Rituxan Whistleblower Lawsuit Settled For $20 Million

A Rituxan whistleblower lawsuit has been settled for $20 million dollars. The settlement mandates Genentech pay due to illegal off-label marketing of its cancer drug.

The settlement, completed last month, is expected to net $5.7 million for whistleblower, John Underwood, said BizJournals. Underwood, who worked at Genentech from December 1986 through January 2005, was the sales department’s senior manager from when Genentech’s oncology unit started up in 1997; he filed the law suit in 2003 when he was a senior hospital systems specialist for Genentech, said BizJournals.

Genentech, a Roche subsidiary, admitted no wrongdoing, according to the agreement, but did, separately, agree to pay Underwood’s attorney’s fees and expenses. The lawsuit was filed in the U.S. District Court for the Eastern District of Pennsylvania.

According to the lawsuit, from 2000 to no earlier than 2002, Genentech, “encouraged oncologists and other physicians and medical providers to bill Medicare and other government reimbursement programs for Rituxan for ‘off-label’ uses” and to present that use as having been of their own independent medical judgment, said BizJournals.

Rituxan is a so-called “monoclonal antibody” approved by the U.S. Food and Drug Administration (FDA) in November 1997 for patients diagnosed with relapsed or refractory, low-grade nonHodgkin’s lymphoma, said BizJournals, adding that the Rituxan label was expanded in April 2001 for other nonHodgkin’s lymphoma patients.

By year-end 2002, Rituxan sales—for approved uses—totaled about 30% of Genentech’s total Rituxan sales of over $1 billion. According to Underwood, as much as 70% of Rituxan sales were generated due to off-label use, said Pharmalot.

The lawsuit also alleged that Genentech urged off-label Rituxan use for other nonHodgkin’s lymphoma patients and for patients with chronic lymphocytic leukemia, idiopathic thrombocytopenic purpura, autoimmune hemolytic anemia, rheumatoid arthritis, and others, said BizJournals.

According to the lawsuit, Genentech hired physicians as independent speakers on behalf of its cancer drug and its off-label uses and paid kickbacks, disguised as consulting fees, to those doctors; “exerted significant pressure” on sales reps to increase off-label Rituxan uses; created and conducted “selling skills workshops” geared to sales reps that focused on off-label uses; and invited physicians to attend “medical education seminars” at “luxurious locations” while financially inducing sales reps to help get doctors selling the most Rituxan to attend the events, reported BizJournals. Pharmalot pointed out that Genentech’s activities cost federal healthcare programs, such as Medicare and Medicaid, by having doctors inappropriately bill the healthcare programs for an array of unapproved Rituxan uses.

Meanwhile, a separate whistleblower lawsuit, also charging off-label Rituxan marketing was filed in 2005 by former Genentech employee, Paul McDermott, who accused Genentech of actively promoting Rituxan to treat rheumatoid arthritis years before it received approval for that purpose, said Pharmalot. McDermott also alleged that the drug maker offered kickbacks and dinners to doctors to promote and prescribe Rituxan, which also ended up defrauding Medicare and Medicaid. That separate action was eventually settled, said Pharmalot.

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