LOESTRIN 24 FE ANTITRUST LITIGATION

FREQUENTLY ASKED QUESTIONS

BASIC INFORMATION

You received this notice because, according to sales data produced by the manufacturers of brand and generic Loestrin 24 Fe and/or brand Minastrin 24 Fe, you may have purchased brand and/or generic Loestrin 24 Fe during the period from September 1, 2009 through June 3, 2015 directly from Defendants or Amneal and/or purchased brand Minastrin 24 Fe during the period from September 1, 2009 through March 14, 2017, directly from Defendants.

TA prior notice about the lawsuit and the Court’s decision to certify the Class was mailed on or about August 28, 2019.

A federal court authorized this second notice because you have a right to know about the proposed settlement and about all of your options before the Court decides whether to grant final approval of the settlement. This notice explains the lawsuit, the settlement, your legal rights, what benefits are available, and eligibility for those benefits. Note that you may have received this notice in error; simply receiving this notice does not mean you are definitely a Direct Purchaser Class Member. You may confirm that you are a Direct Purchaser Class Member by reviewing the criteria set forth in Question 5 below. You may also call or write to the lawyers in this case at the telephone numbers or addresses listed in Question 9 below.

Plaintiff alleges that Warner Chilcott and Watson violated federal antitrust laws by unlawfully impairing the introduction of generic versions of the prescription drug Loestrin 24 Fe into the United States market.

Plaintiff alleges that Warner Chilcott obtained an illegal monopoly on Loestrin 24 Fe through a patent procured by fraud on the U.S. Patent and Trademark Office and then wrongfully listed the fraudulent patent in the FDA’s “Orange Book.” Plaintiff alleges that, after generic manufacturer Watson and other potential generic competitors notified Warner Chilcott that they planned to launch generic versions of Loestrin 24 Fe, Warner Chilcott sued them asserting the invalid, improperly obtained, and unenforceable patent. Plaintiff alleges that Warner Chilcott and Watson later settled the baseless patent infringement lawsuit by entering into an illegal reverse payment agreement whereby Warner Chilcott paid Watson to delay the launch of its generic Loestrin 24 Fe product for more than four years. Plaintiff alleges that, just prior to the launch of Watson’s delayed generic version of Loestrin 24 Fe (named Lomedia 24 Fe and sold by Amneal Pharmaceuticals LLC through an arrangement with Watson), Warner Chilcott implemented an illegal “product hop” by withdrawing Loestrin 24 Fe from the United States market and launching in its place Minastrin 24 Fe, a chewable version of Loestrin 24 Fe that Plaintiff alleges otherwise was indistinguishable and offered no additional benefit over Loestrin 24 Fe.

Plaintiff claims that Class Members were injured as a result of the challenged conduct by paying more for brand and generic Loestrin 24 Fe and brand Minastrin 24 Fe. A redacted public copy of Plaintiff’s Third Amended Consolidated Class Action Complaint and Jury Demand, dated March 28, 2018, is available for download at www.loestrin24antitrustlitigation.com.

Warner Chilcott and Watson deny all of these allegations, including that Plaintiff or Class Members are entitled to damages or other relief. Warner Chilcott and Watson respond that the patent protecting Loestrin 24 Fe was valid and enforceable and that Warner Chilcott’s litigation against companies infringing the patent was reasonable and necessary to protect Warner Chilcott’s legitimate intellectual property. Warner Chilcott and Watson also respond that their settlement of the patent infringement litigation was reasonable, led to earlier availability of generic versions of Loestrin 24 Fe than would have been available without the settlement, and included business deals that introduced new competition in women’s health, among other benefits. Warner Chilcott and Watson also respond that the transition from Loestrin 24 Fe to Minastrin 24 Fe introduced a new competitive option for patients and their physicians, as well as other benefits, and did not have the effect of delaying or impairing any generic competition. Finally, Warner Chilcott and Watson respond that no patients or pharmaceutical purchasers paid higher prices or suffered any harm as a result of Warner Chilcott’s and Watson’s conduct.

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

Judge William E. Smith of the United States District Court for the District of Rhode Island is overseeing this class action and the settlement. The lawsuit is known as In re Loestrin 24 Fe Antitrust Litigation, Civil Action No. 1:13-md-2472-WES-PAS (D.R.I.).

In a class action lawsuit, one or more persons or entities (called the “plaintiff” or “class representative”) sues on behalf of others who have similar claims. Together, they are typically called a “class” or “class members.” Accordingly, entities that purchased brand or generic Loestrin 24 Fe or brand Minastrin 24 Fe directly from Warner Chilcott or Amneal (Amneal sold generic Loestrin 24 Fe on behalf of Watson) during the relevant time periods are considered part of a “class” or “class members.” The company that filed suit is called the plaintiff (or class representative). The companies that are sued, in this case Warner Chilcott and Watson, are called defendants.

In a class action lawsuit, one court resolves the issues for everyone in the class, except for those class members who exclude themselves from the class. The Court, by order dated July 2, 2019 certified the Class in this case. A copy of the Court’s order may be found at www.loestrin24antitrustlitigation.com.

The Court decided that this lawsuit can proceed as a class action because it meets the requirements of Federal Rule of Civil Procedure 23, which governs class actions in federal courts. Specifically, the Court found that:

  • The number of class members is so numerous that joining them all into one suit is impractical.
  • Members of the class share common legal or factual issues relating to the claims in this case.
  • The claims of the class representative are typical of the claims of the rest of the class.
  • The class representative and the lawyers representing the class will fairly and adequately protect the class’s interests.
  • The common legal and factual questions predominate over any questions affecting only individual members of the class, and this class action will be more efficient than individual lawsuits.
  • Damages can be calculated on a class-wide basis.

Common legal and factual questions identified by counsel include:

  • Whether Warner Chilcott listed the Loestrin 24 Fe patent in the FDA’s “Orange Book” even though it could not be reasonably asserted against generics (as it was invalid and/or unenforceable due to fraud);
  • Whether Warner Chilcott wrongfully enforced the Loestrin 24 Fe patent against potential generic competitor Watson, when a sophisticated pharmaceutical manufacturer in Warner Chilcott’s position would not realistically expect to succeed in proving that the generics infringed a valid patent (given that the patent was invalid and/or unenforceable due to fraud and Watson may well have been able to show non-infringement);
  • Whether Warner Chilcott entered into an illegal “reverse payment” agreement with Watson, whereby Warner Chilcott conveyed substantial value to Watson in exchange for Watson’s agreement to delay entry of its generic version of Loestrin 24 Fe;
  • Whether Warner Chilcott’s payments to Watson were necessary to yield any cognizable and nonpretextual procompetitive benefits, and if so whether these payments were the least restrictive means of achieving such procompetitive benefits;
  • Whether Defendants engaged in an anticompetitive “product hop” to Minastrin 24 Fe;
  • Whether Defendants’ conduct suppressed generic competition by delaying or impairing the launch of any competing generic version of Loestrin 24 Fe;
  • Whether the activities of Warner Chilcott and Watson have substantially affected interstate commerce;
  • Whether, and to what extent, Warner Chilcott’s and Watson’s conduct caused antitrust I injury (i.e., overcharges) to direct purchasers.

Plaintiff and Defendants were preparing to proceed with the litigation and go to trial scheduled to begin January 6, 2020, but the Plaintiff and Defendants agreed to a settlement. By settling, Plaintiff and Defendants avoid the risk of trial and the continued costs of litigation. The Plaintiff and Class Counsel believe that the proposed settlement is fair, adequate, reasonable, and in the best interests of the Class.

On July 2, 2019, a federal court allowed this antitrust lawsuit to proceed as a class action, and certified the following class:

  • All persons or entities in the United States and its territories who purchased brand or generic Loestrin 24 directly from Warner [Chilcott] or Amneal at any time during the period from September 1, 2009, through and until June 3, 2015, and all persons or entities in the United States and its territories who purchased brand Minastrin 24 directly from Warner [Chilcott] at any time during the period from September 1, 2009, through and until March 14, 2017 (the “Class Period”). Excluded from the Class are defendants, and their officers, directors, management, employees, subsidiaries, or affiliates, and, all federal governmental entities. Also excluded from the class are educational institutions such as universities and colleges (the “Class”).

  • At their request, in response to a previous notice of pendency of this lawsuit sent to all Class Members, the following entities were also excluded from the Class: Walgreen Co., The Kroger Co., Safeway Inc., HEB Grocery Company L.P., Albertson’s LLC, CVS Pharmacy, Inc., Rite Aid Corporation, and Rite Aid Hdqtrs. Corp.

  • If you fit within the definition of the Class, unless you previously asked to be excluded from the Class, you are a member of the Class for purposes of the settlement (the “Direct Purchaser Settlement 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 or addresses listed in Question 9 below.

  • Defendants’ names and corporate relationships have changed over time. The lawsuit alleges wrongdoing by Warner Chilcott. In 2013 Warner Chilcott became a wholly owned subsidiary of Actavis, plc. In March 2015, Actavis plc completed an acquisition of Allergan, plc, and thereafter changed its corporate name to Allergan, plc. During much of the relevant time period in this case, Warner Chilcott and Watson were separate companies. More recently, these companies have both become part of Allergan, plc.

Defendants have agreed to pay $120,000,000 in cash into an interest-bearing escrow account (“Settlement Fund”) for the benefit of the Direct Purchaser Class. If approved by the Court, the Settlement Fund, minus any Court-awarded fees and expenses to Plaintiffs’ Counsel, the cost of settlement notice and administration, and a service award to the Plaintiff (the “Net Settlement Fund”) will be distributed to Direct Purchaser Class Members who return valid and timely Claim Forms. The distribution will be made on a pro rata basis, consistent with each Direct Purchaser Class Member’s aggregate weighted share of the total Direct Purchaser Class purchases of brand Loestrin 24 Fe and Minastrin 24 Fe and generic Loestrin 24 Fe. The Allocation Plan utilizes the weighted totals of each Class Member’s purchases of brand Loestrin 24 Fe, brand Minastrin 24 Fe, and generic Loestrin 24 Fe to account for the different amount of alleged overcharge associated with purchases of brand and generic products, with brand unit purchases weighted more than generic unit purchases.

Transactional sales data from the Defendants and manufacturers of generic Loestrin 24 Fe will be used to make these calculations. Class Members will be given the opportunity to provide data or information to supplement or correct this information if they choose. Each Direct Purchaser Class Member will receive a Claim Form pre-populated with information about their purchases for review and signature.

Plaintiffs’ Counsel will ask for a service award for the Plaintiff of up to $100,000 from the Settlement Fund in recognition of its efforts to date on behalf of the Class.

In exchange for the Settlement Fund, Defendants will be released and discharged from all antitrust and similar claims relating to Loestrin 24 Fe, Minastrin 24 Fe, Lo Loestrin Fe and the generic forms of these products (“Releasees” and “Released Claims” as defined in the Settlement Agreement). The full text of the releases is included in the Settlement Agreement, available at loestrin24antitrustlitigation.com.

Each Class Member’s proportionate, weighted pro rata recovery will be determined using a Court-approved Plan of Allocation. The detailed Plan of Allocation is posted and can be reviewed at www.loestrin24antitrustlitigation.com. Under the proposed Plan of Allocation, your share of the Net Settlement Fund will depend on the total amount of brand and generic Loestrin 24 Fe and brand Minastrin 24 Fe that you purchased from September 1, 2009 to March 14, 2017 (“Class Purchases”) weighted to account for the different amount of alleged overcharge associated with purchases of brand and generic products, with brand units weighted more than generic unit purchases. Generally, those who purchased more will get a higher recovery, and those who purchased brand Loestrin 24 Fe and brand Minastrin 24 Fe will get more than those who purchased only generic Loestrin 24 Fe, as alleged overcharge damages on purchases of generic Loestrin 24 Fe were lower than alleged overcharges on purchases of brand Loestrin 24 Fe and brand Minastrin 24 Fe

Your share of the Net Settlement Fund will also depend on the number of valid claim forms that Class Members submit. If fewer than 100% of the Class Members send in a claim form, you could get a larger pro rata share.

Money from the settlement will only be distributed to Class Members if the Court grants final approval of the settlement. Payment is conditioned on several matters, including the Court’s approval of the settlement and such approval no longer being subject to any appeals to any court or, if there is an appeal, such appeal being final and no longer subject to any further appeal.

The Settlement Agreement may be terminated if the Court does not approve the settlement or materially modifies it. If the Settlement Agreement is terminated, the lawsuit will proceed against Defendants as if such settlement had not been reached.

If the settlement is approved by the Court, all Direct Purchaser Settlement Class Members will receive a Claim Form by mail 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 Plaintiff will also be paid by the Settlement Fund. Transactional sales data from the Defendants and manufacturers of generic Loestrin 24 Fe 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 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

Claim forms must be postmarked (with any necessary supporting documentation if the claimant disagrees with the information contained in its claim form) within thirty days of the date the claim forms were mailed. At Class Counsel’s discretion, this deadline may be extended by forty-five days.

The Court appointed four law firms to serve as counsel to represent you and all Class Members. Their contact information is as follows (“Class Counsel”):

Thomas M. Sobol
Kristen A. Johnson
HAGENS BERMAN SOBOL SHAPIRO LLP
55 Cambridge Parkway, Suite 301
Cambridge, MA 02142
Telephone: (617) 482-3700
Facsimile: (617) 482-3003

Joseph H. Meltzer
Terence S. Ziegler
KESSLER TOPAZ MELTZER & CHECK LLP
280 King of Prussia Road
Radnor, PA 19087
Telephone: (610) 667-7706
Facsimile: (610) 667-7056

David F. Sorensen
Ellen T. Noteware
BERGER MONTAGUE PC
1818 Market Street, Suite 3600
Philadelphia, PA 19103
Telephone: (215) 875-3000
Facsimile: (215) 875-4604

Peter R. Kohn
David C. Calvello
FARUQI & FARUQI LLP
1617 JFK Boulevard, Suite 1550
Philadelphia, PA 19103
Telephone: (215) 277-5770
Facsimile: (215) 277-5771

You do not need to hire your own lawyer if you are in the Class because the lawyers appointed by the Court are working on your behalf. You may hire a lawyer and enter an appearance through your lawyer at your own expense if you so desire.

The Court will be asked to approve reasonable fees and expenses for the lawyers who worked on the case for reimbursement of the litigation expenses they have advanced on behalf of the Class and fees of up to one-third of the Settlement Fund. If the Court grants Class Counsel’s requests, fees and expenses would be deducted from the Settlement Fund. Members of the Class will not have to pay any attorneys’ fees or expenses out of their own pockets.

Any application by Class Counsel for an award of attorneys’ fees, reimbursement of expenses and service award to the Plaintiff will be filed with the Court and made available for download and/or viewing on or before April 20, 2020 on www.loestrin24antitrustlitigation.com, as well as the offices of the Clerk of Court for the United States District Court for the District of Rhode Island, 1 Exchange Terrace, Providence, RI 02903, during normal business hours.

If you are a member of the Direct Purchaser Class, you can object to the settlement if you do not like it. The Court will consider your views. To object, you must send a letter via First Class U.S. Mail saying that you object to the settlement in In re Loestrin 24 Fe Antitrust Litigation, Civil Action No. 1:13-md-2472-WES-PAS (D.R.I.). Be sure to include your name, address, telephone number, your signature, and the reasons why you object to the settlement. Mail the objection to all of the following:

Counsel for Defendants

Peter J. Carney
WHITE & CASE LLP
701 Thirteenth Street, NW
Washington, DC 20005

David F. Sorensen
Ellen T. Noteware
BERGER MONTAGUE PC
1818 Market Street, Suite 3600
Philadelphia, PA 19103

Peter R. Kohn
David C. Calvello
FARUQI & FARUQI LLP
1617 JFK Boulevard, Suite 1550
Philadelphia, PA 19103

Joseph H. Meltzer
Terence S. Ziegler
KESSLER TOPAZ MELTZER & CHECK LLP
280 King of Prussia Road
Radnor, PA 19087

Clerk of the Court

Clerk of the United States District Court for the District of Rhode Island
United States Courthouse
1 Exchange Terrace
Providence, RI 02903

Your objection must be postmarked no later than May 11, 2020.

The Court will hold a Fairness Hearing at 10:00 a.m. on August 27, 2020, in the Courtroom of the United States District Court for the District of Rhode Island, 1 Exchange Terrace, Providence, Rhode Island 02903. At this hearing, the Court will consider whether the settlement is fair, reasonable, and adequate. If there are objections, the Court will consider them. After the hearing, the Court will decide whether to approve the settlement. We do not know how long these decisions will take.

No, you do not have to attend the hearing. Class Counsel will answer any questions that Judge Smith may have. You are welcome to attend at your own expense, however.

If you send an objection, you do not have to come to Court to talk about it. So long as you mail your written objection on time, the Court will consider it. You may also pay your own lawyer to attend, but it is not necessary for you to do so to receive a pro rata share of the Net Settlement Fund.

If you are a member of the Direct Purchaser Class, you may ask the Court for permission to speak at the Fairness Hearing. To do so, you must send a letter via First Class U.S. Mail saying that it is your “Notice of Intention to Appear in In re Loestrin 24 Fe Antitrust Litigation, Civil Action No. 1:13-md-2472-WES-PAS.” Be sure to include your name, address, telephone number, and your signature, as well as 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 postmarked no later than May 11, 2020, and must be sent to the Clerk of the Court, Class Counsel and Counsel for Defendants, at the addresses set forth in the responses to Question 12.

You cannot speak at the hearing if you do not send a Notice of Intention to Appear.

If you are a member of the Direct Purchaser Class and you do nothing, and the Court approves the settlement, then you will remain in the Direct Purchaser Class and be eligible to participate in the settlement as described in this Notice and you will release your claims against Warner Chilcott, Watson, and related entities as described in the Settlement Agreement. However, you will need to complete, sign and return the Claim Form (once it is sent to you) within thirty days in order to obtain a payment.

For more detailed information about this litigation, please refer to the papers on file in this litigation, which may be inspected at the Office of the Clerk, United States District Court for the District of Rhode Island, United States Courthouse, 1 Exchange Terrace, Providence, Rhode Island 02903 during regular business hours of each business day. You may also get additional information about the settlement by calling or writing to Class Counsel as indicated above, or by visiting www.Loestrin24AntitrustLitigation.com, or by writing to the Notice Administrator, RG/2 Claims Administration, at the following address:

RG/2 Claims Administration
P.O. Box 59479
Philadelphia, PA 19102-9479