UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF ALABAMA
Southern Division

In re:                                                                                                                  )
                                                                                                                          )
SILICONE GEL BREAST IMPLANTS                                                            ) Master File No. CV 92-P-10000-S
PRODUCTS LIABILITY LITIGATION                                                           )
(MDL-926)                                                                                                       )

SANDY ALTRICHTER, et al.,                                                                          )
                     Plaintiffs;                                                                                        )
                                                                                                                          )
    -vs.-                                                                                                               ) Case No. CV 97-P-11441-S
                                                                                                                          )
                                                                                                                          )
INAMED CORP., et al.,                                                                                    )
                     Defendants.                                                                                   )

BREAST IMPLANT LITIGATION NOTICE

Please read this Notice carefully.

It affects your legal rights.

NOTICE OF CLASS ACTION AND PROPOSED SETTLEMENT WITH
INAMED CORPORATION AND RELATED PARTIES
(INCLUDING McGHAN MEDICAL CORPORATION AND CUI CORPORATION)

TO: All persons who have had breast implants(1) manufactured or sold by McGhan Medical Corporation, CUI Corporation (a/k/a Cox-Uphoff), INAMED Corporation or Minnesota Mining and Manufacturing Company (3M), and the spouses, parents, children, relatives, "significant others", representatives, estates, assignees and subrogees of such persons:

 

The purpose of this notice is to inform you that the court has provisionally certified a mandatory, limited fund settlement class and preliminarily approved a proposed settlement with INAMED Corporation and its affiliates (including McGhan Medical Corporation and CUI Corporation) (collectively "INAMED"), to inform you of the settlement approval procedure, and to inform you of your rights in connection with the proposed settlement.

In accordance with Rules 23(d) and 23(e) of the Federal Rules of Civil Procedure, you are notified of the following:

I. THE LITIGATION AND THE SETTLEMENT CLASS.

1. Thousands of lawsuits claiming injuries resulting from breast implants are pending in many federal and state courts. On June 25, 1992, the Judicial Panel on Multidistrict Litigation transferred to the United States District Court for the Northern District of Alabama a series of federal cases seeking damages or injunctive relief for injuries allegedly resulting from breast implants. These cases, together with hundreds of cases later transferred by the Panel or filed in the Northern District of Alabama, are pending before the Honorable Sam C. Pointer, Jr., Chief Judge, as part of a coordinated proceeding captioned In re Silicone Gel Breast Implants Products Liability Litigation, MDL No. 926, Master File No. CV 92-P-10000-S. INAMED and the Released Parties have been named in many, but not all, of these cases as defendants.

2. On June 2, 1998, the court provisionally certified one of these cases, Sandy Altrichter, et al., vs. INAMED Corp., et al., Case No. CV 97-P-11441-S, as a class action for settlement purposes on behalf of all persons, wherever located, who have or may in the future have claims against INAMED or the Released Parties based on breast implants implanted before June 1, 1993.

The size of the class cannot be fixed with any precision at this time. However, it is known that almost 44,000 implant recipients who registered with the Claims Office have notified the Claims Office that their only identifiable implants are INAMED implants and another 27,500 registered implant recipients notified the Claims Office that they had at least one INAMED implant in addition to implants from other manufacturers. In addition, there would be an unknown number of other persons, many of whom opted out of the original global settlement and have instituted suits in federal or state court against INAMED, who never registered with or provided information to the Claims Office.

3. The court has designated Sandy Altrichter, Janell Crumley Black, Darlene Davis, Lois Hamilton, Rose Marie Hodges, and Gloria Jones as Representative Plaintiffs for the class. The court has appointed the following attorneys experienced in breast implant and class action litigation as Settlement Class Counsel:

Ralph I. Knowles, Jr.
Leslie J. Bryan
DOFFERMYRE, SHIELDS, CANFIELD, KNOWLES & DEVINE
Suite 1600
1355 Peachtree Street
Atlanta, GA 30309

Elizabeth J. Cabraser
Heather A. Woodard
LIEFF, CABRASER, HEIMANN & BERNSTEIN, LLP
30th Floor, Embarcadero Center West
275 Battery Street
San Francisco, CA 94111

Dianna Pendleton
BLIZZARD & McCARTHY
Lyric Center
440 Louisiana, Suite 1710
Houston, TX 77002-1689

Ernest H. Hornsby
FARMER PRICE HORNSBY & WEATHERFORD, LLP
P. O. Drawer 2228
Dothan, AL 36302

The court has reserved the power to appoint additional class representatives or class counsel, or to designate appropriate subclasses, should it later deem such appointments or designations appropriate.

4. The court has provisionally certified the class as a mandatory, "limited fund" settlement class under Federal Rule of Civil Procedure 23(b)(1)(B), based on evidence that the costs and risks of litigating breast implant cases would quickly exhaust INAMED's limited resources, and that the $31,500,000 settlement fund, most of which will be provided as new capital by outside investors and which far exceeds INAMED's present ability to pay claims, would be unavailable to class members absent mandatory class certification.

5. There is no right to opt out of a mandatory class action certified under Rule 23(b)(1)(B). The class serves as a vehicle for equitable distribution of all class members' claims in light of the limited available funds. Therefore, if you fall within the class definition described above, you are a member of the class and you cannot exclude yourself ("opt out"). This is so whether or not you have brought your own lawsuit in federal or state court, and whether or not you suffer from a medical condition associated with a breast implant inserted on or before June 1, 1993. If, after the fairness hearing described below, the court confirms the class certification and enters a judgment approving the proposed class settlement, you will be bound by that judgment.

6. You have the right to comment on or object to the certification of the class and/or the terms of the proposed class settlement, provided you comply with the procedures and deadlines set forth in this notice.

7. In order to preserve INAMED's assets and enhance its ability to fulfill the terms of the class settlement should it be approved, the court has entered an order temporarily enjoining class members from instituting, prosecuting or individually settling any claims against INAMED or the Released Parties that are covered by the proposed class settlement. This injunction does not preclude class members from pursuing or settling claims they may have against parties other than INAMED or the Released Parties. Further, should the class settlement with INAMED not be approved, class members will regain the right to pursue individual claims against INAMED or the Released Parties in existing or new cases. Any motions for relief from, and any direct or collateral challenges to, this injunction shall be made to this court.

8. In provisionally certifying a mandatory class for settlement purposes and preliminarily approving the proposed settlement, the court has made no ruling on the propriety of class certification outside the settlement context. The court also has made no ruling as to the merits of the plaintiffs' underlying claims or INAMED's denials and defenses. Plaintiffs and their counsel have vigorously pursued the plaintiffs' claims, and INAMED has denied any wrongdoing or liability. This notice is not an expression by the court of any opinion on the likelihood of recovery by the plaintiffs or on the merits of any defense asserted by INAMED.

II. SUMMARY OF THE INAMED SETTLEMENT TERMS.

The terms and conditions of the proposed settlement are contained in the Settlement Agreement between INAMED Corporation and Representative Plaintiffs, filed with the court on May 21, 1998. The Settlement Agreement is lengthy and complex. This notice is intended as a summary only. You may obtain a copy of the Settlement Agreement by following the procedures in "Examination of Papers" below.

Settlement Fund. INAMED has agreed to pay $31,500,000, plus interest as specified in the Settlement Agreement, into a court-supervised settlement fund. On October 2, 1998, INAMED deposited the full principal amount of this obligation with the court-appointed fund agent as follows:

1. $3 million in cash;
2. $3 million in common stock; and
3. $25.5 million in an interest bearing note (the "Note").

Under the terms of the Settlement Agreement and the Note, both the common stock and the Note will be redeemable for cash at their combined face value ($28,500,000) on the later of April 30, 1999, or ninety-one days after a judgment approving the proposed class settlement becomes final and appeals, if any, have been exhausted. This fund will be increased by the amount of unused funds, of approximately $500,000, previously contributed by INAMED to an earlier proposed settlement fund, this enhanced fund being called the "increased class settlement fund."

If the class settlement is not approved, the parties are to be restored to their pre-agreement positions. The funds needed to pay INAMED's obligations under the Settlement Agreement are being provided through outside capital conditioned upon approval of the settlement and will not become assets of INAMED if the settlement is not approved.

Breast Implant Studies. INAMED is required to provide Settlement Class Counsel access to reports of ongoing research concerning breast implants and breast implant materials.

3M Contractual Indemnity Claims. The proposed settlement is conditioned on release by 3M of certain contractual indemnity claims that 3M asserts against INAMED's McGhan Medical subsidiary under an agreement by which McGhan Medical purchased 3M's breast implant business in 1984. McGhan Medical and 3M have entered into a separate agreement providing such a release in exchange for McGhan Medical's agreement to (1) pay 3M $3 million on the later of April 30, 1999, or ninety-one days after a judgment approving the proposed class settlement becomes final and appeals, if any, have been exhausted, (2) use that $3 million to obtain provisional releases of 3M from an agreed minimum number of claims asserted against 3M by persons with implants manufactured by McGhan Medical after its purchase of 3M's implant business (the "3M Condition"), and (3) assume limited continuing indemnification obligations going forward. If the 3M Condition is not satisfied or waived, the proposed class settlement will terminate. As of the date of this notice, INAMED has made substantial progress in obtaining the conditional releases needed to satisfy this condition and expects to have completed, or virtually completed, this task by year-end. Based on INAMED's showing in this regard and the desire of all parties not to delay the implementation of the settlement, the court has authorized the issuance of this notice scheduling the fairness hearing on the class settlement for January 11, 1999.

Other Contribution and Indemnity Claims. The proposed settlement is also conditioned on the court's inclusion, in its final approval order, of a finding that the settlement was made in good faith and a provision barring, under applicable state law, all statutory or common law claims for contribution or indemnification against INAMED or the Released Parties. The Settlement Agreement further provides that in jurisdictions whose laws may not provide for such a bar order, class members shall reduce any judgments they may obtain against third parties to the extent necessary to ensure that INAMED and the Released Parties do not have to pay anything to such third parties by way of contribution or indemnity.

Release. If the proposed settlement is approved, class members will forever release INAMED and the Released Parties (identified in Exhibit 2 of this notice) from any and all liability for any and all of the claims covered by the settlement (as described in Part I above). This release extends to all rights, claims, and causes of action, known or unknown, filed or unfiled, pleaded or not pleaded, suspected or unsuspected, concealed or unconcealed, for damages, medical monitoring, and injunctive or other relief (including punitive damages) relating to the covered claims. The release does not, however, extend to any claims you may have against any parties other than INAMED or the Released Parties. The Settlement Agreement fully reserves your rights to pursue any unresolved claims you may have against such other parties, except to the limited extent that the contribution and indemnification provisions described in the preceding paragraph may require you to reduce a judgment against a third party by the amount, if any, needed to ensure that INAMED and the Released Parties will not have to pay the third party anything by way of contribution or indemnification.

Exclusive Remedy. The proposed settlement, if approved, will be class members' exclusive remedy against INAMED and the Released Parties for claims covered by the settlement. INAMED and the Released Parties will have no liabilities relating to such claims other than their obligations under the Settlement Agreement. The judgment approving the settlement will legally bar class members from initiating, asserting, or prosecuting any settled claims against INAMED and the Released Parties.

III. RECOMMENDATION OF COUNSEL

1. Settlement Class Counsel have thoroughly investigated the merits of the claims against INAMED. Assisted by expert financial advisors, Ernst & Young LLP, they have also thoroughly investigated INAMED's financial condition, its ability to respond to the pending breast implant litigation, and its ability to raise funds to support a class settlement. Settlement Class Counsel have concluded that: (1) the continued prosecution of individual suits against INAMED through trial and appeals would require considerable expense and time, with a high degree of risk and uncertain prospects for recovery; (2) INAMED does not have sufficient financial resources or insurance to defend against and/or satisfy the thousands of claims pending against it; and (3) the continued prosecution of separate actions by individual class members would result in only a very small number of class members being able to obtain compensation from INAMED and in tens of thousands of class members being deprived of any opportunity to obtain any compensation from INAMED. After considering all available alternatives, including allowing INAMED to go bankrupt, Settlement Class Counsel have reluctantly concluded that the proposed settlement is superior to such other alternatives and that in light of such alternatives, it is fair, adequate, reasonable, and in the best interests of class members.

2. Although agreeing to the proposed settlement, INAMED has denied, and continues to deny, the claims and contentions in the Altrichter action and any wrongdoing or any legal liability of any kind. The proposed settlement and this notice are not to be construed as an admission of liability of any kind whatsoever by INAMED or the Released Parties. Notwithstanding this, INAMED recognizes that the costs and risks of litigating the thousands of breast implant claims pending against it far exceed its limited resources, and that settlement is therefore both necessary and appropriate from the company's standpoint.

IV. FUTURE ALLOCATION OF SETTLEMENT FUND.

1. The Settlement Agreement does not specify any particular allocation of settlement proceeds. Instead, it leaves to later proceedings, after the entry of final judgment approving the settlement, the development of procedures for equitable allocation and distribution of the settlement fund to members of the class. The parties contemplate that, in order to minimize the cost of claim administration and maximize distributable benefits, the distribution procedures will be designed, to the extent feasible, to utilize the existing MDL 926 claims database and claims processing facilities, while at the same time permitting claims by class members who may not have previously provided appropriate information to the Claims Office. The Settlement Agreement expressly provides that the court shall retain jurisdiction to make such other orders as it deems appropriate to ensure that relevant interests are afforded adequate representation and the opportunity to be heard in such proceedings. Class members will be given notice and an opportunity to be heard before any final allocation or distribution decisions are made.

2. The cost of this notice, all subsequent notice expenses, and all costs of claims administration will be paid from the increased class settlement fund, except that any cost of this providing this notice in excess of $400,000 will be borne by INAMED without any right to recoupment from the settlement fund.

3. As of the date of approval of this notice, a group representing approximately two-thirds of the nation's health insurers had under review a proposal by INAMED and Settlement Class counsel to release all their potential subrogation claims against INAMED, the settlement fund, or individual class members for $750,000. If consummated, this agreement will result in a charge of $250,000 against the increased class settlement fund, with the balance to be separately paid by INAMED. Any subrogation claims by workers' compensation insurers and health care insurers or providers not so resolved shall be mailed to INAMED Settlement Proceedings (P. O. Box 2785, Birmingham, AL 35202-2785), postmarked no later than January 11, 1999. All such claims shall be clearly marked "Subrogation Claim" and shall specifically identify the individual Claimants by name and social security numbers and shall include with specificity the particulars of the subrogation claims for that class member. Each subrogation claim shall be filed in a separate document. After the expiration of the deadline for filing subrogation claims, the court will consider the payment of timely subrogation claims, after notice and opportunity to be heard by interested parties, from the amounts allocated from the settlement fund to the respective individual class members against whom subrogation has been asserted. The failure to timely assert claims as set forth above shall constitute a waiver of such claims.

4. As of the date of approval of this notice, the United States had under review a proposal that, in exchange for a separate payment of $25,000 by INAMED, it would agreed not to assert any direct or subrogation claim against INAMED and not to directly make against the settlement fund prior to distribution any lien claim upon amounts payable to class members. Acceptance by the United States of this proposal would facilitate distribution of payments from the settlement fund and, as a practical matter, would likely result in most situations in the United States not pursuing subrogation or similar claims against individual class members or their representatives, though, as a legal matter, it would not bar the United States from independently asserting and pursuing statutorily-authorized claims or relieve such persons from statutory obligations such as those imposed on Medicare recipients with respect to third-party recoveries.

V. HOW YOUR RIGHTS ARE AFFECTED.

As stated above, the INAMED settlement class is a mandatory class. If you fall within the definition of the class as described above, you are automatically a member of the class, and, although you may comment on or object to the class certification or the proposed settlement, you may not exclude yourself from the class and will be bound by the court's orders and judgments in the Altrichter action if the class is certified and the settlement is approved. For purposes of this settlement, class members are automatically represented by the Settlement Class Counsel previously appointed by the court and identified above. You may hire an individual attorney, at your own expense, to intervene or appear on your behalf for the purpose of commenting on the matters contained in this notice, but you are not required to hire an attorney in order to appear, comment, or be heard at the fairness hearing, or to participate in the settlement if it is approved.

VI. ATTORNEYS' FEES AND EXPENSES.

1. Settlement Class Counsel will not apply to the court for any award of attorney fees from the settlement fund for their services in negotiating the settlement or in representing the INAMED Settlement Class. Although Settlement Class Counsel may apply for reimbursement of their out-of-pocket expenses incurred in connection with the settlement, such expenses will not be paid unless first approved by the court as fair and reasonable. In view of the limited amount of available funds that can be provided by INAMED in relation to the number and potential amount of claims of class members, the Common Benefit Fund previously established to compensate plaintiffs' counsel for fees and expenses incurred for the "common benefit" has agreed to forego and waive its entitlement to an assessment and charge under Order No. 13 and subsequent orders against the settlement amount provided to INAMED class members.

2. If you are separately represented by your own attorney, any claims by that attorney to a portion of any funds ultimately distributable to you from the settlement fund, for fees and expenses, will depend upon the terms of your agreement with that attorney, subject to court approval, and will not be paid separately out of the settlement fund. The court reserves the right to impose limitations upon the amount of fees that may be claimed by privately-retained attorneys with respect to amounts distributable under this settlement.

VII. SETTLEMENT HEARING.

1. A fairness hearing will be held in Courtroom 8, Hugo L. Black Courthouse, 1729 Fifth Avenue North, Birmingham, Alabama, on January 11, 1999, at 9:00 a.m. to determine whether the Settlement Agreement is fair, reasonable, and adequate and should be approved by the court.

2. At the hearing, any class member may appear in person or through counsel and may be heard in support of or in opposition to the certification of the mandatory settlement class and/or the fairness, reasonableness, and adequacy of the proposed settlement. If you wish to be heard at the fairness hearing, you must mail copies of your intention to appear and your written comments or objections, postmarked no later than December 11, 1998, to:

INAMED Settlement Proceedings
P.O. Box 2785
Birmingham, AL 35202-2785

3. You do not need to appear at the fairness hearing in order for your written comments or objections to be considered. The court will consider all comments or objections mailed to the above address and postmarked no later than the December 11, 1998, deadline. The court will not consider any comments or objections postmarked after that date.

4. Any class member who does not timely mail an intention to appear or written comments or objections to the indicated post office box shall be deemed to have waived any objections and shall be foreclosed from later objecting (by appeal or otherwise) either to the certification of the class or to the proposed settlement. ANY CLASS MEMBER WHO DOES NOT OBJECT TO THE PROPOSED CLASS CERTIFICATION AND SETTLEMENT NEED NOT APPEAR AT THE HEARING OR SUBMIT ANY COMMENTS.

VIII. EXAMINATION OF PAPERS.

This Notice provides only a summary of the proposed class settlement, which is documented in a lengthy Settlement Agreement on file with the court. For a more detailed statement of the matters involved in the Altrichter action, including the claims asserted, the terms of the Settlement Agreement, and the basis for Settlement Class Counsel's recommendation of the settlement, you are referred to the papers on file under the caption Altrichter, et al. vs. INAMED Corp., et al., Civil Action No. CV 97-P-11411-S, which may be inspected during regular business hours at the office of the clerk of the United States District Court in Birmingham, Alabama. The terms of the Settlement Agreement are also available for download on the internet at www.fjc.gov/BREIMLIT/mdl926.htm. You may also write for copies to Plaintiffs' Liaison Office, The Singer Building, 2008 2nd Avenue North, Birmingham, AL 35203. PLEASE DO NOT CONTACT THE COURT OR THE CLAIMS OFFICE. The Judge's office, the Clerk's office, and the Claims Office are not permitted to give legal advice.

Dated: October 12, 1998.

Perry D. Mathis
Clerk

 FOOTNOTES

FN1. As used in this notice, the term "breast implants" includes any breast implant device containing or consisting of saline, silicone, silicone gel, or an elastomer made of silicone, including implants designed for temporary implantation in the breast (i.e., tissue expanders). Implant brands covered by this notice include all brands listed in the attached Exhibit 1.

FN2. The Released Parties are listed in the attached Exhibit 2.


EXHIBIT 1

IMPLANT BRANDS OF INAMED AND AFFILIATED COMPANIES:

Biocell RHP (Round High Profile)
Biodimensional RLD (Round Low Profile DRIE)
Biospan RLP (Round Low Profile)
Cox Uphoff RTV/RTT (Smooth/Textured)
CZV/CRS (Croissant Versafil Low Profile) Ruiz-Cohen
DRI RZV/SRV (Rectangular Versafil Tissue Expander)
DRIE SCC (Cylindrical Tissue Expander)
EHP (Enhanced High Profile) SCS (Crescent Tissue Expander)
FZV/SFV (Round Versafil LP Tissue Expander) SEE (Mini-crescent Tissue Expander)
Gibney SFS (Saline Fill Skin and Tissue Expander)
Intrashiel (manufactured after 8/2/84) SGO (Saline Gel Oval)
Intravent SGR (Saline Gel Round)
IOC (Cylindrical Intraoperative Tissue Expander) SLP (Single Lumen Adjustable)
IOM (Intravent Intraoperative Expander) SLS (Longitudinally Curved Tissue Expander)
IOS (Spherical Intraoperative Tissue Expander) SOE (Small Oval Tissue Expander)
Magna-Site SOS (Ear Shaped Tissue Expander)
Maxwell SPS (Pear Shaped Tissue Expander)
McGhan (manufactured after 8/2/84) SRS (Rectangular Tissue Expander)
MFE (Man Facelift Expander) SSS (Spherical Tissue Expander)
Microcell SWS (Wedge Shaped Tissue Expander)
OHP (Oval High Profile) SZR (Round Low Profile Sizer)
OLP (Oval Low Profile) TLL (Triple Lumen Round)
RCP (Round Conical Profile) Tri-Lumen
RCR (Ruiz-Cohen Expanders) TRL (Tri-Luman Implants)
RDD (Reserve Double Lumen DRIE) TSO (Triple Lumen Low Profile Oval)
RDL (Reverse Double Lumen) TSR (Triple Lumen Round Low Profile)
RDL-XPAND UHP
RDX (Round Double Lumen) Ultra High Performance
Reverse Double Lumen Versafil
RHD (Round High Profile)  



IMPLANT BRANDS OF 3M and MMC/3M (HERE DEFINED AS INAMED IMPLANTS FOR THE LIMITED PURPOSE OF RELEASING CLAIMS AGAINST INAMED AND THE RELEASED PARTIES BASED ON SUCH IMPLANTS):

3M
McGhan (manufactured before 8/3/84)
Intrashiel (manufactured before 8/3/84)
Natrashiel

 


EXHIBIT 2

RELEASED PARTIES

Biodermis Corporation
Biodermis Ltd.
BioEnterics Corporation
BioEnterics Latin America
BioEnterics, Ltd.
Bioplexus Corporation
Bioplexus Ltd.
Lawrence Birnbaum
Chamfield Ltd.
CUI Corporation
   (f/k/a Cox-Uphoff International Corporation)
   (a/k/a Cox-Uphoff Corporation)
Jack Fisher
Flowmatrix Corporation
INAMED B.V.
INAMED B.V.B.A.
INAMED B.V.(R.O.R.)
INAMED Corporation
INAMED do Brasil LTDA
INAMED Development Company
INAMED GmbH
INAMED Japan
INAMED Ltd.
INAMED Medical Group
INAMED S.A.
INAMED S.A.R.L.
INAMED S.R.L.
Innovative Surgical Products, Inc.
Ron E. Iverson
G. Patrick Maxwell
Donald K. McGhan
McGhan Limited
McGhan Medical Asia/Pacific
McGhan Medical Corporation, a California corporation
McGhan Medical Mexico, S.A. de C.V.
Medisyn Technologies Corporation
Medisyn Technologies Ltd.
Silicone Engineering, Inc.
Scott L. Spear
Specialty Silicone Fabricators, Inc.
John B. Tebbetts
John L. Williams

Corporate "Released Parties" listed above include their respective parents, subsidiaries and affiliates, each of their predecessors, successors and assigns (provided that 3M and MMC/3M, insofar as they may be considered predecessors of MMC, are expressly excluded from the definition of "Released Parties" herein), and each of their current and former officers, directors, employees, agents and attorneys, acting in their capacities as such and/or in connection with INAMED or INAMED Breast Implants.