Mass Tort Defense : Mass Tort Defense Lawyer & Attorney : Sean P. Wajert : Dechert Law Firm : Products Liability, Class Actions, Pharmaceutical Litigation

The Third Circuit has affirmed the dismissal of two putative class actions that sought medical monitoring for workers and neighbors of factories using beryllium. Sheridan, et al.  v. NGK Metals Corp., et al., 2010 WL 2246392 (3d Cir. June 7, 2010). 

Readers may recall that previously we posted on the district court's dismissal of the claims against one of the defendants, an engineering firm that, according to the plaintiffs’ Amended Complaint, was involved with testing, sampling, analyzing, and monitoring the air quality and levels of beryllium at one plant involved in the cases. The Third Circuit affirmed.  Boiled down to its core, plaintiffs’ Amended Complaint contended that the engineering firm breached its duty of reasonable care by failing to warn members of the community surrounding one of the plants at issue about the alleged beryllium emissions from the facility. But there was no legal duty to warn.  In order for the engineers to have negligently failed to warn plaintiffs of harmful beryllium exposures, they must have undertaken the responsibility of making that warning. Plaintiffs never alleged that the firm negligently performed the tasks it actually undertook—that is, testing, analyzing, and monitoring the levels of beryllium, and reporting those tests to the owner and operator of the facility. 

Also of note for readers is the remainder of the court's analysis regarding other defendants, which focused on one of the elements of medical monitoring.

Some background.  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 alleged increased risk of developing chronic beryllium disease int he future. In the first action, (the “Anthony action”), the District Court granted defendants’ joint motion for summary judgment. In the second (the “Zimmerman action”), the District Court addressed three separate legal issues— medical monitoring under Pennsylvania law, claim preclusion of the claims of one named plaintiff, Sheridan, and third-party liability—and issued final orders in favor of defendants. Although the cases presented similar legal issues, they arose out of different locations and distinct facts. However, plaintiffs’ lawyers, many of the expert witnesses, and one defendant, were the same in each case. The Third Circuit did not consolidate the two separate appeals, but resolved them in one opinion.

Inhaling beryllium particles can lead to scarring of the lungs, a condition known as chronic beryllium disease.  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 the 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.

The dose-response picture is a bit unusual. Mere 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 did not dispute that BeS is a necessary precursor to CBD. BeS by itself causes no abnormal lung function and requires no treatment (i.e., it is asymptomatic).  The experts debated how many people have the marker with estimates ranging from below 10% to 40% of the population. The most common test for sensitization is the beryllium lymphocyte proliferation test (“BeLPT”), which is not a test for the genetic marker, but a reasonably accurate test for sensitization according to the experts.

Readers know that one of the typical elements of a medical monitoring claim is proof of a significantly increased risk (of contracting the latent disease for which plaintiff seeks medical monitoring). Plaintiffs' expert testimony was that all individuals exposed to beryllium at above background levels are at a significantly increased risk and require medical monitoring. They  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 exposure disease.  Defendants' expert opined that given class rep Anthony’s negative result in the test to show whether he had become sensitized, 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.

In the other class action, the parties stipulated that class rep Zimmerman was not beryllium sensitized. Plaintiff experts argued, however, that anyone who has lived in the area surrounding the plant in question was at a significantly increased risk given the levels of beryllium in the
ambient air and documented cases of CBD in the community. They made a quantitative risk assessment based on collected exposure data, concluding that the risk of contracting CBD to the members of the proposed class represented by Zimmerman was 3 per 10,000, and for those
individuals who have lived near the plant for at least ten years, the risk allegedly increased to 1 per 500.

The Third Circuit noted that the intermediate appellate court in Pennsylvania had addressed analogous medical monitoring claims in Pohl v. NGK Metals Corp., 936 A.2d 43 (Pa. Super. Ct. 2007). The Pennsylvania Superior Court concluded there that the record provided no support for plaintiffs’ contention that they were sensitized to beryllium and thus that they faced a significantly increased risk of contracting CBD. Plaintiffs in federal court contended that Pohl was neither controlling nor persuasive, because it was a fact-specific decision in which the state court dismissed the three plaintiffs’ claims based on their individual failure of proof.

The court of appeals, however, concluded that the state court drew a line along the exposure-to-disease continuum -- at sensitization. The Third Circuit held that unlike its role in interpreting federal law, it may not "act like a judicial pioneer" in a diversity case. Contrary to both Anthony’s and Zimmerman’s contentions, Pohl was not based only on a simple lack of proof; it was based on plaintiffs’ failure to meet the requisite threshold for establishing significantly increased risk due to (1) the undisputed facts about beryllium exposure, BeS, and CBD, and (2) plaintiffs’ inability to demonstrate a significant increase in risk of disease before sensitization. Although the disparate data on how many people have the marker shows the gaping holes in the current state of scientific research, as well as the substantial factual disagreements between scientists, it was not material to this appeal. The parties stipulated that Anthony had not developed BeS, and there was no proof that he has the genetic marker associated with CBD. This background data did not prove his individual significantly increased risk.

As to the Zimmerman class (all persons who resided within a one-mile radius of the Reading Plant for at least six months during the time period between 1950 and 2000), the court noted that plaintiffs tried to make a different showing, including by presenting data on specific exposure levels around the Reading Plant and the number of documented cases of CBD in the community there. From Zimmerman’s perspective, exposure to beryllium is analogous to exposure to other toxins, such as asbestos and PCBs. Defendants contended CBD’s immunological nature distinguishes beryllium from other toxins, which do not invoke an allergic response in only a subset of susceptible persons and instead have a more linear exposure-to-disease relationship.

The state of the art is that only a small subset of an exposed population (those who carry the genetic marker) is at risk of developing CBD; the relationship between beryllium exposure and CBD is relatively non-linear, making generalized risk assessments inappropriate. Thus, there was a failure of proof on the risk element, given the current state of scientific knowledge on the
relationship between beryllium exposure and disease. Plaintiff failed to present sufficient evidence that as a proximate result of the exposure, he had a significantly increased risk of contracting
CBD.

The failure of the class reps to show they could meet a necessary element of the claim meant that the class actions could not proceed. (Sheridan's claim was barred.)

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A federal district court recently denied class certification in toxic tort litigation alleging that a chemical plant's long-term airborne release of vinyl chloride had risked their health and lowered property values. Gates v. Rohm and Haas Co.,  2010 WL 774327 (E.D. Pa. 3/5/10).

Plaintiffs alleged that vinyl chloride released from Rohm & Haas’s specialty chemicals manufacturing facility in Ringwood, Illinois contaminated the groundwater in and around McCollum Lake Village, as well as the air in the Village. Plaintiffs allege that between 1968 and 2002, the vinyl chloride evaporating from the shallow plume blew over the Village, contaminating the air in the Village and causing some Village residents to breathe varying amounts of it. Plaintiffs claimed that the levels of vinyl chloride in the Village air are higher than the background level. 

They asked the court to certify two classes: (1) a medical monitoring class, and (2) a property damage class.  On the latter, although plaintiffs alleged that the Village’s water and air have been contaminated, plaintiffs sought class certification only on the “outdoor air” theory. On the former class, the parties disputed whether, and the extent to which, exposure to vinyl chloride is associated with brain cancer in humans. Plaintiffs alleged that exposure to vinyl chloride placed Village residents at a higher-than-normal risk of contracting brain cancer, requiring periodic monitoring. In support of the medical monitoring program, plaintiffs submitted the report of an expert who opined that a class-wide medical monitoring regime using MRI's was medically reasonable given the alleged exposure to vinyl chloride.

Plaintiffs moved for certification of their property class under Rule 23(b)(3) and for certification of their medical monitoring class under both Rule 23(b)(2) and (b)(3). Rule 23(b)(2) permits certification where “the party opposing the class has acted or refused to act on grounds generally applicable to the class, so that final injunctive relief or corresponding declaratory relief is appropriate respecting the class as a whole.” Fed. R. Civ. P. 23(b)(2). Rule 23(b)(3) permits class actions where “the court finds that the questions of law or fact common to class members predominate over any questions affecting only individual members, and that a class action is superior to other available methods for fairly and efficiently adjudicating the controversy.” Fed. R. Civ. P. 23(b)(3).

The Third Circuit has clarified the legal standard for class certification and the district courts’ attendant duties in In re Hydrogen Peroxide Antitrust Litigation, 552 F.3d 305 (3d Cir. 2008).  The decision to certify a class calls for findings by the court, not merely a threshold showing by a party, that each requirement of Rule 23 is met.  Proper analysis under Rule 23 requires rigorous consideration of all the evidence and arguments offered by the parties.  Weighing conflicting expert testimony at the certification stage is not only permissible; it may be integral to the rigorous analysis Rule 23 demands. The court may not decline to resolve a genuine legal or factual dispute because of concern for an overlap with the merits. See also Hohinder v. United Parcel Service, Inc., 574 F.3d 169 (3d Cir. 2009).

As is typical, the battleground was the predominance and cohesiveness requirements of the rule.  (The court found that the individual issues that defeat the predominance requirement of Rule 23(b)(3) also defeat the cohesion requirement of Rule 23(b)(2)).

Regarding the elements of a medical monitoring claim, the court noted that whether vinyl chloride is a hazardous substance, whether a responsible monitoring procedure exists that makes the early detection of the disease possible, and whether the prescribed monitoring regime is different from that normally recommended in the absence of the exposure, did not here appear to present individualized questions in the context of this case.  (However, they can present individual issues in other cases depending on the substance, exposure, and risk.)

Next was the exposure element of the claim, with the key question being whether each plaintiff in the proposed class was exposed to a level greater than the normal background level. Plaintiffs must demonstrate that common proof may be used to determine whether each and every Class Member was exposed to a minimum level of vinyl chloride by Rohm and Hass that exceeds the applicable background levels.  While admitting individual exposure will vary depending on factors such as the time spent in the Village, plaintiffs asserted that class treatment is appropriate because there is a common minimum average daily exposure rate over time for any point within the Village. However, a rigorous analysis of plaintiffs’ expert evidence revealed that it does not reflect that all class members were exposed to vinyl chloride at a minimum level above  background, or that this determination could be made with common proof. Plaintiff's expert's  methodology  employed an averaging technique, making certification is inappropriate. Suffice it to say, an average is an average is an average. It is, in essence, a convenient fiction made up of numbers that are higher and lower than the average; it does not reflect whether every putative class member was exposed to vinyl chloride at a level above background, let alone at a level that carries a significantly increased risk of a latent disease. Exposures in the Village would vary  from year to year, such that a putative class member’s exposure would depend on the particular year or years in which he or she lived there. Individual class members’ locations and lifestyles potentially could result in significant differences in exposure, making Plaintiffs’ calculation of an “average exposure” even less useful. The time that each Village resident spent indoors, as opposed to outdoors, and the time that each individual spent away from the Village at work, away at school, on extended vacations, for example, are other factors that raise significant individual issues with respect to exposure levels. The evidence reflected that the putative class members’ habits, work schedules, and school schedules may have caused significant variations in the time that class members actually spent in the Village.

Of course, said the court, plaintiffs are not charged with the duty of calculating the precise exposure of any given individual, much less all of them, in order to secure class certification. However, plaintiffs must demonstrate that they can use common proof to demonstrate that each individual was exposed to a level above background levels. This, they had not done.

On the significant risk element, the court noted that it was impossible to tell from plaintiffs’ presentation of the average level of exposure to vinyl chloride - which itself is based on an average of certain vinyl chloride levels that were detected in certain test spots - whether every class member has a significantly increased risk of contracting a serious latent disease.  The first problem is that the level used by plaintiffs, derived from a regulatory figure, was not developed with an appropriate methodology for calculating a danger point for purposes of a medical monitoring claim. The value identified by plaintiffs only reflected the level of vinyl chloride at and below which a mixed population is safe, in the opinion of a public health agency. It did not, however, demonstrate the opposite, i.e., that any extra levels above the level are significantly harmful to necessitate medical monitoring.  Such a regulatory risk assessment cannot and does not support an opinion that each individual class member has experienced a significantly increased risk of disease.  The value may be appropriate as a prophylactic safety marker, perhaps for regulatory use, to minimize potential risks and protect the groundwater and air of a mixed population of individuals; however, it ought not be used as a predictive measure of actual risks for every individual in that population.  Precautionary measures to keep the general population safe are a fundamentally distinct form of relief from the medical monitoring cause of action. 

The court then turned to the question of whether the prescribed monitoring regime (that is, serial MRI exams) was reasonably necessary according to contemporary scientific principles. The court recognized that a medical monitoring program cannot be left open for the class members to fashion at will, but must consist of a specific form of monitoring different from what class members would ordinarily receive from regular physicals.  Plaintiffs argued  that serial MRIs are reasonable for the proposed class, but that in any event, the scheme could be modified after certification or allow individuals to tailor it to their particular circumstances (for example, a CAT scan for people who cannot tolerate MRIs).

The court had two problems with this argument.  One issue was what we may call the "more harm than good" calculus.  A blanket prescription for serial MRIs in asymptomatic individuals, coupled with the risks and drawbacks of serial MRI procedures, only strengthened the denial of class certification. For instance, the proposed class includes all residents of the Village, including children. The administration of MRIs to young children presents certain challenges because the children must lie still in the MRI machine for long periods of time. Conducting MRIs on children may require administering drugs to sedate or anesthetize them, a process that may prompt side effects of its own. The contrast agent used may pose risks for patients with kidney disease, for whom it can lead to nephrogenic systemic fibrosis, a potentially fatal condition; therefore, gadolinium is not recommended for use with such patients. In addition, medical monitoring in general, and MRIs in particular, can lead to stress and other adverse psychological consequences, and may induce claustrophobia in some patients.

The second problem with plaintiffs' flexible approach to their plan (i.e., that individual differences and medical needs can be accommodated through the use of CAT scans, open MRI machines, and other neurological exams. later), is that the determination of which accommodation, if any, is appropriate for which patient necessarily involves individual questions that cannot be determined on a class-wide basis. Moreover, the problems with the monitoring scheme can not be alleviated by a decision to just “deal with it later” at the summary judgment stage. Although the court may alter a monitoring scheme after the certification stage of the litigation has passed, that does not mean that problems with a monitoring plan can be ignored at the certification stage.

Turning to the property damage class, plaintiffs focused on "liability" as a common issue.  But the court found that even assuming that the fact of contamination was provable by common proof here, liability alone could not be proven with common proof. Common evidence may offer one potential source of the contaminants, but many other explanations may exist that are specific to a particular property. See Fisher v. Ciba Specialty Chems. Corp., 238 F.R.D. 273, 307 (S.D. Ala. 2006); see also Thomas v. FAG Bearings Corp., 846 F. Supp. 1400, 1404 (W.D. Mo. 1994).This can be especially true in this case, where differing levels of potential contamination over time affected different portions of the Village to different extents, depending on location, all of which must be compared to
the background level.

Finally, the court’s concerns about the number, complexity, and scope of issues that are plaintiff-by-plaintiff determinations also went to the superiority issue. Even if the court were to certify alleged common issues, the subsequent separate proceedings necessary for each plaintiff would undo whatever efficiencies such a class proceeding would have been intended to promote. Even more problematic, because a jury may be called upon to weigh the potential impact from Rohm and Haas’s actions on a particular property against those of another source of contamination, the “second” jury could well wind up re-considering the evidence of Rohm and Haas’s actions presented in the class proceeding.  

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The U.S. Food and Drug Administration announced this week that it will set new safeguards for medical imaging to reduce the amount of radiation to which patients may be exposed through increasingly common radiation-based diagnostic procedures.

Like all medical procedures, computed tomography (CT), fluoroscopy, and nuclear medicine imaging exams present both benefits and risks. These types of imaging procedures have led to improvements in the diagnosis and treatment of numerous medical conditions. At the same time, these types of exams expose patients to ionizing radiation, which may elevate a person’s lifetime risk of developing cancer.

Through the Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging, FDA is advocating the universal adoption of two principles of radiation protection: appropriate justification for ordering each procedure, and careful optimization of the radiation dose used during each procedure. In other words, each patient should get the right imaging exam, at the right time, with the right radiation dose.

According to a March 2009 report by the National Council on Radiation Protection and Measurements (NCRP), the U.S. population’s total exposure to ionizing radiation has nearly doubled over the past two decades. This rise is largely attributable to increased exposure from CT, nuclear medicine, and interventional fluoroscopy. NCRP estimates that 67 million CT scans, 18 million nuclear medicine procedures, and 17 million interventional fluoroscopy procedures, and 18 million nuclear medicine procedures were performed in the U.S. in 2006.

Concerns have been raised about the risks associated with patients’ exposure to radiation from medical imaging. Because ionizing radiation can cause damage to DNA, exposure can increase a person’s lifetime risk of developing cancer. Although the risk to an individual from a single exam may not itself be large, millions of exams are performed each year, making radiation exposure from medical imaging an important public health issue. Some experts have estimated recently that t approximately 29,000 future cancers could be related to CT scans performed in the U.S. in 2007. While estimates vary, most responsible public health officials agree that care should be taken to weigh the medical necessity of a given level of radiation exposure against the risks.

Against this backdrop, plaintiff lawyers continue to seek medical monitoring in the form of CT and other scans for millions of proposed class members around the country.  Plaintiffs' theory is that exposure to an alleged toxic substance has put the class at an increased risk of developing disease in the future, and thus they need medical monitoring to early detect the disease.  Most jurisdictions have not recognized this claim, but in those that do, defendants will want to pay close attention to the elements of the claim that require a plaintiff to prove that the testing is reasonably medically necessary or part of the standard of care.  The reason that treating physicians and public health agencies do NOT recommend monitoring in the form of CT scans for healthy, asymptomatic folks may increasingly include this issue of potential over-exposure.  While jurors may come to the court room with the pre-load that monitoring is great because early detection saves lives, the reality is that in many contexts, monitoring may do more harm than good.

Because CT, fluoroscopy, and nuclear medicine require the use of radiation, some level of radiation exposure is inherent in these types of procedures. Only when these procedures are conducted appropriately do the medical benefits they can provide generally outweigh the risks.  In the medical monitoring context, patients may be exposed to radiation without sufficient clinical need or benefit. Unnecessary radiation exposure, and thus cancer risk, results from the performance of a particular medical imaging procedure when it is not medically justified given a patient’s signs and symptoms, or when an alternative might be preferable given a patient’s lifetime history of radiation exposure.  That kind of needed individual assessment is one of the reasons why class-wide determination of medical monitoring is a bad idea. While plaintiffs trumpet the new technology, reports suggest that the radiation dose associated with one CT abdomen scan is the same as the dose from about 400 chest X-rays.

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A federal court has granted defendant CSX Transportation, Inc.’s Motion for Summary Judgment in a medical monitoring case arising from a train accident. See Mann v. CSX Transportation, et al., NO. 1:07-cv-3512 (N.D. Ohio Nov. 10, 2009).

The case arises from the derailment of 31 rail cars, nine of which contained hazardous materials, and the subsequent fire that burned for around sixty hours. Ohio emergency personnel oversaw an
evacuation of a one half mile radius. The next day, plaintiffs filed a putative class action complaint in state court, which was removed to the Northern District of Ohio. Plaintiffs’ complaint, under
theories of strict liability and negligence, primarily sought the establishment of a judicially administered medical monitoring program.

After discovery had been completed, defendant filed its motion for summary judgment. The court began by noting that Ohio law recognizes medical monitoring as a form of remedy for an underlying tort. See Wilson v. Brush Wellman, 817 N.E.2d 59, 63 (Ohio 2004). (Readers will note some states consider it a separate cause of action.) Therefore, medical monitoring is only granted if a plaintiff is able to prove all the elements of the underlying tort and the elements of medical monitoring. On the first part, in order to avoid summary judgment, plaintiffs thus must make a showing of a genuine issue of material fact as to the elements of a negligence claim under Ohio law: (1) defendant had a duty to plaintiffs, (2) defendant breached that duty, and (3) plaintiffs suffered damages directly and proximately caused by defendant’s breach. See, e.g., Menifee v. Ohio Welding Products, 15 Ohio St. 3d 75, 77 (Ohio 1984).

The first two issues were not contested for purposes of the motion. On injury and causation, the court noted the overlap with typical medical monitoring requirements, such that to meet this aspect of their negligence claim plaintiffs must demonstrate a genuine issue of material fact that: (1) the chemicals (dioxins) released into the air by the fire are known causes of human disease; and (2) that the plaintiffs were exposed to the dioxins in an amount sufficient to cause a significantly increased risk of disease such that a reasonable physician would order medical monitoring.

Plaintiff experts relied on classifications of the chemicals as carcinogens as their only evidence that dioxins cause the various endpoint diseases for which they seek medical monitoring.  Plaintiffs’ experts also failed to provide an independent assessment of the causal link between dioxins and disease.  Instead they "parroted" the conclusions of other experts and cited to EPA, IARC and NTP documents labeling dioxins as known carcinogens. This was an insufficient showing, said the court.

But even if plaintiffs could demonstrate a causal relationship between dioxins and cancer, plaintiffs had failed to establish that they were exposed to dioxins in an amount warranting a reasonable physician to order medical monitoring. See Day v. NLO, 851 F.Supp.869, 881 (S.D. Ohio 1994).

Plaintiffs’ theory was that they were at an increased risk of disease because they lived for eighteen months with alleged contamination from the fire inside and around their homes. However, none of the named plaintiffs presented evidence that a physician has examined them or their medical records and opined that they are at an increased risk of disease. Similarly, plaintiffs’ experts had not conducted any measurement of dioxin inside or outside of the homes of five of the seven named plaintiffs. At least three of the seven had not even lived in their air dispersion modeling expert's "impact zone" long enough to qualify for his proposed medical monitoring program. Even for those that did, mere residence in the so-called impact zone is insufficient evidence of sufficient contamination and increased risk because it ignores any individual variables, including other sources, and most notably, at what level each of the named plaintiffs was actually exposed to dioxins. The Sixth Circuit has stated “generalized proofs will not suffice to prove individual damages.”  Sterling v. Velsicol Chem. Corp., 855 F.2d 1188, 1200 (6th Cir. 1988).

Again, even if plaintiffs had presented sufficient evidence of the amount of named plaintiffs’ dioxin exposure, plaintiffs did not demonstrate that a reasonable physician would order medical monitoring based on this exposure. Plaintiffs attempted to rely upon the EPA soil cleanup level after the accident as a basis for justifying medical monitoring. The court found two fatal defects in using this EPA soil cleanup level. First, demonstrating why regulatory guidelines are often not useful in the tort litigation context, see Rowe v. E.I. DuPont de Nemours & Co., 2008 WL 5412912 (D.N.J. Dec. 23, 2008); Redland Soccer Club, Inc. v. Dep’t of the Army, 55 F.3d 827 (3d Cir. 1995), the EPA soil cleanup level represented a threshold for the cleanup of contaminated soil, not a danger point
above which individuals would require medical monitoring. And even if government regulations were relevant to showing increased risk, a conservative soil cleanup level should not be used in place of a medically based risk assessment or evidence of the actual dose level at which dioxin truly causes cancer – the danger point critical to a medical monitoring determination.  Second, the EPA’s threshold soil cleanup level represents an increase in the risk of developing cancer from the baseline level for the general population of one in a million. Thus, even assuming there were a million members in this class who had been exposed to this level of dioxin over their entire lives, and assuming causation, only one of them would develop cancer because of the exposure. Plaintiffs thus sought to commence medical monitoring based on this one-in-a-million risk, but this risk and indeed risks higher, have been found insignificant as a matter of law.  Medical monitoring typically requires a significantly increased risk. Plaintiffs' expert opinion to the contrary was a legal conclusion, and thus it did not create a genuine issue of material fact.

In sum, the court concluded that the plaintiffs had not presented a genuine issue of material fact that the circumstances would warrant a reasonable physician to order medical monitoring. Medical monitoring in Ohio is a form of relief which should only be granted "with prudence."  Interestingly, the court concluded that plaintiffs’ proposed program would likely be extremely expensive, said the court, and inconvenience thousands of people for many years in the future. (Note to readers, the potential down-sides of medical monitoring must be explored in each case.) Plaintiffs had not presented enough evidence for a reasonable jury to conclude that such a burdensome program is warranted.

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In the Digitek MDL, the parties have been wrangling over the defense motion for a Lone Pine order. See generally Lore v. Lone Pine, No. L-336006-85, 1986 WL 637507 (N.J. Super. Ct. Nov. 18, 1986).

Dozens of product liability cases alleging that defendants Actavis Totowa LLC, Actavis Inc. and Actavis Elizabeth LLC marketed Digitek tablets containing double the appropriate dosage were transferred to an MDL assigned to Chief Judge Goodwin of the Southern District of West Virginia last summer. In Re: Digitek Products Liability Litigation, MDL No. 1968 (S.D. W.Va.).
 

Defendants recently moved for a Lone Pine order under which each plaintiff must submit an "affidavit from a medical expert in each case establishing that there is medical evidence of digoxin toxicity." Readers of MassTortDefense recognize this important and logical procedural tool for management of mass toxic tort litigation.  When the major factual battles will be over injury and causation, it may make sense to focus discovery on these issues, and prior to resorting to expensive and time-consuming discovery, to require plaintiffs to come forward with some prima facie showing of injury and specific causation, or as the court put it, "some evidence of certain elements of their claims, e.g. medical causation, to support a credible claim."

The plaintiffs in the federal Digitek multidistrict litigation filed a brief opposing the motion, arguing that the discovery in the MDL is still in its "incipient stages."  As they typically do, the plaintiffs argued that such orders "effectively function as untimely and unjust summary judgment devices and violate the discovery rules for expert witness disclosures and reports." They also argued that they have provided significant case-specific discovery in the form of Plaintiffs' Fact Sheets and records authorizations.

The court entered PTO #43 (Order re Request for Lone Pine Order), saying the motion is taken under advisement pending completion of basic fact discovery of Group 1 cases. Under the latest schedule, Plaintiff shall serve their reports from liability experts no later than March 15, 2010.  The parties shall complete their depositions of Plaintiffs’ liability experts no later than May 28, 2010.  Defendants shall serve their reports from liability experts no later than June 15, 2010. The parties shall complete their depositions of Defendants’ liability experts no later than August 31, 2010. 

At the November 20, 2009, conference each party is to present to the court their choice of five cases that they believe to be representative plaintiffs for trial in accordance with PTO #38, governing the creation of a trial pool upon completion of basic fact discovery, including but not limited to the depositions of plaintiffs, plaintiffs’ physicians who prescribed Digitek® to them, physicians who treated Plaintiffs for alleged digoxin toxicity, and pharmacists who filled plaintiffs’ prescriptions for Digitek®.
 

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Readers of MassTortDefense involved in the defense of medical monitoring cases will want to follow the ongoing debate occasioned by the New York Times story this week, quoting Dr. Otis Brawley, chief medical officer of the American Cancer Society, admitting that American medicine has over-promised when it comes to medical screening and that the advantages of screening have been “exaggerated.”

Medical monitoring, whether a remedy or cause of action, is a claim for the cost of medical screening for a plaintiff exposed to a toxic substance allegedly because of the defendant’s wrongful conduct and who is accordingly at risk of future disease. Medical monitoring is designed to early detect the disease and thus maximize the chances of a cure or beneficial treatment.

As a an advocacy matter, medical monitoring is presented by plaintiffs with the seemingly unchallengeable notion that early detection saves lives. Plaintiff attorneys rely heavily on juror pre-loads about the importance and benefits of screening; virtually every juror has had a Pap smear, or mammogram, or prostrate test, and they have all been inundated with messages from the American Cancer Society that screening is highly efficacious-- messages that ignore the risks of screening. Defendants fight an uphill battle when they try to get the jury to keep an open mind about the risks and benefits of plaintiffs’ experts' proposed screening program.

Reportedly, the ACS is now working on a message, to put on its Web site early next year, to emphasize that screening for breast, prostate, and other cancers can come with a real risk. Those risks include not only the risks of the screening procedures themselves (such as radiation), but the risks of false positives, and the follow-on risks of over-treating a nodule that would never have developed into life-threatening disease. On the flip side, many researchers point out that the prostate cancer screening test has not been shown to prevent prostate cancer deaths. Similar lack of benefit has been noted with chest x-rays and CT scans for lung cancer. If cancer screening was really as effective as plaintiffs assert, the cancers that once were found late, when they were untreatable or incurable, would now be found earlier, when they could be treated and cured. Thus, a large increase in early cancers found would be accompanied by a decline in late-stage cancers, and an improvement in mortality. That just hasn’t happened for many types of screening.

Whether the issue is the screening tool or the screening itself, plaintiffs should no longer be allowed to base their medical monitoring claims on a widely accepted misconception that all screening is good, and all early detection saves lives.  Defense attorneys may have a juror pool more receptive to the evidence-based argument that plaintiffs must be held to their burden of proof to show that a monitoring procedure exists that makes early detection of the disease possible; the prescribed monitoring regime is different from that normally recommended in the absence of the exposure; and the prescribed monitoring regime is reasonably necessary according to contemporary scientific principles.
 

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Readers of MassTortDefense interested in the issues surrounding medical monitoring will want to keep their eyes on Hess v. A.I. DuPont Hosp. For Children, 2009 WL 2776606 (E.D.Pa., August 28, 2009).  The court recently granted Defendants' Petition for Certification of Immediate Appeal (to the Third Circuit).

Doctors at the A.I. duPont Hospital for Children in Wilmington, Delaware, implanted a Cheatham Platinum stent (“CP stent”) in plaintiffs, who alleged that they had been injured or were at risk of injury from the use of the CP stent. After discovery, the trial court granted summary judgment to defendants on a number of the claims, but summary judgment was denied on Count VI, the medical monitoring claim. The trial court predicted that the Delaware Supreme Court would recognize a medical monitoring cause of action if presented with the facts of these cases.

The trial court recognized that there are substantial grounds for disagreement over whether Delaware will actually recognize a cause of action for medical monitoring. While Delaware courts, including the Delaware Supreme Court, have had medical monitoring claims before them on several occasions and have not totally disavowed medical monitoring as a legally cognizable cause of action, neither have they formally recognized the tort as a legally cognizable cause of action.  (In some jurisdictions it is a remedy, not a cause of action.)

Even if the Delaware Supreme Court were to recognize a medical monitoring tort, there are substantial grounds for disagreement over whether plaintiffs here could state a claim. Plaintiffs' theory that medical devices can be the basis for a medical monitoring claim is novel, at best  (and has been rejected in many states: Drugs and devices do not present the same policy issues as involuntary exposure to environmental toxins).   Indeed, there appear to be no cases precisely like this one in which a plaintiff has alleged and a court has recognized a medical monitoring claim where the plaintiff has had a Class III medical device implanted that did not have FDA premarket approval and where the plaintiff did not offer evidence that the device was defective. The court was satisfied that plaintiff's novel theory here is one in which certification of an interlocutory order for appeal is appropriate.

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A California appellate court last week affirmed a trial court ruling denying class certification to a group of Boeing employees suing over alleged exposure to harmful levels of beryllium. Marin v. Brush Wellman Inc.,  No. B208202 (Calif. Ct. App., 2nd Dist. Aug. 24, 2009).

The plaintiffs alleged that Brush Wellman, a contractor of their employer, misrepresented the permissible limit for beryllium exposure. Beryllium is a potentially toxic metal that is used in aircraft construction and other industrial applications because of its light weight and great strength. However, some exposed persons are beryllium sensitization, which can be a precursor to chronic beryllium disease, which is a serious illness. 

The court of appeals agreed with the trial court that common issues did not predominate. In a toxic tort case, the plaintiff must first establish some threshold exposure to the defendant's defective, toxic products, and must also establish to a reasonable medical probability that a particular exposure or series of exposures was a legal cause of his injury, i.e., a substantial factor in bringing about the injury. This typically requires expert testimony about the level of exposure that is unsafe, and expert testimony that exposure above a certain level will cause injury or disease. The significance of this is  that when individual claimants differ both in their makeup and in the amount of their exposure to the substance, the evidence of their injuries will differ from individual to individual.

Here, each of the class members would have to show where he worked, when he worked within each location or facility, what the beryllium levels were at these locations, and how much of the beryllium was Wellman's.  It is patent that each such package of facts will be largely unique to each claimant.  The six named plaintiffs worked at six different facilities, some of which had multiple buildings, over differing periods covering up to 40 years. Boeing's air monitoring and industrial hygiene records showed non-uniform results. In other words, the levels of exposure varied widely among the facilities over time, and even within a single facility. The sales and use evidence that could be used to trace the beryllium to Wellman implicated a necessarily individualized inquiry, not a common one.

In an effort to salvage a class, plaintiffs' counsel explained at oral argument that the proposed class was only for those who required medical monitoring. Those persons who actually contracted illness would be excluded from the class as their claims would be necessarily unique and individualized.  Even assuming this issue was properly presented to the trial court, the plan to certify a class of persons requiring medical monitoring and, in addition to such a class, allowing the more serious cases to proceed individually and separately, was to the court "an invitation to a litigation disaster."   Recourse to such a class would do nothing to streamline this litigation but would most probably convert it into a nightmare.

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The Medicare Payment Advisory Commission reported this month the results of a study suggesting that when physicians have a financial interest in medical imaging equipment, they are more likely to order imaging tests and incur higher overall spending on their patients' care.  The June MedPAC report is titled Report to the Congress: Improving Incentives in the Medicare Program.  Such an issue seems important to the current debate on health care reform and efforts to curb the rising costs of health care.  But is it of interest to readers of MassTortDefense?

Imaging, particularly the use of PET scans and CT scans, is a favorite tool of plaintiffs' lawyers seeking medical monitoring. Currently before the Massachusetts Supreme Judicial Court is a case involving a proposed class action seeking CT scans for lung cancer. See Kathleen Donovan, et al. v. Philip Morris USA, Inc., SJC No. 10409 (Mass. SJC, argued June 9, 2009)

Multiple policy grounds support the decision to reject  medical monitoring. Metro-North Commuter Railroad Company v. Buckley, 521 U.S. 424 (1997). This imaging issue stands as yet another reason courts need to be careful with claims for medical monitoring and wary of plaintiff experts opining that imaging is reasonably medically necessary ( a typical element of a medical monitoring claim) because it is supposedly becoming more widely used. See Redland Soccer Club, Inc. v. Dept. of the Army and Dept. of Defense of the U.S., 548 Pa. 178, 696 A.2d 137, 145-46 (1997) (requiring the prescribed monitoring regime is reasonably necessary according to contemporary scientific principles); Wyeth, Inc. v. Gottlieb, 930 So.2d 635 (Fla.App. 3 Dist.2006) (same).

MedPAC is an independent advisory body charged with providing policy analysis and advice concerning the Medicare program, and issued its most recent report to Congress on imaging, among other topics.  The commission noted that rapid technological progress in diagnostic imaging over the last decade has enabled physicians to more effectively diagnose and treat certain illnesses. At the same time, use of medical imaging has grown in certain areas of the country, without a clear benefit in terms of the quality of care.   The report also noted that recent research indicates a particular expansion of in-office imaging as many physicians buy and use machines in their offices, rather than refer patients out.

The report cites the 2008 Government Accountability Office report which ties the growth in Medicare spending to the increase in physicians who perform advanced imaging services in their office. That GAO report found that Medicare spending for imaging services performed by doctors doubled from 2000 to 2006. In particular, costs for advanced imaging such as computed tomography (CT) scans and nuclear medicine rose faster than other standard previous imaging services such as MRIs.

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As posted by MassTortDefense, the Digitek MDL judge late in 2008 issued a pretrial order regarding multi-plaintiff complaints. In Pretrial Order No. 7, the court ordered the severance of most multi-plaintiff cases (other than spouses). In Re: Digitek Products Liability Litigation, MDL No. 1968 (S.D. W.Va.). The court noted that several complaints in this MDL action join multiple plaintiffs whose only apparent connection with one another is that they allegedly ingested the drug at issue. Other MDL judges have noted the case management, tracking, and other difficulties often accompanying that joinder practice, citing Vioxx and diet drugs.

Plaintiffs’ Co-Lead Counsel were to submit to the court a report identifying multi-plaintiff actions docketed prior to this Order that are subject to severance, and submit a suitable proposed severance order. One of the reasons plaintiffs resist such severance is the need to pay separate filing fees for all the separate claims filed, but the Order required the fees.

The plaintiffs in the Digitek multidistrict litigation then identified five class actions that they say meet the court's requirements for severance under Pretrial Order No. 7. The plaintiffs said that the five cases they identified have multiple class representatives, but  -- despite the order -- they propose that they be continued with multiple class representatives until "class certification issues are addressed and determined by the Court to ascertain suitability and typicality of the class representatives' claims."  These kinds of personal injury claims are typically inappropriate for class treatment.  Individual issues of causation, injury, and damages predominate over any alleged common issues.  Choice of law issues can make the class device unmanageable.

MassTortDefense also posted before about defendants' proposal to centralize the cases filed in New Jersey, and plaintiffs' proposal to designate the New Jersey cases as a mass tort.

New Jersey state court Digitek cases have now been designated a mass tort by a New Jersey Supreme Court Order, and have been assigned to the Bergen County Superior Court. The centralized mass tort docket has been assigned to Judge Jonathan N. Harris.

The state’s mass tort website states that Digitek is a medication used to treat heart failure and abnormal heart rhythm. The NJ complaints seek damages, medical monitoring and other relief due to the purchase or ingestion of allegedly defective Digitek tablets which the plaintiffs claim were released with as much as twice the appropriate thickness. The complaints further allege that patients were thus taking twice the intended dosage. A Class I recall was initiated by the defendants after receiving some reports of illness and injuries consistent with potential overdoses of Digitek. It is alleged that this condition is dangerous especially among individuals suffering from renal failure because the Digitek may accumulate in the body of such individuals, rather than be excreted normally in urine. 

The pattern of federal case MDL and mass tort treatment of multiple filings in a given state's court has been seen in numerous other pharmaceutical cases, including Vioxx and Seroquel.
 

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The Fifth Circuit has affirmed a trial court decision that a group of space center workers in Mississippi cannot pursue personal injury claims for their alleged exposure to beryllium-containing products because they could not show any “compensable injury.” Paz v. Brush Engineered Materials Inc., 2009 WL 73874 (5th Cir. 2009).

Pursuant to Mississippi law, claims of negligence, products liability, and breach of warranty all require an identifiable injury. Plaintiffs alleged that they had beryllium sensitization (BeS), i.e., an increased sensitivity to the potentially toxic substance. According to their expert, BeS is by definition the demonstration of an abnormal immune response to beryllium, usually, though not always based on an abnormal challenge test.

The issue was whether the BeS was a compensable injury pursuant to Mississippi law. The employees argued BeS is a present injury and “the beginning of an actual disease process,” specifically the beginning stage of Chronic Beryllium Disease;  therefore there is a reasonable probability of future consequences from BeS. Plaintiff experts’ published work, however, stated that “BeS precedes the formation of … clinical illness.”  And it indicates that individuals with BeS exhibit evidence of an immune response to beryllium but have no evidence of lung pathology or impairment. Further, there was no dispute that the rate of progression from BeS to CBD is unknown to any degree of reasonable medical certainty.

The expert evidence from both sides clearly established that excessive exposure to beryllium provokes a physical change in the body, causing BeS. The quintessential issue, said the 5th Circuit, is whether any or every physiologic change in the body rises to the level of compensable injury pursuant to Mississippi law. The federal court found guidance in the state court’s recent decision in this same case on medical monitoring, which we have mentioned before. In answering the 5th Circuit's certified question, the Mississippi Supreme Court stated “a claim for medical monitoring, as Plaintiffs present it, lacks an injury.” 949 So.2d at 3. The Mississippi Supreme Court concluded that because “Mississippi requires the traditional elements of proof in a tort action, it has refused to recognize a category of potential illness actions.” The Mississippi Supreme Court noted “[n]one of the plaintiffs ha[d] suffered physical injury from the alleged exposure.” Pursuant to Mississippi law, “exposure” is “a claim for harm which is not compensable under Mississippi law.”

The sub-clinical and sub-cellular changes, which none of the parties disputed, are akin to what the Mississippi Supreme Court refused to recognize as physical injuries. Thus, the logical conclusion is BeS is not a compensable injury pursuant to Mississippi law. This seems to be the Mississippi Supreme Court's “line in the sand" for a plaintiff's legally protected interest.  Summary judgment affirmed.

While states vary on the point, this is an important issue: as medical technology advances, the ability to show some sub-clinical or sub-cellular impact on the body becomes increasingly common.  Will every such change, what traditionally has been seen as mere exposure lacking sufficient impact, impairment, symptom, be an injury?  Plaintiffs may like to think so in some cases, but won't the single injury rule and statute of limitations bite them in others?
 

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A couple months ago, MassTortDefense posted about a decision in which the federal court in West Virginia denied class certification in a claim brought against DuPont for the alleged release of perfluoroctanoic acid, a substance also known as PFOA or C-8, from its Washington Works plant in Wood County, West Virginia, into drinking water. See Rhodes v. E.I. DuPont De Nemours and Co., 2008 WL 4414720 (S.D. W.Va., September 30, 2008). Plaintiffs are appealing that.

Now, the federal district court in New Jersey has similarly rejected class certification in two consolidated suits in which state residents argued that DuPont should pay for a medical monitoring program because their drinking water was allegedly contaminated with a Teflon-related chemical. See Rowe v. E.I. du Pont de Nemours & Co., D.N.J., No. 06-1810; Scott v. E.I. du Pont de Nemours & Co., D.N.J., No. 06-3080.

PFOA, also known as C-8, is made by DuPont for use in a variety of consumer products, including in non-stick cookware. Plaintiff sought medical monitoring to detect disease in the future they were allegedly put at risk for based on exposure to the chemical. But to recover medical monitoring costs, plaintiffs must show “significant exposure” to a chemical. Plaintiffs argued they had sufficient common proof of “significant exposure” to PFOA because tests revealed that the water supply around DuPont's Chambers Works Plant in New Jersey allegedly exceeded .04 parts per billion (ppb) for the substance, and the New Jersey Department of Environmental Protection recommended .04 ppb as the “safe” level of exposure. The plaintiffs also offered Dr. David Gray, a toxicologist, to testify that .02 ppb was actually the level at which negative health affects may start showing up in individuals.

The court first rejected any use of the settlement by DuPont of previous PFOA claims to show the existence of common issues. The other case was ultimately resolved through “voluntary settlement,” the court said. DuPont's statements cannot be considered admissions of liability, causation, or appropriate damages.

The court also rejected plaintiffs use of regulatory-based risk assessments. While they may be an appropriate way to determine for the public what health and environmental officials believe are “safe” levels of a chemical in drinking water, they are not themselves an adequate means of showing the kind of significant exposure to a substance that is required to support medical monitoring claims. There is a difference between a “safe” level for public policy and regulatory purposes and the “significant exposure” that creates the sufficiently excessive risk needed to trigger medical monitoring. “Such methodology does not work in the tort litigation context, where a plaintiff must prove that he has suffered an actual increased risk of disease in order to merit recovery in the form of medical monitoring.”

Also affecting their utility in the class context, the risk assessments are based on assumptions about the general population, and are thus not applicable to show class-wide significant exposure. Plaintiffs’ expert merely assumed that class members all weighed a certain amount and consumed a certain amount of allegedly contaminated water. Those assumptions are not necessarily true for all class members—indeed, they are undoubtedly false, as the class contained thousands of individuals who are different sizes and have different water consumption habits.

Importantly, given plaintiff’ counsel refrain about the cost of pre-complaint, pre-certification homework, and the frequent "we'll deal with that later" mentality, the court noted while it would take significant investigative efforts to obtain information specific to each individual in the proposed class, the difficulty of this task does not excuse plaintiffs from doing it. A class action is not intended to be an easy way around research problems. Plaintiffs have the burden of proving that each class member has suffered significant exposure to PFOA—they cannot circumvent this requirement by simply relying on assumptions about the general population.
 

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The federal court in the FEMA Trailer MDL has denied class certification to a class of plaintiffs alleging that they were harmed or put at risk of future harm by formaldehyde exposure after residing in Federal Emergency Management Agency trailers following Hurricanes Rita and Katrina. See In re FEMA Trailer Formaldehyde Products Liability Litigation, MDL No.1873 (E.D. La., class certification denied 12/29/08).

In a previous post, MassTortDefense reported on the court’s analysis of the personal injury class claims. Today, we look at the medical monitoring class claims, a topic about which we have posted before.

In addition to all the general reasons set forth for why class certification was inappropriate, the court offered additional analysis as to why certification of the medical monitoring class (the "future medical services sub-class" ) was inappropriate.

Plaintiffs contended that class-wide common issues of law and fact included: (1) whether certain plaintiffs were significantly exposed to formaldehyde, an allegedly hazardous substance; (2) whether certain plaintiffs now suffer a significantly increased risk of contracting a serious latent disease, associated with formaldehyde exposure; (3) whether certain plaintiffs’ risk of contracting such a disease is greater than (a) the risk of contracting the same disease had there been no exposure, and (b) the chances of members of the public at large of developing the disease; (4) whether a medical procedure exists that makes the early detection of any such diseases possible; (5) whether the future medical services regime for such detection is different from medical services recommended in the absence of exposure; and (6) whether there is some demonstrated clinical value in the early detection and diagnosis of any such diseases. In essence, plaintiffs alleged that most of the elements of a medical monitoring claim were common.

The Court felt, however, that the first two allegedly class-wide issues, exposure and increased risk, were actually individual issues. Whether an individual has been “significantly exposed” to formaldehyde will differ depending on several variables, including other exposures, past and present cigarette use, formaldehyde-containing cosmetics use, etc. Thus, an accurate exposure level for a class representative has no bearing on an accurate exposure level for any other member of the proposed class because of these differing variables. Similarly, determining an individual’s risk of developing a particular formaldehyde-related disease or injury is keyed to several individual factors, including level of exposure, duration of exposure, and other individual characteristics such as whether the person has other risk factors for contracting a particular injury or disease.

Second, while the proposed medical monitoring sub-class would require the application of laws of “only” four different states, plaintiffs failed to make any substantial attempt to explain whether any individual variations in those states’ laws are manageable here, or whether they would “swamp common issues of law and fact.”

Next, the court found that plaintiffs’ proposed class was unorthodox in that it sought an order to monitor and treat the injuries that have resulted from that exposure. That is, a future medical services subclass should be certified to set up and maintain a program by which plaintiffs’ injuries may be detected and treated. Seemingly, plaintiffs went beyond the usual talk of treatment in the context of whether treatment exists such that monitoring could be beneficial, to essentially call for the development of a program aimed at also providing treatment to individuals (especially children) who have been adversely affected by hazardous levels of formaldehyde in the units.

But, by essentially requesting monitoring and treatment in the class, subclass members would arguably be relieved of the burden that they would bear in an individual suit, relative to proving any current manifest injury or disease. The court agrees found that plaintiffs were indeed attempting to skip over the process of obtaining the requisite liability finding against the manufacturing defendants, by holding them responsible for funding a monitoring and treatment service for injuries that a jury may later deem was never their responsibility. In other words, the monitoring program requested by plaintiffs seems to bypass a liability finding on injury in favor of immediate medical monitoring and treatment, both. Plaintiffs failed to demonstrate to the court why defendants should be asked to pay for such a program without, first, a finding of liability against them.

Finally, defendants contended that plaintiffs, as a group, did not meet the “manifest physical injury” requirement, which they asserted is a prerequisite for medical monitoring in Texas, Louisiana, Mississippi, and Alabama. Plaintiffs, on the other hand, asserted that they meet this requirement because the physical injury they claim to have suffered is in the form of “cellular and molecular” damage. Even without addressing the issue whether such cellular damage qualifies as a manifest present injury, the court felt it would still be faced with the individualized inquiry of whether formaldehyde exposure resulting from the units caused those "injuries." This is not an issue that can be determined on a class-wide basis.

Accordingly, the medical monitoring class claims involved too many individual issues. 

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