Attorney General Martha Coakley And 33 Other Attorneys General Announce $60 Milion Settlement With Pfizer

Main Category: Litigation / Medical Malpractice
Also Included In: Pharma Industry / Biotech Industry
Article Date: 23 Oct 2008 - 3:00 PDT

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Today, Attorney General Martha Coakley's office, along with 33 other Attorneys General, reached a $60 million settlement with Pfizer Inc., resolving a five-year investigation into allegations of improper marketing of the drugs Bextra® and Celebrex®. Under the judgment filed today in Suffolk Superior Court, Pfizer will be prohibited from deceptively promoting its products, and Massachusetts will receive $2,521,257 to assist and educate consumers and to pay for the cost of the Commonwealth's investigation and litigation.

"Consumers and health care providers alike are inundated with pharmaceutical marketing on a daily basis. It is essential that drug companies properly promote their products and not create an environment where the health of some may be put at risk and costs are driven up for all," said Attorney General Coakley. "While we are pleased with the monetary payment and plan to use these funds to improve the health and welfare of Massachusetts residents, it is the comprehensive injunctive relief that will ensure that Pfizer, the world's largest drug manufacturer, can no longer deceptively promote its products."

The multistate investigation was initiated in 2003 to determine whether Pfizer misrepresented that its "Cox-2" drug Celebrex® was safer and more effective than traditional non-steroidal anti-inflammatory drugs (NSAIDs) such as Ibuprofen (Advil®) and naproxen (Aleve®). As the investigation proceeded, additional concerns were raised regarding Pfizer's second generation Cox-2 drug: Bextra®. The investigation concluded that Pfizer engaged in an aggressive, deceptive and unlawful campaign to promote Bextra® "off-label" for uses that had been expressly rejected by the Food and Drug Administration (FDA). While a physician is allowed to prescribe drugs for off-label uses, the law prohibits pharmaceutical manufacturers from marketing their products for off-label uses.

In a civil complaint filed in Suffolk Superior Court, the Attorney General's Office alleges that Pfizer conducted a systematic, multi-pronged campaign to promote Bextra® for the "off-label" indications that the FDA denied. Specifically, the Attorney General's Office alleges that Pfizer (1) disseminated positive studies without disclosing negative studies or disclosing that the FDA had expressly rejected Bextra® for the uses being promoted, (2) distributed Bextra® samples to doctors for off-label use, (3) encouraged sales staff to promote Bextra® for off-label uses, and (4) influenced doctors improperly through paid consulting agreements and continuing medical education events.

In addition, the complaint alleges that Pfizer misrepresented that Bextra® was a safe alternative to other pain relief drugs, marketed Bextra® as reducing serious gastrointestinal side effects without possessing competent and reliable evidence to support this claim, and failed to disclose that Bextra® increased the risk of serious adverse events including death. Ultimately, Bextra® was withdrawn from the market in 2005 and Celebrex® was required to carry the FDA's most stringent "black box" label warning consumers of increased cardiovascular risks.

Today's consent judgment contains comprehensive injunctive terms addressing all concerns raised during the investigation into Bextra® and Celebrex®. Under the judgment, Pfizer is prohibited from:

- Deceptively or misleadingly advertising and promoting any drug
- Distributing samples with the intent to encourage off-label prescribing
- Disseminating information about any FDA-denied use unless Pfizer also discloses the denial and reason for denial
- Inappropriately distributing scientific data in a promotional manner
- "Ghost writing" articles and studies
- Incentivizing sales staff to promote drugs off-label
- Paying physicians to spend time with Pfizer sales staff
- Using grants to encourage use of Pfizer's drugs
- Using patient testimonials to misrepresent a drug's efficacy

The consent judgment also requires Pfizer to disclose conflicts of interest for Pfizer promotional speakers, submit all "direct-to-consumer" (DTC) television drug advertisements to the FDA for approval and comply with all FDA comments, delay DTC advertising for up to 18 months for any new pain relief drug should the FDA recommend such a delay, register all clinical trials and results, and ensure that subjects in Pfizer sponsored clinical trials give adequate informed consent.

Of the $2,521,357 that Massachusetts will receive under the consent judgment:

- $200,000 will go into the Commonwealth Local Consumer Aid Fund;
- $2,000,000 will be distributed to a political subdivision, a state agency or program, a non-profit corporation, and/or a charitable organization, at the sole discretion of the Attorney General, to fund programs that will benefit low income or disabled consumers of prescription medications, to promote initiatives that will lower health care costs for Massachusetts residents, or to fund other programs reasonably targeted to benefit a substantial number of persons affected by the Covered Conduct that is the subject of this Consent Judgment; and
- $321,357 will cover costs and attorneys fees

The Massachusetts action was handled by Assistant Attorney General Emiley Zalesky Lockhart with assistance from Assistant Attorney General Emily Paradise, Mediator Rebecca Peyton, and Division Chief Quentin Palfrey, all of Attorney General Coakley's Health Care Division. Joining Massachusetts in today's settlement are: Alaska, Arizona, Arkansas, California, Connecticut, Florida, District of Columbia, Idaho, Illinois, Iowa, Kansas, Kentucky, Maine, Maryland, Michigan, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Washington, and Wisconsin.

Source
Jill Butterworth
Deputy Press Secretary
Office of Attorney General Martha Coakley
http://www.mass.gov/ago