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Using Science Day to Your Advantage

The more I’m learning about this, the less I know.

District Court Judge Patti B. Saris
in Average Wholesale Pricing Multidistrict Litigation

A judge’s docket includes a wide range of cases which may deal with issues as diverse as landlord-tenant, employment, child support, and medical malpractice. It comes as no surprise then that a judge, unlike the lawyers on both sides, is unable to devote a significant amount of time to learning about the complicated scientific or technological issues usually involved in pharmaceutical and medical device cases. When the time comes to educate the court about your company’s product or business, what is the best way to do it? The use of court tutorials, or a “Science Day,” devoted to teaching the court — in a neutral setting — the science involved in your case is becoming more popular. An effective presentation of your position through counsel and experts can set the tone for your case.

When Have Courts Allowed Tutorials?

The idea of educating a court about complex issues unique to the case through a tutorial is not new. The ABA Civil Trial Practice Standards, the Federal Judicial Center’s Manual for Complex Litigation and Reference Manual on Scientific Evidence all endorse tutorials as one way to educate the court on the fundamental issues in the litigation.1  Courts in patent cases frequently order tutorials providing background and education on the technology implicated by the presented claim construction issues. As noted by the United States District Court for the Eastern District of Virginia, “in those instances where the patent subject matter is especially complex and abstruse, district judges may consider extrinsic evidence (usually in the form of expert affidavits, tutorials, or hearing testimony) in the quest to gain further assistance in understanding the underlying science or technology.”2

Like patent cases, pharmaceutical or medical device products liability cases are also rife with complex scientific issues. Over a decade ago, litigants presented an all-day “tutorial” to the court on the science related to silicone breast implants and the plaintiffs’ claimed injuries.3 The tutorial prompted the court to appoint technical advisors who ultimately recommended excluding much of the expert evidence supposedly supporting a causal link between breast implants and the plaintiffs’ claimed injuries.4

More recently, judges in coordinated products liability proceedings have been using “private educational meetings to inform the judicial officers on the science behind the product.”5 For instance, the judges in coordinated proceedings concerning products liability claims against the manufacturers of NuvaRing,® Fosamax,® Ortho Evra® products, Bextra, ® and Celebrex® have each ordered a “Science Day” for tutorials presented by the parties.6

Courts have also benefitted from tutorials in complicated business and antitrust matters. For instance, in In re Pharmaceutical Industry Average Wholesale Price Litigation, some of the defendants asked to present a tutorial relating to drug pricing and reimbursement prior to a class certification hearing to ensure “that the Court’s decision is based on a clear understanding of the relevant facts.”7 The judge granted this request and allowed each side to present a “general overview of pricing reimbursement and distribution of pharmaceutical products in the United States.”8

What issues are addressed?

Courts ordering tutorials are clear that “[t]he focus of the presentations shall be solely on education, not argument.”9 In products liability cases involving pharmaceuticals or medical devices, the court tutorials have focused on the type of injuries claimed in the litigation, the terminology used to discuss the product and the injuries claimed, and how the medication or device works and affects the body. But within this discussion, the court may allow the parties to present the science on whether or not the product is associated with the claimed injury. For example, in the NuvaRing® multidistrict litigation, the “Science Day” will address, among other things, “whether the use of the NuvaRing® increases the propensity of blood clot formations leading to potential deep vein thrombosis and/or pulmonary embolism.”10

How has the information been presented?

There is no single format for a court tutorial. The format of the presentation is almost always determined in advance by agreement of the parties and then presented to the court for consideration. The ABA Civil Practice Standards indicate that courts may consider the following presentation formats:

  • An in-court or recorded presentation by an expert jointly selected by the parties;
  • An in-court or recorded presentation by one or more experts on behalf of each party;
  • An in-court or recorded presentation by counsel for each party;
  • A combined in-court or recorded presentation by counsel and one or more experts on behalf of each party;
  • Recorded presentations that have been prepared for generic use in particular kinds of cases by reliable sources such as the Federal Judicial Center.11

In fact, the cases reflect a good deal of variation in presentation styles. In the Fosamax® cases coordinated in New Jersey, each side was allowed ninety minute presentations.12 In the average wholesale pricing multidistrict litigation, parties first submitted presentations addressing the issues to the court and then presented tutorial experts at hearing a few days later.13 The tutorial experts provided a thirty-minute summary, and then were subject to a thirty-minute cross examination and a fifteen-minute redirect.14 In contrast, the court in the Bextra® and Celebrex® multidistrict litigation ordered the parties to “present the ‘science’ in any format they choose.”15

However the information is presented, certain courts may request that the information be somehow preserved for the court alone so that it can refer to it throughout the litigation. The Ninth Circuit Court of Appeals has specifically endorsed this practice:

I salute the district court and the parties for having held a tutorial on the technology. It was undoubtedly valuable to the district judge. The only problem is, it was unreported (which is understandable, as a principal benefit of a tutorial is the opportunity for informal exchange) and thus, it was unavailable to assist us. In future cases where such formats are used — and I encourage it, having benefitted from similar tutorials when I served as a district judge — I urge district judges and litigants to consider the possibility of videotaping the tutorial for whatever assistance it may be to the court of appeals.16

Although the information may be preserved for the court, in products liability cases, the information is not generally available to the parties for impeachment or other purposes. Treating the tutorial like trial testimony may inhibit the open dialogue and candid discussion that best serves the educational objective of the tutorial. If an expert presents the tutorial material to the court, he or she generally is not put under oath or subject to cross-examination, and the parties ordinarily will not be able to use the presentations in future court proceedings for any purpose.17

Early Requests and Agreed Upon Formats and Subject Matter Increase a Tutorial’s Usefulness

Most courts are receptive to the idea of tutorials, particularly if the parties can agree in advance upon a format and present the idea in a joint motion to the judge. If a tutorial will benefit your company, have your counsel confer with the other side in an attempt to agree on both a format and use restrictions, and then move for leave to present the tutorial to the court. The request for a tutorial should generally come shortly after assignment to the judge and certainly well before a hearing on any motion that requires applying the science involved in the case. In cases involving class issues, such as the average wholesale pricing litigation, the tutorial should precede the class certification hearing. In others, such as products liability cases, it should, at a minimum, come before hearings on admissibility of expert testimony.

Tutorials can vary significantly in both format and the breadth of issues addressed. Providing clear guidelines for both format and substance helps ensure that the parties will be addressing the same issues and avoid being faced with subject matters for which their counsel or experts have not prepared. Success of the tutorial depends in part on the parties’ not being able to use it later in the proceedings for impeachment purposes. For this reason, it is essential that the order agreed upon address whether the presentations will be transcribed, videotaped, or otherwise recorded as well as restrictions on future use of the information presented.

In addition to considering prior orders for “Science Day,” counsel should check the local rules for potential format guidelines. For instance, the United State District Court for Minnesota’s local rules provide that tutorials in patent cases need not be videotaped, and “[s]hould the parties determine that a format other than video tape be more appropriate, such as a DVD or a computerized presentation, they may suggest the format at the initial pretrial conference.”18

In an ideal world, judicial decisions would be based on perfect information. In the real world, the litigating parties must deal with time and space constraints in presenting the facts underlying their case. Court ordered tutorials provide an opportunity for the parties to educate the court in a neutral setting. The presentation of an effective tutorial pushes the real courtroom a little closer to the perfect courtroom.


[i] Civil Practice Standards, American Bar Association, updated August 2007 at p. 12; MCL 4th §33.23 at 615; Reference Manual on Scientific Evidence, Second, Annotated, “Management of Expert Evidence” at 43 (West 2005).

[ii] Synthon IP Inc. v. Pfizer Inc. 446 F.Supp.2d 497, 505 (E.D. Va., 2006); see also Takeda Chemical Industries, Ltd. v. Mylan Laboratories, Inc., 417 F.Supp.2d 341, 344 (S.D.N.Y. 2006) (holding a science tutorial at the outset of trial).

[iii] Hall v. Baxter Healthcare Corp., 947 F. Supp. 1387, 1415 (D. Or. 1996).

[iv] Id. at 1414-15.

[v] In re: Ortho Evra Products Liability Litigation, MDL No. 1742, Case No. 1:06-40000, “Case Management Order No. 19” (N.D. Ohio June 12, 2007).

[vi] Id.; In re: NuvaRing Products Liability Litigation, 4:08 MDL 1964 RWS, “Stipulated Order Granting Defendants’ Motion for a NuvaRing ‘Science Day’” (E.D. Mo. July 22, 2009); In re: Fosamax Litigation, Case No. 282, “Order Concerning Science Day” (Super. Ct. N.J. Atl. Co. January 9, 2009); In re: Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation, MDL No. 1699, Case No. M:05-cv-01699-CRB, “Order re: Tutorial Transcript” (N.D. Cal. October 11, 2006).

[vii] In re Pharmaceutical Industry Average Wholesale Price Litigation, MDL No. 1456, Civil Action No. 01-CV-12257 PBS, “The Track One Defendants’ Motion for Leave to Present a Tutorial to the Court Regarding Pharmaceutical Pricing Reimbursement” at 3 (D. Mass. September 16, 2004).

[viii] In re Pharmaceutical Industry Average Wholesale Price Litigation, MDL No. 1456, Civil Action No. 01-CV-12257 PBS, “Case Management Order No. 12 Tutorial Procedures in Connection with Class Certification Motion” (D. Mass. October 20, 2004); see also McCoy v. Health Net, Inc. 569 F.Supp.2d 448, 452 (D.N.J. 2008) (noting that the court held a “tutorial” hearing to better understand insurer’s out-of-network claims process prior to approval of settlement).

[ix] In re: NuvaRing Products Liability Litigation, 4:08 MDL 1964 RWS, “Stipulated Order Granting Defendants’ Motion for a NuvaRing ‘Science Day’” (E.D. Mo. July 22, 2009); see also Amgen, Inc. v. Ariad Pharmaceuticals, Inc., Civil Action No 06-259-KAJ, “Scheduling Order,” (D. Del. July 19, 2006) (ordering that the technology tutorial “should focus on the technology at issue and should not be used to argue the parties’ claim construction contentions”).

[x] Id.

[xi] Civil Practice Standards, American Bar Association, updated August 2007 at p. 12.

[xii] In re: Fosamax Litigation, Case No. 282, “Order Concerning Science Day” (Super. Ct. N.J. Atl. Co. January 9, 2009).

[xiii] In re Pharmaceutical Industry Average Wholesale Price Litigation, MDL No. 1456, Civil Action No. 01-CV-12257 PBS, “Case Management Order No. 12 Tutorial Procedures in Connection with Class Certification Motion” (D. Mass. October 20, 2004). A redacted version of the plaintiffs’ written tutorial is available through PACER at docket no. 1222, filed December 9, 2004. A transcript of the defendants’ submitted tutorial is available through PACER at docket no. 1224, filed December 10, 2004.

[xiv] Id.

[xv] In re: Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation, MDL No. 1699, Case No. M:05-cv-01699-CRB, “Order re: Tutorial Transcript” (N.D.Cal. October 11, 2006).

[xvi] Altera Corp. v. Clear Logic, Inc., 424 F.3d 1079, 1093 (9th Cir. 2005).

[xvii] See, e.g., In re: NuvaRing Products Liability Litigation, 4:08 MDL 1964 RWS, “Stipulated Order Granting Defendants’ Motion for a NuvaRing ‘Science Day’” (E.D. Mo. July 22, 2009) (“If a science day presenter later becomes a witness in the litigation, the presentation may not be used to cross-examine or impeach the presenter”); In re: Fosamax Litigation, Case No. 282, “Order Concerning Science Day” (Super. Ct. N.J. Atl. Co. January 9, 2009) (“No part of these presentations shall be admissible for any reason in any future proceeding, be they in a court of law, arbitration session, mediation session, or otherwise); In re: Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation, MDL No. 1699, Case No. M:05-cv-01699-CRB, “Order re: Tutorial Transcript” (N.D.Cal. October 11, 2006) (“because the tutorial is an informal proceeding designed to educate the court on the background science, the transcript of the tutorial may not be used in any subsequent MDL 1699 proceeding for any purpose”).

[xviii] 2005 Advisory Committee’s Note to Local Rule 16.2 and Form 4 and 5 of the United States District Court for the District of Minnesota.

Finis

Citations

  1. Civil Practice Standards, American Bar Association, updated August 2007 at p. 12; MCL 4th §33.23 at 615; Reference Manual on Scientific Evidence, Second, Annotated, “Management of Expert Evidence” at 43 (West 2005). Jump back to footnote 1 in the text
  2. Synthon IP Inc. v. Pfizer Inc. 446 F.Supp.2d 497, 505 (E.D. Va., 2006); see also Takeda Chemical Industries, Ltd. v. Mylan Laboratories, Inc., 417 F.Supp.2d 341, 344 (S.D.N.Y. 2006) (holding a science tutorial at the outset of trial). Jump back to footnote 2 in the text
  3. Hall v. Baxter Healthcare Corp., 947 F. Supp. 1387, 1415 (D. Or. 1996). Jump back to footnote 3 in the text
  4. Id. at 1414-15. Jump back to footnote 4 in the text
  5. In re: Ortho Evra Products Liability Litigation, MDL No. 1742, Case No. 1:06-40000, “Case Management Order No. 19” (N.D. Ohio June 12, 2007). Jump back to footnote 5 in the text
  6. Id.; In re: NuvaRing Products Liability Litigation, 4:08 MDL 1964 RWS, “Stipulated Order Granting Defendants’ Motion for a NuvaRing ‘Science Day’” (E.D. Mo. July 22, 2009); In re: Fosamax Litigation, Case No. 282, “Order Concerning Science Day” (Super. Ct. N.J. Atl. Co. January 9, 2009); In re: Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation, MDL No. 1699, Case No. M:05-cv-01699-CRB, “Order re: Tutorial Transcript” (N.D. Cal. October 11, 2006). Jump back to footnote 6 in the text
  7. In re Pharmaceutical Industry Average Wholesale Price Litigation, MDL No. 1456, Civil Action No. 01-CV-12257 PBS, “The Track One Defendants’ Motion for Leave to Present a Tutorial to the Court Regarding Pharmaceutical Pricing Reimbursement” at 3 (D. Mass. September 16, 2004). Jump back to footnote 7 in the text
  8. In re Pharmaceutical Industry Average Wholesale Price Litigation, MDL No. 1456, Civil Action No. 01-CV-12257 PBS, “Case Management Order No. 12 Tutorial Procedures in Connection with Class Certification Motion” (D. Mass. October 20, 2004); see also McCoy v. Health Net, Inc. 569 F.Supp.2d 448, 452 (D.N.J. 2008) (noting that the court held a “tutorial” hearing to better understand insurer’s out-of-network claims process prior to approval of settlement). Jump back to footnote 8 in the text
  9. In re: NuvaRing Products Liability Litigation, 4:08 MDL 1964 RWS, “Stipulated Order Granting Defendants’ Motion for a NuvaRing ‘Science Day’” (E.D. Mo. July 22, 2009); see also Amgen, Inc. v. Ariad Pharmaceuticals, Inc., Civil Action No 06-259-KAJ, “Scheduling Order,” (D. Del. July 19, 2006) (ordering that the technology tutorial “should focus on the technology at issue and should not be used to argue the parties’ claim construction contentions”). Jump back to footnote 9 in the text
  10. Id. Jump back to footnote 10 in the text
  11. Civil Practice Standards, American Bar Association, updated August 2007 at p. 12. Jump back to footnote 11 in the text
  12. In re: Fosamax Litigation, Case No. 282, “Order Concerning Science Day” (Super. Ct. N.J. Atl. Co. January 9, 2009). Jump back to footnote 12 in the text
  13. In re Pharmaceutical Industry Average Wholesale Price Litigation, MDL No. 1456, Civil Action No. 01-CV-12257 PBS, “Case Management Order No. 12 Tutorial Procedures in Connection with Class Certification Motion” (D. Mass. October 20, 2004). A redacted version of the plaintiffs’ written tutorial is available through PACER at docket no. 1222, filed December 9, 2004. A transcript of the defendants’ submitted tutorial is available through PACER at docket no. 1224, filed December 10, 2004. Jump back to footnote 13 in the text
  14. Id. Jump back to footnote 14 in the text
  15. In re: Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation, MDL No. 1699, Case No. M:05-cv-01699-CRB, “Order re: Tutorial Transcript” (N.D.Cal. October 11, 2006). Jump back to footnote 15 in the text
  16. Altera Corp. v. Clear Logic, Inc., 424 F.3d 1079, 1093 (9th Cir. 2005). Jump back to footnote 16 in the text
  17. See, e.g., In re: NuvaRing Products Liability Litigation, 4:08 MDL 1964 RWS, “Stipulated Order Granting Defendants’ Motion for a NuvaRing ‘Science Day’” (E.D. Mo. July 22, 2009) (“If a science day presenter later becomes a witness in the litigation, the presentation may not be used to cross-examine or impeach the presenter”); In re: Fosamax Litigation, Case No. 282, “Order Concerning Science Day” (Super. Ct. N.J. Atl. Co. January 9, 2009) (“No part of these presentations shall be admissible for any reason in any future proceeding, be they in a court of law, arbitration session, mediation session, or otherwise); In re: Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation, MDL No. 1699, Case No. M:05-cv-01699-CRB, “Order re: Tutorial Transcript” (N.D.Cal. October 11, 2006) (“because the tutorial is an informal proceeding designed to educate the court on the background science, the transcript of the tutorial may not be used in any subsequent MDL 1699 proceeding for any purpose”). Jump back to footnote 17 in the text
  18. 2005 Advisory Committee’s Note to Local Rule 16.2 and Form 4 and 5 of the United States District Court for the District of Minnesota. Jump back to footnote 18 in the text