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IN RE EPHEDRA PRODUCTS LIABILITY LITIGATION

September 19, 2005.

In re: EPHEDRA PRODUCTS LIABILITY LITIGATION.


The opinion of the court was delivered by: JED RAKOFF, District Judge

OPINION AND ORDER

In Case Management Order No. 14 dated June 23, 2005, the Court granted in part and denied in part the respective motions of the Defendants' Coordinating Counsel (the "DCC") and Plaintiffs' Coordinating Counsel (the "PCC") to exclude, pursuant to Rule 702, Fed.R.Evid., and Daubert v. Merrell Dow Pharm., 509 U.S. 579 (1993), the testimony of certain "generic" experts. Specifically, the Court held that
[t]he PCC's experts shall not be permitted to testify with "medical certainty" or "scientific certainty" that ephedra caused the alleged injuries. However, they will be permitted to testify (if otherwise admissible under applicable state and federal law) that ephedra may be a contributing cause of stroke, cardiac injury, and seizure in some people. A Memorandum Order [or, as here, an Opinion and Order] further detailing and elaborating on these ruling and including other holdings, such as more particularized rulings on the opinions offered by Dr. James Knochel and Dr. Kristie L. Ebi, will be filed in due course.
Case Management Order No. 14, June 23, 2005, ¶ 3. As promised, this Opinion and Order serves to explain, elaborate, and refine those determinations and decide certain related, outstanding issues.

By way of background, there are presently consolidated before the Court about 500 civil actions claiming personal injury or wrongful death caused by dietary supplements containing ephedra. Some 360 were transferred here pursuant to 28 U.S.C. § 1407 for pretrial purposes only, while the remainder — cases against the former Twin Laboratories Inc., a debtor in bankruptcy in this district, plus a few other cases commenced in this district — are here for all purposes. Following consolidation, the Court issued Case Management Order No. 1, dated April 26, 2004, which among other things, provided that the PCC

 
shall identify, in a document served on all parties, generic expert witnesses who are reasonably expected to testify [at subsequent trials] for the plaintiffs on issues of general or widespread applicability ("Generic Experts"), including, but not limited to, experts who will testify on general causation. The plaintiffs may identify up to three Generic Experts with respect to each of the following categories of injuries: (a) ischemic stroke, (b) hemorrhagic stroke, (c) seizures, (d) cardiac injury, (e) psychotic injury, and (f) primary pulmonary hypertension. For each Generic Expert so identified, Plaintiffs' Coordinating Counsel, on behalf of all plaintiffs, shall serve upon all parties the disclosures required by Fed.R.Civ.P. 26(a)(2), except that such disclosures need not include such testimony, if any, that such Generic Expert is expected to offer relating only to liability or damages as to a particular plaintiff.
Case Management Order No. 1, April 26, 2006, at 22-23. Further, the Order permitted the DCC to designate responsive generic experts and directed the PCC and DCC to complete generic-expert depositions and make any Rule 702 motions by specified dates. By subsequent agreements approved by the Court, heat-related injury was added as a topic for generic experts, while psychotic injury and pulmonary tension were removed from the generic expert category and made the responsibility of counsel in individual cases.

  In compliance with the foregoing, the DCC moved in December 2004 to exclude the testimony of all nine generic experts designated by the PCC, while the PCC moved to exclude the testimony of one of the DCC's designated experts. In January and February 2005, the Court held an extensive "Daubert" hearing, at which all ten challenged experts testified and were cross-examined, along with two other experts called by the DCC in support of their motion. In addition, hundreds of documents — mainly articles from medical journals and textbooks — were received as exhibits at the hearings. (They will be referred to hereafter as "PCC Exh. ___" and "DCC Exh. ___".) The parties then submitted post-hearing briefs and made their closing oral arguments on March 16, 2005.

  Ephedra is plant, also known by the Chinese name ma huang, that contains several chemically related biologically active substances known as "ephedrine alkaloids."*fn1 The ephedra products in these cases combined ephedra with caffeine and were marketed to consumers seeking weight loss, increased energy and improved athletic performance. The predominant ephedrine alkaloid in all the products was ephedrine itself, which is chemically identical to the synthetic ephedrine contained in some pharmaceutical products. Since ephedrine accounts for more than 70% of the ephedrine alkaloids in ephedra, and since the others have similar (though not identical) biological effects, the parties, experts and scientific literature often use data on synthetic ephedrine as a surrogate for data on the mix of ephedrine alkaloids found in ephedra products. The label of Metabolife 356 (the most widely distributed product involved in the pending cases) states a "suggested use" of one or two capsules every four hours with a maximum of eight capsules per day, which adds up to 96 mg per day of ephedrine alkaloids. PCC Exh. 16. The main issue presented by the DCC's motion to exclude the PCC's generic experts is whether there may be introduced into evidence, consistent with the requirements of Rule 702, testimony that ephedra causes strokes, heart attacks, and heat stroke (the "listed injuries"). This is often referred to as an issue of "general causation" (i.e., does use of ephedra cause a given kind of injury), as opposed to specific causation (i.e., did a given person's use of ephedra cause his particular injury). While many federal cases state that a plaintiff, in order to recover in a "toxic tort" case, must prove both general and specific causation, see, e.g., In re Rezulin Products Liability Litigation, 369 F. Supp. 2d 398, 401-02 & n. 9 (S.D.N.Y. 2005) (collecting cases), in the cases here consolidated what plaintiffs must prove is determined by state law. Neither side here, however, has suggested that general causation is not a requirement under the law of the relevant states, and the Court will so assume for purposes of this motion.

  Assuming, then, that general causation is part of what any plaintiff here must prove in order to ultimately prevail, expert testimony about general causation is sufficiently reliable to be admissible under Rule 702 if "(1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case." Rule 702, Fed.R.Evid.

  In contending that the PCC's generic experts fail to meet these requirements, the DCC's primary argument is as follows: The parties agree that any listed injury caused by ephedra would manifest itself within a relatively short time after ingestion. Tens of thousands of people have used ephedra products at recommended doses without manifesting a listed injury, and millions of people have suffered the listed injuries without using ephedra. Where a listed injury has occurred, there is no post-injury examination or autopsy that can determine whether the injury was caused by ephedra. Under these circumstances, the only scientifically valid way to prove general causation is by controlled epidemiological studies with statistically significant results showing that ephedra (or ephedrine) materially increases the risk of the listed injuries. Since there are no such studies yielding such results, the PCC's experts should be excluded because their opinion that ephedra causes the listed injuries is not scientifically valid and therefore not reliable under Rule 702.

  This argument finds superficial support in certain dictum in Daubert, where the Supreme Court stated that "[i]n a case involving scientific evidence, evidentiary reliability will be based upon scientific validity." Id. at 591 n. 9 (emphasis in original). Nevertheless, for reasons developed below, the Court is persuaded by the DCC's view of science but not by its interpretation of the law. The evidentiary hearings demonstrated that general causation has not been established by scientific standards of proof. Accordingly, the PCC's witnesses will not be permitted to testify with any degree of medical or scientific "certainty" that ephedra causes the listed injuries. However, the absence of epidemiological studies establishing an increased risk from ephedra of sufficient statistical significance to meet scientific standards of causality does not mean that the causality opinions of the PCC's experts must be excluded entirely. The hearings also demonstrated that the PCC's experts have a reliable basis for forming a professional opinion that ephedra may be a contributing cause of cardiac injury and stroke in some people, such as those with a heart condition, high blood pressure, or a genetic sensitivity to ephedrine, if that opinion is appropriately qualified. Accordingly, the PCC's experts will be permitted to express that opinion (if relevant) at trial, provided that they qualify it with a statement that there is not enough data to prove it definitively and that controlled studies, if and when they are done, may disprove it.*fn2 Turning first to the legal standard: although, as noted, there is dictum in Daubert that could be read to support the DCC's position, it must be read in light of the subsequent development of the law. After Daubert, the Supreme Court decided two more Rule 702 cases,*fn3 and then promulgated an amendment to Rule 702 that took into account not only the three Supreme Court opinions but also many post-Daubert decisions of the lower courts. See Rule 702, Committee Notes on Rules, 2000 Amendment.

  Even prior to the amendment to Rule 702, two Second Circuit holdings had rejected the argument that Daubert requires exclusion of a causation opinion unless it is based on published studies. Zuchowicz v. United States, 140 F.3d 381, 386-87 (2d Cir. 1998); McCullock v. H.B. Fuller Co., 61 F.3d 1038, 1043-44 (2d Cir. 1995). After the amendment to Rule 702, a third Second Circuit decision, Amorgianos v. National Railroad Passenger Corp., 303 F.3d 256 (2d Cir. 2002), signaled the continuing authority of Zuchowicz and McCullock under the amended Rule by repeatedly citing and relying on them. Id. at 265-67.

  Zuchowicz and McCullock stand for the proposition that "differential etiology" properly performed by a qualified physician is sufficiently reliable to render admissible the physician's opinion on causation. McCullock describes differential etiology as a "scientific analysis" which "requires listing possible causes, then eliminating all causes but one." 61 F.3d at 1044. It is a method of legal proof approved by the Second Circuit for showing the external cause (e.g., ephedra) of an injury. Some other courts call this method of proof "differential diagnosis," borrowing from medicine the name of a technique used to identify the disease or disorder causing observed symptoms, for the purpose of treatment and prognosis. See REFERENCE MANUAL ON SCIENTIFIC EVIDENCE (Federal Judicial Center, 2d ed. 2000) at 443-444. What differential diagnosis in medicine and differential etiology in law have in common is the use of medical knowledge, training and experience to list and eliminate possible causes. The legal analysis in individual cases often does not separate general and specific causation as has been necessary here in order to decide together issues of general causation that are common to dozens of MDL cases. Nevertheless, the experts in Zuchowicz and McCullock, when they listed the possible causes, were stating an opinion on general causation.

  In McCullock, in particular, the court affirmed admission of a physician's causation opinion even though he "could not point to a single piece of medical literature that says glue fumes cause throat polyps." 61 F.3d at 1043. Here, in contrast, the PCC's experts cite a considerable amount of medical literature supportive of their view — just none reporting controlled epidemiological studies with statistically significant results showing general causation. Any rule that would automatically exclude causation testimony unless it is based on such studies is irreconcilable with Zuchowicz and McCullock and with the admonition in Amorgianos that "[s]uch a bright-line requirement would be at odds with the liberal admissibility standards of the federal rules and the express teachings of Daubert" about the need for flexibility in the district court's gate-keeping role. 303 F.3d at 267.

  Under Rule 702, federal courts routinely permit witnesses with "technical or other specialized knowledge" to state opinions on matters where the data falls short of proving the witness's conclusion. For example, an art appraiser testifying about a painting's authenticity might state an opinion based in part on scientific analysis, but the ultimate conclusion would come from the witness's specialized knowledge, training and experience. Scientists, too, form professional opinions that are reasonably based on "good science" but where the data is insufficient for definitive scientific proof. To hold the opinions of scientists inadmissible unless backed by statistically significant results from tightly controlled (and very expensive) experiments would set a separate, higher standard for scientists than for other witnesses with specialized knowledge.

  Such a difference is without support in the language of Rule 702 itself, which "makes no relevant distinction between `scientific' knowledge and `technical' or `other specialized' knowledge." Moreover, there is no "convincing need to make such distinctions. Experts of all kinds tie observations to conclusions through the use of what Judge Learned Hand called `general truths derived from . . . specialized experience.'" Kumho Tire, 526 U.S. at 148, quoting L. Hand, Historical and Practical Considerations Regarding Expert Testimony, 15 Harv. L. Rev. 40, 54 (1901). The Court in Kumho Tire rejected the view that Rule 702 sets a lower standard for witnesses with "technical or other specialized knowledge" than for ...


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