MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9226

HARVEY BARTLE, III, District Judge.

The Estate of Dennis J. Kennedy ("Estate"), a representative claimant under the Diet Drug Nationwide Class Action Settlement Agreement ("Settlement Agreement") with Wyeth,1 seeks benefits from the AHP Settlement Trust ("Trust").2 Based on the record developed in the show cause process, we must determine whether the Estate has demonstrated a reasonable medical basis to support its claim for Matrix Compensation Benefits ("Matrix Benefits").3

To seek Matrix Benefits, a representative claimant4 must first submit a completed Green Form to the Trust. The Green Form consists of three parts. The representative claimant completes Part I of the Green Form. Part II is completed by an attesting physician, who must answer a series of questions concerning the Diet Drug Recipient's medical conditions that correlate to the Matrix criteria set forth in the Settlement Agreement. Finally, if the representative claimant is represented by an attorney, the attorney must complete Part III.

In December, 2011, Patti Kennedy, the personal representative of the Estate, submitted a completed Green Form to the Trust signed by the attesting physician, Manoj R. Muttreja, M.D. Based on an echocardiogram dated February 7, 2002, Dr. Muttreja attested in Part II of the Green Form that Mr. Kennedy suffered from mild aortic regurgitation and had surgery to repair or replace the aortic and/or mitral valve(s) following the use of Pondimin® and/or Redux™. Based on such findings, the Estate would be entitled to Matrix A-1, Level III benefits in the amount of $859,612.5

Dr. Muttreja also attested in the Green Form that Mr. Kennedy did not suffer from congenital aortic valve abnormalities. Under the Settlement Agreement, the presence of congenital aortic valve abnormalities, specifically, "unicuspid, bicuspid or quadricuspid aortic valve[s], [or] ventricular septal defect associated with aortic regurgitation," requires the payment of reduced Matrix Benefits. Settlement Agreement § IV.B.2.d. (2) (c)i)a). As the Trust does not contest the Estate's entitlement to Level III benefits, the only issue before us is whether the Estate is entitled to payment on Matrix A-1 or Matrix B-1.

The Trust forwarded the claim for review by Rohit J. Parmar, M.D., F.A.C.C., one of its auditing cardiologists.6 In audit, Dr. Parmar concluded that there was no reasonable medical basis for Dr. Muttreja's representation that Mr. Kennedy did not have a congenital aortic valve abnormality. Dr. Parmar explained:

Based on Dr. Parmar•s finding that Mr. Kennedy had a congenital aortic valve abnormality, the Trust issued a post-audit determination that the Estate was entitled only to Matrix B-1, Level III benefits. Pursuant to the Rules for the Audit of Matrix Compensation Claims ("Audit Rules"), the Estate contested this adverse determination.8 In contest, the Estate argued that Dr. Parmar inappropriately relied solely on the pathology report for Mr. Kennedy's aortic valve surgery and, in doing so, "disregarded the instructions that are found in Part II of the Green Form." The Estate contended that the Green Form required a review of an echocardiogram, a cardiac catheterization, or surgical examination to determine the presence of a specific medical condition.9 Accordingly, the Estate asserted that it was entitled to Matrix A-1 benefits because the auditing cardiologist did not find echocardiographic evidence of a congenitally bicuspid valve and the surgeon stated that Mr. Kennedy's aortic valve was "trileaflet."10

Although not required to do so, the Trust forwarded the claim to the auditing cardiologist for a second review. Dr. Parmar submitted a declaration in which he again concluded that there was no reasonable medical basis for the attesting physician's finding that Mr. Kennedy did not have a congenital aortic valve abnormality. Dr. Parmar stated, in pertinent part:

The Trust then issued a final post-audit determination, again determining that the Estate was entitled only to Matrix B-1, Level III benefits. The Estate 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 this claim should be paid. On January 25, 2013, we issued an Order to show cause and referred the matter to the Special Master for further proceedings. See PTO No. 8997 (Jan. 25, 2013).

Once the matter was referred to the Special Master, the Trust submitted its statement of the case and supporting documentation. The Estate then served a response upon the Special Master. The Trust submitted a reply on March 28, 2013, and the Estate submitted a sur-reply on April 18, 2013. Under the Audit Rules, it is within the Special Master's discretion to appoint a Technical Advisor11 to review claims after the Trust and the representative claimant have had the opportunity to develop the Show Cause Record. See Audit Rule 30. The Special Master assigned a Technical Advisor, Gary J. Vigilante, M.D., F.A.C.C., to review the documents submitted by the Trust and the Estate and to prepare a report for the court.12 The Show Cause Record and Technical Advisor Report are now before the court for final determination. See id. Rule 35.

The issue presented for resolution of this claim is whether the Estate has met its burden of proving that there is a reasonable medical basis for the attesting physician's finding that Mr. Kennedy did not have a congenital aortic valve abnormality. See id. Rule 24. Ultimately, if we determine that there is no reasonable medical basis for the answer in the 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 reasonable medical basis for the answer, we must enter an Order directing the Trust to pay the claim in accordance with the Settlement Agreement. See id. Rule 38 (b).

In support of its claim, the Estate reasserts the arguments made in contest. The Estate also argues that the reasonable medical basis standard requires that deference be given to the conclusions of the attesting physician. In addition, the Estate contends that, because the auditing cardiologist did not find evidence of a bicuspid aortic valve on Mr. Kennedy's February 7, 2002 echocardiogram, the bicuspid valve was not "congenital" as required by the Settlement Agreement. The Estate also submitted a declaration of Paul W. Dlabal, M.D., F.A.C.P., F.A.C.C., F.A.H.A., who stated, in pertinent part:

Finally, the Estate asserts that the Settlement Agreement and the Seventh Amendment to the Settlement Agreement "guaranteed class members certain benefits related to valve surgery."

In response, the Trust argues that the Estate has not established a reasonable medical basis for Dr. Muttreja's representation that Mr. Kennedy did not have a congenital aortic valve abnormality. In addition, the Trust asserts that it properly applied the reasonable medical basis standard.

The Technical Advisor, Dr. Vigilante, reviewed the echocardiograms dated February 7, 2002; March 5, 2007; and March 28, 2007 and concluded that there was no reasonable medical basis for the attesting physician's finding that Mr. Kennedy did not have a congenital aortic valve abnormality. As to the February 7, 2002 echocardiogram, Dr. Vigilante stated, in pertinent part:

As to the March 5, 2007 echocardiogram, Dr. Vigilante observed that, "In the parasternal long-axis view, the [aortic] valve did not close in the middle axis with a congenital bicuspid aortic valve noted.'' As to the March 28, 2007 echocardiogram, Dr. Vigilante explained, in pertinent part:

Evaluation of the aortic valve demonstrated this to be an obvious congenital bicuspid valve with congenital fusion of the left and right coronary leaflets. There was a raphe noted between these two leaflets. . . . This congenital bicuspid valve was obvious in real time loops 10, 11, 12, 13, 28, 29, 30, and 43 . . . . It should be noted that Dr. Dlabal is wrong when he stated that there was no evidence of a bicuspid aortic valve on this study. Indeed, the three screen shots submitted by Dr. Dlabal clearly show a bicuspid aortic valve with a raphe between the right and left coronary leaflets classic for a congenitally bicuspid aortic valve.

In response to the Technical Advisor Report,14 the Estate argues that the Technical Advisor substituted his own opinion for that of Mr. Kennedy's cardiologists and that he did not consider all of the relevant evidence, including evidence supportive of the Estate's arguments.15

After reviewing the entire Show Cause Record, we find the Estate's arguments are without merit. As noted, the Settlement Agreement requires that a claim for Level III Matrix Benefits based on damage to the aortic valve be reduced to the B Matrix if the Diet Drug Recipient had a congenital aortic valve abnormality, such as a bicuspid valve. See Settlement Agreement § IV.B.2.d. (2) (c)i)a). According to claimant, there is a reasonable medical basis for finding Mr. Kennedy did not have a congenital aortic valve because Dr. Dlabal found that Mr. Kennedy's March 28, 2007 echocardiogram did not show a bicuspid aortic valve.

Dr. Parmar, however, reviewed the March 28, 2007 echocardiogram and determined that it demonstrated a bicuspid aortic valve.16 In addition, Dr. Vigilante reviewed the March 28, 2007 echocardiogram and concluded it "to be an obvious congenital bicuspid valve with congenital fusion of the left and right coronary leaflets." Dr. Vigilante also observed that "the three screen shots submitted by Dr. Dlabal clearly show a bicuspid aortic valve with a raphe between the right and left coronary leaflets classic for a congenitally bicuspid aortic valve."17

Significantly, although the Estate argued that Mr. Kennedy's valve could not have been "congenital" unless it was present on the February 7, 2002 and March 5, 2007 echocardiograms, the Estate's physicians did not specifically address these echocardiograms. As to these echocardiograms, the Estate relies only on the echocardiogram reports. These reports, however, do not establish that Mr. Kennedy did not have a bicuspid aortic valve. In fact, neither report states that Mr. Kennedy's aortic valve was normal or trileaflet. In addition, Dr. Vigilante reviewed these two echocardiograms and concluded that both studies were diagnostic of a bicuspid aortic valve.18

In addition, the Estate's argument that the pathology report, which specifically notes in the "Final Diagnosis" that Mr. Kennedy had a "[c]ongenitally bicuspid aortic valve with fibrosis," should be disregarded because the presence of a congenital aortic valve abnormality only can be determined through echocardiographic evidence or surgical examination is misplaced.19 The Settlement Agreement identifies certain reduction factors that are only applicable when there is echocardiographic evidence of the condition. See e.g., Settlement Agreement§ IV.B.2.d. (2) (c)ii)e) (rheumatic mitral valve); § I.39 (mitral valve prolapse). As nothing in the Settlement Agreement limits application of the reduction factor of congenital aortic valve abnormalities to those that are present based solely on a review of an echocardiogram, a cardiac catheterization, or surgical examination, we decline the Estate's request to impose this limitation. In any event, Dr. Parmar and Dr. Vigilante each found echocardiographic evidence of a bicuspid aortic valve.20

Finally, we do not agree that the Estate is entitled to Matrix A-1, Level III benefits under the Seventh Amendment. As an initial matter, the Seventh Amendment specifically states, "The determinations and actions of the Trust on any aspect of a claim for Cash/Medical Services Benefits of a Category One Class Member or Category Two Class Member, or on any claim for the Matrix Election Payment, shall have no preclusive or precedential effect of any kind on the Trust in the administration . . . of claims for Seventh Amendment Matrix Compensation Benefits."21 Seventh Amendment § IX.E. The Seventh Amendment further provides that:

Id. § IX.A.2. (emphasis added). Section IV.B.2.d. sets forth "[t]he circumstances which determine whether Matrix A-1 or Matrix B-1 is applicable. . . ." Settlement Agreement § IV.B.2.d. As the Estate has not established a reasonable medical basis for finding that Mr. Kennedy did not have a congenital aortic valve abnormality, the Settlement Agreement requires that the Estate's Level III claim be reduced to the B Matrix.

Therefore, we will affirm the Trust's denial of the Estate's claim for Matrix A-1 benefits and the related derivative claim submitted by Mr. Kennedy's spouse, Patti Kennedy.