IN RE: DIET DRUGS (PHENTERMINE/FENFLURAMINE/DEXFENFLURAMINE) PRODUCTS LIABILITY LITIGATION
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. 9087
HARVEY BARTLE, III, District Judge.
Kelly M. Woodman ("Ms. Woodman" 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 her claim for Matrix Compensation Benefits ("Matrix Benefits").
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 completes Part III if claimant is represented.
In February, 2003, claimant submitted a completed Green Form to the Trust signed by her attesting physician, Robert N. Notske, M.D., F.A.C.C., F.A.C.P. Dr. Notske is no stranger to this litigation. According to the Trust, he has attested to at least 45 Green Forms on behalf of claimants seeking Matrix Benefits. Based on an echocardiogram dated August 1, 2002, Dr. Notske attested in Part II of Ms. Woodman's Green Form that she suffered from moderate mitral regurgitation, an abnormal left atrial dimension, and a reduced ejection fraction in the range of 50% to 60%. Based on such findings, claimant would be entitled to Matrix A-1, Level II benefits in the amount of $567, 341.
In the report of claimant's echocardiogram, the reviewing cardiologist, Khusrow Niazi, M.D., F.A.C.C., stated that claimant had moderate mitral regurgitation, which he measured at 29%. 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 August, 2005, the Trust forwarded the claim for review by Rohit J. Parmar, M.D., one of its auditing cardiologists. In audit, Dr. Parmar concluded that there was no reasonable medical basis for Dr. Notske's finding that claimant suffered from moderate mitral regurgitation because claimant's echocardiogram demonstrated only mild mitral regurgitation. In support of this conclusion, Dr: Parmar explained,
The [mitral regurgitation] is mild by Singh criteria. The [echocardiogram] technician has over-estimated the [RJA] by inclusion of low velocity flow. The LAA has been under-estimated. These mis-assessments has [sic] erroneously given an elevated [RJA]/LAA ratio. My calculation shows mild [mitral regurgitation] by Singh criteria (by my assessment the [RJA]/LAA ratio is 12%).
Based on Dr. Parmar's finding that claimant did not have moderate mitral regurgitation, the Trust issued a post-audit determination denying Ms. Woodman's claim. Pursuant to the Rules for the Audit of Matrix Compensation Claims ("Audit Rules"), claimant contested this adverse determination. In contest, claimant submitted declarations of Dr. Notske and William S. Murphy, M.D., F.A.C.C., F.C.C.P. In his declaration, Dr. Notske stated:
Both the Trust screening cardiologist and the attesting cardiologist found that there was moderate mitral regurgitation based upon the Singh criteria. The auditing cardiologist cites no violation of either Feigenbaum or Weyman in how the echocardiogram was performed or interpreted by the Trust screening cardiologist or the attesting cardiologist....
The auditing cardiologist states "[t]he [echocardiogram] technician has over-estimated the [RJA] by inclusion of low velocity flow. The LAA has been under-estimated." The lower portion of the mitral regurgitation jet, which was measured, contains the scintillation phenomenon associated with higher velocity flow. Also, "[w]ith transthoracic echocardiography [as distinguished from transesophageal echocardiograms], however, one should take the entire mitral regurgitant jet, including the surrounding, lower flow spray." Feigenbaum, at 253 [emphasis added]. In other words, the Feigenbaum text requires a more expansive measurement of the regurgitant flow area than the measurement of the auditing cardiologist.
The auditing cardiologist also asserts that the "LAA has been under-estimated, " but... the Trust's screening cardiologist's measurements, at least based upon the apical four chamber view and the parasternal long axis view, are larger than those of the auditing cardiologist.
In his declaration, Dr. Murphy stated that he concurred with Dr. Niazi's assessment that the echocardiogram demonstrated that claimant had "moderate mitral regurgitation equal to or exceeding 20% RJA/LAA."
The Trust then issued a final post-audit determination, again denying Ms. Woodman'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. Woodman's claim should be paid. On January 19, 2006, we issued an Order ...