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

Your humble blogger will speak at the American Conference Institute's Chemical Products Liability and Environmental Litigation Conference (April 28-29, 2010).

On April 29, I will be joined by Gradient's Dr. Barbara Beck and Jerome Doak of Jones Day on a panel program entitled Presenting Effective Arguments to Courts Against Awarding Medical Monitoring Damages. Against the background of recent court decisions regarding medical monitoring, the program will address key legal and scientific issues often pivotal in medical monitoring cases. I will focus on medical monitoring class action issues.

More information here.

 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

 

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

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

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

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

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

 

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

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

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

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

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

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

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

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

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

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A federal judge has dismissed a proposed class action that alleged that Playtex Products Inc. sold  insulated baby-bottle coolers with excessive levels of lead. Ramos v. Playtex Products Inc. et al., No. 1:08-cv-02703 (N.D. Ill. 2009).

At MassTortDefense we love talking about defense wins, and especially love posting about early wins.  Here, Judge Joan Humphrey Lefkow dismissed all counts in the consolidated complaint without prejudice. The court relied first on the federal pleading requirements as described in Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007); and Ashcroft v. Iqbal, 129 S. Ct. 1937, 1953 (2009) (stating that “Twombly expounded the pleading standard for all civil actions”). We have posted on that before.
 

Plaintiffs alleged that the vinyl fabric from which these coolers are constructed contains dangerous levels of lead and that Playtex marketed these products as being safe, despite its awareness of regulations prohibiting the use of lead in children’s products and knowing that children who ingest lead suffer long-term injuries. Plaintiffs asserted claims for violation of the consumer fraud statutes of forty-three jurisdictions (Count I), common law negligence (Count II), and unjust enrichment (Count III). In the motion papers, the negligence claim became a medical monitoring claim.

The judge said the plaintiffs’ complaint was unable to meet pleading standards for the
claims alleged. The plaintiffs had failed to articulate many important points, including the basis for  their claims under any consumer protection statutes other than in New York and California. Named plaintiffs, Suarez and Stanford, were residents of New York and California, respectively, and neither alleged injury in, or contact with, any jurisdiction other than New York or California.

Additionally, the plaintiffs' claims failed to meet pleading standards of Rule 9(b) because of the absence of numerous crucial details, including where and from whom they purchased the coolers, specifics regarding the presence of lead in the products, such as where and how accessible it was, and whether they relied on statements from Playtex about the coolers’ safety before making their purchases. Averments of consumer fraud generally must be pleaded with the same particularity as common law fraud. See, e.g., Kearns v. Ford Motor Co., 567 F.3d 1120, 1125 (9th Cir. 2009). Even where, as here, plaintiffs assert that fraud is not a necessary element of a claim, any claim with a basis that nonetheless sounds in fraud is subject to the heightened pleading standard of Rule 9(b).  Plaintiffs quoted statements on Playtex’s website assuring customers that its products “surpass the most stringent domestic and international regulatory guidelines on . . . safety matters,” Am. Compl. ¶ 33, but failed to allege whether or when they relied on, or even saw, these statements prior to purchasing the coolers.

Additionally, plaintiffs wanted Playtex to pay for the cost of lead testing for their children, presumably a medical monitoring claim, yet at no point did they make any allegation that their children were exposed to lead.  Indeed, Suarez and Stanford fail to allege that they even have children. Playtex pointed out that the plaintiffs had not described any physical or economic injury associated with the product.  Plaintiffs expressly disclaimed personal injuries in this case at oral argument. What is required to support a claim for medical monitoring is that plaintiffs plead and prove that medical monitoring is probably, reasonably, not just possibly, necessary. The plaintiffs had asserted no allegation that any child came into contact with one of the coolers.  Thus, no allegation of the exposure element of a medical monitoring claim either.

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

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

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

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

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

 

 

 

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Judge Engelhardt of the U.S. District Court for the Eastern District of Louisiana, overseeing the MDL relating to the alleged formaldehyde contamination of FEMA trailers used in the aftermath of Hurricane Katrina, has chosen a lawsuit by a New Orleans woman and her son to serve as the first bellwether case in this MDL. See In re: FEMA Trailer Formaldehyde Products Liability Litigation, MDL-1873 (E.D. La.).  Plaintiffs generally allege that trailers issued by the government following Hurricane Katrina exposed residents to high levels of the chemical formaldehyde.

The court had ordered the parties to submit the names of no less than 50 potential bellwether trial plaintiffs. From these names, one plaintiff for each of four bellwether jury trials was to  be selected. The manufacturer defendants for these four trials had to be the four estimated to have the most emergency housing units at issue in this proceeding. (These four manufacturers are Gulf Stream, Fleetwood, Forest River, and Keystone RV.)  Only plaintiffs who have identified and sued one of the four manufacturers, the relevant contractor, and the Government, were eligible to serve as bellwether trial plaintiffs. In addition, the bellwether plaintiffs must be selected from those plaintiffs for whom Plaintiff Fact Sheets already have been obtained and provided to the defendants. In addition, actions chosen for bellwether trials must have proper venue in the Eastern District of Louisiana, unless the parties in question consent to trial in this district.  The court, from that list, selected the case brought by Alana Alexander and Christopher Cooper against Gulf Stream Coach Inc. to be the first that will be tried in federal court. The trial is set for Sept. 14, with three other cases against the other different defendants scheduled to follow as the court approached the hundreds of suits through a series of bellwether trials.

Readers will recall that last December, the court properly refused to grant class certification to the six proposed subclasses of plaintiffs, finding they did not meet the standards required for class certification under Rule 23. The plaintiffs had sought certification of four state subclasses of individuals who resided in trailers provided by the Federal Emergency Management Agency in Louisiana, Texas, Alabama and Mississippi following hurricanes Katrina and Rita, as well as a future medical monitoring subclass, and an economic loss subclass.

The U.S. Judicial Panel on Multidistrict Litigation consolidated a number of suits against the
government and a handful of trailer manufacturers over the alleged formaldehyde exposure
in October 2007, despite defendants’ objections. The Centers for Disease Control and Prevention  released in 2008 the results of a study which it commissioned concerning formaldehyde levels in mobile homes provided to residents of the Gulf Coast affected by Hurricane Katrina in 2005.  CDC has been working with FEMA and other agencies to investigate possible levels of formaldehyde in the trailers and mobile homes.
 

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Two recent, related federal court opinions illustrate just how unsettled the law of medical monitoring continues to be. Molly Guinan V. A.I. Dupont Hospital For Children, 2009 WL 311113 (E.D.Pa. Feb. 6, 2009); Molly Guinan V. A.I. Dupont Hospital For Children, 2009 WL 307019 (E.D.Pa. Feb. 6, 2009).

Plaintiff is one of several infants who had what the court called a “controversial” procedure to correct a congenital heart defect performed on her by doctors at the A.I. duPont Hospital for Children in Wilmington, Delaware. Cardiologists implanted a covered stent manufactured by NuMed, Inc., a New York corporation that is one of the few developers of pediatric medical devices in the United States. The stent had not been approved by the Food and Drug Administration when implanted. Plaintiff developed serious conditions that were allegedly side effects of the treatment, and there were factual disputes surrounding the treatment plaintiff received when her injuries first began manifesting themselves.

Plaintiffs sued the doctors, hospital, and device maker. Plaintiff articulated two different theories of negligence against the treaters: (1) medical negligence premised on malpractice; and (2) lack of informed consent. (The plaintiff parents claimed they weren’t told anything, and the defendant doctors claimed they told the parents everything.) At bottom, Guinan is another of an increasing number of cases in which what are in reality malpractice cases are being twisted into product liability litigation. Even worse when they get stretched into medical monitoring claims. Multiple summary judgment motions were filed.

The first question was choice of law. Plaintiffs were residents of New Jersey, and the complained-of surgery occurred in Delaware. Plaintiffs sued in the Eastern District of Pennsylvania, where the child was then being treated for the complications. The aspect of most interest for readers of MassTortDefense is not the malpractice claim, but the medical monitoring claim. The court noted that Pennsylvania and New Jersey recognize medical monitoring as a cause of action. However, there are differences between the laws of the two states that created a conflict. See In re Paoli R.R. Yard PCB Litig. (Paoli II), 35 F.3d 717, 787-88 (3d Cir.1994) (identifying potential conflict between Pennsylvania and New Jersey medical monitoring causes of action). In Delaware, the court said that it is not clear whether medical monitoring is an independent tort or whether medical monitoring is simply a remedy. However, while some Delaware decisions have mentioned medical monitoring, Mergenthaler v. Asbestos Corp. of Am., 480 A.2d 647, 651 (Del.1984), the state has never adopted medical monitoring.

The court concluded that Delaware had the greatest interest in seeing its law applied to this action and thus Delaware law would control. Again, Delaware has never recognized medical monitoring as a legally cognizable cause of action. See Mergenthaler, 480 A.2d at 649 (affirming Delaware Superior Court's dismissal of plaintiffs' “claim for the expenses of medically required surveillance ... where there [was] no present physical injury,”). Going through an Erie analysis, the district court predicted that the Delaware Supreme Court would permit a claim for medical monitoring if it were confronted with the facts of this case. Such a prediction seems in direct contrast to 3d Circuit guidance on the issue. E.g., Lexington National Insurance Corp. v. Ranger Insurance Co., 326 F.3d 416, 420 (3d Cir. 2003) (federal court in a diversity case should be reluctant to expand the common law); Werwinski v. Ford Motor Co., 286 F.3d 661, 680 (3d Cir. 2002)(court should opt for the interpretation that restricts liability, rather than expands it).

Several considerations militated in favor of allowing plaintiff to proceed with a medical monitoring claim, said the court. It is undisputed that plaintiff has a Class III medical device in her body. Moreover, it is undisputed that the device did not have premarket approval from the FDA. The FDA, NuMed, and the Institutional hospital defendants have all suggested that plaintiff should receive follow-up care to monitor the stent. “This is compelling, if not conclusive, evidence that medical monitoring is appropriate in this case.”

The court rejected any countervailing policy considerations. See, e.g., Metro-North Commuter R.R. Co. v. Buckley, 521 U.S. 424, 443-44, 117 S.Ct. 2113, 138 L.Ed.2d 560 (1997) (discussing potential for a “ ‘flood’ of less important cases” that could “entail systemic costs without corresponding benefits” if the Supreme Court were to recognize a “full-blown” medical monitoring tort in the context of the Federal Employers' Liability Act (FELA). In sum, considerations of fairness, efficiency, and deterrence favored recognizing a cause of action for medical monitoring, according to the court.

The second, companion opinion’s choice of law analysis included New York, NuMed's state of incorporation. The court found again that Delaware has the greatest interest. And while Delaware has not expressly adopted a medical monitoring claim, for the same reasons as above, the court again predicted that the Delaware Supreme Court would adopt a claim for medical monitoring.

The surprisingly simplistic analysis boils down to bad facts make bad law (or bad predictions of the law). The plaintiff's novel theory that a tort claim for medical monitoring can be applied to medical procedures and devices raises serious policy issues that the court never analyzed. In a case involving HRT, Vitanza v. Wyeth, Inc., 2006 WL 462470 (N.J. Super. Ct. 24 Jan. 2006), claimants sought class certification of a group defined as all persons in New Jersey who had taken the drug Prempro and were not suffering from breast cancer, but who wanted medical monitoring for an alleged increased risk of future cancer. The court dismissed the claim, noting that the state's recognition of medical monitoring came in the unique context of manifest exposure to toxic substances in environmental tort actions, and is to be applied sparingly. The policy reasons applicable to the environmental exposure context (including the difficulty in proving exposure levels and duration, and even the identity of the chemicals at issue) are not present in the prescription drug context where claimants have access to relevant information through the label, pharmacy records, and their prescribing physician. The need to deter polluters, perceived to be present in the toxic tort context, does not apply to life sciences companies. See also Parker v. Howmedica Osteonics Corp., 2008 WL 141628, at *5, n.6 (D.N.J. 14 Jan. 2008)(applying similar reasoning to device context). See generally Sinclair v. Merck & Co., 195 N.J. 51, 948 A.2d 587 (N.J. 2008)(plaintiffs could not maintain an action for medical monitoring in a pharmaceutical product liability action). That the device was not approved yet for this use doesn't change the fact that the FDA has primary responsibility for regulating use of the product.

Moreover, from a doctrinal perspective, medical monitoring requires an underlying tort or tortious conduct. Redland Soccer Club, Inc. v. Department of the Army, 696 A.2d 137, 145 (Pa. 1997); Potter v. Firestone Tire & Rubber Co., 863 P.2d 795, 823 (Cal. 1993) (“as a result of a defendant's tortious conduct”); Meyer v. Fluor Corp., 220 S.W.3d 712, 717 (Mo. 2007); (“consequences of the defendant’s tortious conduct”); Hansen v. Mountain Fuel Supply Co., 858 P.2d 970, 979 (Utah 1993) (“which exposure was caused by the defendant’s negligence”); (“through the tortious conduct of the defendant”); Bower v. Westinghouse Electric Corp., 522 S.E.2d 424, 432 (W. Va. 1999); Petito v. A.H. Robins Co., 750 So.2d 103, 106 (Fla. App. 1999) (“caused by the defendant’s negligence”). Here, the negligence claim was dismissed for lack of any viable expert opinion on either liability or damages. There was no viable product defect claim, because of the experimental product. There was no proof of fraud. Bottom line, there was no tort upon which to predicate medical monitoring. Was the court predicting that Delaware would not only adopt the claim, but would do so without this essential element?
 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

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The federal court in the FEMA Trailer MDL has denied class certification to a class of plaintiffs alleging that they were harmed 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).

The plaintiffs had filed claims against the United States and several manufacturers alleging that they were exposed to high levels of formaldehyde contained in emergency housing provided to them by FEMA. The plaintiffs proposed six subclasses, including four subclasses for residents divided by state (Louisiana, Alabama, Texas, and Mississippi), a medical monitoring (“future medical services”) subclass, and an economic loss subclass.

More on the medical monitoirng in a later post.  Today, the focus is the current injruy claims.

Judge Engelhart found that the proposed subclasses did not meet the requirements of Federal Rule of Civil Procedure 23(a) or 23(b)(3).

Commonality

Interestingly, the court found that the plaintiffs had not met the commonality requirement of 23(a), usually not a demanding test. Plaintiffs alleged that common questions existed relating to why and how formaldehyde exposure occurred, what level of formaldehyde exposure was experienced, and who was exposed to the formaldehyde. Plaintiffs, as is typical, claim that defendants’ conduct or fault was a central and common issue. Plaintiffs argued that common issues of fact also relate to the scientific nature and behavior of formaldehyde. On the other hand, defendants argued that there is no commonality because plaintiffs lived in different units, and the court agreed. This case did not involve one single product that is alleged to have caused plaintiffs damage. Instead, plaintiffs have alleged that dozens of different manufacturing defendants have manufactured products that have caused them harm. The court found that the question of defendants’ conduct or fault in the failure to exercise reasonable care is clearly not a common issue because there are dozens of defendants who have manufactured numerous different products that have allegedly caused harm to plaintiffs. In that regard, a determination of fault as to one defendant will not answer the question as to any other defendant. Last, a determination relating to the scientific nature and behavior of formaldehyde is not common as to all class members as the true issue relates to the specific level of formaldehyde that each plaintiff experienced in his/her unit and the resulting symptoms allegedly suffered by that particular plaintiff.

Typicality

A second significant part of the analysis focused on 23(a)’s requirement of typicality. defendants noted that the proposed class representatives claim a myriad of symptoms and conditions, including unconsciousness, convulsions, nephritis, and hypothermia. Indeed, the Plaintiff Fact Sheet (“PFS”) designated a total of 47 alleged formaldehyde-related symptoms, ranging from low blood pressure to miscarriage and stillbirth. Plaintiffs have diverse medical histories, symptoms, and alleged exposures. Typicality is not satisfied where plaintiffs’ claims and defenses will be dominated by individual evidence. Thus, this MDL involves factual variations as to each plaintiff and proposed class representative which spawn individual issues relating to injury and causation as to each individual. Each plaintiffs’ claims and alleged injuries will require an examination of individual evidence, precluding the satisfaction of the typicality requirement for class certification. For example, plaintiffs admitted that a child’s lungs react differently to formaldehyde exposure than an adult’s lungs. Plaintiffs’ counsel also admitted that temperature, humidity, and ventilation affect and contribute to differences in formaldehyde levels in the units.

Predominance

Turning to Rule 23(b)(3), the court found common issues did not predominate and the class method was not superior: this MDL involves hundreds of models of trailers, produced by dozens of different manufacturers. Moreover, even units of the same make and model, made by the same manufacturer, can differ in regards to what components parts were used and when it was manufactured. Further complicating this aspect of these claims, exposure to formaldehyde (at certain levels) is fairly common in today’s society and the chemical is produced by the human body itself. Each plaintiffs’ potential formaldehyde exposure and any resulting health effects vary according to several different factors. Each plaintiff’s habits vary greatly, resulting in the necessity for individualized inquiries delving into the use of heating and air conditioning, and also window or door use (important to how ventilated a particular unit was). Some
plaintiffs are exposed to sources of formaldehyde and eye/nose/throat irritants unrelated to that said to be found in the units (resulting from contact with air pollution, pesticides, pets, cleaning agents, mold, bacteria, and viruses).

Further, as for the alleged injuries to the plaintiffs themselves, the court said that each one has suffered an individual physical injury that is specific to that particular individual, precluding the predominance of issues relating to the plaintiffs themselves. Also, the personal injury claims among plaintiffs vary greatly.

The Court concluded that plaintiffs’ claims will, to a significant degree, be individualized with respect to causation and will include individual issues of exposure, susceptibility to illness, and types of physical injuries. Hence, no class action.

 

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The MDL court in the Teflon products litigation has refused to certify 23 proposed statewide consumer fraud class actions. In re Teflon Products Liability Litigation, 2008 WL 5148713 (S.D. Iowa, 2008).

Plaintiffs alleged that in producing and marketing Teflon® and unbranded, non-stick cookware coatings (“NSCC”), defendant DuPont allegedly made misleading representations regarding safety. None of the proposed class representatives alleged that he or she had been injured by the use of DuPont NSCC. Rather, in each of the purported class actions, plaintiffs sought recovery solely for economic damage and injunctive relief. In particular, plaintiffs demanded creation of a fund for scientific researchers to further investigate the potential for adverse health effects from the use of products containing DuPont's non-stick coating; that DuPont discontinue selling cookware containing the non-stick coating; that DuPont stop making alleged misstatements regarding the safety of its product; that DuPont replace and/or exchange all existing cookware containing DuPont non-stick coating possessed by class members with non-hazardous cookware; rescission and restitution; and/or that DuPont provide a new warning label or other disclosure on cookware made with or containing DuPont non-stick coating.

DuPont has steadfastly denied that PFOA's or any other chemicals are released at harmful levels when cookware coated with Teflon is used as intended.

The Class
The court first identified key deficiencies in plaintiffs’ attempt to define an ascertainable class. As they typically do, plaintiffs argued that at this stage, they do not need to show that each class member ultimately will be able to prove his or her membership; rather, the court need only ensure that the appropriate criteria exists to evaluate membership when the time comes. The court felt this argument necessarily depended upon the availability of evidence to establish membership at a later stage of the proceeding. No such evidence existed to be produced in the case. Deposition testimony showed that it is virtually impossible to identify a brand of non-stick coating based on a visual examination of the item of cookware. Testimony from the class members was thus a key component of the product identification and thus class membership issue. But, even after a lengthy discovery period, during which each proposed representative was thoroughly deposed, many class reps were unable to ascertain whether they belonged in the class or a particular sub-class. An “abundance” of proposed representatives had no memory whatsoever of the circumstances surrounding their purchase of the cookware—let alone records to document their purchase. Bottom line, too many infirmities existed in the class definitions to ensure that the court could determine objectively who was in the class, without resort to speculation. For example, many class representatives mistakenly believed their product contained Teflon coating-even when they were informed the particular brand of cookware at issue never used Teflon.

Lastly, membership in this class necessarily required a plaintiff to pinpoint the date on which he or she purchased the item of cookware; the proposed class representatives were unable to recall this information one-fourth of the time.

Typicality, Coherence, Predominance
An analysis of the claims made clear that common issues did not predominate; class reps’ claims were not typical. Plaintiffs built the majority of their claims around statements made and/or marketing practices employed by DuPont regarding its NSCC products. According to plaintiffs, the fact that each cause of action derived from an alleged  “common practice or course of conduct” on the part of DuPont rendered the claims made by a representative plaintiff typical of the claims of all class members. However, the alleged misstatements cited by plaintiffs span a forty-plus-year period, across a wide variety of advertising and promotional media. Each plaintiff was exposed to different representations, at different time periods. Because reliance is a key element of plaintiffs' claim for negligent misrepresentation, and is necessary for recovery under the consumer fraud statutes in many jurisdictions, an individualized inquiry must be conducted not only to pinpoint the representations at issue, but also to determine the extent to which each plaintiff relied upon the particular representations. Due to the widespread nature of DuPont's advertising over the years, however, determining the precise statements each plaintiff heard could only be accomplished through individualized inquiry.

The court also pointed out the varying degrees to which each plaintiff became educated about NSCC prior to purchase.  Even if class members were exposed to the same representation, advertisement, or omission, the court could not presume that each member responded to the representation or omission in an identical fashion. Here, some proposed class representatives who were informed of potential health risks from NSCC stopped using the cookware, but others exposed to similar information continued to use their existing cookware, and others purchased new non-stick cookware.

Finally the court worried that plaintiffs were splitting their cause of action and thus harming absent class members. Under any one of their alternative bases for relief, plaintiffs necessarily must establish first that DuPont's non-stick cookware coating is dangerous to the health of its users. But the class disclaimed personal injury and had abandoned their original claims for medical monitoring. The representative plaintiffs risked a future waiver not only of their own personal injury and medical monitoring claims, but also those of the absent class members.

 

 

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Your faithful blogger is in NY today speaking at the ACI Drug and Medical Device CLE Seminar.

On this topic of CLE seminars, however, a note that I will be co-presenter at the upcoming webinar, Defending Medical Monitoring Claims— Recent Developments and Best Practices. The webinar is presented by DRI’s Product Liability Committee and its Mass Torts & Class Actions Subcommittee. Co-presenter Jeff Holmstrand, Esquire.

This webinar is designed to help attorneys representing companies in the pharmaceutical, medical device, chemical, and consumer product industries understand what to expect when facing a claim for medical monitoring. In addition to a discussion of important developments and trends in medical monitoring law—including recent cases and an update on the ALI Restatement section related to monitoring—this course will explore some critical actions that clients and their counsel can take to maximize their chances of defeating class certification and prevailing on the merits of medical monitoring claims at trial.

DATE AND TIME

Tuesday, December 16, 2008
3:00 p.m. – 4:30 p.m. Eastern

Register.

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MassTortDefense has posted about medical monitoring claims. One of the advantages plaintiffs may have with juries in such claims is the pre-loaded notion that early detection is "always" better; therefore, screening tests must be helpful, right? Jurors are inundated with messages from public health authorities, government agencies, insurers and others about getting this or that screening test. The latest we saw: get your husband a colo-rectal screening for Christmas.

Undoubtedly, preventive care is crucial, and early detection by some tests of some disease has been shown to save lives. But not every test regime conjured up by plaintiffs' attorneys or their experts for a class of litigants falls into the same category as tests recommended for specific populations by, for example, the US Preventive Services Task Force.

Defendants need to explore the argument that a proposed monitoring test may do more harm than good. Proposed tests have potential side effects, risks. For example, researchers are looking at the risks posed by CT scans.

Researchers from Brigham and Women's Hospital in Boston told a meeting of the Radiological Society of North America in Chicago last week that as many as 7 percent of patients from a large U.S. hospital system had enough radiation exposure from CT scans during their lifetime to noticeably raise their risk of cancer. CT scans help diagnosis of a variety of illness and injuries, and are routinely used to track the advance of cancer. But a number of recent studies have raised alarms about the potential cancer risks from the radiation. The BWH group studied all patients who had a CT scan in 2007 at Brigham and Women's Hospital, or at the Dana-Farber Cancer Institute, in Boston. Then they checked on prior CT scans from a database that includes 20+ years of patient history and calculated overall radiation exposure based on the type and location of the scan. This allowed them to determine a lifetime risk. They found about 7 percent of the patients did have a cancer risk that increased by at least 1 percent over the baseline cancer rate.

And that's for symptomatic patients using the scans. For them, the radiation exposure from CT scans may be worth the risk. But for non-symptomatic, healthy plaintiffs who claim some often unverified level of exposure to a toxic substance, getting repeated CT scans under a medical monitoring regime could raise their risk of a tumor. And certain groups are more likely to be harmed by radiation, including younger people whose growing tissues may be more vulnerable according to some studies.

A typical CT scan can deliver 50 to 100 times more radiation than a conventional X-ray, depending on the site being examined and the type of the machine. Some 62 million CT scans are done in the U.S. annually.

 

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Your faithful blogger will be co-presenter at the upcoming webinar, Defending Medical Monitoring Claims— Recent Developments and Best Practices. The webinar is presented by DRI’s Product Liability Committee and its Mass Torts & Class Actions Subcommittee. Co-presenter Jeff Holmstrand, Esquire.

This webinar is designed to help attorneys representing companies in the pharmaceutical, medical device, chemical, and consumer product industries understand what to expect when facing a claim for medical monitoring. In addition to a discussion of important developments and trends in medical monitoring law—including recent cases and an update on the ALI Restatement section related to monitoring—this course will explore some critical actions that clients and their counsel can take to maximize their chances of defeating class certification and prevailing on the merits of medical monitoring claims at trial.

DATE AND TIME

Tuesday, December 16, 2008
3:00 p.m. – 4:30 p.m. Eastern
2:00 p.m. – 3:30 p.m. Central
1:00 p.m. – 2:30 p.m. Mountain
12:00 p.m. – 1:30 p.m. Pacific

Register here
 

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MassTortDefense has posted about a number of food-related product issues, including the recent China dairy crisis. Now the World Health Organization (WHO) reports that food-borne illnesses are increasing, and not just in the developing world. In the US, food poisoning causes about 76 million illnesses, 325,000 hospitalizations, and up to 5,000 deaths, annually, according to the federal Centers for Disease Control and Prevention (CDC). There is some indication that the problem is increasing. Approximately one-third of new infectious diseases originate in bacteria, viruses, parasites, chemicals, and toxins introduced along food production chains.

The WHO is the coordinating authority for health within the United Nations system. Their view is that eradication of food-borne diseases requires a concerted effort on the part of the three principal partners: governments, the food industry, and consumers.  WHO is urging monitoring of the entire food chain, citing the emerging so-called “farm to fork” approach. WHO rejects the notion that you can deal with it at the end of the food chain. Often, there is a lack of collaboration, organization, or cooperation is problematic. In China, for example, there are 16 different authorities involved in some way in dealing with the melamine crisis.

Experts are also concerned about the long-term consequences of food problems. For example, E. coli is now known to cause pediatric kidney failure. This issue can implicate medical monitoring claims.

In the United States, food-borne disease outbreaks are typically linked to eggs, poultry and dairy products, but they have recently been caused by fresh produce. Tomatoes were suspected in the U.S. outbreak before the salmonella was traced to peppers from Mexico. The FDA, last week, announced the formal opening of the first of several offices in China, which are designed to place experts “on the ground” in the areas of China where many food and other imported products originate.
 

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The U.S. District Court for the Eastern District of Pennsylvania has recently dismissed a class action seeking a medical monitoring program for employees at a beryllium plant alleging exposure to airborne beryllium. Anthony v. Small Tube Manufacturing Corp., 2008 WL 4443896 (E.D.Pa.).

Gary Anthony, as sole class representative, asserted a claim of negligence on behalf of himself and a class of employees and former employees at the U.S. Gauge facility in Sellersville, Pa. The complaint alleged that the employees were exposed to airborne beryllium while working at the plant. The class was alleged to include several thousand members. The workers allegedly faced an increased risk of contracting “chronic beryllium disease” as a result of their exposure to airborne beryllium. CBD is a lung disorder which occurs when a person's immune system over-reacts to inhaled particles of beryllium and produces pathological changes in the lungs called granulomas.

Beryllium is a strong, lightweight metal with a high melting point, high stiffness-to-weight ratio, and excellent thermal and electrical conductivity. Beryllium is used as a pure metal, but more frequently it is incorporated at low levels into alloys. Beryllium copper is the most widely used alloy, but beryllium is also combined with aluminum, nickel and magnesium, to produce a panoply of products from non-sparking tools, and aircraft brakes, to laser targeting systems and nuclear weapons.

The putative class sought the establishment of a medical monitoring program funded by defendants, and administered under court supervision. As readers of MassTortDefense may recall, a claim for medical monitoring under Pennsylvania law, requires a plaintiff to 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 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 v. Department of the Army, 548 Pa. 178, 195-196, 696 A.2d 137, 145-146 (1997).

Defendants here sought summary judgment, attacking the validity of the claim of the named representative. (And if he did not have a viable claim, he was not an adequate class rep.). Plaintiff could not show he was “sensitized” to beryllium. Defendants averred that beryllium sensitization is required to sustain a claim for medical monitoring based on exposure to beryllium. That is, without being sensitized to beryllium, a plaintiff cannot demonstrate that he is at a significantly increased risk of contracting chronic beryllium disease (CBD), the only known latent disease which results from beryllium exposure. A person becomes sensitized to beryllium when his immune system recognizes beryllium as a foreign agent and builds cells in the bloodstream to react against it. The defendants contended that this sensitization is a necessary precondition to the development of chronic beryllium disease.

Plaintiff argued that all individuals sufficiently exposed to beryllium are at risk for the development of beryllium-related health effects. The putative class, having been exposed, was at a significantly increased risk of contracting CBD and should be medically monitored for the development of beryllium sensitivity. Plaintiff contended that it has “long been known” that machinists of beryllium are at a significantly increased risk of contracting CBD, and, therefore, summary judgment was inappropriate in this case.

Defendants further asserted that the Pennsylvania intermediate appellate court’s decision in Pohl v. NGK Metals Corporation, 936 A.2d 43 (Pa.Super.2007), allocatur denied, 952 A.2d 678 (Pa.2008) (per curiam), specifically rejected a plaintiff's experts' conclusions that mere exposure to beryllium is sufficient to create a significantly increased risk of contracting CBD. Plaintiff responded that, at best, Pohl stands for the proposition that the plaintiffs in that case were unable to demonstrate that their specific exposures to beryllium rose to the level of creating a significantly increased risk of harm.

The federal court did not read the Superior Court decision in Pohl as establishing a positive rule of law that a plaintiff must prove that he or she is beryllium sensitized in all cases seeking medical monitoring for beryllium exposure. However, as a matter of expert proof, it was clear to the court that to be diagnosed with CBD one must in fact be both beryllium sensitized (as demonstrated by a positive test result) and have a positive pulmonary biopsy indicating the presence of granulomas. Without being sensitized to beryllium, plaintiff cannot ever have a diagnosis of chronic beryllium disease. Therefore, plaintiff cannot demonstrate he is at a significantly increased risk of developing CBD, the only latent disease which results from exposure to beryllium.

While plaintiffs’ experts opined that all individuals exposed to beryllium, including machinists like plaintiff, were at a significantly increased risk of contracting chronic beryllium disease, even before they become beryllium sensitized, the court found that the experts did not have the data necessary to support their conclusions in this regard. The “opinions” were “merely assumptions and speculation.” Specifically, they did not have, or base their opinions upon, any beryllium readings, measurements, or other exposure data from the U.S. Gauge plant.

 

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The U.S. Preventive Services Task Force has released its recommendations for colon cancer screening, suggesting that most people over age 75 should stop getting routine colon cancer tests. In a decision at odds with some traditional views, the USPSTF opted not to give its approval to CT colonography, virtual colonoscopy, and the stool DNA test. (The 2002 guidelines did not give an age limit for screening.)

What is significant to readers of MassTortDefense is not the specific review of these tests, but the important recognition underlying the decision: that risks of screening at that age are too great to justify any possible benefit. After reviewing research on the tests, the government-appointed panel of independent medical experts concluded that the benefits of detecting and treating colon cancer decline after age 75 and the risks rise too much.

The U.S. Preventive Services Task Force (USPSTF), first convened by the U.S. Public Health Service in 1984, and since 1998 sponsored by the Agency for Healthcare Research and Quality (AHRQ), is perhaps the leading independent panel of private-sector experts in prevention and primary care. The USPSTF conducts rigorous assessments of the scientific evidence for the effectiveness of a broad range of clinical preventive services, including screening, counseling, and preventive medications. Its recommendations are considered in some circles the "gold standard" for clinical preventive services.
 

In medical monitoring claims, typically a plaintiff must prove that screening tests are reasonably medically necessary for plaintiffs because of the risks of the allegedly tortuous exposure. Despite plaintiffs’ typical theme about early detection always being efficacious, the reality is that many “routine” screening procedures have their own risks and potential side effects. As the Task Force said, “The risks and benefits of these screening methods vary.”  Where doctors must assess the risks and benefits, a powerful individual issue may emerge, affecting class certification. Even in a class setting, on the merits, the risks of procedures sought by the plaintiffs may outweigh the benefits. Thus, in this context, the Task Force noted, “The primary established harms of colorectal cancer screening are due to the use of invasive procedures initially or in the evaluation sequence. Harms may arise from the preparation the patient undergoes to have the procedure, the sedation used during the procedure, and the procedure itself.”  Colonoscopy is considered the gold standard but it is not perfect. A long, thin tube with a small video camera is snaked through the large intestine to view the lining and any growths are removed.
 

Defendants in medical monitoring claims will want to assess the state of the art recommendations of bodies such as the USPSTF, as well as the specific literature on the risks of proposed screening tests.

 

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A federal court in West Virginia has 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). According to the court, plaintiffs had presented sufficient evidence that exposure to C-8 may be harmful to human health, but what “the plaintiffs misunderstand, however, is what they must show in order for me to certify the class. I cannot certify a class based on some potential harm to the general public, rather, there must be specific injuries to each member of the proposed class. The fact that a public health risk may exist … does not show the common individual injuries needed to certify a class action.”

The court viewed the plaintiffs as seeking primarily injunctive or declaratory relief in the form of a court-supervised medical monitoring program. While the likelihood of the plaintiffs' success on the merits is not relevant, the court must still engage in “rigorous analysis” to determine whether the proposed class meets the Rule 23 requirements. Gen. Tel. Co. v. Falcon, 457 U.S. 147, 161 (1982). A court may “probe behind the pleadings” to determine whether class certification is appropriate. Id.

A proposed class must be “cohesive” to be certified under Rule 23(b)(2). See Barnes v. Am. Tobacco Co., 161 F.3d 127,143 (3d. Cir.1998). This is particularly so because in a (b)(2) action, unnamed members are bound by the action without the opportunity to opt out. Barnes, 161 F.3d at 142-43. The cohesiveness requirement is similar to but “more stringent” than the commonality requirement of Rule 23(a). See Lienhart v. Dryvit Syst., Inc., 255 F.3d 138,147 n. 4 (4th Cir.2001); Barnes, 161 F.3d at 142-43.

Under West Virgina law, medical monitoring plaintiffs must first show a significant exposure. In a class action, if significant exposure is not a common issue, cohesiveness will be lacking. Exposure is significant if a plaintiff has been exposed to a larger quantity of the toxic substance or has been exposed for a longer duration than the general population. Thus, a plaintiff must be able to demonstrate that his exposure was somehow greater than what would normally be encountered by a person in everyday life.

Here, while the plaintiffs had evidence of the levels of chemical released, that evidence told the court nothing about how the plaintiffs’ C-8 exposure level compares to the level of C-8 exposure experienced by the general population. Evidence of the elevated C-8 concentrations in the named plaintiffs' blood likewise fails to show common exposure on a class-wide basis. The evidence of the higher C-8 concentration in the named plaintiffs' blood as compared to the general population suggests only that the named plaintiffs have possibly been “significantly exposed.”  Plaintiffs’ expert testimony did not provide a relevant comparison between the plaintiffs' exposure and the exposure of the general population. On this record, the general population's level of exposure to C-8 in their drinking water was unknown.

Under the second pertinent element of the medical monitoring cause of action, a plaintiff must demonstrate that her or she has suffered a significantly increased risk of contracting a particular disease relative to what would be the case in the absence of exposure. Furthermore, a plaintiff must also show that the exposure caused by the defendant was the proximate cause of that increased risk. In other words, the risk must be different and greater than it would have been absent the significant exposure at issue. Common proof of this element is always complicated because the plaintiffs must not only show that the class members have experienced a significantly increased risk but also that: 1) the risk is of a serious latent disease, 2) the defendant proximately caused that risk to each class member, and 3) the risk is significant relative to what it would have been absent the exposure.

The court agreed with DuPont’s argument that the plaintiffs could not show an increased risk of disease with class-wide proof because each class member's risk of disease will vary based upon: (a) variations in C-8 exposure and dose, and (b) variations in an individual's background risk of disease absent C-8 exposure. Plaintiffs had to concede that individual characteristics and habits will affect the level of risk experienced by each class member.

In a useful analysis, the court also explained why a regulatory risk assessment cannot and does not support an opinion that each individual class member had experienced a significantly increased risk of disease. In fact, a risk assessment is of limited utility in a toxic tort case, especially for the issue of causation, because of the risk assessment's distinct purpose. Risk assessments have largely been developed for regulatory purposes and thus serve a protection function in providing a level below which there is no appreciable risk to the general population. They do not provide information about actual risk or causation. See Bernard D. Goldstein & Mary Sue Henifin, Reference Guide on Toxicology in Federal Judicial Center Reference Manual on Scientific Evidence 413 (2d ed. 2000). Because of their appropriately prudent assumptions when there are limited data, risk assessments intentionally encompass the upper range of possible risks. Id.; see also Sutera v. Perrier Group of Am. Inc., 986 F.Supp. 655, 664 (D.Mass.1997) (rejecting regulatory standards as a measure of causation because the purpose of regulatory standards is to reduce public exposure to harmful substances); Allen v. Pa. Eng'g Corp., 102 F.3d 194, 198 (5th Cir.1996)); O'Neal v. Dep't of the Army, 852 F.Supp. 327, 333 (M.D.Pa.1994) (determining that risk figures based on the EPA's upper-bound estimates for another chemical are appropriate for regulatory purposes in which the goal is to be particularly cautious but overstate the actual risk and so, are inappropriate for use in determining whether medical monitoring should be instituted.).

Because a risk assessment overstates the risk to a population to achieve its protective and generalized goals, it is impossible to conclude with reasonable certainty that any one person exposed to a substance above the criterion established by the risk assessment has suffered a significantly increased risk. Precautionary measures to keep the general population safer are fundamentally distinct from the medical monitoring cause of action which provides relief to individuals that have already been “injured.”

Finally, on the element of need for medical monitoring, the court again found an absence of cohesion because if the individual nature of the inquiry. Plaintiffs’ expert seemed to assume that a member of the proposed medical monitoring class can have the determination of their particular and individualized diagnostic needs deferred until after the implementation of the medical monitoring protocol. While the proposed medical monitoring program was to be set up based on the “common” exposure, the implementation would be individualized. But while individualized implementation may be standard in public health monitoring programs, the tort of medical monitoring requires that determination to occur prior to a finding of liability. Plaintiffs were thus recommending a public health medical monitoring program rather than medical monitoring addressing tortious injuries to individuals. Plaintiffs thus merely deferred the individual issues that meant the class was not cohesive.
 

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The U.S. District Court for the Western District of Missouri has dismissed a medical monitoring claim brought against the manufacturer of a medical device, finding that the applicable state law permits such a claim only in a true toxic tort case. Ratliff v. Mentor Corp., 2008 WL 3126300 (W.D. Mo.,  Aug. 5, 2008).

Plaintiff Toni Ratliff had a Mentor UB-Tape sling surgically implanted in her pelvis area to treat a condition. She brought a putative class action, including “all persons or entities in the State of Missouri who were treated, implanted or otherwise received the UB-Tape, designed, tested, manufactured, distributed and/or sold by Mentor Corporation.” Excluded from the class were all people with claims for personal injury or wrongful death. She alleged the device caused extrusions, infections and abscesses, often requiring secondary surgical procedures to correct the problem.

The relief sought included a notification, research, and medical monitoring fund for tests to catch those problems. Mentor moved to dismiss, arguing that a medical monitoring claim is not recognized in Missouri outside of the toxic torts context.

The court noted that Meyer v. Fluor Corp., 220 S.W.3d 712 (Mo. 2007) is the first and only Missouri Supreme Court case dealing with medical monitoring claims. It has been cited for the general proposition that Missouri recognizes a claim for medical monitoring. However, in Meyer, children allegedly exposed to lead sued smelter operators to recover damages for the expense of medical monitoring. The Missouri Supreme Court held that the children were entitled to recover such damages under a “medical monitoring claim” that “seeks to recover the costs of future reasonably necessary diagnostic testing to detect latent injuries or diseases that may develop as a result of exposure to toxic substances.” Id. at 716. Thus, by the Missouri Supreme Court’s own definition of a medical monitoring claim, the Meyer decision does not apply to potential latent injuries resulting from anything other than exposure to toxic substances.

The strict holding of Meyer is that, in Missouri, medical monitoring claims are available in toxic tort cases. Meyer does not necessarily support recognition of medical monitoring claims in garden variety products liability cases like plaintiff contended. This explicit limitation in Meyer led the district court to believe that the Missouri Supreme Court would dismiss medical monitoring claims that do not result from exposure to toxic substances.

Although the court did not get into policy issues, MassTortDefense notes that there is a growing recognition that medical monitoring should not be available in the context of drugs and medical devices. The voluntary use of a medical device or medicine prescribed by a health care professional is arguably far removed from the original medical monitoring notion of involuntary exposure to a chemical in the environment. In a case involving HRT, Vitanza v. Wyeth, Inc., 2006 WL 462470 (N.J. Super. Ct. Jan. 24, 2006), plaintiffs sought class certification of a group defined as all persons in New Jersey who had taken the drug Prempro and were not suffering from breast cancer, but who wanted medical monitoring for an alleged increased risk of future cancer. The court dismissed the claim, noting that the state's recognition of medical monitoring came in the unique context of manifest exposure to toxic substances in environmental tort actions, and was to be applied sparingly. The policy reasons applicable to the environmental exposure context (including the difficulty in proving exposure levels and duration, and even the identity of the chemicals at issue) are not present in the prescription drug context where claimants have access to relevant information through the label, pharmacy records, and their prescribing physician. The need to deter polluters, perceived to be present in the toxic tort context, does not apply to life sciences companies selling a product screened by the FDA.

The absence of these policy factors in a life sciences context was also observed in a recent Vioxx case. Sinclair v. Merck & Co., 195 N.J. 51, 948 A.2d 587 (N.J. 2008). The state supreme court ruled as a matter of law that plaintiffs could not maintain an action for medical monitoring in a pharmaceutical product liability action because they did not allege a presently manifested injury. The court held that the New Jersey Products Liability Act requires present manifest injury and therefore bars medical monitoring unless the present manifest injury element is satisfied. The court also examined prior precedents where medical monitoring was approved, and found those precedents were limited to personal injury stemming from asbestos exposure and exposure to environmental contamination. The majority declined to recognize any common law medical monitoring remedy. See also Parker v. Howmedica Osteonics Corp., 2008 WL 141628, at *5, n.6 (D.N.J.,  Jan.  14, 2008)(applying similar reasoning to device context). Similarly, in Conway v. A.I. DuPont Hosp. for Children, 2007 WL 560502 (E.D. Pa., Feb. 14, 2007), the court denied the defendant's motion to dismiss a medical monitoring claim regarding a medical device used in children with congenital heart defects. The court did, however, note that while medical monitoring was "suitable" in toxic substance exposure cases, the "same argument cannot be made for medical monitoring relief in products liability cases where diseases" are not caused by exposure to toxic substances.
 

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A federal court earlier this month permitted a proposed class action to move forward with its central allegation that Christian Dior lipstick contains excessive levels of lead. See Stella v. LVMH Perfumes and Cosmetics USA Inc., No. 1:07-cv-06509, 2008 WL 2669662 (N.D. Ill. 7/8/08).

Named plaintiff Pamela Stella alleges that she purchased Christian Dior "Addict Positive Red" lipstick, manufactured by LVMH Perfumes and Cosmetics USA Inc., at a Nordstrom department store in June, 2007. The so-called “Campaign for Safe Cosmetics” group issued a report in October, 2007 claiming that tests showed a lead level in LVMH lipsticks which slightly exceeds the regulatory limit established by the Food and Drug Administration for lead content in certain products like candy.  In reality, the average amount of lead a woman would be exposed to when using cosmetics is 1,000 times less than the amount she would get from eating, breathing and drinking water that meets Environmental Protection Agency (EPA) drinking water standards, according to the Cosmetics, Toiletry and Fragrance Association (CTFA).

Plaintiff then sued LVMH in November, 2007 on behalf of a proposed nationwide class of lipstick purchasers. She alleged that the company violated the Illinois deceptive business practices statute and breached an implied warranty of merchantability. She also brought claims for strict liability, negligence per se, unjust enrichment, and injunctive relief.

Judge Elaine E. Bucklo of the U.S. District Court for the Northern District of Illinois denied defendant’s motion to dismiss. She determined that Stella sufficiently alleged a claim under the deceptive trade practices law, including its requirement of actual damages. Stella sought to recover actual damages, the court said, "in the form of pecuniary damages (the cost of the lipstick).” The court also noted that plaintiff had alleged that her reliance on defendant's omission caused her to buy the lipstick and become exposed to lead. “This sufficiently alleges proximate cause.”

The court also agreed with plaintiff that Illinois law would permit medical monitoring as a remedy. The Illinois Supreme Court has not ruled on the question. But in Carey v. Kerr-McGee Chemical Corp., 999 F. Supp. 1109, 1118-19 (N.D. Ill. 1998), the district court had predicted that medical monitoring would be recognized as cognizable under Illinois law.

MassTortDefense has posted on medical monitoring before, 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.

Medical monitoring is almost always seen as a potential class action claim, for several reasons:
• First, the individual damages associated with periodic testing of a so-far healthy plaintiff may not be all that financially attractive to plaintiff attorneys.
• Secondly, a number of the elements of the claim (or remedy) of medical monitoring seem, on the surface, amenable to “common” proof in the form of epidemiological evidence. For example, the increased risk that typically must be shown.

When the issue is ripe, it should be clear that such claims are not appropriate for class treatment, as numerous individual issues will arise, including choice of law, properly viewed, in a nationwide class.

Defendant LVMH's also challenged the implied warranty claims, based on the absence of contractual privity between plaintiff and LVMH. But the court narrowly construed the privity requirement to say that Illinois law requires contractual privity as a prerequisite for breach of implied warranty claims only for recovery of economic losses. Voelker v. Porsche Cars North Am., Inc., 353 F.3d 516, 527 (7th Cir.2003). The medical monitoring claim, as "a form of personal injury claim," brought plaintiff out from under this privity requirement, said the court.

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The Supreme Court of New Jersey has just issued its opinion in the closely watched medical monitoring case, Phyllis Sinclair v. Merck & Co. Because your faithful blogger’s firm is involved in the Vioxx litigation, MassTortDefense presents you with the opinion and, as Joe Friday said, just the facts. No commentary or editorializing.

In this products liability case the Court considered whether plaintiffs may recover the costs of medical monitoring despite their failure to allege a physical injury. This litigation arises from the use of Vioxx, a prescription drug manufactured and sold by Merck. In November 2004, plaintiffs filed a class action complaint on behalf of a proposed national class of individuals who ingested Vioxx and who allegedly may suffer from serious latent injury for which they may require medical monitoring. Plaintiffs later refined the factual allegations advanced in the complaint and alleged that as a result of the direct consumption of Vioxx, they are at enhanced risk of serious undiagnosed and unrecognized myocardial infarction, and other latent injuries. Plaintiffs sought the cost of medical testing in the form of a court-administered screening program to provide medical diagnostic tests for each member of the proposed class and follow-up with an epidemiologist.

The trial court reviewed the standards governing pleadings and motions to dismiss, as well as the
facts and holdings of several cases that addressed medical monitoring: Ayers v. Township of Jackson, 106 N.J. 557 (1987), Mauro v. Raymark Industries, Inc., 116 N.J. 126 (1989), and Theer v. Philip Carey Co., 133 N.J. 610 (1993). The trial court granted Merck’s motion and dismissed plaintiffs’ complaint. It found that the PLA limits compensation to harm as defined by N.J.S.A. 2A:58C-1b(2), and reasoned that medical monitoring has not been applied to a products liability action to which the PLA applies. Additionally, the trial court noted that the medical monitoring is an unavailable remedy under the New Jersey Consumer Fraud Act.

On appeal, the Appellate Division reversed and remanded for further proceedings. Sinclair v. Merck & Co., 389 N.J. Super. 493 (2007). The panel noted the lack of facts and expert testimony at the motion stage of the proceedings, and remanded for discovery and an evidentiary hearing. The state Supreme Court granted Merck’s petition for certification and also granted amicus curiae status to various entities.

Today’s opinion holds that the N.J. Products Liability Act, which is the sole source of remedy for plaintiffs’ defective product claim, does not include the remedy of medical monitoring when no manifest injury is alleged. This Court reads the PLA to require a physical injury. And thus medical monitoring plaintiffs cannot satisfy the definition of harm to state a product liability claim under the PLA. The Court further holds that claims for harm caused by a product are governed by the PLA irrespective of the theory underlying the claim. The heart of plaintiffs’ case is the alleged potential for harm allegedly caused by Merck’s drug. It is thus a product liability claim. Consequently, plaintiffs may not maintain a CFA claim.

Chief Justice Rabner and Justices Lavecchia, Rivera-Soto and Hoens joined in Justice Wallace’s majority opinion. Justice Long filed a separate, dissenting opinion. Justice Albin did not participate.

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The United States District Court for the Eastern District of Pennsylvania issued an interesting medical monitoring ruling last week, which dealt with who is a proper defendant for this type of claim. In Sheridan, et al. v. NGK Metals, No. 06-5510, 2008 WL 2156718 (E.D. Pa. May 22, 2008), the court addressed the potential liability for medical monitoring relief of a unique type of defendant, a consultant hired to sample and monitor air quality. 

The decision is noteworthy in the context of plaintiffs' attempts to expand this non-traditional remedy. (and for another good application of the Twombly pleading decision to a toxic tort context.)

The proposed plaintiff class sought medical monitoring for residents of the Reading, Pennsylvania area who were allegedly exposed to beryllium emitted into the air from one of the defendant’s manufacturing facilities. According to the plaintiffs, members of the proposed class resided and/or regularly worked in close proximity to the Reading Plant at some time during the period from 1950 to 2000.

Defendant Spotts, Stevens & McCoy (SSM) was 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 the Reading Plant.

The District Court considered SSM’s motion to dismiss, noting that while a complaint need not contain detailed factual allegations, the plaintiff must provide more than labels and conclusions, and more than a formulaic recitation of the elements of a cause of action will not do, under the new Supreme Court guidance in Bell Atlantic Corp. v. Twombly, 127 S.Ct. 1955, 1964-65 (2007).

Medical Monitoring

MassTortDefense has posted on this claim before. Medical monitoring is recognized under Pennsylvania law, 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).

Negligence Element

As the third element listed indicates, a medical monitoring plaintiff must prove the underlying tort of negligence in Pennsylvania.  And an action in negligence is premised upon the existence of a duty owed by one party to another. Here, plaintiffs alleged that the engineering firm owed them a duty under the notion expressed in Section 324A of the Restatement (Second) of Torts regarding Liability to Third Person for Negligent Performance of Undertaking (the so-called "Good Samaritan" rule).  It states:

One who undertakes, gratuitously or for consideration, to render services to another which he should recognize as necessary for the protection of a third person or his things, is subject to liability to the third person for physical harm resulting from his failure to exercise reasonable care to protect his undertaking, if

(a) his failure to exercise reasonable care increases the risk of such harm, or

(b) he has undertaken to perform a duty owed by the other to the third person, or

(c) the harm is suffered because of reliance of the other or the third person upon the undertaking.

Restatement (Second) of Torts § 324A (1977).

Pennsylvania is one of many jurisdictions that has adopted Section 324A. See Cantwell v. Allegheny County, 506 Pa. 35, 40, 483 A.2d 1350, 1353 (1984). It has been interpreted to mean that absent any evidence that a defendant assumed an affirmative duty, there can be no liability for negligently performing that duty. See Wenrick v. Schloemann-Siemag Aktiengesellschaft, 523 Pa. 1, 564 A.2d 1244, 1248 (Pa.1989). Section 324A cannot be invoked to create a duty where one does not exist.

Plaintiffs' Allegations/Response

Plaintiffs alleged that SSM was responsible for advising the other defendants with regard to the air quality and for informing and/or warning the other defendants (the plant owners) about the results of air sampling and testing. Thus, a duty allegedly existed for SSM to act with reasonable care and prevent any increased risk of harm to the plaintiffs. Defendants responded that because the plaintiffs failed to allege that SSM undertook the specific duty to warn the plaintiffs, or that they negligently performed its undertaken tasks, no claim existed. SSM never expressly undertook a duty to warn the plaintiffs of the harmful beryllium exposures at the Reading Plant.

The Ruling: No Claim

The Court noted that the Amended Complaint did not allege that SSM was negligent in performing the testing, sampling, analyzing or monitoring of the air quality in the Reading Plant, or that the engineers failed to report, or were negligent in reporting, the results of its research to the plant owners. The pleading did not allege any circumstances under which such a duty, as a matter of law, could arise “implicitly” or “derivatively.” And absent a duty owed to the plaintiffs here, the Court need not reach the question of whether plaintiffs' alleged injuries were foreseeable.

Plaintiffs also needed to properly allege one of the three subsections of Section 324A, (a) failure to exercise reasonable care that increases the risk of harm, or (b) an undertaking to perform a duty owed by the other to the third person, or (c) the harm is suffered because of reliance of the other or the third person upon the undertaking.

On part (a), plaintiffs confused sins of commission rather than omission when they alleged that SSM allowed beryllium levels at the Reading Plant to rise to unsafe levels. Plaintiffs (discovery was well along) could not allege that SSM assumed or had any control over what caused the beryllium concentrations to rise to excessive levels, or contracted to undertake any corrective action to prevent these excesses from occurring. SSM undertook to test the beryllium emission at the plant, and report those emissions to the plant owners. The Amended Complaint did not allege that Plaintiffs' injuries arose from any alleged negligent testing.

With respect to subsection (b), plaintiffs argue that the engineering firm undertook to perform a duty owed by the plant owners to the plaintiffs. However, SSM agreed to take the steps of merely testing, sampling, monitoring, etc. Mere knowledge of a dangerous situation does not suffice to impose liability under Section 324A(b). Finally, as to subsection (c), plaintiffs failed to allege that they suffered any harm because of their reliance upon SSM undertaking to perform certain tests for the plant owners.

The Court concluded that plaintiffs essentially were advancing the proposition that SSM owed a “social duty” to them, and to the public at large. However, the scope of a good Samaritan’s duty is measured by the scope of his or her undertaking. Section 324A does not impose any “social,” “implied” or “derivative” duty. Rather, Section 324A imposes liability, reaching to third persons, upon a party's breach of a specifically undertaken duty. If a defendant did not undertake to perform a specified task, it cannot be held liable under Section 324A for failing to perform that task.

The medical monitoring claim against the engineers was dismissed.

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The Eight Circuit’s recent decision, In re: St. Jude Medical, Inc., Silzone Heart Valve Products Liability Litigation, No. 06-3860, 2008 WL 942274 (8th Cir. April 9, 2008), offers a number of potential lessons for mass tort defendants, and not just those in the medical device arena. (As always at MassTortDefense, we try to cross-pollinate from industry to industry and mass tort to mass tort those theories, rulings, etc. that can potentially assist a broad range of defendants.) So many lessons, in fact, that one posting can’t do them all justice. So let’s break it down into some sub-parts and see if we can’t gain some insights.

Today’s focus is medical monitoring, which of course is near and dear to MassTortDefense ever since having tried to a defense verdict a medical monitoring class action in West Virginia a few years back.

Some Background

As readers may know, before the 8th Circuit decertified a class of an estimated 11,000 plaintiffs who received one of St. Jude Medical Inc.’s allegedly defective Silzone heart valves, the case had a bit of an up and down history. The district court originally certified two subclasses of plaintiffs seeking damages and injunctive relief, respectively. Then in In re St. Jude Med., Inc., 425 F.3d 1116 (8th Cir. 2005), the appeals court reversed the district court’s certification of a subclass of plaintiffs seeking injunctive relief, which was described as a “medical monitoring class,” because the class presented “a myriad of individual issues making class certification improper.” Id. at 1122.

With respect to the subclass seeking damages and described as a “consumer protection class,” the 8th Circuit held that the district court should have conducted a more thorough choice-of-law analysis before it determined to apply Minnesota law to the claim of every plaintiff. Id. at 1121. It remanded the case to the district court for further consideration. On remand, the district court determined that Minnesota law should apply to all claims in the nationwide class, and recertified the consumer protection class pursuant to Federal Rule of Civil Procedure 23(b)(3). In re St. Jude Medical, Inc., No. 01-1396, 2006 WL 2943154 (D. Minn. 2006). St. Jude’s appeal of this certification of the class led to the April decision we discuss here.

Medical Monitoring

Among the individual issues that would predominate over so-called common questions were several related to the "highly individualized remedy of medical monitoring.” 2008 WL 942274 at *4. Medical monitoring, generally defined, is periodic testing and/or examination to facilitate the diagnosis and treatment of a latent disease by early detection. It is not the diagnostic testing that accompanies symptoms, but rather testing of seemingly healthy, asymptomatic persons who have been exposed to a potentially harmful substance and are at risk of future disease or injury.

Medical monitoring is almost always seen as a potential class action claim, for several reasons:

• First, the individual damages associated with periodic testing of a so-far healthy plaintiff may not be all that financially attractive to plaintiff attorneys.
• Secondly, a number of the elements of the claim (or remedy) of medical monitoring seem, on the surface, amenable to “common” proof in the form of epidemiological evidence. For example, the increased risk that typically must be shown.

Plaintiffs’ attempts to certify medical monitoring classes have come under both Rule 23 (b)(2) and (b)(3). The 23(b)(2) claim typically alleges that the defendant has acted on grounds generally applicable to the class (for example, making a defective product or failing to warn of its hazards) and that injunctive relief for the class is appropriate in the form of a requirement that the defendant provide medical monitoring for the class. Claimants seeking certification under Rule 23(b)(2) often seek a court-established monitoring program, alleging it to be a claim for injunctive relief (see In re Sulzer HipProsthesis and Knee Prosthesis Liab. Litig., 455 F.Supp.2d 709 (N.D. Ohio 2006) ). Such a claim, however, may simply be an artful pleading of a simple pass-through mechanism in which claimants seek monetary damages for the payment of medical test bills for class members: essentially, a suit for damages. Thomas v FAG Bearings Corp., 846 F. Supp. 1400 ( W.D. Mo. 1994 ). The 23(b)(3) claim typically asserts that the defendant’s conduct, the significant exposure of class members, the hazardous nature of the product in question and the increased risk of future disease each class member faces, are common issues that predominate over any questions affecting only individual class members.

The 8th Circuit previously rejected certification of a medical monitoring class under Rule 23 (b)(2), saying in its 2005 opinion that whether an individual plaintiff will require additional monitoring "is an individualized inquiry depending on that patient's medical history, the condition of the patient's heart valves at the time of implantation, the patient's risk factors for heart valve complications, the patient's general health, the patient's personal choice, and other factors." Now, even if one assumed Minnesota law would apply to all the claims, the need for these detailed and individual factual inquires concerning the appropriate remedy weighed against a (b)(3) class certification as well. 2008 WL 942274 at *4-5.

This language is useful for defendants opposing (b)(2) or (b)(3) medical monitoring putative classes. While plaintiff’s proposed medical monitoring plan is typically a one-size fits all program, and hence seemingly a common issue, the court noted as a potential individual issue what the appropriate monitoring may be -- turning, as it does, on the class member’s medical history, condition, risk factors for complications, and general health. The court also noted that a class member who had been implanted with the device might already require future medical monitoring – some type of periodic follow-up medical checks – as an ordinary part of his or her follow-up care.

Whenever this is the case, plaintiffs will stumble on the typical medical monitoring element that the testing being sought would not be done as part of the ordinary standard of medical care. Often called the “over and above” element, most courts that have adopted some form of medical monitoring require that the testing that defendant is being asked to pay for is something that is needed because of the harmful exposure to the defendant’s product, and not something that plaintiff needed and would or should have gotten even in the absence of exposure to defendant’s product. Very often, whether the recipient of an implant, the taker of a prescription drug, the user of a consumer product, might or would or should have undergone the same periodic medical testing is provable, and at the least, is an individual inquiry that depends on the specific facts concerning each putative class member.

Same Notion Seen in HRT

This notion was also explored in Wyeth, Inc. v. Gottlieb, 930 So.2d 635 (Fla. 3d Dist. Ct. App. 2006),
review denied, 950 So.2d 413 (Fla. 2007). The Florida appellate court reversed the decision of the state trial court to certify a state-wide medical monitoring class of about 300,000 women who took Prempro. The court saw the proposed monitoring plan for the HRT class as nearly the same medical testing recommended for all post-menopausal women. A person seeking medical monitoring must show that, given her own unique medical and other exposure history, the exposure caused by the defendants significantly increased her risk and necessitated the monitoring recommended for her. The HRT schemes proposed by plaintiffs are not programs for at risk Prempro users, but for any woman who had any breast cancer risk factor, including age, family history, weight or alcohol use. As a jury issue, the over and above notion has worked well for the tobacco industry, which has been subjected to multiple putative class actions seeking medical monitoring.

Medical monitoring remains a potential threat. While the Mississippi Supreme Court rejected medical monitoring in Paz v. Brush Engineered Materials, Inc., 949 So.2d 1 (Miss. 2007), the Missouri Supreme Court recognized a medical monitoring remedy in Meyer ex rel. Coplin v. Fluor Corp., 220 S.W.3d 712 (Mo. 2007). And the American Law Institute (ALI) has released a “Council Draft” of a Restatement (Third) Torts: Economic Torts and Related Wrongs, which would recognize a “limited” form of medical monitoring claim. Clear and careful analysis like that of Judge Colloton and the 8th Circuit panel is useful in responding to the threat.

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