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

United States District Court, E.D. Pennsylvania

March 26, 2014

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

MEMORANDUM IN SUPPORT OF SEPARATE PRETRIAL ORDER NO. 9218

HARVEY BARTLE, III, Judge.

Michele E. Lee ("Ms. Lee" 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, Stephen Raskin, M.D. Based on an echocardiogram dated March 25, 2010, [3] Dr. Raskin attested in Part II of claimant's Green Form that Ms. Lee suffered from moderate mitral 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.[5]

Dr. Raskin also attested in claimant's Green Form that Ms. Lee suffered from mitral annular calcification. Under the Settlement Agreement, the presence of mitral annular calcification requires the payment of reduced Matrix Benefits. See Settlement Agreement§ IV.B.2.d. (2) (c)ii)d). As the Trust does not contest Ms. Lee's entitlement to Level III benefits, the only issue before us is whether claimant is entitled to payment on Matrix A-1 or Matrix B-1.

In April, 2011, the Trust forwarded the claim for review by Waleed Irani, M.D., F.A.C.C., one of its auditing cardiologists.[6] In audit, Dr. Irani concluded that there was a reasonable medical basis for Dr. Raskin's finding that Ms. Lee had mitral annular calcification.

Based on the auditing cardiologist's finding, the Trust issued a post-audit determination that Ms. Lee 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 the audit and her Green Form "are all mistaken" as to the presence of mitral annular calcification because the "best evidence" is the surgeon's operative report, which does not mention mitral annular calcification. Claimant also contended that the fact that the initial auditing cardiologist did not find mitral annular calcification on her November 23, 1998 echocardiogram provides additional support for the assertion that she did not have mitral annular calcification.

In addition, claimant submitted a letter from Dr. Raskin in which he stated, in relevant part, that the March 25, 2010 "echocardiogram suggests that the slightly more prominent mitral annular echoreflectance without echo shadowing is most likely explained by the acoustic proportion of fibrosis and the exaggerating effect of tissue harmonic imaging and not to annular calcification. " (Emphasis in original.) Accordingly, Dr. Raskin stated, "The previously reported finding of [mitral annular calcification] as noted in the 3/25/10 pre-operative Green Form is incorrect and should be amended."[8]

Claimant also submitted a declaration of Kamal Khabbaz, M.D., the surgeon who performed her mitral valve surgery. Dr. Khabbaz stated, in penitent part:

My operative report 4/5/10 for Ms. Lee carefully described the procedure conducted on Ms. Lee, a mitral valve replacement with a 27-mm St. Jude Medical Epic tissue valve.
Whenever I perform a mitral valve replacement, I carefully study and always describe in my operative report the presence of any mitral annular calcification because its presence is very significant to such surgery. The presence of mitral annular calcification requires the area to be debrided to successfully accept a prosthetic valve.
In the case of Michele Lee, my operative report reveals no mitral annular calcification and, as a result, she did not have mitral annular calcification. If she had had mitral annular calcification, I would have had to debride her valve prior to replacing it and no such debridement is reflected in the operative report and no such debridement occurred. Again, that is because she did not have mitral annular calcification.

Although not required to do so, the Trust forwarded the claim to Dr. Irani for a second review. Dr. Irani submitted a declaration in which he again concluded that, consistent with Dr. Raskin's initial Green Form representation, claimant had mitral annular calcification and Dr. Raskin's later assertion that claimant did not have mitral annular calcification lacked a reasonable medical basis. Specifically, Dr. Irani stated, in pertinent part, that:

10. Based on my review, I find that there is no reasonable medical basis for Dr. Raskin's representation, at Question D.9 of the Green Form signed on June 1, 2011, that Claimant did not have mitral annular calcification. At Contest, I reviewed the March 25, 2010 echocardiogram several times. Mitral annular calcification ("MAC") is certainly present and it is unreasonable to say it is not. MAC is present in the parasternal long axis view, apical 4 chamber and apical 2 chamber. This is not merely increased echoreflectance. There is ...

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