IN RE: DIET DRUGS (PHENTERMINE/FENFLURAMINE/DEXFENFLURAMINE) PRODUCTS LIABILITY LITIGATION.
AMERICAN HOME PRODUCTS CORPORATION THIS DOCUMENT RELATES TO: SHEILA BROWN, et al. No. 2:16 MD 1203.
MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9078.
HARVEY BARTLE, III, District Judge.
Dana R. Dancer ("Mr. Dancer" or "claimant"), a class member under the Diet Drug Nationwide Class Action Settlement Agreement ("Settlement Agreement") with Wyeth,  seeks benefits from the AHP Settlement Trust ("Trust"). Based on the record developed in the show cause process, we must determine whether claimant has demonstrated a reasonable medical basis to support his claim for Matrix Compensation Benefits ("Matrix Benefits").
To seek Matrix Benefits, a claimant must first submit a completed Green Form to the Trust. The Green Form consists of three parts. The claimant or the claimant's representative completes Part I of the Green Form. Part II is completed by the claimant's attesting physician, who must answer a series of questions concerning the claimant's medical condition that correlate to the Matrix criteria set forth in the Settlement Agreement. Finally, claimant's attorney must complete Part III if claimant is represented.
In January, 2012, claimant submitted a completed Green Form to the Trust signed by his attesting physician, Manoj R. Muttreja, M.D. Based on an echocardiogram dated November 13, 2002, Dr. Muttreja attested in Part II of claimant's Green Form that Mr. Dancer had severe aortic regurgitation, surgery to repair or replace the aortic and/or mitral valve(s) after use of Pondimin® and/or Redux, and ventricular fibrillation or sustained tachycardia which resulted in hemodynamic compromise. Based on such findings, claimant would be entitled to Matrix B-1,  Level V benefits in the amount of $271, 456.
In March, 2012, the Trust forwarded the claim for review by Robert L. Gillespie, M.D., F.A.C.C., F.A.S.E., one of its auditing cardiologists. In audit, Dr. Gillespie concluded that there was no reasonable medical basis for Dr. Muttreja's finding that claimant suffered from ventricular fibrillation or sustained ventricular tachycardia which resulted in hemodynamic compromise. Dr. Gillespie explained, "[Ventricular fibrillation] occurred intraoperatively which would not meet criteria. This occurred during manipulation of the heart/aorta."
Based on Dr. Gillespie's finding, the Trust issued a post-audit determination denying Mr. Dancer's claim. Pursuant to the Rules for the Audit of Matrix Compensation Claims ("Audit Rules"), claimant contested this adverse determination. In contest, Mr. Dancer argued that there was a reasonable medical basis for his claim because the auditing cardiologist admitted that ventricular fibrillation occurred. Claimant, relying on a declaration of Robert L. Rosenthal, M.D. and a number of articles, also asserted that the Settlement Agreement does not support the Trust's contention that ventricular fibrillation must occur spontaneously. In addition, claimant contended that intraoperative ventricular fibrillation is neither induced nor benign. Finally, Mr. Dancer argued that his ventricular fibrillation occurred after removal of the aortic cross clamp and not during manipulation of his heart or aorta.
Although not required to do so, the Trust forwarded the claim to the auditing cardiologist for a second review. Dr. Gillespie submitted a declaration in which he again concluded that there was no reasonable medical basis for the attesting physician's finding that Mr. Dancer suffered from ventricular fibrillation or ventricular tachycardia which resulted in hemodynamic compromise. Specifically, Dr. Gillespie stated, in relevant part, that:
10. Based upon my review, I affirm my finding that there is no reasonable medical basis for the Attesting Physician's affirmative answer to Question L.5 of the Green Form. In reaching this conclusion I considered the recommendations provided by the Consensus Expert Panel (the "CEP") concerning Section IV.B.2.c(S) (d) of the Settlement Agreement, in light of the medical documentation submitted with this claim. A copy of the CEP recommendations is attached as Exhibit B to this Declaration.
11. At Contest, I reviewed Dr. Rosenthal's excellent review of the literature concerning reperfusion ventricular fibrillation. I agree that reperfusion ventricular fibrillation has the potential to cause harmful effects and is not desirable. At no point did I contend that ventricular fibrillation in this setting is benign. Rather, it is an expected event when separating from the bypass pump immediately after surgery and not a separate worsened condition.' Indeed, none of the medical records submitted in this claim document any spontaneous ventricular fibrillation after that induced by separation from the bypass pump.. [sic]
12. The very articles that Dr. Rosenthal cited substantiate a very high incidence of ventricular fibrillation in the immediate time frame after reperfusion after cardiac surgery. In the article labeled Exhibit B, an incidence rate of "reperfusion-induced ventricular fibrillation (RVF) in 60% to 100%" in all cases after aortic unclamping during cardiopulmonary bypass. Furthermore, it is suggested that RVF is caused by oxygen free radicals and ionic disturbances involving sodium and calcium ions. The article labeled as Exhibit C quotes an incidence of RVF to be 74% to 96%. Exhibit D quotes an RVF incident of 45% to 100%. Exhibit F noted that only 13 out of 99 patients did not develop [ventricular fibrillation] in the immediate post op[erative] period, again showing the very high incident of [ventricular fibrillation] after reperfusion.
13. In conclusion, while [ventricular fibrillation] may have deleterious effects on the heart, it is an expected event incidental to cardiac surgery. Even in patients with normal to near normal cardiac function with no evidence of myocardial scar or preexisting arrhythmia, the incidence of [ventricular fibrillation] is very high as noted in Lake et. al. (Dr. Rosenthal's Exhibit F). This study excluded all patients with "history of arrhythmias or need for antiarrhythmic drugs, congestive heart failure, or ejection fraction less that SO%." Even in this low risk group, 87% of patients required defibrillation after reperfusion. This event does not indicate increased medical severity, as spontaneous ventricular fibrillation does. The medical documentation submitted in support of this Claim does not support [ventricular fibrillation] occurring beyond the immediate time frame after reperfusion.
The Trust then issued a final post-audit determination, again denying Mr. Dancer's supplemental claim. Claimant disputed this final determination and requested that the claim proceed to the show cause process established in the Settlement Agreement. See Settlement Agreement§ VI.E.7.; PTO No. 2807, Audit Rule 18(c). The Trust then applied to the court for issuance of an Order to show cause why Mr. Dancer's claim should be paid. On February 25, 2013, we issued an Order to show cause and referred the matter to the Special Master for further proceedings. See PTO No. 9005 (Feb. 25, 2013).
Once the matter was referred to the Special Master, the Trust submitted its statement of the case and supporting documentation. Claimant then served a response upon the Special Master. The Trust submitted a reply on April 30, 2013, and claimant submitted a sur-reply on May 16, 2013. The Show Cause Record is now before the court for final determination. See Audit Rule 35.
The issue presented for resolution of this claim is whether claimant has met his burden of proving that there is a reasonable medical basis for the attesting physician's finding that he suffered ventricular fibrillation or ventricular tachycardia which resulted in hemodynamic compromise. See id. Rule 24. Ultimately, if we determine that there is no reasonable medical basis for the answer in claimant's Green Form that is at issue, we must affirm the Trust's final determination and may grant such other relief as deemed appropriate. See id. Rule 38(a). If, on the other hand, we determine that there is a ...