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(1) Dispute Resolution Concerning Exposure Only Payments. In the event that Baxter decides to challenge a claim for an Exposure Only Payment, Baxter shall submit a Notice of Challenge to the Settlement Administrator, Class Counsel, and the settlement class member (and any identified individual counsel for the class member) no later than 60 days after final approval of the settlement. The Notice of Challenge shall state the reasons for the challenge and shall include any evidence relied upon in support of the challenge. The settlement class member and Class Counsel have the right to submit a written response to Baxter's Notice of Challenge, including any supplemental or rebuttal evidence, to Baxter and to the Special Master (who will decide the challenge) within 30 days of the date of the Notice of Challenge. It is the settlement class member's burden to prove that the Recipient was infused with Gammagard® IVIG during the Window Period. Baxter shall then have 15 days within which to either withdraw its challenge or file a reply. The Special Master shall issue an Order deciding the challenge based solely on the written submissions of each side, without any discovery, oral testimony or oral argument by either side. The Special Master shall provide copies of the Order to the settlement class member, Baxter, Class Counsel, and the Settlement Administrator.
(2) Dispute Resolution Concerning Past Infection and Current Infection Payments. In the event that Baxter decides to challenge a claim for either a Past Infection or Current Infection Payment, Baxter shall submit a Notice of Challenge to the Settlement Administrator, Class Counsel, and the settlement class member (and any identified individual counsel for the class member) no later than 60 days after receiving from the Settlement Administrator the completed Supplemental Medical Information Form submitted by the class member. The Notice of Challenge shall state the reasons for the challenge and shall include any evidence relied upon in support of the challenge. Baxter may file a Notice of Challenge on either (or both) of the following grounds: (a) the settlement class member submitting the claim has failed to supply the information and documents required and/or (b) there is evidence of "Alternative Causation." "Alternative Causation" means the Recipient’s medical records reveal exposure to credible alternative risk factors for HCV, including, but not limited to, unscreened blood transfusions; infusions or transfusions of therapies and materials derived from whole blood, such as plasma, platelets, packed red blood cells, and other IVIGs; needle sticks; and illegal drug use, prior to the Recipient’s diagnosis with HCV; OR any of the following objective indications in the Recipient’s medical records suggesting that HCV infection or liver disease occurred prior to the Recipient’s receipt of Gammagard® IVIG or January 1, 1993, whichever date is later: (i) elevated results in liver function tests; (ii) positive test results in antibody or antigen tests for the presence of HCV; (iii) biopsy results showing the presence of or consistent with HCV; (iv) hepatomegaly by physical examination or sonograms; (v) liver transplant; (vi) diagnosis of cirrhosis; or (vii) medical diagnosis by treating doctors referring to chronic or active liver disease. Mere evidence of Alternative Causation shall not be sufficient to defeat a claim; instead, Baxter shall have the burden of proving that Alternative Causation was a more likely cause of the Recipient’s HCV infection than the Recipient’s infusion with Gammagard® IVIG.
Baxter has the right to submit a request for further information to the settlement class member by attaching such request to Baxter’s Notice of Challenge. Any objection by the class member to the request for information shall be submitted to the Special Master, with a copy to Baxter, within 15 days of the Notice of Challenge. In the absence of such an objection, the class member shall produce the requested information to both Baxter and the Special Master within 30 days of the date of the request. If an objection is made to the request for further information, Baxter shall have 15 days in which to respond to the objection and the Special Master shall rule on the objection. If the Special Master approves the information request in whole or in part, the class member shall produce the information to both Baxter and the Special Master within 30 days after the date of such approval. Upon the production of such further information, Baxter shall have 15 days in which to withdraw its Notice of Challenge or to supplement its Notice of Challenge. If the challenge is not withdrawn, the class member and Class Counsel have the right to submit a written response, including any supplemental or rebuttal evidence, to Baxter and to the Special Master within 45 days of the production of the further information.
In the event that no further information is sought by Baxter, the settlement class member and Class Counsel have the right to submit a written response, including any supplemental or rebuttal evidence, to Baxter and to the Special Master within 30 days of the date of the Notice of Challenge. Similarly, if upon the class member’s objection to Baxter’s request for further information, the Special Master determines that no further information need be produced, the class member and Class Counsel have the right to submit a written response, including any supplemental or rebuttal evidence, to Baxter and to the Special Master within 30 days of the ruling on the request for further information. In connection with any such written response, the class member shall have the burden of submitting the information required by the Supplemental Medical Information Form and proving that the Recipient identified in the claim was infused with Gammagard® IVIG during the Window Period and that such infusion caused the Recipient’s HCV infection.
Once the deadlines for all written submissions has passed, the Special Master shall promptly review the matter and, generally, will issue an Order resolving the challenge based solely on the written submissions of the parties, providing copies of the Order to the settlement class member, Baxter, Class Counsel and the Settlement Administrator. However, the Special Master shall have the discretion to request clarification or additional information from either party. Any such request by the Special Master shall be communicated to both sides, and both sides shall have the right to respond to any such request. The Special Master shall have the discretion to conduct a hearing on the Special Master's own volition or at the request of Baxter, the class member or Class Counsel. In the event that the Special Master concludes that such a hearing would be appropriate, the Special Master shall attempt to schedule the hearing within 60 days after the dispute has been submitted to the Special Master for resolution. The hearing shall be conducted at a location convenient for the parties, taking into account the residence of the class member and any appropriate witnesses. Alternatively, the hearing may be conducted telephonically. Following the hearing, the Special Master shall promptly issue an Order resolving the challenge, providing copies of the Order to the class member, Baxter, Class Counsel, Settlement Administrator and the Court.
(3) Objections to the Special Master's Orders. Any Order of the Special Master as to which objections are not timely filed shall become final. Any party dissatisfied with any Order of the Special Master shall have 30 days after the issuance of the Order to file objections to the Order with the Court, addressed to the Honorable Manuel L. Real, United States District Judge, United States District Court, Central District of California, 312 North Spring Street, Los Angeles, California 90012-4793. Where objections are timely filed and served on all other parties, the other parties shall have 30 days within which to file any response, followed by 15 days for the objecting party to file a reply. Thereafter, the Court shall approve, modify or reject the Order of the Special Master or request that the Special Master reconsider the objection and issue a new Order.
(1) Baxter’s Right to Seek Additional Information Relating to Additional Payments. Within 90 days of the date Baxter receives an application for an Additional Payment with all required supporting documents, Baxter shall determine whether the information submitted justifies the requested Additional Payment. If Baxter deems the information submitted inadequate, Baxter may: (1) request additional medical documentation or responses to written questions; (2) submit the application and medical records to a physician of its choosing; (3) conduct an interview of the Recipient and/or settlement class member; and/or (4) require the Recipient to submit to a medical examination by a physician of Baxter's choosing.
Where Baxter elects to submit the application to a physician of its choosing, Baxter shall arrange to receive the written opinion of such physician within 150 days after receipt of the claim documents, or within 60 days after receiving any supplemental information requested by Baxter pursuant to the preceding paragraph, whichever is later. If the physician concurs in the diagnosis and eligibility under the settlement, then the Additional Payment shall be made. If the physician chosen by Baxter does not agree with the diagnosis or with eligibility, Baxter shall elect within 30 days after it receives the report from the physician selected by Baxter either to make the Additional Payment or to challenge the application.
(2) Dispute Resolution for Additional Payments. If Baxter elects to challenge the application for an Additional Payment, Baxter shall provide written notice to the class member and to the attorney, if any, for such class member. Baxter's challenge shall be submitted for binding arbitration to a three-person committee of health care professionals as follows:
(a) Selection of Panel. The settlement class member shall select one panelist with credentials and qualifications described in Section (e)(i) below and shall send written notification to Baxter of the selection. Within 20 days of receipt of said notification, Baxter shall select one additional panelist with credentials and qualifications described in Section (e)(i) and send written notification to the class member of the selection. The class member and Baxter shall then jointly notify the two panelists of their nomination and shall request those two panelists to disclose any conflicts of interest or other reasons that would prevent service on the panel. If the disclosures require no disqualification, the two panelists shall be instructed to select by mutual agreement a third panelist from the panel listed in Section (e)(ii) below. If the disclosures require the disqualification of a panelist nominated by the parties, the party that nominated the panelist shall select, within ten days of the disqualification, a new panelist with credentials and qualifications described in Section (e)(i), after which the newly selected panelist shall participate, along with the other original panelist, in the selection of the third panelist. If, but only if, none of the persons listed in Section (e)(ii) are willing or able to serve on the panel in a timely fashion, the two panelists shall jointly select a third panelist with credentials equal or similar to those of the individuals listed in Section (e)(ii), keeping in mind the desire to have arbitration decisions rendered by well-recognized professionals experienced in the research, treatment or education about HCV. After the third panelist has been selected by the two panelists nominated by the parties, the third panelist shall disclose any conflicts of interest or other reasons that would prevent service on the panel. If the disclosures require no disqualification, the panel shall be confirmed and the arbitration shall proceed. If the disclosures require the disqualification of the panelist nominated by the other panelists, the two panelists shall be instructed to select a new panelist from the persons listed in Section (e)(ii). In the event that any party fails to make a nomination within the required deadline, the other party may obtain judicial relief compelling the first party to make the required nomination.
(b) Arbitration Schedule. The arbitration proceeding shall be conducted as soon as possible and no later than 120 days from the date that Baxter demands arbitration. The parties shall request the panel to render a decision within 30 days after all evidence is submitted. The parties may, by mutual agreement, extend any of the deadlines. The panel of medical professionals may likewise, for good cause shown, extend or advance any of those deadlines.
(c) Effect of Decision. The decision of the panel may be entered as a judgment of the court, and may be challenged solely on the grounds specified in Sections 10 and 11 of the Federal Arbitration Act (9 U.S.C. §§ 10-11). If the decision of the panel is in favor of the settlement class member, then the specified payment shall be made within 30 days of the award. Such payment shall include interest at the rate of 6% per annum simple interest from 150 days after the submission of the Additional Payment Medical Proof Form.
(d) Payment of Fees and Costs of Panel. The fees and costs of the panel shall be paid by Baxter except as follows. If Baxter believes that the application is either frivolous or presented without a good faith belief that the Recipient qualifies for the Additional Payment(s), Baxter shall have the option of notifying the settlement class member at least 30 days prior to the hearing of Baxter's intention to seek an order from the panel directing the class member to pay the fees and costs of the panel if the application is denied. If such notice is given by Baxter and the panel ultimately not only denies the application but also finds that the application was either frivolous or presented without a good faith belief that the Recipient qualifies for the Additional Payment(s), the panel shall order the class member to pay all of the fees and costs of the panel (reimbursing Baxter for any amounts previously advanced by Baxter). Notwithstanding the foregoing provision, each party shall be responsible for his or her own attorney’s fees and costs in connection with the arbitration.
(e) Qualifications of Panel.
(i) Panelists Selected by the Parties. Each party shall nominate as an arbitrator an individual who has been appointed to an academic position in a United States (AAMC) approved medical school, either as a full-time, part-time or volunteer appointment, in a department or division with a specialty designation relating directly to gastroenterology or to infectious disease. No such panelist may serve more than twice as a panelist in arbitrations under this settlement or any comparable settlements involving other individuals and Baxter.
(ii) Selection of the Third Panelist.The arbitrators selected by the parties shall select a third panel member from the following list of individuals:
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Professor of Medicine Harvard Medical School & Chair, Dept. of Gastrointestinal Diseases Brigham & Women’s Hospital Boston, MA |
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Professor & Chair Dept. of Epidemiology School of Public Health Columbia University New York, NY |
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Professor & Chair Dept. of Gastroenterology Duke University Medical School Durham, NC |
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Professor & Chair Dept. of Epidemiology School of Hygiene & Public Health Johns Hopkins University Baltimore, MD |
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Professor & Chair Dept. of Gastroenterology Pritzker School of Medicine University of Chicago Chicago, IL |
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