Prograf Indirect Purchaser Class Action Lawsuit Settlement

Astellas has reached a preliminary $13.25 million class action lawsuit settlement with indirect purchasers of its brand name immunosuppressant Prograf, resolving claims that it purposely delayed generic versions of the drug.

In 2011, several class action lawsuits against the drug maker were consolidated into a multidistrict litigation claiming Astellas violated various state antitrust, unfair competition, consumer protection, and unjust enrichment laws by filing a bogus citizen petition in September 2007 with the FDA, which delayed the FDA’s approval of generic versions of Prograf.

The plaintiffs maintain that the drug company wanted to thwart entry of a less expensive generic version of Prograf (known as tacrolimus), an immunosuppressant prescription which is used to prevent organ rejection by kidney, liver, heart and lung transplant patients into the U.S. market.

A a result of its petition, Astellas effectively delayed generic Prograf entry by up to two years, during which time the brand drug enjoyed more than $1 billion in sales, the plaintiffs claim.

This alleged anticompetitive conduct by Astellas caused some consumers and third party payors to overpay for Prograf during the period from Sept. 3, 2008 to Dec. 31, 2010, according to the lawsuit.

The Court originally refused to certify a Class of indirect purchasers in 2013, ruling that the plaintiffs couldn’t show the entire Class overpaid as a result of the alleged ploy, let alone prove damages on a Class-wide basis. But the judge later agreed to certify a narrower Class focused solely on whether Astellas violated antitrust laws.

Earlier this year, the parties agreed to a settlement deal where Astellas would pay $13.25 to cover damages to the purchasers as well as the cost of notice and attorneys’ fees of up to one-third the settlement fund.

Astellas asserts that the petition it filed with the FDA properly requested that the FDA modify its policies concerning the testing required for the approval of generic versions of immunosuppressants and raised legitimate medical concerns about the sustainability of different versions of tacrolimus.

Astellas denies that the petition delayed the market entry of generic versions of Prograf.

Class Members who wish to be excluded from the settlement must do so by Sept. 8, 2016. Those who want to object to the terms of the class action settlement must do so no later than Oct. 21, 2016.

Who’s Eligible

As a Consumer, you are eligible if between Apr. 15, 2008 and Dec. 31, 2010, you purchased or paid for some or all of the purchase price for Prograf and/or its generic equivalent in capsule form, for consumption by yourself or a member of your family in:

• Arizona
• California
• Delaware
• District of Columbia
• Florida
• Georgia
• Idaho
• Illinois
• Iowa
• Kansas
• Maine
• Massachusetts
• Michigan
• Minnesota
• Mississippi
• Missouri
• Nebraska
• Nevada
• New Hampshire
• New Mexico
• New York
• North Carolina
• North Dakota
• Oregon
• Pennsylvania
• Puerto Rico
• Rhode Island
• South Dakota
• Tennessee
• Vermont
• West Virginia
• Wisconsin

As a Third Party Payor, you are eligible if between Apr. 15, 2008 and Dec. 31, 2010, you purchased or paid for some or all of the purchase price for Prograf and/or its generic equivalent in capsule form, in capsule form for consumption by your members, employees, insureds, participants, or beneficiaries, and not for resale in:

• Arizona
• California
• Delaware
• District of Columbia
• Florida
• Georgia
• Idaho
• Illinois
• Iowa
• Kansas
• Maine
• Massachusetts
• Michigan
• Minnesota
• Mississippi
• Missouri
• Nebraska
• Nevada
• New Hampshire
• New Mexico
• New York
• North Carolina
• North Dakota
• Oregon
• Pennsylvania
• Puerto Rico
• Rhode Island
• South Dakota
• Tennessee
• Vermont
• West Virginia
• Wisconsin

Note:
  If your insurance always required you to pay the same co-payment for a prescription regardless of whether it is a branded or generic drug; or you are an officer, director, manager, employee, subsidiary or affiliate of Astellas; or during the Class Period, you purchased Prograf directly from Astellas or its affiliates; or during the Class Period, you purchased Prograf and/or its generic equivalent only for resale purposes; or during the Class Damage Period, your only purchases of Prograf were subsidized through Astellas’ Patient Assistance Program (PAP) and/or the Astellas Prograf Value Card program; or you are an immediate family member of the Judge in this lawsuit, you are NOT an eligible Class Member.

Potential Award

VARIES.

Your share of the Net Settlement Fund will depend on the amount of Prograf you purchased and/or the amount you paid for Prograf during the Class Damage Period of Sept. 3, 2008 to Dec. 31, 2010.

Generally, those who purchased or paid for more Prograf during the Class Damage Period will get a higher recovery.

Your share of the Net Settlement Fund will also depend on the number of valid Claim Forms that settlement Class Members submit. If less than 100 percent of the settlement Class sends in a Claim Form, you could get a larger pro rata share.

Money from the Net Settlement Fund will only be distributed to settlement Class Members if the Court grants final approval of the settlement.

Proof of Purchase

As a Consumer, along with the completed Claim Form you must provide one of the following acceptable proof of payment:

1. Records from a pharmacy or other supplier. These may include receipts or other records indicating the number of prescriptions or pills purchased, the date of purchase, the location of the pharmacy or other supplier, and the amount of your actual net out- of-pocket payment for Prograf or its generic equivalent during the Class Damage Period Sept. 3, 2008 through Dec. 31, 2010
2. Records from your health insurance provider(s), such as purchase records or an EOB (explanation of benefits) reflecting the address of the pharmacy or other supplier and your unreimbursed payment or payment obligation for Prograf or its generic equivalent during the Class Damage Period of Sept. 3, 2008 through Dec. 31, 2010
3. Any other record issued by a licensed pharmacy or your insurance company that adequately demonstrates proof of such payments

As a Third Party Payor, you are required to supply an electronic dataset for each claimant that includes an entry for each prescription that you reimbursed and which is included in the Calculated Claim Total set forth in Section 3B of the Claim Form.

This dataset should, to the extent possible, include the following fields:

1. Unique patient identification number or code
2. NDC Code identifying the drug purchased
3. Fill date
4. Amount billed by pharmacy (not including dispensing fee)
5. Amount of any co-pay, coinsurance, and/or deductible
6. Amount paid by TPP net of co-pay, coinsurance, and/or deductible

If possible, please provide electronic data in either Microsoft Excel format or ASCII flat-file pipe-delimited (“|”) or fixed-width format. This file can be e-mailed to Questions@PrografIndirectPurchaserSettlement.com.

Claim Form

CLICK HERE TO FILE A CLAIM »

Claim Form Deadline

12/06/2016

The Claim Form process requires claimants to enter contact information, which will then generate a Claim Form with a barcode that can then be printed in order to fill out and mail.

Case Name

In re Prograf Antitrust Litigation, Civil Action No. 1:11-cv-02242-RWZ, in the U.S. District Court for the District of Massachusetts

Final Hearing

11/02/2016

Settlement Website

www.PrografIndirectPurchaserSettlement.com

Claims Administrator

Prograf Indirect Purchaser Settlement
c/o GCG
PO Box 10112
Dublin, OH 43017-3112
844-322-8238

Email: Questions@PrografIndirectPurchaserSettlement.com

Class Counsel

Gerard Stranch IV
Joe P. Leniski Jr.
BRANSTETTER STRANCH & JENNINGS PLLC

James R. Dugan II
Douglas Plymale, Ph.D.
David Franco
DUGAN LAW FIRM

Defense Counsel

John W. Treece
Jana D. Wozniak
SIDLEY AUSTIN LLP

Richard M. Zielinski
Elizabeth K. Levine
GOULSTON & STORRS PC