Ohio Attorney General Announced Settlement for Unlawful Promotion of Rapamune

The Ohio Attorney General, Mike DeWine, recently announced that Ohio is included in the $35 million settlement to resolve allegations of unlawful promotion of Rapamune.  Rapamune is approved for use in kidney transplant patients in order to prevent the body from rejecting the transplant.  This drug is made by Wyeth Pharmaceuticals, Pfizer being the parent company.

According to the Dayton Business Journal, Ohio in particular, will receive $984, 812 as part of the settlement.

“Promoting pharmaceutical drugs for unapproved purposes is not only potentially dangerous, it’s also a violation of consumer protection laws,” DeWine said. “Investigators found that Wyeth promoted Rapamune for use by lung and other organ transplant patients, which is not approved by the FDA.”

The following is the proposed settlement still pending court approval that requires Pfizer to ensure that marketing and promotional practices do not unlawfully promote any Pfizer product.

  • Make, or cause to be made, any written or oral claim that is false, misleading, or deceptive regarding any Pfizer product;
  • Make any claim comparing the safety or effectiveness of a Pfizer product to another product when that claim is not supported by substantial evidence as defined by federal law and regulations;
  • Promote any Pfizer product for off-label uses;
  • Include mechanisms in its financial incentives to provide incentive compensation for sales that may be attributable to the off-label uses of any Pfizer product;
  • Affirmatively seek the inclusion of Rapamune in hospital protocols or standing orders unless Rapamune has been approved by the FDA for the indication for which it is to be included in the protocol or standing order;
  • Disseminate information describing any off-label or unapproved use of Rapamune unless such information and materials comply with applicable FDA regulations and the recommended actions in FDA Guidances for Industry; or
  • Seek to influence the prescribing of Rapamune in hospitals or transplant centers in any manner (including through funding clinical trials) that does not comply with the federal anti-kickback statute.

According to the Dayton article, the other states involved in the settlement are as follows:  Alabama, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin.

In 2013, Ohio received more than $2.5 million in the $491 million settlement to resolve the civil and criminal allegations regarding the same issues mentioned here.

The law firm of Zoll & Kranz, LLC (“ZK”) devotes its practice to the field of pharmaceutical and medical device litigation. ZK is dedicated to compelling companies to produce safer products. Injured clients and partnering attorneys from across the U.S. appreciate and rely upon over 50 years of combined experience in pharmaceutical mass torts and multidistrict litigation. For additional information about Rapamune or other potentially dangerous drugs, contact ZK toll-free at (888)841-9623 or visit the firm’s website at . Initial consultations are always free and confidential.