March 15, 2018
A whistleblower who originally brought a case against three major drug companies in 2009 will have another chance to make his case. The United States Court of Appeals for the Ninth Circuit vacated the decision of the district court based on new case law interpreting the “original source” rule for qui tam relators.
Frank Solis alleged that pharmaceutical companies Millennium, Schering-Plough, and Merck promoted dangerous off-label uses of the drug Integrilin. The district court ruling, which the Ninth Circuit overturned, found that the allegations were similar to other lawsuits, and were therefore barred by the “public disclosure” rule.
9th Circuit Court Found Errors, Outdated Tests
On March 15, 2018, a unanimous three-judge panel of the Ninth Circuit vacated the dismissal of Solis’ case. The Court held that while the allegations were similar to other lawsuits, Mr. Solis might qualify as an “original source” under the newer law. The Court remanded the case for the district court to determine whether Solis qualified as an original source under United States ex rel. Hartpence v. Kinetic Concepts. Inc., 792 F.3d 1121, 1123 (9th Cir. 2015).
In Hartpence, which was decided after the district court’s decision in Solis, the Ninth Circuit ruled that the public disclosure bar of the False Claims Act does not apply when the relator is an original source of the allegations. Hartpence changed the test for when a relator qualifies as an original source, by removing the requirement for the relator to have been involved in the other disclosures.
The Ninth Circuit also determined that the lower court had made a mistake regarding Solis’ Avelox claims. “The district court clearly erred in finding that the Avelox claims were publicly disclosed based on court complaints that never mentioned Avelox,” the ruling states. However, the panel found that these claims were insufficiently pleaded, and remanded with instructions that the district court determine whether Solis may amend.
Solis Was Hired to Market Drugs That He Said Were Part of Illegal Doctor Kickbacks
Solis was initially hired by Millennium Pharmaceuticals, Inc. to help sell a drug called Integrilin, which is used to help prevent blood clots and heart attacks. Schering-Plough Corporation then acquired the rights to market Integrilin and Solis went to work for them in the same pursuit, as well as in the promotion of a drug called Avelox—an antibiotic used against a range of bacterial infections.
Shortly thereafter Schering-Plough Corporation merged with Merck & Company, Inc., who kept Solis on in his same role for a year before firing him.
Solis filed his case against the three-drug corporations that same year, and in his claim, he alleged that each company had violated state laws and the FCA when they paid physicians kickbacks to prescribe the two medications in question and promoted off-label uses that could result in harm to customers.
Solis alleges that Schering-Plough Corporation “promoted the use of Integrilin in combination with the drugs tenecteplase and heparin.” Solis said that the corporation was aware that the combination could be “extremely dangerous,” and came with an “increased bleeding risk.” Furthermore, Solis argued Schering-Plough knew of study results that demonstrated the risks and sales representatives for Integrilin had seen those study results.
Whistleblower lawsuits are utilized in the United States to enable employees to speak out against wrongdoing they witness within the companies they work for and to allow them to work with the government to seek justice.
These lawsuits give employees a protected avenue to bring relevant information before the government and are a way for the government to begin investigating the claims before they are public knowledge. Resulting payouts can be in the millions.
Whistleblower lawsuits are vital for holding companies accountable for their wrongdoing. For example, in November of 2014, Biotronik, Inc. had to pay almost $5 million after U.S. courts found they had violated the FCA and the law by providing monetary and other incentives to physicians to get them to use Biotronik devices, which were covered by Medicare and other federal health care systems.
If you have found wrongdoing within the corporation you work for and believe the acts to be illegal or detrimental to the government, you may be in the position to file a whistleblower lawsuit. Cutter Law can lead you through the process, ensuring that every step is handled with your wellbeing in mind and that proper retribution is sought. Our attorneys have extensive experience in qui tam and whistleblower litigation and have brought many corporations to justice, with millions of dollars of settlements. Contact us today for a free case evaluation.