In Re Diet Drugs (Phentermine/Fenfluramine/Dexfen-Fluramine) Products Liability Litigation

385 F.3d 386, 2004 WL 2220322
CourtCourt of Appeals for the Third Circuit
DecidedOctober 5, 2004
Docket03-2025, 03-2063, 03-2072
StatusPublished
Cited by1 cases

This text of 385 F.3d 386 (In Re Diet Drugs (Phentermine/Fenfluramine/Dexfen-Fluramine) Products Liability Litigation) is published on Counsel Stack Legal Research, covering Court of Appeals for the Third Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In Re Diet Drugs (Phentermine/Fenfluramine/Dexfen-Fluramine) Products Liability Litigation, 385 F.3d 386, 2004 WL 2220322 (3d Cir. 2004).

Opinion

OPINION OF THE COURT

FUENTES, Circuit Judge.

This appeal arises from the multi-dis-trict litigation (MDL) 1203 diet drug product liability litigation. The appeal concerns the validity of an amendment (the “Sixth Amendment”) to the Nationwide Class Action Settlement Agreement (the “Settlement Agreement”) executed between Appellants and American Home Products Corporation (a.k.a. “Wyeth”) 1 in relation to the diet drugs litigation. The Sixth Amendment was approved by the District Court in Pretrial Order (“PTO”) No. 2778. The Amendment gives claim *389 ants who would otherwise have been bound by the Settlement Agreement the right to opt out of the Agreement and proceed with tort litigation'against Wyeth in the event that the fund established to pay claims under the Settlement Agreement (i.e., the “Settlement Trust”) becomes insolvent. Under the Sixth Amendment, claimants’ rights to sue Wyeth are subject to certain restrictions. Because of these restrictions, Appellants here argue that the District Court should not have approved the Sixth Amendment as fair, adequate and reasonable. Appellants further argue that they were deprived of due process in that they (1) did not receive adequate notice of the risk of Trust insolvency when they opted to be bound by the Settlement Agreement and (2) did not receive adequate representation.

Because we believe that the Sixth Amendment provides class members with additional rights that did not exist under the original Settlement Agreement (specifically, the right to sue Wyeth, Albeit subject to certain conditions) we will affirm the District Court’s approval of the Amendment as fair, adequate and reasonable. We reject the due process notice and adequate representation arguments, because- those arguments relate to the original Settlement Agreement, the validity of which is not properly before this Court, and have been previously and finally heard and rejected by this Court. Accordingly, we hold the Sixth Amendment to the Settlement Agreement to be valid.

I. FACTUAL BACKGROUND AND PROCEDURAL HISTORY

Prior to 1997, Wyeth sold two prescription drugs for the treatment of obesity, fenfluramine and dexfenfluramine, marketed as “Pondimin” and “Redux.” In September 1997, the U.S. Food and Drug Administration (FDA) issued a press release reporting abnormal echocardiograms in a “higher than expected percentage of’ patients taking the drugs. See Press Release, FDA, FDA Announces Withdrawal of Fenfluramine and Dexfenfluramine (Fen-Phen) (Sept. 15, 1997). Subsequent studies suggested that the drugs may have been linked to serious cardiopulmonary side effects, including heart-valve regurgitation (the reverse flow of blood through a closed valve of the heart).

After the withdrawal of the diet drugs, 18,000 individual suits and 100 class actions were filed in state and federal courts. In December 1997, the federal cases were consolidated for pretrial purposes in the Eastern District of Pennsylvania pursuant to MDL 1203. In November 1999, Wyeth entered into a Nationwide Class Action Settlement Agreement with users of the diet drugs in the United States. After conducting fairness proceedings, the District Court in the Eastern District of Pennsylvania certified a settlement class ánd approved the Settlement Agreement, finding it “fair, reasonable and adequate.” See PTO 1415. The Settlement Agreement became final upon exhaustion of all appeals. The Settlement Agreement established the Settlement Trust to administer Wyeth’s obligations to class members who agreed to participate in the- Settlement.

Diet drug users who wished to opt out of the Settlement Agreement could do so by fifing an “Initial Opt Out” form by March 30, 2000. Putative class members were informed of the right to opt out through “an elaborate and extensive plan of notice,” which included weeks of television, print, and internet advertising, patient notification materials provided through pharmacists and prescribing doctors, a toll-free number, and a detailed “notice package” sent to all possible class members whose names and addresses were known or who *390 called the toll-free number. PTO 1415. Persons who timely exercised initial opt out rights were free to pursue any and all claims against Wyeth. Those who did not remained members of the class and agreed to be bound by the conditions and benefits of the Settlement Agreement. Upon approving the Settlement Agreement, the District Court entered PTO 1415, which expressly “bars and enjoins” all class members “from asserting, and/or continuing to prosecute” amy settled claim against Wyeth. 2

The Settlement Agreement contained an exception to this bar, permitting class members who met specific physical requirements (diagnosed as having a severity of heart-valve regurgitation defined as “FDA Positive”) to pursue “Intermediate Opt Out” rights. These rights allowed class members to opt out of the Settlement at a date beyond the Initial Opt Out period (without Wyeth asserting statute of limitations defenses) and to pursue claims against Wyeth subject to certain limitations. These limitations included a prohibition against “seekfing] punitive, exemplary, or any multiple damages.” App. at 85-86.

Diet drug users who currently suffer from severe heart-valve regurgitation or from moderate regurgitation with complicating features, or who have less severe heart-valve conditions that progress to the more serious levels in the fifteen years following execution of the Settlement Agreement, may claim and recover compensation under the Settlement. The amount of their recovery is determined by damage “Matrices” that assess factors such as severity and length of illness to calculate the damage award. 3 Alternatively, class members with conditions that would allow them to qualify for these “Matrix” benefits (and who fulfill other eligibility requirements set out in the Agreement) may exercise “Back-End Opt Out” rights and pursue tort claims against Wyeth, so long as they have not already made a claim for compensation under the Settlement Agreement. Once a class member discovers that his heart-valve condition is serious enough to qualify him for Matrix-level benefits, the class member must make an election as to which option to pursue. The Settlement Agreement specifically provides that “[a] Class Member may not exercise a Back-End Opt Out right after claiming any Matrix Compensation Benefits.” App. at 575. As with the Intermediate Opt Out, class members exercising Back-End Opt Out rights will not be blocked by statute of limitations defenses, but are restricted from asserting punitive, exemplary, or multiple damages.

Thus, according to the system set out in the Settlement Agreement, any diet drug users who fail to exercise Initial, Intermediate, or Back-End Opt Out rights are bound by the terms of the Settlement Agreement and its bar against attempting to pursue any claims against Wyeth. For those who remain in the Settlement, a claim for Matrix benefits is made by submitting a three-part “Green Form” to the Settlement Trust. Wyeth funds payment of Matrix benefits through deposits into the Trust. Under the Settlement Agreement, Wyeth’s funding obligation is limited to $3.75 billion, plus any increase in value

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Bluebook (online)
385 F.3d 386, 2004 WL 2220322, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-diet-drugs-phenterminefenfluraminedexfen-fluramine-products-ca3-2004.