MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 8907

HARVEY BARTLE, Judge.

Carol M. Rounds ("MS. Rounds" 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 claimant has demonstrated a reasonable medical basis to support her claim for Matrix Compensation Benefits (" Matrix Benefits").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 must complete Part III if claimant is represented.

In September, 2002, claimant submitted a completed Green Form to the Trust signed by her attesting physician, Robert E. Fowles, M.D., F.A.C.C. Dr. Fowles is no stranger to this litigation. According to the Trust, he has signed at least 109 Green Forms on behalf of claimants seeking Matrix Benefits. Based on an echocardiogram dated March 26, 2002, Dr. Fowles attested in Part II of claimant's Green Form that Ms. Rounds suffered from severe mitral regurgitation, an abnormal left atrial dimension, and a reduced ejection fraction in the range of 50% to 60%.4 Based on such findings, claimant would be entitled to Matrix A-1, Level II benefits in the amount of $462,103.5

In the report of claimant's echocardiogram, the reviewing cardiologist, Alan A. Gabster, M.D., stated that Ms. Rounds had left atrial enlargement with a left atrial dimension of 44 mm. The Settlement Agreement defines an abnormal left atrial dimension as a left atrial supero-inferior systolic dimension greater than 5.3 em in the apical four chamber view or a left atrial antero-posterior systolic dimension greater than 4.0 em in the parasternal long axis view. See Settlement Agreement§ IV.B.2.c. (2) (b) ii). Dr. Gabster also measured claimant's ejection fraction to be 72%. An ejection fraction is considered reduced for purposes of a mitral valve claim if it is measured as less than or equal to 60%. See id. § IV. B. 2. c. (2) (b) iv).

In November, 2005, the Trust forwarded the claim for review by Vincent L. Sorrell, M.D., F.A.C.P., F.A.C.C., one of its auditing cardiologists. In audit, Dr. Sorrell determined that there was no reasonable medical basis for the attesting physician's finding that claimant had an abnormal left atrial dimension or a reduced ejection fraction in the range of 50% to 60%. Specifically, Dr. Sorrell measured claimant's left atrial antero-posterior dimension to be 37 mm and her left atrial supero-inferior dimension to be 50 mm. In addition, he explained that "[t]he [left atrial antero-posterior dimension] shown on the video was off-axis." With respect to claimant's ejection fraction, Dr. Sorrell noted that "[t]he [left ventricular ejection fraction] was entirely normal at >60%."

Based on the auditing cardiologist's findings, 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.6 In contest, claimant argued that there was a reasonable medical basis for the attesting physician's finding of an abnormal left atrial dimension.7 In support, Ms. Rounds submitted a notarized letter from Richard L. Callihan, M.D.,8 who asserted that claimant had an abnormal left atrial dimension. Specifically, Dr. Callihan wrote, in pertinent part, that:

Although not required to do so, the Trust forwarded the claim to the auditing cardiologist for a second review. Dr. Sorrell submitted a declaration in which he again concluded that there was no reasonable medical basis for the attesting physician's finding that claimant suffered from an abnormal left atrial dimension. Specifically, Dr. Sorrell stated:

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 the claim should be paid. On June 21, 2006, we issued an Order to show cause and referred the matter to the Special Master for further proceedings. See PTO No. 6384 (June 21, 2006).

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 September 27, 2006. Under the Audit Rules, it is within the Special Master's discretion to appoint a Technical Advisor9 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 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 in proving that there is a reasonable medical basis for the attesting physician's finding that she had an abnormal left atrial dimension. 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 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).

The Technical Advisor, Dr. Abramson, reviewed claimant's echocardiogram and concluded that there was no reasonable medical basis for the attesting physician's finding of an abnormal left atrial dimension. Specifically, Dr. Abramson stated that:

After reviewing the entire Show Cause Record, we find claimant's arguments are without merit. As stated above, the Settlement Agreement defines an abnormal left atrial dimension as a left atrial supero-inferior systolic dimension greater than 5.3 em in the apical four chamber view or a left atrial antero-posterior systolic dimension greater than 4.0 em in the parasternal long axis view. See Settlement Agreement § IV.B.2.c. (2) (b)ii). Here, both Dr. Sorrell and Dr. Abramson found that claimant's left atrial antero-posterior systolic dimension measured no more than 3.8 em in the parasternal long-axis view. In addition, Dr. Sorrell observed that "[t]he [left atrial antero-posterior dimension] shown on the video was off-axis," and Dr. Abramson concluded that "[t]he left atrium measurement on the tape was incorrectly obtained on an oblique angle; therefore the dimension obtained by the technologist (4. 4 em) on the tape is larger than the true dimension."10 While claimant's expert, Dr. Callihan, opines that "the measurement is taken from the leading edge of the posterior aortic wall to the leading edge of the posterior wall of the left atrium," he does not address whether the image is off-axis.11 Such unacceptable practices cannot provide a reasonable medical basis for the resulting diagnoses and Green Form answer.

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 an abnormal left atrial dimension. Therefore, we will affirm the Trust's denial of the claim of Ms. Rounds for Matrix Benefits and the related derivative claim submitted by her spouse.