The court's findings of fact and conclusions of law are as follows. The amount of both of these types of credits is the lesser of the payment AHP makes to the claimant or the matrix level for which such claimant would be entitled to under the Settlement. Rosen testified that AHP continues to generate better than half a billion dollars per quarter, or approximately .3 billion per year. The deadline for completing the BLUE FORM was open-ended. P-211, P-24, P-46 & P-38.) The notice package also contained a GREEN FORM that class members and physicians were required to complete in order for class members to obtain Matrix Compensation Benefits now or in the future. P-31 2.) Finally, the notice package contained a postage-prepaid business reply envelope that class members could use to return the relevant forms. P-211 & P-48.)The notice packages were not the only source of information concerning the settlement. 618.) Although there is currently no deadline for the submission of PINK FORMS or BLUE FORMS, as of May 8, 2000, 119,011 class members had executed PINK FORMS registering for AIO benefits and 97,544 class members had executed BLUE FORMS registering for settlement benefits in the event that the settlement received Final Judicial Approval. By August 8, 2000, 51,467 ORANGE FORMS, 164,291 PINK FORMS, 108,572 BLUE FORMS and 12,014 GREEN FORMS were submitted. 646.) However, it appears that many of these forms need more complete information. 8/10/00 at 65 & 80.)The response by members of the class to the notice is significant in three ways. The vast number of class members and their dispersed geographic locales exceeds the threshold for a conclusion that joinder is impracticable. With regard to common questions of fact, the diet drugs at issue here are essentially a single product--in that Pondimin and Redux are chemically related--marketed by a single major manufacturer--AHP.
"Fund B" is intended to provide funding to pay for matrix benefits for class members and the associated costs of administering those benefits. Kursh testified that, assuming a 100% participation rate in the settlement, the cost of paying matrix level benefits was .88 to 4.55 billion present value. Autopsy demonstrating histopathologic changes in the lung consistent with primary pulmonary hypertension and no evidence of congenital heart disease (other than a patent foramen ovale) with left-to-right shunt, such as ventricular septal defect as documented by a Board-Certified Pathologist; and This definition is consistent with the long standing consensus in the medical community with respect to the proper definition of the disease, except to the extent that it permits the diagnosis of PPH based on pulmonary artery pressure 60 mm Hg as determined by Doppler echocardiography--and is thus somewhat over-inclusive. To the extent that any balance remains in the escrow account after payment of any fee awarded by the court, that balance will be returned to AHP. P-3 at 134-135 of 148.) The court may order reimbursement of all out-of-pocket costs reasonably related to the creation of Fund A from the fund itself. P-3 at 23 of 148.) The Settlement Agreement provides that for purposes of awarding attorneys' fees from Fund B, attorneys' fees should be awarded and paid as a percentage of or otherwise based on the net present value, as of the date of Final Judicial Approval, of the maximum amounts AHP may be legally obligated to pay to Fund B for the benefit of the settlement class pursuant to the principle of law expressed in , 444 U. However, Class Counsel have agreed that the amount of such fees shall not exceed 9 million which is nine percent of the ,550,000,000.00 present value amount of Fund B. P-3 at 135-136 of 148.) This cap on the award of common benefit fees in relation to Fund B is consistent with a prior determination by the court that it was appropriate to set aside nine percent of the amount recovered by plaintiffs in MDL 1203 and coordinated state litigation to pay "common benefit fees." Pretrial Order Nos. In addition, Class Counsel have the right to apply to the court for reimbursement of costs expended for the common benefit of class members from Fund B. P-3 at 28 of 148.) Attorneys for individual class members who recover Matrix Compensation Benefits are entitled to recover the total attorneys' fees due under the terms of any valid written contingent fee agreement with such class member less the percentage amount awarded by the court to Class Counsel and other attorneys for their services in creating Fund B and securing the benefits it provides. This court has subject matter jurisdiction pursuant to 28 U. Notice packages were transmitted by first class mail to each of these 287,108 individuals. P-211.) The notice itself consisted of several elements. 1992) (stating that "[i]mpracticability does not mean impossibility, but rather that the difficulty or inconvenience of joining all members of the class calls for class certification"). The court will treat these requirements together "[b]ecause 23(b)(3)'s predominance requirement incorporates the commonality requirement" of Rule 23(a)(2).
Treatment of PPH Under the Settlement Agreement...................... Level II describes those individuals with moderate to severe regurgitation who have evidence of changes in their cardiac status such as hypertrophy, dilatation, reduced ejection fraction, pulmonary hypertension and the like.
Level I describes those individuals who either have severe regurgitation or have suffered bacterial endocarditis.
Matrix A-1 describes the compensation available to diet drug recipients with serious VHD who took diet drugs for 61 days or longer, who are registered as having FDA Positive levels of valvular regurgitation by Date 2 and who do not have any of the alternative causes of VHD that make the B matrices applicable. P-3 at 39-55 of 148.) Matrix A-2 describes the compensation available to spouses, parents, children and significant others of diet drug recipients entitled to compensation on Matrix A-1. P-3 at 39-55 of 148.)Matrix B-1 describes the compensation available to class members with serious VHD who were registered as having only Mild Mitral Regurgitation by the close of the Screening Period, or who took diet drugs for 60 days or less, or who have factors that would make it difficult for them to prove that their VHD was caused by the use of diet drugs.
Finally, if class members with FDA Positive levels of regurgitation progress to serious levels of VHD by the year 2015, they will have a right, as such conditions occur, to receive compensation pursuant to the terms of the settlement matrices or to exercise a "back-end opt-out" and pursue their claim for compensatory damages (but not punitive damages) in the tort system without any time bar or other defense arising from a statute of limitations, a statute of repose or the like. P-3 at 38-56, 61-63 of 148.) Class members who progress to more serious levels of valvular heart disease have the right to "step up" to higher amounts of compensation as those levels occur pursuant to the settlement matrices. P-3 at 38-56 of 148.)There are four matrices under the settlement.
Eligible class members must register for this benefit by Date 1. P-3 at 35 of 148.) Class members who took diet drugs for 61 days or more have the right to receive reimbursement for the cost of their Pondimin and/or Redux prescriptions, subject to a maximum payment of 0 and further subject to the availability of money within Fund A after payment of all other benefits.
This two percent increase is sufficient protection against inflation given the historical annual rate of change in the consumer price index. The relief available to the court upon such an application includes an order disallowing the claim, an order directing an additional audit of other claims involving the same attorney and/or physician who was involved in the claim, an order directing such other additional audits as may be appropriate, an order imposing penalties including the payment of costs and attorneys fees and an order making a referral of the matter to the United States Attorney or other appropriate law enforcement officials for criminal prosecution if there is probable cause to believe that the claim was submitted fraudulently.
Rather, the Matrices represent an objective system of compensation whereby claimants need only prove that they meet objective criteria to determine which matrix is applicable, which matrix level they qualify for and the age at which that qualification occurred. P-3 at 38-56.) In addition, the amounts specified by each cell of each matrix will be increased by 2% per year to provide protection against inflation for individuals who qualify for such payments in the future. Rather, benefits determinations are based on the sworn certification of a board certified physician--primarily a board certified cardiologist or cardiothoracic surgeon--that a class member either has or does not have each of the conditions applicable under the settlement matrices. In addition, the settlement permits AHP to submit additional claims for quarterly audit of up to 10% of the matrix claims submitted and 10% of the non-matrix claims submitted. P-278 31.) The audit procedure requires those responsible for administration of the settlement to gather all medical records relevant to the audited claim and forward them to a highly qualified independent board certified cardiologist who is responsible for making a determination as to whether or not there was a reasonable medical basis for the representations made by any physician in support of the claim. P-3 at 111-15 of 148.) If the auditing cardiologist makes the determination that there was a reasonable medical basis to support the class member's claim and there is no substantial evidence that fraud was committed in connection with the claim, the claim is to be allowed.
Level V describes those individuals whose VHD is so far advanced that it is terminal. Class members do not have to demonstrate that their injuries were caused by ingestion of Pondimin and Redux in order to recover Matrix Compensation Benefits. P-94 at 3 of 41.) Under the Settlement Agreement, the determination of a matrix benefit is not subject to the exercise of discretion by the Administrators of the Settlement or by any court. P-3 at 101-02 of 148.) In order to prevent fraud, the settlement requires the Trustees to perform a quarterly audit of five percent of the total claims for Matrix Compensation Benefits in accordance with a plan of audit adopted by those responsible for administration of the settlement.
Specifically, the settlement requires the creation of a non-profit corporation named the "Cardiovascular Medical Research and Education Fund" to be managed by a Board of Directors consisting of seven persons. P-12, P-17, P-24, & P-25.)This information is to be recorded in a computerized database suitable for use with standard medical research software and maintained as a "registry" for purposes of administering the settlement and for purposes of medical education and research. P-3 at 91-95 of 148.) After redaction of all patient identifying information, the registry/database is to be made available to persons who: (1) provide written proof of their training, qualifications and experience to conduct medical research; (2) provide a research protocol setting forth the purposes for which they seek access to the registry, the research methodology, source of funding and a description of how the proposed research will benefit the settlement class; (3) undertake, in writing, to use the information they receive from the registry solely for medical, scientific and educational purposes; (4) undertake upon completion of the research to provide the Settlement Administrators, the court, AHP and Class Counsel with a copy of any publication based in whole or in part on the information contained in the registry; and (5) undertake not to testify at any time on behalf of any party in any lawsuit relating to the use of Pondimin and/or Redux.
Eligible class members must register for this benefit by Date 1. P-32 2.)The Settlement Agreement requires the establishment of a million fund to be used to finance medical research and education related to heart disease.