Dangerous drug lawyers at Pintas & Mullins Law Firm report that Wyeth Pharmaceuticals, which was recently acquired by Pfizer, recently agreed to pay the U.S. Department of Justice $490.9 million to resolve liability from the illegal marketing of Rapamune for unapproved uses.
Rapamune is a kidney transplant drug approved by the FDA in 1999 only for the use in kidney patients, however, Wyeth was marketing the drug for use in patients undergoing other organ transplants as well. In a statement by the U.S. Department of Justice, the agency affirmed that this was an example of systemic corporate efforts to seek profits over patient safety.
The terms of the agreement requires Wyeth to admit guilt and plead guilty to one count of drug misbranding, as well as pay the $490 million fine. The drug maker is pleading guilty to claims that it trained its sales staff to market Rapamune to physicians who performed heart, liver, pancreas and lung transplants, instead of only kidney.
Officials at Pfizer assert that the illegal marketing of Rapamune occurred before it acquired Wyeth in 2009. Federal investigation into this issue began around that time, which Pfizer was aware of and complied fully with, according to Bloomberg Businessweek. The investigations were sparked by lawsuits filed by two Wyeth sales personnel over the illegal marketing.
The whistleblowers, Marlene Sanders and Scott Paris, were employed as sales reps for Wyeth and handled Rapamune. The two alerted federal agencies about Wyeth’s knowingly unlawful efforts in training reps to sell Rapamune for organ transplants beyond the kidney. They claimed Wyeth used bonuses as incentives for reps to sell the drug.
A third employee, a Wyeth sales manager, also filed a lawsuit over the marketing campaign. The manager, Scott Campbell, testified that Wyeth officials encouraged managers to train sales reps to openly discuss not-approved, off-label uses of Rapamune with physicians, as well as pay speakers to hype the drug’s benefits at doctor meetings.
Internal files from Wyeth affirm that, in 2006, about 90% of Rapamune’s sales (totaling $200 million) were generated by unapproved uses. All three whistleblowers are entitled to recover a percentage of the settlement; however, the exact shares have not yet been decided.
Unfortunately, marketing campaigns that misbrand products and illegally mislead doctors and patients are not that uncommon. One notable example was the Mirena IUD “Simple Style Statement Program,” which the FDA promptly shut down in 2009. In a letter to Bayer Pharmaceuticals, the FDA asserted that not only was the company misrepresenting the effectiveness of Mirena, but it was failing to detail the potential, often devastating side effects of the contarceptive.
Like Wyeth, Bayer misbranded Mirena using unsubstantiated claims, which is a direct violation of federal standards. Fraudulent marketing campaigns like these not only mislead the public, but can potentially harm thousands of patients as well, who are shielded from obtaining accurate information about whether a drug will actually help them.
In recent years Pfizer has paid to settle several other off-label marketing
lawsuits, most tied to Wyeth’s products. In 2012 Pfizer agreed to
pay $55 million to resolve federal investigations into Wyeth’s marketing
and sales of Protonix, a heartburn medication. In 2012, securities filings
disclosed that Pfizer paid nearly $900 million that year to resolve just
over half of the 10,000+ lawsuits over accusations that Wyeth’s
menopause drugs caused breast cancer.
The hormone replacement menopause drug, Prempro, was pushed on physicians for uses it was – again – not approved for, such as the prevention of colorectal cancer and cardiovascular disease. The FDA approves drugs for specific uses after lengthy clinical trials have proven they are safe and effective for that use. Any marketing of the drug beyond that specific use is fraudulent, negligent, and unsafe, putting thousands of patient at risk of unnecessarily dangerous, not always effective drugs.
Whistleblower lawyers at Pintas & Mullins Law Firm encourage anyone with information about threats to the health care system to come forward. Significant results can be obtained through whistleblower lawsuits, as evidenced here, reaffirming the importance of public reporting of abuse, waste or fraud by pharmaceutical giants like Pfizer and Wyeth.