Seventh Circuit Affirms Exclusion of Plaintiff Expert in Device Case

Just about a year ago, we posted about an interesting device case in which the U.S. District Court for the Central District of Illinois, in an opinion by Chief Judge Michael P. McCuskey, found inadmissible plaintiff's expert witness testimony that his knee implant failed due to alleged oxidation caused by the method Zimmer used to sterilize the product. Fuesting v. Zimmer Inc., 2009 WL 174163 (C.D. Ill., 1/26/09).

Last week  the federal appeals court affirmed the judgment for the knee implant maker.  Fuesting v. Zimmer Inc., 2010 WL 271728 (7th Cir. 1/25/10).  Fuesting had alleged he received the Zimmer-made implant in 1994. In 2001, he began experiencing pain in the knee, and his doctor removed the prosthesis in November of that year. Fuesting sued, alleging that Zimmer's sterilization of the prosthesis by gamma irradiation in air (GIA) rendered it defective. At trial, his expert witness, Dr. Pugh, testified that GIA caused the prosthesis to oxidize and delaminate, resulting in premature failure. A jury returned a verdict for plaintiff, but the Seventh Circuit vacated the judgment after finding that Pugh's testimony did not meet the requirements for admissibility of expert testimony under Fed. R. Evid. 702 and the standards set forth in Daubert.

On remand, Fuesting proffered the testimony of a second expert witness, Dr. Rose. But the trial court found that Dr. Rose had not bridged the analytical gap between accepted principles and his complex conclusions. He had not, and could not, show that the prosthesis failed because of the sterilization method used. The expert testimony as to defect also failed.

On appeal, the Seventh Circuit stated that Dr. Rose's testimony did not show that his theory that these knee implants oxidize “in vivo” had sufficient acceptance in the scientific community.  He failed to point to any peer reviewed studies that discuss the oxidation rates of this type of implant in vivo.  Dr. Rose failed to cite any articles or studies that he or any one else conducted regarding how one can discern whether the alleged oxidation occurred before or after implantation.  Dr. Rose also did not rule out possible alternative methods of causation.  Nor did he explain how the device's oxidation caused the device to fail, as the mere presence of oxidation does not prove that the oxidation caused the device to malfunction.

Dr. Rose also failed to “bridge the analytical gap” between the accepted fact that GIA sterilization causes at least some amount of oxidation and his ultimate conclusion that Fuesting's knee implant in particular failed because GIA, rather than another sterilization method, was used. Last, Dr. Rose failed to show that better sterilization alternatives existed in 1991. He concluded, in one sentence of his report, and without any support, that the industry standard was to sterilize implants in an inert gas instead of air. In fact, no manufacturer at that time employed any of  the proffered methods, and Dr. Rose cited no contemporary articles counseling the use of such methods.  For all these reasons, the district court did not abuse its discretion in excluding Dr. Rose's testimony.


 

British Journal Finally Retracts Autism Article

The British medical journal "The Lancet" has  finally issued a full retraction of a study it ran in 1998 purporting to link the measles-mumps-rubella (MMR) vaccines to autism.  Wakefield, et al., "Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children," Lancet 1998; 351: 637-641.

The journal noted that following the judgment of the U.K. General Medical Council's "Fitness to Practice Panel" concerning the lead author, it had become clear to the journal that several elements of the 1998 paper by Wakefield, et al., were "incorrect," and contrary to the findings of an earlier investigation. Therefore, the journal "fully retracted" this paper from the published record.

Readers of MassTortDefense know how one article purporting to link a drug to a side effect, a chemical to an adverse effect, a product to an illness, can spawn significant products litigation, and even a mass tort.  Here, the study not only influenced a decade of litigation, it spurred a public health crisis by sending parents in the U.K. and the U.S. into confusion over the safety of having their children vaccinated.  The overwhelming scientific evidence shows vaccines to be safe, but The Lancet stuck by its article even when it was revealed that the study was connected to plaintiff lawyers' pursuit of litigation. In the meantime, all children were put at risk as Great Britain's child vaccination rates plummeted to below 70% in some areas, and by 2008 there were more than 1000 cases of measles, including fatalities, in  England and Wales.

The Lancet article issues demonstrate how even reputable publications can become conduits for plaintiffs' junk science and political junk science.  It's hard to fathom why it took so long for the retraction.  It calls again for an overhaul of the peer review process, which the Supreme Court in Daubert noted as a hallmark of good science.  Most importantly, it reminds the defense bar and their clients how important it is to have a thorough, searching examination of the science that plaintiffs rely on for general or specific causation.  Nothing can be taken at face value, and sometimes only a dogged pursuit of discovery will uncover the many flaws in a seemingly well-regarded study.

Autism and related developmental disorders are an extremely challenging medical issue, deserving of time and resources.  But the questions cannot be answered by junk science.

Informal Discovery Leads to Dismissal in MDL

The court in the welding fume MDL litigation has dismissed the claims of the  plaintiff who had been chosen for the seventh bellwether trial in this national consolidated welding fume products liability litigation. In re: Welding Fume Products Liability Litigation [Ernest Ray, No. 04-18252], MDL 1535, No. 03-17000, N.D. Ohio.

Plaintiff Ray had moved to dismiss his claim, with prejudice, last November. Thousands of claims have been dismissed in this litigation, so why post about this one?  A reminder to readers of MassTortDefense to travel all lanes of the information superhighway in doing fact investigation, including the so-popular social media hubs.

It appears that plaintiffs were forced to move to dismiss the Ray case after plaintiff’s claims of severe disability were refuted by Internet (specifically Facebook) photos discovered by defendants that appeared to show plaintiff competing in strenuous high-speed powerboat races.

In 2006, the MDL Court implemented a new case evaluation process to try to ensure that only “trial-worthy” cases reached the later stages of pre-trial litigation. This process, which required medical records collection and a certification by plaintiffs’ attorneys that cases were trial‐worthy, prompted plaintiffs to dismiss thousands of cases.  Even with that, this is about the sixth trial-ready case plaintiffs have been forced to dismiss due to revelations in discovery.

Appropriate review of public web sites requires no disclosure to opposing counsel, and can be done relatively cheaply. Today's technology, via the Internet, can result in a wealth of information on the opposing party or witness.  Web sites like the popular myspace.com and facebook.com can now provide a profile of a witness or opposing party, or, like here, information on interests and activities. An individual might have posted comments about his condition, as well. Good luck surfing!

7th Circuit Weighs In on CAFA Issue

The Seventh Circuit recently issued a decision clarifying an issue under the Class Action Fairness Act:  when the federal court denies class certification in a case in federal court because of CAFA, does that divest the court of jurisdiction?  The court of appeals reversed an Illinois district court ruling that a failed class action lost jurisdiction, ruling that the lower court misinterpreted CAFA. Cunningham Charter Corp., et al. v. LearJet Inc., No 09-8042 (7th Cir., Jan. 22, 2010).

Cunningham sued Learjet in an Illinois state court asserting claims for breach of warranty and products liability on behalf of itself and all other buyers of Learjets who had received the same warranty from the manufacturer that Cunningham had received. The defendant removed the
case to federal district court under CAFA. Eventually, the district judge denied the motion on the ground that neither proposed class satisfied the criteria for certification set forth in Rule 23 of the Federal Rules of Civil Procedure. The judge then ruled that the denial of class certification
eliminated subject-matter jurisdiction under the Act, and so he remanded the case to the state court.

The 7th Circuit, per Judge Posner, disagreed.  the court offered some context, a textual explanation, and policy reasons. The general principle that jurisdiction once properly invoked is not lost by developments after a suit is filed, such as a change in the state of which a party is a citizen that destroys diversity. E.g., St. Paul Mercury Indemnity Co. v. Red Cab Co., 303 U.S. 283, 293-95 (1938). That general principle was applicable to this case because no one suggests that a class action must be certified before it can be removed to federal court under the Act.  Cases should not be shunted between court systems; "itigation is not ping-pong."

Text: The Act defines class action as “any civil action filed under rule 23 of the Federal Rules of Civil
Procedure or similar State statute or rule of judicial procedure authorizing an action to be brought by 1 or more representative persons as a class action.” § 1332(d)(1)(B). No requirement of certification.

Policy: If a state happened to have different criteria for certifying a class from those of Rule 23, the result of a remand because of the federal court’s refusal to certify the class could be that the case would continue as a class action in state court. That result would be contrary to the Act’s purpose of relaxing the requirement of complete diversity of citizenship so that class actions involving
incomplete diversity can be litigated in federal court.

In finding that federal jurisdiction under the Class Action Fairness Act does not depend on certification, the court joined Vega v. T-Mobile USA, Inc., 564 F.3d 1256, 1268 n. 12 (11th Cir. 2009).

Judge Posner concluded, that  is the better interpretation." See Richardson, “Class Dismissed, Now What? Exploring the Exercise of CAFA Jurisdiction After the Denial of Class Certification,” 39
New Mex. L. Rev. 121, 135 (2009); Clermont, “Jurisdictional Fact,” 91 Cornell L. Rev. 973, 1015-17
(2006).

 

 

Nanotechnology Legislation Introduced in Senate

Two Democratic legislators have introduced a bill that would create an FDA program to assess the potential health and safety effects of nano-technology ingredients in various consumer products.  Sens. Mark Pryor (D-Ark.) and Benjamin L. Cardin (D-Md.) introduced the "Nanotechnology Safety Act of 2010," S. 2942, last week. Their introductory remarks here.

The FDA established a Nanotechnology Task Force, which issued a report in July 2007. In the task force report, recommendations were made regarding FDA’s future direction for regulating nanomaterial-containing products. Guidance development was included as one the recommendations. The FDA’s Advisory Committee for Pharmaceutical Science and Clinical Pharmacology met In 2008. Among the agenda topics was a discussion of issues pertaining to the use of nanotechnology in drug manufacturing, drug delivery, or drug products.  Later, FDA held a public meeting to gather information that will assist the agency in further implementing the recommendations of the Nanotechnology Task Force Report relating to the development of agency guidance documents concerning nanotechnology.

The bill would create a program for the scientific investigation of nanoscale materials included or intended for inclusion in FDA-regulated products, to address the potential toxicology of such materials, the effects of such materials on biological systems, and interaction of such materials with biological systems.  Specifically, FDA would be charged to assess scientific literature and data on general nanoscale material interactions with biological systems and on specific nanoscale materials of concern to Food and Drug Administration, and collect, synthesize, interpret, and disseminate scientific information and data related to the interactions of nanoscale materials with biological systems.

Nanotechnology applications in drug development are likely to have a significant impact on the products that FDA regulates. Products containing nanomaterials are being investigated for potential applications as therapeutics, and some products containing nanoscale materials are already on the market. While some of these nanomaterials are nanoscale versions of larger materials used in approved products, other nanomaterials are novel and have never been used in drug products. In 2009, the FDA introduced the "Nanotechnology Initiative", a collaborative effort between FDA and the Alliance for NanoHealth.

The proposed law would also require a report from FDA by 2012 that includes a review of the coordination of activities under the program with other departments and agencies participating in the National Nanotechnology Initiative. The bill would send $25 million annual funding to the agency for the program. The bill was referred to the Committee on Health, Education, Labor, and Pensions,

Many readers of MassTortDefense know that nanotechnology refers to a new field of technology that seeks to manipulate and control products, really matter, on the atomic and molecular scale, typically 100 nanometers or smaller. To give some sense of scale, one nanometer is one billionth, or 10-9 of a meter. A nanometer compared to a meter is the roughly the same ratio as that of a baseball to the size of the Earth. Or another analogy, a nanometer is the length a man's whiskers grow in the time it takes him to lift his razor to his face to shave. We have posted on this topic here, here, and here.
 

MDL Court Addresses Ex Parte Communication With Treating Physicians

A recent federal court  decision explores a seemingly small but potentially crucial issue involving a product liability plaintiff's treating physicians.  In Re: Ortho Evra Products Liability Litigation, No. 1:06-40000, MDL Docket No. 1742 (N.D. Ohio).

Many product liability suits turn on a battle of the experts on issues of injury and causation.  In many cases, a key set of witnesses, therefore, are the plaintiffs' treating physicians. When the views of the treater are on the side of one party, that party will typically emphasize the "neutral" status of the witness and the fact that the treater has had more and closer contacts with the plaintiff.  Whichever side disagrees with the treater will try to emphasize that the doctor is not the "world class" expert on the relevant scientific issues, and that his or her real function was to treat the injury/illness, not figure out whether a particular product caused it.  Accordingly, the deposition of treating physicians -- and the preparation for those depositions -- can be a critical stage of products liability litigation.

In this MDL, defendants moved to regulate ex parte contacts with plaintiffs’ treating physicians. Defendants sought to prevent what many see as an unfair advantage by plaintiffs lobbying their theories of liability and causation upon the treating physicians during such ex parte contact -- often on the eve of deposition. 

Defendants asserted that this issue had been taken up by the New Jersey court in the Zometa/Aredia Litigation litigation.  In that New Jersey litigation, Gaus v. Novartis Pharmaceuticals Corp., No. MID-L-007014-07-MT (New Jersey, Oct. 29, 2009), the court emphasized the “unique set of practical concerns presented in mass tort cases” as well as the number of plaintiffs in determining that the court’s resources would be impaired by a flood of discovery disputes regarding each treating physician. To ensure the same right of access and promote an efficient discovery process, the court there ordered all parties to proceed by way of formal deposition of plaintiffs’ treating physicians. See also In re NuvaRing Products Liability Litigation, 2009 WL 775442 (E.D. Mo., 2009).

Here, the MDL court allowed plaintiffs’ counsel to have ex parte contact with treating physicians with an important limitation. Specifically, plaintiffs’ counsel can meet ex parte to discuss the physicians’
records, course of treatment and related matters, but not as to liability issues or theories, product warnings, defendant's research documents, or related materials. Violations of this approach, the court said, will result in sanctions.

 

 

 

 

State Supreme Court Reverses Class Certification on Predominance Grounds

The Alabama Supreme Court has recently reversed a lower court's certification of a class of third-party payers of health care services who complained about damages allegedly flowing from the recall of a drug from the market.  Wyeth, Inc. v. Blue Cross and Blue Shield of Alabama, 2010 WL 152123 (Ala. Jan. 15, 2010).

Defendant Wyeth voluntarily withdrew Duract from the market, notifying the public of its decision to do so through a press release.  As part of the process of withdrawing Duract from the market, Wyeth voluntarily instituted a customer refund program for customers who still had Duract capsules in their possession. The third-party payers sued Wyeth solely on a theory of unjust enrichment, alleging that their payment for the drug had conferred an inappropriate benefit on Wyeth in light of the withdrawal.

After a hearing on the class certification motion, the trial court entered an order certifying a nationwide class of TPPs who paid for the prescription drug Duract that was not used as of the date of its withdrawal from the market.  On appeal, the defendant argued that predominance of common issues had not been established, a requirement of Alabama Rule 23 analogous to FRCP 23 (b)(3).

As in many states, Alabama recognizes that unjust enrichment claims are particularly unsuitable for class treatment. Funliner of Alabama, L.L.C. v. Pickard, 873 So.2d 198, 211 (Ala.2003) (unjust enrichment claims based on allegations of mistake or fraud require an individualized inquiry into the state of mind of each plaintiff).  The trial court distinguished this body of law, finding that this particular enrichment claim was not based on fraud or mistake, but on the somehow different theory that “equity and good conscience” required the defendant to disgorge money that belongs to the plaintiff.

The court observed that Wyeth probably had the better of the argument on this, meaning that the trial court had fashioned on a distinction without a difference.  But the state high court did not need to resolve the unjust enrichment issue under Alabama law, because the plaintiffs sought a nationwide class. Regardless of what Alabama law was, there had been no adequate showing, either to the trial court or to the Supreme Court, that the laws of all (or even most of) the 49 other states would allow unjust enrichment claims to proceed on such a "good conscience" basis somehow distinct from a traditional claim. 

Even a cursory examination showed that variances exist in state common laws of unjust enrichment. The actual definition of unjust enrichment varies from state to state. Some states do not specify the misconduct necessary to proceed, while others require that the misconduct include dishonesty or fraud. See Clay v. American Tobacco Co., 188 F.R.D. 483, 501 (S.D.Ill.1999).

Accordingly, common issues could not predominate.  Certification was vacated.

Federal Rule of Civil Procedure 26: Amendment Update

We love to hear from our faithful readers, and one recently asked us to update the status of the proposed amendments to Rule 26. We posted on them last year, noting that there would be public comment opportunities throughout 2009.

Below, a review of those comments.  But first a reminder of the proposed changes. The amendments would extend work-product protection to the discovery of draft reports by testifying expert witnesses and, with three important exceptions, to the discovery of communications between testifying expert witnesses and retaining counsel. The amendments also provide that a lawyer relying on a witness who will provide expert testimony but is not required to provide a Rule 26(a)(2)(B) report – because the witness is not retained or specially employed to provide expert testimony and is not an employee who regularly gives expert testimony – must disclose the subject matter of the witness’s testimony and summarize the facts and opinions that the witness is expected to offer. The 1993 amendments to Civil Rule 26 have been interpreted by some courts to allow discovery of all draft expert witness reports and all communications between counsel and testifying expert witnesses. The experience under those amendments revealed significant practical problems in the eyes of many litigators.

The comments? First, the arguments in favor:

• Lawyers and expert witnesses take elaborate and costly steps to avoid creating any discoverable draft report or any discoverable communications between the lawyer and expert. These steps can include hiring two sets of experts, one to testify and one to consult; avoiding any note-taking by the expert; and avoiding the creation of any draft report. At the same time, lawyers take elaborate and
costly steps to attempt to discover all of the other side’s drafts and communications.


• Experience has shown that the elaborate steps to avoid creating discoverable drafts or communications result in inefficient, costly, and wasteful litigation behavior. At the same time, experience has also shown that extensive, time-consuming, and costly efforts to discover every change in draft reports by experts and every communication between experts and retaining counsel rarely produces information that bears on the strengths or weaknesses of the experts’ opinions.

• Many experienced lawyers routinely stipulate that they will not seek to discover draft reports from each other’s experts or communications between the experts and the retaining lawyers. That good lawyers stipulate to avoid the present rule indicates problems with it.

• Some states have implemented procedures similar to the proposed amendments.  State  practitioners representing both plaintiffs and defendants report a degree of consensus about the success of these procedures in improving the ability to use expert witnesses and to discover the basis for their opinions.


• The proposed amendments would not limit discovery into the areas that are genuinely important for learning the strengths and weaknesses of a testifying expert’s opinion. The proposed amendments specifically allow discovery into communications between a lawyer and testifying expert about: (1) the compensation for the expert’s study or testimony; (2) the facts or data provided
by the lawyer that the expert considered in forming opinions; and (3) the assumptions provided by the lawyer that the expert relied upon in forming an opinion.

Opposing Views:

• The proposed amendments limit discovery that could show the extent of the retaining lawyer’s influence on the testifying expert’s opinions. That could make it easier for lawyers to influence the opinions their testifying experts present.

• The proposed amendments only limit discovery of draft reports and certain communications. They do not apply to inquiries into such matters at the trial itself. It may be unclear whether the draft reports and communications will be protected from disclosure at trial. As a result, the amendments may not eliminate the costly and wasteful steps to avoid creating draft reports or records of attorney/expert communications. (MassTortDefense wonders how many lawyers will venture into these issues at trial without the benefit of any discovery.)

Overall, comments received during the notice-and-comment period made it appear that the vast majority of practitioners, on both the plaintiff and defense sides, support the proposed rule amendments. Interestingly, lots of academics spoke up against the rule.

So what's the status? On September 15, 2009, the Judicial Conference met and approved the recommendations of the Committee on Rules of Practice and Procedure and approved the proposed rules. The rules were then transmitted to the Supreme Court in December with a recommendation that they be approved and transmitted to Congress in accordance with the Rules Enabling Act.  The schedule would still have them taking effect, if not rejected by the Court or Congress, on December 1, 2010.

 

Rule 15 Amendments May Impact Removal Prospects

Readers of MassTortDefense know how important the choice of forum can be for significant product liability and mass tort matters.  The differences between federal and state court -- perhaps right down the street from each other -- can be huge, with differing juror pools, differing procedural rules, differing views on class actions, different methods of selecting the judiciary, etc.

Thus, it is worth making sure a subtle amendment to Rule 15 of the Federal Rules of Civil Procedure, which took effect Dec. 1, 2009, does not miss your attention, because of the potential impact it has on removal to federal court.

Prior to the amendments to Rule 15 — which governs amended and supplemental pleadings —  a plaintiff could amend the complaint once as a matter of course before any responsive pleading was filed.  Responsive pleading came to mean the defendant’s answer, and not a motion to dismiss.  E.g., Foster v. DeLuca, 545 F.3d 582 (7th Cir. 2008).  Thus, a defendant could eliminate the plaintiff’s right to amend as a matter of course by serving an answer.  That is, under the old version of Rule 15, a defendant could prevent amendments designed to eliminate the basis for removal by serving an answer just prior to or along with the filing of the notice of removal. When a plaintiff wanted to amend after the defendant had removed and answered, the plaintiff had to obtain consent or leave of court. So what about the removal, then? Any proposed amendment to the complaint affecting the court’s jurisdiction would trigger a heightened scrutiny of the amendment.  E.g., Hensgens v. Deere & Co., 833 F.2d 1179 (5th Cir. 1987). Defendants could argue that the  proposed amendment should be rejected on this basis. 

The new Rule 15 permits a plaintiff to amend “as a matter of course” even after the defendant has served “a responsive pleading.”  A party may file an amended pleading without leave of court within 21 days after service of a responsive pleading or 21 days after service of a Rule 12 motion, whichever is earlier. After that, a party may file an amended pleading only with leave of court. 

That raises the issue for your consideration whether the new ability of the plaintiff to amend “as a matter of course,” even after the defendant has served an answer, permits the plaintiff to make one of those jurisdiction-destroying amendments.  One possibility is that courts will look at "matter of course" amendments under the new rule the same way they were analyzed by many courts under the old rule.  That is, courts were guided by 28 U.S.C. § 1447(e), which states that if after removal the plaintiff seeks to join additional defendants whose joinder would destroy subject matter jurisdiction, the court may deny joinder, or permit joinder and remand the action to the state court. Schur v. L.A. Weight Loss Centers, Inc., 577 F.3d 752, 759 (7th Cir. 2009); Whitworth v. TNT Bestway Transp. Inc., 914 F.Supp. 1434 (E.D.Tex.,1996).  Courts, in the motion for leave context and sometimes in the "as of course" context as well, to decide between those two choices, would scrutinize the amendments closely, and due consideration is given to the original defendant’s interest in the choice of forum. Courts examine whether the purpose of the amendment is to defeat federal jurisdiction; how timely/prompt the plaintiff has been in seeking the amendment; whether the plaintiff will be prejudiced if amendment is not allowed; and any other equities. Bailey v. Bayer CropScience L.P., 563 F.3d 302 (8th Cir. 2009).

If this heightened scrutiny is applied to "matter of course" amendments made under the new version of Rule 15, removals may be in less jeopardy when when a plaintiff attempts to amend the complaint post-removal, post-answer  “as a matter of course.”

Court Excludes Toxic Tort Causation Testimony

A federal court has excluded plaintiffs' expert testimony in litigation alleging personal injury and property damage from releases at a Midwest refinery.  Baker, et al. v. Chevron USA Inc., et al., No. 05-cv-00227 (S.D. Ohio Jan. 6, 2010). In the absence of necessary expert testimony, the claims were subject to summary judgment.

Plaintiffs in this case were residents of the villages of Hooven and Cleves, Ohio, who asserted claims for personal injury and property damage allegedly resulting from the Gulf Oil refinery, now owned by defendant Chevron USA.  Gulf operated a gasoline refinery which was situated on the eastern edge of Hooven from 1930 to 1985. Gulf also refined diesel fuel, jet fuel, and fuel oil at the refinery and operated an asphalt plant at this location. Gulf and Chevron merged in 1985, and Chevron closed the refinery in 1986.

Plaintiffs alleged that Gulf’s operation of the refinery resulted in the release of millions of gallons of gasoline and diesel fuel.  But these plaintiffs did not claim injuries resulting from groundwater contamination. Rather, they asserted injuries allegedly caused by air emissions from the refinery and, in particular, the benzene contained in those emissions. Benzene is ubiquitous in the ambient air and is a component or constituent of vehicle exhaust and cigarette smoke. In the petroleum industry, benzene is found in small amounts in gasoline.

For case management purposes, the matter was bifurcated between personal injury claimants and property damage claimants. The parties were permitted to select bellwether plaintiffs for each trial group. This opinion dealt with the claims of the bellwether personal injury claimants, and a key issue, as is often the case in toxic tort litigation, was causation.

Regarding their alleged benzene exposure, plaintiffs offered a three-step procedure. First, expert Dr. Cheremisinoff calculated a gross amount of benzene released from the refinery through emissions. Then, using those calculations, Dr. Rosenfeld, plaintiffs’ second expert, used an air flow model to calculate the cumulative dose of benzene to which each plaintiff was exposed. Third, using those dose estimates, a third expert, Dr. Dahlgren, submitted opinions that each plaintiff’s dose of benzene was sufficient to cause her illness. 

Chevron moved to exclude Dr. Dahlgren's opinions under Daubert, and for summary judgment contingent  upon the striking of  plaintiffs' causation evidence. The principal argument raised was that Dr. Dahlgren’s opinions were unreliable because there was an insufficient scientific or medical basis to conclude that the doses of benzene to which plaintiffs’ were exposed were large enough to have caused their illnesses. Relatedly, Chevron contended that there is an insufficient scientific or medical basis to conclude that benzene even causes some of the illnesses alleged. The Court held a hearing on Chevron’s Daubert motion during which Dr. Dahlgren and Chevron’s medical expert also testified.

In a toxic tort case, the plaintiff must present evidence of both general causation and specific causation. General causation establishes whether the substance or chemical at issue is capable of causing a particular injury or condition. Specific causation relates to whether the substance or chemical in fact caused this plaintiff’s medical condition. Without expert medical testimony on both general causation and specific causation, a plaintiff’s toxic tort claim will fail.

In this case, Dr. Dahlgren offered causation opinions based largely on epidemiological studies. (Epidemiology is the study of the incidence, distribution, and etiology of disease in human populations.) Epidemiology is usually considered highly probative evidence on general causation in toxic tort cases. The court may nonetheless exclude expert testimony based on epidemiological studies where the studies are insufficient, whether considered individually or collectively, to support the expert’s causation opinion. Nothing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence that is connected to existing data only by the ipse dixit of the expert. A court may thus conclude that there is simply too great an analytical gap between the data and the opinion proffered.

A couple of parts of the court's detailed analysis are worth highlighting for readers of  MassTortDefense:

First, Dr. Dahlgren’s reliance on the “one-hit” or “no threshold” theory of causation in which exposure to one molecule of a cancer-causing agent has some finite possibility of causing a genetic mutation leading to cancer. The court noted that while the one-hit theory has been accepted for purposes of establishing regulatory safety standards, it has not been accepted as a reliable theory for causation under Daubert standards.  See Allen v. Pennsylvania Eng’g Corp., 102 F.3d 194, 199 (5th Cir. 1996) (“Scientific knowledge of the harmful level of exposure to a chemical, plus knowledge that the plaintiff was exposed to such quantities, are minimal facts necessary to sustain the plaintiffs’ burden in a toxic tort case.”); McClain v. Metabolife Int’l, Inc., 401 F.3d 1233, 1240 (11th Cir. 2005) (holding that district court erred by not excluding plaintiff’s expert’s causation opinion because he neglected dose-response relationship); Henricksen v. ConocoPhillips Co., 605 F. Supp.2d 1142, 1162 (E.D. Wash. 2009) (excluding expert’s opinion pursuant to Daubert where “he presumed that exposure to benzene in gasoline can cause AML in any dose.”); National Bank of Commerce v. Associated Milk Producers, Inc., 22 F. Supp.2d 942, 961 (E.D.Ark. 1998), aff’d, 191 F.3d 858 (8th Cir. 1999); Sutera v. Perrier Group of Am., Inc., 986 F. Supp. 655, 667 (D. Mass.
1997). Moreover, since benzene is ubiquitous, causation under the one-hit theory could not be established because it would be just as likely that ambient benzene was the cause of plaintiffs’ asserted illnesses.

Second, the court noted that to the extent that Dr. Dahlgren relied on the evidence that plaintiffs were exposed to benzene in excess of regulatory levels, that is insufficient to make his opinions admissible. The mere fact that plaintiffs were exposed to benzene emissions in excess of mandated limits is insufficient to establish causation. Nelson v. Tennessee Gas Pipeline Co., 243 F.3d 244, 252-53 (6th Cir. 2001); David L. Eaton, Scientific Judgment and Toxic Torts- A Primer in Toxicology for Judges and Lawyers, 12 J.L. & Pol’y 5, 39 (2003) (“regulatory levels are of substantial value to public health agencies charged with ensuring the protection of the public health, but are of limited value in judging whether a particular exposure was a substantial contributing factor to a particular individual’s disease or illness.”). This is because regulatory agencies are charged with protecting public health and thus reasonably employ a lower threshold of proof in promulgating their regulations than is used in tort cases. Allen, 102 F.3d at 198.

Third, the court focused on the issue of the link between cited literature and the actual specific opinion given. The court recognized that an expert’s opinion does not have to be unequivocally supported by all epidemiological studies in order to be admissible under Daubert. But here, the opinions expressed in Dr. Dahlgren’s revised report were based "on a scattershot of studies and articles which superficially touch on each of the illnesses at issue." The expert had not differentiated the cases in any way and simply assumed that each reference supported his causation opinion on each and every illness. That clearly was not the case. Also, none of the cited studies supported an opinion that benzene can cause the illnesses from which plaintiffs suffer at the extremely low doses or exposures experienced in this case. Even if it is medically accepted that benzene can cause disease at high doses, Dr. Dahlgren could not cite any paper finding that the relevant low cumulative exposure significantly increases the risk of developing the injuries.

The court, therefore, found that the expert's causation opinions were not reliable under the standards enunciated by Daubert and, consequently, inadmissible. Without Dr. Dahlgren's testimony, the plaintiffs were unable to establish that their illnesses were caused by alleged emissions from the plant, the court observed, and so granted Chevron's motion for summary judgment on all four bellwether personal injury plaintiffs.