A medical contraindication is a factor or condition that increases the risks to your health (and life) from taking a particular drug, undergoing a specific medical procedure, or undertaking a particular activity. Some contraindications are absolute, which means there are no reasonable circumstances for taking the drug or course of action. For example, a person with an anaphylactic food allergy should never eat that particular food in any amount whatsoever.

Other contraindications are relative, meaning that the patient is at higher risk of complications, but that these risks may be outweighed by other considerations or mitigated by other medical measures. Caution and second opinions are advisable in these cases.

Absolute Contraindications

• severe liver disease
• pregnancy
• coronary artery disease (CAD)
• venous thrombosis
• well-differentiated and early endometrial cancer

Relative Contraindications

• migraine headaches
• personal history of breast cancer
• history of uterine fibroids
• atypical ductal hyperplasia of the breast
• active gallbladder disease

The National Institutes of Health (NIH) has released a cautionary statement on short-term side effects of Prempro that is a good follow-up to this article.

A new study that compared the costs and benefits of accepting a settlement offer as opposed to going to trial, concluded that when you are suing and a deal is offered by the defendent, you should take the deal. That is the lesson from the biggest study ever undertaken on the impact of plaintiff decisions to accept a settlement instead of going to trial. Researchers found that most plaintiffs who pass up settlement offers to go to trial end up getting less money than if they had taken the settlement.

Are You Likely to Get an Offer?

Wyeth, the maker of Prempro, has already settled with two women who were plaintiffs in a lawsuit against Wyeth who they blamed for their breast cancer. Rather than allowing the court case to proc lawsuit eed, Wyeth offered a settlement of an undisclosed amount of money to each woman, and they accepted. Did they do the right thing? Would they have been better off taking their case to court?

The co-author of a new study, previewed in the NY Times (August 8, 2008), reviewed over 2000 lawsuits brought to civil courts between 2002 and 2005. In 61% of cases, plaintiffs who decided to pass up a settlement and go to trial, ended up with less money than if they had accepted the settlement offer. 15% of cases, both sides were right in going to trial in just 15% of cases.

Your Lawyer Might Think Otherwise

The author speculates that lawyers may not be explaining the odds of winning at trial adequately. Factors that influence plaintiff decisions to go to trial instead of settling include contingency fee arrangements. Lawyers, who like to gamble, may be willing to bet on a big fee from a trial rather than a more modest fee from a settlement.

The findings are consistent with what psychologists have found. People are more averse to taking risks when they expect to have something to lose, and more willing to take risks when they reasonably stand to gain something.

People considering a Prempro-related lawsuit may want to fully explore the issue of settlements with their attorney before any offer is on the table. That will give your attorney a chance to know your preferences and for him or her to explain his/her views on the subject to you. That way, both of you will be prepared and won’t feel ambushed by the other.

Need an Attorney?

Need an attorney to talk with about your concerns? Fill out a contact form on one of the pages on this website and we will pass it along to an experienced attorney who can help you think through your situation, gratis. To help you prepare for your conversation with an attorney, you may want to review Prempro On Trial and other articles on this site.

In the good old days (1938), when the FDA was first established, drugs were approved after only a few short weeks of study, usually after testing them on no more than a few hundred people. What’s more, the studies were (and still are) conducted by the same companies that manufactured the products and had the most to lose by a negative FDA response.

As a result, the FDA doesn’t know the long-term risks of any drug until it is in the market for several years and then, only when there is a public outcry about harm the product is causing. That puts the FDA in the position of always having to react to emergencies, rather than doing their work proactively to avoid them. This is not just a matter of bureaucratic inefficiency but safeguarding people’s lives which may hang in the balance while the FDA dithers about what to do.

New Authority for the FDA

You know things have gotten bad when both the Democrats and Republicans in the Congress pass a bill (in 2007) that increases FDA’s authority to monitor drugs after they are put on the market.  Unfortunately, the new law also mandates the collection of user fees by the FDA from the drug companies that produce the products and are being monitored. Some people consider that another bite of the apple for drug industry lobbyists.

In recent years, there have been numerous Congressional Hearings criticising drug companies for greed and failing to protect consumers from flawed drugs. But no matter how many hearings are held, the cozy relationship between lawmakers, the medical insurance industry and the pharmaceutical industry seems to get stronger and more resistent to the voices of concerned consumers. Today, physicians write more than 2 billion prescriptions each year, an average of 7 for every person in the USA. This is more than in any other country on earth, yet many nations exceed the US in every indicator of positive health.

Rx or Marketing?

The pharmaceutical industry markets directly to physicians, plying them with gifts, food, continuing medical education, trips, and consultant fees. In a recent survey reported in the New England Journal of Medicine (NEJM), 94 percent of physicians said they receive food, drug samples, and/or payments from the pharmaceutical industry.

It’s only after new drugs intended for long-term use are intensively marketed by drug companies via TV ads and physician office visits (by drug company representatives), that drug safety problems start to emerge. When problems come to light, drug companies tend to shrug them off as coincidental, but if the FDA were monitoring these cases directly and not depending on the companies for the data, thousands of cases of serious injury or death might be averted. Congress has pushed the FDA to approve drugs more quickly, which they are doing, but sometimes the speed of approval is what allows a dangerous new drug to slip through safety testing with horrible human consequences. To top it off, drug companies spend twice as much on the marketing of new drugs as on research to establish effectiveness and safety. Yet, the costs of research are cited as the main reason for the soaring high prices of new drugs.

Criticism of Big Pharma

The British National Health Services chief, Sir Michael Rawlins, has taken the global pharmaceutical industry to task for making huge profits on new drugs, which has more to do with keeping their share prices high in order to justify the extravagant pay of pharmaceutical executives, than development costs when many drugs could be produced for a fraction of their current costs. In an interview given to the British weekly, The Observer (August 17, 2008), Rawlins chastises the industry for charging whatever they think they can get away with, rather than any consideration for the needs of patients. The surge in new drug costs is a major factor in the British government-run, National Health Services, now considering health care services rationing.

The drug industry employs more than 90,000 representatives (reps) and spends an average of $8,800 directly marketing their products to each of 817,000 physicians in the United States. A survey in the Journal of the American Medical Association (JAMA) documented the negative affects these interactions have on physicians. These include:

• reduced generic drug prescribing
• increased numbers of prescriptions written overall
• quick pick-up of the newest, most expensive drugs
• requests for new drugs from formularies that have few advantages over existing drugs.

Physicians admit that without the gifts, meals, and trips, they would have less interaction with the drug industry. Physicians and the pharmaceutical industry have introduced voluntary measures to try to regulate these interactions, including:

• AMA guidelines on gifts to physicians from Industry, limiting gifts to those of modest value
• the pharmaceutical industry’s Code for Interaction with Healthcare Professionals, that limits to $100 the value of gifts drug companies may give to MDs
• the federal government’s compliance program offering guidance for pharmaceutical manufacturers.

These codes and guidelines have not worked. Even small gifts can exert undue influence on physicians. There are no measures to monitor compliance, and there is widespread, non-compliance with self-regulation. Several states have Sunshine Laws with limits on industry payments to physicians and requiring disclosure of these payments. States with such laws include Minnesota, Vermont, Maine, District of Columbia, and West Virginia. Other states, including New York, are considering similar laws. But these are only first steps to getting the medical conflict-of-interest genie back into the bottle.

Conflicts of Interest Exposed

Disclosure data from states with sunshine laws have spelled out additional areas of conflict-of-interest that have gone undetected until now:

• payments of tens of thousands of dollars to physicians serving on medical committees that determine what drugs should be approved in the Medicaid program;
• physicians who are paid by drug companies to conduct clinical trials or to promote certain drugs, who have been sanctioned by State Boards of Medicine for disregarding the welfare of their patients.

A New Way of Doing Business

A growing number of states are using academic detailing as a way to reduce the cost of prescription drugs, improve the quality of care, and increase the value of drug coverage programs. Reviews of the effectveness of this approach from Canada and Australia have concluded that academic detailing positively influences physician practices and promotes safe, appropriate drug use. It also has been found to be cost-effective.

Academic detailing programs provide physicians with balanced, reliable, objective information on commonly used prescription drugs based on scientific information not marketing hype. Information is delivered via outreach visits to physicians’ offices by clinicians, nurses and pharmacists, tailored to the needs and time constraints of individual physicians.

Physicians acknowledge their need for unbiased, non-product-driven information about the drugs they prescribe. When offered academic detailing through convenient office-visits, physicians readily accept them. Academic detailing programs have been proven to reduce over-prescribing, making this approach not only cost-effective but cost-efficient.

Currently, there are several existing academic detailing programs on-going in several states.  These include:

• Pennsylvania’s Independent Drug Information Service (IDIS), sponsored by the Pennsylvania Department of Aging Pharmaceutical Assistance Contract for the Elderly (PACE). Clinical information on drugs is created by an independent group of physicians at Harvard Medical School, and trained detailers with nursing or pharmacy backgrounds provide this information in personalized visits to doctors’ offices. The program costs $1 million annually to administer. Results of 2,400 visits over 23 months show a significant decrease in inappropriate prescribing. (Launched October, 2005)
• The University of Vermont Medical School’s (UVM) academic detailing program is offered in coordination with the Vermont Area Health Education Center (AHEC). It is promoted as a free educational opportunity available to Vermont health care professionals to promote high-quality, evidence-based, patient-centered, cost-effective, pharmaceutical treatment decisions. The program presents educational sessions in physician offices by a clinical pharmacist or physician who provides an objective, unbiased overview of medications based on studies of drugs used to treat specific conditions. One health condition is the focus each year. Current budget of $50,000 supports 25 visits annually but additional funding of $150,000 will allow more educational visits. (On-going since 2004).
• South Carolina Offering Prescribing Excellence (SCORE), University of South Carolina Department of Health and Human Services and the South Carolina College of Pharmacy was launched in 2007. The aim of the program is to improve quality of care by promoting evidence-based, cost-effective drug therapy decisions with the patient as the focus.

The transformation of the American health care system is underway because medical leadership has determined that it is needed and overdue. Patients and government health experts agree. The models are being developed now, and academic detailing is proving to be a viable, cost-effective approach that could lead to a saner, more cost-efficient health services system in the United States.

For decades, women were advised to take hormone therapy to avoid the discomforts of menopause and be protected against many chronic diseases common in the post-menopause years. In addition to decreasing hot flashes and other signs of menopause, replacing the natural hormones lost in menopause was thought to be a good way of protecting women against heart disease, osteoporosis, memory loss, wrinkles, and mood swings. To gain these assumed benefits, women were advised to begin taking hormones before menopause, and to continue taking them for many years, or even decades post-menopause, in order to have the best quality of life and avoid serious illness.

Doctors usually prescribed a combination of synthetic estrogen and progestin to replace falling levels of the two hormones, a natural condition of menopause. Women who had a hysterectomy only needed to take estrogen. The latest studies, which are considered definitive, have clearly shown that the risks of taking these hormones far outweigh the benefits. Women taking Prempro, the combination hormone pill used in the aborted clinical trials, were far more likely to develop breast cancer, stroke, blood clots, and Alzheimer’s, and just as likely to develop heart attacks, compared to women taking a placebo. Women taking estrogen alone (Premarin), had increased risks of blood clots and stroke.

The first shift in thinking about hormone therapy was a name change. Hormone replacement therapy was changed to hormone therapy to underscore that hormones don’t necessarily need to be replaced in menopause. Doctors now tend to prescribe hormones only in cases of severe menopause
symptoms, when discomforts interfere with the quality of life.

New Guidelines from the FDA

The FDA has issued guidelines to advise physicians and drug companies with regard to patient education. If the guidance you received differs from this, you should contact your physician to discuss these recommendations and question whether you should change anything you are doing, including stopping taking Prempro or other hormone therapy for menopause.

Listed below are the new FDA recommendations:

• Hormone therapy is effective for short-term relief of moderate to severe menopausal symptoms such as hot flashes;
• Hormone therapy can be effective for moderate to severe vulvar and vaginal atrophy, but topical agents should be tried first;
• Hormone therapy is effective for reducing the risk of osteoporosis, but it should only be considered for women at major risk for osteoporosis who can’t take other medications to prevent osteoporosis.
• Hormone therapy should only be taken at the lowest possible dose and for the shortest possible time to achieve a therapeutic benefit.

The Bottom Line

Hormone therapy is not a miracle drug to restore your youth, protect your health, and stave off the diseases of old age. In fact, it can have the opposite effect and stack the deck so you are more likely to experience breast cancer, stroke, Alzheimer’s disease, dementia and blood clots. It does have some limited benefits for treating short-term symptoms of menopause such as hot flashes and insomnia. If you have symptoms of menopause which you find hard to live with, discuss options with your physician. Even small amounts of hormones have powerful effects on the body. Take them with caution, if at all.

Prempro, formerly known as Hormone Replacement Therapy (HRT), is a medication prescribed for hormone treatment of menopausal women. It is given to prevent hot flashes and other uncomfortable symptoms of menopause that are caused by falling and erratic circulating levels of the hormones estrogen and progesterone. Prempro, which combines synthetic estrogen and progestin, is designed to artificially boost circulating levels of the two hormones.

Who Should Not Take Prempro?

Do not take Prempro if you have or have had a heart condition, high blood pressure, cancer but especially, breast, ovarian, uterine, or other hormone-dependent cancers, a bleeding or blood-clotting disorder, liver disease, abnormal vaginal bleeding, or if you are postmenopausal and past the discomforts of menopause. Do not take Premprin to prevent heart disease or osteoporosis. It is only approved in the USA for the short-term treatment of menopause symptoms.

What Should I Know About Prempro?

In 2002, the Women’s Health Initiative (WHI) of the National Institutes of Health, was halted prematurely when researchers found that women in the treatment arm of the study taking HRT ( Prempro) had more cases of breast cancer and strokes, compared to women in the control group who did not take HRT. The WHI findings were later confirmed in a second, even larger, British study, known as the Million Women Study.

As a result of these findings, warnings were published in medical journals and in announcements from the FDA, cautioning that women with normal menopause should only take prescribed hormone treatments at the lowest feasible doses, and for the shortest possible time, if at all. For health problems associated with menopause such as osteoporosis (a small percentage of postmenopausal women are at risk of severe bone loss), other lifestyle changes and/or medications are recommended. Hormone therapy is for short-term relief (often one or two years, usually less than five) from symptoms of menopause.

How Many Postmenopausal Women Are Taking Prempro?

Wyeth, the manufacturer, estimates that 10 million postmenopausal women are taking the medication, or some other form of estrogen, either in combination with progestin (synthetic progesterone) or alone.

What Are the Possible Side Effects of Prempro?

Wyeth reports these side effects: Irregular or abnormal vaginal bleeding, including spotting, breakthrough bleeding, prolonged or heavier vaginal bleeding, or bleeding completely stopped after 10 months on the pill, vaginal itching or irritation, thick white vaginal discharge, sharp chest or lower leg (calf) pain, breast lumps or tenderness, severe headaches, shortness of breath, coughing up blood, severe stomach pain or swelling, mild dizziness, nausea and fluid retention, memory loss, dementia.

What Is the Legal Definition of Pharmaceutical Negligence, and Is Prempro an Example?

Legal definitions vary from state to state, but generally, it means that a drug company failed to act within an appropriate standard of care by causing injury or death to a consumer who used their product(s). This could be the result of a drug that was not tested adequately or due to failure to provide appropriate warnings to physicians prescribing the drug to patients.

Is There a Time Limit on When a Lawsuit Can Be Brought Against a Drug Manufacturer?

Yes. Each state and the federal government have very different statutes of limitations on the time period when a malpractice suit can be pursued. For that reason it is best not to wait too long to look into whether you have a viable case. The referral form on the pages of this website will provide an opportunity to query an attorney, free of charge, who is experienced in these matters. Simply fill out the form and we will initiate a contact for you.

Now that you’ve begun your research on Prempro, you might want to explore the need for safer drugs and better prescribing practices, next.

In September 2007, President Bush signed into law a bill passed by the Congress that gave the Food and Drug Administration (FDA) more power to monitor the safety of prescription drugs. The bill was written because of Congressional concern that too many harmful medications were reaching the public. The law gives the FDA authority to monitor the safety of drug products after they go on the market, not just before, and to order that warnings be added to labels and patient information when new side effects become evident. The Prescription Drug User Fees Act of 2007 (PDUFA) gives the FDA power to take swift, decisive action to protect consumers when new information comes to light about risks and side effects.

Experience with the dangerous side effects of Vioxx (Merck), a drug linked to heart attacks and strokes, Avandia (GlaxoSmithKline) to heart attacks, and Prempro (Wyeth) to breast cancer, heart attacks, strokes, and dementia, as well as other dangerous new drugs, convinced lawmakers that the FDA needed to be able to police drug safety even after products are on the market. PDUFA gives the FDA that responsibility and to help defray costs, provisions are included for $400 million in industry user fees, and the authority to levy more fines if companies fail to comply.

Industry Pays FDA’s Bill

User fees were first put into law by Congress in 1992 in response to complaints from drug companies and patients rights groups about excessively long lag times in drug approvals. The fees allowed the FDA to employ more drug reviewers and bring medicines to market faster. It speeded up approval times for new drugs from an average of 27 months to 14 months, according to the Government Accountability Office (GAO). But critics of the law are far from satisfied.

Critics contend that faster drug approval times have resulted in less attention to drug safety. The same GAO report that studied the impact of user fees on the speed of drug approval, also found that since passage of the user fee law, a higher percentage of prescription drugs have been withdrawn from the market because of patient safety concerns. Critics point out that user fees create a built-in conflict of interest for the agency by making the FDA dependent on the industry it regulates to pay its bills. With user fees, the FDA has two customers, the public and the drug industry, an obvious conflict-of-interest.

User Fees, A Form of Lobbying

In 2009, the FDA is scheduled to collect $626 million in user fees from the drug industry, a quarter of its annual budget. The industry spent $168 million on lobbying in 2007, reports the Center for Public Integrity, based on an analysis of federal lobbying data. Nine out of ten lobbying dollars were spent by just 40 drug and medical equipment companies and three industry trade groups. The oversized budgets of Washington’s largest lobby, the pharmaceutical industry, is credited with passage of the Medicare reform act of 2003 which contained a prescription drug benefit but disallows the government from negotiating for lower drug prices. In this context, user fees amount to another avenue for lobbying Congress and the White House by the pharmaceutical industry.

The reauthorization of the Prescription Drug User Fee Act (PDUFA) of 2007 has kicked up more opposition to the notion of industry-paid user fees to fund the regulatory oversight work of the FDA. Public Citizen’s Health Research Group, a leading health advocacy organization, says user fees create an untenable conflict of interest in which the FDA is in hock to the industry it is supposed to regulate. The results have been a decline in safety standards at the FDA, with a lengthy record of drug withdrawals for safety reasons. They cite the GAO report which documents that a higher proportion of drugs has been withdrawn from the market for safety reasons since the original PDUFA was enacted. The report was published before the Vioxx and Bextra bans, the early termination of the Women’s Health Study, and the disclosures of the witholding of antidepressant drug data by the industry and the FDA.

FDA Called A Sweatshop

Morale at the FDA is low, insiders report, because since the passage of user fees, strict deadlines for drug reviews have created sweatshop conditions at the agency. While user fees may save the government some modest dollars, it is at an unacceptable cost to public health, a former senior staff member at the FDA contends. He and others urge a return to total funding of the FDA by taxpayers at a level commensurate with the job.

Full Public Disclosure

PDUFA, passed in 2007, was prompted, in part, by experiences with the pain medication Vioxx, and the anti-depressant drug Paxil, two cases in which drug companies did not make public their complete clinical trial study results that showed that the drugs had dangerous side effects yet the companies continued to market the drugs intensively, without warning about side effects. Thanks to the lobbying efforts of Consumers Union (CU), the new bill contains a provision that requires results from clinical drug trials be made public on the internet, so consumers can know both what is good and what is bad about medications. CU managed to convince lawmakers that, “We can’t have a fair and safe marketplace if industry keeps this vital information from the public.”

Other groundbreaking provisions of PDUFA include:

• record-monitoring to detect problems with new drugs
• encouraging more accurate drug advertising and heavier fines for misleading ads
• print ads that must include a toll-free number and a website for reporting side effects to the FDA
• limiting conficts of interest because of ties or income from drug companies for FDA advisory committee members
• opening up internal FDA debates on drug approval
• some first steps in food safety reform, including expanding inspections of imported food, seafood, and pet foods

Restoring Public Confidence

Consumers Union, which lobbied for reform of drug safety for three years, was enthusiastic about PDUFA. Drugmakers also were happy with the legislation, according to a lobbyist for Pfizer. They hope it will restore public confidence in the FDA’s oversight of drug safety. Trial lawyers were pleased, too, because of language in the bill that could make it harder for drug manufacturers to win lawsuits filed by plaintiffs who say they’ve been harmed by medications. The new bill requires companies to disclose risks and side effects on package labels as they are discovered. Previously, companies could argue they were not at fault because all the FDA required on the label was published when the drug first entered the marketplace.

On balance, the bill has something for everyone, and the general opinion is that drug safety has been improved. It represents an important addition to FDA authority for keeping the public safe. Only time will tell if the bill results in safer drugs and fewer lawsuits.

In mid-July, 2008, Wyeth settled lawsuits with two Nevada women who blamed their breast cancers on the company’s drug Prempro, which they took to relieve hot flashes and menopause symptoms. Vesta Woodhouse, 71, and Annie Woods, 61, are among millions of women who used Prempro as a hormone replacement therapy. Woodhouse took Prempro for 19 months before developing breast cancer. Woods took Premarin, Provera, and Prempo for about 5 years before developing breast cancer. Their lawsuits claimed that Wyeth failed to warn them about breast cancer risks. Wyeth settled with both women for an undisclosed amount.

Judge Rules Against Wyeth

New Jersey Superior Court judge, Bryan Garruto, in June 2008, issued a pre-trial rulng that a federal law does not bar state product liability lawsuits against drug makers. The ruling is the third by state and federal judges finding that lawsuits alleging drug companies did not adequately warn about a product’s dangers are not pre-empted by the US Food and Cosmetics Act. In other words, the law gives the 50 states, not the FDA pre-emption in matters pertaining to the safety of drugs.

The ruling allowed plaintiff Ellen Deutsch’s lawsuit to proceed. Deutsch, in her early 60s, took Prempro from 1996 to 2002 along with an older Wyeth menopause drug, Premarin. Deutsch alleges that the drugs caused her breast cancer. This is the first Prempro case to reach the courts in New Jersey, and was set to go to trial in July, 2008, the first of 250 trials pending in the state and one of 10,000 filed nationwide.

Wyeth Pays Big

In March 2008, Wyeth and Pfizer Inc. were ordered to pay an Arkansas woman $27.1 million in punitive damages. The Arkansas jury found that Wyeth’s Prempro and Pfizer’s Provera had caused the plaintiff to develop breast cancer, and further determined that the companies had shown reckless disregard for the health risks posed by their HRT drugs and should be punished. Wyeth’s share of the punitive damages came to $19.3 million.

Judge Reduces Jury Verdict

In February 2008, a district court judge in Nevada reduced a jury award against Wyeth from $134 million to $58 million. The damages included both compensatory and punitive damages based on the theory that the drugs Premarin and Prempro caused the plaintiff’s breast cancer. The judge was concerned that the amounts represented “the result of passion and prejudice.” The judgment was the largest award to date against Wyeth, which faces about 5,300 similar lawsuits across the country involving the drugs Premarin, an estrogen replacement, and Prempro, a combination of estrogen and progestin.

Summary Judgment for Wyeth

A judge in Minnesota dismissed a product liability lawsuit against Wyeth, granting the drugmaker’s motion for summary judgment in a case in which a woman blamed the company’s hormone replacement therapy for her breast cancer. In dismissing the case, which had been scheduled to go to trial in January 2008, Judge George McGunnigle of the Hennepin County District Court in Minneapolis found that the plaintiff, Patricia Zandi, had not offered any scientifically valid evidence to support her claim that she had developed breast cancer as a result of using Wyeth’s Premarin and Prempro.

Wyeth Loses Prempro Trial

A jury found that Prempro caused the plaintiff’s breast cancer and awarded Jennie Nelson and her husband $3 million, in a retrial of a Philadelphia HRT case. Wyeth indicated it would appeal.

In a prior Philadelphia trial, a jury also found in favor of the plaintiff, Jennie Nelson, but the judge threw out the verdict and declared a mistrial due to “extraneous circumstances” related to misconduct of a juror. The original jury awarded Nelson and her husband $1.5 million in compensatory damages. This time, Nelson was awarded $2.4 million and her husband $600,000, for a total of $3 million.

Mistrial in Prempro Case

In Jennie Nelson v. Wyeth Pharmaceuticals, the judge declared a mistrial and ordered a new trial, overturning a verdict against Wyeth. An attorney for the plaintiff stated that the mistrial was due to “extraneous circumstances,” but gave no details because the judge’s order was under seal.

The Nelson trial had been divided into two phases, with the first phase addressing causation and compensatory damages and the second liability and punitive damages. The jury concluded, at the end of phase one, that Prempro was the cause of the plaintiff’s breast cancer. The amount of compensatory damages awarded was $1 million for Nelson and $500,000 for her husband. The punitive damages phase was scheduled to begin the following day.

Texas Case Dismissed

A Texas judge dismissed a hormone replacement therapy case that was on the verge of going to trial, brought by a woman who claimed she developed breast cancer as a result of taking Prempro. The judge, Caroline E. Baker of Houston, said the woman couldn’t accuse Wyeth of failing to warn about risks associated with Prempro because drug labels are regulated by the U.S. Food and Drug Administration, according to a Wyeth statement. Wyeth lawyers have said the company did what the FDA told them to do.

Judge Denies Punitive Damages

In the Prempro trial of Mary Daniel v. Wyeth, the jury rendered a verdict for the plaintiff for $1.5 million in compensatory damages and found a basis to move to a punitive damages phase, but today the judge ruled, as a matter of law, that the evidence was insufficient to hold Wyeth liable for punitive damages. However, the judge apparently has decided to allow the jury to hear the evidence on punitive damages and to render a verdict — under seal — in case her ruling is reversed on appeal. The punitive damage award will not be made public unless an appeals court overturns the judge’s ruling.

Previously, a jury found that Wyeth failed to properly warn about the cancer risks associated with Prempro, and that the drug was responsible for plaintiff Mary Daniel’s breast cancer. It awarded Daniel and her husband $1.5 million in compensatory damages. The jury also found that Wyeth’s conduct was malicious or showed reckless indifference, a finding that under Pennsylvania law could send the jury back to determine additional punitive damages to be paid by the New Jersey-based company.

The jury was expected to return in a matter of days to decide punitive damages, finding Wyeth’s conduct to be “malicious, wanton, willful, oppressive or showing reckless indifference to the interest of others,” in failing to provide adequate warnings about Prempro and breast cancer risk.

WARNING

Estrogens and progestins should not be used for the prevention of cardiovascular disease. The Women’s Health Initiative (WHI) reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women during 5 years of treatment with conjugated equine estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative to placebo. Other doses of conjugated estrogens and medroxyprogesterone acetate, and other combinations of estrogens and progestins were not studied in the WHI …

Hormone replacement therapy may cause various serious side effects. Tell your doctor if these symptoms appear, are severe or do not go away:

• headache
• upset stomach
• vomiting
• stomach cramps or bloating
• diarrhea
• appetite and weight changes
• changes in sex drive or ability
• nervousness
• brown or black skin patches
• acne
• swelling of hands, feet, or lower legs (fluid retention)
• bleeding or spotting between menstrual periods
• changes in menstrual flow
• breast tenderness, enlargement, or discharge
• difficulty wearing contact lenses

The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• double vision
• severe abdominal pain
• yellowing of the skin or eyes
• severe mental depression
• unusual bleeding
• loss of appetite
• rash
• extreme tiredness, weakness, or lack of energy
• fever
• dark-colored urine
• light-colored stool

Hormone replacement therapy may increase the risk of developing endometrial cancer and gallbladder disease. Talk to your doctor about the risks of taking this medication.

Hormone therapy may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s MedWatch Adverse Event Reporting program online at MedWatch or by phone (1-800-332-1088).

States differ in drug liability standards and limitations. Arguments that are successful in some states, fall flat in others and in federal courts. For that reason, the first few Prempro liability cases have been closely watched by patients, physicians, lawyers, company officials, and stock analysts to see just how these early cases trend in state and federal courts.

So far, Wyeth has lost four out of seven cases brought against Prempro, the menopause drug used in the aborted Women’s Health Trial, since 2006 when Prempro lawsuits first began to be heard in state and federal courts. To date, these cases have been brought by women who developed breast cancer after taking Prempro for 17 months to 6 or more years.

FDA Tries to Carry A Bigger Stick

Prempro litigation began in earnest after an article appeared in the Journal of the American Medical Association (JAMA) in 2003, revealing increased risk of dementia and Alzheimer’s disease in women 65 years and older taking Prempro. Plaintiffs claimed that menopausal and postmenopausal women were being over-prescribed Prempro by their physicians and erroneously told to continue taking Prempro indefinitely, in the hope that the drug would protect the women against heart disease and osteoporosis, even though the drug was only approved for treatment of menopause symptoms. Inadequate Prempro labeling failed to fully alert women to the many dangerous side effects from taking the drug long-term.

Lawyers argued that it is the responsibility of the manufacturer to protect patients from harmful side effects and to warn of these on the label. But Wyeth, the maker of Prempro, had a shield against such arguments, or so they thought. The doctrine of “preemption,” Wyeth contended, absolved them from these burdens. Wyeth was referring to the FDA declaration that the agency possessed preemption power, an authority the agency had announced in the preamble of new rules for drug labeling the agency had issued on June 30, 2006. The preemption statement was an attempt to ban plaintiffs from filing lawsuits against a drug that the FDA had approved based on pre-market data.

Backdoor Preemption

While some courts have upheld the FDA’s preemption rights, others have not. Plaintiff attorneys say this was a backdoor attempt by the FDA at tort reform, giving the FDA new powers to trump state liability laws. But state courts have a legal right to police public health issues, and injured plaintiffs have a right to have their warning label claims heard by a jury, say attorneys for plaintiffs.

Unfortunately, the FDA didn’t monitor post-market adverse Prempro effects, at the time, and lawsuits were the only meaningful safety checks that remained to consumers. That is now remedied by the PDUFA of 2007, which goes into effect in 2009. The FDA’s role is parallel to, not in conflict with, the judiciary system. Further, the FDA statement in the preamble of a rule on drug labeling doesn’t have the force of law. The FDA did not go through the proper administrative rule-making procedures that are necessary for such an expansion of FDA authority. In the end, it is Congress that has the final legal authority to amend the functions and responsibilities of Executive agencies, not agency directors.

Both sides, in this legal standoff, believe it could come down to a decision by the US Supreme Court. Until the top court decides whether or not to rule on the matter, the action is in the appellate courts, and both sides are watching to see how things turn out there.

Defending Patients’ Rights

An extraordinary editorial in a July 2008 issue of the New England Journal of Medicine, written by the top editorial leadership of the journal, which is, arguably, one of the most prestigious publications in medicine, places medical science squarely on the side of the patient in the debate about preemption. The authors conclude that preemption will result in drugs and devices that are less safe and that will undermine national efforts to improve patient safety. Further, that approval of a new drug by the FDA is no guarantee of safety. Serious side effects come to light only after a drug is on the market for a while. But the FDA has no power to do anything about it, unlike other federal agencies, and is both beholden to and dependent on the manufacturers to reveal information about adverse patient experiences.

The editorial closed with a request that Congress put the matter of patient redress through the courts into law. As we move toward reform of the health care system, patient rights are going to be a flagship issue. Perhaps in the next administration, the FDA will resume a more balanced role as the arbitor of fairness in protecting both drugmakers and the public, rather than primarily a defender of corporations and the status quo.

Courts Reject Preemption

Perhaps the most significant event in the brief history of Prempro lawsuits was the news that Wyeth had settled lawsuits brought by two Nevada women who had taken Prempro and developed breast cancer, just before their trial was to start. In mid-July 2008, Wyeth avoided a trial by agreeing to settle with the two women, paying them an undisclosed dollar amount to resolve allegations that Wyeth had failed to adequately warn about breast cancer risks for women taking Prempro.

The Wyeth settlement comes on the heels of the US Supreme Court’s decision not to take up a case that would have determined whether FDA’s drug preemption authority supercedes state laws that allow plaintiffs to challenge a drug’s safety, efficacy or labeling. Drugmakers and the FDA argued that preemption exists as the FDA’s actions are considered the final word on drug safety and effectiveness. Earlier, a state judge in New Jersey, who is handling hundreds of Prempro lawsuits, ruled that a federal law does not bar state product liability lawsuits against drugmakers. This ruling is the third at the state level to find that a drug’s approval by the FDA does not protect drug companies from being sued. The FDA rulings are a floor, not a ceiling, and drug companies can always strengthen warnings and add new ones, the appellate Judge in the case ruled.

Wyeth Takes Stock

Now that the drug Industry’s preemption defense has been shot down by medical authorities and the courts, and the Supreme Court has decided not to get into the matter, Wyeth may have taken stock of what’s ahead and concluded that the courts may not be inclined to protect Wyeth’s bottom line. Meanwhile, Prempro lawsuits are clogging court calendars and continuing to draw media attention to women’s injuries from Prempro. Wyeth’s recent decision to settle two cases out of court may be a harbinger of what’s to come. Settling may be a way for the company to control costs and halt bad publicity from the tsunami of lawsuits waiting in the wings. We’ll keep you posted on this and other news on the patients rights and litigation front, so stay tuned!