On Appeal from the United States District Court for the Eastern District of Pennsylvania D.C. Civil Action No. 06-cv-5510 (Honorable Gene E.K. Pratter) D.C. Civil Action No. 06-cv-4419 (Honorable James Knoll Gardner)
The opinion of the court was delivered by: Scirica, Circuit Judge.
Before: SCIRICA, BARRY and SMITH, Circuit Judges.
This is a diversity case. In these putative class actions seeking medical monitoring, we determine whether, under Pennsylvania law, a person exposed to beryllium above background levels, absent sensitization, can be at a "significantly increased risk" of contracting chronic beryllium disease. There are two separate appeals. Plaintiffs in each case filed a putative class action lawsuit against multiple defendants, alleging negligence in connection with beryllium exposure and seeking a medical monitoring trust fund based on their increased risk of developing chronic beryllium disease. In the first action, No. 08-4374 (the "Anthony action"), the District Court granted defendants' joint motion for summary judgment. In the second action, No. 08-4373 (the "Zimmerman action"), the District Court addressed three separate legal issues-medical monitoring under Pennsylvania law, claim preclusion, and third-party liability-and issued final orders in favor of defendants.*fn1 As a consequence, neither action addresses the class certification issues. Plaintiffs appeal. We will affirm.
Both cases are based on exposure to beryllium, a steel-gray metal produced from naturally occurring beryl ore. Beryllium is an extremely stiff, light metal with a high melting point and excellent thermal and electrical conductivity. Because of these properties, beryllium is used as structural material for high-speed aircraft, missiles, space vehicles, and communications satellites. It is also used in radiation windows for x-ray tubes, and as a reflector and moderator in nuclear reactors. Although it is occasionally used as a pure metal, it is more commonly incorporated at low levels into alloys.
Beryllium is highly toxic, odorless, and tasteless. Inhaling beryllium particles can lead to scarring of the lungs, a condition known as chronic beryllium disease ("CBD"). CBD occurs when the immune system mounts an attack against beryllium particles that have entered the body. The lung sacs become inflamed and fill with large numbers of white blood cells that accumulate wherever beryllium particles are found. The cells form balls around the particles called granulomas. Eventually, the lungs become scarred and lose their ability to transfer oxygen to the blood stream. This leads to shortness of breath, chronic cough, fatigue, fever, loss of appetite, and, potentially, death.
Although some scientific studies suggest there may be a relationship between the level of beryllium exposure and the likelihood of developing CBD, exposure itself appears to be insufficient because only persons who have a particular genetic "marker"-the Human Leukocyte Antigen (HLA)-DPB1 allele-can potentially recognize beryllium in the lungs as an antigen. This reaction is called beryllium sensitization ("BeS"). The parties do not dispute that BeS is a necessary precursor to CBD. BeS itself causes no abnormal lung function and requires no treatment (i.e., it is asymptomatic). But when the reaction leads to the formation of granulomas in the lungs, BeS has progressed to CBD. Some studies show this temporal progression varies-the development of CBD in a sensitized person has ranged from months to several years. However, some sensitized individuals have not developed CBD, and a small percentage of them have become "desensitized."
Multiple studies have attempted to determine the percentage of the population that is genetically predisposed, or "susceptible," to CBD. The results so far are inconclusive and disputed. There are substantial disagreements between the expert opinions in these cases: Craig S. Glazer, M.D., M.S.P.H., F.C.C.P., an expert for plaintiff Gary Anthony, stated that 30--40% of the population has the genetic marker, while Lawrence H. Repsher, M.D., F.C.C.P., defendants' expert in the Anthony action, stated that only 1--3% of the overall population can become sensitized-that is, only this percentage has the genetic marker. And in another study, researchers found that 3--10% of workers exposed to occupational beryllium may develop CBD or BeS.*fn2 Once a person is sensitized, the data also varies on the likelihood that person will develop CBD. While Dr. Glazer declared that more than 50% of individuals with BeS will develop CBD, another study found that 6--8% of persons with BeS develop CBD each year, but refused to speculate on the total progression rate from BeS to CBD.*fn3
Because BeS is asymptomatic, scientists have developed tests to determine whether a person is sensitized. Although lung biopsies, chest x-rays, and computed axial tomography (CAT) scans of the chest can be used to diagnose BeS and CBD, the most common test for sensitization is the beryllium lymphocyte proliferation test ("BeLPT"). Developed in its modern form in the 1980s, the BeLPT is performed by extracting lymphocytes from blood or lung lavage fluid and exposing them to beryllium. If the lymphocytes proliferate in response to beryllium, then the BeLPT is "positive," which means that the individual's immune system has begun to recognize beryllium as an antigen. Due to the risk of false positives, it is generally accepted that two positive blood BeLPTs, or one positive BeLPT performed on lung lavage fluid, are required to demonstrate sensitization. But a negative BeLPT result is not necessarily indicative of future results-the test only reflects a person's current reaction (or lack thereof) to beryllium.
In summary, the pathogenesis of CBD is as follows: (1) a person is exposed to beryllium; (2) based on exposure and one's genetic predisposition, he may develop BeS; and (3) that sensitization may (or may not) eventually lead to CBD. Although BeS is a necessary precursor to CBD, the progression rate from BeS to CBD is varied and uncertain, dependent on a multitude of factors, many of which are unknown.
Beryllium was discovered in 1798, but its use in the United States can be traced back only to World War II and the Cold War era, when the United States government purchased significant quantities of the metal to produce weapons and aircraft, primarily from Brush Wellman and The Beryllium Company.*fn4 Although the government's need for beryllium has declined, a private sector market has developed as manufacturers of metal-based products such as automobiles, golf clubs, bicycles, dental appliances, and computers have begun to use beryllium alloys.
As early as the 1940s, workers at beryllium plants were showing signs of CBD. Because the Atomic Energy Commission ("AEC") was the initial purchaser of beryllium, it developed the first safety guidelines for beryllium use. In 1949, it adopted a standard of 2 micrograms per cubic meter (ug/m3 of air averaged over an eight-hour period. See Morgan v. Brush Wellman, Inc., 165 F. Supp. 2d 704, 710--11 (E.D. Tenn. 2001) (providing a brief history of the regulation of beryllium). In 1971, the Occupational Safety and Health Administration ("OSHA") adopted the 2 ug/m3 standard and also recommended a peak concentration of 25 ug/m3 of air for a maximum duration of thirty minutes. 29 C.F.R. § 1910.1000. The Department of Energy ("DOE") then promulgated the most recent regulations, maintaining the exposure limit set by the AEC, but also requiring the use of periodic medical surveillance and the implementation of worker protection programs when the level of airborne concentration of beryllium exceeds 0.2 ug/m3. 10 C.F.R. §§ 850.3, .22, .23. Other governmental agencies also have issued recommendations for beryllium levels. The Environmental Protection Agency ("EPA") promulgated its own rule, limiting exposure to 0.01 ug/m3 of air averaged over a thirty-day period. 40 C.F.R. § 61.32. The National Institute for Occupational Safety and Health ("NIOSH") has collaborated with Brush Wellman by conducting multiple studies on exposed employees to better understand the relationship between beryllium exposure, the HLA-DPB1 marker, BeS, and CBD.
In addition to government standards and studies, both private and public employers have implemented screening programs for their employees. Brush Wellman, the predominant producer of beryllium products in the United States today, began providing the BeLPT to its employees at some of its beryllium plants in the early 1990s, and created a formal screening program in 1999. Similarly, OSHA personnel who have participated in inspections of industries where beryllium is used are offered the opportunity to be medically monitored for beryllium disease.
Both the Anthony action and the Zimmerman action were filed in 2006 in the Philadelphia County Court of Common Pleas and were timely removed to the United States District Court for the Eastern District of Pennsylvania under the Class Action Fairness Act of 2005 ("CAFA"), Pub. L. No. 109-2, 119 Stat. 4 (codified in scattered sections of 28 U.S.C.), where Judge Gardner presided over the Anthony action and Judge Pratter presided over the Zimmerman action.*fn5 Both courts granted defendants' respective motions to dismiss, for judgment on the pleadings, and for summary judgment.*fn6 Although we denied plaintiffs' motion to consolidate the Anthony and Zimmerman appeals, our opinion resolves both actions.*fn7
Gary Anthony worked at the U.S. Gauge Plant in Sellersville, Pennsylvania from May 1972 to May 2004. U.S. Gauge used beryllium-based products to manufacture various commercial goods, causing the emission of respirable beryllium dust, particles, and fumes in the facility. Anthony commenced a putative class action, of which he is the sole representative, comprising all current and former employees of U.S. Gauge who were exposed to a beryllium-containing product at the facility for a period of at least one month while employed there. Defendants are U.S. Gauge's suppliers of beryllium-based products (Small Tube Manufacturing Corp., Admiral Metals, Inc., Tube Methods, Inc., and Cabot Corp.), as well as three third-party defendants.*fn8 Anthony's Complaint asserts a single negligence claim in which he contends that members of the proposed class were exposed to beryllium during their employment, which resulted in an increased risk of contracting CBD. He seeks the establishment of a medical monitoring trust fund for the benefit of the putative class. Medical monitoring would include testing, examination, and preventative and diagnostic screening for BeS and CBD.
Defendants removed the action to federal court and filed a joint motion for summary judgment. The court granted limited discovery. Anthony presented two experts, Adam M. Finkel, Sc.D., M.P.P., CIH, and Dr. Glazer; defendants presented one expert, Dr. Repsher. The parties agreed on the aforementioned pathogenesis of CBD, the fact that BeS is a necessary precursor to developing CBD, and that two positive blood BeLPTs are necessary to show sensitization. They also stipulated that Anthony had taken one blood BeLPT, which was negative, and accordingly he was not beryllium sensitized. But they disagreed on when "significantly increased risk" attaches to persons exposed to beryllium. The gist of Dr. Glazer's and Dr. Finkel's testimony is that all individuals exposed to beryllium at above-background levels are at a significantly increased risk and require medical monitoring. Dr. Finkel also declared that there is a direct relationship between the level of exposure and risk, and that CBD is not "qualitatively different from any other environmental disease, for which susceptibility is continuous (not either/or) and for which both susceptibility and exposure matter fundamentally." Decl. of Dr. Finkel (Anthony action) ¶ 17. In contrast, Dr. Repsher opined that given Anthony's negative BeLPT result and the fact that only a small percentage of the population can become sensitized, Anthony was not at a significantly increased risk of developing CBD. Decl. of Dr. Repsher (Anthony action) ¶ 11.
Judge Gardner granted defendants' summary judgment motion against Anthony. Applying Pennsylvania law, the court looked to the seven-element test for a medical monitoring claim set forth in Redland Soccer Club, Inc. v. Dep't of the Army, 696 A.2d 137 (Pa. 1997), and focused on whether "as a proximate result of the exposure," Anthony had "a significantly increased risk of contracting a serious latent disease." Id. at 145. It then looked to the Pennsylvania Superior Court's decision in Pohl v. NGK Metals Corp., 936 A.2d 43 (Pa. Super. Ct. 2007), alloc. denied, 952 A.2d 678 (Pa. 2008), the only state appellate court opinion to apply Redland Soccer to a medical monitoring claim for exposure to beryllium. Because the plaintiffs in Pohl were not beryllium sensitized and had not otherwise made a plausible showing that they faced a "significantly increased risk" of developing CBD, the Superior Court held that these plaintiffs had failed to make a prima facie showing of their medical monitoring claim under Redland Soccer. Anthony v. Small Tube Mfg. Corp., 580 F. Supp. 2d 409, 428 (E.D. Pa. 2008).*fn9
Judge Gardner read Pohl as a fact-specific decision, but concluded that the expert opinions Anthony presented were "merely assumptions and speculation, rather than opinions" because they were not supported by data from the U.S. Gauge Plant. Id. at 426--27. Because Anthony was not sensitized to beryllium and had not presented alternative evidence to raise a genuine issue of material fact regarding the risk of developing CBD, the court granted defendants' summary judgment motion. Id. at 428.
James Zimmerman resided within one mile of the Reading Beryllium Facility in Muhlenberg Township, Pennsylvania from 1977 to 1984. The facility extracted beryllium hydroxide and manufactured products containing beryllium from 1936 to 2000. Zimmerman, together with Shirley Sheridan, discussed infra, commenced a putative class action lawsuit. The Complaint is almost identical to the Anthony Complaint-it asserts one negligence claim in which plaintiffs contend that because of their residency in close proximity to the Reading Plant they were exposed to beryllium particles in the ambient air. Defendants include NGK Metals Corp., owner and operator of the Reading Plant from 1986 through 2000; Cabot Corp., owner and operator of the plant for at least fifty years before 1986; and Spotts, Stevens & McCoy, Inc., an engineering firm that was responsible for testing and monitoring the levels of beryllium at the facility. Like Anthony, Zimmerman and Sheridan seek the establishment of a medical monitoring trust fund for themselves individually and on behalf of a putative class, which includes all persons who resided within a one-mile radius of the Reading Plant for at least six months between 1950 and 2000.
Defendants removed the action to federal court, and the parties commenced bifurcated discovery so that discovery related to the issue of class certification would be completed prior to merits discovery. Defendants Cabot and NGK Metals moved for summary judgment before the court ruled on plaintiffs' motion for class certification.*fn10 Zimmerman provided the opinions of several experts, including Lisa A. Maier, M.D., M.S.P.H., John W. Martyny, Ph.D, C.I.H., Milton Rossman, M.D., Dr. Finkel, and Dr. Glazer, the last two of whom served as experts in the Anthony action. Defendants did not submit expert testimony, relying on the Pohl decision to support their motion. The parties ...