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. 9132
HARVEY BARTLE, III, District Judge.
John V. Davis ("Mr. Davis" 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 July, 2010, claimant submitted a completed Green Form to the Trust signed by his attesting physician, Manoj R. Muttreja, M.D. Based on an echocardiogram dated April 21, 2003,  Dr. Muttreja attested in Part II of claimant's Green Form that Mr. Davis suffered from moderate mitral regurgitation, an abnormal left atrial dimension, and ventricular fibrillation or sustained ventricular tachycardia which results in hemodynamic compromise. Based on such findings, claimant would be entitled to Matrix A-1, Level V benefits in the amount of $1, 059, 643.
In the report of claimant's April 21, 2003 echocardiogram, the reviewing cardiologist, James W. Smith, M.D., stated, "The mitral valve shows calcification of the mitral annulus with mild systolic anterior motion of the anterior leaflet." In addition, in the report of claimant's June 14, 2002 echocardiogram, the reviewing cardiologist, David Liang, M.D., stated, "There is mild mitral annular calcification." Under the Settlement Agreement, the presence of mitral annular calcification requires the payment of reduced Matrix Benefits. See Settlement Agreement § IV.B.2.d. (2)(c)ii)d). Dr. Muttreja, however, attested in claimant's Green Form that Mr. Davis did not suffer from mitral annular calcification.
In September, 2010, the Trust forwarded the claim for review by Waleed N. Irani, M.D., F.A.C.C., one of its auditing cardiologists. In audit, Dr. Irani determined that there was no reasonable medical basis for the attesting physician's representation that claimant had moderate mitral regurgitation based on claimant's April 21, 2003 echocardiogram. Specifically, Dr. Irani explained, "Only mild [mitral regurgitation] seen on study with ratio of approximately 10-1596." Dr. Irani also concluded that there was a reasonable medical basis for the Green Form representation that claimant did have mitral annular calcification based on claimant's June 14, 2002 echocardiogram because "mild posterior [mitral annular calcification] [was] present."
Based on Dr. Irani's finding that claimant's April 21, 2003 echocardiogram demonstrated only mild mitral regurgitation, the Trust issued a post-audit determination denying the claim. Pursuant to the Rules for the Audit of Matrix Compensation Claims ("Audit Rules"), claimant contested this adverse determination. In contest, Mr. Davis argued that the auditing cardiologist should have determined whether claimant's June 14, 2002 echocardiogram demonstrated an abnormal left atrial dimension. According to claimant, he may rely on his June 14, 2002 echocardiogram to satisfy the Matrix Level II prerequisite to his claim for Matrix Level V benefits based on ventricular fibrillation or sustained ventricular tachycardia which results in hemodynamic compromise, irrespective of the results of the audit of his April 21, 2003 echocardiogram. Claimant also contended that the auditing cardiologist's finding of mitral annular calcification was not supported by the evidence.
Although not required to dO so, the Trust forwarded the claim to the auditing cardiologist for a second review. Dr. Irani submitted a declaration in which he concluded that there was no reasonable medical basis for finding that Mr. Davis did not have mitral annular calcification. In particular, Dr. Irani explained:
11. At Contest, I was also asked to determine whether mitral annular calcification is present on the April 21, 2003 echocardiogram of attestation, the June 14, 2002 eligibility echocardiogram, and echocardiogram studies dated November 30, 2001, May 28, 2002, and September 20, 2002.
12. Upon review of the April 21, 2003 echocardiogram study at Contest, I observed posterior mitral annular calcification that is mild, but present, in the PLAX images. There is no reasonable medical basis to conclude that mitral annular calcification is not present on this study.
13. Mitral annular calcification is also present on the June 14, 2002 echocardiogram study, as I noted at audit. There is no reasonable medical basis to conclude that mitral annular calcification is not present on this study.
Dr. Irani also reviewed claimant's June 14, 2002 echocardiogram and determined that, in addition to moderate mitral regurgitation, "it would not be unreasonable to conclude that left atrial enlargement is present on that study."
The Trust then issued a final post-audit determination, again denying the 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 his claim should be paid. On April 13, 2011, we issued an Order to show cause and referred the matter to the Special Master for further proceedings. See PTO No. 8634 (Apr. 13, 2011).
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 July 14, 2011, and claimant submitted a sur-reply on August 2, 2011. Under the Audit Rules, it is within the Special Master's discretion to appoint a Technical Advisor to review claims after the Trust and claimant have had the opportunity to develop the Show Cause Record. See Audit Rule 30. The Special Master assigned a Technical Advisor, Sandra V. Abramson, M.D., F.A.C.C., to review the documents submitted by the Trust and ...