Imagine this scenario: You’re the vice president of legal operations for a publicly traded U.S.-based pharmaceutical company called Gotham Sciences. Your company’s blockbuster diabetes drug, Glucomex, is about to go off patent.
In a hypothetical case study, the American Conference Institute’s “Government Investigations for Life Sciences” conference in Philadelphia Sept. 27 and 28 explores the dynamics of a government negotiation as a fictional pharmaceutical company attempts to resolve legal jeopardy stemming from an aggressive search for new profits.
A mock negotiation will pit the former chief of the Justice Department’s Criminal Fraud Section, Steven Tyrrell, against two former Fraud Section prosecutors: Kirk Ogrosky and Jay Darden. Tyrrell, now a partner at Weil Gotshal & Manges LLP, will represent the government while Ogrosky of Arnold & Porter and Darden of Patton Boggs LLP will represent the company.
Jennifer Bragg, a partner at Skadden, Arps, Meagher & Flom LLP, will also represent the fictional Gotham Sciences; while Daniel R. Miller of Berger & Montague P.C. in Philadelphia, a former director of the Delaware Medicaid Fraud Control Unit, will round out the government team for the mock negotiation.
In the fictional cases of Gotham Sciences, the company launches an aggressive plan to compensate for the expected multi-billion-dollar drop in profits from the loss of patent protection for its top drugs.
It creates an off-label marketing campaign for a drug called Glucomex, which has shown promise in treating migraines and depression in elderly patients.
Although it hasn’t secured FDA approval for the off-label uses, Gotham moves ahead by hiring a PR firm to ghostwrite a medical journal article touting Glucomex as a treatment migraines and depression. The article downplays potential health risk of the off-label uses, including studies that show dangerous increases in cholesterol in non-diabetic patients.
In a parallel plan to boost its international sales, the company acquires a U.K. medical device manufacturer named Etronex, which has strong elbow replacement sales in Russia and Central and Eastern Europe.
The combined new business strategy is a success. Gotham Sciences profits grow by a robust 40 percent over the preceding fiscal year.
Then the company is hit with a surprise: The Securities and Exchange Commission issues a subpoena to review documents in connection with the purchase of the Etronex subsidiary.
Gotham also finds out that Etronex reps had been giving lavish gifts to doctors at the Russian state-run hospitals that bought the company’s replacement elbows, a possible violation of the Foreign Corrupt Practices Act.
And to top things off, a disgruntled former sales rep for Gotham files a qui tam case in Philadelphia alleging the company defrauded the U.S. government.
At the risk of tipping their hands, the panelists have agreed to preview their negotiating strategies. Click on the links below for a peek:
Jennifer Bragg - Skadden, Arps, Slate, Meagher & Flom LLP
Jay Darden - Patton Boggs, LLP
Daniel R. Miller - Berger & Montague P.C.
Kirk Ogrosky - Arnold & Porter LLP
Steven Tyrrell - Weil Gotshal & Manges LLP