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

United States District Court, Third Circuit

August 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. Civil Action No. 99-20593

MEMORANDUM IN SUPPORT OF SEPARATE PRnTRIAL ORDER NO. 9133

HARVEY BARTLE, III, District Judge.

Bethany Massey ("Ms. Massey" 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 April, 2008, claimant submitted a completed Green Form to the Trust signed by her attesting physician, Gary L. Murray, M.D. Based on an echocardiogram dated February 18, 1999, Dr. Murray attested in Part II of Ms. Massey's Green Form that she suffered from moderate mitral regurgitation and had surgery to repair or replace the aortic and/or mitral valve(s) following the use of PondiminĀ® and/or ReduxTM.[3] Based on such findings, claimant would be entitled to Matrix A-1, Level III benefits in the amount of $879, 943.[4]

Dr. Murray also attested that claimant did not have a rheumatic mitral valve. Under the Settlement Agreement, the presence of a rheumatic mitral valve requires the payment of reduced Matrix Benefits. See Settlement Agreement Ā§ IV.B.2.d. (2)(c)ii)e). Evidence of a rheumatic valve is defined by the Settlement Agreement as "doming of the anterior leaflet and/or anterior motion of the posterior leaflet and/or commissural fusion." See id. As the Trust does not contest claimant's entitlement to Level III Matrix Benefits, the only issue before us is whether claimant is entitled to payment on Matrix A-1 or Matrix B-1.

In June, 2008, the Trust forwarded the claim for review by Craig M. Oliner, M.D., one of its auditing cardiologists.[5] In audit, Dr. Oliner concluded that there was no reasonable medical basis for Dr. Murray's finding that claimant did not have a rheumatic mitral valve. Specifically, Dr. Oliner stated:

There is definite anterior leaflet diastolic mild doming, consistent with rheumatic mitral valve disease. Both leaflet tips are thickened, consistent with rheumatic mitral valve disease. There is submitral apparatus involvement. The surgical report states the intraoperative [transesophageal echocardiogram] confirmed a rheumatic looking valve. At surgery, the mitral valve was found to be scarred, with the anterior leaflet pulled inward and the papillary heads fused to the back of the valve. The [transesophageal echocardiogram] report from 10/5/01 states the mitral valve was rheumatic in morphology.

Based on Dr. Oliner's finding, the Trust issued a post-audit determination that Ms. Massey 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.[6] In contest, claimant argued that her February 18, 1999 echocardiogram did not demonstrate a rheumatic mitral valve and that the other materials submitted with her claim, including an October 5, 2001 echocardiogram, an October 5, 2001 operative report, and an October 6, 2001 pathology report did not establish that Ms. Massey had rheumatic mitral valve disease at the time of her mitral valve replacement surgery. In support, claimant submitted a verified statement of Manoj R. Muttreja, M.D. Dr. Muttreja stated, in pertinent part, that:

In his Report of Auditing Cardiologist Opinion Concerning Green Form Questions at Issue, Dr. Oliner stated, "There is definite anterior leaflet diastolic mild doming, consistent with rheumatic mitral valve disease." Presumably this observation pertains to the 02/18/1999 [transthoracic echocardiogram]. As an initial matter, this statement is inconsistent in its conflation of "mild" and "definite." The interpreting cardiologist of this study did not mention these findings or come up with the overall conclusion that Ms. Massey had the findings of a rheumatic valve in his report of this study. In my review of the videotape, I saw perhaps only mild doming in some off-axis views. The mild doming was inconsistent throughout the study and did not appear in any standard views and, in my opinion, was certainly not consistent with the findings of a rheumatic valve. Moreover, this echocardiogram contained additional views during the stress component. No doming or restriction of the anterior leaflet (hockey-sticking) occurred during these additional stress images of the echocardiogram when the patient reached her peak goal heart rate. This finding would definitely be present and blatantly obvious if Ms. Massey truly had a rheumatic mitral valve. Dr. Oliner also noted that "both leaflet tips are thickened, consistent with rheumatic mitral valve disease." However, leaflet tip thickening is not a finding specific to rheumatic heart disease and is present in multiple different pathologies.
Dr. Oliner also referenced the surgical report and intraoperative [transesophageal echocardiogram] in his report. First, I would like to point out that a rheumatic heart valve cannot be diagnosed by the surgeon. A surgeon can only see the gross view of the valve during his operation. The gross findings of a rheumatic valve are very nonspecific and can be seen in multiple different pathologies. Such a diagnosis can be suggested by echocardiography and definitely made by pathologyJ The report of the 10/05/2001 intraoperative [transesophageal echocardiogram] while indeed stating that the mitral valve appears "rheumatic in morphology" also states that posterior leaflet is fixed but the anterior leaflet opening appears normal. Again, one would see restricted motion of the anterior leaflet in the case of a rheumatic mitral valve and not just the involvement of a portion of the valve. The surgeon found the valve to be scarred with the anterior leaflet pulled inward and the papillary heads fused to the back of the valve. Such findings are not specific to rheumatic mitral valve, and could, in fact, be more indicative of lesions induced through fenfluramine exposure. I have seen multiple valves like the one described by this surgeon in my experience that have been caused by fenfluramine exposure and not rheumatic heart disease.
Interestingly, Dr. Oliner appears to have completely disregarded the 09/07/2001 [transesophageal echocardiogram] and the surgical pathology report. I have reviewed the videotape of the 09/07/2001 [transesophageal echocardiogram]. Although the report of the [transesophageal echocardiogram] states the mitral valve appears to be normal, the valve appears thickened and there is some restriction of the posterior leaflet. However, there is no heavy calcification or doming which would be present in the case of a rheumatic mitral valve.
Most importantly, the surgical pathology report contains no indication whatsoever that her excised mitral valve was rheumatic. The pathologist's diagnosis is "atherosclerosis, calcification and myoxid degeneration." Her findings are not consistent with a diagnosis of rheumatic mitral valve disease. Rheumatic valve disease would have been mentioned as a matter of course had it been indicated by the pathologist's findings.
In summary, it is my opinion from the review of the materials provided, that Ms. Massey did not have a rheumatic mitral valve before the mitral valve replacement. Dr. Oliner's finding that she exhibited a rheumatic valve appears to have been based primarily on the surgeon's comments rather than pathological evidence and evidence from the echocardiograms.

Although not required to do so, the Trust forwarded the claim for a second review by the auditing cardiologist. Dr. Oliner submitted a declaration again concluding that there was no reasonable medical basis for the attesting physician's determination that ...


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