firms are girding for another wave of diet drug litigation, although they disagree on how big it will be.
Some attorneys believe the bulk of the cases will come with final approval of the national settlement, when intermediate opt outs have the option of filing cases. Other firms are advertising aggressively for new clients. Lawyers cite the numbers: of 6 million former diet drug users, as many as 2 million may have been injured, while fewer than 500,000 have been compensated in settlements with American Home Products.  Some of the new cases involve primary pulmonary hypertension (PPH), a fatal disease in which the blood vessels in the lungs narrow and raise the pulmonary blood pressure. PPH is not covered by the national settlement, and cases may be brought at any time. 
Holmes Case
Two such cases have been filed in California by attorney Michael A. Hackard of Hackard & Holt, including Donna Holmes, et al. v. American Home Products, et al.(J.C.C.P. No. 4032, No. 0127398, Calif. Super., San Benito Co.). The action was brought by survivors of Donald Holmes Sr., who died Nov. 29, 2000, of PPH, according to the complaint. 
 The complaint also names as defendants a physician, Wal-Mart, pharmacists and John Does and incorporates the master complaint filed in the Los Angeles County Superior Court.  Hackard opined on the PR Newswire that the next wave of diet drug litigation could equal the first round in its cost to AHP. Other attorneys are doubtful. PPH is so rare even among former diet drug users that one plaintiff attorney with several PPH cases doubted more than a few dozen would emerge in a given year.  Although AHP has settled with most of the initial opt outs, attorneys say a few are still awaiting trial or settlement. But several attorneys agree that the bulk of new cases will be the thousands of potential intermediate opt outs currently being signed up by law firms, former users who had an FDA-positive echocardiogram after                     September 1999.
‘Wild Guess’
 One attorney involved in diet drug litigation said a "wild guess" would place the number of former diet drug users eligible at around 10,000 but because those cases have given up the right to seek punitive damages, some attorneys think they’re a bad bet.
Other firms are actively pursuing new heart valve cases in which people with few or no symptoms put off being tested. Lawyers monitoring the television advertising of several Utah firms say the firms appear to have spent tens of thousands of dollars looking for new clients and claim in published articles that the public is responding. 

The Business Journal of Kansas City, September 28, 2001 

Federal grand jury indicts owners of OP weight-loss clinic
A federal grand jury in Kansas City has indicted the owners of a weight-loss clinic in Overland Park for allegedly conspiring to import 22 pounds of fenfluramine from the United Kingdom. 
Fenfluramine is one of two drugs used in the appetite-suppressant prescription combination known as fen-phen. It is a controlled substance that was formally banned from the market in the United States in March 1999 after a series of studies concluded that it was unsafe. 
Jackie Ray Springer, 50, and Gregory Chollet, 49, are charged with one count of conspiracy to unlawfully import a controlled substance and defraud the United States, one count of importation by means of false statements and one count of distributing misbranded drugs. 
Springer, a medical doctor licensed to practice in Kansas, operates the Chollet Clinic for Weight Control Inc. at 11802 Quivira Road. Gregory Chollet is the office manager. 
If convicted as charged in the indictment, Springer and Chollet each could face as many as 10 years in prison without parole plus fines of as much as $750,000. 
In addition to the criminal indictment, the U.S. Attorney's Office for the Western District of Missouri filed a civil suit seeking monetary penalties and other relief from Springer, Gregory Chollet, Regina Chollet and two corporate entities associated with the clinic. 

Tue, July 31, 2001 
SALT LAKE CITY -- Thousands of Utah residents have responded to advertisements by lawyers seeking fen-phen users to join in the suits over the diet drugs. 
Kathy Weaver of North Ogden took fen-phen for 10 months in 1996 and 1997. The recent wave of advertisements for free screenings, combined with the urging of a co-worker, prompted her to undergo an exam. 
"I kept avoiding it," said Weaver, 49. "I wasn't nervous at first because I didn't have any symptoms, and I thought, 'I'm fine - this is just routine stuff."' 
However, an echocardiogram taken this month showed three of her heart valves were damaged and that her left atrium was enlarged. The condition can be controlled with medication or surgery, but can worsen if left untreated. 
About 5.8 million people nationwide took fen-phen, a prescription that included American Home Products' Pondimin, brand name for fenfluramine, in combination with phentermine. The company also sold Redux, similar to Pondimin. 
Redux and fenfluramine were removed from pharmacies in 1997 after a Mayo Clinic study linked fenfluramine to potentially fatal heart valve damage. 
The resulting litigation against American Home Products has proved to be lucrative for lawyers and patients. A federal judge approved a $3.75 billion settlement in a class-action lawsuit against the manufacturer in August 2000. 
That settlement is on appeal, effectively extending the timeline for those with heart damage to opt out of the class action and pursue their own lawsuits. Meanwhile, law firms are taking the opportunity to gather clients. 
At least three Wasatch Front firms have advertised free testing for those who used fen-phen, and they have seen a remarkable response. 
Sandy-based Ashton, Braunberger, Boud & Draper has screened 2,000 to 3,000 people since February. Attorney Tad Draper estimated that about 25 percent showed some kind of heart damage. 
Marvin Sims, administrator of the Utah Department of Commerce's Controlled Substance Database, said many patients have called the state looking for proof that they took the drug. The department got three or four calls a day in June, he said. 
"A lot of pharmacies claim they don't have (the records) or don't want to get involved," Sims said, so patients "turn to us because by law they can have their own information." 
According to the database, at least 64,358 Utah residents were prescribed fenfluramine, and 82,757 were prescribed phentermine. About 6,215 residents were prescribed Redux. 
About 44,000 people have opted out of the nationwide settlement. As of April 15, American Home Products either had reached agreements or already settled claims from approximately 85 percent of those patients, according to a company spokesman. 

SACRAMENTO, Sept. 10, 2001 /PRNewswire/ -- Two wrongful death complaints filed today in California could signal a renewed wave of lawsuits against American Home Products  just as the pharmaceutical company coaxes investors back with predictions that its legal troubles over Fen-Phen/Redux are coming to an end. 
 The lawsuits were filed just days before the anniversary of Fen-Phen's removal from the U.S. market on Sept. 15, 1997. Since then, more than $11 billion has been distributed to victims of the drug or their families. That figure could easily double as more former users of Fen-Phen/Redux are diagnosed with either heart valve damage  or primary pulmonary hypertension, commonly called PPH, said attorney Michael Hackard of Sacramento, a leading attorney in Fen-Phen/Redux cases. 
"As much as American Home wants to sweep Fen-Phen/Redux under the carpet, the devastation caused by this drug is about to reach epidemic levels as the effects of heart and lung damage caused by Fen-Phen become apparent to hundreds of thousands of former patients," Hackard said. "This company must be held responsible
for marketing a drug they knew could hurt and even kill people." 
Hackard represents the surviving families of Donald Holmes of San Juan Bautista, who died last November at age 63, and Yolanda Gallegos of Downey, who died three weeks ago at age 55. Both died of PPH resulting from their ingestion of
   Fen-Phen/Redux to lose weight. The Holmes lawsuit was filed in San Benito County Superior Court, and the Gallegos case was filed in Los Angeles County Superior Court.
 In the United States, between 6 million and 7 million people took Fen-Phen/Redux. As the diet pills' popularity soared, doctors started connecting the use of the drug with heart valve damage and PPH, which shrinks and hardens blood vessels in the lungs. Those findings resulted in the U.S. Food and Drug Administration pressuring American Home to withdraw Fen- Phen/Redux from the market. 
A Boston University School of Medicine study charted the heart valve defect rate caused by Fen-Phen/Redux at 28 percent. That means almost 2 million former users have heart valve damage. So far, fewer than 500,000 users have received compensation from lawsuits. 
A recent surge in diagnosed cases of primary pulmonary hypertension would echoearlier findings by French doctors on a nearly identical diet drug called Aminorex used in Europe during the 1960s. That study outlined a roughly 4-to-6-year interval between Aminorex use and the onset of an epidemic in cases of PPH, which continued into the 1970s, years after the European authorities pulled Aminorex from the market.
  "Even though it's been four years since Fen-Phen/Redux was pulled from the market, many users are just now being diagnosed with valve problems or PPH," Hackard said. "We hope this information will help save lives as former users seek exams from their doctors." 
Before the advent of Fen-Phen/Redux and other appetite suppressants, PPH was  rare, with one or two cases reported among 1 million people in a year. That same number is now 23 to 46 new cases among 1 million people a year, according to medical journals. 
"Although this incidence is still relatively low, it represents a significant increase over the background incidence of a potentially lethal disease," stated an article in the medical journal Chest, published by the American College of Chest Physicians. American Home Products settled 375,000 cases through a $3.7 billion class-action  suit. But claims continued to mount, and the company agreed to settle 75,000 more cases.   Hackard added that American Home is throwing complicated legal delays into new  cases as a deliberate attempt to wait until patients die, because wrongful death suits are less expensive for the drug company to settle than cases pursued by living plaintiffs. 
"American Home Products' market capitalization is more than $75 billion. They've already set aside close to 16 percent of that market capitalization to pay for their wrongdoing. By the time this is over, they may have to add another 16 percent," Hackard said. "In the meantime, they're literally running the clock on people's lives. It takes corporate cynicism to new depths." 

"Socrates"
In Loving Memory of 
Joan Anderson

Click for memorial page

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Leflaw's Fen Phen E-sources

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• Free Echo Assistance Program at www.reduxsettlement.com
• new and improved bulletin board at www.noticenetwork.com
• fenpalscrapbook
• MDL Order 2152 Re 9% Fee
  • Exhibit A-Example
  • Memo & Order 467
  • Order 467
  • Order 517
• Phila Court Of Common Pleas Update
• Fen Phen II information at http://fenfenclassaction.com/

The diet drug combination fenfluramine-phentermine, better known as fen-phen, was removed from the marketplace in 1997 because it was associated with acquired heart valve abnormalities. 
Now a research team led by a Children's Hospital of Philadelphia physician has uncovered some of the cellular events, apparently triggered by the neurotransmitter serotonin, that may help explain the disease mechanisms that are involved. 
Fen-phen use was associated with an abnormal thickening of heart valve leaflets in a number of patients. This drug combination strengthens serotonin effects, and therefore the association of fen-phen usage with heart valve disorders suggested to the researchers that serotonin itself may play a role in progressive heart valve disease. Serotonin is a naturally occurring chemical that plays important roles in the nervous system. 
"A better understanding of the effects of serotonin on heart valve cells may have broader implications beyond the adverse effects of fen-phen," said Robert J. Levy, M.D., director of the Pediatric Cardiology Research Laboratory at The Children's Hospital of Philadelphia and senior author of the study. 
The researchers explored a chain of chemical reactions, beginning with serotonin and ending with cellular events hypothesized to be associated with valve disease. 
Cells on heart valves have been shown to have receptors for serotonin. Serotonin takes part in biochemical interactions that lead to increased production of a key signaling molecule called TBF-beta-1. This molecule, in turn, stimulates cells in the aortic valve to produce abnormal structural features comparable to those associated with fen-phen heart valve disease, according to Dr. Levy. 
The cell culture study was presented on November 13 by Bo Jian, M.D., a cardiology research fellow at Children's Hospital, during the national scientific sessions of the American Heart Association in New Orleans. 
Another aspect of valve disease research is the fact that a naturally occurring amino acid, tryptophan, is a precursor to serotonin. While tryptophan plays an essential role in health and nutrition, excess amounts of it could possibly contribute to valve disease. 
"Since serotonin may also affect the progression of valve disease, the effects of tryptophan in one's diet may turn out to be important," said Dr. Levy. One next step, he added, is to design clinical studies to further explore possible links between serotonin levels, tryptophan levels and valve disease. 
Co-authors with Drs. Levy and Jian are Bruce Liang, M.D., of the University of Pennsylvania Medical Center and colleagues from that institution and from Children's Hospital. - By John Ascenzi 

Court upholds fen-phen diet drug settlement

"We are pleased that the Court of Appeals has rejected these challenges to our diet drug settlement," American Home Products President and Chief Executive Robert Essner said in a statement. "This is an important step in putting this matter behind us."

Barring any appeals to the United States Supreme Court, the settlement will by its terms become final by the end of the year. American Home Products had previously taken charges of $12.25 billion related to the settlement and will have paid out $11 billion of that by the end of 2001.

American Home Products recalled the diet drugs, which were used by 6 million Americans, in 1997 after their use was linked to damage to heart valves.