Depo Provera

Depo Provera

Depo-Provera class action

FOR IMMEDIATE RELEASE:

Contact: Glyn Hotz, Hotz Lawyers

Telephone Number: 416-590-7823

Email Address: hotz@sympatico.ca

Web site address: http://www.glynhotz.com/

Depo Provera Class Action filed in ONTARIO SUPERIOR COURT OF JUSTICE

against Pfizer Canada, Inc and Pfizer Inc.

Proceeding filed under the Class Proceedings Act, 1992

Representative plaintiffs:

JACQUELINE (ONTARIO), KIMBERLEY (B.C.), SHERIDAN (B.C.), and TAMARA (NEWFOUNDLAND)

Defendants:

PFIZER CANADA INC. and PFIZER INC.

North York, ON, CANADA, 12/15/2005 -

RELIEF SOUGHT: Relief of general damages in the sum of $500,000,000, special damages on account of, among other things, all medical and other expenses for testing, treatment and medical monitoring in such amount as is proved at trial, and punitive, aggravated and exemplary damages in the sum of $200,000,000., or such other amount as the Honourable court deems just is sought on behalf of the representative plaintiffs, on their own behalf and on behalf of all members of the Class, the Subclass, and the Family Class.

INJURIES SUFFERED: The plaintiffs are long-term users of Depo-Provera, an injectable birth control sold by defendant Pfizer. Plaintiffs have been diagnosed as having various bone mass density (BMD) problems, which among them include: bone density loss, fractures, hip and spine problems, avascular necrosis, osteoporosis and other low bone density injuries which they each attribute to the use of Defendant's product.

DUTIES OF THE DEFENDANTS:

The claim alleges, among other duties, that the defendants owed to the plaintiffs and Class Members a duty of care:

(a) to ensure that Depo-Provera was appropriately tested to determine whether there were any potentially adverse effects due to the use of Depo-Provera;

(b) to ensure that Depo-Provera was fit for its intended or reasonably foreseeable use;

(d) to conduct adequate tests and clinical trials to determine the degree of risk associated with the use of Depo-Provera;

(e) to ensure that prescribing physicians were kept fully and completely informed of all risks associated with Depo-Provera;

(f) to conduct ongoing tests and clinical trials with long-term follow-up to determine the long-term effects and risks of continued use of Depo-Provera;

(g) to monitor, investigate, evaluate and follow up on adverse reactions to the use of Depo-Provera;

(h) to properly inform Health Canada and other regulatory agencies of the risks of BMD loss or related conditions, including osteopenia and osteoporosis, associated with the use of Depo-Provera.

FAILURES OF THE DEFENDANTS:

The Plaintiffs and Class Members pleadings include, but are not limited to allegations that:

(1) the defendants knew or ought to have known of a number of studies, as will be proven by plaintiffs, which showed marked BMD and which did not show that it was reversible.

(2) the defendants failed to warn or adequately warn the physicians to conduct tests to obtain bone density measurements for women other than those who have “multiple risk factors,” especially as the drug was touted as safe for long-term use.

(3) the defendants owed a duty but failed to update in the CPS that in the New Zealand study, 24 months after cessation of Depo-Provera use, bone density remained 9.0% lower than that in a group of 18 age-matched controls who had never taken the medication. The defendants owed to the plaintiffs and Class Members a duty to reveal this fact which was never revealed by the defendants. It was not revealed either pre-approval or post-approval. It has still not been revealed to Health Canada.

(4) the defendants failed to warn or adequately warn the physicians to conduct tests to obtain bone density measurements for women other than those who have “multiple risk factors,” especially as the drug was touted as safe for long-term use.

BACKGROUND OF WHAT WAS KNOWN BY DEFENDANTS: Defendants tried to introduce their product in the Canadian market, but were rejected in 1988. Finally, Depo Provera was introduced to the Canadian market in 1997 after repeated attempts by the Defendants. Thereafter, Depo-Provera was heavily marketed. For example in 2004, 625,000 prescriptions for Depo-Provera were filled, worth $25 million, according to IMS Health. Despite the drug's new black box warning, issued in the U.S. on November 17, 2004, and the warning in Canada on June 30, 2005, Pfizer continues to make statements about the safety of the drug, including to Macleans in an article on November 24, 2005: “Pfizer Canada Inc., the drug's manufacturer, declined to be interviewed for this article, but issued a statement saying Depo-Provera, which contains the synthetic hormone medroxy-progesterone acetate, `has been used safely by millions of women around the world for decades.'”

Studies immediately after approval in Canada also showed irreversible bone mineral density loss, as did pre-approval studies.

On October 29, 1992, the FDA provided in a Press Release (P92-31) indicating that "Recent data have also demonstrated that long-term use may contribute to osteoporosis. Since then a number of studies continue to show these bone loss dangers. A number studies have been conducted to determine the extent of bone mass problems caused by Depo Provera. Dr. Diane F. Merritt conducted research for Upjohn, as "principal investigator,” and others like Merritt have been provided “research support” by Pfizer. The research by Dr. Merritt took place over a 7 year period between 1995-2002. Recently Pfizer pointed to a study in its latest package insert that covers the exact same time period of seven years. It is known that at least 3 research sites had been utilized to study the BMD effect in women, of which Dr. Merritt's research was one such site.

ACTIONS BEING INVESTIGATED IN THE UNITED STATES: Counsel in the United States have also been consulted by Hotz Lawyers in the preparation of these claims. Monheit Law, P.C. is actively investigating claims and has evaluated over 1000 potential plaintiffs for individual damage claims against Pfizer related to Depo Provera BMD problems and has worked with Hotz Lawyers in the evaluation of the various medical studies which form the basis of these allegations. In addition, a medical monitoring class action is being considered for the USA.

Glyn Hotz, Hotz Lawyers can be reached by email: hotz@sympatico.ca, on the web at http://www.glynhotz.com or by phone: 416-590-7823.

Michael Monheit, Esq., at Monheit Law, P.C. can be reached by email: michael@monheit.com. on the web at http://www.monheit.com/depo-provera or by phone at 215-840-6573.

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Boxed WARNINGS (as of June 30, 2005)

The use of DEPO-PROVERA has been associated with loss of bone mineral density (BMD) which may not be completely reversible. Loss of bone mineral density is greater with increasing duration of use.

It is unknown if use of DEPO-PROVERA during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life.

DEPO-PROVERA should be used as a birth control method or endometriosis treatment only if other treatments have been considered to be unsuitable or unacceptable, and should be used for the shortest period of time possible. The risks and benefits of treatment should be carefully re-evaluated on a regular basis in all users of the drug.

INDICATIONS and CLINICAL USE

Although there are no studies addressing whether calcium and vitamin D may lessen BMD loss in women using DEPO-PROVERA, all patients should have adequate calcium and vitamin D intake. Cessation of smoking and regular weight bearing exercise should be discussed with all patients.

CONTRAINDICATIONS

DEPO-PROVERA should not be used before menarche.

WARNINGS

Loss of Bone Mineral Density

Contraception/Endometriosis

Use of DEPO-PROVERA should be considered a risk factor for osteoporosis. The use of DEPO-PROVERA should be considered in light of a patient's possible other risk factors for osteoporosis (including metabolic bone disease, chronic alcohol and/or tobacco use, anorexia nervosa, strong family history of osteoporosis or chronic use of drugs that can reduce bone mass such as anticonvulsants or corticosteroids).

BMD should be monitored in women using DEPO-PROVERA for longer than 2 years, or earlier as clinically appropriate. In adolescent females, interpretation of BMD results should take into account patient age and skeletal maturity. If a clinically significant decrease in BMD is detected, treatment with DEPO-PROVERA should be reconsidered.

Oncology

There are no studies on the effects of the high doses of parenteral medroxyprogesterone acetate (e.g. for oncology use). If a patient is using DEPO-PROVERA as part of adjunctive or palliative treatment of endometrial, renal cell or breast carcinoma, evaluation of BMD is recommended as deemed clinically appropriate.

Post-marketing experience

In post-marketing experience, there have been cases of osteoporosis including osteoporotic fractures reported in patients taking DEPO-PROVERA. Patient age ranged from 16 years to 48 years.

As a result of new clinical studies, one with adults and one with adolescents, clinical data regarding the use of Depo-Provera and its associated effect on bone mineral density suggest that women who use Depo-Provera contraceptive injection may lose significant Bone Mineral Density. Bone loss is greater with increasing duration and may not be completely reversible. Use of of Depo-Provera during adolescence or early adulthood, a critical period of bone accretion, may reduce peak bone mass and increase the risk of osteoporotic fracture in later life.

Please feel free to contact us if you have suffered this or other side effects.

The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties.

June 30, 2005

Subject

Important Safety Update: Potential effect of DEPO-PROVERA (medroxyprogesterone acetate injectable suspension, USP) on Bone Mineral Density (BMD) changes in adults and adolescents

Dear Health Care Professional,

Pfizer Canada Inc. in consultation with Health Canada, would like to inform you of important updated safety information and upcoming changes to the Product Monograph for DEPO-PROVERA (medroxyprogesterone acetate injectable suspension, USP), indicated for conception control (prevention of pregnancy), treatment of endometriosis, adjunctive and/or palliative treatment of recurrent and/or metastatic endometrial or renal cell carcinoma (hypernephroid carcinomas) and adjunctive or palliative treatment of hormonally-dependent, recurrent, inoperable or metastatic carcinoma of the breast in post-menopausal women.

As a result of new clinical studies, one with premenopausal adult women (age 25-35 years) and one with adolescent women (age 12-18 years) using DEPO-PROVERA 150 mg IM for contraception, we now have data regarding the use of DEPO-PROVERA and its associated effect on bone mineral density (BMD). The data indicate that women who use DEPO-PROVERA may lose significant BMD. The data also indicate that bone loss is greater with increasing duration of use and may not be completely reversible. The DEPO-PROVERA Product Monograph has been revised to include the following new information in addition to a summary of the available data:

Boxed WARNINGS