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HRT Patient's Personal Injury Claim Found to Be Time-Barred
Gina Passarella for The Legal Intelligencer
September 25, 2007

A woman who sued Wyeth Pharmaceuticals, claiming that the hormone replacement therapy she took was the cause of her breast cancer, is barred by the two-year statute of limitations from bringing a personal injury claim, a Philadelphia Common Pleas judge ruled Monday.

In his opinion in Coleman v. Wyeth, Judge Allan L. Tereshko ruled that the statute of limitations for Elizabeth Coleman's claim was not tolled under the discovery rule, which Coleman argued allows for a delay in filing if the plaintiff did not immediately know the cause of the injury.

"Coleman argues that the sine qua non for triggering the running of the statute of limitations in Pennsylvania is a requirement that plaintiff know of a definitive association between her injury and the hormone therapy she received," Tereshko said. "That has never been the law in Pennsylvania."

Tereshko said the clock on the statute of limitations begins when a plaintiff discovers that she is injured, not when she figures out what caused the injury.

"Here, there is no dispute that damage was ascertainable when Coleman was diagnosed with breast cancer," he said. "Therefore, Coleman's statute of limitations began to run on that date."

As hormone replacement therapy (HRT) cases have become recognized by litigators and judges as a hotbed of litigation in the common pleas court's Complex Litigation Center, Tereshko's ruling could affect hundreds of cases.

"In order to toll the two-year statute of limitations, plaintiff must show that she made a reasonably diligent effort to obtain information regarding her injury and why it was unobtainable at that time," Tereshko said. "This court finds that not only did plaintiff not undertake a diligent investigation of the causes of her injury, but that she undertook no investigation whatsoever."

Coleman had taken hormone replacement therapy drugs from 1991 until she found out she had breast cancer on Oct. 20, 2000. Wyeth and Pharmacia & Upjohn -- another defendant in the case -- manufactured some of the drugs she took during that time, according to the opinion.

Coleman filed her suit against the companies on June 28, 2004, after she read the results of the Women's Health Initiative Study in July 2002 that looked at the benefits and risks of HRT, Tereshko said.

The judge wasn't convinced, however, pointing out several examples starting in 1997 of published media reports that showed a link between HRT and breast cancer.

Coleman said she was not told by any of her doctors at the time she was diagnosed that HRT could have played a causal role, he said.

"Nonetheless, it is clear from the record that at the time of her injury, both Coleman (and her doctors) had sufficient information about the increased risk of breast cancer associated with HRT to 'begin doing those things for which the statute of limitations specifically provides time,' such as investigating the basis for her claim," Tereshko said, citing the 1986 Superior Court ruling in Groover v. Riddle Memorial Hospital.

He said he found it "significant" that Coleman did not think to link the HRT to her breast cancer when her doctors told her to stop taking it at the time of her diagnosis in fear of spreading the illness.

"This court finds, however, that the instructions of Coleman's doctors to discontinue the HRT after her diagnosis put her on notice of a link between the drug and her cancer," he said.

Tereshko also pointed out that the study upon which Coleman relied showed a lower risk of breast cancer for women on HRT than previously thought at that time.

Tereshko likened Coleman's situation to that of the sexual abuse victims in Meehan v. Archdiocese of Philadelphia, in which the plaintiffs argued that new harm was created by the church's cover up of sexual abuse by priests and should therefore toll the statute of limitations.

As the court did in Meehan, Tereshko dismissed Coleman's suit as untimely and granted Wyeth's summary judgment.

Kenneth M. Rothweiler of Eisenberg Rothweiler represented Coleman in the case and he said he is confident the Superior Court would overturn Tereshko's ruling. He said many women have come from across the country to try similar cases in Philadelphia.

"We are disappointed that the court acted as the fact finder when ruling on a motion for Summary judgment," Tereshko said in an e-mail. "The opinion represents a departure from the rulings of several Common Pleas Court judges who have ruled differently in the past."

Rothweiler said Coleman is the first decision to find that the plaintiff is not protected under the discovery rule.

Several of the defense attorneys on the docket were not immediately available for comment by the time of publication.

Jacques E. Rossouw, M.D.
Chief, WHI Branch
National Heart, Lung, and Blood Institute National Institutes of Health
U.S. Department of Health and Human Services Bethesda, Maryland

Marcia L. Stefanick, Ph.D.
Chair, WHI Executive Committee
Professor of Medicine and Professor of Obstetrics & Gynecology
Stanford University Stanford, California

We Stand by Data on Heart Disease Risk in Estrogen Drug Study July 21, 2007; Page A5 On behalf of the Women's Health Initiative investigators, we wish to address misperceptions in your article "How NIH Misread Hormone Study in 2002" (Marketplace, July 9). First, we want to clarify 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.

Specifically, our conclusions in 2002 that the increased risk of heart disease due to estrogen-plus-progestin (in women who had undergone natural menopause) didn't depend on age or health status have been borne out in all subsequent re-analyses of the data. Estrogen-plus-progestin increased this risk in both women with and without prior heart disease, and the increased risk due to the drug at age 50-59 was of the same magnitude as the increased risk in the overall age group of 50-79. In addition, this drug increased the risk of breast cancer, stroke and blood clots. Overall, women's risk of all of these diseases is typically low in the first few years after menopause, so our 2002 conclusion that the short-term use of hormone therapy is a reasonable option for relief of hot flashes and night sweats during menopause, which was later reinforced by the FDA, also holds true.

The findings from the separate trial of estrogen-alone (without progestin) in women who had previously had a hysterectomy were published in 2004. Many of these women had undergone premature menopause. These trials were similar in that they were both designed to test the effects of hormone therapy on several diseases in postmenopausal women aged 50-79. Both trials were designed to last eight years, but both were stopped early because of increased health risks. Both forms of hormone therapy failed to prevent heart disease overall, the key question being addressed. And both drugs increased the risk of stroke and blood clots (and in older women, the risk of memory problems or dementia). These serious adverse effects overshadow the benefit from hormone therapy in reducing the risk of fractures and clearly indicate that hormone therapy shouldn't be used long-term to prevent chronic disease.

We have found some important differences between the two hormone therapy trials. Estrogen-alone didn't increase the risk of heart disease overall, and the results suggested that there might be a different effect of estrogen in younger versus older participants. Although the findings on the effects of age weren't statistically significant, they prompted us to conduct a sub-study to measure the amount of calcium, a marker of atherosclerosis, in the coronary arteries of women aged 50-59 who had been in the estrogen-alone trial.

The younger women who took estrogen-alone had less coronary calcium than the women who didn't take the drug, suggesting that estrogen-alone might offer some benefit for heart disease in the short term. But since there was no reduction in clinical heart disease in older women, it would be unwise to presume that any benefit in younger women would persist into older ages if women continued to use estrogen. There is no evidence that estrogen-alone will continue to protect against the foreseeable, age-related deterioration of the arteries. Potential benefit may thus revert to potential harm, as seen in older women.

It is important to note that the findings from the estrogen-alone trial don't apply to women who go through menopause naturally. Estrogen-alone is known to cause endometrial cancer, and thus it is only used in women who have had a hysterectomy; for women with a uterus, hormone therapy includes progestin, which prevents endometrial cancer, combined with estrogen.

In our most recent analysis in 2007, we combined the data from the two trials to better understand some of the mechanisms at play. This analysis included some data not available to us in 2002. We found that age didn't significantly modify the effect of hormones on heart disease or stroke risk. However, total deaths appeared to be reduced in the hormone group at age 50-59; we couldn't identify any specific reason for this reduction. But, we found that years since menopause may modify hormone effects, with no increased risk of heart attacks in women within 10 years of menopause compared with the clearly increased risk in women more distant from menopause. Even in women close to menopause, however, the drugs increased the risk of stroke and blood clots, and the risk of breast cancer on estrogen-plus-progestin.

The latest analyses add some further reassurance to women wishing to take hormone therapy in the short term for the relief of hot flashes and night sweats. They don't provide evidence that even estrogen-alone can help prevent heart attacks in the long term. To lower the risk of heart disease, more effective options are recommended, including adopting healthy lifestyles and identifying and treating risk factors such as high blood cholesterol and high blood pressure. (See related correction).

Excerpt from Article Appearing on Law.com:
$3 Million Verdict Tossed in Hormone Therapy Case
By Asher Hawkins; The Legal Intelligencer, June 4, 2007

Philadelphia's juries seem to be persuaded by the arguments presented by hormone therapy litigation plaintiffs in their products liability actions against a locally based pharmaceuticals giant, but the city's judges don't.

A ruling Wednesday by Philadelphia Common Pleas Senior Judge Ricardo C. Jackson granting the defense judgment NOV in Nelson v. Wyeth means that the first hormone therapy case to reach trial in the city's Complex Litigation Center has effectively ended with a Wyeth victory despite a sizable jury award in favor of the plaintiffs.

The February jury in Nelson had announced a unanimous verdict in favor of Jennie and Lawrence Nelson of Dayton, Ohio, awarding Jennie $2.4 million, with the remaining $600,000 going to her husband.

According to attorneys involved in the case, Jackson decided after the plaintiffs had rested that the jurors wouldn't be permitted to consider punitive damages.

At about the same time, a colleague of Jackson's presiding over the Complex Litigation Center's second hormone therapy trial also concluded that punitive damages weren't warranted in that action, captioned Daniel v. Wyeth. That trial ended in late January with a $1.5 million compensatory damages verdict for that case's wife-and-husband plaintiffs, who are natives of Hot Springs, Ark.

The first Nelson jury had concluded in October 2006 that Wyeth, if found liable during the second phase of that reverse-bifurcated litigation, would have to pay the plaintiffs $1.5 million.

At one point, it seemed as if a mistrial in those proceedings might be declared post-verdict after the court learned that one juror had threatened another with a detached table leg during deliberations.

But ultimately, Senior Judge Norman C. Ackerman -- the former head of the CLC -- made the decision to have a second go-around in 2007 when counsel for Wyeth revealed that one juror had failed to disclose a felony theft conviction during voir dire.

Recent docket entries in Daniel indicate that the punitive damages issue has been appealed and that Judge Allan L. Tereshko, the new head of the CLC, is overseeing post-trial litigation in that case.

Just weeks after the Daniel trial ended, the Nelson re-trial's nine-member panel -- which included three women -- went on to deliberate as to compensatory damages only, following a roughly monthlong re-trial.

In orders dated Wednesday, Jackson granted a Wyeth motion for JNOV as to causation, and also denied the plaintiffs' post-trial motion seeking a new trial as to punitive damages.

Tobi Millrood of Schiffrin Barroway Topaz & Kessler in Radnor, Pa. -- the Nelsons' attorney, and plaintiffs-side liaison counsel for the CLC's hormone therapy program -- said his clients will be appealing Jackson's ruling.

Appearing in the New England Journal of Medicine:
SPECIAL REPORT: "The Decrease in Breast-Cancer Incidence in 2003 in the United States" (PDF, 166k)

April 18, 2007

Excerpt from Article Appearing in the Washington Post:
ARTICLE: "Drop in Hormone Use Linked to Breast Cancer Decline"
By Rob Stein; Washington Post Staff Writer, Wednesday, April 18, 2007; 5:02 PM

New federal statistics provide powerful evidence that the sharp drop in hormone use by menopausal women that began in 2002 caused a dramatic decline in breast cancer cases, according to an analysis being published Thursday.

The statistics show that the number of women diagnosed with breast cancer abruptly began falling after concerns emerged about the safety of hormone treatment and that the decrease persisted into the following year, strengthening the case that the trends are related, researchers said.

"At first I didn't believe it -- it was so astounding," said Donald A. Berry of the University of Texas, who led the analysis published in The New England Journal of Medicine. "But it really looks like it's a story that holds together."

Based on the findings, the researchers estimated that about 16,000 fewer cases of breast cancer are being diagnosed each year because of the precipitous fall in hormone use, a stunning reversal of a decades-long increase in cases.

"This is colossal," said Rowan Chlebowski of the Harbor-UCLA Medical Center, who helped conduct the analysis. "It translates into thousands of fewer breast cancers that have been diagnosed in women in the United States and could be in the future."

The findings also help explain one of the biggest mysteries about breast cancer -- why the number of cases rose steadily for decades. Increasing hormone use probably played a key role, along with better detection by mammography and other factors, several experts said.

"I think this solves at least part of the mystery," Berry said.

Others said the findings underscored the danger of drug therapies becoming widespread before they have been carefully tested.

"An awful lot of breast cancer was caused by doctors' prescriptions," said Larry Norton of Memorial Sloan-Kettering Cancer Center in New York. "That's a very serious and sobering thought."

Norton and others said the findings should encourage more women to discontinue hormone use and only take them at the lowest dose for the shortest time necessary.

"These data add to the message that we really should be discouraging women from initiating menopausal hormones," said Marcia L. Stefanick of Stanford University. "We need to stop underplaying those risks. They are very real."

Some researchers, however, questioned the findings, saying the drop in breast cancer occurred too soon to have been caused by the decline in hormone use.

"Even if there was a cause-and-effect, you wouldn't expect it to show up for five or 10 years," said Hugh S. Taylor of Yale University. "It just doesn't fit with what we know about the basic biology of breast cancer."

Wyeth Pharmaceuticals, which makes the most widely prescribed hormones, also questioned the link, saying hormone use continued to fall while the breast cancer rate remained stable after the initial drop. The researchers, they said, had failed to rule out other causes, such as a decline in mammogram use.

"We do respectfully disagree with the conclusion here," said Joseph S. Camardo, Wyeth's senior vice president of global medical affairs.

Millions of women took hormones for years to alleviate hot flashes and other symptoms of menopause and in the belief they were a virtual fountain of youth -- boosting energy, preventing wrinkles and providing a host of health benefits, including reducing the risk of heart disease.

In 2002, however, the large federal Women's Health Initiative study stunned doctors and patients when it showed that the hormones not only failed to protect women's hearts, they appeared to increase the risk of heart attacks and strokes, as well as breast cancer and other health problems. The news prompted millions of women to abandon the drugs.

Researchers first reported last fall that the breast cancer rate had dropped in 2003 after rising steadily since the 1980s, and that the drop appeared to coincide with the news about hormones. Experts have been waiting for the latest federal data, from 2004, to see if the trend persisted.

The new analysis showed that the breast cancer rate began falling almost immediately after the Women's Health Initiative findings were released in July 2002, dropping 6.7 percent between 2002 and 2003. The 2004 data showed that the rate remained at the lower level, having fallen 8.6 percent between 2001 and 2004.

The researchers said that indicates the drop was due primarily to the decrease in hormone use and not other factors, such as fewer women getting mammograms, greater use of hormone-blocking drugs like tamoxifen or some unknown change in the environment, and that it will be long-lasting.

"The fact that the incidence rate did not go back up suggests that the effects will be long-lived," said Peter M. Ravdin of the University of Texas, who helped conduct the analysis.

The link is strengthened by the fact that the decline occurred primarily in women ages 50 to 69, the age group most likely to use hormones, and predominantly in a form of breast cancer sensitive to the hormone estrogen. New cases of this type fell 14.7 percent, the researchers said.

The researchers and others stressed that further research will be needed to determine whether the reduction in diagnoses will translate into fewer deaths.

Researchers suspect hormone use may mostly spur the growth of tumors that may never become life-threatening. In the absence of hormones, they may remain small enough to never be detected by mammograms or may even shrink.

"Think of a cancer that you are feeding with hormones and now you stop the fuel. What's going to happen to it?" Berry said. "Most likely it stops growing and stays under the radar, or maybe even regresses. It could even disappear."

March 22, 2007

I attended the most recent status conference in Philadelphia on March 19, 2007. These conferences are held to discuss the progress of the hormone therapy cases. It is always an interesting occurrence when so many attorneys are gathered in one place. Needless to say, there are not many moments of silence! These conferences are an important part of the process. Many issues are discussed at these meetings. Through these conferences issues are stated, argued, and often resolved. The Court tries to address issues prior to the actual trials. Hopefully, through these conferences, issues will be settled, which will enable the trials to be conducted in a more efficient manner.

At this conference, discussion was held regarding the future cases. There are still several more bellwether or “test” cases to be conducted. Two of these cases will begin on April 16, 2007. Another will be heard in May. There will be a brief break in the summer, then another case heard in September. All total, there are approximately 1814 hormone therapy cases filed in Philadelphia. As you can imagine, this will be quite a logistical feat to have all these cases tried. Of course, there is always the hope that these cases will be resolved through settlement. It is our hope that the continued successes of bellwether cases will lead to the ultimate settlement of all cases. Until then, we will continue to fight for your rights and continue our periodic trips to the status conferences.

The following from Newswire serves as a hormone therapy update relating to the trial, Nelson v. Wyeth. The Joel Bieber Firm is providing this information because we currently represent ladies in the hormone therapy litigation, against Wyeth.

Wyeth provided inadequate warnings on its drug Prempro and that the Hormone Therapy drug caused invasive breast cancer in Jennie Nelson, a 67 year old Ohio woman. The jury of nine awarded damages to Mrs. Nelson of $2.4 million and an additional $600,000 to her husband. This is the third time in which a Philadelphia state court jury found that Wyeth's Hormone Therapy drugs caused a woman's breast cancer.

"We are very grateful to the members of the jury who carefully considered the facts in Mrs. Nelson's case. We also find it especially rewarding that two separate juries have believed in the merits of the case and found for Mrs. Nelson," said Tobias Millrood of the law firm Schiffrin Barroway Topaz & Kessler, co-counsel for Jennie Nelson. "Both times this case has been heard on terms established by Wyeth and still the juries have clearly found that Prempro causes breast cancer."

In 2001, Mrs. Nelson underwent a double mastectomy and chemotherapy and radiation and today remains on anti-hormonal medication. Mrs. Nelson's case was originally heard by a jury in the fall of 2006 and on October 4, 2006 the jury found in the first phase of the trial that her use of Wyeth's postmenopausal hormone replacement therapy drug Prempro was a cause of her invasive lobular breast cancer. In October 2006, the jury awarded Mrs. Nelson $1.5 million in compensatory damages, on the Phase I verdict. A mistrial was later granted on the basis of juror ineligibility based on a motion by Wyeth.

"Jennie Nelson and her husband Lawrence are very courageous people, waging a brave fight and representing the thousands and thousands of women suffering from breast cancer as a result of Wyeth's hormone therapy drugs," continued Millrood. "The evidence presented at trial revealed that Wyeth has known for decades that postmenopausal hormone therapy causes breast cancer but that Wyeth chose to avoid testing this dangerous hormone combination and delayed stronger warnings for fear of flagging sales. We hope that this verdict sends a clear message to Wyeth that these courageous women are fighters."

The retrial began on January 11, 2007 in the Philadelphia Court of Common Pleas. The case, which lasted four and a half weeks, was heard by Judge Ricardo C. Jackson.

* The Amount of the Nelson verdict is not to suggest that any other pending cases in the hormone therapy litigation are worth less or more than this verdict. Each case is different and this update should not serve to establish any expectation for any case that this firm is currently handling.

Drug Reactions: Hormone Therapy

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