Timothy S. Black, United States District Judge.
Before the Court is the Joint Motion for Final Approval of Proposed Amendment to the Settlement and the Proposed Distribution (Doc. #3136) ("Joint Motion").
In considering the Joint Motion, the Court also has taken into consideration the presentations at the hearing on October 29, 2015, as well as the following prior filings in this case, which are relevant to the proposed Amendment and distribution: Trustee's Position on Funds Needed for the Administration of the Bowling-Pfizer Settlement (Doc. #2821); Report and Recommendations of the Supervisory Panel re: the Guidelines, the Future Scope of Work of the Panel and Recommendations for the Use of Any Remaining Money in the Patient Benefit Fund (Doc. #2871); Response of Class Counsel and Public Citizen to the Report and Recommendations of the Supervisory Panel re: the Guidelines, the Future Scope of Work of the Panel and Recommendations for the Use of Any Remaining Money in the Patient Benefit Fund (Doc. #2881); Response of Special Counsel to the Report and Recommendations of the Supervisory Panel re: the Guidelines, the Future Scope of Work of the Panel and Recommendations for the Use of Any Remaining Money in the Patient Benefit Fund (Doc. #2883); Response of Pfizer to the Report and Recommendation of the Supervisory Panel re: the Guidelines, the Future Scope of Work of the Panel and Recommendations for the Use of Any Remaining Money in the Patient Benefit Fund (Doc. #2884); Report and Recommendations of the Supervisory Panel re: the Guidelines, the Future Scope of Work of the Panel and Recommendations for the Use of Any Remaining Money in the Patient Benefit Fund [sic] (Doc. #2889); Notice of Filing of Financial Information for the Bowling-Pfizer Heart Valve Litigation Settlement Fund for the Years 2010, 2011, 2012 and 2013 (Doc. #2937); and Joint Motion for Preliminary Approval of Proposed Amendment to the Settlement, and for Approval of Proposed Notices to the Class and Proposed Notice Procedures (Doc. #3100).
The principal issues raised by the Joint Motion and the other filings listed above are the final approval of the proposed Amendment to the Settlement Agreement in this case ("the proposed Amendment") and of the proposal by Class Counsel to distribute money from the Patient Benefit Fund directly to members of the Settlement Class ("the proposed distribution"). For the reasons set forth below, the Court approves both the proposed Amendment and the proposed distribution.
The original Settlement Agreement in this case was signed on January 23, 1992.
Finding it to be "fair, adequate, and reasonable," Judge Spiegel approved the "Supplemented Agreement of Compromise and Settlement" (Doc. #245) in an order dated August 19, 1992 (Doc. #250). In his order approving the Settlement Agreement, Judge Spiegel provided the following background information regarding the claims asserted in this case:
Id. at 6-7.
In the same order, Judge Spiegel mentioned several features of the Settlement Agreement that are relevant to the proposed Amendment currently before the Court, including the following:
As of January 23, 1992, the date the original Settlement Agreement was signed, approximately 84,000 individuals had been implanted with the Bjork-Shiley convexoconcave ("BSCC") artificial heart valve.
The Settlement Class currently includes anyone who had been implanted with a BSCC artificial heart valve as of January 23, 1992 and is still alive, and that person's spouse if the spouse was married to the implantee on that date and still is married to him or her.
Section 5 of the Settlement Agreement established the Patient Benefit Fund. Under the Settlement Agreement, Shiley and Pfizer devoted $75 million to that fund to support programs, including valve-related medical research aimed at developing a non-invasive medical device that would diagnose fracture-prone BSCC valves.
Paragraph 5.5 of the Settlement Agreement anticipated that at some point the Supervisory Panel might determine that research no longer would be useful and that the remaining money in the Patient Benefit Fund should be devoted to other uses beneficial to the Settlement Class. In this regard, Paragraph 5.5 currently states as follows:
Settlement Agreement, p. 18.
When the Supervisory Panel determined in 2010 that valve-related research no longer would be useful, it invoked Paragraph 5.5 of the Settlement Agreement. Doc. #2670. Subsequent to that, however, in 2014, at the urging of Class Counsel, Pfizer, Public Citizen, and the Special Master/Trustee, Judge Weber approved a Cleveland Clinic research study entitled "Assessment of Outlet Strut Status on Bjork-Shiley Prosthetic Valves Using High Resolution X-Ray Computed Tomography." Doc. #3000. At the time of its approval, the Cleveland Clinic study was viewed as a test — in all probability the last test — of the Supervisory Panel's conclusion that further research into diagnostic tests would not be useful. In September 2014, the data obtained from that study confirmed that the imaging technique studied could not detect a fractured valve, so the decision was made not proceed further with any research. No active research programs are underway.
The decision now before the Court is what to do with the remainder of the Patient Benefit Fund, currently $18,610,233.
As it now reads, Paragraph 5.5 of the Settlement Agreement would prohibit distributing money in the Patient Benefit Fund directly to the members of the class. Class Counsel and Pfizer have agreed on
The proposed Amendment, which Class Counsel and Pfizer jointly submitted to the Court for approval and which Special Counsel and Public Citizen also support, would eliminate a prohibition in current Paragraph 5.5,
In addition, the proposed Amendment addresses and provides for several other eventualities.
First, it provides that, "If the Supervisory Panel at any time determines that the money remaining in the Patient Benefit Fund cannot productively be spent for the specific purposes set forth in Paragraph 5.2, excepting subsection 5.2.3, the Panel shall recommend to the Court that the remainder of the Patient Benefit Fund be devoted to some other purpose for the benefit of the Settlement Class. Upon receiving such recommendation from the Panel under this Paragraph, the Court may either terminate the work of the Supervisory Panel or suspend it until, in the opinion of the Court, circumstances warrant further involvement by the Panel or any of its members."
Second, the Amendment provides that, "If the Court opts to terminate or suspend the work of the Supervisory Panel under this Paragraph 5.5, the Court may retain as a consultant any medical or scientific expert it deems necessary."
Third, the Amendment provides that, "If the Court approves the recommendation of the Supervisory Panel under this Paragraph 5.5, the Court may order that the remainder of the Patient Benefit Fund be distributed to some or all of the members of the Settlement Class."
Fourth, the Amendment provides that, if the Court orders a distribution to some or all of the members of the class, a sufficient amount of money will remain in the Patient Benefit Fund to cover the future costs of administering the settlement, which amount shall be approved by the Court (the "hold-back"). The Amendment states that the hold-back shall be:
And, fifth, the proposed Amendment states that "Nothing in this Paragraph 5.5 shall affect Shiley's and Pfizer's obligations under Section 7 or any other provision of this Agreement, including the payment of `additional or alternative benefits' referred to in Paragraph 5.6 and set forth thereafter; except that, if the Court orders that the remainder of the Patient Benefit Fund (minus the appropriate hold-back as described above) be distributed directly to some or all of the members of the Settlement Class, upon completion of that distribution all of Shiley's and Pfizer's obligations under subsection 5.3.3 of this Agreement shall cease. Notwithstanding any other provision of this Agreement, the provisions of this Paragraph 5.5 are controlling." This language means that if the Court approves the proposed Amendment, Shiley and Pfizer would continue to compensate class members for any individual valve-fracture claims. This language also means that Shiley and Pfizer would continue to pay the additional or alternative benefits referred to in section 5.6 of the Settlement Agreement. These additional or alternative benefits include payment of $38,000 for all miscellaneous costs and expenses relating to and following hospitalization for qualifying valve replacement surgery; payment for such class member's actual lost income due to time lost from work (up to $1500 per week up to 16 weeks, and longer in the case of a class member who becomes disabled as a result of the surgery) to the extent not otherwise covered by workers' compensation, sick pay, disability, or other benefits; and other payments in the event such class member dies or becomes disabled as a result of qualifying valve replacement surgery.
To clarify further the ramifications of the Amendment, claims by eligible class members for reimbursement of the uninsured costs of qualifying valve replacement surgeries would be among the expenses paid out of the hold-back. Under subsection 5.3.3 of the Settlement Agreement, the uninsured costs of qualifying valve replacement surgeries currently are paid out of the Patient Benefit Fund, and Shiley and Pfizer currently would have an obligation to pay those uninsured costs if that fund ever ran out of money. Although this obligation would cease under the proposed Amendment, Class Counsel, Pfizer, Special Counsel, Public Citizen, and the Special Master/Trustee all maintain that the proposed amount of the hold-back — $1,619,835 — would be sufficient to cover these and other costs, given the relatively minimal amounts that have been expended for that purpose in recent years.
If the Court approves the proposed Amendment, Class Counsel also asks the Court to approve a direct distribution to Settlement Class members of the money in the Patient Benefit Fund, minus the appropriate hold-back discussed above. Class Counsel propose that $16,990,398 of the $18,610,233 currently in the Patient Benefit Fund be distributed directly to the members of the class — in other words, a hold-back of $1,619,835. Class Counsel, Special Counsel, Public Citizen, and Pfizer
If the Court approves this proposed distribution, Class Counsel have proposed that each living registered implantee class member would be eligible to receive a share of it, as would each living spouse of an implantee class member who was married to that implantee as of January 23, 1992 and who is still married to that implantee when the proposed distribution is approved.
Class Counsel have proposed that the total amount of money available for the qualifying spouses' aggregate awards ("the spouses' aggregate share") would be one-eighth of the total amount of money available for the qualifying implantees' aggregate awards ("the implantees' aggregate share"), just as with the original distribution. Under this proposal, each qualifying implantee would receive a larger percentage of the implantees' aggregate share than in the original distribution, and each qualifying spouse would receive a larger percentage of the spouses' aggregate share than in the original distribution. The reason for this is logical — there would be fewer eligible implantees and eligible spouses this time around due to deaths among implantee class members and deaths or divorces among spouse class members.
The first step in the process of approving a proposed class action settlement — or, as in this case, an amendment to one — is commonly known as "preliminary approval." It warrants preliminary approval if it is within the range of what ultimately could be considered fair, reasonable, and adequate — a determination left to the sound discretion of the Court.
The original 1992 notice involved an extensive combination of worldwide first-class-mail and publication notice, which Judge Spiegel found met the demands of Rule 23 and due process. Although the original notice did not indicate that monetary payments would or could be made from leftover Patient Benefit Fund monies, it did inform class members that they would receive at least $80 million (and as much as $130 million) in cash, representing at least $2,500 per class member. See Bowling v. Pfizer, Inc., 143 F.R.D. 141, 149 (S.D.Ohio 1992) (describing the original cash distribution aspect of settlement).
Although previous modifications of the Settlement Agreement before, during and after the original fairness hearing did not trigger any new class notices, and due process may not have required class notice in this instance, out of an abundance of caution the Court deemed it is advisable to provide class members with the best practicable notice of the proposed Amendment and the proposed distribution.
In the motion seeking preliminary approval, Class Counsel, Pfizer, Special Counsel, and Public Citizen proposed a long-form notice and short-form notice. They further recommended that the proposed long-form notice be mailed to every member of the class and that the shortform notice be posted on various websites. The Special Master/Trustee joined in these recommendations.
The long-form notice explained the proposed Amendment and the proposed distribution, including the dollar amounts that would be distributed and held back, and the approximate dollar amount that each class member could expect to receive under each proposal. That notice also adequately informed class members of the scheduled hearing and of their opportunity to comment on or object to the proposed Amendment and the proposed distribution before or at that hearing. It also properly advised class members on the importance of updating their personal information (e.g., change of address, death of implantee or spouse, etc.) to help ensure the efficiency and accuracy of the proposed cash distribution, if one were to be ordered; and it adequately described the various means by which class members could do so (i.e., online via a website, by email, by mail, or by calling the settlement administrator's office free of charge). For the Medic Alert registrants only, the proposed long-form notice properly explained that any distribution to a Medic Alert registrant would be contingent on the individual granting permission to the settlement administrator to add his or her name to the list of registered class members and provided directions on the various means by which Medic Alert registrants could grant such permission (again, online via a website, by email, by mail, or by calling the settlement administrator's office free of charge).
The Court approved the long-form notice and the proposed procedures for its dissemination in the Order dated July 24, 2015 (Doc. #3111).
The short-form notice proposed by Class Counsel and Pfizer and agreed to by all counsel and the Special Master/Trustee provided class members with a more limited amount of information about the proposed Amendment and distribution, while directing them to more complete information, including the long-form notice and the Bowling/Pfizer settlement website. The Court approved the short-form notice in
On October 27, 2015, the Special Master/Trustee filed the Declaration of Nancy A. Johnson, President of CAC, the settlement administrator in this case. In her Declaration, Johnson stated the following with respect to the actions taken to comply with the Order of July 24:
5. Given the preceding information, I caused the following to occur as effort to fulfill the Notice requirements outlined in the Notice:
6. As of October 21, 2015, twenty-nine (29) Notice Packets were returned to CAC by the U.S. Postal Service with forwarding addresses. The Class Member List was subsequently updated with the new addresses and a Notice Packet was re-mailed to said Settlement Class Members at each of the new addresses.
7. As of October 21, 2015, six hundred and two (602) Notice Packets have been returned to CAC by the U.S. Postal Service without forwarding addresses. A skip trace was performed and four hundred eighty-two (482) new addresses were found. The Class member List was subsequently updated with the new addresses and a Notice Packet was remailed to said Settlement Class Members at each of the new addresses. CAC will explore any available options for locating domestic Class Members whose packets were returned and whose addresses were not found through the skip tracing utilized thus far.
8. As of October 21, 2015, fifty-two (52) foreign Notice Packets have been returned to CAC by the U.S. Postal Service without forwarding addresses. We have no means to do skip tracing on foreign mail so no further action was taken.
Declaration of Nancy A. Johnson (Doc. # 3134-1), ¶¶ 5-8.
Based on the Declaration of Nancy A. Johnson, the Court is satisfied that the Special Master/Trustee and the administrator complied with the July 24 Order to the best of their ability.
Even though the parties, when they originally executed the Settlement Agreement, anticipated that the day could come when it no longer would be useful to devote money from the Patient Benefit Fund to diagnostic research and that another use for that Fund would have to be found, they also originally agreed that direct cash payments to class members would not be permitted. One might argue that this should be the last word on the subject. It is important to note, however, that the parties specifically reserved the right to modify or amend their Settlement Agreement by mutual consent. See Paragraph 12.3 of the Settlement Agreement (permitting modifications or amendments in writing, signed by all parties, meaning Pfizer and the class). Indeed, the parties modified the Settlement Agreement multiple times before Judge Spiegel approved it. See Doc. #250, p. 3. It is, therefore, clearly within the capacity of these parties to modify or amend the terms of their Settlement Agreement to fit changed circumstances.
Any proposed amendment or modification is, of course, subject to this Court's approval. The question for the Court is whether the proposed Amendment is fair, reasonable, and adequate. See Fed. R. Civ. P. 23(e)(2).
Class Counsel and Pfizer submit that their proposed Amendment is fair, reasonable, and adequate because it facilitates a direct distribution to class members, which they contend represents the optimal use of the money remaining in the Patient Benefit Fund, subject to a hold-back of funds sufficient to cover essential ongoing settlement benefits and expenses. Special Counsel
Class action case law and the Settlement Agreement itself require that remaining monies be used to benefit the people whose legal claims led to the settlement and the creation of the fund in the first place — that is, the members of the class. See Settlement Agreement, current Paragraph 5.5 (noting that after the Panel determines that medical research will no longer be fruitful, the remaining funds should be "devoted to some other purpose for the benefit of the Settlement Class").
Now that all diagnostic research sponsored by the Supervisory Panel has come to an end (based on the recommendation of the Panel itself), devoting funds to further research is not a viable option. Other possible uses for the funds would be far less likely to benefit a large number of class members than would a direct distribution. For example, a cy pres distribution to a charity that conducts research or other programs generally related to the needs of the class (e.g., a charity that sponsors cardiac research or provides cardiac care to needy people) is unlikely to confer a direct benefit on many, if any, of the remaining class members, who are spread all over the world. In contrast, a cash distribution would confer a direct and immediate benefit on thousands of class members, including all currently registered class members and BSCC Medic Alert members who have been notified and have chosen to register with the settlement administrator.
Similarly, using the remaining monies to set up a fund to pay for implantees' medical expenses or for medical monitoring of some kind is less likely to confer a direct benefit on class members than would a cash distribution. Given the demographic and geographical attributes of the class, most implantees-class members' medical care already is covered by Medicare in the case of U.S. implantees or national health insurances programs in the case of non-U.S. implantees. Moreover, a settlement-administered medical care program, though commendable in some ways, would encounter inefficiencies that a direct distribution program would not. The claims administrator would be required to decide class members' eligibility for any such new medical benefits, and determinations would have to be made as to whether implantees were already covered by private or public insurance. See Settlement Agreement, Paragraph 3.8, and Subsections 5.2.2, 5.6.1.2, and 5.6.1.3 (medical benefits under the Bowling settlement are paid only when not covered by private or public insurance). In contrast, a direct distribution to class members would allow them to decide what to do with the remaining money. If a class member would prefer to devote the amount received to a charitable donation or toward additional medical care for himself or herself, he or she simply could choose to use some or all of the cash distribution for one or both of those purposes. Moreover, a non-monetary benefits program would continue to require the expenditure of the class members' funds on various administrators, lawyers, and others, while the proposed direct distribution program would devote those funds to the class members themselves.
Accordingly, the Court agrees that a distribution to the class members represents the optimal use of the remainder of the Patient Benefit Fund because it would confer a direct and immediate benefit on thousands of implantees and their loved ones and would allow them to decide how best to use it. The parties originally intended the Patient Benefit Fund to be used primarily for research purposes. However, the Supervisory Panel's determination that research no longer would be
Under the circumstances that currently exist, the Court is satisfied that permitting money in the Patient Benefit Fund to be distributed directly to class members is fair, reasonable, and appropriate. The Court also is satisfied that, even as it opens the door to a direct cash distribution and relieves Pfizer and Shiley of their obligation to replenish the Patient Benefit Fund, the proposed Amendment preserves other significant payment obligations on the part of Pfizer and Shiley, which will continue to provide tangible benefits and comfort to the members of the class.
As noted above, under the Amendment, Shiley and Pfizer would continue to compensate class members for any individual valve-fracture claims, including paying the additional or alternative benefits referred to in Paragraph 5.6 of the Settlement Agreement. These additional or alternative benefits include payment of $38,000 for all miscellaneous costs and expenses relating to and following hospitalization for qualifying valve replacement surgery; payment for such class member's actual lost income due to time lost from work (up to $1500 per week up to 16 weeks, and longer in the case of a class member who becomes disabled as a result of the surgery) to the extent not otherwise covered by workers' compensation, sick pay, disability, or other benefits; and other payments in the event such class member dies or becomes disabled as a result of qualifying valve replacement surgery. Moreover, as also noted above, claims by eligible class members for reimbursement of the uninsured costs of qualifying valve replacement surgeries would continue to be paid out of the hold-back.
Accordingly, the Court approves the proposed Amendment to the Settlement Agreement.
In addition to proposing the Amendment, Class Counsel, Pfizer, Special Counsel, and Public Citizen also proposed that a significant portion of the remaining settlement funds should be distributed to class members in cash, setting aside a limited reserve fund (i.e., the hold-back) that would be sufficient to reimburse the uninsured costs of future qualifying valve-replacement surgeries as well as cover the costs of the remaining settlement administration.
In response to the notice, Class Counsel received very few written communications from class members regarding the proposed Amendment and distribution. None of the class members who communicated in writing with Class Counsel prior to the fairness hearing objected to or opposed either the Amendment or the distribution. Three class members offered specific written comments.
Dr. Walter Löwe of Germany, an implantee and a retired federal judge, wrote as follows (in German, translated into English) on behalf of himself and his qualifying spouse:
Doc. #3133-2.
Another implantee, Siegfried Leiter, also of Germany, wrote as follows (in English) with respect to the Amendment and distribution:
Doc. #3135-1.
Dr. Gerard Batts, an implantee from Switzerland, submitted a lengthy statement criticizing much of the way the settlement has been handled. Agreeing with the distribution, Dr. Batts nevertheless characterized the amount he expects class members to receive as "nominal" in comparison to amounts charged by "the lawyers and the Supervisory Panel members" over the years. For example, he stated:
Doc. 3133-1, pp. 1-2 (emphasis omitted). Dr. Batts added:
Id. at 3 (emphasis in original). Dr. Batts concluded his submission by stating that, while he agreed with the distribution, he also would favor holding back (1) additional dedicated funds in the amount of $100,000-$200,000 for immediate reassessment and reinstitution of the Hershey study done many years ago, (2) additional dedicated funds in the amount of $100,000-$200,000 "only for future imaging research" if "in the opinion of the Court circumstances would warrant a Panel member or other imaging specialist to be activated to assess the potential of new imaging technologies as they arise that might benefit Class Members in future years," and (3) an unspecified additional amount for "close monitoring of the BSCC patient cohort ... to detect any future spikes in fractures." Id. at 4.
Class Counsel also received oral feedback from the remaining class representatives who could be located, namely Emma Wright, Archie Calvert, and Janet Boggess. All of them expressed support for the proposed Amendment and distribution.
The Court agrees with Class Counsel, Pfizer, Special Counsel, and Public Citizen that money from the Patient Benefit Fund should be distributed directly to the members of the class; that each living implantee-class member should receive a share of the distribution, as would each living spouse of an implantee-class member who was married to that implantee as of January 23, 1992 and who is still married to that implantee when the proposed distribution is approved; that the total amount of money available for the spouses' aggregate share would be one-eighth of the total amount of money available for the implantees' aggregate share, just as with the original distribution; and that each qualifying implantee would receive a percentage of the implantees' aggregate share that is similar but not identical to the percentage they received in the original distribution, and each qualifying spouse would receive a percentage of the spouses' aggregate share that is similar but not identical to the percentage they received in the original distribution.
We therefore turn to the appropriate amount of the hold-back. The Settlement Agreement provides that the Patient Benefit Fund is to be used to reimburse eligible class members for the uninsured costs of qualifying valve replacement surgery. However, a relatively small number of class members are eligible for this benefit. Fewer than 50 class members currently qualify for this benefit under the guidelines, and that number is decreasing rapidly. The Supervisory Panel's decision in 2012 not to revise the guidelines ensures that this number will continue to decrease steadily until 2036, when it is estimated that the last qualified class member will become ineligible for this benefit. Given the history of such reimbursements over the course of this settlement, it would be unjustifiable to reserve more than all agree is necessary to cover future reimbursements of uninsured costs of qualifying valve replacement surgeries in the years ahead.
Research sponsored by the Supervisory Panel ceased in 2009, and in 2012 the Panel decided not to revise its guidelines. These developments signaled the end of the Panel's work for all practical purposes.
Implementing the direct distribution to class members will undoubtedly require additional attorney time, which must be covered by the hold-back. After the distribution, however, there will be far less need for significant attorney time and, thus, far less justification for substantial attorney fees, particularly because Class Counsel and Special Counsel
Finally, to determine the appropriate amount of the hold-back, it is necessary that the Court assess Dr. Batts's proposals. As noted above, Dr. Batts suggests that a total of $200,000 to $400,000 be held back for further x-ray imaging research, with a specific recommendation that $100,000 to $200,000 of that be spent for imaging of class members at the Hershey Medical Center. Doc. #3133-1, at 4. Many years ago, the Supervisory Panel recommended, and Judge Weber approved, funding for an x-ray imaging program at Hershey. The Supervisory Panel later determined that the Hershey program should end, and it did end six years ago. For the reasons that follow, the Panel was correct to end that program, and Dr. Batts's suggestions for reviving it are rejected.
Before explaining why, on purely scientific grounds, the Hershey program (or any other imaging program) should not be reinstated, two preliminary points warrant mention. First, Dr. Batts appears to be asking this Court to order the diversion of funds to reinstitute a Hershey program and for other future imaging research. This Court, like any federal court, lacks that power. Class action settlements, and amendments to them, are matters of contract between the parties, with courts having up or down approval authority, but nothing more. Evans v. Jeff D., 475 U.S. 717, 726, 106 S.Ct. 1531, 89 L.Ed.2d 747 (1986) ("[T]he power to approve or reject a settlement negotiated by the parties before trial does not authorize the court to require the parties to accept a settlement
Second, Dr. Batts's suggestion would reallocate money currently proposed to be distributed to individual class members. If Dr. Batts's suggestion were adopted, the total amount of money available to class members would be smaller than the amount set forth in the notice previously sent to the class members. Though the total amount would be reduced by a relatively small amount, before this Court considers whether Dr. Batts's proposals should become a part of the settlement, class members arguably would be entitled to a revised notice and another opportunity to object and explain why the money should go to them and not to imaging programs.
In any case, Dr. Batts's proposals are unwarranted on their own terms. The purpose of imaging technology is to determine whether a BSCC valve inside a patient's chest contains a single-leg separation ("SLS"). SLS is a precursor to a potentially catastrophic outlet strut fracture ("OSF"). OSF is either fatal or results in serious injuries. So, the overall theory of a successful imaging program is that, if the technology can reliably diagnose SLS in living patients implanted with BSCC valves, patients who test positive for SLS may then undergo valve replacement surgery and thereby avoid OSF.
But as the Supervisory Panel told Judge Weber in 2010, the Hershey program failed because it could not show that the imaging technology had the capacity to reliably diagnose SLS in BSCC patients:
Doc. #2670, at 13 (Jan. 15, 2010).
As the Supervisory Panel emphasized in its submission, a key problem with the Hershey study was that very few patients (39) were willing to participate and far fewer still (7) later had their valves explanted. See id. The latter number is critical because only by explanting valves and examining them for SLS can anyone know whether the technology is capable of accurately detecting valves with SLS. These low numbers are not surprising. Despite the Supervisory Panel's efforts to enroll class members, very few class members, many of whom are elderly and infirm, wanted to expose themselves to radiation in an effort to test unproven technology. Moreover, given the serious risks of open-heart surgery (particularly for older patients), only a tiny number of class members, understandably, wanted to take on those risks.
If the Hershey program were revived, or a program like it were instituted, the number of study participants and explantation surgeries would likely be even smaller than they were in the original program (as noted, 39 and 7, respectively). Since the Hershey program ended more than six years ago, with the passage of time, the number of living class members has steadily declined. Moreover, as Dr. Batts acknowledges (Doc. #3133-1, at 2), thankfully, very few outlet strut fractures have occurred in recent years. See generally Doc. #2670, at 5 (discussing this phenomenon). Moreover, as class members get older, it makes less sense for them to undergo
For all of these reasons, it would be impossible to recruit enough class members to validly test x-ray technology aimed at detecting SLS valves in living class members. On that ground alone, Dr. Batts's suggestions are rejected.
One other consideration is even more important. Dr. Batts's proposal appears to assume that, other than draining the fund of several hundred thousand dollars, there could be no possible harm to class members by reinstating the Hershey program or a program like it. Using the money for research, Dr. Batts believes, may not help class members, but it cannot hurt them. But that assumption is incorrect, as the results of the original Hershey study demonstrate. The imaging technology used at Hershey did not exhibit the level of accuracy that modern science demands. That technology failed to predict the valve's correct status for at least four of the seven values explanted during surgery. See Doc. #2670-7 (Jan. 15, 2010).
For all of these reasons, this Court defers to the Panel's expertise and rejects Dr. Batts's proposals.
Having considered the arguments presented in the Joint Motion and at the hearing, and the views of the class members, the Court accepts the unanimous assessment of Class Counsel, Pfizer, Special Counsel, Public Citizen, and the Special Master/Trustee that the proposed hold-back of $1,619,835 would be more than sufficient to cover the reasonable and foreseeable (a) costs of reimbursing qualified class members' uninsured expenses related to explant surgeries under subsection 5.2.3, including those who qualify under the Supervisory Panel's guidelines and those later diagnosed with single-leg fractures; (b) fees and expenses of the Settlement Administrator; (c) fees and expenses
Accordingly, the Court hereby (1) approves the proposed Amendment and the proposed distribution, (2) determines that $1,619,835 is an appropriate amount to be held back for the purposes mentioned in new Paragraph 5.5(a) through (f), (3) orders that this amount be held back for these purposes, and (4) instructs the Special Master/Trustee and the administrator to carry out the distribution forthwith.
