In re Diet Drugs (Phentermine/Fenfluramine/Dexfenfluramine) Prod. Liab. Litig., 12–1180.

• Decision Date: 28 January 2013
• Docket Number: No. 12–1180.,12–1180.
• Citation: 706 F.3d 217
• Parties: In re DIET DRUGS (PHENTERMINE/FENFLURAMINE/DEXFENFLURAMINE) PRODUCT LIABILITY LITIGATION, Carmen Cauthen and Ricky Leon Cauthen, Appellants.
• Court: U.S. Court of Appeals — Third Circuit

706 F.3d 217

In re DIET DRUGS (PHENTERMINE/FENFLURAMINE/DEXFENFLURAMINE) PRODUCT LIABILITY LITIGATION, Carmen Cauthen and Ricky Leon Cauthen, Appellants.

No. 12–1180.

United States Court of Appeals,Third Circuit.

Argued Nov. 13, 2012.

Filed: Jan. 28, 2013.

W. Steven Berman, Napoli Bern Ripka & Associates, Marlton, NJ, Paul J. Napoli, Napoli, Kaiser, Bern & Associates, Great River, NJ, Denise A. Rubin [Argued], Napoli, Bern, Ripka & Shkolnik, New York, NY, for Appellants.

Heidi L. Levine, DLA Piper LLP, Anand Agneshwar [Argued], Arnold & Porter LLP, New York, NY, Raymond M. Williams, DLA Piper LLP, Philadelphia, PA, Geoffrey J. Michael, Anna K. Thompson, Daniel S. Pariser, Arnold & Porter LLP, Washington, DC, for Appellees Wyeth LLC and Wyeth Pharmaceuticals Inc.

Michael D. Fishbein, Laurence S. Berman, Arnold Levin, Mary E. Gately, Levin, Fishbein, Sedran & Berman, Philadelphia, PA, Charles R. Parker, Houston, TX, for Class Counsel and Plaintiffs Liaison Counsel.

Jules S. Henshell, Semanoff, Ormsby, Greenberg & Torchia, Huntingdon Valley, PA, for AHP Settlement Trust.

Before: SCIRICA, FISHER, and JORDAN.

OPINION OF THE COURT

JORDAN, Circuit Judge.

In November 1999, Wyeth L.L.C. (“Wyeth”) entered into a nationwide class action settlement agreement (the “Settlement Agreement”) with the users of certain diet drugs linked to various health problems. The United States District Court for the Eastern District of Pennsylvania certified the settlement class and entered a pre-trial order enjoining members of the class from suing Wyeth for injuries related to those drugs. Appellants Carmen and Ricky Leon Cauthen brought a lawsuit against Wyeth in the Court of Common Pleas of Philadelphia County, Pennsylvania, seeking to redress Ms. Cauthen's injuries from primary pulmonary hypertension (“PPH”), a condition that she alleges was caused by the diet drugs. Wyeth moved the District Court to enjoin the suit, arguing that it did not qualify under the Settlement Agreement as a cause of action that could proceed despite the settlement. The District Court agreed and enjoined the Cauthens' lawsuit. For the reasons that follow, we will affirm.

I. BackgroundA. Class Action Suit and Settlement Agreement

Between 1994 and 1997, American Home Products Corporation, now Wyeth, marketed and sold fenfluramine and dexfenfluramine, prescription weight loss drugs. After studies linked the drugs to valvular heart disease, and following a U.S. Food and Drug Administration (“FDA”) public health advisory, Wyeth withdrew the drugs from the market in 1997. Thousands of individuals subsequently filed suit, alleging that they had been injured by the drugs.

In December 1997, the Judicial Panel on Multidistrict Litigation entered an order transferring all diet drug cases in federal court to the United States District Court for the Eastern District of Pennsylvania for consolidated pre-trial proceedings. Nearly two years later, Wyeth entered into a Settlement Agreement with users of the diet drugs in the United States and presented the agreement to the District Court for approval. On August 28, 2000, the District Court certified the class, approved the Settlement Agreement, and entered Pre–Trial Order (“PTO”) No. 1415. That order provided that the District Court “retains continuing and exclusive jurisdiction over this action and each of the Parties, including [Wyeth] and the class members, to administer, supervise, interpret and enforce the Settlement in accordance with its terms.” (Supplemental App. at 8.)

Aside from certain narrow exceptions, the Settlement Agreement enjoins class members from suing Wyeth for all diet drug-related injuries. One of the exceptions is at issue in this case: the Settlement Agreement allows class members to sue Wyeth if they can demonstrate that they developed PPH ¹ through the use of the diet drugs. To qualify for the exception, a class member must draw on “[m]edical records” to demonstrate the “exclus[ion]” of certain medical conditions. (App. at 787–88.) To exclude one such condition, which is referred to as “greater than mild restrictive lung disease,” a class member is required by § I.46.a(2)(c) of the Settlement Agreement to produce “pulmonary function tests” ² (“PFTs”) showing that the class member's “total lung capacity” is greater than “60% of predicted at rest.” ( Id. (Settlement Agreement, § I.46.a(2)(c)).)

B. The Cauthens' Lawsuit

In June 2011, the Cauthens filed a complaint in the Philadelphia County Court of Common Pleas, alleging that Ms. Cauthen, a member of the settlement class, developed PPH “as a result of ingesting Diet Drugs.” ( Id. at 3.) The Cauthens produced a “[p]ulmonary consultation note” prepared by Dr. Terry Fortin ( id. at 795–97), a cardiologist certified by the American Board of Internal Medicine. Dr. Fortin stated in the consultation note that, based on a PFT she had conducted, Ms. Cauthen's “total lung capacity [is] 56%,” and Dr. Fortin acknowledged that Ms. Cauthen's lungs “clearly have some restriction.” ( Id. at 796.)

Because Ms. Cauthen's only PFT showed that she had lung capacity of less than 60 percent of predicted at rest, Wyeth notified the Cauthens that they were prohibited from bringing their claim, as Ms. Cauthen did not satisfy § I.46.a(2)(c) of the Settlement Agreement. The Cauthens declined to drop the lawsuit. Wyeth then filed a motion in the District Court seeking to enjoin the Cauthens' state court lawsuit for failing to satisfy the precondition for suit provided by the Settlement Agreement. Opposing Wyeth's motion, the Cauthens submitted a declaration by Dr. Fortin stating that, “to a reasonable degree of medical certainty[,] ... Ms. Cauthen has primary pulmonary hypertension secondary to her use of [one of the diet drugs] in early 1997.” ( Id. at 808.)

In her declaration, Dr. Fortin alluded to the requirement in § I.46.a(2)(c) of the Settlement Agreement that lung capacity must be greater than 60 percent of predicted at rest, and she said that “[i]nsight into underlying pathophysiology can often be gained by comparing the measured values for pulmonary function tests obtained on a patient at any particular point with normative values derived from population studies.” ( Id. at 809.) “The percentage of predicted normal [lung capacity],” she continued,“is used to grade the severity of the abnormality.” ( Id.) She explained that the normative values used to calculate a patient's percentage of lung capacity predicted at rest “are based upon averages for persons of similar height, weight, age, ethnicity, etc.” ( Id.) According to Dr. Fortin, the “standard average reference” used to calculate Ms. Cauthen's percentage of lung capacity was 5.37 liters, a value “taken from the Crapo/Hsu Duke modified guide at [Duke] University.” ( Id. at 810.) Dr. Fortin further explained that, through a battery of tests conducted on April 28, 2009, she had determined that Ms. Cauthen had a lung capacity of 3.03 liters. Dividing 3.03 (Ms. Cauthen's lung capacity) by 5.37 (the average lung capacity of individuals matching Ms. Cauthen's demographic profile), yields Ms. Cauthen's percentage of lung capacity predicted at rest, 56.4 percent.

Dr. Fortin went on to downplay that result by challenging the accuracy of the denominator in the above equation. The figures used to represent average lung capacity by demographic characteristics, she asserted, “are only averages and may vary in actual practice.” ( Id. at 809.) “The 5.37 liter reference is only a reference value,” she continued, “and does not actually represent M[s]. Cauthen's total lung capacity.... [T]he 5.37 liter reference value is just a predicted average of [a] wom[a]n's total lung capacity who fits Ms. Cauthen's age, height, race and weight.” ( Id. at 810.) In fact, Dr. Fortin claimed, the value taken from the Crapo/Hsu Duke modified guide “is just one of the many references available that are out there.” ( Id ) Without providing any other reference, Dr. Fortin concluded “to a reasonable degree of medical certainty that we just do not know conclusively what the true reference value for Ms. Cauthen should be.” ( Id ) Dr. Fortin did offer, however, that, “[i]f we were to use a reference value of 5.05, just 32ccs less than the 5.37 reference originally used[,] then Ms. Cauthen's total lung capacity percent predicted calculation would be 60%.” ( Id. at 811.)

Dr. Fortin also asserted that comparing an individual's lung capacity with the average capacity of persons having a similar demographic profile is important but not determinative in diagnosing PPH. “Cardiologists,” she assured the District Court, “know about the limitations of the percent predicted calculation on a [PFT] and must rely on other methods in order to determine a specific patient's true total lung capacity, such as radiology studies and an exam of the patient's body habitus.” ( Id. at 810.) In fact, Dr. Fortin claimed, “whether [Ms. Cauthen's] total lung capacity percent predicted calculation is 56% or 60% is clinically irrelevant” ( id.), and “Ms. Cauthen's diet drug use was the cause of her [PPH]” ( id. at 811). Without further explanation, Dr. Fortin declared that, “[b]ased upon [her] review of the April 28, 2009 Pulmonary Function Test and other objective tests,” ³ she had “ruled out any restrictive lung disease as a cause of Ms. Cauthen's [PPH].” ( Id.)

Unconvinced, the District Court held that the Cauthens had not produced a PFT that supported their claim that Ms. Cauthen “does not have greater than mild restrictive lung disease,” as required by § I.46.a(2)(c) of the Settlement Agreement. ( Id. at 7.) Dr. Fortin's declaration did not alter the Court's conclusion for two reasons. First, the doctor acknowledged that Ms. Cauthen's only PFT demonstrated that she has a total lung capacity of only 56 percent of predicted at rest. Ms. Cauthen thus did not meet the definition of PPH provided in § I.46.a(2)(c). Second, the Settlement Agreement requires class members...