From a review of the Boston case file, it is clear that a criminal investigation of the predicate facts was underway at various points between 2002 and 2005, at least.
Once the case was transferred to New Jersey, and eventually unsealed, what was a Qui Tam Act suit, was amended to simply assert False Claims Act violations. Here are some of the salient details from the as amended, and unsealed, complaint. [I am still working up a narrative that explores the balancing of interests previously at-play in this case — on the one hand, the fundamental right of each litigant to be present — and at least witness — proceedings on his case, versus the preventing of a leak, or other form of compromise, of a then-pending criminal investigation, on the other — back later with that.]
. . . .4. Dr. Feldstein, individually and on behalf of the United States of America, seeks relief pursuant to 31 U.S.C. § 3729, et seq., commonly known as the False Claims Act. Pursuant to 28 U.S.C. § 1331, this Court possesses subject matter jurisdiction over this claim because it presents a question of federal law. . . .
6. For many years, Organon expended enormous time, money and resources developing and ultimately obtaining regulatory approval for a neuromuscular blocking agent known as Raplon. Raplon was designed to paralyze a patient’s throat area to allow the painless insertion of an endotracheal tube into a patient’s trachea. An endotracheal tube is designed to facilitate the administration of oxygen and anesthetic agents to patients during surgical or obstetric procedures.
7. On August 18, 1999, Raplon received regulatory approval from the United States Food and Drug Administration (the “FDA”). Organon subsequently engaged in extensive efforts to market Raplon to physicians in the United States and abroad.
8. Organon hoped that Raplon would be superior to its competitor drugs because it induced paralysis so rapidly. For example, Raplon would paralyze a patient’s throat area more quickly than the drug most often used, succinylcholine, an older generic drug that competed with Raplon.
9. Raplon, however, sometimes produced an unexpected serious, and sometimes fatal, side effect which met the definition of a serious adverse event (“SAE”) as set forth in the FDA regulations. Certain individuals would suffer severe respiratory problems and, at times, even, “chest rigidity” after receiving Raplon, nothing like a brief bronchospasm (a condition that occurs when a patient’s bronchial tubes close and prevent breathing.)
10. The SAEs generated by Raplon were unique in their severity when compared with similar drugs of its class. The seriousness of these episodes was described as “like having a clamp over the airway” or “the chest felt like concrete”. These SAEs would cause a patient’s entire thoracic region to contract so completely that it became extremely difficult or impossible for physicians to ventilate patients. In certain instances, physicians were unable to reverse the condition before the patient succumbed from a lack of oxygen.
11. On May 31, 2000, Organon hired Dr. Feldstein to serve as Associate Director of Medical Services for Antithrombotics. During his employment, Dr. Feldstein acquired nonpublic information concerning the clinical problems associated with Raplon. This included evidence that Organon had knowingly concealed information and made misrepresentations to the FDA during and after the regulatory approval process concerning SAEs caused by Raplon. . . .
12. In early 2001, Organon’s Associate Director of Anesthesiology, Dr. Daniel Sack, informed Dr. Feldstein that Raplon had caused numerous SAEs and multiple deaths since its approval. Dr. Sack also disclosed to Dr. Feldstein that he was in possession of a private e-mail suggesting that personnel at Organon knew prior to Raplon’s approval by the FDA that Raplon caused SAEs.
13. The e-mail was prepared by Organon’s Director of Hospital Products, Dr. Jonathan Deutsch, and sent to Organon’s Vice President of Medical Services, Dr. Deborah Shapse, prior to the FDA’s approval of Raplon. Dr. Sack discovered the e-mail on Dr. Shapse’s laptop computer after Organon had reassigned the laptop to Dr. Sack for his use. . . .
16. The e-mail also indicates that “Michael may be correct in not wanting to draw attention to bronchospasm.” (emphasis added). Upon information and belief, Michael is a reference to Michael Novinsky, Organon’s Head of Marketing.
17. Dr. Feldstein also discovered that the reference in the e-mail to the Dallas meeting was related to a meeting of the investigators involved in Raplon’s US Phase III Pivotal trial at which Organon disbursed topline data. . . . The investigators understood that these SAEs were caused by Raplon, even though they had used a double blinded trial, because the investigators never experienced this type of SAE during the many years they had worked with the comparator drug succinylcholine. . . .
19. After reviewing other internal, non-public documents and Organon’s various submissions to the FDA, Dr. Feldstein concluded that Organon had failed to disclose to the FDA instances and the severity of the SAEs associated with Raplon both before and after obtaining FDA approval. Upon information and belief, Organon’s submissions to the FDA contained numerous quantitative and qualitative misrepresentations concerning Raplon’s propensity to cause SAEs, which were purposely labeled only as expected and non-life threatening adverse events (“AEs”), such as coughing or wheezing, bronchospasm and other airway symptoms, contrary to the FDA and CFR definitions.
20. Moreover, after receiving FDA approval, Organon never advised doctors or patients of the potential for SAEs in any labeling or package insert and never had a treatment protocol in place prior to or even after launch. . . .
21. The extent of the danger posed by Raplon came to light following its approval by the FDA. In or about August 1999, physicians began reporting instances of SAEs related to Raplon to Organon’s safety department. Organon disingenuously suggested that the cause of these SAEs might have been related to the incorrect insertion of endotracheal tubes by physicians when it knew that Raplon was the true cause.
22. Many individuals died from Raplon. Additionally, reports from physicians indicate that Raplon also caused a significant number of non-fatal cases of SAEs in patients which, in turn, led to innumerable surgical delays, cancellations and/or other unnecessary medical expenses associated with treating same.
23. Organon’s actions have caused false claims to be submitted to and paid by Medicare and Medicaid, which are agencies of the United States government. Raplon’s approval by the FDA was invalid because it was obtained by Organon as a result of a willful failure to disclose and/or through the use of fraudulent and/or deceptive information. Organon, therefore, caused many hospitals, physicians and/or patients to submit false reimbursement claims to Medicare and Medicaid associated with Raplon they otherwise would not have been able to submit. Moreover, Medicare and Medicaid would not have reimbursed hospitals, physicians and/or patients for the use of Raplon had those agencies known that the FDA approved Raplon without the benefit of adequate disclosures regarding the potential for SAEs. Organon’s actions also have caused Medicare and Medicaid to pay for medical costs associated with treating SAEs that never would have been incurred had adequate disclosures been made. . . .
As ever, there
will be is now more to come, on this.