MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9112

HARVEY BARTLE, III, District Judge.

Debbie Gordon ("Ms. Gordon" or "claimant"), a class member 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 Ms. Gordon has demonstrated a reasonable medical basis to support her claim for Matrix Compensation Benefits ("Matrix Benefits") and, if so, whether she met her burden of proving that her claim was not based, in whole or in part, on any intentional material misrepresentation of fact.3

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 completes Part III if claimant is represented.

In January, 2003, claimant submitted a completed Green Form to the Trust signed by her attesting physician, W. Marcus Brann, M.D., F.A.C.C., F.A.C.P. Dr. Brann is no stranger to this litigation. According to the Trust, he has signed at least 765 Green Forms on behalf of claimants seeking Matrix Benefits. Based on an echocardiogram dated November 7, 2002, Dr. Brann attested in Part II of Ms. Gordon's Green Form that she suffered from moderate mitral regurgitation and an abnormal left atrial dimension.4 Based on such findings, claimant would be entitled to Matrix A-1, Level II benefits in the amount of $578,687.5

In the report of claimant's echocardiogram, Dr. Brann stated that Ms. Gordon had moderate mitral regurgitation of 25%. Under the definition set forth in the Settlement Agreement, moderate or greater mitral regurgitation is present where the Regurgitant Jet Area ("RJA") in any apical view is equal to or greater than 20% of the Left Atrial Area ("LAA"). See Settlement Agreement § 1.22. Dr. Brann also stated that "[t]here is mild left atrial enlargement" and noted that the left atrium measured 60 mm in the supero-inferior dimension and 41 mm in the antero-posterior dimension. The Settlement Agreement defines an abnormal left atrial dimension as a left atrial supero-inferior systolic dimension greater than 5.3 cm in the apical four chamber view or a left atrial antero-posterior systolic dimension greater than 4.0 cm in the parasternal long axis view. See id. § IV.B.2.c.(2)(b)ii).

In November, 2005, the Trust forwarded the claim for review by Maged M. Rizk, M.D., Ph.D., F.A.C.C., one of its auditing cardiologists. Dr. Rizk accepted Dr. Brann's findings of moderate mitral regurgitation and an enlarged left atrial dimension. Pursuant to Court Approved Procedure ("CAP") No. 11, the Consensus Expert Panel subsequently reviewed Ms. Gordon's claim and determined the claim should be re-audited because the "[d]egree of [mitral regurgitation] appears less than moderate."6 In June, 2006, the Trust informed Ms. Gordon that it had accepted the Consensus Expert Panel's recommendation that her claim be re-audited.

In July, 2006, the Trust forwarded the claim for review by another auditing cardiologist, Craig M. Oliner, M.D. Dr. Oliner also concluded that there was a reasonable medical basis for Dr. Brann's findings that claimant had moderate mitral regurgitation and an abnormal left atrial dimension. With respect to the level of Ms. Gordon's mitral regurgitation, Dr. Oliner observed, "Although the RJA's are overtraced and include non-[mitral regurgitant] signal and the LAA is undertraced by not including the whole [left atrium], the estimated RJA/LAA is aprroximately [sic] 20%." With respect to her left atrial dimension, Dr. Oliner measured Ms. Gordon's left atrial dimension in the supero-inferior dimension to be 59 mm.

Pursuant to Rule 5 of the Rules for the Audit of Matrix Compensation Claims ("Audit Rules"), the Trust undertook "to determine whether there were any intentional material misrepresentations made in connection with the Claim." As part of this review, the Trust engaged Joseph Kisslo, M.D., to review the integrity of echocardiogram system use during the performance of echocardiographic studies and the resulting interpretations submitted in support of certain claims. As stated in his January 26, 2007 declaration, Dr. Kisslo determined, in pertinent part, that:

Thus, notwithstanding Dr. Oliner's findings at audit, the Trust issued a post-audit determination denying Ms. Gordon's claim based on its conclusion that there was substantial evidence of intentional material misrepresentation of fact in connection with the claim. Pursuant to the Audit Rules, Ms. Gordon contested this adverse determination.7 In contest, claimant noted that she did not dispute the findings of the Trust's two auditing cardiologists who determined there was a reasonable medical basis for her claim. She also attached a September 8, 2005 letter from Class Counsel to the Trust8 and a motion filed on claimant's behalf to enforce the Settlement Agreement.9

The Trust then issued a final post-audit determination, again denying Ms. Gordon's claim. The Trust asserted that Ms. Gordon's contest did not comply with Audit Rule 18(b) because "[ilt does not state the factual reasons for [her] Contest, nor does it identify any alleged errors made by Dr. Kisslo in his Declaration." The Trust further noted that the contest "does not include a verified statement of a medical expert, nor any other evidence relating to the specific issues present in [Ms. Gordon's] claim." The Trust, using Dr. Kisslo's findings for support, also reasserted its allegation that Ms. Gordon's claim contained substantial evidence of intentional material misrepresentations.

Ms. Gordon disputed, the Trust's final determination and requested that her claim proceed through the show cause process as 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 Ms. Gordon's claim should be paid. On June 12, 2007, we issued an Order to show cause and referred the matter to the Special Master for further proceedings. See PTO No. 7253 (June 12, 2007).

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, incorporating by reference the materials she submitted in contest. The Trust did not reply. Under the Audit Rules, it is within the Special Master's discretion to appoint a Technical Advisor10 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, Gary J. Vigilante, M.D., F.A.C.C., to review the documents submitted by the Trust and claimant and to prepare a report for the court. 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 claimant has met her burden of proving that there is a reasonable medical basis for the attesting physician's finding that she suffered from moderate mitral regurgitation and an abnormal left atrial dimension. Where the Trust's Post-Audit Determination finds intentional misrepresentation of fact, the claimant has the burden of proving that all representations of material fact in connection with her claim are true. See id. Rule 24. Ultimately, if we determine that there is no reasonable medical basis for the answers in claimant's Green Form either because of an intentional material misrepresentation of fact or some other valid reason, 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 answers and no intentional material misrepresentation of fact made in connection with the claim, we must enter an Order directing the Trust to pay the claim in accordance with the Settlement Agreement. See id. Rule 38(b).

The Technical Advisor, Dr. Vigilante, reviewed claimant's echocardiogram and concluded that it was not conducted in a manner consistent with medical standards. Specifically, Dr. Vigilante observed:

Despite these deficiencies, Dr. Vigilante noted that he was able to evaluate claimant's echocardiogram and determined that there was no reasonable medical basis for the attesting physician's finding that claimant had moderate mitral regurgitation. Dr. Vigilante explained, in pertinent part, that:

After reviewing the entire Show Cause Record, we find claimant has not established a reasonable medical basis for the attesting physician's finding that she had moderate mitral regurgitation. In reaching this determination, we are required to apply the standards delineated in the Settlement Agreement and Audit Rules. In the context of those two documents, we have previously explained that conduct "beyond the bounds of medical reason" can include: (1) failing to review multiple loops and still frames; (2) failing to have a Board Certified Cardiologist properly supervise and interpret the echocardiogram; (3) failing to examine the regurgitant jet throughout a portion of systole; (4) over-manipulating echocardiogram settings; (5) setting a low Nyquist limit; (6) characterizing "artifacts," "phantom jets," "backflow" and other low velocity flow as mitral regurgitation; (7) failing to take a claimant's medical history; and (8) overtracing the amount of a claimant's regurgitation. See Mem. in Supp. of PTO No. 2640 at 9-13, 15, 21-22, 26 (Nov. 14, 2002).

Here, Dr. Kisslo and Dr. Vigilante each found that claimant's sonographer improperly selected, traced, and measured a supposed regurgitant "jet" that consisted of backflow rather than true high velocity sustained regurgitant flow. In addition, they determined that the sonographer underestimated claimant's LAA, which artificially increased the level of Ms. Gordon's regurgitation. Finally, Dr. Kisslo and Dr. Vigilante found that the echocardiogram of attestation was not conducted in a manner consistent with medical standards because, among other things, the echocardiogram settings included clear evidence of excessive image gain, excessive color gain, decreased velocity scale and PRF, and decreased low velocity reject.

Notwithstanding these deficiencies, Dr. Kisslo and Dr. Vigilante determined that Ms. Gordon's echocardiogram demonstrated only mild mitral regurgitation. In addition, Dr. Vigilante concluded, after a thorough review, that there was no reasonable medical basis for the attesting physician's opinion that Ms. Gordon had moderate mitral regurgitation.11 Specifically, he explained that "the RJA/LAA ratio was less than 16% in those cardiac cycles in which the mitral regurgitation appeared most severe" and that "[t]he majority of cardiac cycles demonstrated RJA/LAA ratios much less than 16%."

Claimant does not substantively challenge the specific findings of Dr. Kisslo and Dr. Vigilante regarding the manner in which her echocardiogram was conducted or her level of mitral regurgitation was evaluated. Rather, claimant refers to documents that contend Dr. Kisslo lacked the requisite independence to validate his findings. Notably, Ms. Gordon makes no such contention against Dr. Vigilante, an independent cardiologist appointed by the court who reached similar conclusions during a separate review. Without identifying some specific error by the Trust's expert and the Technical Advisor, claimant cannot meet her burden of proof in establishing that her claim is payable.

We also reject claimant's argument that she should be paid because her claim passed a second audit pursuant to CAP No. 11 and the Trust therefore was not permitted to submit the claim for review by Dr. Kisslo. As an initial matter, this argument is belied by the express terms of CAP No. 11, which permit the Trust to deny a claim for an intentional misrepresentation of fact after re-audit. Specifically, CAP No. 11 states, in pertinent part, that:

See CAP No. 11 ¶ 10. This argument also ignores the plain language of the Audit Rules, which provides that the Trust must conduct a review separate from the auditing cardiologist with respect to intentional material misrepresentations. Specifically, the Audit Rules state, in pertinent part, that:

Audit Rule 5. Based on the findings of Dr. Kisslo, the Trust denied Ms. Gordon's claim, determining that the claim was based on one or more intentional material misrepresentations of fact.

Ms. Gordon disputed this determination and proceeded to the show cause process. We need not determine whether there was, in fact, any intentional material misrepresentation of fact in connection with Ms. Gordon's claim given our conclusion, based on our review of the entire record, that there is no reasonable medical basis for Dr. Brann's representation that claimant had moderate mitral regurgitation.12

For the foregoing reasons, we conclude that claimant has not met her burden of proving that there is a reasonable medical basis for finding that she had moderate mitral regurgitation. Therefore, we will affirm the Trust's denial of Ms. Gordon's claim for Matrix Benefits and the related derivative claim submitted by her spouse.13