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

United States District Court, Third Circuit

November 20, 2013

IN RE: DIET DRUGS (PHENTERMINE/FENFLURAMINE/DEXFENFLURAMINE) PRODUCTS LIABILITY LITIGATION.
v.
AMERICAN HOME PRODUCTS CORPORATION THIS DOCUMENT RELATES TO: SHEILA BROWN, et al. No. 2:16 MD 1203

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9165

HARVELY BARTLE, III, District Judge.

Beverly A. Ellis ("Ms. Ellis" 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.

In October, 2010, claimant submitted a completed Green Form to the Trust signed by her attesting physician, Paul W. Dlabal, M.D., F.A.C.P., F.A.C.C., F.A.H.A. Based on an echocardiogram dated April 22, 2002,[3] Dr. Dlabal attested in Part II of claimant's Green Form that Ms. Ellis suffered from moderate aortic regurgitation and had surgery to repair or replace the aortic and/or mitral valve(s) following the use of Pondimin® and/or Redux™.[4] Based on such findings, claimant would be entitled to Matrix A-1, Level III benefits in the amount of $335,553.[5]

In the report of claimant's echocardiogram, the reviewing cardiologist, B. Shields Stutts, M.D., F.A.C.C. stated, "There is calcific aortic stenosis, which is mild to moderate." Dr. Stutts measured claimant's aortic valve area to be 1.39 cm2. Dr. Dlabal attested in claimant's Green Form that Ms. Ellis did not suffer from aortic stenosis.[6] Under the Settlement Agreement, the presence of "[a]ortic stenosis with an aortic valve area < 1.0="" square="" centimeter="" by="" the="" continuity="" equation"="" requires="" the="" payment="" of="" reduced="" matrix="" benefits.="" settlement="" agreement="" §="" iv.b.2.d.="" (2)="" (c)i)e).="" as="" the="" trust="" does="" not="" contest="" claimant's="" entitlement="" to="" level="" iii="" benefits,="" the="" only="" issue="" before="" us="" is="" whether="" claimant="" is="" entitled="" to="" payment="" on="" matrix="" a-1="" or="" matrix="">

In December, 2010, the Trust forwarded the claim for review by Robert L. Gillespie, M.D., F.A.C.C., F.A.S.E., one of its auditing cardiologists. In audit, Dr. Gillespie concluded that there was no reasonable medical basis for Dr. Dlabal's finding that claimant did not have aortic stenosis with an aortic valve area less than 1.0 square centimeter by the Continuity Equation. In support of this conclusion, Dr. Gillespie stated, "The aortic valve on 4/22/02 had mild [aortic stenosis] and the subsequent studies on 8/28/09 and 9/4/09 had severe [aortic stenosis]. The [aortic valve area] was not less than 1 cm2 on the first [echocardiogram] but was on the 2 subsequent studies."

Based on Dr. Gillespie's finding, the Trust issued a post-audit determination that Ms. Ellis was entitled only to Matrix B-1, Level III benefits. Pursuant to the Rules for the Audit of Matrix Compensation Claims ("Audit Rules"), claimant contested this adverse determination.[7] In contest, claimant argued that there was a reasonable medical basis for Dr. Dlabal's representation that Ms. Ellis had aortic stenosis because the aortic stenosis on her April 22, 2002 echocardiogram was "insufficient to reduce the claim." According to Ms. Ellis, the Trust is not permitted to rely upon more recent echocardiograms in determining whether to apply a reduction factor because the Settlement Agreement requires that the requisite level of aortic stenosis be present on the echocardiogram that forms the basis for her claim, here, claimant's April 22, 2002 echocardiogram.[8]

Although not required to do so, the Trust forwarded the claim for a second review by the auditing cardiologist. Dr. Gillespie submitted a declaration in which he again concluded that there was no reasonable medical basis for the attesting physician's finding that Ms. Ellis did not have aortic stenosis as defined by the Settlement Agreement. Dr. Gillespie stated, in relevant part:

As I stated at audit, Claimant had mild to moderate aortic stenosis at the time of the 4/22/02 echocardiogram. At that time the aortic valve was stenotic, but the [aortic valve area] was not less than lcm2. However, the studies dated 8/28/09 and 9/4/09, performed shortly before Claimant's 9/15/09 aortic valve surgery, show severe aortic stenosis with an aortic valve area less than lcm2. Therefore, based upon all of the medical records available for review, there is no reasonable medical basis to conclude that Claimant did not have aortic stenosis with an [aortic valve area] less than lcm2.

The Trust then issued a final post-audit determination, again determining that Ms. Ellis was entitled only to Matrix B-1, Level III benefits. 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 this claim should be paid. On August 16, 2011, we issued an Order to show cause and referred the matter to the Special Master for further proceedings. See PTO No. 8666 (Aug. 16, 2011).

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 January 11, 2012:, and claimant submitted a sur-reply on February 7, 2012. Under the Audit Rules, it is within the Special Master's discretion to appoint a Technical Advisor[9] 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 the attesting physician's finding that Ms. Ellis did not have aortic stenosis with an aortic valve area < 1.0="" square="" centimeter="" by="" the="" continuity="" equation.="" 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="">

In support of her claim, Ms. Ellis reasserts the arguments made in contest. In addition, claimant contends that the Settlement Agreement and other related documents provide that the Trust's review is limited only to one echocardiogram. Finally, Ms. Ellis argues that while Dr. Gillespie stated that her echocardiograms dated August 28, 2009 and September 4, 2009 reveal aortic stenosis with an aortic valve area less than 1.0 square centimeter, he did not state that this determination was made by using the Continuity Equation as required by the Settlement Agreement.

In response, the Trust counters that claimant did not establish a reasonable medical basis for Dr. Dlabal's representations that claimant did not have aortic stenosis as defined by the Settlement Agreement. In addition, the Trust asserts that there is no temporal limitation for finding ...


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