IN RE: DIET DRUGS (PHENTERMINE/FENFLURAMINE/DEXFENFLURAMINE) PRODUCTS LIABILITY LITIGATION.
AMERICAN HOME PRODUCTS CORPORATION THIS DOCUMENT RELATES TO: SHEILA BROWN, et al., Civil Action No. 99-20593
MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9076
HARVEY BARTLE, III, District Judge.
Gahla R. Towery ("Ms. Towery" or "claimant"), a class member under the Diet Drug Nationwide Class Action Settlement Agreement ("Settlement Agreement") with Wyeth,  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").
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 March, 2003, claimant submitted a completed Green Form to the Trust signed by her attesting physician, Dominic M. Pedulla, M.D., F.A.C.C. Dr. Pedulla is no stranger to this litigation. According to the Trust, he has signed at least 128 Green Forms on behalf of claimants seeking Matrix Benefits. Based on an echocardiogram dated January 3, 2003, Dr. Pedulla attested in Part II of Ms. Towery's Green Form that she suffered from moderate mitral regurgitation and an abnormal left atrial dimension. Based on such findings, claimant would be entitled to Matrix A-1, Level II benefits in the amount of $486, 424.
In the report of claimant's echocardiogram, Dr. Pedulla stated that claimant had "[m]oderate mitral regurgitation." Dr. Pedulla, however, did not specify a percentage as to claimant's level of mitral regurgitation. 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 § I.22.
In March, 2006, the Trust forwarded the claim for review by Issam A. Mikati, M.D., one of its auditing cardiologists. In audit, Dr. Mikati concluded that there was no reasonable medical basis for Dr. Pedulla's finding that claimant had moderate mitral regurgitation because her echocardiogram demonstrated only mild mitral regurgitation. In support of this conclusion, Dr. Mikati stated, "Black pixels were included to inflate [mitral regurgitation] jet to reach [the] moderate cutoff."
Based on Dr. Mikati's finding that claimant did not have moderate mitral regurgitation, the Trust issued a post-audit determination denying Ms. Towery's claim. Pursuant to the Rules for the Audit of Matrix Compensation Claims ("Audit Rules"), claimant contested this adverse determination. In contest, claimant submitted a letter from Dr. Pedulla wherein he confirmed his finding of moderate mitral regurgitation. In support of his finding, Dr. Pedulla explained that "[t]he inclusion of small areas of black pixels was inadequate to amount to an overestimate" and that the "left atrium area was overestimated leading to a clear-cut moderate' quantitation." Claimant also argued that the auditing cardiologist substituted his opinion for that of the attesting physician.
The Trust then issued a final post-audit determination, again denying Ms. Towery'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 Ms. Towery's claim should be paid. On October 19, 2006, we issued an Order to show cause and referred the matter to the Special Master for further proceedings. See PTO No. 6619 (Oct. 19, 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 December 28, 2006. Under the Audit Rules, it is within the Special Master's discretion to appoint a Technical Advisor 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 of proving that there is a reasonable medical basis for the attesting physician's finding that she had moderate mitral regurgitation. 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).
In support of her claim, Ms. Towery merely refers the court to the arguments she made in contest. In response, the Trust argues that claimant has failed to establish a reasonable medical basis for her claim because neither claimant nor Dr. Pedulla rebuts the specific finding of the auditing cardiologist that black pixels were included to inflate the appearance of mitral regurgitation. According to the Trust, the inclusion of non-regurgitant, low-velocity black pixels and overtracing the amount of regurgitation are indicia of an opinion beyond the bounds of medical reason.
The Technical Advisor, Dr. Abramson, reviewed claimant's echocardiogram and concluded that there was no reasonable medical basis for the attesting physician's finding that Ms. Towery had moderate mitral regurgitation. Specifically, Dr. Abramson observed:
Based on my review of the Special Master Record, including the reports of the Attesting Physician, the Auditing Cardiologist, and the transthoracic echocardiogram dated 1/03/03, the above-named diet-drug recipient does not have moderate [mitral regurgitation]. There is no reasonable medical basis for the physician completing the diet-drug recipient's claim form ...