ProPublica: Doctors Avoid Penalties in Suits Against Medical Firms
on September 20th, 2011 at 8:00 amThis article originally appeared in ProPublica on September 16, 2011
By Tracy Weber and Charles Ornstein — ProPublica
This story was co-published with the Washington Post
Two years ago, drugmaker Eli Lilly pleaded guilty to illegally marketing [1] its blockbuster antipsychotic Zyprexa for elderly patients. Lilly paid $1.4 billion in criminal penalties and settlements in four civil lawsuits.
But a doctor named as a co-defendant in one suit – for allegedly taking kickbacks to prescribe the drug extensively at nursing homes – never was pursued.
Last year, Alpharma paid $42.5 million to settle federal allegations [2] that it paid kickbacks to doctors to prescribe its painkiller Kadian.
“Health-care decisions must be based solely upon what is best for the individual patient and not on which pharmaceutical company is paying the doctor the biggest kickback,” Rod J. Rosenstein, U.S. attorney for the District of Maryland, said in a statement announcing the settlement.
But the doctors accused of trading prescriptions for paid speaking gigs faced no consequences.
At least 15 drug and medical-device companies have paid $6.5 billion since 2008 to settle accusations of marketing fraud or kickbacks. However, none of the more than 75 doctors named as participants were sanctioned, despite allegations of fraud or of conduct that put patients at risk, a review by ProPublica found.
Reporters reviewed hundreds of pages of court records and interviewed current and former federal prosecutors, state medical board officials, attorneys for whistleblowers and, when possible, the doctors. For each doctor identified in a suit, ProPublica checked for state medical board discipline, penalties from the Medicare program and federal criminal charges.
In many of the cases, it appears that not even a cursory investigation was done to see whether the physicians had behaved inappropriately.
“Doctors have kind of gone under the radar,” said Tavy Deming, a Philadelphia lawyer who represents drug company whistleblowers.
Amid concerns about the influence of drug company money on medicine, whistleblower lawsuits have emerged as a headline-grabbing tool for holding manufacturers accountable.
Yet, despite their power to secure large settlements from drugmakers, the suits have failed to resolve the culpability of physicians. Doctors often are not named as defendants, even though descriptions of their alleged misconduct are used to bolster the suits. And even when settling, many companies, including Alpharma, continue to deny the allegations.
After cases are resolved, the internal company documents used as evidence remain confidential, preventing further exploration of the physicians’ behavior. Patients have no way of knowing whether their doctor’s judgment has been compromised, and doctors may be tarnished by spurious accusations.
Medical boards, which normally pursue tips or complaints of wrongdoing, do not routinely scan for such cases. Justice Department lawyers, wary of spending more time and effort on a case, usually are not interested in going after lesser players.
Tony West, the assistant attorney general who oversees civil litigation nationwide for the Justice Department, declined through a spokeswoman to discuss the issue. In announcing settlements with the drug companies, however, West has said that kickbacks undermine doctors’ credibility.
Sen. Charles E. Grassley (Iowa), the ranking Republican on the Judiciary Committee, said in a written statement that it takes “two sides to perpetuate this fraud” and that both need to be held accountable.
“Otherwise, regardless of how big of a civil settlement a drug company makes, the incentive to cheat the taxpayers will still be in place for those willing to take part,” said Grassley, who has led investigations into conflicts of interest in medicine.
Doctors less-attractive targets
In recent years, pharmaceutical and medical-device companies have been barraged by whistle-blower lawsuits [3] detailing how the pursuit of profit allegedly fueled fraud and corruption.
The suits are typically filed by former employees who say that the companies promoted drugs for unapproved uses or paid doctors to prescribe drugs or use medical devices. The suits seek to recover millions – even billions – of dollars spent on these products by government health programs.
The Justice Department joins the cases 2013 known as “qui tam” suits, from Latin – if it believes they have merit. Whistle-blowers and their lawyers get a cut of any money collected. The government has come to rely on such cases to police companies’ conduct.
For Justice Department lawyers, big drug companies make attractive targets. They are flush with profits and determined to avoid crippling legal defeats. Their bureaucratic sprawl often leaves an inadvertent trail of incriminating e-mail and memos. The massive financial settlements they are willing to pay are often modest in light of their annual sales and profits.
Zyprexa, for example, had U.S. sales of nearly $3 billion in 2010 alone. Kadian, Alpharma’s painkiller, brought in nearly $263 million, according to IMS Health, which tracks prescription drug sales.
Also, the rules governing drug and device companies are strict: They are banned from pushing their products for uses not approved by the U.S. Food and Drug Administration.
