Frequently Asked Questions - Consumer
- What are these lawsuits about?
- Why is this a class action?
- What do the Plaintiffs claim?
- What do the Defendants say about the claims?
- Has the Court decided who is right in these lawsuits?
- Am I a Member of one or more of the Classes?
- How do I know if my co-payment was under Medicare Part B?
- How can I tell if the drug I took is included as a Covered Drug?
- Can I get out of these lawsuits and the Classes?
- How do I exclude myself from the Classes?
- What happens if I exclude myself from these lawsuits?
- Can I appear or speak in these lawsuits?
- How do I appear in these lawsuits?
- What happens if I don’t do anything at all?
- Do I have a lawyer in these lawsuits?
- Can you elaborate on who pays the lawyers and how much will they be paid?
- Should I get my own lawyer?
- Are more details and information available?
- How will I be notified about the outcome of the trials?
1. What are these lawsuits about?
Plaintiffs allege that Defendant drug companies either reported the average wholesale price (“AWP”) of each drug they make to trade publications or provided those publications with information from which the publications calculate an AWP for each of Defendants’ drugs. The published AWP of a drug is used to set the price that consumers making Medicare Part B co-payments and Medicare will pay for the drug. The lawsuits claim that Medicare and consumers making Medicare Part B co-payments paid more than they should have paid for the Covered Drugs [go to question #6 on page 3 for a list of the Covered Drugs] because drug companies intentionally reported false and inflated AWPs concerning these drugs.
The Court in charge of the lawsuits is the United States District Court for the District of Massachusetts. The litigation is called In re: Pharmaceutical Industry Average Wholesale Price Litigation, Docket No. 01-CV-12257-PBS. The people who sued are called the Plaintiffs. The drug companies they sued are called the Defendants.
The lawsuits include 42 Defendants. At this time, the Court has certified separate Classes of people who made a Medicare Part B co-payments for Covered Drugs [go to question #6 below for a list of the Covered Drugs] manufactured by the Defendants listed below. The trials for each Defendant will also take place in the order listed below:
- AstraZeneca (AstraZeneca Pharmaceuticals L.P.),
- Bristol-Myers Squibb Group (which includes: Bristol-Myers Squibb Co.; Oncology Therapeutics Network Corp.; and Apothecon, Inc.), and
- Johnson & Johnson Group (which includes: Johnson & Johnson; Centocor, Inc.; and Ortho Biotech Products, L.P.).
The “Defendants” are these three companies: AstraZeneca, Bristol-Myers Squibb Group, and the Johnson & Johnson Group.
2. Why is this a class action?
In a class action lawsuit, one or more people called “class representatives” sue on behalf of people who have similar claims. The people together are a “class” or “class members.” The Court must determine if it will allow the lawsuit to proceed as a class action. If it does, a trial of the claims then decides the lawsuit for everyone in the class. The Court in these lawsuits certified a separate class of people who made Medicare Part B co-payments for drugs manufactured by each Defendant.
3. What do the Plaintiffs claim?
The Plaintiffs claim that the Defendants violated various state consumer protection laws because they intentionally provided false and inflated AWPs on certain types of outpatient drugs, including the Covered Drugs [go to question #6 below for a list of the Covered Drugs]. The lawsuits also claims that the Defendants intentionally reported inflated AWPs with the knowledge that Medicare Part B relies on reported AWPs to determine the prices they will reimburse doctors for those drugs. The lawsuits say that as a result of the inflated AWPs, people who made co-payments under Medicare Part B paid more than they should have. The lawsuits ask the Court to award money damages to those people.
4. What do the Defendants say about the claims?
The Defendants deny the factual allegations being made; contend that the lawsuits and damages are precluded under the law; contend that the alleged conduct, if proved, does not violate the consumer protection laws, and that many Class Members will not be able to establish elements of those laws, or prove they paid payments for the subject drugs.
In addition, Bristol-Myers Squibb points out that it does not report AWPs; it reports list prices at which a substantial percentage of its sales are made. The Johnson & Johnson Group says that Plaintiffs did not calculate Johnson & Johnson’s drug prices correctly and, when these errors are corrected, it is obvious that the published prices for Johnson & Johnson drugs were not inflated. The Johnson & Johnson Group points out that it did not give doctors discounts on the drug Remicade, and the small discounts it gave to doctors on the drug Procrit were disclosed. The Johnson & Johnson Group says its drugs are less expensive than competing therapies, so Class Members who reimbursed for Johnson & Johnson’s products saved money. The Schering Plough Group notes that the prices they report comport with standard industry practice.
5. Has the Court decided who is right in these lawsuits?
No. The Court hasn’t decided who is right in these lawsuits yet. Much more must occur before the Court holds a trial, including notifying Class Members. By deciding now that these lawsuits can continue as a class action, the Court isn’t saying who will win.
6. Am I a Member of one or more of the Classes?
You’re a member of one or more of the Classes and part of these lawsuits if you are a resident of any state in the U.S. (except Alabama, Alaska, Georgia, Iowa, Kentucky, Louisiana, Mississippi, Montana or Virginia), and between January 1, 1991 and January 1, 2005, you paid (or are currently obligated to pay) a co-payment under Medicare Part B for any of the Covered Drugs [see list below] that were manufactured and marketed by the Defendants. The Classes and the drugs involved in each class are as follows:
Defendant Classes |
Subject Drug(s)
|
AstraZeneca Class |
Zoladex (goserelin acetate)
|
Bristol-Myers Squibb Class |
Blenoxane (bleomycin sulfate)
Cytoxan (cyclophosphamide)
Etopophos (etoposide phosphate)
Paraplatin (carboplatin)
Rubex (doxorubicin hcl)
Taxol (paclitaxel)
VePesid (etoposide)
|
Johnson & Johnson Class |
Remicade (infliximab)
Procrit (epoetin alfa) |
You are not a member of any of the Classes if you resided in Alabama, Alaska, Georgia, Iowa, Kentucky, Louisiana, Mississippi, Montana or Virginia at the time you made the Medicare Part B co-payment. The Court excluded persons residing in these states from the Classes because the consumer protection laws of those states don’t allow class actions.
You are also not part of one or more of the Classes if:
(a) You were fully reimbursed for the co-payment you made (for example, your MediGap or other private insurer reimbursed you the full amount); or
(b) Your co-payment was a flat amount instead of a percentage of the total charge (for example, your MediGap or other private insurer paid for all of the co-payment except for a flat amount such as $10 or $20 that you had to pay). If your co-payment is a set dollar amount and does not differ with the price of the drug, your co-payment is a flat co-payment and not a percentage co-payment then you are not a member of one or more of the Classes.
7. How do I know if my co-payment was under Medicare Part B?
If you are 65 or older, or are younger than 65 but receive social security benefits because of a disability, you are entitled to Medicare benefits. Medicare Part A is the primary coverage for your health care costs when you are admitted as a patient in a hospital, and enrollment is generally automatic at age 65.
Medicare Part B helps to pay primarily for outpatient services such as care given in your doctor’s office, outpatient hospital care, and physical therapy. Medicare Part B also has a limited drug benefit. For drugs that are covered under Part B, Medicare pays 80% of the drug cost, and you are responsible for paying the other 20% (which is your co-payment).
Generally, the drugs covered under Medicare Part B are ones that are administered by your doctor, such as cancer treatment drugs that are given through injections or an IV, but Part B also covers some drugs that are self-administered (ones that you take yourself). Those include some oral anti-cancer drugs in pill form, some pills prescribed to help with nausea or anemia in connection with chemotherapy and drugs provided with some durable medical equipment, such as inhalation drugs used with a nebulizer (a compressed air machine).
Like Part A, Medicare Part B coverage is also automatic, but you have the option to decline it. You pay a monthly premium for Medicare Part B coverage (which is typically deducted from your social security check). You can tell if you’re enrolled in Medicare Part B by looking at your Medicare insurance card. It will say if you are enrolled in Part B.
If you took one of the Covered Drugs [go to question #6 above for a list of the Covered Drugs] when you were an inpatient in the hospital, you did not make a co-payment under Medicare Part B. However, if a Covered Drug [go to question #6 above for a list of the Covered Drugs] was prescribed or administered by your doctor as a part of an outpatient treatment at a clinic, and you are enrolled in Medicare Part B, you may have been billed a co-payment of 20% of the drug cost if Medicare is your primary payer.
For the vast majority of people enrolled in Medicare, Medicare is the primary payer. Medicare is your secondary payer only if: (a) you or your spouse have continued to work after age 65 and have accepted the employer’s health care insurance, or (b) you are a disabled person under 65 and have large group health plan coverage through your current job or the job of a family member. Unless either of these situations applies to you, your co-payment for a Covered Drug [go to question #6 above for a list of the Covered Drugs] would have been under Medicare Part B.
8. How can I tell if the drug I took is included as a Covered Drug?
Most, but not all, of the Covered Drugs are ones that a doctor administers to you in the form of an injection – either through a shot, an IV, or an implant beneath the skin. A few are drugs that you take yourself, such as the pill forms of Cytoxan and VePesid – cancer therapy drugs. Most of the Covered Drugs are used for the treatment of various types of leukemia and cancers of the breast, ovaries, cervix, prostrate, testes, lung, brain, and bone marrow. Other Covered Drugs are used to treat nausea or anemia resulting from cancer therapy, asthma, migraines, heart problems, leukemia, herpes, psychoses, or rheumatoid arthritis.
The Covered Drugs, by Defendant that manufactures them, are:
AstraZeneca
AstraZeneca Pharmaceuticals L.P.
Drug Name |
Treatment |
Dosages |
Zoladex
(molecule name)
|
Prostrate and breast cancer; Endometriosis |
Implant: 3.6mg
Injection (3 month): 10.8mg
Kit for injection: 10.8mg syringe; 3.6mg syringe
|
Bristol-Myers Squibb Group
Bristol-Myers Squibb, Oncology Therapeutics Network and Apothecon
Drug Name |
Treatment |
Dosages |
Blenoxane
(molecule name)
|
Cancer of cervix and uterus, head and neck, or testicle and penile cancer; Hodgkin’s disease |
Powder for Injection: 15 Unit Vial; 30 Unit Vial
|
Cytoxan
(molecule name)
|
Cancer (primarily breast, ovarian); Leukemia; Nephrotic syndrome (kidney disease) |
Injection: 100mg; 200 mg; 500mg; 1gm; 1x2gm;
Lyophilized Injection: 100mg; 200mg; 500mg
Powder for Injection: 500mg; 1gm; 2gm
Tablets: 25mg; 50 mg |
Etopophos
(molecule name)
|
Lung and testicular cancer; Cancer of the lymph glands; Leukemia |
Powder for Injection: 100mg |
Paraplatin
(molecule name)
|
Ovarian cancer |
Powder for Injection: 50mg; 150mg; 450mg |
Rubex (molecule name)
|
Ovarian and breast cancer; Cancers of the bone, stomach, lung, bladder and thyroid; Leukemia |
Powder for Injection: 10mg; 50mg; 100mg
Powder for Injection (Under Immunex label): 10mg; 50mg; 100mg |
Taxol (molecule name)
|
Ovarian and breast cancer; Lung cancer; Kaposi’s sarcoma |
Injection: 30mg; 30mg/5ml; 300mg/50ml
Injection Solution: 100mg; 100mg/16.7ml |
VePesid (molecule name)
|
Testicular cancer; Small cell lung cancer |
Injection Solution: 100mg; 150mg; 500mg; 1gm
Capsules: 500mg |
Johnson & Johnson Group
which includes Johnson & Johnson, Centocor, Ortho Biotech, McNeil-PPC and Janssen Pharmaceutical Products
Drug Name |
Treatment |
Dosages |
Remicade
(molecule name)
|
Rheumatoid arthritis; Crohn’s disease; Ulcerative colitis |
Intravenous Injection: 100 mg vial |
Procit
(molecule name)
|
Anemia (especially anemia due to chemotherapy or HIV) |
Solution for Injection:
2,000 Unit/ml; 3,000 Unit/ml;
4,000 Unit/ml; 10,000 Unit/ml;
20,000 Unit/ml; 40,000 Unit/ml |
If your doctor gave you or prescribed one or more of these drugs in the listed forms and dosages between January 1, 1991 and January 1, 2004, you might be a member of one or more of the Classes.
9. Can I get out of these lawsuits and the Classes?
If you don’t want to be in one or more of the Classes and you want to keep the right to sue the Defendants about the same claims on your own, you must take steps to get out of the Classes. This is called excluding yourself. By excluding yourself, you keep the right to file your own lawsuits or join other lawsuits against the Defendants about the claims in these lawsuits. You may exclude yourself from the litigation against one or more Defendants and remain in the litigation against the other Defendants. If you exclude yourself from the Classes, you will not be bound by the results of any of the trials against Defendants.
10. How do I exclude myself from the Classes?
To exclude yourself from one or more of the Classes, fill out and mail the opt-out form in the detailed Notice or send a letter signed by you that includes all of the following:
- Your name, address, and telephone number;
- The name and number of the litigation: In re: Pharmaceutical Industry Average Wholesale Price Litigation, Docket No. 01-CV-12257-PBS;
- If you have hired your own lawyer, the name, address, and telephone number of your lawyer; and
- A statement that you want to be excluded from one or more (or all) of the Classes, specifying whether you wish to exclude yourself from the litigation against all Defendants or just some of the Defendants. If you wish to exclude yourself from the litigation against less than all Defendants, you must specify which Defendants by name.
Your exclusion letter must be mailed first class, postmarked by February 19, 2007, to:
AWP Litigation Administrator
Complete Claim Solutions, LLC
P.O. Box 24654
West Palm Beach , FL 33416
Please remember that you can’t exclude yourself by phone or by sending an email.
11. What happens if I exclude myself from these lawsuits?
If you exclude yourself, you’re no longer part of the Classes, and nothing that happens in these lawsuits affects you, but you can sue or be part of different lawsuits against the Defendants about the claims in this case. If you exclude yourself from one or more of the Classes, you will not get money or benefits from the Classes if any are obtained from a settlement or trial of the lawsuits involving the remaining Defendants.
If you do not exclude yourself, you will be bound by the results in these lawsuits. Thus, if Defendants win, your claim will be extinguished. Defendants claim that the persons and entities representing your interests do not have a valid claim, and if that is correct, your claim will be extinguished unless you exclude yourself.
12. Can I appear or speak in these lawsuits?
As long as you don’t exclude yourself, you can (but do not have to) participate and speak for yourself in these lawsuits through your own lawyer. This is called making an appearance. Remember that you may have to pay for the lawyer yourself. If you appear in these lawsuits, you are still a member of the Classes and can share in any benefits the Classes might receive as a result of settlement or a trial.
13. How do I appear in these lawsuits?
If you want your own lawyer instead of Class Counsel to participate or speak for you in these lawsuits, your lawyer must give the Court a paper that is called a Notice of Appearance. The Notice of Appearance should include the name and number of the litigation, and state that you wish to enter an appearance in these lawsuits.
The Notice of Appearance must be filedwith the Court at the following address:
Clerk of Court
John Joseph Moakley U.S. Courthouse
1 Courthouse Way, Suite 2300
Boston, Massachusetts 02210
The Notice of Appearance must be filed using the following Civil Action Number:
01-CV-12257-PBS
Your Notice of Appearance should be filed with the Court before the beginning of the series of trials of each Defendants in these lawsuits. The first trial is currently scheduled to start on March 5, 2007.
14. What happens if I don’t do anything at all?
If you do nothing, you stay in the Classes and will be represented by Class Counsel. You will share in any benefits from these lawsuits if the Classes win at trial or settle the lawsuits, and you will be bound if the Class Representative loses. By staying in the Classes, all of the Court’s orders in these lawsuits will apply to you, including any decision on the trial. Please remember that staying in the Classes means you can’t sue the Defendants yourself about any of the claims in these lawsuits.
15. Do I have a lawyer in these lawsuits?
Yes. The Court has appointed the following law firms to represent you and other Class Members:
Hagens Berman Sobol Shapiro LLP
www.hagens-berman.com
1301 Fifth Avenue, Suite 2900
Seattle , WA 98101
and
One Main Street , 4th Floor
Cambridge, MA 02142
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Spector Roseman & Kodroff, PC
www.srk-law.com
1818 Market Street, Suite 2500
Philadelphia, PA 19103 |
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Wexler Toriseva Wallace LLP
www.wtwlaw.us
One North LaSalle St., Suite 2000
Chicago, IL 60602 |
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Mark H. Edelson
Edelson & Associates LLC
45 West Court Street
Doylestown , PA 18901 |
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Kline & Specter, PC
www.klinespecter.com
The Nineteenth Floor
1525 Locust Street
Philadelphia, PA 19102 |
These lawyers are called Class Counsel. You won’t be charged personally for these lawyers, but they will ask the Court to award them a fee to be paid out of any recovery. More information about Class Counsel and their experience is available at the lawyers’ Web sites.
16. Can you elaborate on who pays the lawyers and how much will they be paid?
If Class Counsel obtains money or benefits for the Class through a settlement or a successful trial, they will ask the Court for payment of attorneys’ fees and expenses out of the total amount of money and benefits obtained. The Court must approve the amount of attorneys’ fees and expenses. If Class Counsel doesn’t obtain any money or benefits for the Class, they won’t receive or ask to receive any attorneys’ fees or reimbursement of expenses.
17. Should I get my own lawyer?
You don’t need to hire your own lawyer, but if you want your own lawyer to speak for you or appear in Court, you must file a Notice of Appearance (seeQuestion 13 on how to submit a Notice of Appearance). If you hire a lawyer to appear for you in these lawsuits, you will have to make your own arrangement for that lawyer’s compensation.
18. Are more details and information available?
This Notice is just a summary of the lawsuits. More details are in the Complaint filed by Class Counsel, and the other legal documents that have been filed with the Court in these lawsuits. You can look at and copy these legal documents at any time during regular office hours at the Office of the Clerk of Court, John Joseph Moakley U.S. Courthouse, 1 Courthouse Way, Suite 2300, Boston, Massachusetts 02210. Copies of some of the important documents, like the Complaint are also available on this web site at the links on the homepage.
In addition, if you have any questions about the lawsuits or this Notice, you may:
- Write to: AWP Litigation Administrator, Complete Claim Solutions, LLC, PO Box 24654, West Palm Beach, FL 33416; or
- Call toll free 1-800-419-5391 (hearing impaired call 1-561-253-7732)
19. How will I be notified about the outcome of the trials?
Information about the trials will be posted on this Web site as appropriate. You may also register on this Web site or by mail to get notification of the outcome of the litigation and other significant occurrences associated with this case. To register by mail send a letter to the AWP Litigation Administrator, Complete Claim Solutions, LLC, PO Box 24654, West Palm Beach, FL 33416. To register on this Web site, click on the “Register to Receive Email Updates” link on homepage.
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