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In re Human Tissue Products Liability Litigation

October 22, 2008

IN RE HUMAN TISSUE PRODUCTS LIABILITY LITIGATION


The opinion of the court was delivered by: Hon. William J. Martini

MDL No. 1763

OPINION

THIS DOCUMENT RELATES TO: ALL CASES

TABLE OF CONTENTS

I. BACKGROUND

II. PROCEDURAL HISTORY

III. DISCUSSION

A. Defendants' Motion to Exclude the Proposed Testimonies of Plaintiffs' Experts

1. Standard for Admissibility of Expert Testimony under Fed. R. Evid. 702

2. Application of Rule 702 to Plaintiffs' Proposed Experts

i.) Relevant Medical and Scientific Studies and Literature

a) Epidemiological Studies

b) Animal Studies

c) Laboratory Studies

d) Studies regarding the Incubation Period

ii.) Dr. Suzanne Parisian

iii.) Dr. John Kowalski

iv.) Dr. Andrew Klein

v.) Dr. Cosme Manzarbeitia

3. Conclusion on the Admissibility of Plaintiffs' Expert Testimonies

B. Defendants' Motion for Summary Judgment

1. Standard of Review

2. Uncontested Facts

3. Unprocessed Bone Tissue Stored at Room Temperature for More than Thirty Days

i.) Syphilis

ii.) Cancer

iii.) HIV

iv.) HBV & HCV

4. Transmission of Prion Diseases

5. Bone Paste

6. Incubation Period of HIV, HBV, HCV, and Syphilis

i.) HIV

ii.) HBV & HCV

7. Appropriateness of Summary Judgment

8. Conclusion on Defendants' Motion for Summary Judgment

C. Plaintiffs' Motion for Summary Judgment and Motion to Exclude Certain of Defendants' Expert Testimonies

IV. CONCLUSION

MARTINI, U.S.D.J.

This multidistrict litigation arises from a criminal enterprise by Biomedical Tissue Services, Ltd. ("BTS") and its principal Michael Mastromarino to harvest tissue from human corpses without obtaining proper consents and following appropriate regulations. The plaintiffs in this litigation include the recipients of processed tissue supplied by BTS as well as those relatives of the deceased donors. The defendants in this litigation include the principals in the criminal operation, the funeral homes that provided BTS access to the corpses, the companies who processed tissue recovered from cadavers by BTS into various medical products, the distributors of the processed tissue products, and the hospitals and medical personnel who transplanted the processed tissue product. Certain of these defendants have jointly moved for summary judgment on the issue of general causation*fn1 for the various tort claims asserted by the recipient plaintiffs, who allegedly suffered harm from the processed tissue product. The recipient plaintiffs have opposed the motion and filed a cross-motion for summary judgment. Additionally, the parties have sought to exclude the proposed testimonies of their respective experts on the issue of general causation. For the reasons articulated below, the defendants' motion to exclude the proposed testimony of four of recipient plaintiffs' experts and motion for summary judgment are GRANTED IN PART and the recipient plaintiffs' motion to exclude the proposed testimony of six of defendants' experts and cross-motion for summary judgment are RESERVED.

I. BACKGROUND*fn2

The product at issue in this products liability litigation involve human allografts. Human allografts are comprised of tissue recovered from a cadaver for use in surgical procedures. Under federal law, tissue recovery agencies may procure human organs and tissue from deceased human donors after meeting applicable regulations, including obtaining proper donor consent and screening donors for certain infectious diseases. The tissue recovery agency sends the tissue to processing companies regulated by the U.S. Food and Drug Administration ("FDA"). These processing companies manufacture allografts from the recovered tissue by disinfecting, sterilizing, or both and then package the allografts for distribution to hospitals for use in surgical procedures. The allografts are transplanted into patients for the treatment of various medical conditions. For example, bone allografts are processed pieces of bone that are transplanted into and incorporated by a recipient and are used for procedures such as spinal fusion surgery.*fn3

All of the tissue at issue in this litigation was recovered by the now-defunct recovery agency, BTS. Pursuant to various agreements with tissue processors, BTS was responsible for obtaining valid donor consents, screening donors, providing samples of donors' blood for testing, and adhering to all federal and state regulations governing tissue recovery. The tissue processors manufactured and packaged allografts from the tissue recovered by BTS. These allografts were then distributed to various hospitals and surgical centers by a distributor such as SpinalGraft Technologies, LLC. Thereafter, the allografts were used during surgery and implanted into recipients.

BTS's criminal scheme was discovered in 2005. In September and October 2005, tissue processors announced a voluntary market withdrawal and recall of allograft recovered by BTS. On October 26, 2005, the FDA issued an announcement that identified tissue recovered by BTS as having originated "from human donors who may not have met FDA donor eligibility requirements and who may not have been properly screened for certain infectious diseases." (Bense Decl. Ex. 63, Oct. 16, 2007.) Thus, the FDA advised testing for certain infectious diseases and stated, "because of the potential lack of proper screening of the tissue donors, some recipients of the tissues may be at increased risk of infections that could potentially be transmitted through tissues." (Bense Decl. Ex. 63, Oct. 16, 2007.) Furthermore, FDA and Center for Disease Control ("CDC") suggested, that implanting physicians inform their patients that they may have received tissue from a donor for whom an adequate donor eligibility determination was not performed. While the overall infectious risk is likely low, FDA and CDC recommend that physicians offer to provide patients access to appropriate infectious disease testing. The relevant communicable diseases for which a tissue donor is required to be tested are HIV-1 and 2 (the viruses that cause AIDS), hepatitis B virus, hepatitis C virus, and syphilis.*fn4

(Bense Decl. Ex. 63, Oct. 16, 2007.)

In response to the concern regarding the potential for the transmission of blood-borne diseases*fn5 through BTS-recovered tissue, Medtronic Sofamor Danek USA, Inc. offered free blood tests for those patients who received allografts subject to the FDA recall and distributed by SpinalGraft Technologies, Inc. on November 8, 2005. (Initial Submission of Defs. Medtronic, Inc., Medtronic Sofamor Danek USA, Inc., Spinalgraft Technologies, LLC, and Regeneration Technologies, Inc. 17-18.) The FDA subsequently ordered the cessation of BTS operations and recalled all tissue products recovered by BTS. Several individuals involved in the BTS operation were indicted on February 22, 2006, and certain of those individuals have since pled guilty to crimes related to the unauthorized recovery of tissue and falsification of donor records.

Civil litigation followed the discovery of the criminal scheme. The lead case in this litigation, Sechtin v. Regeneration Technologies, Inc., Civ. No. 06-0135, was filed in the United States District Court for the District of New Jersey on January 9, 2006. On June 21, 2006, the Judicial Panel on Multidistrict Litigation consolidated the cases arising out of BTS's illegal scheme as In re Human Tissue Products Liability Litigation, MDL No. 1763, and assigned the litigation to this Court for pretrial proceedings. There are now approximately 353 federal cases consolidated before this Court, and additional cases are pending in numerous state courts.

These complaints have been brought by both individual plaintiffs and by representatives of putative class actions.*fn6 Although the complaints contain a range of claims, the complaints can be categorized generally as: (1) tort claims, such as battery, negligence, product liability, breaches of express and implied warranties, emotional distress, and medical monitoring, by those plaintiffs who allege that they have either contracted a disease, or are in fear of contracting a disease, from transplantation of BTS-recovered allografts;*fn7 and (2) tort claims, predominately alleging emotional distress, by those relatives of decedents whose tissue was recovered by BTS. The pending motions deal with the former category of plaintiffs--those who claim that they have contracted, or are in fear of contracting, infectious diseases from BTS-recovered allografts (hereinafter,"Plaintiffs").

Defendants have argued generally that BTS-recovered allografts are incapable of infecting recipients with certain diseases due to the methods employed by the processing companies to disinfect and sterilize the allografts.

(Defs. Regeneration Technologies, Inc., Medtronic, Inc., Medtronic Sofamor Danek USA, Inc., and SpinalGraft Technologies, LLC, Mot. to Dismiss All Pls.' Claims Because RTI's Sterilized Tissue Allografts are Incapable of Transmitting Disease 3.) For example, Regeneration Technologies, Inc. ("RTI"), a tissue processing company, applies the following sequence of processing for bone allografts: tissue debridement and quality evaluation, bone processing, BioCleanse*fn8 processing, lyophilization ("freeze-drying"), packaging and labeling, and gamma irradiation and sterrad. (Bense Decl. Ex. I, Oct. 16, 2007.) Thus, Defendants argue, even if the recovery agency failed to properly screen donors to minimize the risk of disease transmission, no virus could survive the sterilization process and storage at room temperature for a prolonged period of time. (Defs.' Initial Submission 24-25; Defs.' Mot. to Dismiss 3.)

Pursuant to the Court's duty as the transferee court in this multidistrict litigation, the Court undertook active case management at the outset of this litigation and sought to identify common issues of fact and law in consultation with the parties. After numerous pretrial orders and conferences, Defendants jointly moved to dismiss Plaintiffs' complaints for failure to state a claim on October 20, 2006 ("Science First Motion"). Orders by Magistrate Judge Ronald Hedges refined the subject of the Science First Motion, and the motion was fully briefed on February 16, 2007.

Oral arguments were held by the Court on March 28, 2007, and at that time, the Court reserved on the Science First Motion and indicated its inclination to convert the motion to dismiss into a summary judgment motion on the issue of causation. The Court, therefore, invited the parties to propose questions to be addressed by further briefing and with the benefit of limited discovery. A continuation of the March 28th hearing was held on April 11, 2007, and after considerable input from the parties, the Court settled upon elements of causation as an initial subject for pretrial disposition. The parties were directed to address the following questions:

(1) Assume bone tissue from a cadaver that has been infected with hepatitis B, hepatitis C, HIV, syphilis, cancer (all types), and prions, and has not undergone any processing, is stored at a temperature of [blank] for [blank] days, can the bone tissue still transmitone of these viruses/diseases to a donee?

(2) What is the incubation period for hepatitis B, hepatitis C, HIV, syphilis, cancer (all types), and prions?

(Pls.' Letter to the Ct., June 29, 2007.) The Court invited the parties to supplement their initial Science First Motion submissions with additional expert discovery in response to the Court's two proposed questions. The parties conducted limited discovery, including expert depositions, and submitted supplemental affidavits and supporting documents from their respective experts to the Court. On August 2, 2007, the Court set a briefing schedule for the converted summary judgment motions and motions to exclude the proposed testimony of experts pursuant to Fed. R. Evid. 702 and Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993).

The two discrete questions of science before the Court focus upon certain common elements of causation in this litigation. These questions do not take into consideration any of the sterilization processes that the tissue processing companies allege were employed in manufacturing the bone allografts prior to distribution. The sterilization procedures would arguably be additional steps in ensuring that the bone allografts do not infect recipients with infectious diseases.*fn9

Therefore, the Court is mindful that the present motions only assess the potential for the transmission of diseases short of sterilization. At this juncture, the Court is not assessing whether the tissue processing companies' sterilization procedures prevent the transmission of infectious diseases.*fn10

II. PROCEDURAL HISTORY

Presently, there are several motions pending before the Court on the identified issues of causation. Defendants jointly filed a motion for summary judgment on October 16, 2007.*fn11 Plaintiffs opposed Defendants' motion and submitted a Cross-Motion for Summary Judgment on November 21, 2007. As of December 14, 2007, both summary judgment motions were fully briefed.

In addition, Defendants moved jointly to exclude the proposed testimony of four of Plaintiffs' experts, Suzanne Parisian, M.D., John Kowalski, Ph.D., Andrew Klein, M.D., and Cosme Manzarbeitia, M.D., on October 17, 2007. (Docket No. 433.) Plaintiffs opposed Defendants' motion to exclude. Plaintiffs also submitted a motion to exclude the proposed testimony of six of Defendants' experts, Douglas Richman, M.D., Margaret Koziel, M.D., Marion Kainer, M.B., M.P.H., William Rutala, Ph.D., William Jarvis, M.D., and Daniel Kuritzkes, M.D., on December 17, 2007. (Docket No. 542.) Defendants opposed the motion. Both motions to exclude were briefed by January 28, 2008.

On February 27, 2008, the parties informed the Court of their intention to pursue formal mediation pursuant to L. Civ. R. 301.1. Therefore, this Court ordered a stay on all motions pending mediation on March 3, 2008. On June 5, 2008, the Court was informed that the mediation was unsuccessful, and the stay was subsequently lifted.

On September 4, 2008, the Court conducted a day of oral arguments on both parties' motions for summary judgment as well as their respective motions to exclude the proposed testimonies of various experts. Without objection from any of the parties in this litigation, the Court determined that an evidentiary hearing, including additional testimony from the experts, on the motions to exclude was unnecessary as the parties had submitted all relevant evidence in support of their motions.*fn12 The parties' motions are now properly before the Court.

III. DISCUSSION

A. Defendants' Motion to Exclude the Proposed Testimonies of Plaintiffs' Experts

In concert with the issues raised in Defendants' summary judgment motion, Defendants moved to exclude the proposed testimonies of Drs. Parisian, Kowalski, Klein, and Manzarbeitia regarding the transmission of HBV, HCV, HIV, syphilis, cancer or prion disease through the transplantation of unprocessed human cadaveric bone tissue stored at room temperature for a given period of time. Defendants also moved to exclude the proposed testimonies of Drs. Klein and Manzarbeitia regarding the length of the incubation period, or the time between exposure to and detection of an infection, for HBV and HCV. Defendants argued generally that the proposed testimonies of these experts failed to meet the standards for the admission of expert evidence under Fed. R. Evid. 702 and Daubert. Plaintiffs opposed the motion and argued that their experts' opinions satisfied the evidentiary standards for the admission of expert testimony. The motion has been fully briefed along with all supporting documentation.

After conducting a searching review of the parties' submissions and thoroughly considering all of the motions, it is clear to the Court that the central conflict among the parties involves time, not capacity. For the purposes of these motions, there is no genuine conflict among the parties that unprocessed bone tissue stored at room temperature*fn13 can transmit HIV, HBV, HCV, syphilis, and cancer. Rather, the real issue before this Court is for what period of time can such bone tissue transmit these diseases--is it a matter of hours, days, months, or years? The parties agree that unprocessed bone tissue stored at room temperature is capable of transmitting these diseases for some initial period of time. The parties diverge, however, on the issue of transmission after thirty days. Defendants contend that the transmission of disease cannot occur after thirty days, and Plaintiffs have sought to extend the period of transmission beyond thirty days. Similarly, with respect to the incubation period for hepatitis and HIV, Defendants contend that HBV, HCV, and HIV infections can be detected within six months, while Plaintiffs argue that the detection of HBV and HCV infection can take up to two years and HIV between six to eight months. Defendants' motion to exclude challenges whether Plaintiffs' experts have reliably concluded that the diseases at issue can be transmitted beyond thirty days and that the incubation periods for HBV, HCV, and HIV are beyond six months. Thus, the question that the Court is addressing in the present motion is whether Plaintiffs' expert opinions, extending the transmission and incubation periods of these diseases, is based upon reliable scientific and medical knowledge or whether they are based upon subjective belief and unsupported speculation.

1. Standard for Admissibility under Fed. R. Evid. 702

Under the Federal Rules of Evidence, the trial court acts as a gatekeeper in ensuring the relevance and reliability of all expert testimony. See Pineda v. Ford Motor Co., 520 F.3d 237, 243 (3d Cir. 2008). Fed. R. Evid. 702 governs the admissibility of expert testimony, and it provides that:

If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, 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 articulates three fundamental requirements: (1) the expert must be qualified to render his or her opinion; (2) the scientific process or methodology employed by the expert in rendering his opinion must be reliable; and (3) the expert's testimony must assist the trier of fact. See Pineda, 520 F.3d at 244. In short, an expert's conclusion must meet the "trilogy of restrictions on expert testimony: qualification, reliability and fit." Schneider v. Fried, 320 F.3d 396, 404 (3d Cir. 2003). The party offering the proposed expert testimony bears the burden of establishing the admissibility of the testimony by a preponderance of the evidence. See Padillas, 186 F.3d at 417-18.

Experts are qualified to render an opinion when he or she "possesses specialized expertise." Pineda, 520 F.3d at 244 (quoting Schneider, 320 F.3d at 404). This qualification requirement is interpreted liberally, and formal education as well as a "broad range of knowledge, skills, and training" may provide the necessary qualifications. Id. (quoting In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 741(3d Cir. 1994)). Consistent with this liberal policy of admissibility, courts have been cautioned not to exclude expert testimony merely because the court feels that the expert is not the best qualified or that the expert does not possess the most appropriate specialization. Id. (citing Holbrook v. Lykes Bros. S.S. Co., 80 F.3d 777, 782 (3d Cir. 1996)).

The second prong of admissibility under Rule 702 requires a determination of the reliability, or inquiry into the underlying substance, of the expert's opinion. Expert testimony is "admissible so long as the process or technique used in formulating the opinion is reliable," and the principles and methods employed by the expert are applied reliably to the facts of the case. Id. at 247 (citing Paoli, 35 F.3d at 742); Fed. R. Evid. 702 advisory committee's note. An "expert's opinions must be based on the methods and procedures of science, rather than on subjective belief or unsupported speculation." Paoli, 35 F.3d at 742 (citations and internal quotations omitted). Thus, "the expert must have 'good grounds' for his or her belief." Id. (quoting Daubert, 509 U.S. at 590). These good grounds must support each step of the analysis and "any step that renders the analysis unreliable under the Daubert factors renders the expert's testimony inadmissible." Id. at 745.

In determining the reliability of expert testimony, trial courts have been directed to consider the following Daubert-related factors: (1) whether the scientific method or theory can be or has been tested; (2) whether the method or theory has been subject to peer review and publication; (3) the known or potential rate of error when applied; (4) the existence and maintenance of standards and controls; (5) whether the method or theory is generally accepted in the scientific community; (6) the relationship of the technique or theory to methods or theories which have been established to be reliable; (7) the qualifications of the expert witness testifying based on the methodology or theory; and (8) the non-judicial uses to which the method or theory has been put. United States v. Mitchell, 365 F.3d 215, 234-35 (3d Cir. 2003) (listing factors under Daubert, 509 U.S. at 593-95, and United States v. Downing, 75 ...


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