Saturday, March 10, 2012

Premarin: The consequences of deception – A litany of litigation

Tuesday's Horse

Written by JANE ALLIN
Lady Liberty (c) Bill Frymire
In early July of 2002 the alarming news of the National Institutes of Health Women’s Health Initiative (WHI) study sent shock waves through the medical and scientific communities. Wyeth’s hormone combination replacement therapies (e.g. Prempro®), long believed to provide cardiovascular benefits to the millions of menopausal women who took them, now proved to be deadly carcinogens and cardiovascular antagonists.
With the reports that long-term use of HRT derived from conjugated equine estrogens increased the risk of invasive breast cancer, stroke, cardiovascular disease, heart attack, pulmonary embolism and blood clots, sales of these drugs quickly plummeted.
Closely on the heels of the WHI, the National Cancer Institute also shook the public with the news that estrogen alone (i.e. Premarin®) puts long-term users at increased risk of developing ovarian cancer. Doctors and their patients were aghast at the deception of Big Pharma and its lack of ethics in failure to disclose potentially life-threatening risks associated with their HRT drugs. How could this happen?
Through an exceedingly misleading and conspiratorial marketing campaign Wyeth managed to convince the world that menopause is a disease and requires medical intervention to mitigate its ravages on the female body. Needless to say what followed was, and is today, one of the most scandalous events to have occurred in the pharmaceutical industry which has led to an epidemic of mass tort litigation. Rather than accept responsibility for their heinous actions and provide compensation to their victims, Wyeth and now Pfizer, continue in their quest to defend their right to sell these carcinogenic concoctions.
Currently Pfizer has settled approximately half of the more than 10,000 lawsuits it has faced in product liability claims regarding Prempro and Premarin and their link to increased risk of breast cancer. Moreover in 2011 Pfizer added another $68 million to an already massive fund of $772 million to address and resolve the on-going cases.
What is appalling is despite the fact these hormone replacement therapies are clearly linked to a surfeit of disease and death Pfizer continues to appeal the trials and delay proceedings while turning massive profits from the very drugs at the center of the controversy, year after year. Many of the victims have already succumbed to breast cancer or other insidious illnesses affiliated with the use of these drugs however the emotional and physical scars of the survivors and their families live on. Heedless of the suffering, Pfizer/Wyeth remain steadfast in their litigation efforts without compassion or accountability. Profit over safety at all costs.
Pfizer’s mission:
“We dedicate ourselves to humanity’s quest for longer, healthier, happier lives through innovation in pharmaceutical, consumer, and animal health products. To achieve this purpose and mission, Pfizer affirm the values of Integrity, Leadership, Innovation, Performance, Teamwork, Customer Focus, Respect for People and Community.”
Partial and radical mastectomy, mutilated breasts, chemotherapy, radiation, cardiac surgery, exorbitant medical costs and death. I think not. Mission impossible.
The Lawsuits: In Review
2002 – 2006:
Prempro. Image by J B Reed / Bloomberg News.
Prempro. Image by J B Reed / Bloomberg News.
Prior to August of 2006 when the first Prempro® trial began, Wyeth and Pharmacia & Upjohn prevailed in a great majority of HRT hormone therapy cases previously set for trial through a combination of rulings by judges and dismissals by plaintiffs themselves to avoid being put to trial.
First Prempro trial begins in August of 2006 in Little Rock AR (Linda Reeves) but the trial is short-lived when a jury dismisses negligence by Wyeth in September.
At this time 5,000 lawsuits had been filed against Wyeth.
In October 2006, a jury awarded Jennie Nelson $1.5 million in compensatory damages, on the Phase I verdict. In 2001 Mrs. Nelson underwent a double mastectomy and chemotherapy and radiation for invasive breast cancer. A mistrial was later granted on the basis of juror ineligibility based on a motion by Wyeth.
In January 2007 a Philadelphia jury found that Prempro was responsible for Mary Daniel’s breast cancer and ordered Wyeth to pay $1.5 million in compensatory damages. The jury concluded that Wyeth was negligent in failing to provide adequate warnings about the risk of breast cancer associated with Prempro.
In February 2007 a jury in Philadelphia found that Prempro caused Jennie Nelson’s breast cancer and awarded her and her husband $3 million in damages. Nelson previously had been awarded $1.5 million by a jury in October 2006, but a mistrial was declared after the verdict had been returned.
In March a conference was held in Philadelphia to discuss future cases, two of which began in April, another in May and one in September. There were, at this time, a total of about 1814 HRT cases filed in Philadelphia.
According to an analysis published in April, statistics showed that the sharp drop in hormone use by menopausal women that began in 2002 as a result of the WHI study caused a dramatic decline in breast cancer cases strengthening the case that the trends are related.
In June, despite the jury awarding the Nelson’s $3 million in February of 2007, the first HRT case to reach trial ended with a Wyeth victory.
In response to an article published in the Wall Street Journal, “How NIH Misread Hormone Study in 2002”, WHI executives reply that the WHI investigators and the National Institutes of Health, which funds the WHI, are jointly responsible for all scientific articles arising from the study. Both parties stand by the original findings and conclusions.
A trial scheduled for September in Philadelphia is denied as a result of the two-year statute of limitations from bringing a personal injury claim.
However in October Wyeth was ordered to pay $134.1 million including $99 million in punitive damages, over its mishandling of menopause drugs and concealing the breast-cancer risks of its Prempro and Premarin drugs that helped cause three Nevada women’s cancer (Arlene Rowatt, Jeraldine Scofield and Pamela Forrester).
The October verdict was the largest related to Wyeth’s HRT drugs. A fourth woman settled before trial and passed away in April 2007 at the age of 59.
A trial scheduled for January 2008 was dismissed by a Minnesota judge who found that Patricia Zandi failed to provide valid scientific evidence to support her claim that she had developed breast cancer as a result of taking Wyeth’s Premarin and Prempro.
In February a district court judge in Nevada reduced the $134 awarded to Arlene Rowatt, Jeraldine Scofield and Pamela Forrester to $58 million citing that he felt concern that the amount awarded was “the rest of passion and prejudice” rather than reflective of appropriate compensatory settlement.
Wyeth and Pfizer were ordered to pay an Arkansas woman $27.12 million in March of 2008 determining that Prempro and Provera were the cause of the woman’s breast cancer and that the companies had shown reckless disregard. Wyeth’s share of the punitive damages came to $19.3 million.
In June a New Jersey Superior Court Judge issued a pre-trial ruling that federal law does not bar state product liability lawsuits against drug makers. With this ruling Ellen Deutsch’s lawsuit was allowed to proceed. This was the first Prempro case to reach the courts in NJ of the 2500 trials pending in the state and one of 10,000 filed nationwide.
By mid-July Wyeth settled lawsuits with two Nevada women, Vesta Woodhouse and Annie Woods, for an undisclosed amount.
In April The Texas Court of Appeals held that a lawsuit against drug manufacturer Wyeth could proceed. The court found that the claims were not preempted by federal law.
Ghost writing image.
Ghost writing image.
The unsealing of thousands of documents pertaining to the ghostwriting practices of Wyeth was ordered in July by a federal judge overseeing Prempro litigation.
In October a Philadelphia jury decided Wyeth should pay an Illinois woman $3.7 million in punitive damages without making a decision as to whether the company was at fault.
Again in November a court ruled in affirming a jury’s liability verdict based on the fact that the claims against the manufacturer of estrogen and progestin drugs are not preempted or barred by the statute of limitations.
Also in November there were two hefty verdicts in Pennsylvania, the first for $75 million and the second for $34 million in punitive damages regarding the link between breast cancer and HRT as well as finding that the drug maker willfully failed to warn patients of cancer risks associated with the hormone replacement drugs Premarin, Provera and Prempro.
In December Wyeth was ordered to pay the $75 million in punitive damages recommended by a jury in November. In the same month a New York trial court judge dismissed lawsuits brought by 23 women who claim hormone replacement therapy drugs manufactured by Wyeth caused them to develop breast cancer.
In January of 2010 the largest individual HRT verdict was handed down by a Philadelphia. $78.75 million in damages was awarded to an Illinois woman who claimed Prempro caused her breast cancer.
In February the Prempro litigation in Philadelphia turned feverish with both sides continuing the fight it out in court. 8 out of the 11 cases that have gone to jury have been in favor of the plaintiffs however two of those verdicts were reversed on appeal, and post-trial motions are pending in other cases. Plaintiffs were successful in the first trail with a $9.45 million verdict in Philadelphia’s Common Pleas Court for Audrey Singleton, a retired school bus driver from Alabama. Pfizer said it would appeal.
However, no more than two days later, a different Philadelphia jury ruled in favor of Pfizer in another Prempro case. The plaintiff, Cheryl Foust, from Richmond Indiana, had been taking Prempro for about four years before she learned in 2003 that she had breast cancer. Foust died in 2005 at age 56.
The U.S. Supreme Court denied Wyeth’s petition for certiorari in a Prempro case earlier this week, allowing a new trial on punitive damages. In March 2008, Donna Scroggin won nearly $30 million – including $27 million in punitives – against Wyeth and Upjohn Co., subsidiaries of Pfizer Inc.
In August a Philadelphia PA Common Pleas Court jury denied that the two women’s breast cancer was linked to Prempro. In the same month Pfizer agreed to settle an Arkansas woman’s claims prior to inception of another trial over punitive damages.
The Pfizer/Wyeth trial litigation is turning into one of the longest-running mass torts in US history.
A Pennsylvania court ruled that plaintiffs in HRT liability trials should have been allowed to have juries decide when it was reasonable for them to have discovered that their breast cancer was linked to the use of Wyeth’s HRT drugs.
In September an Arkansas District ruled that expert witnesses lacked sufficiently reliable scientific data to testify that estrogen-only HRT medications can cause breast cancer.
According to a new federal study post-menopausal women who take Prempro are at increased risk of getting breast cancer as well as dying from it.
In October, a federal Arkansas jury rules for the defense in the case of 81 year old Margaret Wilson.
Year end brought another victory for Wyeth when a jury rejected a Virginia woman’s claim for damages saying that the drug company properly warned her about the risks of Prempro. The Nevada Supreme Court also ruled that liability claims regarding HRT drugs are governed by the law of the state the plaintiffs became ill regardless if they had taken the drugs in other states prior to the onset of their illness.
The new year saw a Puerto Rico jury hold Pfizer accountable for $1.5 million in damages to a pharmacist who developed breast cancer after taking one of its HRT drugs.
In February Pfizer Inc. agreed to pay about $330 million to resolve claims that its Prempro menopause drug caused breast cancer, in the first large-scale settlements in eight years of litigation.
A Pennsylvania appellate court in June ruled that a jury’s $1.6 million verdict for a plaintiff in a Prempro case was to be reinstated along with a sealed punitive award against Wyeth. There was sufficient evidence to permit the jury to conclude that Wyeth’s failure to perform adequate tests of the risk of breast cancer was intentional, because it did not want confirmation of those risks and the resulting loss of sales and profits.
In July a US District Court in West Virginia denied a treating physician’s testimony as an expert alleging that HRT drugs caused the plaintiffs breast cancer.
Wyeth wins another victory in October when the 8th circuit rules that the plaintiff’s product liability claims over Prempro were properly dismissed as time-barred in New York.
In December after a jury in Philadelphia awarded $76 million in compensatory damages to three women who claimed that Wyeth’s HRT drugs caused their breast cancer, Wyeth settled the cases for a confidential amount.
As of year-end 2011 Pfizer and affiliates had settled almost half of the product liability claims involving their HRT drugs -Prempro, Premarin and Provera.
In January a Pennsylvania appellate court ruled that evidence of Wyeth’s marketing campaign for “off-label” Prempro uses was admissible in a breast cancer victim case. That same month the court also ruled that a $28 million award of punitive damages was not excessive in one of the HRT liability cases.
A US District Court in Mississippi ruled that a lawsuit against Wyeth would not be barred as a result of the plaintiff’s failure to declare her claim as an asset in her bankruptcy case prior to obtaining a discharge of debts.
Conjugated Equine Estogens: About the Horses
Premarin Foal
For every 150 women who stop taking Premarin, one mare is spared from the “pee line” and seven or eight “byproduct” foals will not be slaughtered for their meat.
The drugs made the basis of this article are manufactured with conjugated equine estrogens (CEEs), now commonly referred to as simply conjugated estrogens. Make no mistake, these drugs — including the drug Aprela currently awaiting FDA approval — are made with the estrogen rich urine taken from pregnant mares.
Once these mares are no longer able to conceive, they are disposed of typically at livestock auctions. Tens of thousands of byproduct foals are also sent to auctions where they fall prey to buyers hired to supply horses to slaughter plants. The horses are killed and their meat processed for human consumption. In some instances, foals are shipped live for slaughter for human consumption. Only a tiny percentage of these horses are rescued or bought and given another chance of life.
© Int’l Fund for Horses

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