MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9201
HARVEY BARTLE, III, District Judge.
Cynthia L. Elliott ("Ms. Elliott" 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"). 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").2
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.
Under the Settlement Agreement, only eligible claimants are entitled to Matrix Benefits. Generally, a claimant is considered eligible for Matrix Benefits if he or she is diagnosed with mild or greater aortic and/or mitral regurgitation by an echocardiogram performed between the commencement of Diet Drug use and the end of the Screening Period.3 See Settlement Agreement § IV.B.1.a.
In January, 2003, claimant submitted a completed Green Form to the Trust signed by her attesting physician, George P. Hanna, M.D., F.A.C.C. Based on an echocardiogram dated October 24, 2002, Dr. Hanna attested in Part II of claimant's Green Form that Ms. Elliott suffered from mild mitral regurgitation and had surgery to repair or replace the aortic and/or mitral valve(s) following the use of Pondimin® and/or Redux2122.4 Based on such findings, claimant would be entitled to Matrix B-1,5 Level III benefits in the amount of $152,118.6
In the report of claimant's echocardiogram, Dr. Hanna stated that claimant had mild mitral regurgitation. Dr. Hanna, however, did not specify a percentage as to claimant's level of mitral regurgitation. Under the definition set forth in the Settlement Agreement, mild mitral regurgitation is defined as "(1) either the RJA/LAA ratio is more than five percent (5%) or the mitral regurgitation jet height is greater than 1 cm from the valve orifice, and (2) the RJA/LAA ratio is less than twenty percent (20%)." Settlement Agreement§ I.38.
In January, 2012, the Trust forwarded the claim for review by Noyan Gokce, M.D., F.A.C.C., F.A.S.E., one of its auditing cardiologists. In audit, Dr. Gokce determined that there was no reasonable medical basis for the attesting physician's representation that Ms. Elliott had at least mild mitral regurgitation between the commencement of Diet Drug use and the end of the Screening Period. Specifically, Dr. Gokce explained, "The study is technically limited. There was no evidence of any sustained or discernable jet of mitral regurgitation in any of the views."7
Based on Dr. Gokce's finding that there was no reasonable medical basis for finding that Ms. Elliott had at least mild mitral regurgitation between the commencement of Diet Drug use and the end of the Screening Period, the Trust issued a post-audit determination denying Ms. Elliott's claim. Pursuant to the Rules for the Audit of Matrix Compensation Claims ("Audit Rules"), claimant contested this adverse determination.8 In contest, Ms. Elliott argued that the reports of her August 30, 2000 and October 24, 2002 echocardiograms indicate at least mild mitral regurgitation. According to claimant, the auditing cardiologist substituted his opinion for that of her treating cardiologist.
Although not required to do so, the Trust forwarded the claim for a second review by the auditing cardiologist. Dr. Gokce submitted a declaration in which he again concluded that there was no reasonable medical basis for the attesting physician's representation that Ms. Elliott had mild mitral regurgitation. Specifically, Dr. Gokce explained, in pertinent part:
8. I was asked to determine whether there is a reasonable medical basis (1) for the Green Form representation that claimant had mild mitral regurgitation and (2) for Claimant's assertion in Contest, that she had mild mitral regurgitation in between Diet Drug use and the close of the Screening Period (January 3, 2003), based upon studies dated 8/30/00 and 10/24/02.
9. In accordance with the Trust's request, I reviewed the Claim and Claimant's Contest. I reviewed the 10/24/02 echocardiogram of attestation, the 6/19/01 study, and the report of the study dated 8/30/00. (The 8/30/00 study was not available for review.)
10. I confirm my finding at audit that there is no reasonable medical basis for the Attesting Physician's Green Form representation that Claimant had mild mitral regurgitation. As I noted at the time of audit, the October 24, 2002 echocardiogram of attestation is of very poor quality, and there are no findings by Color Doppler assessment that would qualify for even mild mitral regurgitation, as defined by audit criteria, in any views. There is no reasonable medical basis to conclude that mild mitral regurgitation is present on this study which is technically poor quality.
11. I also find, after review of Claimant's medical records at Contest, including the 10/24/02 echocardiogram of attestation, the 6/19/01 study, and the 8/30/00 echo report, that there is no reasonable medical basis to conclude that Claimant had mild mitral regurgitation in between Diet Drug use and the close of the Screening Period (January 3, 2003). The June 16, 2001 [sic] study is of very poor quality. By Color Doppler, there is nothing that that [sic] qualifies as mild mitral regurgitation. There is no reasonable medical basis to conclude that mild mitral regurgitation is present on the June 16, 2001 [sic] study.
The Trust then issued a final post-audit determination, again denying Ms. Elliott's 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 July 9, 2012, we issued an Order to show cause and referred the matter to the Special Master for further proceedings. See PTO No. 8904 (July 9, 2012).
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 informed the Special Master by letter dated November 15, 2012 that it did not intend to submit a reply. 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, 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 finding that Ms. Elliott suffered from at least mild mitral regurgitation between the commencement of Diet Drug use and the end of the Screening Period. 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 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 her claim, Ms. Elliott reasserts that there is a reasonable medical basis for Dr. Hanna's representation that she had mild mitral regurgitation. According to claimant, she received a letter from the Trust confirming that she was FDA Positive based on an echocardiogram performed in the Screening Program by Dr. Hanna.10 In addition, claimant notes that she received benefits pursuant to the Seventh Amendment because she had aortic and mitral regurgitation. Claimant also contends that she would have obtained another echocardiogram if the Trust had timely informed her that the October 24, 2002 echocardiogram was of poor quality. Finally, claimant asserts that two physicians can read the same study and come to different conclusions.
The Technical Advisor, Dr. Vigilante, reviewed claimant's echocardiograms and concluded that there was no reasonable medical basis for finding that Ms. Elliott had mild mitral regurgitation prior to the end of the Screening Period. Specifically, Dr. Vigilante explained, in pertinent part:
I reviewed the tape of the Claimant's echocardiogram of attestation. The Claimant's name and date of October 24, 2002 were documented on the study. . . . This was a poor quality study. There was poor ultrasound transmission with decreased endocardial definition. There was increased echo gain. The Nyquist was appropriately set at 57 cm/sec at 24 cm of depth in the apical four chamber view. In addition, this was an incomplete study as there was no evaluation of the aortic regurgitant jet in the parasternal long-axis view and there was no evaluation of mitral regurgitation in the apical two chamber view.
. . . . Visually, mitral regurgitation was not seen on color flow evaluation in the apical four chamber view. I digitized the cardiac cycles in the apical four chamber view during color flow evaluation. In a frame-by-frame evaluation, there was no sustained jet of mitral regurgitation seen on this study. Pulse wave Doppler of this study failed to demonstrate an envelope of mitral regurgitation . . . .
. . . .
I also reviewed the tape of the Claimant's echocardiogram of June 19, 2001 . . . . This was a poor quality study with poor ultrasound transmission and decreased endocardial definition. In addition, there was no evaluation of mitral regurgitation in the apical two chamber view.
. . . . Evaluation in the apical four chamber view failed to demonstrate a sustained jet of mitral regurgitation. On continuous wave Doppler, a faint jet of [mitral regurgitation] was noted. However, there was no RJA that could be possibly planimetered on this study . . . .
After reviewing the entire Show Cause Record, we find the claimant's arguments are without merit. As an initial matter, claimant does not adequately rebut the findings of the auditing cardiologist or the Technical Advisor. Dr. Gokce reviewed claimant's June 19, 2001 and October 24, 2002 echocardiograms and determined that there was no evidence of mild mitral regurgitation. Although claimant contested the findings, she did not identify any error in his analysis.11 In addition, Dr. Vigilante reviewed claimant's June 19, 2001 and October 24, 2002 echocardiograms and concluded that "these two echocardiograms do not show a sustained jet of mitral regurgitation in the apical four chamber view."12 Mere disagreement with the auditing cardiologist and the Technical Advisor without identifying any specific errors by them is insufficient to meet a claimant's burden of proof.
We also reject claimant's assertion that she is entitled to Matrix Benefits because her eligibility echocardiogram was conducted in the Screening Program for Fund A Benefits under the Settlement Agreement. See Settlement Agreement § IV.A. The Settlement Agreement clearly provides that the sole benefit a class member is entitled to receive for a favorable echocardiogram under the Screening Program is a limited amount of medical services or a limited cash payment:
All Diet Drug Recipients in Subclass 2(b) and those Diet Drug Recipients in Subclass 1(b) who have been diagnosed by a Qualified Physician as FDA Positive by an Echocardiogram performed between the commencement of Diet Drug use and the end of the Screening Period, will be entitled to receive, at the Class Member's election, either (i) valve-related medical services up to $10,000 in value to be provided by the Trust; or (ii) $6,000 in cash.
Id. § IV.A.1.c. Thus, by the plain terms of the Settlement Agreement, a Screening Program echocardiogram does not automatically entitle a claimant to Matrix Benefits.
Indeed, this conclusion is confirmed by the Settlement Agreement provisions concerning claimants eligible for Matrix Benefits. Specifically, claimants receiving a diagnosis of FDA Positive or mild mitral regurgitation merely become eligible to seek Matrix Benefits. See id. § IV.B.1. Further, adopting claimant's position would be inconsistent with § VI.E. of the Settlement Agreement, which governs the audit of claims for Matrix Benefits, as well as this Court's decision in PTO No. 2662, which mandated a 100% audit requirement for all claims for Matrix Benefits. See Mem. in Supp. of PTO No. 2662 at 13 (Nov. 26, 2002). As nothing in the Settlement Agreement supports the conclusion that a favorable Screening Program echocardiogram for purposes of Fund A Benefits results in an immediate entitlement to Matrix Benefits, we decline claimant's request to interpret the Settlement Agreement in this fashion.
Finally, to the extent claimant attempts to rely on inter-reader variability to establish a reasonable medical basis for the attesting physician's representation that she had mild mitral regurgitation, such reliance is misplaced. The concept of inter-reader variability is already encompassed in the reasonable medical basis standard applicable to claims under the Settlement Agreement. In this instance, the attesting physician's opinion cannot be medically reasonable where the auditing cardiologist and the Technical Advisor concluded, and claimant did not adequately dispute, that Ms. Elliott's June 19, 2001 and October 24, 2002 echocardiograms did not demonstrate even mild mitral regurgitation. Adopting claimant's argument would allow a claimant to recover benefits without meeting the requirements of the Settlement Agreement.13
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 at least mild mitral regurgitation between the commencement of Diet Drug use and the end of the Screening Period. Therefore, we will affirm the Trust's denial of Ms. Elliott's claim for Matrix B-1, Level III benefits.