Today, Pharmalot has an item about a dispute between AstraZeneca and Pharmac, New Zealand’s drug buying agency, over a cardiovascular drug called Betaloc.
Pharmac medical director Peter Moodie had this to say about AstraZeneca’s patent tactics — a quotation that could easily apply to numerous other brand name pharmaceutical companies’ manipulation of patents to forestall competition:
“Pharmaceutical suppliers must realise that when a patent runs out, other suppliers will enter the market and it is not acceptable to hold patients to ransom for commercial gain in such an unethical way. It is not acceptable for AstraZeneca to gamble with the lives of acutely ill patients in order to protect itself from competition.”
Zelnorm, a drug that was approved in 2002 for short-term treatment of women with “irritable bowel syndrome” and in 2004 for chronic constipation for men and women under age 65, was withdrawn from the market in March 2007 after studies showed an increased risk of heart attacks and heart problems.
Zelnorm was also very aggressively advertised and promoted, particularly through infamous TV ads showing people with wavy lines and messages written on their stomachs. These ads, and the overall promotional campaign of which they were a part, didn’t just market Zelnorm — they also marketed “Irritable Bowel Syndrome” (IBS) as a condition, working to convince millions of viewers that they have “IBS,” rather than more conventional occasional and symptomatic digestive problems.
By the time Novartis voluntarily withdrew Zelnorm from the market in March 2007, millions of people had taken it, and certainly many who did not truly have IBS or chronic constipation. Novartis racked up $560 million in Zelnorm U.S. sales in 2006 – not technically a “blockbuster” (a term reserved for drugs with at least $1 billion in annual sales), but not too shabby either. As Ed Silverman at Pharmalot pointed out back in March:
The review showed that only 0.1 percent of 11,600 Zelnorm patients, or 13 people, experienced serious heart problems; one died. Of 7,000 placebo patients, 0.01 percent of the patients, or just one person, reported cardiovascular problems. In medical terms, the absolute risk of a serious problem was small, but the relative risk was high.
More than 2.6 million prescriptions were written for Zelnorm in 2006. If the 0.1 percent rate of patients holds true, that would mean that 2,600 of those 2.6 million had heart problems. It’s likely that, due to the aggressive advertising, a significant portion of those 2.6 million did not in fact have IBS. These patients were thus unnecessarily exposed to this heart attack risk – a risk that may be small, but even a small unnecessary risk is still unnecessary. This week, the FDA permitted Zelnorm to return to the market under a very restricted program. The FDA’s press release described it:
The U.S. Food and Drug Administration announced that it is permitting the restricted use of Zelnorm (tegaserod maleate) under a treatment investigational new drug (IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 who meet specific guidelines.
In some instances, patients with a serious or life-threatening disease or condition who are not enrolled in a clinical trial may be treated with a drug not approved by the FDA. Generally, such use is allowed within guidelines called a treatment IND, when no comparable or satisfactory alternative drug or therapy is available.
In addition to the age and gender restrictions, the IND protocol for Zelnorm limits use of the drug to those with IBS-C or CIC whose physicians decide the drug is medically necessary. Patients must sign consent materials to ensure they are fully informed of the potential risks and benefits of Zelnorm.
For this population, the benefits of Zelnorm may outweigh the risks. But the aggressive ad campaign resulted in millions of people taking it for whom the benefits most certainly did not outweigh the risks.
And therein lies one of the main problems with Direct to Consumer Advertising of drugs: Drugs that may be important for a small subset of patients are instead marketed to all consumers, causing many people who don’t need the drug to ask their doctors for prescriptions for it, and for their doctors to prescribe them. By the time side effects that only surface after the drug has been on the market for several years have finally surfaced, millions of people who didn’t need the drug have taken it, and been exposed to that unnecessary risk (not to mention expense).
Vioxx is the most famous example of this. More than 20 million people took it, despite the fact that only 1-2% were actually at risk of the ulcers and gastric complications that Vioxx was designed to prevent. Vioxx was never any better at pain relief than pennies-a-pill over-the-counter ibuprofen. Its only advantage was a (somewhat) lower risk of gastrointestinal problems. But the majority of the 20 million people who took it did so not because they had ulcers, but because they saw the ads featuring Dorothy Hammill skating again after taking Vioxx.
One change that some have pushed to deal with this is to require a delay or moratorium on drug advertising for some period of time after a drug is approved. Provisions to require this were originally in the Congressional bills to reauthorize the Prescription Drug User Fee Act (PDUFA), but did not make it into the final House and Senate versions. PhRMA’s “Guiding Principles on Direct to Consumer Advertisements” call for companies to voluntarily wait an unspecified “appropriate amount of time to educate health professionals about a new medicine or a new therapeutic indication before commencing the first DTC advertising campaign.”
Delays and moratoria might reduce the number of people who are exposed to such side effects, but they don’t address the core problems of DTCA in encouraging people who don’t need expensive and potentially hazardous brand-name prescription drugs to take them. Every other country by the U.S. and New Zealand has concluded that advertising prescription drugs directly to the public just doesn’t make sense, and thus don’t allow them. There’s no doubt that in the more than 50 other countries where Zelnorm is or was sold but without advertising, the number of people who took it, and who had heart problems as a result, was much lower.
In the wake of the drug safety scandals of the past few years (Vioxx, Celebrex, Paxil, etc), there were widespread predictions that Direct-to-Consumer Advertising (DTCA) of prescription drugs (TV commercials, magazine ads, etc) would become less prevalent and less effective. Both predictions have proven false — spending on consumer drug ads hit an all-time high in 2006 of $4.8 billion. And the makers of the top three best-selling drugs in the U.S. in 2006 spent a combined total of $460.5 million on drug ads last year. See the chart below.
(Sources: IMS Health, “Top 10 Products by U.S. Sales”, and DTC Perspectives, June/July 2007)
Of course, not every prescription for these drugs is due to advertising. But, for each of these drugs, aggressive advertising to consumers has significantly contributed to their sales. The worst (or best, depending on your perspective) example of this is Nexium. Nexium, the so-called “healing purple pill” is nothing more than an isomer of Prilosec — in essence, Nexium is a molecular “mirror” of the Prilosec molecule. However, there’s essentially no difference between Nexium and Prilosec in terms of their effectiveness. AstraZeneca has aggressively marketed Nexium as though it were some miraculous improvement, despite an amazing lack of evidence that this is the case.
It calls to mind an excellent quotation by Dr. Marcia Angell, former editor of the New England Journal of Medicine and author of The Truth About the Drug Companies:
T]o rely on the drug companies for unbiased evaluations of their products makes about as much sense as relying on beer companies to teach us about alcoholism…The fact is that marketing is meant to sell drugs, and the less important the drug, the more marketing it takes to sell it. Important new drugs do not need much promotion. Me-too drugs do.”
And that’s enough right there to give you heartburn.
One of our goals here at the Prescription Access Litigation Blog is to highlight the good work being done by members of PAL’s coalition of 130+ organizations. Below is an July 22 editorial from the Santa Rosa Press Democrat, written by Shirlee Zane, CEO of the Council on Aging of Sonoma County (CA). The Council on Aging is a member of the PAL Coalition. To see the original article, click here.
Universal health care is a moral necessity
By SHIRLEE ZANE
Shirlee Zane is a Santa Rosa resident and the chief executive officer of the Council on Aging.;
During my recent visit to the Lake District in England, my father-in-law, George Kingston, hiked up a 1,000-foot hill and hiked five miles around a lake on a rugged, swampy trail. He is almost 88 years old, and I have been watching him age for the past few years. I have been able to do my own independent study of health and aging in the United Kingdom through my numerous trips to England.
Universal health care was adopted in England when the World War II veterans came home wounded and insisted on it. When Margaret Thatcher came into power, she virtually undid almost all of the government programs with the exception of the National Health System. She knew she would be quickly voted out of office if she touched it.
I have been a believer in universal health care for more than 10 years. I believe we have come to a point in our history as a nation when we simply can’t afford to not have it. Lives are at stake, and the underlying values of the medical profession are being eroded so that the self interests of industry profits can be satisfied.
Every day across the United States men, women and children experience health care crises. With 40 million people without even basic health care insurance, these crises often lead to homelessness, bankruptcy and loss of home ownership. The material losses simply cannot measure the emotional losses and stress that accompany them: depression, anxiety, despair and sometimes suicide.
Ten years ago, when Hilary Clinton tried to restructure health care, about 40 percent of Americans believed we needed a national health care program. Today that figure has risen to more than 70 percent of Americans. We simply are no longer buying the myth that socialized medicine is bad for us, because the facts bear otherwise.
A report in 2000 by the World Health Organization put the United States 37th out of 190 nations in health care services. The 36 countries that have lower infant mortality and greater longevity all have one thing in common: They have a form of universal health care. This ranking of the United States also explodes the myth that we have the best medical care in the world.
The only universal health care program we have, Medicare, is now being privatized; it is being financially tapped by private HMOs and the pharmaceutical industry through the Medicare Prescription Drug Plan. Medicare has less than 2 percent overhead, but our current system of private insurance has 25 percent to 30 percent overhead. It is no surprise that we pay more for health care than any other country in the world with that kind of obscene profit margin.
Another “myth” that has long been circulated is the myth of waiting for procedures. A recent study demonstrated that if you have a serious disease, such as cancer, you will wait longer for surgery in the United States than you will for surgery in Canada. The wait for elective surgeries in Canada is longer, but then again, those are not life-threatening.
My father-in-law, who has spent a lot of time in the United States, once commented that he and his late wife thought Americans lived in a great deal of fear over whether they’d lose their jobs, health care or housing. Universal health care does more than assure health care for all, it also addresses the stress levels of the millions of people who live in fear that a medical crisis will destroy them financially.
We’ve long talked about the importance of “prevention in health care.” One of my observations of the English is that the National Health System encourages prevention and better health habits, such as walking and maintaining a healthy weight. My father-in-law frequently walks around his village on the hilly narrow roads. He also played a weekly nine holes of golf, walking the course, until a year ago.
Both the French and the English drink and smoke a great deal more than Americans but have much better overall health and live longer. Could this be because they have national health care?
Health care in a civilized society should be a right. It should be about people and not about profit. Our system that is largely based on profit is immoral when you consider that financial gain is being valued over lives of human beings. We must insist that our elected officials stop trying to please the health care industries and their lust for higher profit margins. We must demand affordable, accessible care for all so we can age with kindness, respect and without the dark cloud of fear that a medical crisis will destroy us.
PAL member Breast Cancer Action issued the following statement yesterday. This raises some important issues — about the use of prescription drugs to prevent cancer, about the environmental vs. individual factors in disease, and about how to deal with serious illnesses like cancer — especially whether to emphasize prevention vs. treatment, and even within prevention, whether to address individual prevention measures vs. social/epidemiological prevention measures.
July 24, 2007 (San Francisco)-Breast Cancer Action (BCA) opposes today’s recommendation by a U.S. Food and Drug Administration (FDA) advisory panel to approve the use of raloxifene (tradename Evista) to reduce the risk of breast cancer in postmenopausal women who do not have breast cancer but are considered at high risk for developing the disease.
In December 2005, raloxifene’s manufacturer, Eli Lilly, paid a fine of $36 million for illegally promoting the drug to doctors as a breast cancer “preventative.” Now, the company is one step closer to getting FDA approval to market the drug to reduce the risk of breast cancer in women deemed at high risk, despite the fact that the drug increases the risk of serious-and potentially fatal-side effects.
BCA has long opposed a pills-based approach to breast cancer prevention, believing that any pill powerful enough to prevent breast cancer will most certainly cause another disease.
“The relatively few number of women who may avoid breast cancer by taking raloxifene is far outweighed by the risk of blood clots and strokes from the drug that they and thousands of other women will experience,” says BCA Executive Director Barbara A. Brenner.
“If Eli Lilly is permitted to market raloxifene, many women will consider taking it because most women overestimate their risk of breast cancer,”
Tamoxifen, the only other drug that the FDA has approved to reduce the risk of breast cancer, has not sold well for this purpose because most women are not willing to take a drug with such serious side effects. Raloxifene was tested against tamoxifen, and the data from that study showed very little difference in the side effects of the two drugs.
BCA strongly urges FDA Commissioner Andrew von Eschenbach to seriously consider the views of the FDA scientists and committee members who opposed approval, and oppose today’s recommendation.
Breast Cancer Action (www.bcaction.org) is a non-profit education and advocacy organization that does not accept funding from pharmaceutical companies or any other organizations that profit from or contribute to the breast cancer epidemic.
According to an increasing number of judges, the FDA should stick to regulating drugs for efficacy and safety and let the courts decide the scope of their own authority.
A series of recent federal and state court opinions have rejected arguments that the FDA’s authority to approve prescription drugs and their labels “preempts” state law court claims, and have refused to dismiss claims that drug companies failed to warn patients of dangers from certain prescription drugs. Recent rulings against the manufacturers Wyeth Pharmaceuticals, Eli Lilly & Co. and Merck & Co. Inc suggest that courts believe they are in the strongest position to protect the public from fraudulent pharmaceutical practices.
On July 3, 2007, Judge Eldon Fallon, U.S. Circuit Judge for the Eastern District of Louisiana, denied Merck & Co. Inc.’s motion for summary judgment, which argued that failure-to-warn claims were preempted by FDA labeling rules. The suits were filed by plaintiffs who suffered heart attacks after taking Merck’s now infamous pain reliever Vioxx. This ruling follows on the heels of a New Jersey Superior Court ruling in late June which denied a motion to dismiss a product liability claim, also based on preemption grounds, against Wyeth for its cancer-inducing hormone replacement therapy (HRT) drug Prempro.
Over the past few years, the FDA has been arguing that state failure-to-warn cases are preempted by the FDA’s authority. The FDA included a lengthy “preamble” to its revised guidelines on the labeling of prescription drugs, outlining its arguments on why such claims are preempted. The doctrine of federal preemption comes from the Supremacy Clause of the U.S. Constitution which states, “[t]his Constitution, and laws of the United States…shall be the supreme law of the land; and the judges in every state shall be bound thereby.” Thus, the FDA argues that once it has approved a drug label, a state court claim that consumers were injured by a drug company’s failure to include a warning about a known risk in the drug’s label conflicts with the FDA’s approval of the label. When federal law and state law conflict, the Supremacy Clause says that federal law prevails. Thus, the FDA argues that the courts cannot provide any redress to injured consumers in such failure-to-warn cases.
In denying Merck’s motion for summary judgment, Judge Fallon concluded that the Food Drug and Cosmetic Act (FDCA) lacks any express statement that Congress intended to displace state law claims in the prescription drug context. He went on to say that there is a well-established presumption against implying preemption since historically states’ “police powers” permit them to protect the health and welfare of their citizens.
Judge Fallon also does an admirable job disposing of the FDA preamble language. He finds that concluding that the claims are preempted, based upon the FDA’s preamble “inserted at the eleventh hour and drafted by an agency without the express or implied authority to abolish such remedies is Draconian and unacceptable.”
Bristol Myers Squibb (NYSE:BMY) is the latest defendant to reach a settlement with plaintiffs in the massive Average Wholesale Price litigation (In re Pharmaceutical Average Wholesale Price Litigation, before Judge Patti Saris of the U.S. District Court for the District of Massachusetts). A number of PAL coalition organizations are plaintiffs in this massive case, against dozens of pharmaceutical defendants. In a nutshell, the case alleges that the defendants fraudulently and artificially inflated the “Average Wholesale Prices” (AWPs) of hundreds of physician-administered drugs. These AWPs are listed in commercial pricing publications and were used by Medicare and insurers to determine how much to pay doctors for drugs administered in doctors’ offices.
A trial of Medicare patients’ claims against BMS was originally slated to begin this coming Monday, July 23. Last month, Judge Saris issued a 183-page decision in another phase of the case, in which she found that BMS and two other defendants (Astra Zeneca and Warrick, a subsidiary of Schering-Plough) caused the publication of false and inflated Average Wholesale Prices for seven drugs. The BMS drugs were Taxol, Vepesid, Cytoxan, Blenoxane and Rubex.
The decision last month found BMS and the other defendants liabile for damages caused to classes of Massachusetts insurance companies and non-Medicare consumers in Massachusetts. The trial that was slated to begin next week concerned damages caused to a nationwide class of Medicare patients. The settlement is not surprising in the wake of Judge Saris’ decision last month. The claims of the nationwide Medicare class are based on the same facts as those that Judge Saris found in her recent decision, and the causes of action (primarily state consumer protection acts) pretty closely mirror those in that decision as well (which were based on the Massachusetts Consumer Protection Act, Chapter 93A). Thus, if the trial had gone forward, it’s likely that the facts that were established in the previous decision would have already been found to be true (known in legal parlance as “collateral estoppel”) — the only issues thus would have been whether BMS violated those other state consumer protection acts and the federal RICO statute, and the extent of damages that caused.
No settlement has been filed with the Court yet, but on July 18 Bloomberg News reported on the fact that a settlement was reached:
Bristol Avoids Trial Over Taxol Price With Settlement (Update2)
By Cary O’Reilly
July 18 (Bloomberg) — Bristol-Myers Squibb Co. agreed to settle a class-action lawsuit over prices the company charged for its Taxol cancer drug and other medicines, just before a trial was set to begin in Boston.
The company, which admitted no wrongdoing, agreed to pay $13 million to settle all claims in the nationwide suit, Bristol spokeswoman Laura Hortas said. The case, which was set for trial July 23, was filed on behalf of consumers in dozens of states who made copayments for company drugs based on prices that had been artificially inflated, according to the complaint.
U.S. District Judge Patti Saris in Boston last month ordered Bristol, AstraZeneca Plc and Schering-Plough Corp. to pay damages for overcharging on drugs through so-called average wholesale pricing, or AWP. The trial that was to begin next week concerned only copayments for Bristol drugs. Taxol generated $1.6 billion in sales in 2000 before Bristol lost patent protection for it.
“We’re quite pleased with the settlement,” plaintiffs attorney Steve Berman of Hagens Berman Sobol Shapiro in Seattle said in an interview. “Any time you get over 100 cents on the dollar in recovery for consumers, that’s pretty darn good.”
The company also agreed to pay as much as $1 million for the cost of notifying affected consumers.
Consumers made insurance plan copayments under Medicare Part B based on average wholesale prices for Bristol drugs, including Taxol, that were far higher than what the company was charging doctors and hospitals, according to the complaint.
Out of Pocket
Chemotherapy and other medicines administered in physician offices were covered under Medicare Part B, with patients in many instances paying 20 percent of those costs out of pocket. That meant any increase in the average wholesale price for Taxol could result in higher fees for patients on chemotherapy.
Saris will hold a hearing Aug. 9 to consider the Bristol settlement, according to a docket entry on her court’s Web site.
“Bristol-Myers Squibb is pleased to have reached a settlement of the Class 1 claims in the average wholesale price litigation,” Hortas said.
In an earlier case, Saris found that Bristol-Myers inflated AWP for five medications, including Taxol. The AWP price for the cancer drug was found to be as much as 500 percent higher than what was charged to doctors.
AWP, which is self-reported by drugmakers, was once used by government health programs such as Medicare to set reimbursement rates. Medicare has moved away from the system, though some private insurance plans, including Blue Cross, still use it.
Medicare, the federal health plan for the elderly, switched in 2004 from AWP to a system of paying 106 percent of the average reported sale price of a drug.
Consumers who say they were harmed by AWP pricing for more than 300 drugs sued in 2001, alleging an industrywide scheme to defraud the U.S. health-care system. The suit was carved up by Saris based on different drug types to make the litigation more manageable.
GlaxoSmithKline Plc, Europe’s biggest drugmaker, agreed in August to pay about $70 million to settle claims by state attorneys general and consumers that the company used AWP to overcharge government health programs for its medicines.
Bristol shares fell 7 cents to $32.07 as of 12:45 p.m. in New York Stock Exchange composite trading, giving the company a market value of $63.3 billion.
The case is In Re: Pharmaceutical Industry Average Wholesale Price Litigation, MDL No. 1456, U.S. District Court, District of Massachusetts (Boston).
To contact the reporter on this story: Cary O’Reilly in Washington at firstname.lastname@example.org
The Public Patent Foundation (“PubPat”) is a member of the PAL Coalition. PUBPAT is a not-for-profit legal services organization that represents the public’s interests against the harms caused by the patent system, particularly the harms caused by undeserved patents and unsound patent policy.
Below is a release they issued on Wednesday, reporting that the US Patent & Trademark Office has granted each of PUBPAT’s requests to review four key HIV/AIDS drug patents held by Gilead Sciences, Inc. PUBPAT alleges that there was “prior art” that the Patent Office did not review when considering the patent applications. Prior art “constitutes all information that has been made available to the public in any form before a given date that might be relevant to a patent’s claims of originality. If an invention has been described in prior art, a patent on that invention is not valid.” (Wikipedia entry on prior art)
KEY HIV/AIDS DRUG PATENTS TO BE REVIEWED BY U.S. PATENT OFFICE: Prior Art Submitted by PUBPAT Raises Substantial Doubt Regarding Validity of Gilead Sciences Claims
New York, NY — July 18, 2007 — The Public Patent Foundation (“PUBPAT”) announced today that the U.S. Patent & Trademark Office has granted each of PUBPAT’s requests to review four key HIV/AIDS drug patents held by Gilead Sciences, Inc. (NASDAQ: GILD). The patents relate to the drug known generically as tenofovir disoproxil fumarate (TDF), a key weapon in the battle against HIV/AIDS. Gilead markets TDF in the United States under the brand name VIREAD and as a part of its ATRIPLA combination product.
Roughly 40 million people worldwide are infected with HIV/AIDS, including more than 1.2 million Americans. The U.S. Food and Drug Administration will not allow anyone other than Gilead distribute TDF in the United States because Gilead claims the four challenged patents give them the exclusive right to do so.
“Every person suffering from HIV/AIDS has a right to get the best medical treatment science can offer, without any unjustified impediments placed in their way,” said Dan Ravicher, PUBPAT’s Executive Director. “This includes Americans infected with HIV/AIDS, who are entitled to the best pharmaceuticals possible without undeserved patents making them exorbitantly expensive.”
In its March filings challenging the patents, PUBPAT submitted prior art that the Patent Office did not review before granting the patents to the Foster City, California, biopharmaceutical giant. PUBPAT also described in detail how the prior art invalidates the patents. The Patent Office has now found that PUBPAT’s filings indeed raised “substantial questions” regarding the validity of each of the four Gilead Sciences patents. Having granted PUBPAT’s requests to review each of the patents, the Patent Office will now turn to deciding whether they deserve to exist or not.
“We are very pleased that the Patent Office has agreed with us that there are indeed significant questions about the validity of the Gilead patents on TDF,” said Ravicher. “This is a very strong first step towards ending the harm being caused to the public by Gilead’s use of those patents to prevent anyone else from offering TDF to HIV/AIDS patients in the United States.”
The Gilead Sciences TDF patents challenged by PUBPAT now being reviewed by the Patent Office are U.S. Patents No. 5,922,695, 5,935,946, 5,977,089 and 6,043,230. Gilead has applied for similar patents on TDF in other countries throughout the world, including India, where they have received fierce opposition by non-profit AIDS patient groups.
More information about the reexaminations of the four Gilead Sciences TDF patents challenged by PUBPAT, including copies of the official Office Actions issued by the Patent Office granting PUBPAT’s four requests for reexamination, can be found at http://www.pubpat.org/gileadhivaidsdrug.htm
Consumers and third party payors in California who paid for Premarin, used to relieve the symptoms associated with menopause and to prevent osteoporosis in postmenopausal women, may be eligible to receive payments from a $5.2 million settlement fund. For more details, go to premarinclassaction.com
Claims must be filed by October 1, 2007. Objections to the settlement must be filed by August 15, 2007.
Trivia tidbit: Premarin is made from the urine of pregnant horses — Premarin = PREgnant MARes uRINe.
A Proposed Settlement has been reached in a class action, Elizabeth Blevins, et al. v. Wyeth-Ayerst Laboratories, Inc., et al., Case No. 324380, filed in the Superior Court of California, County of San Francisco.
The Superior Court of the State of California for the County of San Francisco entered an Order Granting Preliminary Approval of Settlement, Directing Notice to the Class, and Scheduling Fairness Hearing. The Court has scheduled a Fairness Hearing on final settlement approval on September 10, 2007.
Description of the Lawsuit
Premarin® is a conjugated estrogens product prescribed by doctors to relieve the symptoms associated with menopause and to prevent osteoporosis in postmenopausal women. Plaintiff alleges that the manufactures Wyeth Pharmaceuticals (formerly Wyeth-Ayerst Laboratories, Inc.) and Wyeth (formerly American Home Products Corporation) violated California’s antitrust and unfair competition laws by engaging in anti-competitive and exclusionary conduct that blocked consumer access to Cenestin®, which was an alternative to Premarin®. Plaintiff does not challenge the safety or effectiveness of Premarin®.
The lawsuit claims that the Defendants violated California antitrust, unfair competition, unfair trade practices, and unjust enrichment laws by entering into exclusive rebate contracts with managed care organizations such as HMOs, insurance companies, and pharmacy benefit managers (“Third-Party Payors”). Defendants deny that they committed any violation of law or any wrongdoing or that they have any liability with respect to Plaintiff or the Class. However, the parties have agreed to this Proposed Settlement to avoid the risks and expense of continuing the case.
The Class includes all persons or entities who purchased or reimbursed others for the purchase of Premarin® from March 24, 1999 through April 3, 2007 in California for consumption by themselves, family members or covered individuals, and not for resale.
The Defendants have agreed to pay $5.2 million to settle this case. After deductions of Court-approved costs and expenses, the remaining amount will be divided between consumers and Third-Party Payors in the Class, subject to available funds based on the actual claims received.
“Class Member” Description
The proposed “Class” includes:
All persons or entities who, during the period from March 24, 1999 to April 3, 2007, purchased, paid for, or reimbursed for Premarin® purchased in the State of California for consumption by themselves, family members or covered individuals (including members, beneficiaries, employees and insureds) and who suffered economic loss thereby as a result of allegedly anticompetitive conduct by Defendants.
Excluded from the Class are Defendants and their respective subsidiaries and affiliates, all governmental entities, and all persons or entities that purchased Premarin®: (i) for purposes of resale, or (ii) directly from any of the Defendants. The Class also excludes those Class Members who have properly opted out of the Class.