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

United States District Court, Third Circuit

May 29, 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. 9076

HARVEY BARTLE, III, District Judge.

Wendy Isakson ("Ms. Isakson" 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").[2] 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").[3]

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 February, 2003, claimant submitted a completed Green Form to the Trust signed by her attesting physician, W. Marcus Brann, M.D., F.A.C.C. Dr. Brann is no stranger to this litigation. According to the Trust, he has signed at least 765 Green Forms on behalf of claimants seeking Matrix Benefits. Based on an echocardiogram dated July 26, 2002, Dr. Brann attested in Part II of Ms. Isakson's Green Form that claimant suffered from moderate mitral regurgitation, pulmonary hypertension secondary to moderate or greater mitral regurgitation, an abnormal left ventricular dimension, an abnormal left atrial dimension, and a reduced ejection fraction in the range of 40% to 49%.[4] Based on such findings, claimant would be entitled to Matrix A-1, Level II benefits in the amount of $641, 205.[5]

In the report of claimant's echocardiogram, the reviewing cardiologist, James D. Watson, M.D., F.A.C.C., stated, "The degree of mitral regurgitation seen is 31 percent by the Singh method." 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 April, 2006, the Trust forwarded the claim for review by one of its auditing cardiologists.[6] Although the auditing cardiologist accepted Dr. Brann's finding of moderate mitral regurgitation, pursuant to Court Approved Procedure ("CAP") No. 11, the Consensus Expert Panel subsequently reviewed Ms. Isakson's claim and determined that it should be re-audited because the "[d]egree of [mitral regurgitation] appears less than moderate by Singh criteria."[7] In August, 2006, the Trust informed Ms. Isakson that it had accepted the Consensus Expert Panel's recommendation that her claim be re-audited.

In September, 2006, the Trust forwarded the claim for review by another auditing cardiologist, Craig M. Oliner, M.D. Dr. Oliner concluded that there was no reasonable medical basis for the attesting physician's finding that claimant had moderate mitral regurgitation because her echocardiogram demonstrated only mild mitral regurgitation. In support of this conclusion, Dr. Oliner observed:

There is mild [mitral regurgitation]. The RJA's are freeze frames that do not represent the mild [mitral regurgitation] seen in real time. Most of the RJA's include substantial non-[mitral regurgitant] low velocity signal. Color gain is excessive and Nyquist is borderline low at 51cm/sec.

Based on Dr. Oliner's finding that claimant did not have moderate mitral regurgitation, the Trust issued a post-audit determination denying Ms. Isakson's claim. Pursuant to the Rules for the Audit of Matrix Compensation Claims ("Audit Rules"), claimant contested this adverse determination.[8] In contest, claimant argued that the Green Form she previously submitted provided a reasonable medical basis for Dr. Brann's representation that Ms. Isakson had moderate mitral regurgitation.

The Trust then issued a final post-audit determination, again denying Ms. Isakson'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. Isakson's claim should be paid. On February 28, 2007, we issued an Order to show cause and referred the matter to the Special Master for further proceedings. See PTO No. 7011 (Feb. 28, 2007).

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 May 17, 2007. 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, Sandra V. Abramson, 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 she had moderate mitral regurgitation. 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 38(b).

In support of her claim, Ms. Isakson states that she disagrees with the auditing cardiologist's determination. In response, the Trust asserts that claimant did not rebut Dr. Oliner's findings that the freeze frames on which Dr. Brann relied did not reflect mitral regurgitation in real time and that the jet observed included non-regurgitant, low velocity signal. The Trust also contends that a low Nyquist setting and excessive color grain likely contributed to Dr. Brann's inaccurate evaluation of claimant's level of mitral regurgitation.

The Technical Advisor, Dr. Abramson, reviewed claimant's echocardiogram and concluded that there was no reasonable medical basis for the attesting physician's finding that claimant had moderate mitral regurgitation. Specifically, Dr. Abramson observed:

I reviewed the transthoracic echocardiogram dated 7/26/02 from Echo Express, Inc. The left ventricle is markedly dilated with severely decreased systolic function; ejection fraction is in the range of 30-35%. The machine settings inappropriately maximize the mitral regurgitation jet. Also, the Nyquist limit is set at 51 em/sec, which will increase the appearance of the mitral regurgitation more than a Nyquist limit set at 60 to 70 em/sec. In addition, the color gain settings are set too high, which will increase the appearance of the mitral regurgitation. Despite this, by visual estimate, there appears to be mild mitral regurgitation. The technologist performed six measurements of the mitral regurgitant jet and two measurements of the left atrial area. The first three measured RJA of 3.6 cm2, 3.9 cm2, and 4.6 cm2 include appropriate high velocity, regurgitant flow. The last three measurements were over traced and include low velocity, non-regurgitant flow. There was a left atrial area measurement of 25.1 cm2, which was appropriately traced. The other left atrial measurement was not obtained at end-systole, thus the measurement was incorrect. Using these three RJA and the one LAA, I calculated RJA/LAA ratios of 14%, 16%, and 18%. All of these ratios are less than 20%, which is consistent with mild mitral regurgitation. I received the study as a continuous movie on a CD so I was unable to perform my own measurements.

After reviewing the entire Show Cause Record, we find claimant's arguments are without merit. We disagree with claimant that the Green Form and the echocardiogram report submitted in connection with her claim provide a reasonable medical basis for Dr. Brann's representation of moderate mitral regurgitation. We are required to apply the standards delineated in the Settlement Agreement and Audit Rules. The context of those two documents leads us to interpret the "reasonable medical basis" standard as more stringent than claimant contends. For example, as we previously explained in PTO No. 2640, conduct "beyond the bounds of medical reason" can include: (1) failing to review multiple loops and still frames; (2) failing to have a Board Certified Cardiologist properly supervise and interpret the echocardiogram; (3) failing to examine the regurgitant jet throughout a portion of systole; (4) over-manipulating echocardiogram settings; (5) setting a low Nyquist limit; (6) characterizing "artifacts, " "phantom jets, " "backflow" and other low velocity flow as mitral regurgitation; (7) failing to take a claimant's medical history; and (8) overtracing the amount of a claimant's regurgitation. See PTO No. 2640 at 9-13, 15, 21-22, 26 (Nov. 14, 2002).

Here, Dr. Oliner reviewed claimant's echocardiogram and determined that "[t]he RJA's are freeze frames that do not represent the mild [mitral regurgitation] seen in real time." He also observed that "[m]ost of the RJA's include substantial non-[mitral regurgitant] low velocity signal" and that the "[c]olor gain is excessive and Nyquist is borderline low." In addition, Dr. Abramson determined that three of the RJAs on the tape "were over traced and include low velocity, non-regurgitant flow." Dr. Abramson also determined that one of the LAA measurements on the echocardiogram tape "was not obtained at end-systole, thus the measurement was incorrect." Finally, she determined that the "machine settings inappropriately maximize the mitral regurgitation jet, " i.e., the Nyquist was too low and the color gain settings were too high. Neither claimant nor Dr. Brann adequately disputed these findings.[10] Such unacceptable practices cannot provide a reasonable medical basis for the resulting diagnosis and Green Form representation of moderate mitral regurgitation. To conclude otherwise would allow claimants who do not have moderate or greater mitral regurgitation to receive Matrix Benefits, which would be contrary to the intent of the Settlement Agreement.

For the foregoing reasons, we conclude that claimant has not met her burden of proving that there is a reasonable medical basis for finding that she had moderate mitral regurgitation. Therefore, we will affirm the Trust's denial of Ms. Isakson's claim for Matrix Benefits and the derivative claims submitted by her children.


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