United States District Court for the District of Massachusetts
Here you can find answers to common questions about this Settlement. You can either use the search box to type in your own question or click on a question from the list below. After you type in your question, click on the SEARCH button and choose from the displayed answers. These answers provide a general reference only. Please refer to the Detailed Notice or the Summary Notice at this site, for additional information. If after reading this, you still have questions, please call 1-866-410-7650 for assistance. To see an answer
to a question listed below just click on the question. To return to the list of
questions, just click on RETURN TO QUESTIONS after the answer, or use your
browser's "Back" button. Why
was this notice issued? A
Court authorized this notice because you have a right to know about a nationwide
proposed settlement of this class action, including the right to claim money,
and about all of your options, before the Court decides whether to give “final
approval” to the settlement. If
the Court approves the settlement, and after any appeals are resolved, payments
will be made to everyone who submitted a valid claim.
This notice explains the lawsuit, the settlement, your legal rights, what
benefits are available, who may be eligible for them, and how to get them. Judge
Richard G. Stearns of the United
States District Court for the District of Massachusetts is overseeing this class action. The
case is known as In re Lupron®
Marketing and Sales Practices Litigation,
No. 01-CV-10861-RGS, MDL 1430.
The people who sued are called the “Plaintiffs,” and the companies they
sued, TAP Pharmaceutical Products Inc. (“TAP”), Abbott Laboratories, and
Takeda Pharmaceutical Company Limited (formerly known as Takeda Chemical
Industries, Ltd.), are called the “Defendants." There are lawsuits about the cost of Lupron®,
an injectable drug usually given by a doctor to treat prostate cancer in men,
endometriosis and uterine fibroids in women and precocious puberty in children.
The litigation is about whether people or entities were unlawfully
overcharged and defrauded by the Defendants.
This does not involve the safety or effectiveness of Lupron®.
The Plaintiffs say that there was a fraudulent scheme by the Defendants
about the marketing, sale and distribution of Lupron®, and that the
alleged scheme caused people to overpay for Lupron®.
They say the scheme involved: 1) artificially inflating the average
wholesale price (“AWP”) so that doctors could charge more for Lupron®;
2) giving free samples to doctors knowing they would charge patients and
insurers for them; and 3) giving valuable gifts to doctors as incentives to
prescribe Lupron® instead of other less costly alternatives. The
Defendants deny all of these claims. Specifically,
the Defendants say they have many defenses, that they are not liable to the
Plaintiffs, and that the Plaintiffs are not entitled to any money or benefits
from the litigation. The Defendants
say the federal government created and still uses AWP instead of cost-to-acquire
as a basis for reimbursing physicians, despite decades of knowledge and
criticism that AWP does not necessarily reflect the actual cost-to-acquire.
Defendants also believe that the Plaintiffs cannot prove they lost any
money or had “damages” from free samples given by TAP to certain doctors. In a class action, one or more
people or entities like you, called Class Representatives, sue on behalf of
people who have similar claims. All
these people are a “Class” or “Class Members.”
One court resolves the issues for all Class Members, except for those who
exclude themselves from the Class. Both
sides agreed to a settlement to avoid the cost and risk of a trial, and so that
the people affected can get compensation, in exchange for releasing the
Defendants from all liability. The
settlement does not mean the Defendants did anything wrong or that they violated
any laws. The Class Representatives and the lawyers representing them think the
settlement is best for all Class Members. The Court decided that
Class Members in the settlement include: All individual persons or entities
who paid for Lupron® from January 1, 1985 through March 31, 2005. Note:
This includes all formulations of Lupron®, including Lupron Depot®. Excluded
from the class are several large insurers called “Settling Health Plans” who
are settling separately (See Question 10), the Defendants, their
respective present and former, direct and indirect, parents, subsidiaries,
divisions, partners and affiliates; and the United States government, its
officers, agents, agencies and departments, and all other government entities’
claims, to the extent that they previously released their claims pursuant to the
2001 Settlement Agreement and Release resolving the matter of United States
of America v. TAP Pharmaceutical Products Inc. (D. Mass.) and related
litigation. Consumers, i.e., people who paid any
amount for Lupron®, including co-pays and deductibles, are included in the
settlement. Lupron® is not the typical prescription drug that is "paid
for" at a pharmacy. Instead, your doctor usually injects it -- to treat
prostate cancer in men, endometriosis and uterine fibroids in women, or
precocious puberty in children -- and includes a charge for it on your bill. You
may have paid for a portion of the cost of Lupron® if your insurance company
did not pay your doctor his/her full charge for Lupron® (e.g. you paid a "copay").
If you have no insurance, or your insurance does not cover Lupron®, you may
have paid more. Entities,
also known as “third party payors,” could include health insurers (other
than the Settling Health Plans) that paid part or all of the cost of Lupron®
for their insured patients. Entities
may also include employee welfare benefit plans, governmental plans or union
plans that paid some portion of the cost of Lupron® for insureds,
employees or family members of employees insured under these plans. If
you are not sure whether you or your company is included in the Class, you may
call the toll-free number 1-866-410-7650 with questions.
You may also write with questions to Lupron Settlement Administrator,
P.O. Box 24604, West Palm Beach, FL 33416. Up
to $150 million will be paid by TAP, on behalf of all the Defendants.
After allocating $55 million to a separate settlement with the Settling
Health Plans, a $95 million fund will be set up for the Class Members in this
settlement. After deducting certain
amounts, including attorneys’ fees, expenses, and payments to Class
Representatives (See Question 20), the net fund will be distributed in
cash to consumers who submit valid claim forms, as well as to third party payors.
Consumers will receive up to 42.1% of the net fund, and up to 57.9% will
go to third party payors. The
amount of money for third party payors may be reduced if the Settling Health
Plans show that their claims entitle them to more than the $55 million currently
allocated to them. If
you are a third party payor and want to get out of the settlement (See
the section called “Excluding Yourself From the Settlement” below), the
third party payor settlement fund will be reduced by the amount of money you
could have received if you had filed a valid claim. More details are available in the Settlement Agreement at www.lupronclaims.com. Your share of the
settlement fund will be based on how much Lupron® you paid for and
on how many Class Members file valid claims.
Consumers will get $100 each or 30% of their Lupron®
purchases from January 1, 1985 through March 31, 2005, whichever is greater.
If the amount of claims received is too great to allow payment of either
of these amounts, consumers will get a pro rata share (based on what each
consumer paid in proportion to what all consumers paid).
Third party payors’ payments will be pro rata, based on how much
Lupron® third party payors paid for, and the January 1, 2000 through
December 31, 2001 time period will be used to determine each pro rata
share. The
Defendants will not be involved in deciding how much money you may receive. If
the settlement becomes final, consumer and third party payor Class Members will
be releasing the Defendants and other people and entities for all the claims
described and identified in paragraphs 2(y) and 18 of the Settlement Agreement.
The Settlement Agreement is available at www.lupronclaims.com.
The Settlement Agreement describes the released claims with specific
descriptions, in necessarily accurate legal terminology, so read it carefully.
The release does not cover any legal claims about the safety or
effectiveness of Lupron®. Even
if you registered with, or excluded yourself from, a different Lupron®
lawsuit about similar claims, you’ll be giving up rights described in this
Settlement Agreement. To ask for a payment,
you must complete and submit a claim form. You can get a claim form at www.lupronclaims.com
or by calling the Settlement Administrator at 1-866-410-7650 or writing to the
address below. If you are a consumer Class Member you need to include the dates
you used Lupron® and send proof that you paid for Lupron® sometime from
January 1, 1985 through March 31, 2005 (only one proof of purchase is required),
and any amount paid during that period. Proof may be in the form of: 1) a
written prescription for Lupron®, 2) a receipt, cancelled check, or credit card
statement that shows that you paid for Lupron®, 3) an EOB (explanation of
benefits) that shows you made a co-pay for Lupron®, 4) a letter from your
doctor saying he or she prescribed and that you paid part of the cost of Lupron®
at least once, including the amount paid or 5) a notarized statement saying you
paid a co-pay or cash payment for Lupron® from January 1, 1985 through March
31, 2005 and noting the total out-of-pocket payments you made during that time.
Third party payors need to provide all of the information required on the claim
form, including the amount paid for Lupron® from January 1, 2000 through
December 31, 2001. On third party payors' claims for purchases over $300,000,
more information must be provided. Claim
forms must be postmarked by May 15, 2005, and mailed to: Lupron
Settlement Administrator P.O.
Box 24604 West
Palm Beach, FL 33416 Payments
will be mailed to Class Members after the Court grants “final approval” of
the settlement and any appeals are resolved.
Send in your claim form postmarked by May 15, 2005.
The Court is scheduled to consider final approval at a hearing on April
13, 2005 (See section called “The Court’s Fairness Hearing”
below). No.
If you exclude yourself, you cannot get money from this settlement, and
should not send in a claim form to request a payment.
If you ask to be excluded, you will not get any settlement payment, and
you cannot object to the settlement. But
you may sue, continue to sue, or be part of a different lawsuit against
Defendants in the future. You will
not be bound by anything that happens in this lawsuit or settlement.
If a third party payor excludes itself, the share of the money it could
have received if it had stayed in will be removed from the $55 million set aside
for third party payors and given back to TAP. You may have received or seen other notices about
other class actions about the cost of Lupron®, including a national
case in a North Carolina court, Stetser v. TAP Pharmaceutical Products, Inc.,
and a statewide case in a New Jersey court, Walker v. TAP Pharmaceutical
Products, Inc. If you
registered with, or if you excluded yourself from, one of those or other cases,
you need to exclude yourself from this case if you want to sue, continue
to sue, or be part of a different lawsuit against the Defendants about the cost
of Lupron® or any other legal issues in this case, ever again.
The courts overseeing those cases may dismiss those cases, but they may
not, so check with your lawyer about how this case will affect your rights. No.
Unless you exclude yourself, you give up the right to sue the Defendants
for all the claims that this settlement resolves. You must exclude yourself from this Class to start or
continue your own lawsuit, or to be part of any different lawsuit relating to
these claims. If you wish to be excluded from the settlement
you must, in writing, state that you want to be excluded from In re Lupron® Marketing and
Sales Practices Litigation, provide the time period (month/year to
month/year) during which you paid for Lupron®, include your name,
address, taxpayer identification number, telephone number, fax number (if any),
and your signature. Third party payor Class
Members must include the total amounts paid for Lupron® from January
1, 2000 through December 31, 2001. If
you are submitting an exclusion request on behalf of a third party payor Class
Member, you must also provide a signed certification with the following wording,
indicating that the Class Member has given you the authority to submit the
exclusion: “The undersigned
individual hereby represents that he/she has authority to sign and submit this
notice of exclusion on behalf of the above-named class member.
The undersigned also certifies that he/she has not received any advice
from the parties to this litigation or their attorneys concerning his/her or the
class member’s fiduciary obligations under the Employee Retirement Income
Security Act of 1974, 29 U.S.C. § 1100, et seq., or other laws governing their
obligations to any class member. The
undersigned understands that by submitting this notice of exclusion, the class
member identified above will not be entitled to receive any proceeds of the
Class Settlement Fund. By affixing
my signature below, I certify under penalty of perjury that the foregoing is
true and correct. 28 U.S.C. §
1746.” Any
exclusion requests must be received on or before April
1, 2005 at this address: Lupron
Settlement Administrator P.O.
Box 24604
West Palm Beach, FL 33416
The Court
has appointed the law firms of Cohen, Milstein, Hausfeld, & Toll, P.L.L.C.,
of Washington, DC; Foote Meyers Mielke & Flowers, of Geneva, IL; Hagens
Berman LLP, of Cambridge, MA; Lieff Cabraser Heimann & Bernstein, LLP, of
San Francisco, CA; and Spector Roseman & Kodroff, of Philadelphia, PA to represent
you and other Class Members as “Class Counsel.”
You will not be charged for
these lawyers. If you want to be
represented by your own lawyer, you may hire one, at your own cost. Class Counsel will ask the Court for
attorneys' fees not to exceed 30% of the $95 million settlement fund (after
deducting any amount that TAP gets back from any third party payor
exclusions-See Question 15) plus reimbursement of their expenses. The Defendants
have agreed not to oppose these fees and a request for reasonable expenses.
Class Counsel will also ask for a payment for the Class Representatives, who
helped the lawyers on behalf of the whole Class. The Court may award less than
these amounts to Class Counsel or to the Class Representatives. If
you are a Class Member and you do not exclude yourself, you can object to the
settlement if you don’t like any part of it. If
you decide to object to the settlement you should give reasons why you think the
Court should not approve it. The
Court will consider your views. To
object, you must do so in writing. Be
sure to include your name, address, telephone number, your signature, and the
reasons why you object to the settlement, and any documentation supporting your
objection. Send the objection to
these three different places postmarked no later than March 15, 2005: Clerk
of Court Edward
Notargiacomo Jason
G. Winchester Objecting
is simply telling the Court that you don’t like something about the
settlement. You can object only if
you stay in the Class. Excluding
yourself is telling the Court that you don’t want to be part of the Class.
If you exclude yourself, you cannot object to the settlement or to the
attorneys’ fees because the case no longer affects you, and you will not
receive any settlement payment. The Court will hold a Fairness
Hearing at 2:30 p.m. on Wednesday, April 13, 2005 at
the United States District Court for the District of Massachusetts, Court Room
No. 21, 1 Courthouse Way, Boston, MA.
At this hearing the Court will consider whether the settlement is fair,
reasonable, and adequate. The Court
will consider whether to approve the settlement and the request for attorneys’
fees, expenses, and awards for Class Representatives and others.
If there are objections, the Court will consider them.
The hearing may be moved to a different date without additional notice,
so it is a good idea to check www.lupronclaims.com
for updated information. No.
Class Counsel will answer any questions the Court may have.
But you are welcome to attend the hearing at your own expense.
If you send a written objection, you don’t have to come to Court to
talk about it. As long as you
mailed your written objection on time, the Court will consider it.
You may also pay your own lawyer to attend, but it is not necessary. To speak at the Fairness Hearing,
you must send a letter or other written document saying that the letter or
document is your “Notice of Intention to Appear” in In re Lupron®
Marketing and Sales Practices Litigation, No.
00-CV-10861-RGS, MDL 1430. Be
sure to include your name, address, telephone number, and your signature.
You must also include the information on what you intend to say at the
hearing. You must send your “Notice
of Intention to Appear” to the
three addresses listed in Question 21 above.
It must be postmarked no later than March 15, 2005.
The Court will decide if you will be allowed to speak at the hearing. If
you do nothing, you will not get any payment from this settlement.
And, unless you exclude yourself from this Class, you will not be able to
start a lawsuit, continue with a lawsuit, or be part of any other lawsuit,
including any other class action lawsuit, against the Defendants about the cost
of Lupron® or any other legal issues in this case.
FAQ
Detailed Notice
Summery Notice
What is the litigation about?
Why is this a class action?
Why is there a settlement?
How do I know if I am
part of the settlement?
Are there exceptions to being
included?
How are consumers included?
Which entities are included?
What if
I'm not sure whether I'm included in the settlement?
What does the settlement provide?
How much will my payment be?
What am I giving up as
part of the settlement?
How can I get a payment?
When would I get my payment?
If I
exclude myself, can I get money from this settlement?
What about other cases
involving Lupron®?
If I don't exclude
myself, can I sue later?
How do I get out of the
settlement?
Do I have a lawyer in the case?
How will the lawyers be paid?
How do I tell
the Court if I don't like the settlement?
What's the
difference between objecting and excluding?
When
and where will the Court decide to approve the settlement?
Do I have to come to the hearing?
May I speak at the hearing?
What happens if I do nothing at
all?
How do I get more information?
Summary
Notices Detailed
Notice Get
a Claim Form Answers
to Common QuestionsSettlement
Agreement Preliminary
Approval Order Notificación
en Español
Call 1-866-410-7650 with Questions - Click
here to get updates by email.Why
was this notice issued?
What
is the litigation about?
Why
is this a class action?
Why
is there a settlement?
How
do I know if I am part of the settlement?
Are
there exceptions to being included?
How
are consumers included?
Which
entities are included?
What
if I'm not sure whether I'm included in the settlement?
What
does the settlement provide?
How
much will my payment be?
What
am I giving up as part of the settlement?
How
can I get a payment?
When
would I get my payment?
If
I exclude myself, can I get money from this settlement?
What
about other cases involving Lupron®?
If
I don't exclude myself, can I sue later?
How
do I get out of the settlement?
Do
I have a lawyer in the case?
How
will the lawyers be paid?
How
do I tell the Court if I don't like the settlement
Court
Class
Counsel
Defense
Counsel
John Joseph Moakley U. S. Courthouse
1 Courthouse Way
Boston, MA 02210
Hagens
Berman, LLP
225
Franklin Street, 26th Floor
Boston,
MA 02110
Jones Day
77 West Wacker, Suite 3500
Chicago, Illinois 60601-1692What's
the difference between objecting and excluding?
When
and where will the Court decide whether to approve the settlement?
Do
I have to come to the hearing?
May
I speak at the hearing?
What
happens if I do nothing at all?
This notice summarizes the proposed settlement. You can get a copy of the Settlement Agreement at www.lupronclaims.com. You may also write with questions to Lupron Settlement Administrator, P.O. Box 24604, West Palm Beach, FL 33416. You can get a claim form at the website or by calling the toll free number below.