Defense Equal Access to Potential Experts Upheld in Device Case

A Joe Friday post today- just the facts with no commentary.  A state appellate court earlier this month overturned a trial court order that had limited one side's ability to consult with or retain knowledgeable physicians as witnesses. See In re Pelvic Mesh Gynecare Litigation, No. A-5685-10T4 (N.J. Super. Ct. App. Div., 6/1/12).

The issue arose in the mass tort involving medical devices used primarily to treat pelvic organ prolapse and stress urinary incontinence. Plaintiffs in the New Jersey cases had filed suit against
defendants alleging injuries sustained as a result of the surgical implantation of the pelvic mesh product. As is not atypical, some of the most qualified experts had previously prescribed or implanted the device at issue. And it was possible that some former patients would or had become plaintiffs. In January 2011, defendants moved to establish a protocol similar to ones used in some federal litigation for consulting with and possibly retaining as defense experts physicians who had treated a different plaintiff in the pelvic mesh litigation.  Defendants proposed that a treating physician would have no communication with the defense about his or her own patient-plaintiff an would not be used as an expert witness in the patient-plaintiff's own case. Plaintiffs' counsel opposed the motion and cross-moved for a protective order barring defendants from retaining or consulting with any physician who at any time had treated any of the plaintiffs in the pelvic mesh litigation.

The lower court issued an order in May, 2011, barring defendants from consulting with or retaining any physician who had at any time treated any plaintiff in the pelvic mesh litigation. Defendants estimated that more than 1,000 physicians were disqualified as potential defense experts.

The appellate court granted defendants' motion for leave to appeal, and subsequently stayed discovery to the extent it applies to defense experts.

The appellate division vacated the protective order because, it concluded, the order profoundly
impaired defendants' ability to defend the lawsuits because it prevented them from employing qualified experts in cases against plaintiffs other than their own current or past patients; not only did the order severely limit the pool of qualified and willing physicians that defendants could consult and engage as expert witnesses but it placed defendants in the precarious position of consulting and preparing experts only to have them later disqualified if new plaintiffs were added to the litigation.

On the issue of doctor-patient privilege, the court concluded that a plaintiff in these cases cannot claim the privilege as to the diagnosis and treatment of her medical condition that is the
subject of the lawsuit, and a treating physician can be compelled to testify as a fact witness regarding those subjects, including the doctor's determination of the cause of the plaintiff's disorder. Doctors can be expected to understand they are subject to ethical constraints against disclosure of confidential patient information. The court said that the key issue in this appeal was not whether the physician-patient privilege prevented engagement of a treating physician as an expert for the defense. The issue is whether some other rule or judicial or public policy categorically bars a treating physician from serving as an expert witness against the "litigation interests" of his or her patient, although in a different plaintiff's case.The court concluded that the trial court's ruling was a mistaken exercise of authority to manage this litigation. It inappropriately equated a plaintiff's "litigation interests" with a patient's "medical interests," and it elevated those "litigation interests" to a preemptive level not previously recognized by binding authority.

In many types of personal injury cases, said the court, physicians who testify for the defense or consult with defense counsel provide those services contrary to the interests in litigation
of other patients they have treated or continue to treat. For example, radiologists, orthopedists, and neurologists who routinely testify as experts for the defense in numerous personal injury cases in state courts are likely to be treating or consulting physicians for other patients with similar injuries, and some of those patients may also have filed lawsuits or may do so in the future. "Our system of civil justice does not bar a physician from expressing a position in litigation of one plaintiff that is contrary to the litigation interests of a current or past patient in another case."

Here, said the appellate division, the physician's information that defendants seek to use is neither the particular diagnosis or condition of a patient that the physician treated nor the fruit of expert
consultation to assess or prepare plaintiffs' claims. Rather, it is the physician's overall knowledge regarding the nature, use, risks, and safety of defendants' pelvic mesh products and the conditions that patients may experience as a result of their use. The fact that plaintiffs filed suit in New Jersey and invoked the rules for joint case management should not affect the availability of relevant evidence to both sides.

Moreover, the "litigation interests" of one patient may or may not be consistent with or contrary to the "medical interests" of the physician's other patients. For instance, specialists in gynecology, urology, or urogynecology may disagree with the claims of plaintiffs in this litigation that  defendants' products are defective and caused their injuries. Those specialists may believe that defendants' pelvic mesh products are not only safe but necessary or the most beneficial treatment
for conditions suffered by their patients. They may believe that supporting the defense in this litigation will be beneficial to most of their patients. The trial court's order not only bars physicians from truthfully expressing opinions favorable to the defense but it may potentially harm the
"medical interests" of other patients and interfere with the ability of physicians to provide the best available care for all their patients.

Rather than disqualifying as a group all treating physicians who ever treated any plaintiff, said the appeals court, the trial court should address such concerns by allowing plaintiffs to demonstrate why a particular expert retained by defendants should not be permitted to testify or assist in the
case of a different plaintiff. The fact that this litigation involves coordinated case management did not justify a broad finding of presumed prejudice to plaintiffs and the blanket ban. If plaintiffs make such a particularized showing, the court was directed to consider appropriate protective measures, including disqualification where lesser measures are not sufficient or feasible.
 

In summary, said the appeals court, both sides in this litigation should have the opportunity to present evidence from the most qualified physicians who can serve as experts. The trial court's order unfairly impeded defendants' access to many of those physicians, and so, must be reversed. 

New Edition of Reference Manual on Scientific Evidence

The National Research Council and Federal Judicial center last week released the new edition of the Reference Manual on Scientific Evidence. Readers of MassTortDefense know   about this manual as a guide for judges searching for effective and fair ways to handle science-based issues, including assessing expert testimony. The Supreme Court has made clear that the law imposes on trial judges the duty, with respect to scientific evidence, to become evidentiary gatekeepers. The judge, without interfering with the jury’s role as trier of fact, must determine
whether purported scientific evidence is “reliable” and will “assist the trier of fact,” thereby keeping from juries testimony that  lacks the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.

The manual is intended to assist judges in managing cases involving complex scientific and technical evidence by describing the basic tenets of key scientific fields from which legal evidence is typically derived and providing examples of cases in which that evidence has been used. As the introduction to the new edition notes, the search is not a search for scientific precision. Courts cannot hope to investigate all the subtleties that characterize good scientific work. A judge is not a scientist, and a courtroom is not a scientific laboratory. But the objective is to seek legal decisions that fall within the boundaries of scientifically sound knowledge.

The Manual includes general chapters such as on "The Admissibility of Expert Testimony" and "How Science Works," and specific chapters on (of interest to our readers) Exposure Science,  Epidemiology, and Toxicology, and new chapters on Neuroscience, and Mental Health Evidence. The authors note the new edition has a focus on two critical topics that judges frequently confront, causation and expert bias.

The new edition was produced by a committee of judges, scientific experts, attorneys and academics. Bu it will be interesting to see if readers, after getting a chance to review it, will find that this version inappropriately undermines the Daubert guidelines enunciated by the Supreme Court and overemphasizes the "discretion" of trial judges to "manage" their dockets despite the meaning of the Federal Rules of Evidence.

 

 

Amended Federal Rules Take Effect

Readers will recall from our previous posts that amendments to the Federal Rules of Civil Procedure were in the works for some time.  They finally took effect earlier this month. With regard to Rule 26, the amendments 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 prior 1993 amendments to Civil Rule 26 had 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 rule changes are generally seen as an improvement for trial lawyers.  Experts and attorneys may now communicate more freely, such as by email, instead of engaging in time-consuming dances designed to avoid creating potentially discoverable communications. The amendment allows attorneys and experts to exchange draft reports for review and discussion without fear of the consequence of the production of such communications. It also eliminates attorney time spent trying to negotiate a stipulation with opposing parties in order to avoid disclosure of this type of information. 

The rules still permit discovery of communications related to the experts' compensation, any assumptions provided by counsel to the expert to rely on; and facts or data that counsel provided to the testifying expert.  Time will tell if the courts interpret the latter two as being limited to disclosure of objective information the lawyer provided to the expert, and not the general conversations they had surrounding those facts or interpretations of those facts.  One likely effect is that counsel will want experts, to the extent possible, to find facts and data for themselves in public sources.

 

Causation Expert Opinions Excluded in Toxic Tort Case

A federal judge has issued an opinion explaining her Daubert and summary judgment rulings in a case brought by a consumer who alleged he contracted lung disease from the fumes of microwave popcorn. Newkirk et al. v. ConAgra Foods Inc., No. 2:08-cv-00273 (E.D. Wash. 7/2/2010).

Readers of MassTortDefense may be familiar with the so-called "popcorn lung" litigation in which plaintiffs have alleged they contracted a series of diseases, including Bronchiolitis obliterans, from inhaling the chemical diacetyl which had been used in the artificial butter on microwave popcorn.  Most of the claims have been made by workers with alleged industrial-level exposures on a daily basis in popcorn factories several years ago.  There are, however, a handful of cases by consumers claiming they somehow had sufficient exposure in their homes to have the same respiratory injuries.  These latter cases raise significant issues of general and specific causation, arising from the central tenet of toxicology: the dose makes the poison.  The studies relied on by plaintiffs noted that the cumulative exposure to diacetyl was correlated with chronic effects on lung function in plant workers.

Plaintiff Newkirk claimed that the natural and artificial butter flavoring in ConAgra's Act II Butter and Act II Butter Lovers popcorn products caused him severe and progressive damage to the respiratory system, extreme shortness of breath, and reduced life expectancy.  He claimed that he ate between five and seven bags of ConAgra's popcorn every day for more than a decade.

The motions centered around plaintiff's burden to prove causation. Plaintiffs in toxic tort cases must establish both general and specific causation. Golden v. CH2M Hill Hanford Group, Inc., 528 F.3d 681, 683 (9th Cir.2008). Evidence supporting general causation addresses “whether the substance at issue had the capacity to cause the harm alleged.” In re Hanford Nuclear Reservation Litigation, 292 F.3d 1124, 1133 (9th Cir.2002). Specific causation, by contrast, concerns whether a particular individual suffers from a particular ailment as a result of exposure to the substance. Defendants challenged plaintiff's proof of both under Daubert.

Plaintiffs retained Dr. Egilman to offer an opinion on general causation, as well as to examine Mr. Newkirk, diagnose him, and offer an opinion regarding the specific cause of his condition. The expert opinion testimony of Dr. Egilman was the plaintiffs’ primary evidence supporting general causation. (All of the Newkirks’ other causation expert witnesses assumed that general causation already has been established.)  He opined that,  “There is no known safe level of diacetyl exposure. Existing scientific studies also suggest that levels of diacetyl exposure below and around 1 ppm can cause BO and other respiratory illnesses.”


The court found, however, that Dr. Egilman's attempt to analogize kitchen to industrial exposures failed. He offered no sufficient basis or methodology for support for the conclusion that there is no important (medically relevant) qualitative difference between the vapor from butter flavoring slurry in a mixing vat in a popcorn plant and the vapor from butter flavoring that is emitted from microwave popcorn in the home. There was nothing to support Dr. Egilman’s conclusions that were at the heart of this case: that the vapors emitted from a microwave popcorn bag contain the same proportion of chemicals or in sufficient doses or that all of the substances in the two instances are identical. In other parts of his reports and testimony, the court found, Dr. Egilman relied on some existing data, mostly in the form of published studies, but drew conclusions far beyond what the study authors concluded.

Or, Dr. Egilman manipulated the data from those studies to reach misleading conclusions of his own. Slip opin. at 25. For example, he relied on statements by a Dr. Cecile Rose, on a patient (and another consumer plaintiff), Mr. Watson, who allegedly contracted disease from popcorn fumes. But this was in the nature of a single case report, and in it even Dr. Rose did not assert that her conclusions could be extrapolated to other consumers in the absence of publication or peer review; Dr. Egilman acknowledged that Dr. Rose did not publish the exposure levels measured in Mr. Watson’s home -- so no such comparison was possible.  Dr. Rose herself qualified her conclusions: “It is difficult to make a causal connection based on a single case report. We cannot be sure that this patient’s exposure to butter flavored microwave popcorn from daily heavy preparation has caused his lung disease.” 
 

The expert also relied on testing conducted by Dr. John Martyny in a kitchen (not of a consumer), despite that doctor's own reflections that the methodology underlying the work could not support extrapolating to general causation for a broader group of consumers.  The expert also relied on animal studies. Expert opinion relying on animal studies to reach an opinion on causation in humans is usually admissible only when the expert explains how and why the results of the animal toxicological study can reliably be extrapolated to humans. General Electric Co. v. Joiner, 522 U.S. 136, 143-45 (1997).  Dr. Egilman offered no such analytical bridge between the animal studies finding harm from high levels of diacetyl exposure to lab rats and his conclusion that those studies demonstrate that diacetyl exposure causes decreased lung function in humans. He offered no sufficient explanation for how and why the results of those studies could be extrapolated to humans, let alone low-dose consumer contexts.

Without Dr. Egilman's testimony to support causation, the plaintiffs' other expert witnesses couldn't establish this element either.

Note also that the court excluded Dr. Egilman's "legal conclusions" from his expert report and affidavits, since the witness was no more capable than the fact-finder to draw such a conclusion. See Nationwide Transp. Fin. v. Cass Info. Sys., 523 F.3d 1051, 1059-60 (9th Cir.2008) (expert witness cannot give an opinion as to her legal conclusion, i.e., an opinion on an ultimate issue of law). For example, Dr. Egilman tried to opine that about what the defendant "knew" and "failed to warn" consumers. This is another useful precedent against plaintiffs' mis-use of the conduct "expert" who provides mere legal conclusions and invades the province of the jury.

(Your humble blogger is involved in the diacetyl litigation, but not this case.)

Welding Fume MDL Court Releases "Trial Template"

The Judge overseeing the Welding Fume Products Liability MDL Litigation has issued a “Trial Template” to assist transferor courts in handling the 3,900 remaining cases in the future.  In re: Welding Fume Products Liability Litigation, MDL No. 1535 (N.D. Ohio).

The document outlines the proceedings that have occurred in this MDL since its 2003 inception,
and summarizes the court’s pretrial rulings applicable to every MDL case. (All of this MDL court's written Orders cited in the document are available through the MDL court’s site.)  The stated purpose of the document is to assist trial judges in transferor courts who may preside over the trial of an individual welding fume case, after the Judicial Panel on Multi-District Litigation remands the
case from the MDL court back to the transferor court.

(Another good source on this mass tort for the interested reader is Jowers v. Lincoln Elec. Co., 608 F.Supp.2d 724 (S.D. Miss. 2009), in which the court reviewed all of the parties’ evidence in the context of resolving defendants’ post-judgment motions, filed after the jury reached a rare plaintiff’s verdict in the fourth MDL bellwether trial.)

Key points: since the MDL was created in the U.S. District Court for the Northern District of Ohio in June 2003, more than 9,800 cases have been transferred from other courts, and 2,700 have been removed to or directly filed with the court. Voluntary dismissals, remands and other events have reduced the number of pending cases to approximately 3,900. The gravamen of the complaint in each of these cases is that manganese contained in the fumes given off by welding rods has caused the plaintiff to suffer neurological injury, and the defendant manufacturers of these welding rods failed to warn of this hazard. At trial, defendants typically interpose some or all of the following fact-based defenses: (1) the warning language defendants used was adequate; (2) the plaintiff did not prove he used a particular defendant’s welding rods; (3) the plaintiff did not prove he saw a particular defendant’s warnings; (4) the plaintiff did not prove his neurological condition was caused by exposure to welding fumes; (5) the plaintiff’s neurological condition is not manganese-induced "Parkinsonism," it is something else (e.g., psychogenic movement disorder); (6) the defendants are immune pursuant to their role as government contractors; (7) the defendants are not liable because the plaintiff’s employer was a learned intermediary; (8) the defendants are not liable because the plaintiff was a sophisticated user; (9) the plaintiff did not prove that a better warning would have made any difference; (10) the plaintiff is, to some degree, responsible for his own injuries under the theories of contributory negligence, comparative negligence, or assumption of the risk; and (11) punitive damages are not available because the plaintiff did not present clear and convincing evidence of gross negligence.

The MDL court presided over six bellwether trials and is now in the process of suggesting remand to transferor courts of cases that have become close to trial-ready, the judge said. The court has so far applied the laws of five states in MDL bellwether trials: Mississippi, Texas, South Carolina, California, and Iowa. The parties sometimes, but not always, have agreed on which state’s law applies. In cases of disagreement, the choice-of-law analysis a transferor court will have to apply is likely to be fact-specific.

The court has granted summary judgment to certain defendants (MetLife & Caterpillar) in all welding fume cases. Further, the Court entered a “Peripheral Defendant Dismissal Order,” dismissing without prejudice all defendants in every case except those against whom a given plaintiff is most likely to proceed at trial. Still remaining as defendants in virtually every case are five of the biggest welding rod manufacturers: (1) Lincoln Electric Company, (2) BOC Group (formerly known as Airco) (3) ESAB Group, (4) TDY Industries (formerly known as Teledyne Industries and Teledyne McKay), and (5) Hobart Brothers Company. Defendant-specific discovery in each case may lead to dismissal of some of these five defendants, and possibly to renaming of some previously-dismissed defendants, the court observed. 

Regarding discovery, the parties have engaged in huge amounts of generic discovery directed at
information potentially relevant to every case. This includes, for example, the defendants’ alleged historical knowledge of the hazards posed by welding fumes, the warnings defendants provided to welders over time, and the state of medical and scientific knowledge regarding neurotoxicity of manganese in welding fumes. For the most part, the parties have completed all general discovery. To prepare for trial in a specific welding fume case, the parties must engage in substantial case-specific discovery directed at information relevant to the individual plaintiff’s particular claims and circumstances. This discovery typically will address the plaintiff’s employment history, medical history, and welding experiences. The court observed that at least some of this plaintiff-specific discovery may not occur until after the MDL court has remanded the case to the transferor court. Accordingly, a transferor court may need to oversee some aspects of case-specific discovery.

As to plaintiffs, about ten years ago, the national plaintiffs’ bar engaged in a concerted effort to notify welders that, if they suffered from a movement disorder, their neurological injury might be caused by exposure to welding fumes. The MDL court then imposed several obligations on plaintiffs’ counsel to ensure they intend to actually try the cases they filed. These additional obligations include the filing of: (1) a “Notice of Diagnosis” of neurological injury, signed by a medical doctor; and (2) a “Certification of Intent to Try the Case,” to be submitted by plaintiff’s counsel following initial medical records discovery. These obligations have winnowed the plaintiffs’ cases substantially, so the MDL court believes that there is some likelihood that a case remanded to a transferor court will go to trial.

On the expert front, the parties sought to introduce at trial testimony from a plethora of experts in a number of fields, including neurology, neuro-pathology, neuro-psychology, neuro-radiology, epidemiology, bio-statistics, industrial hygiene, industrial engineering, chemistry, materials science, toxicology, warnings, corporate ethics, military specification and procurement, economics, government lobbying, and ancient corporate documents. Early in this MDL, the court held a multi-day Daubert hearing to determine the admissibility of opinions offered by these experts. Further, the court engaged in additional analyses of the admissibility of expert testimony prior to each MDL
bellwether trial.

Before each MDL bellwether trial, the parties filed numerous motions in limine addressing the admissibility of various pieces of evidence, ranging from critical documents to relatively short comments made by witnesses. The court reviews each of those rulings in this latest document.  Similarly, the court had ruled on a number of motions for summary judgment as a matter of state and federal law. These motions are also described in the document.  For example, to prevail on his product liability claims against a particular manufacturing defendant, a welding fume plaintiff must show he actually used that manufacturer’s products. Because many plaintiffs worked as welders for a variety of employers in different locations over many years, and because welding rods are somewhat fungible, the discovery of product identification evidence can be difficult, and the results less than clear, said the court. Whether a given defendant is entitled to judgment as a matter of law based on lack of product identification is a highly fact-specific question, and the answer as to certain defendants in certain cases may not become clear even until after trial.

Finally, the court provides a number of useful appendices and charts, including MDL Bellwether Trial Result Summary and MDL Bellwether Trial Witness Chart.