Supreme Court Grants Cert. In Vaccine Case

A case to watch:  earlier this month the Supreme Court granted certiorari in Bruesewitz v. Wyeth, 2010 WL 757696, which raises important issues under the National Childhood Vaccine Injury Act of 1986 (“Vaccine Act”) , 42 U.S.C. §§ 300aa-1 et seq.  The Act expressly preempts state law claims against vaccine manufacturers if the injury or death giving rise to such a claim results from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warning. 

But the lower courts have split on the meaning of that provision. Does the Vaccine Act preempt all design defect claims against vaccine manufacturers, or must the preemption of particular design claims be decided on a case-by-case basis?

In this case, the 3rd Circuit correctly held that the Vaccine Act preempts all design defect claims,  including negligence and strict liability design claims. 561 F.3d 233 (3d Cir. 2009). The Georgia Supreme Court, by contrast, is  one court that had previously held that a design defect claim is not preempted unless the manufacturer demonstrates, on case-by-case basis, that there was no safer design that could have avoided the injury giving rise to the claim. Am. Home Prods. Corp. v. Ferrari, 668 S.E.2d 236 (Ga.2008).

One of the many ways that the Ferrari court's construction is contrary to the structure of the Act and intent of Congress is that it does not necessarily bar any design defect claims. If the court interpret the Vaccine Act to allow case-by-case analysis of whether particular vaccine side effects are avoidable, then every design defect claim is subject to evaluation by a court, and theoretically every one of them could be found not-preempted by the state courts around the country. That clearly is not what Congress meant. 
 

Court Sets Aside Punitive Damages in Toxic Tort Case

The federal court in a toxic tort case has set aside the jury's punitive damages award. Garner v. BP Products North America, 2010 WL 1049794 (S.D.Tex.)(3/16/10).

The plaintiffs and over 100 other individuals filed suit against the defendant asserting that the defendant released an unidentified toxic substance into the atmosphere at its refinery causing personal injuries to workers. Several workers were transported to local hospitals where they were examined, treated, and released. At the time, the plaintiffs were employees of various sub-contractors at the site. In the trial of the first group of plaintiffs, a jury found for plaintiffs and went on to find that the conduct of the defendant was such that punitive damages should be awarded. It awarded punitive damages of $10 million to each plaintiff.

The punitive damages, inter alia, were challenged on post-trial motions. Under Texas law, in order to recover exemplary damages, the plaintiffs must establish at least gross negligence. The statute requires that the evidence pass both an objective and subjective test. The objective test requires a showing of an extreme risk of harm-- one that involves both high probability and high potential severity of an occurrence. Here, the trial court found the evidence failed to establish a legal connection between the event at issue and a known and extreme risk. The nature of refinery work is such that workers are subject to a variety of toxic odors at all times. The defendant, its employees and contractors, are generally aware of the potential hazards that exists in a refinery.  A disconnect existed here, however, said the court, because while there may have been some probability that a worker will be exposed to a toxic substance, the evidence did not support the high potential severity side of the test. Most of the exposures are minor and not harmful.

Nor did the evidence show a high probability of exposure from the same source. The source here was never identified, and in the prior releases or spills at the site, injuries were not always associated with each event and there was no showing of a recurring source.

Also missing from the equation, said the court, was the element of specific intent. The statute requires that the plaintiff establish a “specific intent” by clear and convincing evidence.  Specific intent requires more than a showing that a defendant had an awareness of the possibility of a spill or release. See Diamond Shamrock Refining Co. v. Hall, 168 S.W.3d 164, 171 (Tex.2005). It requires a showing that a defendant ignored the obvious or known risk and took no precautions that would minimize or arrest the harm anticipated. Id. at 171-72. The evidence showed that the defendant implemented safety precautions, such as requiring each worker to wear a monitor to detect the most toxic chemicals present at the refinery. And, there was evidence that monitors were installed and operational on the ground as well as on the towers in the refinery.

Therefore, the court concluded, as a matter of law, that gross negligence was not proved by clear and convincing evidence, and thus the jury's exemplary damage award must be set aside.

Seventh Circuit Decides FDCPA Class Claims And Offers Survey Guidance

The Seventh Circuit recently issued an interesting decision in two consolidated consumer cases. Dekoven v. Plaza Associates, Nos. 09-2016, 09-2249 (7th Cir. 3/17/10).  In the two closely related class action suits under the Fair Debt Collection Practices Act, 15 U.S.C. §§ 1692-1692p, which the appeals court had consolidated for decision, the plaintiffs complained about dunning letters sent to them by the a debt collection agency.

What is most interesting to our readers is not the Fair Debt Collection Practices Act issues, perhaps, but the court's guidance on survey evidence. In both cases the district court had entered summary judgment in favor of defendant after rejecting the survey evidence prepared by the plaintiffs’ expert witness, Howard L. Gordon.   Indeed, while the court could see a potential for deception of the unsophisticated debtor in letters sent offering some kind of compromise of their debts, it had no way of determining whether a sufficiently large segment of the unsophisticated were likely to be deceived to enable the court to conclude that the statute had been violated.

For that conclusion, evidence is required, the most useful sort, observed the court, being the kind of consumer survey described in Johnson v. Revenue Management Corp., 169 F.3d 1057, 1060-61 (7th Cir. 1999); see also Hahn v. Triumph  Partnerships LLC, 557 F.3d 755, 757 (7th Cir. 2009); Williams v. OSI Educational Services, Inc., 505 F.3d 675, 678 (7th Cir. 2007). (But see, for criticism of the use of survey evidence, Judge Jolly’s dissenting opinion in Gonzalez v. Kay, 577 F.3d 600, 609-11 (5th Cir. 2009).)

Here, the plaintiffs’ expert did conduct a survey. But both trial court  judges considered it  inadmissible under the standards governing the admission of survey evidence (a form of expert evidence) in federal court. See, e.g., Muha v. Encore Receivable Management, Inc., 558 F.3d 623, 625-26 (7th Cir. 2009); Peaceable Planet, Inc. v. Ty, Inc., 362 F.3d 986, 992 (7th Cir. 2004); United States v. Curtin, 588 F.3d 993, 997-98 (9th Cir. 2009); Vail Associates, Inc. v. Vend-Tel-Co., Ltd., 516 F.3d 853, 864 n. 8 (10th Cir. 2008).

Judge Posner agreed.  One of the issues was the high percentage of people in the control group in the survey who answered "don't know/not sure."   The control approach was thus not adequate and may have confused respondents, maybe even others besides those who answered “don’t know/not sure.”  Therefore the entire survey was no good, as the judges below found.

It was no good for another reason: if the don’t know/not sure respondents were eliminated, the control group would shrink to 27 persons. Determining the minimum sample size from which reliable extrapolations can be made to the sampled population is tricky, said the court. See Fowler, Survey Research Methods 45 (4th ed. 2008). But 27 is too small a sample, concluded the appeals court.  Especially since the sample drawn by the plaintiffs’ expert was what is called a “convenience” sample — convenient to the sampler — as distinct from a “representative” sample —  representative of the population sampled.

A properly designed control group is vital in such a survey, including one intended to reveal whether a debt collector is confusing debtors. Cf. Free v. Peters, 12 F.3d 700, 705-06 (7th Cir. 1993); Penney v. Praxair, Inc., 116 F.3d 330, 333-34 (8th Cir. 1997); United States v. Aguilar, 883 F.2d 662, 706-08 (9th Cir. 1989). The debt collector can’t be blamed if consumers don’t understand his dunning letter unless he should have added or subtracted something to make it clearer. The plaintiff  thus has to show that the additional language of the letters unacceptably increased the level of confusion; many unsophisticated consumers would be confused even if the letters they received contained nothing more than a statement of the debt and the statutory bare bones notice.

Interestingly, the court said that district judges may want to consider exercising the clearly authorized but rarely exercised option of appointing their own expert to conduct a survey in FDCPA cases. Fed. R.Evid. 706(a); General Electric Co. v. Joiner, 522 U.S. 136, 149-50 (1997) (Breyer, J., concurring); In re High Fructose Corn Syrup Antitrust Litigation, 295 F.3d 651, 665 (7th Cir. 2002); Indianapolis Colts, Inc. v. Metropolitan Baltimore Football Club Ltd. Partnership, 34 F.3d 410, 414-15 (7th Cir. 1994).  Judges can assure themselves of the expert’s neutrality by (as in arbitration) asking the parties’ own experts to nominate a third expert to be the court-appointed expert.  The decision to appoint an expert is within the discretion of the trial judge, of course.

State Supreme Court Overturns Verdict In Sudden Acceleration Case

A recent state supreme court decision offers an interesting take on the use of experts in product liability cases. Watson v. Ford Motor Company , No. 26786 (S.C. March 15, 2010).

Plaintiffs filed a products liability suit against Ford, alleging that the cruise control system on the accident vehicle was defective and the cause of a serious accident. Watson testified that when she entered the interstate, she promptly set the cruise control, but shortly thereafter, the vehicle began to suddenly accelerate. Watson testified that she pumped her brakes to no avail before crashing. Plaintiff's theory of the case was that the vehicle's cruise control system was defective because it allowed electromagnetic interference (EMI) to affect the system. To support this theory, they presented Dr. Antony Anderson, an electrical engineer, who testified as to his theory that EMI can interfere with the speed control component of a cruise control system and cause a vehicle to suddenly and uncontrollably accelerate. Dr. Anderson further opined that this was the cause of the accident, and that Ford could have employed a feasible alternative design to prevent EMI.  Plaintiffs also presented testimony from Bill Williams who was qualified as an expert on “cruise control diagnosis.”

The jury found Ford liable on the cruise control products liability claim, and awarded compensatory damages of $15 million to Watson and $3 million to the estate of passenger Patricia Carter.

The appeal presented three issues: did the trial court err in qualifying Bill Williams as an expert in cruise control systems; did the trial court err in allowing Dr. Anderson’s expert testimony regarding EMI and alternative feasible design; did the trial court err in allowing evidence of other incidents of alleged sudden acceleration in Explorers?

On question one, the court found error. Williams testified that he had worked in the automotive industry since the early 1980s and was currently conducting seminars to train automobile technicians who focus on the brake systems in vehicles. While Williams may have been qualified as an expert in other aspects of automobile components, such as the brake system, the trial court failed to properly evaluate Williams’ qualifications specific to cruise control systems. Notwithstanding this error, the court did not believe that this error alone prejudiced Ford’s defense. Williams’ testimony essentially consisted of a description of the system accompanied by models and diagrams of the components. Furthermore, the trial court prohibited Williams from testifying to matters outside of his scope, specifically noting he could not testify as to electrical engineering matters.

On the second issue, the court addressed an issue that reflected the lack of fit between the opinion and the witness' qualifications in the particular area of expertise. Beyond that, Ford claimed that Dr. Anderson's theory regarding EMI as the cause of the sudden acceleration failed to meet the reliability requirements for the admission of expert testimony. The court reiterated several factors that the trial court should consider when determining whether scientific expert evidence is reliable:(1) the publications and peer review of the technique; (2) prior application of the method to the type of evidence involved in the case; (3) the quality control procedures used to ensure reliability; and (4) the consistency of the method with recognized scientific laws and procedures.

Dr. Anderson’s background involved working with massive generators which have entirely different electrical wiring systems and different voltage levels. He had no experience in the automobile industry, never studied a cruise control system, and never designed any component of a cruise control system. Dr. Anderson had not even operated an automobile with a cruise control system before this litigation; yet, he offered testimony regarding EMI and its effect on the cruise control system.  While he was an expert, perhaps not in the area he opined about.

Even assuming Dr. Anderson was properly qualified as an expert in this area, his testimony was found not reliable. Dr. Anderson declared that the alternative design (twisted pair wiring) would have prevented EMI but did not explain how twisted pair wiring could be incorporated in to a cruise control system and did not offer any model comparison. Furthermore, Dr. Anderson concluded that this design was economically feasible, but offered no basis to support this conclusion.

Dr. Anderson admitted that his theory had not been peer reviewed, he had never published papers on his theory, and he had never tested his theory. He also admitted that he would not be able to determine exactly where the EMI (which he opined caused the cruise control to malfunction) originated or what part of the system it affected. He further testified that it would not be possible to replicate the alleged EMI malfunction of a cruise control system in a testing environment.

The court concluded that there was no evidence indicating that Dr. Anderson’s testimony contained "any indicia of reliability." He had never published articles on his theory nor had he tested his theory. Importantly, Dr. Anderson admitted that it was not possible to test for EMI. Furthermore, although it is not a prerequisite in South Carolina that scientific evidence attain general acceptance in the scientific community before it is admitted, the court found it instructive that not only had the underlying science not been generally accepted, Dr. Anderson’s theory was rejected in the scientific community.  Next, the court found that Ford was prejudiced by the admission of this testimony. Indeed, the only evidence plaintiffs presented to support their theory that the vehicle was defective was Dr. Anderson’s testimony.

On the third issue, evidence of similar accidents, transactions, or happenings is admissible in South Carolina where there is some special relation between the accidents tending to prove or disprove some fact in dispute. Typically, a plaintiff must present a factual foundation for the court to determine that the other accidents were substantially similar to the accident at issue. The court will look at whether (1) the products are similar; (2) the alleged defect is similar; (3) causation related to the defect in the other incidents; and (4) exclusion of all reasonable secondary explanations for the cause of the other incidents.

Here, plaintiffs failed to show that the incidents were substantially similar and failed to establish a special relation between the other incidents and the relevant accident. The other incidents involved Explorers that were made in different years and were completely different models with the driver’s seat located on the right side of the vehicle. More importantly, plaintiffs failed to show a similarity of causation between the malfunction in this case and the malfunction in the other incidents. Plaintiffs presented only the testimony of the other drivers and did not present any expert evidence to show that EMI was a factor in the malfunction in the other incidents.

This evidence was highly prejudicial. Courts require a plaintiff to establish a factual foundation to show substantial similarity because evidence of similar incidents may be extremely prejudicial. Plaintiffs' counsel highlighted this improper evidence in closing arguments and thereby possibly induced the jury to speculate as to other causes of the accident not supported by any evidence.

Upcoming DRI Product Liability Seminar

Well, it may be too late to switch Northern Iowa for Kansas in your office pool (for amusement purposes only), but it is not too late to sign up to attend the 2010 DRI Product Liability Conference, "The Masters of Product Liability Litigation."

The conference will be held at the fabulous Venetian in Las Vegas on April 7-9, 2010. As always, this annual meeting offers premier educational and networking opportunities.

In addition to the general sessions, the various sub-committees, including the Mass Torts & Class Action group chaired by your humble blogger, will host breakout workshops focusing on topics particular to their practice areas.

Our breakout will include insights from two experienced in-house counsel, Matt Flesher, Assistant General Counsel of Cessna Aircraft Company, and Andy Rudd, General Counsel for the Home and Family Group of Newell Rubbermaid, a group that includes Graco Children’s Products, Calphalon Corporation, Goody Products, Levolor window coverings, and Rubbermaid consumer products. 

If interested, please check out the info here.

Federal Court Denies Medical Monitoring Class Action

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


 

Causation Expert Excluded Under Daubert In Chemical Case

A federal court recently granted the defendant's Daubert motion, excluding plaintiff's causation expert in a case alleging that defendant's chemical caused plaintiff's non-Hodgkins Lymphoma. Pritchard v. Dow Agro Sciences, et al., 2010 U.S. Dist. LEXIS 23098 (W.D. Pa. March 11, 2010).  The case is illustrative of three main points.

But first, the background. In this toxic tort case, Mr. Pritchard and his wife alleged that chemicals manufactured and sold by defendants caused Mr. Pritchard to develop NHL.  Plaintiff asserted claims of negligence and strict liability.  In particular, the dispute surrounded whether Mr. Pritchard's exposure to Dursban was the legal cause of his disease. Dursban is the trade name for a group of insecticide products containing chlorpyrifos as the active ingredient. The etiologies or causes of NHL and plaintiff's subtype, are generally unknown. Several risk factors have been identified, including: people with severe immunodeficiency, human immunodeficiency virus (HIV), human T-cell leukemia virus type 1, hepatitis C virus; a family history of NHL; and occupational exposure to herbicides, and certain other chemicals, said the court.

In support of their claim that Mr. Pritchard's exposure to Dursban caused his NHL, plaintiffs identified Dr. Bennet Omalu as their expert on medical causation and submitted his expert report. Defendants filed a Motion to Exclude the Expert Causation Testimony of Dr.  Omalu,  attaching rebuttal experts reports.  The court held a Daubert hearing during which the parties presented no additional evidence, only arguing the legal issues in dispute.  Under the federal rules, the district court acts as a gatekeeper, preventing opinion testimony that does not meet the requirements of qualification, reliability and fit from reaching the jury. In this role, the district court must satisfy itself that good grounds exist for the expert's opinion.

The opinions.  Dr. Omalu concluded that Mr. Pritchard's prolonged occupational exposure to Dursban insecticides significantly contributed to the patho-etiology of his Non-Hodgkin's Lymphoma. He described the general risk of exposure to pesticides to humans, stating that these chemicals are highly toxic and dangerous and have been identified as human carcinogens.  He further opined that no level of exposure to agricultural chemicals should be deemed safe. The expert testified at his deposition that he had considered and analyzed other potential causes of Mr. Pritchard's Non-Hodgkins Lymphoma, ruling out those other causes that were not sufficient to be a sole cause of the disease. Dr. Omalu also testified that diabetes may have contributed to Mr. Pritchard's disease but that it was "less likely to have contributed" and that Mr. Pritchard's obesity and body mass index were not highly associated with NHL. 

The challenge.  Defendants attacked the reliability of Dr. Omalu's proffered testimony, arguing that his opinions did not reliably establish general causation, i.e., that exposure can cause NHL, or specific causation, i.e., that Mr. Pritchard's exposure to Dursban caused his NHL. Courts in toxic tort cases often separate the causation inquiry into general causation -whether the substance is capable of causing the observed harm in general-  and specific causation -whether the substance actually caused the harm a particular individual suffered.  E.g.,  Perry v. Novartis Pharmaceuticals Corp., 564 F.Supp.2d 452, 463 (E.D.Pa. 2008).

General causation.  General causation is often established in a toxic tort case through the use of epidemiological studies. Epidemiology is 'the primary generally accepted methodology for demonstrating a causal relation between a chemical compound and a set of symptoms or a disease. E.g.,  Soldo v. Sandoz Pharmaceuticals Corp., 244 F.Supp.2d 434, 532 (W.D.Pa. 2003); Conde v. Velsicol Chem. Corp., 804 F.Supp. 972, 1025-26 (S.D.Ohio 1992); see also Perry, 564 F.Supp.2d at 465. Epidemiological studies examine the pattern of disease in human populations, General Elec. Co. v. Joiner, 522 U.S. 136, 144 n.2, (1997), and, more specifically, epidemiological evidence identifies agents that are associated with an increased risk of disease in groups of individuals, quantifies the amount of excess disease that is associated with an agent, and provides a profile of the type of individual who is likely to contract a disease after being exposed to an agent. Federal Judicial Center, REFERENCE MANUAL ON SCIENTIFIC EVIDENCE, Reference Guide on Epidemiology at 335-36 (2d ed. 2000).

The Third Circuit has recognized that epidemiology is a well-established branch of science, and epidemiological evidence has been accepted in numerous cases. The parties here agreed that general causation can be established through the use of such studies. (Of course, the leap from association shown by such studies to a causation conclusion is a judgment based on the assessment of the strength, power, and plausibility of the studies, among other factors.)  However, defendants challenged Dr. Omalu's general causation opinion that exposure to Dursban can cause NHL because his opinions did not rely on statistically significant epidemiological studies, and that Dr. Omalu did not rely on an epidemiological study showing an association between chlorpyrifos and NHL with a relative risk greater than 2.0. They also argued that Dr. Omalu's opinion was unreliable because he ignored published epidemiology studies which show a lack of an association or an inverse relationship between chlorpyrifos and NHL.

Plaintiffs contended that they were not required to present statistically significant studies which demonstrate an association between chlorpyrifos and NHL in order to demonstrate general causation. The court found that the law regarding the need for such epidemiological studies is not clearly established; therefore, the court was hesitant to adopt per se rules of admissibility but should consider the following as factors in determining the reliability of an expert's opinion on general causation: whether the expert relied on epidemiological studies; whether the expert ignored or sufficiently addressed epidemiological studies which contradicted his hypothesis, explaining the discrepancy between his hypothesis and that of the authors; and, whether the findings set forth in the studies are statistically significant.  Clearly if epidemiology studies are not available, an expert must offer a reliable causation opinion through the use of some other valid scientific methodology.

On the issue of relative risk, some courts have refused to consider epidemiology studies with less than a relative risk of 2.0 as supporting an association between a chemical agent and a disease. See Daubert v. Merrell Dow Pharmaceuticals, Inc., 43 F.3d 1311, 1320 (9th Cir.), cert denied, 516 U.S. 869 (1995); see also In re W.R. Grace & Co., 355 B.R. 462, 482 (D. Del. Bankr. 2006)(adopting 2.0 relative risk standard). Other courts have permitted the use of studies showing less than a 2.0 relative risk in support of a causation opinion. See In re Joint E. & S. Dist. Asbestos Litig., 964 F.2d 92, 97 (2d Cir. 1992). But see DeLuca by DeLuca v. Merrell Dow Pharmaceuticals, 911 F.2d 941, 958-59 (3d Cir. 1990)(if New Jersey law requires plaintiffs to show that it is more likely than not that Bendectin caused the injury, and if plaintiffs rely solely on epidemiological analysis in order to avoid summary judgment, the relative risk from the epidemiological data relied upon will, at a minimum, have to exceed 2).  Here the court decided to follow the approach taken in Magistrini v. One Hour Martinizing Dry Cleaning, 180 F.Supp.2d 584, 606 (D.N.J. 2002), where the district court explained that a relative risk of 2.0 is not so much a password to a finding of causation as one key piece of evidence, among others for the court to consider in determining whether an expert has employed a sound methodology in reaching his or her conclusion.

The court found that the expert had not relied on statistically significant studies. Some were clearly not significant, while on others there was no evidence of record explaining the method that Dr. Omalu used. Plaintiffs' counsel's heavy involvement in drafting the expert declaration further undermined the reliability of the opinions contained therein. (Plaintiffs' counsel admitted that he drafted the declaration, and the expert then signed it without any changes.) 

On the issue of the admissibility of expert testimony that fails to account for published epidemiology studies with conclusions contrary to the expert's opinion, the court looked at Perry v. Novartis Pharmaceuticals Corp., 564 F. Supp.2d 452 (E.D.Pa. 2008). In Perry, the district court recognized that "no reliable scientific approach can simply ignore the epidemiology that exists." Perry, 564 F.Supp.2d at 465.  Dr. Omalu never addressed two studies raised by defendants.  Dr. Omalu offered no explanation regarding the studies' findings and his hypothesis in this case.

Thus in sum, Dr. Omalu's general causation opinion that exposure to Dursban could cause NHL was found unreliable. Plaintiffs could not rely on Dr. Omalu's bare assertions that "studies" show that there is an association.

Specific Causation.  The court then turned to the parties' respective positions on Dr. Omalu's specific causation opinions that Mr. Pritchard's exposure to Dursban caused his NHL. Plaintiffs, as is typical, relied on a so-called differential diagnosis. The use of differential diagnosis is "the basic method of internal medicine," and is generally accepted for diagnosing a patient.  The process rules in potential explanations for the patient's symptoms, and then rules each disease out until a final diagnosis remains.  More controversial is its use to explain the cause of the disease.  But here the district court notes that it has been accepted in some courts as a technique that involves assessing causation with respect to a particular individual.  "Differential diagnosis, or differential etiology, is a standard scientific technique which identifies the cause of a medical problem by eliminating the likely causes until the most probable one is isolated."  Magistrini, 180 F.Supp.2d at 609.  Although the use of differential diagnosis is generally accepted, said the court, an expert's use of same must still be evaluated in order to ensure that the methods employed are reliable.  The mere statement by an expert that he or she applied differential diagnosis in determining causation does not ipso facto make that application scientifically reliable or admissible.

Here, defendants contended that Dr. Omalu's differential diagnosis was unreliable because of his limited review of Mr. Pritchard's case, not physically examining Mr. Pritchard, not reviewing all of his medical records and relying, in part, on an oral medical history transmitted to others.  The district court concluded that the expert's failure to review all of Mr. Pritchard's medical records, his discovery responses, his deposition testimony, his application records, or any other evidence regarding Mr. Pritchard's exposure to chlorpyrifos or other pesticides, left his opinions unsupported and rendered his differential diagnosis methodology unreliable.

While an expert may not always have to exclude all other theoretically possible causes, an expert surely must rule out obvious alternative causes, and also address the plausible alternative causes proposed by a defendant. It is necessary for the plaintiff's expert to offer a good explanation as to why his or her conclusion remains reliable in the face of plausible alternatives. Significantly, Dr. Omalu did not attempt to rule out that Mr. Pritchard's NHL is the result of an idiopathic or unknown cause despite the fact that the general cause of NHL is unknown. Standing alone, the presence of a known risk factor is not sufficient basis for ruling out idiopathic origin in a particular case, particularly where most cases of the disease have no known cause. Likewise, Dr. Omalu's conclusion that Mr. Pritchard's NHL is not idiopathic because he determined that his disease was caused by exposure to Dursban, was not a sufficient explanation, as it is merely a circular conclusion.  

Fit.  The court also found that the conclusion reached by Dr. Omalu did not reliably flow from the data and methodology used in this case. For one, the data was flawed as Dr. Omalu failed to properly consider all of the relevant materials, specifically, Mr. Pritchard's medical records, as well as all the exposure information. 

Finally, plaintiffs also raised a novel argument as an alternative to the defendants' challenges based on Federal Rule of Evidence 702 and Daubert and its progeny. They contended that the application of several principles argued by the defendants, if applied to exclude Dr. Omalu's testimony, would violate the Erie doctrine. (Yes, we are going back to first year civil procedure.)  The Erie doctrine provides that a federal court sitting in diversity must apply state substantive law and federal procedural law. In other words, the application of Daubert principles were inconsistent with state substantive law on causation.  The court noted first that the expert's proffered testimony was not being excluded solely on the challenged bases, which were considered among a host of other deficiencies in Dr. Omalu's proffered testimony. The court did not adopt any "bright-line" rules but instead evaluated the testimony using a "flexible" approach.  In any event,  the court briefly addressed the contention and concluded that state substantive law does not change the federal standard for the admissibility of expert testimony. Federal Rule of Evidence 702 could and must be applied to this action.

Appeals Court Affirms Summary Judgment Based on Learned Intermediary Rule

A federal appeals court recently affirmed judgment for the maker of an anti-depressant drug, ruling that the plaintiff could not show that an allegedly inadequate warning caused the injury at issue. Dietz v. Smithkline Beecham Corp., 2010 WL 744273 (11th Cir. 2009).

The case reminds readers about the importance of the testimony of the prescriber in a pharmaceutical case. The plaintiff's physician diagnosed him with major depression and offered him hospitalization for psychiatric treatment, which Dietz declined. The doctor then prescribed him Paxil, a selective serotonin reuptake inhibitor (“SSRI”) antidepressant.  Eight days after having filled and begun his Paxil prescription, Dietz apparently committed suicide by throwing himself in front of a train.

Appellant filed a diversity suit. During discovery, the parties deposed Dietz's physician, who testified that he had considered the potential risks and benefits of prescribing Paxil to Dietz when he wrote the prescription in 2002.  He also testified that, even in retrospect, he agreed with his decision to treat Dietz with Paxil and would do so again today under the same circumstances.

Within the context of prescription drugs, Georgia employs the learned intermediary doctrine, which alters the general rule which imposes liability on a manufacturer for failing to warn an end user of the known risks or hazards of its products. According to the doctrine, the manufacturer of a prescription drug does not have a duty to warn the patient of the dangers involved with the product, but instead has a duty to warn the patient's doctor, who acts as a learned intermediary between the patient and the manufacturer. The rationale for the doctrine is that the treating physician is in a better position to warn the patient than the manufacturer, in that the decision to employ prescription medication involves professional assessment of potential medical risks in light of the physician's knowledge of a patient's particular needs.

Here the court affirmed summary judgment for the manufacturer since the appellant could not demonstrate that any alleged failure to warn the treater about increased suicide risks associated with Paxil proximately caused Dietz to commit suicide. The doctor provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings, he still would have prescribed Paxil for Dietz's depression. Pursuant to Georgia's learned intermediary doctrine, this assertion severs any potential chain of causation through which appellant could seek relief. 

Senate Hearing on TSCA Reform Featured Industry Experts

The Senate Subcommittee on Superfund, Toxics, and Environmental Health convened a hearing last week with leaders of businesses that manufacture or use chemicals to hear their business views on reforming U.S. chemical safety law. The hearing was the third in a series of oversight hearings leading up to the possible introduction of legislation to reform the Toxic Substances Control Act (TSCA). 

Entitled "Business Perspectives on Reforming U.S. Chemical Safety Laws," the hearing featured testimony from Charlie Drevna, President of the National Petrochemical and Refiners Association.  His remarks addressed the call from some observers for a European-style replacement regulatory regime. The European Union has started to implement new legislation – Registration, Evaluation and Authorization of Chemicals (REACH), but many of the perceptions of REACH are incorrect. For example, rather than relieving the government of the burden of chemical safety, REACH only increases the burden on industry while it does not reduce the burden on government. No government authority is going to receive a chemical dossier from industry and take it at face value. Furthermore, REACH places so much burden on industry that small- and medium-sized chemical manufacturers are already facing significant difficulties complying with the program. REACH, contrary to some commentary, is unlikely to spur innovation in safer chemicals. Innovation is a function of spending on research and development and ease of entry into the marketplace. Toxicity and other laboratory testing is considered part of research and development and typically comes out of R&D budgets. That leaves less money for new, and often safer, product development. REACH is a regulatory concept that has never been attempted anywhere in the world, at any time. Authorities in Europe have already been inundated with so much information that they simply cannot keep up.
 

Dr. Neil C. Hawkins, Vice President, EH&S and Sustainability  for The Dow Chemical Company testified that an ideal chemical safety program would base its decisions on a consistent scientific
evaluation of both hazard and potential exposure (an evaluation of risk), using a weight-of-evidence approach. A weight-of-evidence approach requires critical evaluation of the entire body of available data for consistency and biological plausibility. Studies conducted and funded by industry are necessary and valuable contributions to the understanding of potential public health and environmental effects related to the manufacture and use of its products. Industry scientists have expert knowledge of the chemicals they manufacture, especially as this relates to the development and interpretation of the science needed to comply with governmental requirements around
the world. Research should be judged on the basis of scientific merit, without regard for funding source or where the studies are conducted (e.g. academia, government, or industry). 

Also testifying was Linda Fisher, Vice President, Safety Health and the Environment for DuPont.  She stressed in her remarks that as the agency contemplates exposure reductions it is important that the EPA be required to take into account the societal benefits from the use of chemicals and the time and complexity of bringing substitutes to market. Congress should avoid presumptive bans or rigid phase-out schedules. Bans and deadlines for phase-outs or substitution that fail to account for the realities of transitioning to new ingredients, receiving needed customer and regulatory approvals, or modifying manufacturing facilities, are counter-productive. Such actions could lead to unnecessarily disrupting markets, reduce public access to valued products, and cede markets to global competitors.

The issue of confidential business information, or CBI, also needs attention. The ability to preserve legitimate CBI and prevent piracy of intellectual property is critical to U.S. competitiveness and innovation. If companies simply give innovation away there is little reason to innovate.  Intergovernmental sharing of CBI data with proper protections, whether between state and federal governments or nation to nation, should be facilitated.


 

FDA Official Testifies Before Congress on REMS and Sentinel

Last week, the House Energy and Commerce Committee's Health Subcommittee held a hearing on drug safety.  A quick report: Chairman Waxman's opening comments indicated that the committee was eager to hear about FDA’s implementation of the 2007 FDA Amendments Act, giving FDA the authority to require manufacturers to implement “Risk Evaluation and Mitigation Strategies” or “REMS.”

FDA Principal Deputy Commissioner Joshua Sharfstein indicated that using this REMS authority is “a work in progress” and acknowledged a "lack of clarity" in certain provisions of the law with respect to REMS. FDA recognizes that designing and implementing the most comprehensive REMS requires a careful balancing of the need to adequately manage risks and also to maintain patient access to important medications. In the design of REMS with elements to ensure safe use (the most comprehensive REMS programs), FDA is mindful, he said, that the elements to ensure safe use must not be unduly burdensome on patient access to the drug, and be designed to be compatible with established distribution, procurement, and dispensing systems for drugs.

If FDA determines that a REMS is necessary to ensure that the benefits of a drug continue to outweigh the risks of the drug, FDA can require manufacturers to have a REMS in place when a drug comes on the market, or implement one later if FDA becomes aware of new safety data. Most of the REMS with elements to ensure safe use include educating prescribers about the risks and appropriate use of the drug as a condition of certification or enrollment in the REMS program. Some programs require the prescriber to monitor the patient immediately following drug administration and for a period of time afterwards. 

The FDA official also gave a brief update on the Sentinel Initiative. FDAAA requires the HHS Secretary to develop methods to obtain access to disparate data sources and to establish a post-market risk identification and analysis system to link and analyze health care data from multiple sources. On May 22, 2008, FDA officially launched the Sentinel Initiative with the ultimate goal of creating and implementing the Sentinel System—a national, integrated, electronic system for monitoring medical product safety. The Sentinel System, testified the Commissioner, once up and running, will enable FDA to actively gather information about the post-market safety and performance of its regulated products—a significant change from the current, primarily passive safety surveillance systems. The law sets a goal of access to data from 25 million patients by July 1, 2010, and 100 million patients by July 1, 2012.

FDA has gathered public input on issues related to the creation and development of Sentinel, held numerous meetings and a public workshop, and established a working group consisting of representatives of numerous federal agencies to share information and discuss issues related to ongoing efforts that are complementary to Sentinel. FDA has awarded key contracts for a pilot project to gather information that will be essential to fully implementing the Sentinel System. As we posted about before, there is still work to be done to address significant issues with this plan.

One risk is that plaintiffs’ attorneys will find a way to misuse the system, to “find” spurious associations between drugs and effects, to assert a causal link based on the “government approved, government sanctioned” database program, and to blame the drug companies for not having seen that same link sooner. Fundamentally, the system creates a corresponding need to improve the ability to determine as quickly as possible which findings reflect a genuine and health risk. That determination may take epidemiological investigations or clinical trials before any conclusion about whether a product actually caused an event. And the new system doesn’t change the reality that sometimes patients suffer adverse events after receiving drugs because they are sick, not because the drug has any issues. Plaintiffs have no incentive to place the new product information uncovered in a context of the continuing benefits of the product for many patients, the lack of certainty in the findings, the limitations of the data, etc.

 

Class Action Motion Rejected in Human Tissue MDL

We have posted before about the interesting Human Tissue litigation.  The multidistrict litigation consolidated hundreds of cases filed either by plaintiffs who received allografts — transplants from cadavers — harvested by defendants allegedly without obtaining proper consent and following appropriate regulations, or by those plaintiffs who allegedly had allografts improperly taken from deceased relatives. The MDL court last week denied the latter plaintiffs' motion for class certification. In re: Human Tissue Products Liability Litigation, No. 06-135/MDL 1763 (D.N.J.).

According to the named representative plaintiffs, each of the class members had a deceased family member whose body went to one of the defendant funeral homes; plaintiffs claim that the funeral homes, after taking possession of the bodies, allowed another defendant to extract bones and tissue from the decedents. Following this, the harvested tissue then allegedly was given to other defendants, tissue banks. The purported class consisted of “all next of kin relatives of decedents whose bodies were desecrated by [defendants] for the harvesting and sale of human body parts."

Two parts of the opinion will be of the most interest to readers.  First, under the Rule 23(a) prerequisites, the court found that the typicality element was not established because of the highly individualized nature of the claims in this action.  Plaintiffs asserted emotional distress claims against the funeral homes that handled the donor decedents' remains and the tissue processors who allegedly received the harvested tissue. The Third Circuit has stated that class certification is inappropriate in mass tort claims, generally, because they often present questions of individualized issues of liability. In re Life USA Holding Inc., 242 F.3d 136, 145 (3d Cir. 2001). This observation is particularly true where the tort claims alleged are premised on emotional distress. The factual circumstances underlying each of the individual claims – including but not limited to plaintiffs' relationships with the decedents and the injuries allegedly suffered – were sufficiently personal and specific as to prevent any finding of similarity with regard to their claims.  

Also, plaintiffs were bringing contractual claims against the funeral home defendants, which again hinged on different factual circumstances that also might give rise to different defenses. There was no allegation that the individual contracts made with the funeral homes concerning final arrangements for the donor decedents were identical; in fact, since they were drafted and negotiated by different funeral home representatives and family members, they likely contained different representations, again subject to different defenses. For example, the meetings between funeral home personnel and the decedents' family members involved representations regarding the specific services requested and potential tissue donation. "These are all very personalized discussions," said the court.  All in all, the court found sufficient factual differences among the contracts negotiated with the different funeral homes to preclude a finding of typicality. See In re Schering Plough Corp. ERISA Litig., 589 F.3d 585, 598 (3d Cir. 2009)(“Ensuring that absent class members will be fairly protected required the claims and defenses of the representative to be sufficiently similar not just in terms of their legal form, but also in terms of their factual basis and support.”); see also In re Life USA Holding, Inc., 242 F.3d at 144-46 (vacating class certification in part because plaintiffs' claims of deceptive insurance sales practices arose from individual and non-standardized presentations by numerous independent agents).

It is significant that the court put some teeth into the 23(a) element. While the court acknowledged that factual differences will not automatically render a claim atypical if the claim arises from the same event or practice or course of conduct that gives rise to the claims of the class members, and if it is based on the same legal theory, here plaintiffs failed to demonstrate, other than through a bald assertion, that any practice or course of conduct existed among the funeral homes or among the tissue processors.

The same differences undermined a showing of predominance and superiority under Rule 23(b)(3), which provides for certification when the court finds that the questions of law or fact common to class members predominate over any questions affecting only individual members, and that a class action is superior to other available methods for fairly and efficiently adjudicating the controversy.

The individual factual circumstances, including contractual arrangements, personal relationships with the decedents, injuries suffered, etc. precluded a 23(b)(3) class.  The superiority inquiry compels a court to balance, in terms of fairness and efficiency, the merits of a class action device against those of alternative available methods of adjudication.  Here, the multitude of individualized issues presented in plaintiffs' claims would entail complicated mini-trials within the class action itself.  The claims presented by plaintiffs and their unique factual underpinnings would require such extensive individual consideration that it would be neither more fair nor more efficient to proceed with this matter as a class action.  Class rejected.


 

Summary Judgment for Drug Company in Pain Pump Case

A federal court has granted defendant summary judgment in a case which alleged that cartilage damage sustained by the plaintiff, a former high school athlete, was caused by the post-surgery use of the drug company’s pain medication in an automated pump device. Jensen Meharg, et al. v. I-Flow Corp., et al., No. 1:08-cv-00184 (S.D. Ind. 3/1/10).

The former high school athlete underwent shoulder surgery, after which a pain pump was utilized. The pain pump in question was manufactured and sold by I-Flow Corporation; the local anesthetic–bupivacaine Hcl – was manufactured and sold by defendant AstraZeneca.  AstraZeneca did not in any way promote the use of bupivacaine with pain pumps, and that use was not mentioned in the instructions and warnings provided with the drug -- an off-label use. Several months later, plaintiff began to experience shoulder pain again. An MRI allegedly revealed that plaintiff had developed chondrolysis in her shoulder, which she alleged was caused by the post-surgery administration of the bupivacaine with the pain pump.

The strict liability claim was for alleged failure to warn; a warning defect claim requires that defendant had a duty to warn.  Duty is generally a legal issue.  In the context of a prescription drug manufacturer, the duty to warn does not arise until the manufacturer knows or should know of the risk.  In cases that involve an off-label use of a prescription drug that is not promoted by the manufacturer, the requisite knowledge of the risk, at a minimum, includes that the manufacturer must know (or be charged with knowledge of) both that the off-label use is occurring and that the off-label use carries with it the risk of the harm at issue – in this case, damage to cartilage.

The court found as a matter of law that the information allegedly possessed by defendant was insufficient to trigger AstraZeneca’s duty to warn of the risk of cartilage damage from continuous infusion of bupivacaine into a patient’s joint. Simply put, the plaintiff failed to point to sufficient evidence that demonstrated that at the time of plaintiff’s surgery AstraZeneca knew of that risk or that it should have known of the risk because experts in the relevant field had such knowledge.

More interesting was plaintiff's other theory. Plaintiff's expert also opined that prior to plaintiff’s surgery the defendant supposedly knew that bupivacaine was being used in pain pumps, and that this knowledge triggered an alleged duty to “investigate the nature of that use, determine whether the drug was being promoted in accordance with approved indications, conduct or sponsor those studies necessary to ensure that the promoted use was safe, and to warn physicians that long-term risks to the joint had not been scientifically established but that the risks should be weighed seriously, given that the anticipated use was for elective post-operative pain therapy for which multiple alternatives existed.”  The court noted that such a  “duty” does not exist under relevant (Indiana) law.  The duty to warn does not arise until the manufacturer knows or should know of the risk.  The alleged far broader duty  – a  duty, in essence, to warn physicians that there might be a risk, although we don’t know yet because neither we or the scientific community at large has studied it yet -- doesn't exist.

Such a duty would cause physicians to be inundated with such pseudo-warnings and quasi-risk information distracting them from heeding real warnings of actual risk; and it would add very little to the fact that physicians already know, i.e., that if a use is omitted from a prescription drug’s label, that use has not been tested sufficiently to demonstrate to the FDA that it is safe and effective.

Product Liability Seminar Offers Topical Mass Tort Session

We have posted before about the 2010 DRI Product Liability Conference in Las Vegas in April, as an event worth checking out.

Let me add that one of the attractive feature of the conference is that, in addition to the exceptional program put together for the main stage, there are many great Specialized Litigation Group (subcommittee) programs planned, including the highly-relevant-to-readers Mass Torts & Class Actions SLG.

At the Mass Torts & Class Actions SLG breakout session on Thursday, April 8th (likely to be more daring than Criss Angel, more talented than Terry Fator, more energetic than a Blue Man Group) includes:

Legislative and Regulatory Update: Impact of New Administration and New Statutes, Rollback on Preemption and Effort to Rollback Twombley
Jeffrey A. Holmstrand, McDermott & Bonenberger PLLC, Wheeling, West Virginia
Anthony Sammons, Dinsmore & Shohl LLP, Lexington, Kentucky

Emerging Class Action Issues: Impact of the ALI Project on Aggregation and Update on Problematic Causes of Action (Public Nuisance, Consumer Fraud Act and Medical Monitoring)
Richard A. Oetheimer, Goodwin Procter LLP, Boston, Massachusetts
John Parker Sweeney, Womble Carlyle Sandridge & Rice PLLC, Baltimore, Maryland

Emerging Mass Tort Issues: Examination of Daubert/ Frye Issues, Update on Green-Product Issues and Use of Risk Assessment Concepts
Robert C. James, TERRA Inc., Tallahassee, Florida
David C. Uitti, Dechert LLP, Princeton, New Jersey

Best Practices on Managing Mass Torts: Exploring the Virtual Law Firm, Cost Controls, Alternative Fee Arrangements and Early Case Dispositions
Moderator Kip T. Bollin, Thompson Hine LLP, Cleveland, Ohio
 

You can still register.

Consumer Class Certification Denied -- Again

An up and down class action proceeding involving Listerine has taken a new turn. Pfizer Inc. v. Superior Court of Los Angeles County, No.B188106 (Cal. App. 3/2/10).

Plaintiffs brought a proposed class action on behalf of California consumers who allegedly purchased Listerine on the claim that the mouthwash prevented plaque and gingivitis as effectively as dental floss, relying on the state's Unfair Competition Law (UCL) (Bus. & Prof. Code, § 17200 et seq.) and the False Advertising Law (FAL) (§ 17500 et seq.).  The trial court certified a California class consisting of all individuals who purchased Listerine between June, 2004 and January, 2005.  The appeals court initially ruled in 2006 that the trial court’s certification was overbroad, relying on Proposition 64 which amended standing requirements in such actions and requires proof that the proposed class suffered injury.  Following the decertification order, however, the California Supreme Court ordered the appeals court to revisit the issue in light of its intervening decision in In re: Tobacco II, 46 Cal.4th 298 (2009). 


Upon remand, the court of appeals vacated the prior opinion, received supplemental briefs from the
parties and amici curiae, and reconsidered. Upon reflection, the appeals court concluded that the circumstances of the case still did not warrant class certification.

The court noted that the causation requirement for purposes of establishing standing under the UCL, and in particular the meaning of the phrase "as a result of" in section 17204, holds that a class representative proceeding on a claim of misrepresentation as the basis of his or her UCL action must demonstrate actual reliance on the allegedly deceptive or misleading statements, in accordance with well-settled principles regarding the element of reliance in ordinary fraud actions. Those same principles, the state supreme court had said Tobacco II in an amazingly result-driven fashion, do not require the class representative to plead or prove with an "unrealistic degree of specificity" that the plaintiff relied on particular advertisements or statements when the unfair practice is a fraudulent advertising campaign. But Tobacco II does not stand for the proposition that a consumer who was never exposed to an alleged false or misleading advertising or promotional campaign is entitled to restitution.

The certified class, consisting of all purchasers of Listerine in California, was overbroad because it presumed there was a class-wide injury. However, the record reflected that of 34 different Listerine mouthwash bottles on sale, 19 never included any label that made any statement comparing Listerine mouthwash to floss. Further, even as to those flavors and sizes of Listerine mouthwash bottles to which defendant did affix the labels which were at issue, not every bottle shipped between in the class period bore such a label. Also, although Pfizer allegedly ran four different television commercials with the “as effective as floss” campaign, the commercials did not run continuously and there is no evidence that a majority of Listerine consumers viewed any of those commercials. Thus, many, perhaps the majority of, class members who purchased Listerine during the pertinent period did so not because of any exposure to any allegedly deceptive conduct, but rather, because they were brand-loyal customers or for other reasons. As to such consumers, there is absolutely no likelihood they were deceived by the alleged false or misleading advertising or promotional campaign. Such persons cannot meet the standard of having money restored to them because it “may have been acquired by means of” the unfair practice.

Finally, plaintiff testified he did not make his purchase based on any of the four television commercials or other ads, and that he bought Listerine due to the bottle’s red label (which differed from the other labels), which he recalled said “as effective as floss.”  Because the various commercials and labels contained different language, with some even expressly advising consumers to continue flossing, his testimony as to his reaction to the Listerine label is not probative of his, or absent class members’, reaction to different language contained in television commercials and other labels. Therefore, named plaintiff lacked standing to assert a UCL claim based on those television commercials or other labels.

 

 


 

House Committee to Hold Hearing on FDA

The House Energy and Commerce Committee's Subcommittee on Health will hold a hearing titled, "Drug Safety: An Update from the FDA" -- tomorrow, Wednesday, March 10, 2010.

 At the hearing, the Food and Drug Administration will detail the Agency's views on current challenges and successes in the area of drug safety. Set to testify is Joshua M. Sharfstein, M.D., Principal Deputy Commissioner, Food and Drug Administration. 

 
 

Update on CPSC Database Issues

We have posted before about one of the more controversial aspects of the Consumer Product Safety Improvement Act, the to-be-created publicly accessible database of product safety information.

The CPSIA mandates that the database be completed by March, 2011. The agency views its task as the creation of a public portal and a publicly accessible, searchable database of consumer product incident reports. Through the public portal, consumers will theoretically be able to report potential product safety hazards to CPSC in ways that are supposed to improve the quality, value, and accuracy of the data collected. Manufacturers will be able to investigate and respond to product hazard reports more quickly, and to share information with both CPSC investigators and with the public through the public database. And consumers are supposed to be able to use the public portal and database to find more information about hazards in order to keep their families safe.

Unless done very carefully, the database will be of little use to the average consumer, but subject to potential mischief in the hands of plaintiff lawyers.

Since last Fall, the CPSC has held various meetings and a two-day public workshop to gather stakeholder input on the new database. A number of affected groups have submitted comments on the implementation of the new product safety database, including the Soap and Detergent Association.  A common theme for the comments is the need for the CPSC to focus on verifying and ensuring the accuracy of safety incident reports submitted to the commission. Factual accuracy and veracity are two fundamental elements underpinning a credible incident database. 

CPSC needs to develop a process for addressing false and inaccurate reports that will scare consumers, harm business, and generate no additional safety gains. The commission needs to employ means to prevent the submission of fraudulent reports of harm while not discouraging the submission of valid reports.  CPSC also needs to think about specific disclaimers it should make with regard to the accuracy of the information contained in the public database, and not put the governmental imprimatur on voluntary data that has not been verified.  A sufficient time period should also be allocated for manufacturers to evaluate and respond to any proposed report.    

Companion Bill Introduced To Ease Suits Against Foreign Manufacturers

Previously we alerted readers to the introduction of The Foreign Manufacturers Legal Accountability Act of 2009 (S. 1606),  introduced in the Senate in August 2009 by Sen. Sheldon Whitehouse (D-R.I.). The bill followed up on hearings last Spring during which witnesses testified about the perceived delays and difficulties with serving foreign manufacturers with process and establishing jurisdiction.

Last week, Rep. Betty Sutton (D-Ohio) and several co-sponsors introduced in the House their own version of the Foreign Manufacturers Legal Accountability Act of 2010 (H.R. 4678). The operative provisions of the House bill overlap those in the Senate bill, although the Senate bill also includes a section which discusses the alleged need for the legislation.

The proposed legislation would impact five categories of products: drugs, devices and cosmetics; biological products; chemical substances; pesticides; and consumer products. The bills only apply to manufactured products “in excess of a minimum value or quantity established by the head of the applicable agency" in regulations applying the legislation.

Both bills make consent to jurisdiction and service of process a condition of importing products into the United States. That is, the bills instruct several relevant product-regulating agencies to issue regulations requiring foreign manufacturers and producers to designate a registered agent. A person would not be able to import into the United States a covered product (or component part that will be used in the United States to manufacture a covered product) if such product or any part of such product (or component part) was manufactured or produced outside the United States by a manufacturer or producer who does not have a registered agent. 

Such a system which requiring an agent for service of process for every foreign manufacturer or producer who imports products into the U.S. would render the Hague Convention's  methods for service abroad unnecessary for such companies, and raises the risk that other countries may choose to create similar rules, subjecting U.S. companies to litigation in those other countries where their products may be sold.

Under the bills, a foreign manufacturer or producer of covered products that registers an agent as above thereby consents to the personal jurisdiction of the State or Federal courts of the State in which the registered agent is located for the purpose of any civil or regulatory proceeding.  Presumably, the expanded jurisdiction would also make it easier for U.S. companies to pursue indemnification claims against foreign manufacturers who were upstream suppliers.

Currently, foreseeing that one's product may enter a state is not, on its own, a sufficient basis for that state to assert jurisdiction. Asahi Metal Industry Co., Ltd. v. Superior Court, 480 U.S. 102, 112(1987); but cf. Nicastro v. McIntyre Machinery America Ltd., No. A-29-08 (N.J. 2/2/10).  It has been argued that Congress cannot create jurisdiction where the Constitution would forbid it. And it may be that a constitutional challenge would lie to some applications of the proposed bills. E.g., Texas Trading & Milling Corp. v. Federal Republic of Nigeria, 647 F.2d 300 (2d Cir. 1981). Presumably, the sponsors are looking to bypass the due process concerns by providing for consent to jurisdiction.

It is unclear what the effect of the bills might be on countries around the world regarding their willingness to enforce judgments entered in the United States, as the issue of the lack of foreign manufacturer assets in the U.S. is not addressed by the proposed legislation.


 

 

Fifth Circuit Grants Rehearing En Banc In Climate Change Case

We have posted on the climate change litigation, including inexplicable decisions such as the putative class action alleging that -- follow the chain -- dozens of oil and chemical companies emitted greenhouse gasses which contributed to an impact on the atmosphere which contributed to a rise in temperature of some parts of the ocean which contributed to making Hurricane Katrina stronger which contributed to additional damages to plaintiffs' property. Such decisions represent a clear and dangerous trend within certain courts to usurp Congress, warp the traditional nuisance doctrine, and plunge the federal courts into what are essentially political questions.
 

Now comes the welcome news that the Fifth Circuit has ordered en banc rehearing of the case. Comer et al. v. Murphy Oil USA et al., No. 07-60756 (5th Cir.). The court issued an order last week granting the defendants' petition for a rehearing en banc, vacating the panel decision from last Fall. The Fifth Circuit panel had ruled that private property owners under Mississippi law may have standing to bring climate change-related nuisance and trespass claims for both property and punitive damages.

The defendants will re-brief the issues by the end of this month, and oral argument appears to be set for the end of May.

New Proposed Jury Instruction on Electronic Devices

At its last meeting, the Judicial Conference Committee on Court Administration and Case Management (CACM) endorsed a set of suggested jury instructions that federal district judges are to consider using to help deter jurors from using electronic technologies to research or communicate about cases on which they serve.

The CACM Committee developed these instructions to address the increasing incidence of juror use of such devices as cellular telephones, BlackBerries, or computers to conduct research on the Internet or communicate with others about cases. Such use has resulted in mistrials, exclusion of jurors, and, even, imposition of fines. The suggested instructions specifically inform jurors that they are prohibited from using these technologies in the courtroom, in deliberations, or outside the courthouse to communicate about or research cases on which they currently serve.

The instructions admonish the jurors to decide the case based solely on the evidence presented within the four walls of the courtroom. It also notes in part that jurors may not communicate with anyone about the case on a cell phone, through e-mail, BlackBerry, iPhone, text messaging or on Twitter.

 

Chemical Products Liability Conference This Spring

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.

 

State Supreme Court Issues Noteworthy Personal Jurisdiction Opinion

The New Jersey Supreme Court has recently ruled that a New Jersey court can exercise jurisdiction in a product liability action over a foreign manufacturer based on the manufacturer's relationship with a nationwide distributor and on its presence at national trade shows. Nicastro v. McIntyre Machinery America Ltd.,  No. A-29-08 (N.J. 2/2/10).

Personal jurisdiction addresses the reach of the court’s power over a party, and without such jurisdiction, any ruling by the court is not binding on the party. Plaintiff lawyers focus on personal jurisdiction as part of the equation where they can sue; defendants as part of where they can be sued properly. The rules governing personal jurisdiction are well described in numerous reference works. As a general matter, a defendant can only be sued where it has sufficient minimum contacts with the state such that a suit there does not offend traditional notions of fair play and substantial justice.

In 2001, plaintiff was injured while operating the McIntyre Model 640 Shear, a recycling machine used to cut metal. The Model 640 Shear was manufactured by J. McIntyre Machinery, Ltd., a company incorporated in the United Kingdom, and then sold, through its exclusive United States distributor, McIntyre Machinery America, to the employer.  Plaintiff sued, alleging that the shear machine was defective in that it did not have a safety guard that allegedly would have prevented the accident. The trial court granted the foreign defendant's motion to dismiss the action, finding that the English manufacturer did not have sufficient minimum contacts with New Jersey to justify the state’s exercise of personal jurisdiction. The Appellate Division reversed, concluding that the exercise of jurisdiction by New Jersey “would not offend traditional notions of fair play and substantial justice” and was justified “under the ‘stream-of-commerce plus’ rationale."  Under that test, the actions of a defendant must be “purposefully directed toward the forum State” for a court of that state to exercise personal jurisdiction. Acknowledging that the English company had no presence in, or minimum contacts with, New Jersey, the state Supreme Court said plaintiff's argument for jurisdiction “must sink or swim with the stream-of-commerce theory of jurisdiction.”
 

New Jersey has a long-arm rule that permits service of process on a non-resident defendant “consistent with due process of law.”  Therefore, its courts may exercise jurisdiction over a non-resident defendant “to the uttermost limits permitted by the United States Constitution.” The Supreme Court seemed influenced by the view  that we live in a global marketplace. It also noted that a state has a strong interest in protecting its citizens from defective products as well as a paramount interest in ensuring a forum for its injured citizens who have suffered catastrophic
injuries due to allegedly defective products in the workplace. While its conception of jurisdiction must surely comport with traditional notions of fair play and substantial justice, the court noted it must also reflect modern truths – the radical transformation of the international economy.

Accordingly, the court held that a foreign manufacturer will be subject to this state’s jurisdiction if it knows or reasonably should know that through its distribution scheme its products are being sold in New Jersey. A manufacturer that knows or reasonably should know that its products are distributed through a nationwide distribution system that might lead to those products being sold in any of the fifty states must expect that it will be subject to the state’s jurisdiction if one of its defective products is sold to a New Jersey consumer, causing injury. The focus under this approach is not on the manufacturer’s control of the distribution scheme, but rather on the manufacturer’s knowledge of the distribution scheme through which it is receiving economic benefits in each state where its products are sold. A manufacturer cannot shield itself merely by employing an independent distributor – a middleman – knowing the predictable route the product will take to market. If a manufacturer does not want to subject itself to the jurisdiction of a New Jersey court while targeting the United States market, then, the court said, it must take some reasonable step to prevent the distribution of its products in that state.

The power of the state to subject a person or business to the jurisdiction of its courts has evolved with the changing nature of the American economy, said the court. As the nation is part of a global economy driven by startling advances in the transportation of products and people and instantaneous dissemination of information, the expanding reach of a state court’s jurisdiction, as permitted by due process, has reflected those historical developments.

The stream-of-commerce doctrine of jurisdiction is particularly suitable in product-liability actions, opined the court. It will not necessarily be a substitute for other jurisdictional doctrines -- such as minimum contacts -- that will apply in contract and other types of cases. Within the confines of due process, jurisdictional doctrines must reflect the economic and social realities of the day. The exercise of jurisdiction by New Jersey in this case was called "a reasoned response" to the globalization of commerce that permits foreign manufacturers to market their products through distribution systems that bring those products into the state. With the privilege of distributing products to consumers comes the responsibility of answering in a New Jersey court if one of those consumers is injured by a defective product, concluded the majority.

A lengthy dissent argued that the majority had ignored the fact that the original stream of commerce idea had included the element of a manufacturer's expectation that its products will be purchased in the forum state.  It also criticized an apparent shift in focus from the defendant to the plaintiff, including the severity of injuries.

The majority's test may come to have implications for manufacturers selling to other states as well, outside New Jersey. Many foreign and out-of-state manufacturers reasonably should know that their products are distributed through a nationwide system that might result in sales in any given state. It is quite possible the U.S. Supreme Court will want to clarify the reach of the so-called stream of commerce test, which was mentioned in Justice O’Connor’s plurality opinion in
Asahi Metal Industry Co. v. Superior Court of California, 480 U.S. 102 (1987).