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In re Diet Drugs (Phentermine/Fenfluramine/Dexfenfluramine) Products Liability Litigation

United States District Court, Third Circuit

May 9, 2013

IN RE: DIET DRUGS (PHENTERMINE/ FENFLURAMINE/DEXFENFLURAMINE) PRODUCTS LIABILITY LITIGATION MDL No. 1203
v.
AMERICAN HOME PRODUCTS CORPORATION THIS DOCUMENT RELATES TO: SHEILA BROWN, et al.,

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9060

HARVEY BARTLE III, District Judge.

Celeste A. Barker ("Ms. Barker" 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 claims 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 completes Part III if claimant is represented.

In April, 2003, claimant submitted a completed Green Form to the Trust signed by her attesting physician, A. Razzak Tai, M.D., F.A.C.C., F.A.C.C.P., F.A.C.A., F.A.H.A., F.S.C.I.A.[3] Dr. Tai is no stranger to this litigation. According to the Trust, he has attested to at least 1, 512 Green Forms on behalf of claimants seeking Matrix Benefits. Based on an echocardiogram dated December 12, 2002, Dr. Tai attested in Part II of Ms. Barker's Green Form that claimant suffered from moderate 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 $567, 341.[5]

In the report of claimant's echocardiogram, Dr. Tai noted that Ms. Barker had mitral regurgitation of 30%. 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 February, 2006, the Trust forwarded the claim for review by Zuyue Wang, M.D., F.A.C.C., one of its auditing cardiologists. In audit, Dr. Wang concluded that there was no reasonable medical basis for the attesting physician's finding that claimant had moderate mitral regurgitation. Dr. Wang explained, "The RJA/LAA ratio is less than 20%. The RJA traced should not include the area of low velocity flow."

Based on the auditing cardiologist's findings, the Trust issued a post-audit determination denying Ms. Barker's 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 Dr. Tai's representation of moderate mitral regurgitation because three different cardiologists, based on echocardiograms performed in 2002, concluded that Ms. Barker had moderate regurgitation. Ms. Barker had four echocardiograms. The first occurred on September 19, 1997 and was signed by Allan L. Anderson, M.D. It indicated that claimant had mild mitral regurgitation. The remaining three were performed on: July 18, 2002, signed by Andrew E. Dick, M.D., F.A.C.C.; December 12, 2002, signed by Dr. Tai; and December 20, 2002, signed by Paulo A. Ribeiro, M.D. These three echocardiograms indicated that claimant had moderate mitral regurgitation. The Trust then issued a final post-audit determination, again denying Ms. Barker'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. Barker's claim should be paid. On August 21, 2006, we issued an Order to Show Cause and referred the matter to the Special Master for further proceedings. See PTO No. 6477 (Aug. 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 December 27, 2006.

In support of this claim, Ms. Barker repeats the argument she made in contest, namely, that there was a reasonable medical basis for Dr. Tai's representation of moderate mitral regurgitation because four different cardiologists, based on echocardiograms performed in 1997 and 2002, concluded that she had mild or moderate regurgitation. Claimant also argues that the difference in the determinations of her physicians and the auditing cardiologist fall within the reasonable medical basis standard. Finally, Ms. Barker identifies a number of alleged procedural errors by the Trust in connection with her claim: (1) claimant received a telephone call, rather than a writing, requesting that she submit the echocardiogram associated with her claim; (2) the Trust informed claimant it had requested a Medical Practice Questionnaire from her in 2003 when it had not; (3) the Trust should not have processed her second Green Form; and (4) the Trust "contaminated" her claim file by sending "multiple sources of echocardiographic evidence related to completely separate and independent Green Forms."

In response, the Trust argues that it acted in good faith in processing Ms. Barker's claim and that it processed her most recent Green Form first because that was the Trust's policy absent a clear intention of the claimant to the contrary. The Trust also contends that Ms. Barker's reference to other echocardiograms does not establish a reasonable medical basis for Dr. Tai's representation of moderate mitral regurgitation and does not meet claimant's burden because her echocardiogram reports do not address Dr. Wang's specific findings at audit, that is, that Dr. Tai's finding of moderate mitral regurgitation was based on an overtraced RJA that included low velocity flow.

In September, 2002, claimant submitted another completed Green Form to the Trust signed by her attesting physician, Dr. Dick. He also is no stranger to this litigation. According to the Trust, he has attested to at least 305 Green Forms on behalf of claimants seeking Matrix Benefits. Based on claimant's June 12, 2002 echocardiogram, Dr. Dick attested in Part II of claimant's Green Form that Ms. Barker suffered from moderate mitral regurgitation and an abnormal left atrial dimension.[7] Based on such findings, claimant would be entitled to Matrix A-1, Level II benefits in the amount of $590, 261.[8]

In the report of claimant's echocardiogram, Dr. Dick noted that claimant had mitral regurgitation of 40%. Again, 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 October, 2007, the Trust forwarded the claim for review by Irmina Gradus-Pizlo, M.D., F.A.C.C., one of its auditing cardiologists. In audit, Dr. Gradus-Pizlo concluded that there was no reasonable medical basis for the attesting physician's finding that claimant had moderate mitral regurgitation because the echocardiogram demonstrated only mild mitral regurgitation. Dr. Gradus-Pizlo explained, "Color persistence is too high. Jet area measurements include non-turbulent flow."

Based on the auditing cardiologist's finding, the Trust issued a post-audit determination denying Ms. Barker's claim. Pursuant to the Rules for the Audit of Matrix Compensation Claims ("Audit Rules"), claimant contested this adverse determination.[9] In contest, as with her other claim, Ms. Barker argued there was a reasonable medical basis for the attesting physician's representation of moderate mitral regurgitation because four different cardiologists concluded that Ms. Barker had mild or moderate regurgitation.

The Trust then issued a final post-audit determination, again denying this claim. Claimant disputed the 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. Barker's claim should be paid. On August 21, 2008, we issued an Order to Show Cause and referred the matter to the Special Master for further proceedings. See PTO No. 7925 (Aug. 21, 2008). Once the matter was referred to the Special Master, the Trust submitted its statement of the case and supporting ...


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