THIS PAGE IS RESERVED FOR OUR CLIENTS. IF YOU ARE NOT A CLIENT, YOU ARE NOT PERMITTED TO REVIEW THIS INFORMATION. THIS INFORMATION IS CONFIDENTIAL CLIENT INFORMATION. THIS INFORMATION MAY NOT BE DISSEMINATED IN ANY WAY.
Clients can contact us at: Mdtsprintfidelis@Rheingoldlaw.com
Dear Medtronic Sprint Fidelis Lead Client:
Welcome to the confidential page for our Fidelis clients. This page is intended to update you on current information, as well as be a repository for past updates and important documents.
Medtronic Sprint Fidelis Lead Litigation
The Claims Review Committee had completed the review of all claims and the supporting documentation. As of August 15, 2011 all files were reviewed and reccomendations were submitted to Judge Rosenbaum who will issue the individual awards for each client's claim.
We will notify you once we have the award in your specific case.
There will be a short period to file any appeals or challenges, but this process from past experience may be limited in scope and should be completed by the fall. We are under the impression that payments should be made in late fall in time for the Holiday season. We will update this page as soon as we have more information.
A: THIS IS A CONFIDENTIAL COMMUNICATION THAT IS PROTECTED FROM DISCLOSURE BY THE ATTORNEY/CLIENT PRIVILEGE, THE ATTORNEY WORK-PRODUCT DOCTRINE, AND FEDERAL RULE OF EVIDENCE 408. THE INFORMATION CONTAINED IN THIS LETTER AND THE ATTACHMENTS ARE HIGHLY CONFIDENTIAL AND SHOULD NOT BE FORWARDED TO, OR DISCUSSED WITH, ANYONE OTHER THAN YOUR ATTORNEY.
Re: Medtronic Sprint Fidelis Lead Litigation Proposed Settlement
We are pleased to report that after 3 years of hard fought litigation with Medtronic a proposed settlement has been reached. This agreement was reached after the pending litigation had encountered serious federal preemption hurdles which resulted in cases being dismissed or stayed. This proposed settlement was designed to avoid the uncertainties and risks associated with the federal and state court appeals.
Incredibly, only one week after the settlement agreement was reached with Medtronic, and the very next day after Medtronic's Board of Directors approved the deal and issued an associated press release, the 8th Circuit Court of Appeals issued its decision agreeing with the lower court that dismissal of the lawsuits was proper.
What this means is that there is a proposed settlement in place which you may qualify for even though the appellate court ruled in favor of dismissing the cases. This letter outlines the settlement plan and our recommendations.
The Proposed Settlement
The Proposed Settlement may provide payments to you and certain other clients who previously were and/or currently are implanted with the recalled Medtronic Sprint Fidelis Leads.
For those clients who have a lead that has not yet fractured or failed, you may be eligible to receive a payment now and the right to further compensation if your lead fractures or fails in the future.
For those clients who have already suffered lead failures, you may be entitled to compensation now.
As we had previously advised, both the federal and state court judges have dismissed complaints on the grounds that federal law and FDA approval of the leads completely eliminated your right to sue Medtronic. We appealed both decisions, but were uncertain of the outcome, as was Medtronic. In light of the risk and uncertainty, Medtronic elected to enter into a proposed the proposed settlement described herein, Although this settlement is not what we had hoped for when this litigation began, given the state of the current law and the dismissal of all claims on preemption grounds, we are very pleased that this settlement may provide you with some compensation either now or in the future. We ask that you authorize this law firm to advise Medtronic that you are accepting the terms of the settlement.
I. Terms of Proposed Settlement:
The terms of this proposed Settlement are highly CONFIDENTIAL and should not be discussed with or shown to anyone other than your legal counsel and the attorneys with whom you might consult regarding your rights and participation in the Settlement.
Medtronic has agreed to conditionally resolve claims against it relating to Sprint Fidelis Leads.Specifically, Medtronic has agreed to pay a total of $268 Million Dollars to resolve claims relating to its Sprint Fidelis Leads, inclusive of all Common Benefit Fees and Costs (if any) and settlement administration costs.
II. Allocation Process
The exact amount of each individual claimant's settlement award will be determined through an Allocation Process, which will be supervised and determined by retired federal Judge James M. Rosenbaum, the former Chief Judge of the United States District Court for the District of Minnesota.
Judge Rosenbaum presided over the Medtronic Implantable Cardiac Defibrillator Leads Litigation and the related Settlement. The settlement in this case will NOT be overseen by any judge who presided over and dismissed the Sprint Fidelis cases, nor any other Court, as this is a private settlement governed by the terms of the proposed agreement and only applicable to those Claimants who choose to participate.
Our law firm is recommending that you to participate in this Proposed Settlement. If you do not participate in the settlement, your individual case may be dismissed. Furthermore, if an insufficient number of Claimants elect not to participate in the settlement, then Medtronic has the option of walking away from the settlement, and all Claimants, including those who decided to participate, may receive nothing.
In order to participate in the Allocation Process, you and all other claimants (through your lawyers) will be required to submit supporting documentation. Persons with similar injuries will be treated similarly.
The purpose of the Allocation Process is to establish a system, subject to the oversight of Judge Rosenbaum (ret.), where claims will be quickly and fairly reviewed and resolved. Medtronic will NOT have any role in allocating the individual settlement awards.
Eligibility for payment in the Allocation Program required our law firm to submit a Recommendation Form to Medtronic advising that we will recommend to all our clients that they participate in this settlement. Further, eligibility is based upon completion of a Claim Form, which will be provided shortly, together with submission of relevant medical records and other documentation to support your claim ("Claim Materials").
You must agree to participate in the Settlement before entering into the Allocation Process. We anticipate that the deadline to agree to participate will be sometime late this year or early next year. You and the other Claimants will not be allowed to opt out of the Settlement after the deadline.
You and all other Claimants who elect to participate in the proposed settlement must submit their Claim Materials (through your lawyers) to the Claims Review Committee no later than January 14, 2011. The Claims Review Committee will make its recommendations to Judge Rosenbaum within a reasonable time and will notify claimants of their exact award. You and the other Claimants will then have thirty days to provide (1) a signed Declaration agreeing to the Award Amount, and (2) a Release signed by the Claimant. Claimants who disagree with the Claims Review Committee evaluation and allocation will NOT have an opportunity to opt out of the Settlement. However, at all times, any such Claimant will have an opportunity to have his/her case individually reevaluated and heard by Judge Rosenbaum (ret.).
Generally, the allocation plan contemplates three different categories of Claimants. The First Category will be those Claimants who were implanted with a Recalled Device but the device has not fractured or has not been revised or explanted for reasons relating to the Recall. Those individuals will receive a payment for completing the Settlement and Claim Forms and signing a Release of their claims. Depending on the number of eligible cases, the amount is likely to be within the $1,000 - $2,500 range. Those individuals will then be enrolled in the Settlement and will be eligible for additional compensation if their Recalled Device fractures within a seven (7) year period from the time of the signing of the Master Settlement Agreement.
The Second Category of Claimants is those individuals who were implanted with a Recalled Device which has already fractured and/or been subject to a Qualified Revision (Surgery) or Explant (Removal) for reasons relating to the Recall. Those individuals will receive a base compensation, likely within the range of $12,000 - $35,000, depending on applicable factual circumstances. Within this category of Claimants, the base allocation will depend on (1) whether the Claimant had a revision or whether they had an explant of the Recalled Device; (2) whether there was an actual fracture of the Recalled Device that required a revision (surgery) or explants (removals); and (3) whether the fracture resulted in shocking. Individuals who have not yet had a fracture and/or a revision or explants for reasons relating to the Recall, but within the seven (7) year period of the signing of the Master Settlement Agreement suffer a fracture and/or a revision or explants for reasons relating to the Recall, will then be eligible for base compensation similar to the amounts set forth above for the Current Fracture Claimants.
The Third Category of Claimants will consist of those claimants who suffered extraordinary injuries relating to their fractured Recalled Device or related to the revision or explants of the Recalled Device (if the revision or explants was for reasons related to the fracture). Those individuals will be eligible for additional compensation in addition to their base compensation. The pool of money to be used for those these claims will likely range from $70,000,000 to $85,000,000.
These ranges are estimates based on the information currently known and may increase or decrease depending on the number of individuals who ultimately decide to participate in the proposed settlement. We will continue to keep you updated as to any revisions in these projections. Remember, any decision on amounts for base compensation will be decided by Judge Rosenbaum (ret.) (also referred to as the Third Party Neutral).
III. THE ALLOCATION PLAN DETAILS
1. Registration Payment
The Registration Fund is based on objective criteria set forth in the Claim Materials. In order to be eligible for a payment from the Registration Fund, the Claimant must have: (1) the implant of one or more Recalled Device(s) and (2) must be included on the Final Settlement List. A Registration Fund will be established to finance the Registration Payment for Eligible and Participating Claimants. Recommendations on the amount of the proposed Registration Fund, as well as the amounts of base Registration Payments will be made in the first instance by the Claims Review Committee. Judge Rosenbaum (ret.) shall make the final determination of both the amount of the proposed Registration Fund as well as the amounts of the base Registration Payments.
REGISTRATION PAYMENT DOES NOT REQUIRE A LEAD FRACTURE OR LEAD FAILURE TO QUALIFY.
2. Present Individual Awards
Payment under the Present Individual Award Fund will be based on objective criteria set forth in the Claim Materials. In order to be eligible for a Present Individual Award, a Participating Claimant must have had: (1) the implant of one or more Recalled Device(s) and (2) the Fracture or Revision of one or more Recalled Device(s) as of the date of the execution of the MSA. The Present Individual Award Fund will be established to finance the Present Individual Awards for eligible and Participating Claimants. Guidelines on the amount of the proposed Present Individual Award Fund, as well as the amounts of base Present Individual Awards, by Category, will be made by the Claims Review Committee as a recommendation to Judge Rosenbaum (ret.) who shall make the final determination of both the amount of the proposed Present Individual Award Fund as well as the amounts of the base Present Individual Awards.
3. Future Individual Awards
Payment under the Future Individual Award Fund is based on objective criteria set forth in the Claim Materials. In order to be eligible for a Future Individual Award, a Participating Claimant must have had: (1) the implant of one or more Recalled Device(s); and (2) the future Fracture or Qualified Revision of one or more Recalled Device(s), within seven (7) years of the date of the execution of the MSA. A Future Individual Award Fund will be established to finance the Future Individual Awards for eligible and Participating Claimants. Recommendations on the amount of the proposed Future Individual Award Fund, as well as the amounts of base Future Individual Awards, by Category, will be made by the Claims Review Committee. Judge Rosenbaum (ret.) shall make the final determination of both the amount of the proposed Future Individual Award Fund as well as the amounts of the base Future Individual Awards.
IF YOU HAVE NOT SUFFERED A LEAD FRACTURE OR REPLACEMENT AT THE TIME YOU AGREE TO PARTICIPATE THE ONLY AMOUNT YOU WILL RECEIVE AT THE PRESENT TIME WILL BE THE REGISTRATION PAYMENT.
HOWEVER, UNDER THE FUTURE INDIVIDUAL AWARD FUND, YOU WILL HAVE THE RIGHT TO ADDITIONAL PAYMENT IF YOUR SPRINT FIDELIS LEAD FAILS, FRACTURES OR IS REPLACED WITHIN SEVEN YEARS OF THE SIGNING OF THE MSA. YOU WILL ALSO RECEIVE AN EXTENSION OF THE WARRANTY COVERING YOUR SPRINT FIDELIS LEADS AND WILL BE REGISTERED FOR THE MEDTRONIC CARELINK MONITORING SYSTEM AT NO CHARGE TO YOU. IT HAS BEEN REPORTED THAT THE NEW MONITORING SYSTEM HAS BEEN SUCESSFUL IN GIVING ADVANCE WARNING BEFORE A LEAD FRACTURE OCCURS.
4. Extraordinary Injury Awards
If a Participating Claimant has suffered documented abnormal shocking, infection, additional hospitalizations, complications, death, or other significant injuries or substantial economic losses causally related to the Fracture or Revision of a Recalled Device, that claimant may seek additional compensation through an Extraordinary Injury Fund (EIF). To qualify for an EIF award the claimant must: (1) satisfy the criteria for participation in the Registration Award Fund and either the Present or Future Individual Award Fund; and (2) have a documented significant or extraordinary injury related to the Fracture or Qualified Revision of a Recalled Device.
Recommendations on the amount of the proposed EIF, the base amounts for EIF Categories, and the amounts of the individual EIF Awards for Participating Claimants will be made by the Claims Review Committee. Judge Rosenbaum(ret.) shall make the final determination of the amount of the proposed EIF, the base amounts for EIF Categories, and the amounts of the individual EIF Awards for Participating Claimants.
The exact criteria which will qualify for EIF payments is not yet known. However, once the Claims Review Committee has made a determination of the qualifying criteria, we will provide this information to you.
5. Subrogation Process - Medicare and Medicaid
UNDER VARIOUS LAWS, YOU ARE RESPONSIBLE TO REIMBURSE MEDICARE OR MEDICAID FOR MONEY PAID ON YOUR BEHALF FROM ANY SETTLEMENT PROCEEDS.
A private company, "The Lien Administrator," will identify the Participating Claimants who may have a potential government obligation including Medicare and/or Medicaid obligations related to their Recalled Device and assist with the reimbursement and resolution of those interests in the recoveries of these Participating Claimants. Resolution of these liens shall be made by deducting amounts owed according to the lien from any award allocated to a Participating Claimant who is subject to a government lien.
6. Subrogation Process - Private Third Party Payor Liens
UNDER VARIOUS MEDICAL INSURANCE CONTRACTS, YOU MAY BE RESPONSIBLE TO REIMBURSE YOUR INSURER FOR MONEY PAID ON YOUR BEHALF FROM ANY SETTLEMENT PROCEEDS.
Each Participating Claimant and his or her individual counsel shall be required to identify and determine whether or not any private Third-Party Payer Subrogation Interest exists and, to the extent such subrogation interest does exist, whether those issues have been resolved, or the terms and conditions upon which they will be resolved. Prior to the release of Participating Claimant's total award amount, the Participating Claimant and his or her individual counsel must: (1) certify to Judge Rosenbaum(ret.) that subrogation issues have been, or will be, resolved according to State and Federal law; (2) engage the Lien Administrator to resolve the outstanding subrogation issues; or (3) certify that the Participating Claimant's counsel has reviewed the contents of the Participating Claimant's file, conferred with the Participating Claimant, and confirmed that no Notice of Lien or subrogation claim exists.
All Participating Claimants must also sign an Indemnification Agreement holding Plaintiffs' Lead Counsel and the PSC harmless for any subrogation claims that are made by any private third-party payors related to claims that come within the scope of this Settlement and related state court litigations, and resolved through this Allocation Program. For those Participating Claimants and individual counsel who have not resolved the applicable subrogation interests, the Lien Administrator will work with the individual Participating Claimant's counsel and Judge Rosenbaum (ret.) to evaluate the reimbursement interest of those Private Third-Party Payers. The cost for the Lien Administrator's services to identify, negotiate and resolve the Private Third-Party Payer Subrogation Interest shall be deducted from the Participating Claimant's total award amount.
We have seen in prior settlements of this type that the Lien Administrator is often able to substantially reduce amounts owed pursuant to these liens following settlement.
IV. Trial vs. Settlement
As you have been previously advised, Judge Richard Kyle in the Medtronic Sprint Fidelis Lead Multi-District Litigation, and Judge Denise Reilly of the Minnesota State Court Coordinated Litigation both dismissed all claims against Medtronic based upon federal preemption grounds. Both of these decisions were appealed and on October 15, 2010 the Judge Kyle's decision to dismiss all claims was affirmed by the federal appellate court. The state court appeal is still pending but it was being held by the court until the federal appeals court issued its ruling. We now have reason to believe that the Minnesota Supreme Court may rely upon this decision and also dismiss the state court litigation. While an appeal to the U.S. Supreme Court is a theoretic possibility, even if such an appeal were taken, it does not have to be heard by the Supreme Court. The chances of the Supreme Court agreeing to accept the appeal are small. Furthermore, even if the Supreme Court issued decided to hear the appeal, there is a good possibility that the appellate decision would be affirmed.
Finally, even in the unlikely scenario that the Supreme Court elected to accept the appeal and then reversed the dismissals, your case would still be subject to dismissal again in the future after pre-trial discovery is completed. Furthermore, even assuming all of these hurdles were overcome, you would still then have to prove your case at trial and that result could be appealed. For all of these reasons, we strongly and without any hesitation recommend that you participate in the proposed settlement.
Although we are not saying this settlement is your only option, we are advising that this settlement is the only way you can currently be guaranteed any money from Medtronic resulting from your Sprint Fidelis Leads.
V. Medical Device Safety Act (MDSA)
Many of you have worked very hard alongside us seeking Congressional help to overturn the Riegel v. Medtronic decision and remove the preemption language from the Medical Device Act which Medtronic successfully relied upon to dismiss this litigation. We have been advised by our consultants in Washington that, for now, the MDSA will not be voted upon this year. With a potential change in Congress coming and either a takeover of the House by the Republicans, or a significant increase in the number of Republicans in the House of Representatives, there is little likelihood of success on the MDSA in the coming Congress. Although we had high hopes we could reinstate claims based upon passage of the MDSA, a strong opposition by business oriented members of Congress prevented the bill from coming to a vote this year.
VI. Your Case
Please note that it is common for claimants to experience some level of anxiety due to knowledge about the recall and fear of injury if failure occurs. However, if you have not had a fracture, the settlement plan will only provide the Registration Payment and the right to recover Future Injury Payments when, and if, your lead wire fractures or fails. If you have suffered a fracture and are entitled to Present Injury Payment at this time, these injuries have been considered in negotiating this Settlement and will not be entitled to an Enhanced Award. However, if after being notified about the recall, you were placed on, or received an increased dose of anxiety medication, or required psychological treatment, these conditions may be considered in the settlement evaluation process. However, in both instances, the complication or psychological treatment MUST HAVE OCCURRED AFTER YOU EXPERIENCED A FRACTURE.
The exact amount you will receive in the Settlement and Allocation Process will be established with certainty only after your claim has been fully evaluated.
Please also remember that pursuant to the terms of your Retainer Agreement, litigation costs and attorneys' fees will be deducted from any award you ultimately receive, as well as reimbursement of medical liens, if any, that may exist on your case. (NOTE: Pursuant to the Settlement Agreement, eligible subrogation claims made by Medicare and certain Third-Party Payers/Insurance Companies will be globally negotiated. Your individual award amount may also be reduced if Medicare or certain Third-Party Payers paid for the treatment of your claimed injury).
VII. Ethical Considerations
An aggregate (group) settlement of this kind has issues that need to be disclosed, understood and approved by you. An aggregate settlement is one in which a single offer is extended to resolve a number of individual lawsuits. You should know that the representation of multiple clients against the same parties may result in potential conflict issues for the lawyers. As attorneys, we are governed by specific rules relating to our representation of clients when actual or potential conflicts issues exist. In this regard, Rule 1.8(g) of the Model Rules of Professional Conduct provides:
"A lawyer who represents two or more clients shall not participate in making an aggregate settlement of the claims of or against the clients . . . unless each client gives informed consent, in a writing signed by the client. The lawyer's disclosure shall include the existence and nature of all the claims or pleas involved and of the participation of each in the settlement."
Because this case involves an aggregate settlement involving the division of settlement proceeds among over potentially 10,000 eligible claimants, we, as attorneys, are governed by the above cited rules. Because the total amount of funds available to pay claims under this Settlement is limited, such an aggregate settlement necessitates choices concerning the allocation of settlement amounts among the multiple clients, which creates potential conflict issues.. In this instance, we represent more than one client in this settlement process. Clients' claims vary in terms of the nature, severity, and extent of the injuries suffered and the ability to prove that a Recalled Medtronic Device was the cause of the claimed injury, and the strength and value of different clients' claims may vary based on other factors, including which state law governs.
As stated above, to avoid problems presented by these potential conflict issues, Judge Rosenbaum (ret.) will act as a Third Party Neutral to supervise the implementation, administration, and allocation of the Settlement. The checks and balances in this process include the implementation of objective criteria based upon the medical and scientific documentation provided by each claimant. But even with the benefit of a settlement process overseen by a Third Party Neutral, it is important that you understand that any aggregate settlement involves potential conflict issues, and that you understand that your settlement is part of an aggregate settlement as described in this letter and you authorize us to proceed with this proposed settlement.
If you have any questions concerning this, please do not hesitate to contact me. Also, of course, you have the right and are encouraged to seek independent legal advice at any time throughout this process.
VIII. Concluding Remarks
We hope this letter has provided you with an appropriate overview of the Settlement and Allocation Process. We believe that given all of the factors and the uncertainty of litigation, this Settlement will provide you with the greatest possible compensation in as timely a manner as possible.
We expect that Judge Rosenbaum (ret.) will issue a deadline for all Claimants to confirm participation or non-participation in the Settlement in the near future. The anticipated deadline will be sometime in late 2010 or early 2011. Thus, if you have any questions or concerns about the Settlement in general or the specifics of your case, please contact our office immediately.
In addition, please note that we are going to need your active cooperation and help with providing the necessary records, documentation or information required in order to be able to meet these deadlines and ensure that you are paid your settlement award as quickly as possible. Please also note, however, that if we are unable to document your claim in timely fashion or provide the Claims Review Committee with all necessary information, there will be delays with your Settlement moneys being paid to you since the evaluation of your claim cannot be completed without these critical records and documentation. Nevertheless, we are certain, that with your help and prompt response to all of our requests for information and assistance, we will be able to satisfy all requirements and criteria for the best possible award you may be entitled to under the Settlement Agreement and Allocation Protocols.
What You Need To Do Now
We have included a few documents we need you to return to us in the self addressed stamped envelope we provided. IF YOU INTEND TO FOLLOW OUR RECOMMENDATION, JOIN THE SETTLEMENT AND SEEK PAYMENT ALLOCATED TO YOUR INJURY WE NEED THESE FORMS SIGNED AND RETURNED IN ALL CASES TO PARTICIPATE IN THE SETTLEMENT:
1. General Release Form. Both the husband and wife must sign this form;
2. A signed HIPPAA medical authorization release form.
3. A signed Medtronic Sprint Fidelis Participation Form if you want to be considered a participant in the settlement plan.
We will be having an informational conference call on Saturday, October 30, 2010 at 4:00 pm EDT/ 3:00 pm CDT/ 2:00 pm MDT/ 1:00 pm PDT. The call in number is: 866-337-4015. Please sign into the call approximately 5 minutes before the start time.
Thank you in advance for your cooperation and we will be contacting you soon to review your file with you and advise you what we will need in order to submit a thoroughly documented claim.
Very truly yours,
B. DOCUMENTS OF INTEREST :
- Sprint Fidelis Newsletter June 2012
- MSF Update Letter- June 2011
- 10.30.10 Phone Conference
- Client Checklist
- Client Confidentiality Agreement
- Client MSA
- Client Participation Form
- Client Q & A
- RVRSM Sprint Fidelis Medical Authorization
- Sprint Fidelis Medical Authorization 2
- Update 7.7.2009
- Examining the Sprint Fidelis Effect on Medicare Costs
- Preemption Order - 1 Jan 09
- Recusal Exhibits A through D
- Recusal Brief
- Order Denying Motion for Recusal
- The Medical Device Safety Act of 2009