Drug & Device News

Settlements Reached over Bextra and Celebrex

Pfizer Inc. has announced a settlement between it and about 90% of the claimants nationwide who alleged they were injured by of overcharged for the prescription pain medications Bextra and Celbrex. The $894 million settlement amount breaks down to $745 million to settle personal injury claims, $89 million to settle class actions and $60 million to settle suits brought by 33 states and the District of Columbia.

As part of the settlement, the company also consented to refrain from several marketing practices, including giving incentives to salespeople for promoting off-label use, paying doctors for listening to sales rep pitches and ghost writing articles for named authors not within Pfizer Inc. Massachusetts Attorney General Martha Coakley said of the marketing restrictions, “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.”

In a release issued by the company after the settlement was reached, Joseph M. Feczko, Pfizer's chief medical officer, defended the safety record and efficacy of Celebrex, which is approved for use in 111 countries. Feczko indicated that the bad publicity generated by the lawsuits had unfairly impugned the drug, leading doctors and patients to avoid it. “We believe that putting these matters substantially behind us should better enable physicians to consider Celebrex purely on the strength of its clinical data, and its ability to meet the diverse needs of patients in pain,” said Feczko.

California Grapples with Definition of 'Primary Caregiver'

California's Supreme Court heard arguments in October concerning the definition of “primary caregiver” in the state's medical-marijuana-dispensing law, the Compassionate Use Act of 1996. In accordance with the Act, a primary caregiver, who is exempt from criminal liability for dispensing marijuana, is one who “consistently has assumed responsibility for the housing, health or safety” of patients.

The question of what constitutes a “primary caregiver” came up in the case against Roger Mentch, a Santa Cruz County man who operated “the Hemporium,” which he alleged was a consulting business that provided marijuana to five people who used it to treat depression, colitis and/or insomnia. Mentch was found guilty in 2005 of illegally cultivating and possessing marijuana after the trial court refused to instruct the jurors concerning the affirmative defense that Mentch wanted to offer: that he was a primary caregiver within the law and entitled to dispense marijuana for medicinal purposes.

The attorney for the state argued that the term “primary caregiver” did not encompass one who only sells marijuana to patients. Mentch's attorney countered that his client also counseled patients in how to use the substance and drove them to their medical appointments. A decision is expected by January.

Body-Parts Suit Hits Setback

U.S. District Judge William Martini Jr. in October granted a defense motion to exclude testimony concerning the disease-carrying capacity of human tissue stolen from cadavers in New York, Pennsylvania and New Jersey. The tissues, which were not tested for the presense of disease before distribution, were sold by Biomedical Tissue Services of Fort Lee, NJ, to various tissue banks around the country. The multi-district case, In re Human Tissue Products Liability Litigation, 06-Civ.-135, MDL No. 1763, encompasses hundreds of nationwide actions filed on behalf of people who were implanted with the stolen body parts. The plaintiffs claimed they were potentially exposed to several diseases when they were implanted with the untested body parts, but the court found that plaintiffs' proffered evidence that they could have contracted HIV, syphilis and cancer did not meet the Daubert standard for admissibility.

Marketing of Bayer Aspirin Products Garners Sharp FDA Rebuke

The FDA in October issued a warning letter to Bayer HealthCare for its illegal marketing of two unapproved medications ' Bayer Aspirin With Heart Advantage and Bayer Women's Low Dose Aspirin + Calcium. It is unusual for such a large and sophisticated drug manufacturer to market an unapproved pharmaceutical product, but there may have been some confusion as to when FDA approval for aspirin products is needed. In its warning letter, the FDA told Bayer: “The products are labeled as being a combination of a drug and a dietary supplement, but when a drug and a dietary supplement are combined in a single tablet, the product is regulated by FDA as a drug.” In addition, because the manufacturer stated these products could “fight” oteoporosis or cholesterol buildup, rather than simply preventing these conditions, their statements amounted to a claim that the medications could fight disease. As the warning letter stated, “Products bearing such claims require an approved new drug application from FDA in order to be legally marketed, and cannot be legally marketed for OTC [over-the-counter] use.” Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said in an FDA release: “The marketing of these unapproved drugs is troubling ' [b]ecause OTC drugs are widely used by consumers, without supervision by a doctor or other health care professional, the overuse or misuse of these aspirin-containing products can put consumers at risk for internal bleeding and other adverse events. It is essential that companies obtain FDA approval and fully comply with FDA regulations.”

Settlements Reached over Bextra and Celebrex

Pfizer Inc. has announced a settlement between it and about 90% of the claimants nationwide who alleged they were injured by of overcharged for the prescription pain medications Bextra and Celbrex. The $894 million settlement amount breaks down to $745 million to settle personal injury claims, $89 million to settle class actions and $60 million to settle suits brought by 33 states and the District of Columbia.

As part of the settlement, the company also consented to refrain from several marketing practices, including giving incentives to salespeople for promoting off-label use, paying doctors for listening to sales rep pitches and ghost writing articles for named authors not within Pfizer Inc. Massachusetts Attorney General Martha Coakley said of the marketing restrictions, “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.”

In a release issued by the company after the settlement was reached, Joseph M. Feczko, Pfizer's chief medical officer, defended the safety record and efficacy of Celebrex, which is approved for use in 111 countries. Feczko indicated that the bad publicity generated by the lawsuits had unfairly impugned the drug, leading doctors and patients to avoid it. “We believe that putting these matters substantially behind us should better enable physicians to consider Celebrex purely on the strength of its clinical data, and its ability to meet the diverse needs of patients in pain,” said Feczko.

California Grapples with Definition of 'Primary Caregiver'

California's Supreme Court heard arguments in October concerning the definition of “primary caregiver” in the state's medical-marijuana-dispensing law, the Compassionate Use Act of 1996. In accordance with the Act, a primary caregiver, who is exempt from criminal liability for dispensing marijuana, is one who “consistently has assumed responsibility for the housing, health or safety” of patients.

The question of what constitutes a “primary caregiver” came up in the case against Roger Mentch, a Santa Cruz County man who operated “the Hemporium,” which he alleged was a consulting business that provided marijuana to five people who used it to treat depression, colitis and/or insomnia. Mentch was found guilty in 2005 of illegally cultivating and possessing marijuana after the trial court refused to instruct the jurors concerning the affirmative defense that Mentch wanted to offer: that he was a primary caregiver within the law and entitled to dispense marijuana for medicinal purposes.

The attorney for the state argued that the term “primary caregiver” did not encompass one who only sells marijuana to patients. Mentch's attorney countered that his client also counseled patients in how to use the substance and drove them to their medical appointments. A decision is expected by January.

Body-Parts Suit Hits Setback

U.S. District Judge William Martini Jr. in October granted a defense motion to exclude testimony concerning the disease-carrying capacity of human tissue stolen from cadavers in New York, Pennsylvania and New Jersey. The tissues, which were not tested for the presense of disease before distribution, were sold by Biomedical Tissue Services of Fort Lee, NJ, to various tissue banks around the country. The multi-district case, In re Human Tissue Products Liability Litigation, 06-Civ.-135, MDL No. 1763, encompasses hundreds of nationwide actions filed on behalf of people who were implanted with the stolen body parts. The plaintiffs claimed they were potentially exposed to several diseases when they were implanted with the untested body parts, but the court found that plaintiffs' proffered evidence that they could have contracted HIV, syphilis and cancer did not meet the Daubert standard for admissibility.

Marketing of Bayer Aspirin Products Garners Sharp FDA Rebuke

The FDA in October issued a warning letter to Bayer HealthCare for its illegal marketing of two unapproved medications ' Bayer Aspirin With Heart Advantage and Bayer Women's Low Dose Aspirin + Calcium. It is unusual for such a large and sophisticated drug manufacturer to market an unapproved pharmaceutical product, but there may have been some confusion as to when FDA approval for aspirin products is needed. In its warning letter, the FDA told Bayer: “The products are labeled as being a combination of a drug and a dietary supplement, but when a drug and a dietary supplement are combined in a single tablet, the product is regulated by FDA as a drug.” In addition, because the manufacturer stated these products could “fight” oteoporosis or cholesterol buildup, rather than simply preventing these conditions, their statements amounted to a claim that the medications could fight disease. As the warning letter stated, “Products bearing such claims require an approved new drug application from FDA in order to be legally marketed, and cannot be legally marketed for OTC [over-the-counter] use.” Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said in an FDA release: “The marketing of these unapproved drugs is troubling ' [b]ecause OTC drugs are widely used by consumers, without supervision by a doctor or other health care professional, the overuse or misuse of these aspirin-containing products can put consumers at risk for internal bleeding and other adverse events. It is essential that companies obtain FDA approval and fully comply with FDA regulations.”