MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9464

HARVEY BARTLE, District Judge.

Tamara J. Schatz ("Ms. Schatz" 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. Schatz 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, the claimant's attorney must complete Part III if the 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.4 See Settlement Agreement §§ IV.B.1.a. & I.22.

In June 2014, Ms. Schatz submitted a completed Green Form to the Trust signed by her attesting physician, Azam U. Anasari, M.D., F.A.C.C., F.A.H.A. ("Dr. Ansari"). Based on an echocardiogram dated September 14, 2013,5 Dr. Ansari attested in Part II of Ms. Schatz's Green Form that she suffered from moderate mitral regurgitation and an abnormal left atrial dimension.6 Based on such findings, Ms. Schatz would be entitled to Matrix A-1, Level II benefits in the amount of $678,025.7

In the report of the March 24, 2003 echocardiogram, Dr. Ansari stated that Ms. Schatz had moderate mitral regurgitation, which he measured at 29%. Under the definition set forth in the Settlement Agreement, moderate 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 § I.22.

The Settlement Agreement requires the payment of reduced Matrix Benefits to a claimant who is diagnosed with mild mitral regurgitation8 by an echocardiogram that was performed between the commencement of Diet Drug use and the end of the Screening Period. See id. § IV.B.2.d. (2) (a). As the Trust does not contest the entitlement of Ms. Schatz to Level II benefits, the only issue before us is whether she is entitled to payment on Matrix A-1 or Matrix B-1.

In August 2014, the Trust forwarded the claim for review by Waleed N. Irani, M.D., F.A.C.C., F.A.S.E. ("Dr. Irani"), one of its auditing cardiologists. In audit, Dr. Irani concluded that there was no reasonable medical basis for finding that the March 24, 2003 eligibility echocardiogram demonstrated moderate, as opposed to mild, mitral regurgitation. Specifically, Dr. Irani explained, mitral regurgitation "appears mild on review of all motion images. Still frame image in one view traced giving appearance of larger jet but no hint of moderate [mitral regurgitation] on remainder of" the echocardiogram.

Based on Dr. Irani's finding that Ms. Schatz had only mild mitral regurgitation between the commencement of Diet Drug use and the end of the Screening Period, the Trust issued a post-audit determination that Ms. Schatz was entitled only to Matrix B benefits. Pursuant to the Rules for the Audit of Matrix Compensation Claims (the "Audit Rules"), Ms. Schatz contested this adverse determination.9 In contest, Ms. Schatz argued that the auditing cardiologist should have measured still frame images from her March 24, 2003 echocardiogram rather than "eyeballing" the level of her mitral regurgitation. She also contended that she was entitled to Matrix Benefits because the Trust informed her in connection with the Screening Program that her March 24, 2003 echocardiogram demonstrated moderate mitral regurgitation.10

In addition, Ms. Schatz submitted a verified statement from Dr. Ansari, who confirmed his finding of moderate mitral regurgitation based on Ms. Schatz's March 24, 2003 echocardiogram. Dr. Ansari explained that, unlike the auditing cardiologist, he measured Ms. Schatz's level of mitral regurgitation. He also stated that given Ms. Schatz's pre-Diet Drug health her mitral regurgitation was likely caused by her Diet Drug use. In support of Dr. Ansari's conclusion, Ms. Schatz included still frame images that purportedly demonstrated moderate mitral regurgitation.

Although not required to do so, the Trust forwarded the claim for a second review by the auditing cardiologist. Dr. Irani submitted a declaration in which he again concluded that Ms. Schatz's March 24, 2003 echocardiogram demonstrated only mild mitral regurgitation. Specifically, Dr. Irani stated:

The Trust then issued a final post-audit determination, again determining that Ms. Schatz was entitled only to Matrix B-1, Level II benefits. Ms. Schatz 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.; Audit Rule 18(c). The Trust then applied to the court for issuance of an Order to Show Cause why Ms. Schatz's claim should be paid. On April 20, 2015, we issued an Order to Show Cause and referred the matter to the Special Master for further proceedings. See PTO No. 9407 (Apr. 20, 2015).

Once the matter was referred to the Special Master, the Trust submitted its statement of the case and supporting documentation. Ms. Schatz then served a response upon the Special Master. The Trust submitted a reply on June 19, 2015, and Ms. Schatz submitted a sur-reply on July 20, 2015. 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 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. ("Dr. Vigilante"), to review the documents submitted by the Trust and Ms. Schatz 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 Audit 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 she suffered from at least moderate mitral regurgitation between the commencement of Diet Drug use and the end of the Screening Period. See Audit Rule 24. Ultimately, if we determine that there is no reasonable medical basis for this finding, we must affirm the Trust's final determination and may grant such other relief as deemed appropriate. See Audit Rule 38(a). If, on the other hand, we determine that there is a reasonable medical basis for this finding, we must enter an Order directing the Trust to pay the claim in accordance with the Settlement Agreement. See Audit Rule 38(b).

In support of her claim, Ms. Schatz repeats the arguments raised in contest. In addition, Ms. Schatz contends that she has established a reasonable medical basis for her claim because: (1) the Trust misquoted Dr. Irani's supplemental declaration when it said Dr. Ansari's measurement was "28% greater than my own," because it should be "28% smaller than my own" and misquoted her argument regarding "eyeballing" to be "world of the court" rather than "world of cardiology"; (2) she included three consecutive still frame images that allegedly demonstrate moderate mitral regurgitation (which she contends satisfies the Trust's contention that "a true jet of mitral regurgitation must last at least one-tenth of a second"); (3) Dr. Irani's opinion cannot be relied upon, as it is internally inconsistent; (4) Dr. Irani did not "show his work"; and (5) the Trust did not follow the requirements of the Settlement Agreement.

Ms. Schatz also submitted another verified statement from Dr. Ansari, who again confirmed his finding of moderate mitral regurgitation on the March 24, 2003 echocardiogram. Specifically, Dr. Ansari stated that the mitral regurgitation on the echocardiogram was determined from the maximum jet area, as required by the Settlement Agreement. He also observed that the mitral regurgitation in the still frame images consisted of two regurgitant jets, but that the auditing cardiologist only measured one of these jets. Dr. Ansari further explained that the auditing cardiologist's review and opinion do not meet the requirements of the Settlement Agreement. In addition, he contended that the discrepancies between his findings and those of the auditing cardiologist were due to "significant intra-reader variability." Finally, Dr. Ansari maintained that Ms. Schatz's echocardiogram "is best interpreted within the clinical context at the time" that the echocardiogram was performed.

In response, the Trust asserts that the findings of the auditing cardiologist demonstrate there is no reasonable medical basis for Dr. Ansari's finding of moderate mitral regurgitation on the March 24, 2003 echocardiogram. In particular, the Trust notes that the still frame images on which Dr. Ansari relied were not representative of the level of mitral regurgitation throughout the study. The Trust also argues that the court has repeatedly and consistently approved the use of "eyeballing" in determining the level of regurgitation on an echocardiogram. Finally, the Trust contends that the letter reporting the initial results of Ms. Schatz's March 24, 2003 echocardiogram as part of the Screening Program do not require the payment of Matrix Benefits.

The Technical Advisor, Dr. Vigilante, reviewed the echocardiogram of Ms. Schatz and concluded that there was no reasonable medical basis for finding that Ms. Schatz's March 24, 2003 echocardiogram demonstrated at least moderate mitral regurgitation. Specifically, Dr. Vigilante determined, in pertinent part:

In response to the Technical Advisor report, Ms. Schatz relies primarily on her previous arguments to establish that her March 24, 2003 echocardiogram demonstrates moderate mitral regurgitation. She also takes exception to the Technical Advisor Report because it does not mention the word "mosaic" in characterizing her regurgitant jet. In addition, Ms. Schatz contends that the court should disregard the Technical Advisor Report because Dr. Vigilante refers to the parasternal long-axis view when she believes he should be referring to the apical view and because the report "is merely a manipulative narrative" of the record. Finally, she argues that there is a reasonable medical basis for her claim because her original diagnosis of moderate mitral regurgitation was the result of a "thorough, measured, and unhurried cardiac examination" by a Qualified Physician.

After reviewing the entire Show Cause record, we find the arguments of Ms. Schatz to be without merit. As an initial matter, we disagree with Ms. Schatz that Dr. Ansari's submissions and still-frame images provide a reasonable medical basis for finding that the March 24, 2003 echocardiogram demonstrates moderate mitral regurgitation. We are required to apply the standards delineated in the Settlement Agreement and Audit Rules. The context of those two documents leads us to interpret the "reasonable medical basis" standard as more stringent than Ms. Schatz contends. For example, as we have previously explained, conduct "beyond the bounds of medical reason" can include, among other things, failing to review multiple loops and still frames, failing to examine the regurgitant jet throughout a portion of systole, and characterizing low velocity flow as mitral regurgitation. See Mem. in Supp. of PTO No. 2640 at 9-13, 15, 21-22, 26 (Nov. 14. 2002).

We also have held that for a reasonable medical basis to exist a claimant must establish that the findings of the requisite level of regurgitation are representative of the level of regurgitation throughout the echocardiogram. See, e.g., Mem. in Supp. of PTO No. 6997 at 11 (Feb. 26, 2007); see also, e.g., In re Diet Drugs (Phentermine/Fenfluramine/Dexfenfluramine) Prods. Liab. Litig., 543 F.3d 179, 187 (3d Cir. 2008). To conclude otherwise would allow claimants who do not have the requisite level of regurgitation to receive Matrix Benefits. This would be contrary to the intent of the Settlement Agreement. See Mem. in Supp. of PTO No. 6997, at 11.

Here, Dr. Irani reviewed the March 24, 2003 echocardiogram and determined that it demonstrated mild mitral regurgitation. Dr. Irani also reviewed the still-frame images that Dr. Ansari provided and determined that they were not representative of the level of mitral regurgitation shown throughout the echocardiogram. Dr. Irani also re-reviewed the echocardiogram of Ms. Schatz following her contest and concluded that the LAA traced by Dr. Ansari was not the largest LAA on the study. He also observed that the regurgitant jet shown in the still-frame images was not seen on the tape in the period before or after the still frame.12

In addition, using electronic calipers to measure the most "impressive" mitral regurgitation, Dr. Vigilante determined that only mild mitral regurgitation was present on the March 24, 2003 echocardiogram of Ms. Schatz. Dr. Vigilante also reviewed the still-frame images provided by Dr. Ansari and determined that "[t]he supposed RJA's [sic] traced in these still frame photos are not accurate measurements of the RJA. Instead, these measurements contain low velocity flow and non-regurgitant flow."13 Such unacceptable practices cannot provide a reasonable medical basis for the representation that the echocardiogram of Ms. Schatz demonstrated moderate mitral regurgitation.14

We also disagree with the argument of Ms. Schatz that the auditing cardiologist's use of visual estimation was improper. Although the Settlement Agreement specifies the percentage of regurgitation needed to qualify as having moderate mitral regurgitation, it does not require that actual measurements must be made on the echocardiogram. As we have explained, "`[e]yeballing' the regurgitant jet to assess severity is well accepted in the world of cardiology.'" See Mem. in Supp. of PTO No. 2640 at 15. Ms. Schatz essentially requests that we write into the Settlement Agreement a requirement that actual measurements of mitral regurgitation be made to determine whether a claimant qualifies for Matrix Benefits. There is no basis for such a revision, and the argument made by Ms. Schatz is contrary to the "eyeballing" standards that we previously evaluated and accepted in PTO No. 2640.15

Further, the reliance of Ms. Schatz on her Screening Program echocardiogram to support her assertion that there is a reasonable medical basis for her claim is misplaced. The Settlement Agreement clearly provides that the sole benefit that 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:

Settlement Agreement § 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 the position endorsed by Ms. Schatz would be inconsistent with Section VI.E of the Settlement Agreement, which governs the audit of claims for Matrix Benefits, as well as with this court's decision in PTO No. 2662, which mandated a 100% audit requirement for all claims for Matrix Benefits.16 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 the request of Ms. Schatz to interpret the Settlement Agreement in this fashion.17

Finally, to the extent that Ms. Schatz asserts that she is entitled to Matrix Benefits because her condition is a result of her ingestion of Diet Drugs, such an assertion is erroneous. Causation is not at issue in resolving claims for Matrix Benefits. Rather, claimants are required to show that they meet the objective criteria set forth in the Settlement Agreement. As we previously concluded:

Mem. in Supp. of PTO No. 1415 at 51 (Aug. 28, 2000). In addition, we noted that "individual issues relating to causation, injury and damage also disappear because the settlement's objective criteria provide for an objective scheme of compensation." Id. at 97. If claimants are not required to demonstrate causation, the converse also is true; namely, in applying the terms of the Settlement Agreement, the Trust does not need to establish that a reduction factor caused the medical condition at issue. The Settlement Agreement clearly and unequivocally requires a claim to be reduced to Matrix B-1 if the claimant is diagnosed with mild mitral regurgitation by an echocardiogram performed between the commencement of Diet Drug use and the end of the Screening Period. See Settlement Agreement § IV.B.2.d. (2)(a). We must apply the Settlement Agreement as written. Accordingly, the assertion of Ms. Schatz that her medical condition was caused by her ingestion of Diet Drugs is irrelevant to the issue before the court.

For the foregoing reasons, we conclude that Ms. Schatz has not met her burden of proving that there is a reasonable medical basis for finding that she had moderate 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. Schatz's claim for Matrix A-1 benefits and of the related derivative claim submitted by her spouse.