• Despite growing concern about medical ghostwriting, pharmaceutical companies, universities, medical journals, and communication companies employing ghostwriters have thus far failed to adequately stem the problem. As a result, some commentators have proposed that legal remedies could be sought by patients harmed by drugs publicized in ghostwritten papers.
• In this Essay, we build on a recent analysis by Stern and Lemmens in PLoS Medicine to outline specific areas of legal liability.
• For example, when an injured patient’s physician directly or indirectly relies upon a journal article containing false or manipulated safety and efficacy data, the authors, including guest authors, can be held legally liable for patient injuries.
• In addition, guest authors of ghostwritten articles published by Medicare- and Medicaid-recognized peer-reviewed medical journals used as clinical evidence for indications for off-label uses may be liable under the federal False Claims Act for inducing the United States government to reimburse prescriptions under false pretenses.
• Paying guest authors of ghostwritten papers may influence clinical judgment, increase product sales and government health care costs, and put patients at risk by misrepresenting risk-benefit. Therefore, both physicians and sponsor companies may be liable under the federal Anti-Kickback Statute.
• Although guest authors and pharmaceutical defendants may argue a First Amendment right to participate in ghostwriting, the US Supreme Court has firmly held that the First Amendment does not shield fraud.
In addition to openly infringing academic standards and contributing to fraud, the crisis of credibility resulting from medical ghostwriting persists in published reports on the efficacy and safety of proposed treatments. The situation is so dire that the public is forced to seek judicial intervention to curb dangerous, unethical medical ghostwriting. Stakeholders, including universities, journals, pharmaceutical companies, and academic KOLs, have largely failed to heed public calls for honesty in reporting clinical research. Since these complaints have fallen on deaf ears, we believe the courts now have the task of restoring the integrity of the medical literature.