Sulzer Implant Settlement |
Class Member and Attorney GuidePage 2
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II. BACKGROUND OF THIS SETTLEMENTA. Inter-Op Acetabular ShellSulzer designs, manufactures and distributes orthopedic implants for hips, knees,shoulders, and elbows. Its Inter-Op Shell is one component of a system used for complete hip replacements.
Proper attachment of these replacement components to the bone is essential. Orthopedic implants are often cemented or screwed into position. Some implants are also designed to allow the bone to grow into and around them, holding them securely in place. The Inter-Op Shell was designed to bond with the natural bone. Unfortunately, a manufacturing defect prevented some of Sulzers Inter-Op Shells from bonding with the acetabulum. Sulzer received reports that several individuals who received Inter-Op Shell implants experienced adverse symptoms that included severe groin pain and inability to bear weight on their leg. These symptoms were thought to be caused by loosening of the shell from the bone. In early December of 2000, Sulzer announced a voluntary recall of certain manufacturing lots of its Inter-Op Shells. Most of the recalled products were manufactured during or after October of 1999, but a limited number were produced as early as June of 1997. Sulzer recalled approximately 40,000 units of its Inter-Op Shell, of which about 26,000 had already been implanted in patients. Only a small number of patients who received the shell during their total hip replacement have experienced loosening of the shell. In fact, to date, approximately two thousand eight hundred (2,800) of the patients who received implants of the Inter-Op Shells have undergone "Revision Surgery" removal of one of the recalled Inter-Op Shells and replacement with a new product. For a variety of reasons, not all of the individuals who were implanted with recalled Inter-Op Shells will undergo Revision Surgery. Most patients will not experience any bonebonding failure; other patients may suffer failure but be medically ineligible for Revision Surgery. B. Natural Knee IIŽ Tibial Baseplate
In May 2001, Sulzer issued a Special Notification, informing surgeons who had implanted
Tibial Baseplates of unanticipated adverse clinical outcomes of certain manufacturing lots
of the Tibial Baseplate. These Tibial Baseplates were manufactured between July 2000 and
February 2001. One thousand three hundred forty-three (1,343) Tibial Baseplates were
implanted in the United States. A number of individuals who received the Tibial Baseplate during their total knee
replacement have experienced loosening. To date, approximately five hundred twelve (512)
individuals in the United States who received implants of the Tibial Baseplate have
undergone "Revision Surgery" removal of one of the Tibial Baseplates that
were the subject of the Special Notification, and replacement with a new product. For a
variety of reasons, not all of the individuals who were implanted with the Tibial
Baseplate will undergo Revision Surgery. Most patients will not experience any
bone-bonding failure; other patients may suffer failure but be medically ineligible for
Revision Surgery. III. HISTORY OF THE LITIGATIONShortly after the December 8, 2000 recall of Inter-Op Shells and the May 17, 2001 Special Notification regarding Tibial Baseplates, lawsuits were filed in both state and federal courts throughout the United States against Sulzer. The plaintiffs sued Sulzer for the defective design, marketing and manufacture of its Inter-Op Shell and Tibial Baseplate. Plaintiffs also alleged claims against Sulzer for breach of express and implied warranties associated with these devices. On June 19, 2001, the Judicial Panel on Multi-District Litigation consolidated and
transferred all pending federal litigation relating to the Inter-Op Shell to the Honorable
Kathleen M. OMalley, United States District Court Judge, Northern District of Ohio
("the Court"). Thereafter, on August 29, 2001, the Court provisionally certified
a class of Inter-Op Shell recipients and related Derivative Claimants and granted
preliminary approval to the parties settlement agreement. On September 5, 2001, the
Judicial Panel on Multi-District Litigation transferred a case involving a Tibial
Baseplate to the Northern District of Ohio, because it involved questions of fact that
were similar to those being addressed by the Court in the litigation involving the
Inter-Op Shell. On October 19, 2001, the Court provisionally certified a class that
included recipients of both Inter-Op Shells and Tibial Baseplates, as well as their
related Derivative Claimants. The Court additionally preliminarily approved a settlement
agreement that involved both devices. In addition to the Multi-District Litigation in the Federal Court, a number of cases
were filed and extensively litigated in state courts around the country. The Settlement
Agreement, described below, was reached through the combined efforts of both federal and
state lawyers. On March 13, 2002, this Settlement Agreement received preliminary approval
from the Court. IV. BENEFITS UNDER THE SETTLEMENTYou may be entitled to Benefits under the Settlement Agreement if you were implanted with (1) certain Inter-Op Shells, (2) certain Reprocessed Inter-Op Shells, or (3) certain Tibial Baseplates (collectively "Affected Products"). To confirm that your implant is/was an Affected Product, see the list of lot numbers set forth in the Final Notice or in the Settlement Agreement (on Annex I for Inter-Op Shells and Tibial Baseplates and on Annex II for Reprocessed Inter-Op Shells). Derivative Claimants and legal representatives of individuals who were implanted with an Affected Product may also be entitled to compensation. The Settlement Agreement creates a number of funds that provide a variety of benefits to Class Members. Below is an outline of these funds and instructions on how Class Members can obtain benefits under each fund. A. The Unrevised Affected Product Recipient Fund1. Eligibility.You are eligible if:
NOTE: You are NOT eligible if your Reprocessed Inter-Op Shell has not been removed. 2. Benefits.One Thousand Dollars ($1,000.00) if you are an Affected Product Recipient ("APR") or a Representative Claimant. Derivative Claimants will receive Two Hundred Fifty Dollars ($250.00). These benefits will become available only if the Settlement receives Final Judicial Approval. No attorney fees or expenses will be deducted from these benefits. 3. Claims Process.
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| When will Class Members Receive their Unrevised Affected Product Recipient Fund benefit payment? |
Within a reasonable time after Final Judicial Approval.
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| How much will an APR Receive? |
$1,000.00. No attorney fees or costs will be deducted from this benefit.
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You are eligible if:
One Hundred Sixty Thousand Dollars ($160,000.00) if you are an Affected Product Recipient ("APR") or a Representative Claimant. Derivative Claimants will receive One Thousand Six Hundred Dollars ($1,600.00). If you have an attorney, as an additional benefit, the Sulzer Settlement Trust will pay a portion of your attorney fees (as described in the "Attorney Fees" Section below). Unless you elect the Guaranteed Payment Option ("GPO"), discussed below, these benefits will only become available after Final Judicial Approval.
To register for benefits under the Affected Product Revision Surgery Fund, you must complete and submit the Orange Form to the Claims Administrator on or before the date that is the later of (i) one hundred eighty (180) days after Trial Court Approval, or (ii) one hundred eighty (180) days after your Affected Product Revision Surgery ("APRS"), unless you choose the GPO, as explained below. You will Orange Form.
To register for derivative benefits under the Affected Product Revision Surgery Fund, Derivative Claimants must complete a Yellow Form and the APR with whom you are associated must have timely submitted a completed Orange Form.
In most class action settlements, Class Members must wait until after Trial Court Approval and the resolution of all appeals, in favor of the Settlement, before receiving any benefits. If that process does not result in "Final Judicial Approval" of the Settlement, then none of the Settlement benefits become available. In this Settlement, if Sulzer does not exercise its right to terminate the settlement on or before 5:00 p.m. (EST) on the date that is five (5) business days after the termination of the Opt-Out Period, those eligible to receive benefits under the Affected Product Revision Surgery Fund may elect the GPO. Under the GPO, you will be entitled to receive a portion of your settlement benefits quickly, regardless of whether the Settlement ever receives Final Judicial Approval and without waiting for the entire approval process to be completed. Also, your tota benefits will remain unchanged.
If you elect the GPO, you will give up your right to "Opt-Out" or to exclude yourself from the Settlement. You will also give up your right, from that point forward, to object to the Settlement or to appeal the Courts approval of the Settlement. These limitations apply even if the Settlement does not receive Final Judicial Approval.
To elect the GPO, you must complete the Orange Form and execute the GPO agreement that it contains. You must submit your completed Orange Form with the signed GPO agreement to the Claims Administrator on or before the date that is (i) one hundred twenty (120) days after Trial Court Approval, or (ii) one hundred twenty (120) days after your Affected Product Revision Surgery ("APRS"), whichever is later. GPO elections must be submitted prior to Final Judicial Approval.
Class Members who elect the GPO will receive their benefits under the Affected Product Revision Surgery Fund in three payments, as described below:
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When will Class Members receive their APRS Fund benefit payment?
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Payment 1 Within a reasonable time after Trial Court Approval or within a reasonable time after the Claims Administrator receives the Class Members Orange Form
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Payment 2 Within a reasonable time after Final Judicial Approval. |
Payment 3 Within a reasonable time after the redemption of the CCI*
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| How much will Class Members receive at that time?
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$40,000. No attorney fees will be paid at this time.
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$48,000 and, in addition, up to $25,300 will be paid towards an APRs attorney fees, if the APR is represented.
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$72,000 and, in addition, up to $20,700 will be paid towards an APRs attorney fees, if the APR is represented.
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*The CCI (Convertible Callable Instrument) is a financial instrument to be issued by Sulzer to the Sulzer Settlement Trust for the benefit of the Class in order to finance part of this Settlement. The CCI shall be redeemed in cash unless converted into shares of Sulzer Medica Stock. It will be redeemed or converted on or before the date that is the later of (i) twenty (20) months after Final Judicial Approval or (ii)
Class Members who do not elect the GPO will receive their benefits under the Affected Product Revision Surgery Fund in two payments, as described below:
| When will Class Members receive their APRS Fund benefit payment? |
Payment 1 Within a reasonable time after Final Judicial Approval.
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Payment 2 Within a reasonable time after the redemption of the CCI.
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| How much will Class Members receive at that time? |
$88,000 and, in addition, up to $25,300 will be paid towards an APRs attorney fees, if the APR is represented.
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$72,000 and, in addition, up to $20,700 will be paid towards an APRs attorney fees, if the APR is represented.
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You are eligible if:
The amount of EIF compensation will depend on several factors, including: 1) the complication or other harm that you have experienced; 2) the severity of your complication or other harm; 3) your age at the time that the complication or other harm occurred; and 4) the Claims Administrators assessment of your complication or other harm relative to the complications and harm experienced by other Class Members. Depending on these factors, Class Members may receive up to Eight Hundred Thousand Dollars ($800,000.00) in EIF benefits. Derivative Claimants will receive up to one percent (1%) of the total EIF benefit to which the Affected Product Recipient is entitled. These benefits will only be available after the Settlement receives Final Judicial Approval.
If you have submitted a claim for EIF benefits and subsequently develop a medical condition(s) or complication(s) that qualifies you for EIF benefits greater than those that you have previously received, you are entitled to the difference.
To register for benefits under the EIF, you must have timely submitted a completed Blue Formor Orange Form, as applicable, and must also submit a completed Green Form on or before the date that is the later of (i) five hundred forty-five (545) days after the date of the applicable Covered Revision Surgery or (ii) one hundred eighty (180) days after a "Non-removal Surgery" or (iii) one hundred eighty (180) days after your treating physicians determination that an APRS would be indicated but for a medical condition(s) or (iv) one hundred eighty (180) days after Trial Court Approval. You will also need to provide documentation evidencing the condition(s) and/or complication(s) that form the basis of your claim for EIF benefits, as set forth in the Green Form.
To register for derivative benefits under the Extraordinary Injury Fund, Derivative Claimants must complete a Yellow Form and the APR with whom they are associated must have timely submitted a completed Green Form.
If you have submitted a Claim Form for benefits under the EIF and subsequently develop a medical condition and/or suffered a harm that qualifies you for EIF benefits greater than those you have previously received, you must submit a new Green Form, indicating that it is a supplemental submission. Your supplemental Green Form need not be completed in full; rather, you need only submit changes to information previously provided.
Class Members will receive their benefits under the Extraordinary Injury Fund in two payments, as described below:
| When will Class Members receive their EIF benefit payment?
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Payment 1 Within a reasonable time after Final Judicial Approval.
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Payment 2 Within a reasonable time after the redemption of the CCI.
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| How much will Class Members receive at that time? |
Not less than 50% of their total EIF benefit. In addition, APRs who are represented by an attorney will have a portion of their attorney fees paid, as described in the "Attorney Fees" section below.
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The remaining portion of their total EIF benefit. In addition, APRs who are represented by an attorney will have a portion of their attorney fees paid, as described in the "Attorney Fees" section below.
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1. Eligibility / Benefits
Medicare, health insurance companies and other Third-Party Payors may be entitled to reimbursement for reasonable and necessary medical expenses that they paid or that were incurred on behalf of Class Members. If you have had a Revision Surgery, Sulzer will satisfy these claims for reimbursement. Further, you and/or your attorney will be defended and held harmless against any claims by Medicare, health insurance companies or other Third-Party Payors for reimbursement of medical expenses necessitated by an Affected Product.
If, alternatively, you were not insured at the time you underwent an Affected Product Revision Surgery ("APRS"), you may be entitled to reimbursement of reasonable and necessary out-of-pocket expenses that you incurred as a result of that Revision Surgery.
You will need to register for benefits under the Subrogation and Uninsured Medical Expenses Fund only if you were not insured at the time you underwent an APRS. These benefits will only become available after the Settlement receives Final Judicial Approval.
2. Claims Process.
To register, you must have timely submitted a completed Orange Form and must submit a completed Red Form, on or before the date that is the later of (i) one hundred eighty (180) days after the receipt of medical care for which you seek medical expense reimbursement or (ii) one hundred eighty (180) days after Trial Court Approval. In completing the Red Form, it is necessary that you sign the Declaration therein, indicating that you are not covered by a Third Party Payor of medical expenses (i.e. a medical insurer). You will also need to provide documentation evidencing the payment of any unreimbursed medical expense made necessary by an Affected Product. A list of acceptable documentation is included on the Red Form.
E. The Medical Research and Monitoring Fund
1. Eligibility / Benefits
All Class Members may receive benefits under the Medical Research and Monitoring Fund. These benefits will consist of medical research relating to the recognition and identification of medical issues unique to Class Members. A registry will be maintained to collect the medical records and films of consenting
2. Claims Process
To register for the Research and Monitoring benefits, you must timely complete the Blue Form or Orange Form and specifically indicate (in the designated "Medical Monitoring and Screening" portion) your interest in participating in this program
F. Attorney Fees
Some Class Members have entered into private fee agreements with their own attorneys. Private fee agreements entered into prior to February 2, 2002 will not be affected by this Settlement, with minor exceptions, as noted below. The Sulzer Settlement Trust will pay a portion of the attorney fees owed by Class Members to their attorneys under these private fee agreements.
If a Class Member entered into a contingency fee agreement with his or her own attorney, the contingency fee shall apply against benefits received by the Class Member under the Affected Product Revision Surgery Fund and the Extraordinary Injury Fund. Class Members may also receive benefits under the Unrevised Affected Product Recipient Fund, the Subrogation and Uninsured Medical Expenses Fund and the Medical Research and Monitoring Fund. Contingency fees, however, shall not apply against these benefits.
1. Contingent Fee Calculations
To calculate the fee pursuant to a contingency fee contract, the Class Members attorney shall apply the contingency percentage to the product reached by multiplying the stated benefit (under either the Affected Product Revision Surgery Fund or Extraordinary Injury Fund) amount by 1.25.
Example: If a Class Members stated benefit under the Affected Product Revision Surgery Fund is $160,000, and the Class Members contingency contract rate is 33 1/3%, then the attorney fee calculation will be as follows:
331/3% of $160,000 x 1.25 = $66,666
2. Fee Payment by the Sulzer Settlement Trust
As a benefit to the Class Member, the Sulzer Settlement Trust shall pay a portion of the Class Members attorney fees. This contribution to the attorney fees shall be equal to 23% of the stated benefit x 1.25.
Example:If the stated benefit under the Affected Product Revision Surgery Fund is $160,000 and the contingency contract rate is 33 1/3% then the fee calculation will be as follows:
23% of $160,000 x 1.25 = $46,000
NOTE: This payment towards a Class Members attorney fees shall be a set off from, not an addition to, the amount of attorney fees owed by the Class Member. Therefore, under the above example, the Class Members attorney, after receiving the fee payment benefit under the Settlement, will be entitled to collect up to $20,666 [i.e., $66,666 $46,000] directly from the Class Member.
Individuals With A Sulzer Inter-Op Shell Or Sulzer Tibial Baseplate That Has Not Been Removed
Individuals Who Have Undergone a Revision of a Sulzer Inter-Op Shell, a Sulzer Tibial Baseplate or a Reprocessed Inter-Op Shell.
Cash Benefit:
It is not anticipated that Class Members will receive any portion of their benefit in stock.
YES
$1000 for each Sulzer Inter-Op Shell or Sulzer Tibial Baseplate that has been implanted. (Blue Form)
YES
$160,000 for each Sulzer Inter-Op Shell or Sulzer Tibial Baseplate that has been removed. In addition, up to $46,000 will be paid towards an APRs attorney fees, if the APR is represented. (Orange Form)
Right to Elect the GPO:
Certain Class Members are eligible to receive a portion of their cash benefits regardless of whether the Settlement ever receives Final Judicial Approval.
NO
YES
(Orange Form GPO Agreement)
Right to Register for EIF Benefits:
Benefits are available for certain Class Members who experience extraordinary complications and/or who suffer from other harm, as described in the Settlement Agreement.
YES
Up to $120,000. In addition APRs who are represented will have a portion of their attorney fees paid by the Sulzer Settlement Trust. (Blue Form and Green Form)
YES
Up to $800,000. In addition, APRs who are represented by an attorney will have a portion of their attorney fees paid by the Sulzer Settlement Trust. (Orange Form and Green Form)
Right To Subrogation And Uninsured Medical Costs Reimbursement Benefits :
Sulzer will satisfy claims for reimbursement by Medicare, health insurance companies and other Third-Party Payors. Sulzer may also reimburse Class Members who were uninsured at the time of an APRS for out-of-pocket expenses associated with that APRS.
YES
Sulzer will satisfy claims for reimbursement by Medicare, health insurance companies and other Third-Party Payors. (No form necessary)
YES
Sulzer will satisfy claims for reimbursement by Medicare, health insurance companies and other Third-Party Payors. Additionally, Sulzer may also reimburse Class Members who were not insured at the time of an APRS for out of pocket expenses associated with that APRS. (Orange Form and Red Form)
Right to Register for Medical Research Screening :
Research relating to the incidence and progression of peri-implant radiolucencies and osteolytic lesions associated with cementless acetabular and tibial components, will be sponsored.
YES
(Blue Form Medical Registry Election)
YES
(Orange Form Medical Registry Election)
V. OTHER RIGHTS UNDER THE SETTLEMENT
A. The Right to Object
The Court that is presiding over the litigation involving the Sulzer Inter-Op Shell and Sulzer Tibial Baseplate will hold a Fairness Hearing, beginning on May 6, 2002, at 10:00 a.m. in Courtroom 135, United States Courthouse, 201 Superior Avenue, Cleveland, Ohio 44114. The purpose of the Fairness Hearing is to determine whether to approve the Settlement Agreement and to bind all Class Members who have not Opted- Out.
You can appear at the time of the hearing, in person or through an attorney representing you, and present any objection that you have to the Settlement Agreement, but only if you: 1) have not already accepted the GPO, 2) have not registered for Settlement benefits, 3) have not already exercised an Opt-Out Right, and 4) have filed a written objection with the Court. If your written objection is not received by the Court on or before April 29, 2002, it will not be considered by the Court.
B. The Right to Opt-Out
If you do not wish to participate in the Settlement, you must Opt-Out of (exclude yourself from) the Settlement. To exercise an Opt-Out Right, you must notify the Claims Administrator. The notification must be in writing and signed by the Class Member. It must also set forth ALL of the following:
- Your name, address, and telephone number; AND
- The approximate date of implantation; AND
- The name of the surgeon who implanted the Affected Product; AND
- If you are represented by counsel, the name, address, and phone number ofyour attorney.
In addition to the items listed above, please provide the lot number and product number of the Affected Product, if known. You may also provide your Social Security Number, if you choose. The above information must be received by the Claims Administrator, on or before the date that is five business days after Trial Court Approval, at the following address:
Sulzer Settlement Trust
P.O. Box 94558
Cleveland, Ohio 44101-4558If you do not exercise your Opt-Out Right, you will automatically be bound by the Settlement Agreement. You will not be able to pursue any Settled Claims against Sulzer and/or any other Released Parties.
If you have a question concerning any medical condition that might cause you to consider forgoing the benefits of this Settlement Agreement, you are urged to consult with both a qualified doctor and a lawyer familiar with the Sulzer Hip and Knee litigation claims.
VI. MORE INFORMATION REGARDING THE SETTLEMENT
Further information concerning the Settlement Agreement is included in the detailed Final Notice of Settlement of Nationwide Hip Prosthesis and Knee Prosthesis Product Liability Class Action Litigation, which is also enclosed in the materials you have received.
You may obtain a copy of the entire Settlement Agreement at www.sulzerimplantsettlement.com or by contacting the office of the Claims Administrator at (800) 683-1861.
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| PLEASE BE ADVISED THAT FINAL NOTICE IN
THIS MATTER WAS SENT TO CLASS MEMBERS DURING MARCH 2002. IF YOU BELIEVE THAT YOU ARE A
CLASS MEMBER AND DID NOT RECEIVE FINAL NOTICE BY MARCH 2002, PLEASE CONTACT: Š 2002 - Sulzer Implant Settlement. All Rights Reserved. |