Condemnation by ethicists and loss of grant money are not the only penalties facing academics who put their names on medical-journal articles they didn’t write. Personal-injury lawyers have them in their sights now, too.
In an article published Tuesday in the journal PLoS Medicine, the authors laid out three possible areas of liability, including the federal anti-kickback statute, which can carry prison time plus fines of up to $25,000.
Researchers at major universities, including Brown, Emory, Harvard, Stanford, Tufts, and Yale, have been accused in recent years of signing their names to medical-journal articles that were written by others, articles that promoted the benefits of various medications and were produced under the auspices of pharmaceutical companies trying to boost their products. Last year The Chronicle reported that a University of Pennsylvania psychiatry professor accused five other academics of signing an article that was ghostwritten for the maker of the antidepressant Paxil and made unsupported claims for it.
“By lending his name, the author is contributing to fraud,” says Bijan Esfandiari, one of the authors of the PLoS Medicine article. “And the ghostwriter is involved in the conspiracy as well.”
Mr. Esfandiari is a lawyer with the firm of Baum, Hedlund, Aristei & Goldman in Los Angeles. (“For 25 years we have championed death and injury claims for thousands of clients nationwide,” reads the firm’s Web site.) His co-authors are Xavier A. Bosch, a professor in the department of medicine at the University of Barcelona, and Leemon McHenry, a lecturer and specialist in bioethics in the philosophy department at California State University at Northridge.
The legal liability of ghostwriting, Mr. Esfandiari says, arises because “doctors say they relied on an article in their decision to prescribe drugs, because they thought it came from a reputable academic author.” That author usually hasn’t looked at the data, and the ghostwriter knows the named author didn’t really do the work. Mr. Esfandiari and his co-authors say that under existing law, people behind such intentional misrepresentation, which can cause harm to others, can be held liable in personal-injury lawsuits.
“We’re putting out a novel theory. It hasn’t been tested yet. But I’m sure lawyers will, if the practice doesn’t stop” Mr. Esfandiari says.
The article outlines other serious consequences, as yet untried in court. One is that named authors and ghosts could be charged by the U.S. government under the federal False Claims Act. Because Medicare uses peer-reviewed journal articles in its decisions to allow reimbursement for a particular medication, people responsible for ghost-written articles have perpetrated a fraud against the government, the article says. Drug companies have been fined millions of dollars because of violations of the act; individuals could be held liable for $11,000 for each false claim.
There are also possible violations of the federal anti-kickback statute. That law prohibits pharmaceutical companies from paying physicians or researchers for endorsements, essentially. And paying academics and ghostwriters is just such an endorsement, the article argues. Violating that law is a felony, and carries a maximum fine of $250,000 and a five-year jail term.
Other lawyers have proposed even more grounds for legal trouble. In a 2011 PLoS Medicine article, a professor at the University of Toronto’s law school and a colleague suggested that academics lending their names to articles could be prosecuted under the federal Racketeer Influenced and Corrupt Organizations Act.
The Association of American Medical Colleges has been urging members to police ghostwriting more forcefully, but everyone acknowledges that the practice continues. So, says Mr. Esfandiari, “you need to have some kind of stick to prevent it.”
Correction (1/25, 12:44 p.m.): This article originally reported incorrectly on the amount of the fine that offenders of the federal anti-kickback statute could face. The fine could amount to as much as $25,000, not $250,000. The article has been updated to reflect this correction.
