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

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.

• Email This
• Print
• Comments
• Trackbacks

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.

• Email This
• Print
• Comments
• Trackbacks

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.
 

• Email This
• Print
• Comments
• Trackbacks

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.

• Email This
• Print
• Comments
• Trackbacks

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.

• Email This
• Print
• Comments
• Trackbacks

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.

• Email This
• Print
• Comments
• Trackbacks

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?
 

• Email This
• Print
• Comments
• Trackbacks

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.
 

• Email This
• Print
• Comments
• Trackbacks

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?
 

• Email This
• Print
• Comments
• Trackbacks

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.
 

• Email This
• Print
• Comments
• Trackbacks

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. 

• Email This
• Print
• Comments
• Trackbacks

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.

• Email This
• Print
• Comments
• Trackbacks

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.

• Email This
• Print
• Comments
• Trackbacks

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.

 

• Email This
• Print
• Comments
• Trackbacks