"The Rise of Empty Suit Litigation"

Two of my partners here at SHB, Victor Schwartz (of the famed “Schwartz on Torts” casebook) and Cary Silverman, just published a new article, “The Rise of “Empty Suit” Litigation®. Where Should Tort Draw the Line?”,  80 Brook. L. Rev. 599 (2015) .  

The article focuses on litigation where an individual or class action plaintiff has suffered no real harm, physical, emotional or economic.  These include:

·         claims for recovery of speculative emotional harm;

·         liability for the estimated cost of medical monitoring following exposure to a potentially harmful substance absent a physical injury;

·         class action litigation claiming that a product’s actual value was lower than the purchase price or that the resale value of a product diminished because of an alleged latent defect, even when the product functioned properly for most or all consumers; and

·         class actions challenging product labeling or advertising on behalf of all consumers where few, if any, of them were actually misled.

Empty Suit Litigation®” addresses both individual claims where there has been no real injury or economic loss, and class actions that rely on speculative or expert-driven theories of harm or class-wide damages.

Definitely worth checking out.  

 

Medical Monitoring Class Action Rejected at Pleading Stage

A federal court recently rejected a proposed medical monitoring class action brought by alleged Pepsi drinkers.  The case reminds readers of the importance of the causation element of medical monitoring claims, even though plaintiffs don't need to allege traditional personal injury.  See Riva v. Pepsico, Inc., No. C-14-2929 EMC, 2015 WL 993350 (N.D. Cal.,  3/4/15).

Plaintiffs alleged that two of defendant's beverages contained levels of a chemical, 4–MeI, that caused them to experience an “increased risk of cancer,” specifically bronchioloalveolar cancer.  Plaintiffs sought  medical monitoring as a remedy; specifically, seeking an order requiring Pepsi to establish a “fund from which those individual class members can seek monetary recovery for the costs of actual or anticipated medical monitoring expenses incurred by them.”  Plaintiffs alleged that outcomes in bronchioloalveolar cancer show a clinically significant benefit from early evaluation, detection, and diagnosis. 

California is one of the few states that recognizes a claim for medical monitoring. “In the context of a toxic exposure action, a claim for medical monitoring seeks to recover the cost of future periodic medical examinations intended to facilitate early detection and treatment of disease caused by a plaintiff’s exposure to toxic substances.” Potter v. Firestone Tire & Rubber Co., 6 Cal.4th 965, 1004–05, 25 Cal.Rptr.2d 550, 863 P.2d 795 (1993). In Potter, the California Supreme Court identified five factors in determining the reasonableness and necessity of monitoring:
(1) the significance and extent of the plaintiff’s exposure to chemicals;
(2) the toxicity of the chemicals;
(3) the relative increase in the chance of onset of disease in the exposed plaintiff as a result of the exposure, when compared to
(a) the plaintiff’s chances of developing the disease had he or she not been exposed, and
(b) the chances of the members of the public at large of developing the disease;
(4) the seriousness of the disease for which the plaintiff is at risk; and
(5) the clinical value of early detection and diagnosis.

Based on such factors, the trier of fact decides, “on the basis of competent medical testimony, whether and to what extent the particular plaintiff’s exposure to toxic chemicals in a given situation justifies future periodic medical monitoring.” Id.

Defendant attacked the medical monitoring claim under Rule 12(b)(6), particularly as to the Potter factors related to whether medical monitoring is reasonable and necessary.  Accordingly, the Court examined the allegations related to these critical Potter factors: plaintiff’s exposure to chemicals; the toxicity of the chemicals; and the relative increase in the chance of onset of disease in the exposed plaintiff as a result of the exposure, when compared to (a) the plaintiff’s chances of developing the disease had he or she not been exposed, and (b) the chances of the members of the public at large of developing the disease.

To demonstrate the proximate causation element of the claim, a plaintiff seeking medical monitoring must. among other things, show the significance of her exposure to the toxic chemical. Potter, 6 Cal.4th at 1009, 25 Cal.Rptr.2d 550, 863 P.2d 795; see also Abuan v. Gen. Elec. Co., 3 F.3d 329, 335 (9th Cir.1993) (applying comparable Guam law on medical monitoring). The California Supreme Court has explained, “[e]vidence of exposure alone cannot support a finding that medical monitoring is ... necessary.” Lockheed Martin Corp., 29 Cal.4th at 1108–09, 131 Cal.Rptr.2d 1, 63 P.3d 913. A plaintiff must demonstrate sufficient severity of exposure (its significance and extent) and that “the need for future monitoring is a reasonably certain consequence of [the] toxic exposure” Id. at 1109, 131 Cal.Rptr.2d 1, 63 P.3d 913 (citation omitted).

In this case, Plaintiffs alleged that the chemical had been found to cause lung tumors in laboratory animals -- at a daily dose thousands of times higher than the amount in soda.  Plaintiffs sought to represent a class of all persons who purchased Diet Pepsi or Pepsi One within a four-year period, regardless of consumption amount. What was missing was any allegation of what the significance of this unspecified exposure to the chemical may be; they did not allege what threshold level of exposure allegedly created the increased risk.

Thus, there was insufficient information about the significance and extent of exposure of the class to make the necessary ultimate showing that “the need for future monitoring is a reasonably certain consequence of [the] toxic exposure” Lockheed Martin Corp., 29 Cal.4th at 1109, 131 Cal.Rptr.2d 1, 63 P.3d 913. They simply failed to demonstrate a credible risk of bronchioloalveolar cancer resulting from the human consumption of cola products at the levels alleged by the named plaintiffs. In fact, if anything, the specific scientific finding incorporated into the Complalnt from the mice study was that the amounts of 4–MeI ingested in cola products “may not be significant.”

The Court also found that Plaintiffs had not sufficiently pled their injury or shown the toxicity of 4–MeI. It was not enough thatt 4–MeI is on the Proposition 65 list of known carcinogens, that a toxicologist has stated that there is “no safe level of 4–MeI,” and that advocacy groups have called for the FDA to ban 4–MeI.  The full picture was that “caramel coloring” (the manufacturing of which allegedly produces 4–MEI as a byproduct) is “generally recognized as safe” when used in accordance with good manufacturing practice and as a food color additive. Under the FDCA, the inclusion of “caramel color” as a “color additive” means that the FDA has determined that caramel coloring has not been found “to induce cancer when ingested by man or animal.” 21 U.S.C. § 379e(b)(5)(B).

So while Plaintiffs adequately pled that 4–MeI is toxic and is, generally speaking, a carcinogen—i.e., that 4–MeI is capable of causing cancer, they had not adequately pled their specific theory of injury—an increased risk for bronchioloalveolar cancer sufficient to warrant medical monitoring—“above the speculative level.” Twombly, 550 U.S. at 555. Plaintiffs are not mice, and there was nothing in the Complaint, or the studies incorporated by reference, to suggest that 4–MeI causes this specific form of lung cancer in humans. The same mouse study found no increased cancer in rats and discussed a “species difference” identified in previous studies in terms of how various species absorb, distribute, metabolize, and excrete this very chemical. So this study did not lead to a plausible inference that these Plaintiffs are at increased risk of the specific lung cancer for which they request screening. 


In short, the  Plaintiffs failed to plead factual content to show they had been injured due to a “significant” increase in their risk of lung cancer sufficient to justify medical testing in the absence of any symptoms or present injury. See Potter, 6 Cal.4th at 1008–09, 25 Cal.Rptr.2d 550, 863 P.2d 795. The only factual content supporting the allegation of increased risk of lung cancer came from scientific studies, which had no demonstrable bearing on cancer toxicity for humans at the consumption levels alleged in the case at bar.

A plaintiff seeking medical monitoring must show a need for “specific monitoring beyond that which an individual should pursue as a matter of general good sense and foresight.” Potter, 6 Cal.4th at 1009, 25 Cal.Rptr.2d 550, 863 P.2d 795. In this case, Plaintiffs sought CT scans of their lungs and molecular screening for lung cancer. Lung scans are not needed to remedy injury absent a credible showing that 4–MeI causes this lung cancer in humans.

The Court took the Prop 65 argument head on.  Proposition 65 is broad; its listing embraces “ substances listed as human or animal carcinogens. In other words, “the Proposition 65 list includes chemicals that are known to cause cancer in animals, even though it has not been definitively established that the chemicals will cause cancer in humans.” Baxter Healthcare, 120 Cal.App.4th at 352, 15 Cal.Rptr.3d 430. Furthermore, listing under Proposition 65 only requires one excess case of cancer in an exposed population of 100,000, assuming lifetime exposure at the level in question. Because the burden on a defendant to fund medical screening for thousands, potentially millions, of people is so substantial, the Potter factors serve a critical gatekeeping function, regulating a potential flood of costly litigation; Potter requires a higher level of proof of health risk than that required for inclusion of a substance on the Proposition 65 list.

Finally, the Court addressed the increased risk above background, and other possible sources of exposure.  There can be many possible “causes,” indeed, an infinite number of circumstances which can produce an injury or disease. A possible cause only becomes “probable” when, in the absence of other reasonable causal explanations, it becomes more likely than not that the injury was a result of its action. This is the outer limit of inference upon which an issue may be submitted to the jury. As a result, under California personal injury law the mere possibility of causing cancer alone is insufficient to establish a prima facie case.

The Court said that this concept of causation inheres in the Potter test for the reasonableness of medical monitoring; the trier of fact considers, among other factors, “the relative increase in the chance of onset of disease in the exposed plaintiff as a result of the exposure, when compared to (a) the plaintiff’s chances of developing the disease had he or she not been exposed, and (b) the chances of the members of the public at large of developing the disease.” Potter, 6 Cal.4th at 1009, 25 Cal.Rptr.2d 550, 863 P.2d 795. Consistent with this approach, the Ninth Circuit has affirmed a grant of summary judgment where plaintiffs seeking medical monitoring failed to introduce facts regarding the “quantitative (or even qualitative) increased risk to individuals.” Abuan, 3 F.3d at 335.

The Complaint admitted that there are many sources of consumption of 4–MeI, including “baked goods, confectionary, extruded breakfast cereals, instantaneous soups, and dark beers” as well as “soy sauce and coffee.” The many alternative sources of 4–MeI was problematic to the establishment of any causation between the Pepsi products at issue and the Plaintiffs’ alleged consumption of 4–MeI “at or above certain threshold levels” (whatever those threshold levels, if any, may be). The many sources of 4–MeI prevented these Plaintiffs from satisfying the third Potter factor.

Where the pleadings reveal so many commonly consumed foods with similar levels of a chemicaI, it is implausible to conclude that any alleged increased risk of cancer is “more likely than not” caused by drinking/using one product, said the Court.  As a result, the Plaintiffs’ claims were dismissed. See Twombly, 550 U.S. at 557 (“something beyond the mere possibility of loss causation must be alleged”).

 

 

Summary Judgment Affirmed in Medical Monitoring Class Action

The First Circuit  has affirmed a district court ruling rejecting a proposed class action seeking medical monitoring  for alleged exposure to hazardous beryllium.  See Barry Genereux, et al. v. Raytheon Company, No. 13-1921 (1st Cir. 6/10/14).

MassTortDefense has posted on medical monitoring several times before, incuding here and here. The clear trend has been away from recognizing these claims, see Lowe v. Philip Morris USA, Inc., 344 Or. 403, 183 P.3d 181 (2008), or to narrow their scope. See Sinclair v. Merck & Co., 195 N.J. 51, 948 A.2d 587 (2008).

Where recognized, medical monitoring plaintiffs typically must prove:
1. exposure greater than normal background levels;
2. to a proven hazardous substance;
3. caused by the defendant's negligence;
4. as a proximate result of the exposure, plaintiff has a significantly increased risk of contracting a serious latent disease;
5. a monitoring procedure exists that makes the early detection of the disease possible;
6. the prescribed monitoring regime is different from that normally recommended in the absence of the exposure; and
7. the prescribed monitoring regime is reasonably necessary according to contemporary scientific principles.


The plaintiffs in this case filed a putative class action filed in the United States District Court for the District of Massachusetts, invoking federal diversity jurisdiction under the special jurisdictional provisions of the Class Action Fairness Act, 28 U.S.C. § 1332(d)(2). Their complaint alleged that the defendant, Raytheon Company, endangered the health of the plaintiffs and others similarly situated by negligently exposing them to beryllium used in the manufacturing process at its plant in Waltham, Massachusetts.

Beryllium is a useful but potentially hazardous substance, and sufficient exposure to it is a risk factor for a malady known as Chronic Beryllium Disease (CBD). This malady is characterized by inflammation and scarring of lung tissue. Although there is no known cure for CBD, early detection and treatment can ameliorate its impact. The pathogenesis of CBD may begin with beryllium sensitization (BeS). Even though BeS is regarded as an abnormal medical finding, it can be asymptomatic and is typically not treated. Plaintiffs argued that persons with BeS should receive periodic clinical screenings to detect actual disease onset because those persons who are diagnosed with BeS are allegedly at a risk of developing CBD during their lifetimes.

The plaintiffs sought to represent two proposed classes. One comprised all persons who worked at the Waltham plant for at least one month prior to 1997. The other comprised all persons who lived with members of the first class and thus were subject to alleged take-home beryllium exposure. Persons already diagnosed as having CBD were excluded from both proposed classes. Following extensive pretrial discovery and work devoted to a narrowing of the issues, the district court granted summary judgment in favor of Raytheon. See Genereux v. Hardric Labs., Inc., 950 F.Supp.2d 329, 341 (D. Mass. 2013). An appeal ensued.

The Court of Appeals noted that the cornerstone of an action for medical monitoring under Massachusetts law is the decision in Donovan v. Philip Morris USA, Inc., 914 N.E.2d 891 (Mass. 2009). There, the court ruled that the cost of medical monitoring may be recoverable in a tort suit under Massachusetts law under certain circumstances.  The First Circuit read the Donovan decision as tethering its holding to a doctrinal mooring: a combination of a defendant's alleged failure to meet an appropriate standard of care, a clear causal connection between that failure and the plaintiffs' alleged injuries, and resulting damages. To identify the injury in the absence of evidence that a plaintiff actually has a full-blown disease, the court demanded a showing that some subcellular or other physiological change has put plaintiffs at increased risk. The court noted that under the unique cause of action recognized in Donovan, increased epidemiological risk of illness caused by exposure, unaccompanied by some subcellular or other physiological change, is not enough to permit recovery in tort.

Here, the summary judgment record disclosed no evidence that any plaintiff — named or unnamed, employee class or take-home class — had as yet developed BeS. This gap in the proof was fatal to the plaintiffs' principal theory of liability. The plaintiffs had not carried their burden that under Massachusetts law that defines actionable injury in the medical monitoring milieu in terms of subcellular or other physiological change; the record revealed no significantly probative evidence of such an injury here.

In the alternative, the plaintiffs argued that the Massachusetts high court had speculated about whether a cause of action for medical monitoring might ever exist when no subclinical changes had occurred.  The trial court concluded that plaintiffs hadn't preserved a claim under this alternative theory.  The court of appeals agreed.  In complex cases, considerations of both fairness and efficiency dictate that a trial judge use his best efforts to winnow and clarify the issues.Plaintiffs' counsel had multiple opportunities to expound a new theory of the case that encompassed this issue.  A status conference transcript where the issue was raised was transparently clear: the plaintiffs told the court that they were not pursuing a theory based on any question that the SJC had allegedly left for another day.

Decision Affirmed.

New York High Court Rejects Medical Monitoring

Just the facts on this one, as my firm is involved for defendants in such actions, but word comes that New York's highest court has joined the trend of state courts rejecting medical monitoring. See Caronia v. Philip Morris USA, Inc.,  No. 227 (N.Y., 12/17/13).

Plaintiffs, healthy smokers, sought medical monitoring in the form of low dose CT scans allegedly necessitated by their increased risk of future disease.  The federal court certified the issue of medical monitoring to the state court, specifically, (1) under New York Law, may a current or former longtime heavy smoker who has not been diagnosed with a smoking-related disease, and
who is not under investigation by a physician for such a suspected disease, pursue an  independent equitable cause of action for medical monitoring for such a disease?
(2) If New York recognizes such an independent cause of action for medical monitoring, what are the elements of that cause of action? What is the applicable statute of limitations, and when does that cause of action accrue?

The state court observed that while there is certainly an important health interest in fostering access to medical testing for those whose exposure has resulted in an increased risk of disease, and such testing could possibly lead to early detection and treatment, not only mitigating future illness but also reducing the cost to the tortfeasor.  However, the potential systemic effects of
creating a new, full-blown tort law cause of action cannot be ignored. For instance, dispensing with the physical injury requirement could permit tens of millions of potential plaintiffs to recover monitoring costs, effectively flooding the courts while concomitantly depleting the purported tortfeasor's resources for those who have actually sustained damage.  From a practical standpoint, it cannot be overlooked that there is no framework concerning how such a medical monitoring program would be implemented and administered. Courts generally lack the technical expertise necessary to effectively administer a program heavily dependent on scientific disciplines
such as medicine, chemistry, and environmental science.  The Legislature is plainly in the better position to study the impact and consequences of creating such a cause of action, including the
costs of implementation and the burden on the courts in adjudicating such claims.

The court concluded that these policy reasons militated against a judicially created independent cause of action for medical monitoring. Allowance of such a claim, absent any  evidence of present physical injury or damage to property, would constitute a significant deviation from the state's tort jurisprudence. 

Medical Monitoring at Issue in Oklahoma Federal Court

Readers know that medical monitoring is a recurring topic here at MassTortDefense.  Here is one to keep an eye on, as a defendant recently asked the Oklahoma federal court to reject plaintiffs' claim for medical monitoring in a putative class action. Mitchell McCormick, et al. v. Halliburton Co., et al., Np. 5:11-cv-0127 (W.D. Okla.).

Plaintiffs, about three dozen residents of Duncan, Okla., are seeking, inter alia, medical monitoring, establishment of a class-wide medical registry, and payment for medical research to assist alleged disease identification, prevention and treatment, based on allegations  that defendants exposed the town's residents to toxic substances.

Defendants have moved to dismiss, arguing that there is no cognizable claim for a medical monitoring remedy under Oklahoma law. Defendants noted the absence of any Oklahoma statutes or state court decisions recognizing or even suggesting the availability of medical monitoring, and the important public policy considerations that disfavor medical monitoring relief. Specifically, medical monitoring for uninjured plaintiffs (1) encourages highly speculative claims and equally conjectural awards; (2) diverts scarce medical resources away from truly injured individuals who need them most; (3) subjects defendants to open-ended liability; and (4) places significant strain on a judicial system that is generally ill-equipped to formulate and then supervise complex medical monitoring regimes.

Such fears are reflected in the prevailing trend in other jurisdictions to reject such claims. See Rhodes v. E.I. duPont de Nemours & Co., 657 F. Supp. 2d 751, 774 (S.D. W. Va. 2009) (noting post-Buckley trend); Norwood v. Raytheon Co., 414 F. Supp. 2d 659, 667 (W.D. Tex. 2006) (discussing “the recent trend of rejecting medical monitoring as a cause of action” in light of Buckley); see also Zarov et al., A Medical Monitoring Claim for Asymptomatic Plaintiffs: Should Illinois Take the Plunge?, 12 DEPAUL J. HEALTH CARE L. 1, 2 (2009).

The defendants cited additional authority: Hinton v. Monsanto Co., 813 So. 2d 827, 830 (Ala. 2001) (“To recognize medical monitoring as a distinct cause of action . . . would require this Court to completely rewrite Alabama’s tort-law system, a task akin to traveling in uncharted waters, without the benefit of a seasoned guide. We are unprepared to embark upon such a voyage.”); Badillo v. Am. Brands, Inc., 16 P.3d 435, 441 (Nev. 2001) (en banc) (“[W]e hold that Nevada common law does not recognize a cause of action for medical monitoring”); Wood v. Wyeth-Ayerst Labs., Div. of Am. Home Prods., 82 S.W.3d 849, 857 (Ky. 2002) (“We are supported in rejecting prospective medical monitoring claims (in the absence of present injury) by both the United States Supreme Court and a persuasive cadre of authors from academia. These authorities explain that, while well-intentioned, courts allowing recovery for increased risk and medical screening may be creating significant public policy problems.”); Henry v. Dow Chem. Co., 701 N.W.2d 684, 703 (Mich. 2005) (“To recognize a medical monitoring cause of action would essentially be to accord carte blanche to any moderately creative lawyer to identify an emission from any business enterprise anywhere, speculate about the adverse health consequences of such an emission, and thereby seek to impose on such business the obligation to pay the medical costs of a segment of the population that has suffered no actual medical harm.”); Paz v. Brush Engineered Materials, Inc., 949 So. 2d 1, 5-6 (Miss. 2007) (refusing to recognize a claim for medical monitoring allowing a plaintiff to recover medical monitoring costs for mere exposure to a harmful substance without proof of a current actual bodily injury); Lowe v. Philip Morris USA, Inc., 183 P.3d 181, 187 (Or. 2008) (“[W]e hold that negligent conduct that results only in a significantly increased risk of future injury that requires medical monitoring does not give rise to a claim for negligence.”). 

But see Bower v. Westinghouse Elec. Corp., 522 S.E.2d 424, 431 (W. Va. 1999); Meyer v. Fluor Corp., 220 S.W.3d 712, 717-18 (Mo. 2007); Donovan v. Philip Morris USA, Inc., 914 N.E.2d 891, 901 (Mass. 2009).

 

Medical Monitoring Claim Rejected by Federal Court

Readers know that medical monitoring claims are a focus of MassTortDefense.  In a recent case, a federal trial court granted summary judgment on a medical monitoring claim with an opinion that makes a salient point.  See Sahu v. Union Carbide Corp., 2012 WL 2422757 (S.D.N.Y. June 26, 2012.)

Plaintiffs filed suit as members of a putative class against Union Carbide Corporation, seeking monetary damages and medical monitoring for injuries allegedly caused by exposure to soil and drinking water polluted by wastes allegedly produced by the Union Carbide India Limited plant in Bhopal, India.  After years of discovery and tens of thousands of pages of document produced, defendants were able to move for summary judgment as to all theories of liability.  Specifically, plaintiffs brought negligence, public and private nuisance, and strict liability claims against UCC, seeking compensatory and punitive damages, as well as medical monitoring, for injuries allegedly caused by the Bhopal Plant operations.  But our focus in this post is on the medical monitoring claims.

Plaintiffs in the "Medical Monitoring Class” sought  a “court-ordered medical monitoring program for the early detection of various illnesses which they may develop as a result of exposure to the contaminants and pollutants to which they have been exposed"   The court rejected the claim, noting that medical monitoring was not a feasible remedy,  and was one which would face insurmountable hurdles: locating thousands of people who have resided 8,000 miles away in Bhopal, India, over a span of more than thirty years would be nearly impossible. Plaintiffs sought  relief on behalf of themselves, their families, their minor children, and a putative class of similarly situated people who “continue to reside in the municipal wards and residential areas in the vicinity of the UCIL plant and continue to be exposed to toxins” from contaminated soil and groundwater. Administration of such a program would require identification of every resident considered to be living “in the vicinity” of the Bhopal Plant site, and then further identification of those residents who “continue to be exposed to toxins.” To confirm exposure, it would be necessary to test the soil and drinking water supply throughout Bhopal. Literally construed, plaintiffs' complaint seemed to seek medical monitoring for every current resident of the Bhopal area—an impossible task.

This analysis is a refreshing counterpoint to the alarming feature of some recent medical monitoring decisions, in which the difficulty of identifying and ascertaining class members is somehow de-coupled from class certification and from the elements of the medical monitoring claim, and somehow relegated to an "administrative" feature of the relief program.

Fracking Toxic Tort Case Dismissed Per Lone Pine Order

Readers will recall our earlier postings on "fracking"; natural gas from shale rock promises to provide cleaner, abundant energy for the U.S.  New drilling methods allow companies to tap into huge quantities of gas from shale rock. New estimates show that we have enough of this natural gas to last 100 years at current consumption rates.

The second biggest natural gas field in the world -- the Marcellus -- runs through your humble blogger's home state of Pennsylvania. The energy, jobs, taxes, and independence that tapping into this domestic resource will bring has spurred much interest and anticipation. The method to extract the gas from the rock is called hydraulic fracturing, or fracking, which like any technology, carries potential risks.

However, the potential drilling into the Marcellus Shale has caught the attention of the plaintiffs' bar, including personal injury and environmental class action lawyers. Plaintiffs lawyers are openly speculating about everything from gas leaks and fires, to environmental groundwater impacts, to the problems of large tanker trucks on small rural roadways.

We posted before about one such case already filed regarding another deposit, out West. See Strudley v. Antero Resources Corp., No. 2011CV2218 (Colo. Dist. Ct., Denver Cty., 3/24/11). Plaintiffs sued the gas exploration company and drilling equipment contractor, alleging that the hyrdrofracking contaminated their well water.

Earlier this month, the Colorado court dismissed the claim, relying on a  Lone Pine order, 2012 WL 1932470. The case arose from drilling and completing three natural gas wells in Silt, Colorado known as the Diemoz A well, the Fenno Ranch A well, and the Three Siblings A well. Construction of the Wells allegedly began on August 9, 2010. By January 10, 2011, plaintiffs had moved out of their home and away from Silt.

The central issue was whether defendants caused plaintiffs’ alleged injuries, which
plaintiffs vaguely described as “health injuries” from exposure to air and water contaminated by
defendants with “hazardous gases, chemicals and industrial wastes." Plaintiffs also alleged that
defendants had caused loss of use and enjoyment of their property, diminution in value of
property, loss of quality of life, and other damages. 

Cognizant of the significant discovery and cost burdens presented by a case of this nature, the court endeavored to invoke a more efficient procedure than we see in the standard case management order. The court required plaintiffs, before opening full two-way discovery, to make a prima facie showing of exposure and causation, a form of a Lone Pine order. See Lore v. Lone Pine Corp., No. L-33606-85 1986 WL 635707 (N.J. Sup. Ct. Nov. 18, 1986). The court further
determined that the prima facie showing requirement should  not prejudice plaintiffs because
ultimately they would need to come forward with this data and expert opinion on exposure and causation in order to establish their claims anyway.

The court also seemed influenced by the fact that the Colorado Oil and Gas Conservation Commission (“COGCC”) had conducted an investigation of the plaintiffs’ well water and had concluded that the water supply was not affected by oil and gas operations in the vicinity. Defendants also provided evidence to support their contention that the air emission-control
equipment at the Wells and prevailing wind patterns made it unlikely that plaintiffs or their
property were exposed to harmful levels of chemicals from defendants’ activities.

Specifically, the CMO required plaintiffs to identify the identity of each hazardous substance from defendants’ activities to which he or she was exposed and which caused him or
her injury;  evidence whether any and each of these substances can cause the type(s) of disease or illness that plaintiffs claimed (general causation);  the dose or other quantitative measurement of the concentration, timing and duration of his/her exposure to each substance; a medically recognized diagnosis of the specific disease or illness from which each plaintiff allegedly suffers or is at risk for such that medical monitoring is purportedly necessary; and a conclusion that such illness was in fact caused by such exposure (specific causation).

Plaintiffs were given 105 days to comply with the CMO. After that time, all plaintiff's expert could opine was that “sufficient environmental and health information exists to merit further substantive discovery.” Significantly, he offered no opinion as to whether exposure was a contributing factor to plaintiffs’ alleged injuries or illness. And the requested march towards further discovery
without some adequate proof of causation of injury is precisely what the CMO was meant to
curtail. The expert  suggested, at best, a very weak circumstantial causal connection between the Wells and plaintiffs’ injuries. In fact, he merely temporally associated plaintiff’s symptoms with the Wells being brought into production.

While the proffered evidence showed existence of certain low level gases and compounds in both the air and water of plaintiffs’ Silt home, there was neither sufficient data nor expert analysis stating with any level of probability that a causal connection does in fact exist between the alleged injuries and exposure to defendants drilling activities.  This is particularly telling, since Mr. Strudley complained of “nasal sinus congestion, nose bleeds at inconvenient times” and “an aversion to odors,” while he owns a painting business, and was frequently exposed to paint vapors -- offering a ready alternative explanation for his alleged respiratory symptoms.

The expert did not opine on whether any and each of the substances present in the air and water samples (taken after plaintiffs had moved out) can cause the type(s) of disease or illness that plaintiffs claimed (general causation). He did not discuss the dose or other quantitative measurement of the concentration, timing and duration of the alleged exposure to each substance. Finally, and perhaps most significantly,the expert did not even attempt to draw a conclusion that plaintiffs’ alleged injuries or illnesses were in fact caused by such exposure (specific causation).

The case reflects an effective, but also appropriate, use of the Lone Pine order. It may be a useful model for other fracking toxic tort suits, and is important as an illustration of a method to avoid long, expensive, and unnecessary discovery in such cases. 

 

Update BUT SEE Strudley v. Antero, Colo. Ct. App., No. 12CA1251, 7/3/13.

DRI Product Liability Conference Underway

This week I am attending the DRI Product Liability seminar.  Yesterday's highlights included a keynote address by Hon. Anne Northup, Commissioner of the Consumer Product Safety Commission.  Her remarks covered "The Past, Present, and Future of the CPSC."  She brings an interesting perspective, having formerly been a member of Congress.  As a mother of 6 kids and grandmother of 8, she feels well qualified to understand the use and abuse of children's products in particular. She emphasized that consumers value choice, a vibrant market, innovation and competition-- things that over-regulation can suppress.  She pointed to the onerous third-party testing requirements and record-keeping burdens in many of the recent CPSC rules.  She was cautiously optimistic that the continuing tough economy has given the majority Democrats on the CPSC some pause, as well as pointing to H.R. 2715 in which Congress told the Commission to simplify the burden of certification regulations.

I spoke at the session of the Mass Torts & Class Actions subcommittee, chaired by Glenn Kerner, on the topic of Medical Monitoring.  I tried to give the group some strategies to think about; e.g., recent federal cases have confirmed that the clarified pleading requirements of Twombly/Iqbal do apply to medical monitoring claims. E.g., Hagy v. Equitable Production Co., 2011 WL 1627920 (S.D. W.Va. April 28, 2011). That court dismissed the medical monitoring claim because plaintiff failed to allege sufficient specific facts showing the substance was hazardous, plaintiffs’ risk of future injury was a proximate result of the exposure, monitoring was reasonably necessary due to the increased risk, or that effective monitoring procedures exist. See also Bourgeois v. Exxon Mobil Corp., 2011 WL 6130767 (E.D.La. Dec.8, 2011).  I also touched on Jonathan Hirsch, et al. v. CSX Transportation Inc., 656 F.3d 359 (6th Cir. 2011), and its treatment of the exposure and risk elements of a medical monitoring theory.

Courts typically require that the prescribed monitoring regime is different from that normally recommended in the absence of exposure. One recent case exploring this notion which I pointed out  is In re Avandia Marketing, 2011 WL 4006639 (E.D.Pa. Sept. 7, 2011). In this class action involving the diabetes drug, the medical monitoring claim was denied because plaintiff failed to allege specific facts showing what medical monitoring would actually be needed because of exposure to the drug that would not already be recommended for some plaintiffs living with Type 2 Diabetes who did not take the drug.

Finally, I focused on Gates v. Rohm & Haas Co., 655 F.3d 255 (3d Cir. 2011), in which Third Circuit said it would "question whether the kind of medical monitoring sought here can be certified under Rule 23(b)(2)." If the plaintiffs prevailed, class members' regimes of medical screenings and the corresponding cost would vary individual by individual. A single injunction or declaratory judgment would seem to not be able to provide relief to each member of the class proposed in this case. Rule 23(b)(2) “does not authorize class certification when each class member would be entitled to an individualized award of monetary damages.” Wal-Mart, 131 S. Ct. at 2557.

Medical Monitoring Webinar Next Week

I wanted to remind readers know that I will be speaking in an upcoming Strafford live phone/web seminar entitled "Medical Monitoring in Products Liability Claims: Challenges for Plaintiffs and Defendants" scheduled for Tuesday, March 20, 1:00pm-2:30pm EDT.

We have posted on a number of medical monitoring issues before, and some observers think that the number of medical monitoring claims for future testing to provide for early detection of diseases based on alleged exposure to toxic substances is on the rise.

Courts in various jurisdictions hold different views on the recognition of medical monitoring claims, whether these claims are a cause of action or an issue of damages, and the elements of the theory.

My fellow panelists and I will provide practitioners with a review of defense and plaintiff counsels' perspectives regarding medical monitoring. My focus will be on medical monitoring class actions.

After our presentations, we will engage in a live question and answer session with participants — so we can answer your questions about these important issues directly. I hope you'll join us.
 

You can register here.

 

Upcoming Webinar Worth Checking Out

I wanted to let readers know that I will be speaking in an upcoming Strafford live phone/web seminar entitled "Medical Monitoring in Products Liability Claims: Challenges for Plaintiffs and Defendants" scheduled for Tuesday, March 20, 1:00pm-2:30pm EDT.

We have posted on a number of medical monitoring issues before, and some observers think that the number of medical monitoring claims for future testing to provide for early detection of diseases based on alleged exposure to toxic substances is on the rise.

Courts in various jurisdictions hold different views on the recognition of medical monitoring claims, whether these claims are a cause of action or an issue of damages, and the elements of the theory.

My fellow panelists and I will provide practitioners with a review of defense and plaintiff counsels' perspectives regarding medical monitoring.  My focus will be on medical monitoring class actions.

After our presentations, we will engage in a live question and answer session with participants — so we can answer your questions about these important issues directly.  I hope you'll join us.
 

You can register here

Medical Monitoring Complaint Held Insufficient

A federal trial court last week dismissed a medical monitoring claim by an employee of a pipe cleaning company pursuant to Twombly. Royal v. Exxon Mobil Corp., No. 12-00081 (E.D. La.,  2/6/12).

Junius Royal sued several oil companies for damages in connection with oil pipe cleaning services that he allegedly performed. Plaintiff asserted that the oil pipes he cleaned contained carcinogenic radioactive materials commonly referred to as naturally occurring radioactive material, or "NORMS.'" Plaintiff claimed that the defendants knew about the radioactive material in
the pipes, but failed to warn.  He thus became exposed to dangerously high levels of radiation during his work, and he now has a substantially increased risk of developing cancer. He sought medical monitoring. Defendants moved to dismiss plaintiff's medical monitoring claim for failure to state a claim on which relief could be granted.

To survive a Rule 12(b)(6) motion to dismiss, the plaintiff must plead enough facts to state a claim to relief that is plausible on its face. In re Katrina Canal Breaches Litig., 495 F.3d 191, 205 (5th Cir. 2007) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 569 (2007)). Factual allegations must be
enough to raise a right to relief above the speculative level.  In deciding whether dismissal is warranted, the court will not accept conclusory allegations in the complaint as true. Kaiser Aluminum & Chem. Sales, Inc. v. Avondale Shipyards, Inc., 677 F.2d 1045, 1050 (5th Cir. 1982).

To prove common law medical monitoring claim under Louisiana law (there is a separate statutory claim), a plaintiff must show: (1) Significant exposure to a proven hazardous substance, (2) As a
proximate result of this exposure, plaintiff suffers a significantly increased risk of contracting a serious latent disease, (3) Plaintiff's risk of contracting a serious latent disease is greater than (a) the risk of contracting the same disease had he or she not been exposed and (b) the chances of
members of the public at large of developing the disease, (4) A monitoring procedure exists that makes the early detection of the disease possible, (5) The monitoring procedure has been
prescribed by a qualified physician and is reasonably necessary according to contemporary scientific principles, (6) The prescribed monitoring regime is different from that normally
recommended in the absence of exposure, and (7) There is some demonstrated clinical value in the early detection and diagnosis of the disease. Bourgeois v. A.P. Green Indus., 716 So. 2d 355,
360-61 (La. 1998).

Here, plaintiff failed to allege or urge that he had a manifest physical injury or mental injury or disease, as required by the statute. The fact that he may have been exposed to radiation was not, in and of itself, sufficient. Further, the plaintiff failed to plead facts which bear directly on several of the common law factors. For example, plaintiff made no mention of what type of monitoring he was
looking for, who prescribed him the monitoring, or what the efficacy of the monitoring might be.

 

And Here's Another Reason....

...why medical monitoring often does not make sense.

In our posts on medical monitoring, we have pointed out that even in those jurisdictions which do recognize this type of claim/damages, plaintiffs typically must show that the proposed medical monitoring regime is reasonably medically necessary.  Some courts articulate the notion that the testing be consistent with the standard of care, while others require the monitoring be reasonably necessary according to contemporary scientific principles.

An essential result of this is that the screening cannot risk doing more harm than good.  While the pre-load of a typical jury pool may be that monitoring is always helpful, the reality is that many forms of screening have significant potential costs and risks, associated with the procedure or the inevitable follow-up response to a positive test finding --which may turn out to be a false positive finding.  If those (and other) costs are not outweighed by the decrease in disease mortality fostered by the testing, then the monitoring doesn't make sense medically, and should not be available in a legal setting.

That is why we read with some interest the recent reports that the U.S. Preventive Services Task Force, which studies health screening measures, is planning to downgrade its recommendation on a common form of prostate cancer screening (PSA).  The test now gets a "D," which wasn't good when MassTortDefense was in school, and actually means it recommends against the screening because there is moderate or high certainty that the screening has no net benefit or that the harms outweigh the benefits.

The Task Force recognized that high or increasing levels of PSA can indicate many things besides an increased risk for prostate cancer; PSA tests have resulted in high rates of false positives (10-15%) and thus over-treatment for small, slow-growing cancers that will never actually cause harm. Those treatments, surgery and radiation, are not benign. In contrast, the latest studies of those screened show no statistically significant benefit after 10 years.

The point here for our readers is that if a commonly used, widely accepted test can be shown after actual use to risk more harm than good, then how questionable are the new technologies, made-for-litigation screening programs that plaintiffs' hired experts concoct for a class action?

 

Medical Monitoring Claim Rejected in Rail Spill

The Sixth Circuit recently rejected the medical monitoring claims of a putative class of residents of a small Ohio town who alleged exposure to chemicals released after a CSX Transportation Inc. train accidentally derailed. Jonathan Hirsch et al. v. CSX Transportation Inc., No. 09-4548 (6th Cir. Sept. 8, 2011).

On October 10, 2007, thirty-one cars of a CSX train derailed and caught fire near the town of Painesville, Ohio. As a precaution, emergency personnel removed about 1,300 people from the surrounding half-mile radius. Most of what burned in this fire was non-toxic, but nine of the cars were carrying potentially hazardous materials. The plaintiffs claimed that 2,800 tons of burning material were sent into the surrounding atmosphere, and that, as a result, the level of dioxin in their town was significantly elevated.

While the fire was still burning, several residents of the town brought suit against CSX;  the district court did not allow the plaintiffs to pursue an independent cause of action for medical monitoring, but decided a court-supervised medical monitoring was available as an equitable remedy under Ohio law. See Wilson v. Brush Wellman, 817 N.E.2d 59, 63-65 (Ohio 2004); see also Day v. NLO, 851 F. Supp. 869, 880 (S.D. Ohio 1994).  Defendant then moved for summary judgment, which was granted. The district court held that the plaintiffs had failed to meet their burden to show that (1) the dioxin released into the air by the fire is a known cause of human disease; and (2) that the named plaintiffs were exposed to dioxin in an amount sufficient to cause a significantly increased risk of disease such that a reasonable physician would order medical monitoring. The plaintiffs timely appealed.

The court of appeals focused on the issues of causation and injury. Rather than traditional personal injuries, the alleged injuries consisted solely of the increased risk of—and corresponding cost of screening for—certain diseases that, according to plaintiffs, were more likely to occur as a result of the train crash. Assuming that Ohio would recognize such an injury, the remedy would be a medical monitoring program that would spare the Plaintiffs these expenses. But were plaintiffs actually at such an increased risk of disease that they were entitled to a medical monitoring program? Not every exposure, not every increased risk risk of disease warrants increased medical scrutiny. For the plaintiffs to prevail, there must be evidence that a reasonable physician would order medical monitoring for them.

Plaintiffs hired several experts to try to meet this burden. (No Daubert issue raised; the issue was sufficiency, not admissibility.). They offered a chemical engineer who tested the community for levels of dioxin. He assumed a normal background level of dioxin at 4 parts per trillion and took measurements around Painesville to compare with this baseline. His measurements
showed elevated levels near the crash site.  Plaintiffs had a chemist who speculated about train cargo, nature and amounts; then, a physicist who plotted the dispersion and concentration of the chemicals from the fire on a map for the purpose of showing which members of the community were exposed to what levels of dioxin. Then a medical doctor used this map to determine who in the community was likely exposed to levels of dioxin above what the EPA considers acceptable—levels at which the risk of cancer increases by "one case in one million exposed persons."

The court of appeals saw at least two problems with this offer.  One issue was the use of the regulatory level. The expert not only accepted the risk of one in a million as the threshold for monitoring, but appeared to have halved it. “One should be afforded the benefit of medical
monitoring, if one has sustained a dose equal to or in excess of 50% of the EPA maximum.” There was little explanation as to why he believed that reasonable physicians would order expensive and burdensome testing for such a small risk, but he explained he wanted "to err on the side of patient safety.”  However, a one-in-a-million chance is small. Indeed, it is proverbially small. If something has a one-in-a-million chance of causing cancer in an individual, then it will not cause cancer in 999,999. For some perspective, the National Safety Council estimates a person’s lifetime risk of dying in a motor vehicle accident as 1 in 88. The lifetime risk of dying in “air and space transport accidents” is roughly 1 in 7,000. The risk of being killed by lightning
is roughly 1 in 84,000, while the risk of being killed in a “fireworks discharge” stands at around 1 in 386,000. So, a small risk and no basis to say it called for medical monitoring.  Certainly the EPA didn't base its standard on any medical monitoring analysis.

Second, the doctor based based his assessment on the exposure map.  But the map was unreliable. The estimate of the total material burned was speculative. The expert admitted that “the fire temperature, particle size distribution, and fire area were not established.” And there were other sources of exposure not accounted for.

Plaintiffs thus alleged only a risk that bordered on legal insignificance, and failed to produce evidence establishing with any degree of certainty that they had even this hypothetical risk.

Summary judgment affirmed.

Court of Appeals Rejects Medical Monitoring Class Action

The Third Circuit last week affirmed a lower court decision denying class certification in a medical monitoring case alleging vinyl chloride exposures. Gates v. Rohm & Haas Co., No. 10-2108 (3d Cir.,  8/25/11).

Readers may recall we posted on this case at the trial court level last year.  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 alleged 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 were higher than the background level.

Plaintiffs sought certification of two classes: (1) a class seeking medical monitoring for Village residents exposed to the airborne vinyl chloride between 1968 and 2002, and (2) a liability-only issue class seeking compensation for property damage from the exposure. (We will focus on medical monitoring.)

The district court denied certification; it found the medical monitoring class lacked the cohesiveness needed to maintain a class under Rule 23(b)(2), and that common issues of law and fact did not predominate as required under Rule 23(b)(3). Both failed for the same reason—the “common” evidence proposed for trial did not adequately typify the specific individuals that composed the two classes. In particular, the court found plaintiffs failed to present common proof of three issues critical to recovering on the medical monitoring claim—(1) that plaintiffs suffered from exposure greater than normal background levels, (2) the proximate result of which is significantly increased risk of developing a serious disease, and (3) whether the proposed medical monitoring regime is reasonably medically necessary.  The court also found the remaining individual issues would require individual trial proceedings, undoing any efficiencies of class treatment and possibly leading a second jury to reconsider evidence presented to the jury in the class proceeding.

Plaintiffs took an interlocutory appeal under Fed. R. Civ. P. 23(f) from the denial of class certification. The court of appeals affirmed.

The Third Circuit offered a number of important points for readers that may be confronting putative medical monitoring class actions:

1) what is a medical monitoring class?

A medical monitoring cause of action allows those exposed to toxic substances to recover the costs of periodic medical appointments and the costs of tests to detect the early signs of diseases associated with exposure. The few states that recognize medical monitoring as a remedy recognize it as a cause of action, like Pennsylvania, Redland Soccer Club, Inc. v. Dep’t of the Army, 696 A.2d 137, 142 (Pa. 1997), or treat it as a type of relief granted in connection with a traditional tort cause of action, see, e.g., Bourgeois v. A.P. Green Indus., Inc., 716 So.2d 355, 359 (La. 1998).

The remedy of medical monitoring has divided courts on whether plaintiffs should proceed under Rule 23(b)(2) or Rule 23(b)(3), said the court. The Pennsylvania Supreme Court has talked about awarding medical monitoring damages as a trust fund which “compensates the plaintiff for only the monitoring costs actually incurred.” Redland Soccer Club, 696 A.2d at 142 n.6. But it has not yet clearly decided whether or when medical monitoring awards can be in the form of a lump-sum verdict.

The appeals court noted, however, that some guidance may have come from the fact that the Supreme Court recently clarified that Rule 23(b)(2) applies only when a single injunction or declaratory judgment would provide relief to each member of the class. Wal-Mart Stores, Inc., v. Dukes, 131 S. Ct. 2541, 2557 (2011). In light of the Supreme Court's recent decision, the Third Circuit would "question whether the kind of medical monitoring sought here can be certified under Rule 23(b)(2)."  If the plaintiffs here prevailed, class members' regimes of medical screenings and the corresponding cost would vary individual by individual. A single injunction or declaratory judgment would seem to not be able to provide relief to each member of the class proposed here. Rule 23(b)(2) “does not authorize class certification when each class member would be entitled to an individualized award of monetary damages.” Wal-Mart, 131 S. Ct. at 2557. But it did not need to reach the issue, because certification was improper under either category of Rule 23 for reasons apart from the monetary nature of plaintiffs' claims.

2) Cohesion and (b)(2) Certification

Although Rule 23(b)(2) classes need not meet the predominance and superiority requirements of Rule 23(b)(3), it is well established that the class claims must be cohesive. A key to the (b)(2) class is the indivisible nature of the injunctive or declaratory remedy warranted—the notion that the conduct is such that it can be enjoined or declared unlawful only as to all of the class members or as to none of them. Wal-Mart Stores, Inc, 131 S. Ct. at 2557 (quoting Richard A. Nagareda, Class Certification in the Age of Aggregate Proof, 84 N.Y.U. L. Rev. 97, 132 (2009)). Indeed, a (b)(2) class may require more cohesiveness than a (b)(3) class. As all class members will be bound by a single judgment, members of a proposed Rule 23(b)(2) injunctive or declaratory class must have strong commonality of interests. The Supreme Court in Wal-Mart recently highlighted the importance of cohesiveness in light of the limited protections for absent class members under subsections (b)(1) and (b)(2) of the class rule. 

3) Individual Issues in Medical Monitoring Class

Because causation and medical necessity often require individual proof, medical monitoring classes may founder for lack of cohesion. See In re St. Jude Med. Inc., 425 F.3d 1116, 1122 (8th Cir. 2005); Ball v. Union Carbide Corp., 385 F.3d 713, 727-28 (6th Cir. 2004); Zinser v. Accufix Research Inst., Inc., 253 F.3d 1180, 1195-96, amended, 273 F.3d 1266 (9th Cir. 2001); Barnes, 161 F.3d at 143-46; Boughton v. Cotter Corp., 65 F.3d 823, 827 (10th Cir. 1995). Frequently the rigorous analysis of common and individual issues  will entail some overlap with the merits of the plaintiff‟s underlying claim.  Wal-Mart Stores, Inc, 131 S. Ct. at 2551.  The trial court may consider the substantive elements of the plaintiffs' case in order to envision the form that a trial on those issues would take.  The District Court here did so and found individual issues were significant to certain elements of the medical monitoring claims here.

Readers will recall that to prevail on a medical monitoring claim under Pennsylvania law, plaintiffs must prove:
(a) exposure greater than normal background levels;
(b) to a proven hazardous substance;
(c) caused by the defendant‟s negligence;
(d) as a proximate result of the exposure, plaintiff has a significantly increased risk of contracting a serious latent disease;
(e) a monitoring procedure exists that makes the early detection of the disease possible;
(f) the prescribed monitoring regime is different from that normally recommended in the absence of the exposure; and
(g) the prescribed monitoring regime is reasonably necessary according to contemporary scientific principles.
Redland Soccer Club, 696 A.2d at 145-46.  “Expert testimony is required to prove these elements.” Sheridan v. NGK Metals Corp., 609 F.3d 239, 251 (3d Cir. 2010).

Here, the District Court identified individual issues that would eclipse common issues in at least three of the required elements, noting several potential variations in proving exposure above background, a significantly increased risk of a serious latent disease, and the reasonable necessity of the monitoring regime.

4) Exposure

Plaintiffs proposed to show the exposure of class members through expert opinions on air dispersion modeling that mapped concentrations of vinyl chloride exposure (isopleths) that allegedly could provide average exposure per person. But in fact those isopleths only showed average daily exposure, not minimum exposure, used average exposure over very long periods of time when exposure likely varied, and thus could not show that every class member was exposed above background.  Instead of showing the exposure of the class member with the least amount of exposure, plaintiffs proof would show only the amount that hypothetical residents of the village would have been exposed to under a uniform set of assumptions without accounting for differences in exposure year-by-year or based upon an individual's characteristics. At most, the isopleths showed the exposure only of persons who lived in the village for the entire period the isopleth represents and who behaved according to all assumptions that the experts made in creating the isopleth.

5) Composite Proof
Plaintiffs cannot, said the court,  substitute for evidence of exposure of actual class members evidence of hypothetical, composite persons in order to gain class certification. The evidence here was not  truly common because it was not shared by all (possibly even most) individuals in the class. Averages or community-wide estimations would not be probative of any individual's claim because any one class member may have an exposure level well above or below the average.
Attempts to meet the burden of proof using modeling and assumptions that do not reflect the individual characteristics of class members have been met with skepticism, noted the court of appeals. See In re Fibreboard Corp., 893 F.2d 706, 712 (5th Cir. 1990); In re “Agent Orange” Prod. Liab. Litig. MDL No. 381, 818 F.2d 145, 165 (2d Cir. 1987); see also 2 Joseph M. McLaughlin, McLaughlin on Class Actions: Law and Practice § 8:9, at 8-55 to -57 (3d ed. 2006).

Plaintiffs have traditionally loved medical monitoring in part because they think that class certification may come more readily given their alleged ability to use epidemiological or group or aggregate proof to establish some the elements of the medical monitoring claim.  That is why it is significant that the Third Circuit recognized that plaintiffs' aggregate proof in the form of exposure isopleths did not reflect that different persons may have different levels of exposure based on biological factors or individual activities over the class period. Factors which affect a person's exposure to toxins can include activity level, age, sex, and genetic make-up. See Federal Judicial Center, Reference Manual on Scientific Evidence 430 (2d ed. 2000).  For example, some people will have higher breathing rates per body weight which would create a disparity between the concentrations of vinyl chloride (based on estimated exposure as opposed to actual exposure).
Each person's work, travel, and recreational habits may have affected their level of exposure to vinyl chloride. Differences in the amount of time spent outside the village would create different average concentrations to which the class members were exposed. A person who worked outside the village would have been exposed less than a stay-at-home parent, or retiree. The isopleths approach simply assumed exposure to the same concentration for class members who may have spent very different amounts of time in the village.

6) Significant Increased Risk

Plaintiffs were unable to prove a concentration of vinyl chloride that would create a significant risk of contracting a serious latent disease for all class members. Nor was there common proof that could establish the danger point for all class members. The court rejected plaintiffs' attempted use of a regulatory threshold by the EPA -- for mixed populations of adults and children—as a proper standard for determining liability under tort law. Even if the regulatory standard were a correct measurement of the aggregate threshold, it would not be the threshold for each class member who may be more or less susceptible to diseases from exposure to vinyl chloride.  Although the positions of regulatory policymakers are relevant in litigation, their risk assessments are not necessarily conclusive in determining what risk an exposure presents to specified individuals. See Federal Judicial Center, Reference Manual on Scientific Evidence 413 (2d ed. 2000) (“While risk assessment information about a chemical can be somewhat useful in a toxic tort case, at least in terms of setting reasonable boundaries as to the likelihood of causation, the impetus for the development of risk assessment has been the regulatory process, which has different goals.”); id. at 423 (“Particularly problematic are generalizations made in personal injury litigation from regulatory positions. . . . [I]f regulatory standards are discussed in toxic tort cases to provide a reference point for assessing exposure levels, it must be recognized that there is a great deal of variability in the extent of evidence required to support different regulations.”).  Plaintiffs proposed a single concentration without accounting for the age of the class member being exposed, the length of exposure, other individual factors such as medical history, or showing the exposure was so toxic that such individual factors are irrelevant. The Third Circuit concluded that the trial court did not abuse its discretion in concluding individual issues on this point make trial as a class unfeasible, defeating cohesion.

7) Necessity of Monitoring

Nor did the lower court abuse its discretion in determining individual issues defeat cohesion with respect to whether the proposed monitoring regime is reasonably medically necessary. Many courts have been skeptical that the necessity for individuals' medical monitoring regimes can be proven on a class basis. See Barnes, 161 F.3d at 146; see Principles of the Law of Aggregate Litigation § 2.04 reporter‟s notes cmt. b, at 126 (2010). Plaintiffs' experts had no compelling answer to the point that the negative health effects of screening may outweigh any potential benefits. For example, the proposed regime of serial MRIs would be contraindicated and potentially risky because the contrast agent used for MRIs poses dangers to those with kidney disease.

8) Certification under (b)(3)

Courts have generally denied certification of medical monitoring classes when individual questions involving causation and damages predominate over (and are more complex than) common issues such as whether defendants released the offending chemical into the environment. See In re St. Jude Med., Inc., 522 F.3d 836, 840 (8th Cir. 2008).  Here, the same the inquiries into whether class members were exposed above background levels, whether class members faced a significantly increased risk of developing a serious latent disease, and whether a medical monitoring regime was reasonably medically necessary all required considering individual proof of class members' specific circumstances.  Common issues did not predominate.

 

 
 

State Appeals Court Rejects Medical Monitoring

The Wisconsin court of appeals last week affirmed the dismissal of a plaintiff's medical monitoring complaint for failure to state a claim.  Alsteen v. Wauleco Inc.,  No. 2010AP1643 (Wis. Ct. App., 6/14/11).

Plaintiff alleged that, while living in a nearby neighborhood, she was exposed to carcinogenic
chemicals that defendant Wauleco allegedly released from the Crestline window factory. Alsteen did not allege that she suffered any present health problems due to this exposure; however, she contended she was at an increased risk of developing cancer in the future. She therefore sought damages for future medical monitoring expenses.

From approximately 1946 to 1986, operations at the Crestline site included treatment of wood products with a preservative called “Penta.”  Plaintiff alleged that Penta contains hazardous chemicals, including dioxins, pentachlorophenol, and benzene. These chemicals, plaintiff asserted, are harmful to human health and some are classified as possible carcinogens. As a result, the air, soil, surface water, and groundwater in her River Street neighborhood allegedly  became contaminated with dangerous levels of these hazardous chemicals. Current and former residents of the neighborhood had ingested, inhaled, and absorbed these chemicals, the complaint averred.

Some neighbors sued for personal injuries; others sued for property damage.  A third group, including plaintiff, sued for medical monitoring.  Readers know we have posted on medical monitoring issues before.

The trial court dismissed the action for failure to state a claim.  The key issue on appeal was whether Wisconsin law recognized a cause of action for medical monitoring, for increased risk of future disease in the absence of present injury. The court of appeals affirmed, relying on Wisconsin case law that requires actual injury before a plaintiff may recover in tort;  on the reasoning of the Supreme Court’s decision in Metro-North Commuter Railroad Co. v. Buckley, 521 U.S. 424 (1997)(asymptomatic railroad worker who had been exposed to asbestos could not recover medical monitoring expenses under FELA); and on the persuasive reasoning of courts in several other jurisdictions that have addressed the issue and have articulated sound policy reasons for refusing to recognize medical monitoring claims in the absence of actual injury.

Increased risk of future harm is not an actual injury under Wisconsin law.  Meracle v. Children’s Service Society of Wisconsin, 149 Wis. 2d 19, 437 N.W.2d 532 (1989), and mere exposure to a chemical is not an affront to plaintiff's body that constitutes an actual injury. Dyer v. Blackhawk Leather, LLC, 313 Wis. 2d 803, 758 N.W.2d 167 (2008).  The court recognized that while medical monitoring in essence substitutes the increased risk of future disease for the traditional tort injury element, this argument is inconsistent with Wisconsin law, which requires plaintiffs to prove present injury. This "argument turns tort law on its head by using the remedy sought —compensation for future medical monitoring — to define the alleged injury."  See also Henry v. Dow Chem. Co., 701 N.W.2d 684, 691 (Mich. 2005). Similarly, other courts have rejected the argument that the "need" for medical monitoring itself is an injury, reasoning, “With no injury there can be no cause of action, and with no cause of action there can be no recovery. It is not the remedy that supports the cause of action, but rather the cause of action that supports a remedy.” Wood v. Wyeth-Ayerst Labs., 82 S.W.3d 849, 855 (Ky. 2002).

The state court also found persuasive the worries of the Supreme Court in Buckley: First, it recognized that medical monitoring claims present  special difficulties for judges and juries who will be forced to identify which costs are the extra monitoring costs, over and above those otherwise recommended. This problem is compounded by uncertainty among medical professionals about just which tests are most usefully administered and when. The Court also expressed concern that permitting a medical monitoring claim without actual injury could lead to unlimited and  unpredictable liability.

Importantly, the state court here recognized that many of the policy concerns identified in Buckley also apply in the context of a court-supervised medical monitoring fund (as opposed to damages). Specifically, the Supreme Court’s concerns regarding the difficulty of assessing the costs of the remedy, unlimited and unpredictable liability, and confusion over application of secondary sources of payment, apply regardless of the form of remedy.

Finally the court aligned itself with the trend in recent cases around the country to reject such claims: E.g., Henry, 701 N.W.2d 684; Hinton v. Monsanto Co., 813 So. 2d 827 (Ala. 2001); Lowe v. Philip Morris USA, Inc., 183 P.3d 181(Or. 2008); Badillo v. American Brands, Inc., 16 P.3d 435 (Nev. 2001); Paz v. Brush Eng’d Materials, Inc., 949 So. 2d 1, 3, 5 (Miss. 2007).

The court accordingly refused to “step into the legislative role and mutate otherwise sound legal
principles” by creating a new medical monitoring claim that does not require actual injury.

 

.

 

Fracking Meets Medical Monitoring

We have posted before about medical monitoring claims, and recently noted how plaintiff attorneys have cast their eyes on hydraulic fracturing operations as a new source of revenue.

Now let's see how they combine: some Pennsylvania residents are suing various drilling companies over hydraulic fracturing operations, alleging that such operations have increased their risk of future disease such that they need medical monitoring.  Fiorentino v. Cabot Oil & Gas Co., et al., No. 3:09-cv-02284 (M.D. Pa.).  Plaintiffs seek a medical monitoring trust fund, paid for by the drillers.

The case is in the discovery stages, and defendants, logically, are seeking medical records of the plaintiffs.  Those not familiar with medical monitoring may wonder why medical records would be relevant regarding those plaintiffs who do not allege a traditional present physical injury but only the risk of future injury.  Indeed, plaintiffs earlier this month filed a motion seeking to block defendants from obtaining the medical records.  

However, defendants correctly point out in response that, in Pennsylvania, plaintiffs must prove all of the following elements to succeed on a claim for medical monitoring:
(1) exposure greater than the normal background levels;
(2) to a proven hazardous substance;
(3) caused by the defendant’s negligence;
(4) as a proximate result of the exposure, plaintiff has a significantly increased risk of contracting a serious latent disease;
(5) a monitoring procedure exists that makes the early detection of the disease possible;
(6) the prescribed monitoring regime is different from that normally recommended in the absence of the exposure; and
(7) the prescribed monitoring regime is reasonable necessary according to contemporary scientific
principles.
Redland Soccer Club, Inc. v. Dep’t of Army & Dep’t of Def. of U.S., 696 A.2d 137, 195-96 (Pa. 1997).

At the least, medical records are relevant to the sixth element, namely that “the prescribed monitoring regime is different from that normally recommended in the absence of the exposure.” For example, a plaintiff might already be undergoing testing because of an existing medical condition, or already be a candidate for screening because of other risk factors in his life, such as occupational exposure to toxins or a family history of disease or genetic risk factors, all
requiring their own medical monitoring regime which may overlap the claimed monitoring regime for the alleged exposure in this case. Without medical records, a medical monitoring defendant is denied a fair opportunity to attack plaintiff's proof on this element and to show a plaintiff is not able to satisfy the sixth element of the Redland test -- and, therefore, not prove a claim for medical monitoring. See, e.g., Barnes v. American Tobacco Co., 984 F. Supp. 842, 871-72 (E.D. Pa. 1997).

While arising here in a discovery context, this issue also is relevant to class certification claims in medical monitoring cases, as the individualized nature of the medical monitoring remedy demands that each plaintiff be evaluated to determine whether the medical monitoring on account of the alleged exposure to the class called for by plaintiff experts is any different from the medical monitoring a plaintiff is or should be receiving because of the separate and existing risk factors currently facing an individual proposed class member.  Such an individual issue weighs heavily against class certification.

In any event, several courts have found that a defendant is entitled to the records. See O’Connor v. Boeing North American, Inc., 185 F.R.D. 272, 283 (C.D. Cal. 1999);  Cook v. Rockwell Int’l Corp., 147 F.R.D. 237, 242 (D. Colo. 1993).

Medical Monitoring Class Actions

Last week I spoke at a CLE seminar on "Chemical Products Liability & Environmental Litigation."  The seminar was ably co-chaired by Ted Ray from ExxonMobil and Eric Sarner from Praxair.

My topic was Medical Monitoring Class Actions, with an emphasis on the trend by plaintiffs to seek (b)(2) certification, describing the money damages they want defendants to pay for future medical testing as some sort of court-supervised program and thus injunctive/equitable in nature.

By popular demand (ok, a handful of requests), I am making some slides on the topic available here.  Hope readers of MassTortDefense find them a useful resource.

Class Rep Who Dismisses Individual Claim Lacks Standing to Appeal Denial of Certification

A proposed class representative who voluntarily dismisses his individual claims lacks standing to appeal the denial of certification of the class claims, according to the Fourth Circuit.  Rhodes v. E.I. du Pont de Nemours & Co., No. 10-1166 (4th Cir.,  4/8/11).

The plaintiffs were residents of the City of Parkersburg in Wood County, West Virginia, and  customers of the Parkersburg City Water Department  which supplied water to homes located in Wood County.  DuPont operated a manufacturing facility in Wood County. For an extended period of time, DuPont’s plant  allegedly discharged perfluorooctanoic acid (PFOA) into the environment
surrounding the plant. Measurable quantities of PFOA were allegedly detected in the water that is pumped by the Water Department into the plaintiffs’ residences.

In 2006, the plaintiffs filed a complaint against DuPont in the Circuit Court of Wood County, West Virginia. Defendant removed. The plaintiffs asserted six common law claims, individually and on behalf of a class of customers of the Water Department, addressing the contamination of their municipal water supply and the alleged resulting presence of PFOA in their blood. The plaintiffs sought damages and injunctive relief to obtain medical monitoring for latent diseases on behalf of a class of Water Department customers allegedly exposed to PFOA beginning in 2005.

After conducting a hearing on the plaintiffs’ motion for class certification under Federal Rule of Civil Procedure 23(b), the district court concluded that the elements of a medical monitoring claim could not be proved on a class-wide basis using the type of evidence presented by the plaintiffs. The district court therefore denied the plaintiffs’ motion for class certification of their stand alone medical monitoring claims. The district court further held that the plaintiffs had not met their burden under Rule 23 for certification of a class to pursue medical monitoring relief based on the plaintiffs’ claims of negligence, gross negligence, battery, trespass, and private nuisance, the common law torts. The district court then denied the plaintiffs’ motion for class certification of the traditional common law tort claims for damages also.

DuPont filed motions seeking summary judgment on all the plaintiffs’ claims. The district court granted in part and denied in part DuPont’s motions. The district court granted DuPont’s
motions with respect to all the plaintiffs’ traditional common law tort claims, Rhodes v. E.I. Du Pont De Nemours and Co., 657 F. Supp. 2d 751, 762-73 (S.D.W. Va. 2009), but denied summary judgment with respect to the plaintiffs’ individual claims of medical monitoring.

Rather than proceed to trial on those remaining individual claims, in order to appeal immediately the adverse summary judgment and certification rulings, the plaintiffs filed a stipulation of voluntary dismissal under Federal Rule of Civil Procedure 41(a)(1) of their individual claims for medical monitoring.

The court of appeals affirmed the summary judgments, but what will be of more interest to our readers is DuPont’s argument that the 4th Circuit lacked appellate jurisdiction to address the merits of plaintiff’s appeal of the denial of class certification of their medical monitoring claims. DuPont asserted that the plaintiffs no longer had standing to advance this argument on appeal because, by voluntarily dismissing their individual claims for medical monitoring, the plaintiffs abandoned their interest in litigating the certification question. As a result, DuPont contended, the plaintiffs had no personal stake in this issue and did not satisfy the requirements for Article
III standing.

In response, the plaintiffs maintained that litigants routinely are permitted to dismiss various claims in order to appeal other claims and, that under federal precedent, this court could review the denial of class certification for a particular claim even though no plaintiff presently was advancing individual claims asserting that cause of action. The plaintiffs further argued that by its plain terms, their stipulated dismissal applied only to their individual medical monitoring claims. Thus, the plaintiffs contended that they did not abandon their stake in the certification question.

As a general matter, circumstances may change while a case is pending, thereby leaving a plaintiff
without the personal stake necessary to maintain Article III standing. For example, claims can expire, or parties can settle or dismiss their claims entirely. In such situations, the district court or appellate court must dismiss the case for lack of subject-matter jurisdiction. On the other hand, generally, a class representative not only has a "personal stake" in the substantive claim he or she asserts, but also a distinct procedural right to represent the interests of similarly situated individuals. This second, representative interest sometimes gives a putative class representative a sufficient "stake" in the class certification question to appeal an adverse certification ruling even after the putative class representative’s claim is mooted by intervening events.

Two conditions must be met, however, to retain Article III jurisdiction, according to the 4th Circuit. The imperatives of a dispute capable of judicial resolution must be sharply present, and there must be self-interested parties vigorously advocating opposing positions.

Other federal circuit courts addressing this issue have reached different conclusions on the question whether a plaintiff may voluntarily settle or dismiss his or her individual claims and still
appeal a certification denial. Some courts have held that standing is maintained when a named plaintiff expressly reserves the right to appeal a certification denial. See Richards v. Delta Air Lines, Inc., 453 F.3d 525 (D.C. Cir. 2006) (express reservation of class claim preserves standing of class
representative to appeal certification denial); Dugas v. Trans Union Corp., 99 F.3d 724 (5th Cir. 1996) (reservation of right sufficient to give putative class representative who settles individual claims standing to appeal denial of class certification). Cf. Narouz v. Charter Commc’ns, LLC, 591 F.3d 1261 (9th Cir. 2010) (putative representative retains standing to appeal unless releases interest in class claims in settlement agreement). Other courts have held that even an express reservation of right is not sufficient to satisfy Article III standing requirements. See Muro v. Target Corp., 580 F.3d 485 (7th Cir. 2009) (recitation in settlement agreement that plaintiff reserves right to appeal denial of class certification not sufficient to create concrete interest in class certification issue); Anderson v. CNH U.S. Pension Plan, 515 F.3d 823 (8th Cir. 2008) (same).

Although several of these cases held that the language of a plaintiff’s settlement agreement is determinative of that plaintiff’s "stake" in an appeal, the 4th Circuit seemed less concerned about the language of the dismissal than the fact of dismissal. It concluded that when a putative
class plaintiff voluntarily dismisses the individual claims underlying a request for class certification, as happened in this case, there is no longer a "self-interested party advocating" for class treatment in the manner necessary to satisfy Article III standing requirements.

The court held that it thus did lack jurisdiction to decide the issue whether the district court abused its discretion in denying the plaintiffs’ request for class certification of their medical monitoring
claims.

Plaintiffs Bar Looking to Attack Exploration of Shale Gas

Many of our readers may have seen the recent cover story in Time noting how natural gas from shale rock promises to provide cleaner, abundant energy for the U.S.   While the fuels of the future were often said to be solar, wind, or nuclear (before Japan perhaps?), new drilling methods allow companies to tap into huge quantities of gas from shale rock. New estimates show that we have enough of this natural gas to last 100 years at current consumption rates.

The second biggest natural gas field in the world -- the Marcellus -- runs through your humble blogger's home state of Pennsylvania. The energy, jobs, taxes, and independence that tapping into this domestic resource will bring has spurred much interest and anticipation. The method to extract the gas from the rock is called hydraulic fracturing, which like any technology, carries potential risks.

As detailed in the Legal Intelligencer, however, the potential drilling into the Marcellus Shale has caught the attention of the plaintiffs' bar, including personal injury and environmental class action lawyers.  Plaintiffs lawyers are openly speculating about everything from gas leaks and fires,  to environmental groundwater impacts,  to the problems of large tanker trucks on small rural roadways.

Some plaintiff firms are reportedly trolling for clients, among local residents and workers on Marcellus Shale drill sites as well.

Out west, there has already been litigation filed. See Strudley v. Antero Resources Corp., No. 2011CV2218 (Colo. Dist. Ct., Denver Cty., 3/24/11).  Plaintiffs sued the gas exploration company and drilling equipment contractor, alleging that the hyrdrofracking contaminated their well water. Of more interest to our readers, perhaps, is the count for medical monitoring. Plaintiffs lawyers say they have other case to file, and are quoted as planning other medical monitoring class actions.

Medical monitoring is recognized under Pennsylvania law, and a handful of other states, and a plaintiff must prove:

1. exposure greater than normal background levels;

2. to a proven hazardous substance;

3. caused by the defendant's negligence;

4. as a proximate result of the exposure, plaintiff has a significantly increased risk of contracting a serious latent disease;

5. a monitoring procedure exists that makes the early detection of the disease possible;

6. the prescribed monitoring regime is different from that normally recommended in the absence of the exposure; and

7. the prescribed monitoring regime is reasonably necessary according to contemporary scientific principles.

Redland Soccer Club v. Dep't of the Army, 548 Pa. 178, 696 A.2d 137, 145-46 (Pa.1997).

A number of these elements implicate individual issues that should defeat class certification under the predominance or cohesiveness analyses of Rule 23.  Nevertheless, it should come as no surprise to industry that this vital economic activity comes with litigation risks as well.



 

Jury Rejects Medical Monitoring Claim in Coal Dust Litigation

A West Virginia jury last week ruled in favor of defendant Massey Energy Co. in a class action accusing the company of exposing plaintiffs from an elementary school to toxic coal dust. Dillon et al. v. Goals Coal Co. et al., No. 05-c-781 (Circuit Ct. Raleigh County, W.Va.).

The plaintiffs first filed suit in 2005, complaining about a coal silo near the Marsh Fork Elementary School in Raleigh County.  Coal dust allegedly drifted from the silo into the school, exposing the plaintiffs, and putting them at increased risk of lung disease.  The court eventually certified a class of about 300.

Plaintiffs sought a medical monitoring program to early detect the alleged effects of the exposure.  In order to sustain a claim for medical monitoring expenses under West Virginia law, the plaintiff must prove that (1) he or she has, relative to the general population, been significantly exposed; (2) to a proven hazardous substance; (3) through the tortious conduct of the defendant; (4) as a proximate result of the exposure, plaintiff has suffered an increased risk of contracting a serious latent disease; (5) the increased risk of disease makes it reasonably necessary for the plaintiff to undergo periodic diagnostic medical examinations different from what would be prescribed in the absence of the exposure; and (6) monitoring procedures exist that make the early detection of a disease possible.  See Bower v. Westinghouse Electric Corp., 522 S.E.2d 424 (W. Va. 1999).

The defense challenged both the significant exposure and increased risk prongs. The jury rejected the medical monitoring claim after a 2 week trial.

Third Circuit Rejects Medical Monitoring in Device Case

The Third Circuit has properly recognized that a claim for medical monitoring claim does not lie against the manufacturer of a medical device product. See M.G. v. A.I. DuPont Hospital for Children, No. 09-1426 (3d Cir., 8/24/10).

Readers may recall the post about this appeal last year.  Doctors at the A.I. duPont Hospital for Children in Wilmington, Delaware, had 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 were substantial grounds for disagreement over whether Delaware will actually recognize a cause of action for medical monitoring. Even if the Delaware Supreme Court were to recognize a medical monitoring claim, there were substantial grounds for disagreement over whether plaintiffs here could state a claim. Plaintiffs' specific 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). The trial court was satisfied that plaintiff's novel theory here was one in which certification of an interlocutory order for appeal was appropriate.

The Third Circuit noted that plaintiff’s claim entitled “Medical Monitoring” contended that “[a]s a direct result of defendants’ acts, omissions, and conduct, plaintiffs . . . who have received NuMED CP stent have been exposed to a hazardous procedure and product, and suffered a significantly increased risk of the side effects caused by this device. This increased risk makes periodic diagnostic and medical examinations reasonable and necessary.”

While the district court predicted that the Delaware Supreme Court would recognize a medical monitoring cause of action, the appeals court didn't have to reach that broader question because it concluded that plaintiffs were unable to establish the elements necessary to state a claim for medical monitoring.

Defendants contended on appeal  that the trial court erred in extending Delaware law beyond the bounds of the recognized medical monitoring claim (in those minority of states that accept it) in which a plaintiff alleges long-term involuntary exposure to a proven toxic substance with known tendencies to produce serious future medical injuries. The Third Circuit agreed, finding no persuasive cases anywhere in which a free-standing medical monitoring claim has been allowed to proceed although the plaintiff has not demonstrated significant exposure to a toxic (poisonous) or proven hazardous substance. The lower court’s prediction that the Delaware Supreme Court would permit a claim for medical monitoring on this record thus requires several “leaps” from the current state of the law, generally, let alone Delaware law.

Specifically, here, there was no toxic or hazardous substance, as such. While unapproved devices are termed “adulterated”, they are not necessarily harmful, and certainly not toxic. Moreover, the risk here is not a risk of  “contracting a serious latent disease.” Rather, it is a risk of the need for further care. Further examinations are not to “monitor” the risk of disease, but to perform routine
oversight of the device. Thus, even if the Delaware Supreme Court would recognize a “standard” medical monitoring claim --one which requires a plaintiff to demonstrate that a defendant’s
negligence caused the plaintiff to be exposed to a proven hazardous substance that resulted in a significantly increased risk of contracting a serious latent disease -- the plaintiff here could not demonstrate that she had been exposed to a proven hazardous substance, nor could she prove that such exposure resulted in a significantly increased risk of contracting a serious latent disease.

Accordingly, the court found that plaintiff was unable to establish the elements necessary to make out a claim for medical monitoring.  Summary judgment should have been granted.

On a personal note, also on the winning brief was my former partner, the late R. Nicholas Gimbel, Esq., an outstanding advocate, in one of his last cases.  On the amicus brief for PLAC was my colleague James M. Beck, Esq.
 

Medical Monitoring Class Actions Rejected in Beryllium Cases

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.)

Federal Court Denies Medical Monitoring Class Action

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.  


 

FDA To Revise Guidance on Medical Imaging: What Does That Say About Medical Monitoring?

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.

Summary Judgment in Proposed Medical Monitoring Class Action

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.

 

 

Update on Digitek Litigation

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®.
 

ACS Head Offers Different View of Medical Monitoring

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.
 

 

Medical Monitoring Decision Set For Interlocutory Appeal

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.

Class Certification Denied In Beryllium Exposure Case

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.

Report Offers Another Reason To Reject Medical Monitoring

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.

 

 

 

Update on Digitek Litigation

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.
 

Fifth Circuit Affirms Summary Judgment: Exposure and Risk Are Not Injury

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?
 

Federal Court Denies Certification in PFOA Medical Monitoring Class

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.
 

Class Certification Denied In FEMA Trailers MDL (Part II)

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.