Nevada Attorney General Catherine Cortez Masto filed suit against Wyeth and Pfizer, claiming the companies misled physicians and consumers about the dangers of four pharmaceutical products.
According to the suit, the companies downplayed the risks and exaggerated the benefits of Wyeth’s Premarin, Prempro, and Premphase, and Pfizer’s Provera. As a result, physicians over-prescribed the medications. Cortez Masto also alleges the companies provided false and misleading information in direct-to-consumer advertising, continuing medical education programs, press releases, and ghost-written journal articles.
Documents produced as part of a class action lawsuit against Johnson & Johnson (J&J) claim the company funded a research center at Massachusetts General Hospital in Boston in part to further the company’s commercial goals, according to a New York Times article.
Joseph Biederman, MD, a world-renowned child psychiatrist at Harvard University, is under federal investigation for failing to report $1.6 million he was paid by pharmaceutical manufacturers between 2000 and 2007. According to the Times, Biederman’s research helped lead to a huge increase in the diagnosis of pediatric bipolar disease between 1994 and 2003 and a corresponding increase in the use of antipsychotic medication, such as J&J’s Risperdal, in children.
E-mails suggest J&J helped plan and fund the child psychiatry research center, the Johnson & Johnson Center for the Study of Pediatric Psychopathology, which Biederman ran. Biederman allegedly promised his work would promote the use of antipsychotics in children.
The e-mails also suggest company officials helped to write research done by Biederman and his colleagues, and raise questions about whether J&J promoted Risperdal for unapproved uses through the institute.
J&J, Eli Lilly, and AstraZeneca face a multi-state lawsuit claiming the companies marketed their antipsychotic treatments for off-label uses.
Abbott Laboratories agreed to pay $184 million to settle claims it created a monopoly with its cholesterol-lowering medication TriCor, according to a company filing with the Securities and Exchange Commission.
The settlement resolves claims filed by generic pharmaceutical manufacturers Teva Pharmaceutical and Impax Laboratories Inc., direct-drug purchasers, including CVS Caremark Corp. and Walgreen Co., and distributors, including Rochester Drug Cooperative Inc. and Meijer Distribution Inc.
Abbott Laboratories and Solvay’s Fournier unit allegedly made minor changes to TriCor’s formula, then patented the new formulations to extend patent protection and increase consumers’ costs.
The company also announced it reached agreements to resolve some of the other previously disclosed litigation involving TriCor’s active ingredient.
The First Circuit Court of Appeals in Boston upheld a New Hampshire law prohibiting the sale of physician prescribing information.
New Hampshire passed the Prescription Information Law in 2006, becoming the first state to specifically prohibit selling prescriber information for commercial purposes. Pharmaceutical companies use the information to identify physician preferences and tailor messages from sales representatives.
IMS Health and Verispan, two companies that collect and sell the data, sued, claiming the law violated the First Amendment right to free speech. A lower court agreed and blocked the law.
In the ruling, Judge Bruce Selya said the parts of the law at issue center on conduct and not on free speech. He added the information was not being used to stimulate better informed consumer choices because physicians already know their own prescribing habits.
In a statement, IMS, a data mining company, said it was disappointed in the ruling and is reviewing the decision to determine its next steps.
Other states have also tried to ban data mining. Maine’s data mining ban was struck down in district court earlier this year. A Vermont law banning data mining is scheduled to go into effect next year, but is also facing legal challenges. Washington, DC’s city counsel removed a data mining ban from its SafeRX Act earlier this year.
McKesson agreed to pay $350 million to settle all private party claims relating to First DataBank’s published average wholesale prices (AWP), according to a company release.
The company also established a reserve fund of $143 million to settle future AWP claims by public entities. The settlement, which is still subject to a court review, includes an express denial of liability.
In 2005, a class of consumers and health and welfare funds filed suit against McKesson, claiming it conspired with First DataBank to inflate reimbursement by expanding the spread between AWP and the wholesale acquisition cost by an additional 5%.
AWP is widely used as a pricing standard. In the suit, the plaintiffs claimed the inflated AWP caused consumers and third party payers to overpay for medications.
Protherics Inc.’s Web page and fact sheet for its investigational new drug Voraxaze misbrand the product, according to an FDA warning letter.
The FDA said the claims are problematic from a public health standpoint because the FDA has not approved the product and because the promotional claims are not demonstrated by substantial evidence or substantial clinical experience. Both the Web site and the fact sheet make misleading claims about the safety and efficacy of the product and promote its use. Pharmaceutical companies are not permitted to promote a product prior to FDA approval.
Shionogi USA Inc.’s Professional NDC Sheet and a Cardinal Health NDC Sheet (direct mailers) for Cedax omit and minimize risks associated with the product, according to an FDA warning letter.
The direct mailers are misleading because they present numerous efficacy claims for Cedax but fail to reveal material risk information associated with use of the drug, and suggest Cedax is effective in a broader range of conditions than has been demonstrated by substantial evidence or substantial clinical experience.
The Department of Justice is looking into the off-label use of Medtronic’s Infuse Bone Graft, an implant for promoting bone growth, according to a Wall Street Journal article.
Infuse is FDA-approved for limited use in the lower lumbar region, but the FDA has received 38 reports of complications from cervical uses of Infuse in the past four years. Medtronic said it has not improperly marketed the device, according to the Journal.
Medtronic reached a settlement with one patient who filed a malpractice suit over off-label use of Infuse. The suit focused on off-label use and the relationship between a Medtronic salesman and the spinal surgeon. According to the Journal, the surgeon said in his deposition that the sales representative encouraged the off-label use of Infuse.
Three whistleblower lawsuits filed against the company include allegations of illegal marketing, including paying surgeons to use Infuse and other Medtronic spine products.
The FDA outlines labeling recommendations for natural rubber latex condoms without spermicidal lubricant, a Class II device, in a special control guidance.
The special controls guidance document:
- Provides the classification and product code for latex condoms
- Includes examples of recommended labeling
- Outlines the areas that require special control and recommends mitigation measures
Wisconsin’s False Claims Act meets the requirements set forth in the Deficit Reduction Act of 2005 (DRA) and qualifies the state for an increased False Claims Act recoveries, according to an OIG review.
In a separate review, the OIG determined New Jersey’s False Claims Act does not meet the requirements set forth in the DRA, so the state currently does not qualify for the additional recoveries.
Under the DRA, each state with a False Claims Act that is at least as effective in facilitating and rewarding qui tam actions as the federal False Claims Act in protecting state Medicaid funds is entitled to an extra 10% of fraud recoveries from those actions. For the state to receive the additional money, the OIG must approve the state’s False Claims Act.