United States District Court, E.D. Pennsylvania
IN RE DIET DRUGS PHENTERMINE/ FENFLURAMINE/DEXFENFLURAMINE PRODUCTS LIABILITY LITIGATION THIS DOCUMENT RELATES TO SHEILA BROWN, et al.
AMERICAN HOME PRODUCTS CORPORATION
MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO.
A. Larrieu ("Mr. Larrieu" 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 his
claim for Matrix Compensation Benefits ("Matrix
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
2015, Mr. Larrieu submitted a completed Green Form to the
Trust signed by his attesting physician, Marta C. Sayers,
M.D., F.A.C.C. Based on an echocardiogram dated March 5,
2015,  Dr. Sayers attested in Part II of Mr.
Larrieu's Green Form that claimant suffered from severe
mitral regurgitation and had surgery to repair or replace the
aortic and/or mitral valve(s) following the use of Pondimin
and/or Redux™. Based on such findings, claimant would be
entitled to Matrix A-l, Level III benefits in the amount of
Sayers also attested that Mr. Larrieu did not suffer from
mitral annular calcification. Significantly, the Settlement
Agreement requires the reduced payment of Matrix Benefits for
a claim based on damage to the mitral valve when mitral
annular calcification is present. See Id. §
Trust does not contest claimant's entitlement to Level
III benefits. Thus the only issue before us is whether
claimant is entitled to payment on Matrix A-l or Matrix B-l.
October 2015, the Trust forwarded the claim to M. Michele
Penkala, M.D., one of its auditing cardiologists, for review.
In audit, Dr. Penkala concluded that there was no reasonable
medical basis for finding that claimant did not have mitral
annular calcification. In particular, Dr. Penkala stated,
"From my review of all the studies (12/9/2002, 4/14/12
and 3/5/15) I did think that significant [mitral annular
calcification] was present. In addition, the surgeon noted in
his [operative] report: * evidence that the [mitral valve]
had severe calcification of the posterior leaflet, as well as
on Dr. Penkala's findings, the Trust issued a post-audit
determination that Mr. Larrieu was entitled only to Matrix
B-l, Level III benefits. Pursuant to the Rules for the Audit
of Matrix Compensation Claims ("Audit Rules"), Mr.
Larrieu contested this adverse determination. He argued that
there was a reasonable basis for finding that he did not have
mitral annular calcification on the December 9, 2002 and
March 5, 2015 echocardiograms. In support, Mr. Larrieu
submitted a letter from Dr. Sayers that stated that
"there is no evidence of mitral annual
calcification" and that "[n]o [mitral] annular
calcification was mentioned on the [echocardiogram] from 2
015 also indicating there would be no [mitral] annular
calcification on the [echocardiogram] done in 2002." He
also submitted a letter from Kaye M. Bass, B.S., R.D.C.S.,
R.V.T., which did not address the issue of mitral annular
calcification. He noted that two of his echocardiograms have
been reviewed by auditing cardiologists who did not find the
presence of any mitral annular calcification. Finally, Mr.
Larrieu asserted that any mitral annular calcification, if
present, was either due to his advanced age or was a
relatively minute or insignificant quantity.
not required to do so, the Trust forwarded the claim to the
auditing cardiologist for a second review. Dr. Penkala
submitted a declaration in which she again concluded that
there was no reasonable medical basis for finding that Mr.
Larrieu did not have mitral annular calcification.
Specifically, Dr. Penkala stated:
14. As I noted at audit, the [echocardiogram] study dated
12/9/02 is a very technically difficult study which had
limited images and limited number of views.
15. The 12/9/02 study was apparently performed as a part of a
diet drug valve assessment rather than one performed based
upon clinical necessity.
16. I agree that no clear [mitral annular calcification] is
visible in the parasternal long or short axis views of the
12/9/02 study. However, in the apical 4 chamber and apical 2
chamber view there is a strong suggestion of [mitral annular
calcification] especially on the part of the tape,
approximately from 11:24:34-11:24:42. It should be noted that
the timer is difficult to see clearly. The suggestion of
calcification in the annulus is most prominent in the
intervalvular area between the mitral and the aortic valves.
17. I also reviewed again the study dated 4/14/12. On this
study, the presence of [mitral annular calcification] was
most evident in loops 1, 9, 2 5 and 26. Again, the
calcification is most notable in the intervalvular area
between the mitral and aortic valves.
18. Further, I reviewed again the Echocardiogram of
Attestation identified in the Green Form, the
[transesophageal echocardiogram] dated 3/5/15. On review of
this study, [mitral annular calcification] is seen in images
(runs) 12, 15, 16 and 41. Although the report of this study
is silent as to the presence or absence of mitral annular
calcification, [mitral annular calcification] is seen on the
19. There is no reasonable medical basis for concluding that
Mr. Larrieu did not have [mitral ...