RESTASIS (CYCLOSPORINE OPHTHALMIC EMULSION)
ANTITRUST LITIGATION

IN RE RESTASIS CYCLOSPORINE OPHTHALMIC EMULSION
ANTITRUST LITIGATION
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF NEW YORK

Opt-Out Deadline: August 3, 2020
Objection Deadline: August 3, 2020
Fairness Hearing: September 29, 2020

If you purchased Restasis (Cyclosporine Ophthalmic Emulsion) directly from Allergan, Inc., your rights may be affected by the settlement of a class action lawsuit.

Direct purchaser class plaintiffs FWK Holdings, LLC, KPH Healthcare Services, Inc. a/k/a Kinney Drugs, Inc., Rochester Drug Cooperative, Inc., Meijer, Inc., and Meijer Distribution, Inc. (“Direct Purchaser Class Plaintiffs”), on behalf of a proposed class of direct purchasers (“Proposed Direct Purchaser Class”), have reached a settlement of their class action suit against Allergan, Inc. (“Allergan”) titled In re Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litigation, 18-md-2819 (NG), pending before the Honorable Nina Gershon in the United States District Court for the Eastern District of New York.

The purpose of the Notice and this website is: (1) to alert you to the existence of a Class Action Lawsuit (the “Lawsuit”) brought by direct purchasers of Restasis against Allergan; (2) to inform you that the Court has preliminarily approved the settlement and determined that it is likely to certify, for the purposes of settlement, a class of entities that purchased Restasis directly from Allergan after May 2014 through and including February 16, 2020; and (3) to give you an opportunity to exclude yourself from the Proposed Direct Purchaser Class or object to the proposed settlement reached between Direct Purchaser Class Plaintiffs and Allergan by taking action within 50 days of this notice (August 3, 2020).

The lawsuit alleges that Allergan violated antitrust laws relating to the sale of the prescription pharmaceutical drug Restasis by: 1) procuring patents by fraud, 2) listing those fraudulently acquired patents in the Orange Book, 3) filing serial sham petitions with the FDA, and 4) transferring ownership of the fraudulently acquired patents to the Saint Regis Mohawk Tribe and asserting the Tribe’s sovereign immunity. The lawsuit alleges that these actions by Allergan delayed the entry of generic Restasis into the marketplace. Allergan has denied any wrongdoing.

  • The settlement with Allergan will provide $51,250,000.00 in cash to resolve the Proposed Direct Purchaser Class’s claims against Allergan (the “Settlement Fund”). The released claims are described below.

  • The Court has scheduled a hearing to decide whether to: grant final approval of the settlement; approve the plan for allocating the Settlement Fund to Proposed Direct Purchaser Settlement Class members; certify the Proposed Direct Purchaser Settlement Class; and grant requests from counsel for the Direct Purchaser Class Plaintiffs (“Class Counsel”) to pay settlement administration costs, award attorney’s fees, reimburse Class Counsel’s out-of-pocket expenses and costs, and authorize service awards to the Direct Purchaser Class Plaintiffs. That hearing is scheduled for September 29, 2020 at 10:30 a.m., before U.S. District Court Judge Nina Gershon in Courtroom 6D South of the United States District Court for the Eastern District of New York, 225 Cadman Plaza East, Brooklyn, NY 11201. You may, but are not required to, attend.

    The Court has scheduled a fairness hearing for September 29, 2020 at 10:30 a.m. but acknowledges that due to the COVID-19 pandemic and continuing global health crisis, the hearing may need to be rescheduled. Interim Lead Class Counsel will notify Proposed Direct Purchaser Settlement Class members of any change to deadlines or hearing dates.

What Is This Lawsuit About?

Direct Purchaser Class Plaintiffs allege that Allergan, following the Food and Drug Administration’s (FDA) June 2013 issuance of a draft guidance relating to the approval of generic versions of Restasis, engaged in anticompetitive behavior to delay entry of generic Restasis.

The plaintiffs allege that Allergan obtained an illegal monopoly on Restasis by submitting fraudulent patent applications to the U.S. Patent and Trademark Office (PTO), obtaining fraudulent patents, and then listing those fraudulent patents in the FDA’s “Orange Book.” Specifically, the plaintiffs allege that Allergan procured these fraudulent patents by submitting misleading declarations, presentations, and filings to the PTO that falsely claimed to have found new and unexpected results for an old invention. During the same period, the plaintiffs also allege that Allergan submitted lengthy, baseless citizen petitions to the FDA – a tactic that plaintiffs allege can delay generic competition. Lastly, the plaintiffs allege that Allergan transferred ownership of its fraudulently acquired patents to the Saint Regis Mohawk Tribe and then claimed that its patents could not be challenged or thrown out because the Tribe was immune from certain types of patent challenges.

The plaintiffs claim that class members were injured as a result of the challenged conduct because they paid more for branded Restasis than they would have paid for generic Restasis and brand Restasis during the class period absent Allergan’s misconduct. A copy of the plaintiff’s First Amended Consolidated Class Action Complaint and Jury Demand, dated February 11, 2019, is available for download in the Court Documents page this website.

Allergan denies all of these allegations, including that the plaintiffs or class members are entitled to damages or any other relief. Among other things, Allergan contends that its actions in pursuing its patent rights were reasonable and had a legitimate basis, that its citizen petitions filed with the FDA had scientific and legal merit, and that generic versions of Restasis have not been delayed by the conduct the plaintiffs challenge.

Following full investigation of relevant facts, and negotiations, including use of a court-appointed mediator, the class representatives of the Proposed Direct Purchaser Settlement Class, on behalf of the proposed Class, entered into the Settlement Agreement with Allergan.

There has been no determination by the Court or a jury that the allegations against Allergan have been proven or that, if proven, Allergan’s conduct caused harm to any purchasers.

The Honorable Nina Gershon of the United States District Court for the Eastern District of New York is overseeing this class action and the Settlement. The lawsuit is known as In re: Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litigation, 18-md-2819.

AM I PART OF THE CLASS AND THE SETTLEMENT?

On May 15, 2020, a federal court found that it will likely certify the following class at or following the final fairness hearing:

All persons who or entities which purchased Restasis in the United States or its territories and possessions directly from Allergan at any time after May 2014 through and including February 16, 2020 (the “Class Period”). Excluded from the class are Allergan and its officers, directors, management, employees, subsidiaries, or affiliates, and all governmental entities.

Also excluded from the Class are the following entities, in their own capacity or as assignees, who have filed separate, but coordinated, actions against Allergan: CVS Pharmacy, Inc., Rite Aid Corporation, Rite Aid Hdqtrs. Corp., Walgreen Co., The Kroger, Co., Albertsons Companies, Inc., and HEB Grocery Company L.P.

If you fit within the definition of the Proposed Direct Purchaser Settlement Class, once certified, you are a member of the Class for purposes of the Settlement unless you ask to be excluded from the Class.

If you are not sure whether you are included, you may call or write to the lawyers in this case at the telephone numbers, email addresses, or addresses listed in Question 9 of the Notice and below.

YOUR LEGAL RIGHTS AND OPTIONS IN THIS SETTLEMENT
WHEN YOU RECEIVE A CLAIM FORM, PROMPTLY COMPLETE AND RETURN IT You do not need to do anything now to remain a member of the Proposed Direct Purchaser Settlement Class. If the Settlement with Allergan is approved and you are a member of the Class, you will receive a claim form by mail to complete, sign, and return to obtain a share of the Settlement Fund.
EXCLUDE YOURSELF Ask to be excluded from the Proposed Direct Purchaser Settlement Class. You will not be legally bound by anything that happens in the Settlement with Allergan and you may be able, at your own expense, to pursue a claim against Allergan in the future about the legal issues in this case.
OBJECT TO THE SETTLEMENT Write to the Court about why you do not like the settlement.
GO TO A HEARING Unless you exclude yourself from the Direct Purchaser Settlement Class, you may, but are not required to, attend the hearing and speak to the Court about the fairness of the Settlement, the allocation plan, or Class Counsel’s requests for fees and expenses.
GET MORE INFORMATION If you would like to receive more information about the proposed Settlement, you can send questions to the lawyers identified in this notice and/or attend the hearing at which the Court will evaluate the proposed settlement.

If the proposed Settlement is approved by the Court and the Court certifies the proposed class, all Direct Purchaser Settlement Class members will receive a claim form by both mail and email to request a pro rata share of the Net Settlement Fund. Court-approved fees and expenses for the attorneys and a service award to the plaintiffs will also be paid from the Settlement Fund. Transactional sales data from Allergan will be used to make the pro rata share calculations. You will be asked to verify the accuracy of the information in the claim form that will be mailed and emailed to you if the Court approves the Settlement, and to sign and return the form according to the directions on the form. Class Members will be given the opportunity to provide data or information to supplement or correct this information.

EXCLUDING YOURSELF FROM THE CLASS AND THE SETTLEMENT

You may exclude yourself from the Proposed Direct Purchaser Settlement Class within 50 days of this notice (August 3, 2020).

To exclude yourself, you must send a letter via first-class U.S. mail saying that you want to exclude yourself from the Settlement in the Direct Purchaser Class Action in In re Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litigation, 18-md-2819 (NG) (E.D.N.Y.). Be sure to include your name, address, telephone number, your signature, and the Settlement from which you want to be excluded. Mail the exclusion to: RG/2 Claims Administration, P.O. Box 59479, Philadelphia, PA 19102-9479. Your letter requesting exclusion must be postmarked no later than August 3, 2020. In the event that you are unable to send a letter via first-class U.S. mail, the letter may be emailed to restasisDPPsettlement@rg2claims.com within 50 days of this notice (August 3, 2020).

Due to the COVID-19 pandemic and the current global health crisis, please include in your communication secondary contact information such as email addresses and cell phone numbers to ensure that any changes in deadlines or hearing dates can be communicated to you effectively. Please also continue to check www.RestasisAntitrustSettlement.com for important updates.

If you ask to be excluded from the Proposed Direct Purchaser Settlement Class, you will not get to share in the Settlement. You will not be legally bound by the Settlement, and you may be able to sue Allergan in the future about the legal issues resolved by this Settlement.

If you exclude yourself so that you can start or continue your own lawsuit against Allergan, you should talk to your own lawyer soon, because your claims will be subject to a statute of limitations, which means that your claims may expire if you do not take timely action. You need to contact your own lawyer at your own expense about this issue.

If you do not exclude yourself, you will not be able to start a lawsuit, continue with a lawsuit, or be part of any other lawsuit against Allergan arising from the claims brought in this Lawsuit and resolved by the Settlement. All of the Court’s orders concerning the Lawsuit will apply to you and legally bind you. You will be bound by the Settlement with Allergan, if the Court grants final approval, and the final judgment entered in the case.

OBJECTING TO THE SETTLEMENT

If you are a member of the Proposed Direct Purchaser Settlement Class, you can object to the Settlement if you do not like it. The Court will consider your views. To object, you must send an email to the Court and the parties’ Counsel (listed below) stating that you object to the Settlement in In re: Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litigation, 18-md-2819. Be sure to include your name, email address, physical address, best telephone number, a summary statement outlining your positions and the reasons for them, and copies of any supporting documents or briefs you want the Court to consider. Please email the objection to all of the email addresses bolded below:

Counsel for Allergan Interim Lead Class Counsel
Eric Stock
EStock@gibsondunn.com
GIBSON DUNN & CRUTCHER, LLP
200 Park Avenue
New York, NY 10166

M. Sean Royall
sean.royall@kirkland.com
KIRKLAND & ELLIS LLP
1601 Elm Street
Dallas, TX 75201
Thomas M. Sobol
tom@hbsslaw.com
Kristen A. Johnson
kristen@hbsslaw.com
With copy to: jessicam@hbsslaw.com
HAGENS BERMAN SOBOL SHAPIRO LLP
55 Cambridge Parkway, Suite 301
Cambridge, MA 02142

Courtroom Deputy of Judge Gershon
Victor Joe
Victor_Joe@nyed.uscourts.gov
Courtroom Deputy of Judge Gershon
UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF NEW YORK
225 Cadman Plaza East
Brooklyn, NY 11201

Your objection must be emailed within 50 days of this notice (August 3, 2020)

Please also continue to check www.RestasisAntitrustSettlement.com for important updates.

Interim Lead Class Counsel will file any objection to the settlement on the electronic docket for In re Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litigation, 18-md-2819 (NG) (E.D.N.Y.). Interim Lead Class Counsel will provide any objecting member a receipt of this filing by email.

COURT’S FAIRNESS HEARING

The Court will hold a hearing, called a Fairness Hearing on September 29, 2020 at 10:30 a.m., to decide whether to finally approve the Settlement and certify the proposed class. The hearing will be held at the United States District Court for the Eastern District of New York, 225 Cadman Plaza East, Brooklyn, NY 11201 in Courtroom 6D South.

The Court acknowledges that due to the COVID-19 pandemic and continuing global health crisis, the hearing may need to be rescheduled. Interim Lead Class Counsel will notify Proposed Direct Purchaser Settlement Class members of any change to deadlines or hearing dates.

You may attend, and you may ask to speak, but you do not have to.

If you are a member of the Direct Purchaser Settlement Class, you may ask the Court for permission to speak at the Fairness Hearing. To do so, you must send an email stating that it is your “Notice of Intention to Appear in In re: Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litigation, 18-md-2819.” Be sure to include your name, email address, physical address, best telephone number, a summary statement outlining your positions and the reasons for them, and copies of any supporting documents or briefs you want the Court to consider. Your Notice of Intention to Appear must be emailed within 50 days of this notice (August 3, 2020) and must be sent to the Courtroom Deputy of Judge Gershon (Mr. Victor Joe, Victor_Joe@nyed.uscourts.gov ), Interim Lead Class Counsel (tom@hbsslaw.com, kristen@hbsslaw.com, jessicam@hbsslaw.com), and Counsel for Allergan (EStock@gibsondunn.com, sean.royall@kirkland.com) at the indicated email addresses. You cannot speak at the hearing if you do not send a Notice of Intention to Appear.

Please read the Notice for more information on this hearing.

Please also continue to check www.RestasisAntitrustSettlement.com for important updates.