FAQ

Frequently Asked Questions

What is the Raptiva Lawsuit About?

On April 8, 2009,  Genentech announced that it had begun a voluntary phased withdrawal of Raptiva from the U.S. market. In a letter to Raptiva patients, the company explained that it had received three reports of a fatal brain infection called Progressive Multifocal Leukoencephalopathy (PML) linked to patients taking Raptiva.  Consequently, pharmacies will only refill prescriptions until June 8, 2009.

Vanderhyde and Associates law firm is helping people who have suffered Progressive Multifocal Leukoencephalopathy (PML)  and other side effects associated with the use of Raptiva.

Copies of Letters Sent to Patients and Health Care Professionals are below

Letter sent to Doctors and Health Care Providers

RAPTIVA RECALL LETTER

VOLUNTARY U.S. MARKET WITHDRAWAL OF RAPTIVA® (efalizumab)

“Dear Raptiva Doctor / Healthcare Professional:

Genentech, Inc. would like to inform you of our decision to implement a phased voluntary withdrawal of the psoriasis medication RAPTIVA (efalizumab) from the United States market. We are taking this action due to an increased risk of progressive multifocal leukoencephalopathy (PML) in patients on RAPTIVA therapy.

PML is a rapidly progressive infection of the central nervous system caused by the JC virus that leads to death or severe disability.

Although we believe there are many psoriasis patients who are deriving meaningful clinical benefit from RAPTIVA, the balance between benefit and risk in the psoriasis population for which RAPTIVA was approved has significantly changed.

It is presently not possible to identify patients at increased risk of PML prior to or during RAPTIVA therapy.

There are currently no effective therapeutic options to treat PML.

Effective today, Genentech is implementing a phased voluntary withdrawal; RAPTIVA will not be available after Monday June 8, 2009. The intent of the phased withdrawal is to provide sufficient time for prescribers to identify their patients on RAPTIVA, inform them that they need to discontinue treatment, and plan a careful transition to alternative psoriasis therapies as appropriate.

Guidance for Prescribers

Prescribers should not initiate RAPTIVA treatment for any new patients.
For current patients, RAPTIVA will only be available through Monday June 8, 2009. All healthcare providers should continue to counsel patients about the risks associated with RAPTIVA use.

Prescribers should review the treatment of all patients who are currently receiving RAPTIVA, with a goal of stopping treatment in a prompt but appropriate manner.
Prescribers should carefully manage the transition of patients from RAPTIVA to other appropriate therapies, and should consider the risk that abrupt discontinuation of therapy could result in a worsening of psoriasis. The effect of concomitant or sequential use of other immunosuppressive drugs on the risk of PML is not known (see the enclosed RAPTIVA US Prescribing Information; WARNINGS, PSORIASIS WORSENING AND VARIANTS, PML).

Guidance for Prescribers, continued

After RAPTIVA discontinuation, prescribers should continue to closely monitor patients for any sign or symptom that is suggestive of PML, and for infections or other adverse events after stopping treatment.

Healthcare professionals should report any serious adverse events suspected to be associated with the use of RAPTIVA to Genentech Drug Safety at 1-888-835-2555.
Alternatively, adverse event information may be reported to FDA’s MedWatch reporting system online (https://www.accessdata.fda.gov/scripts/medwatch/), by phone (1-800-FDA1088), by facsimile (1-800-FDA-0178), or by mail using the MedWatch Form FDA 3500 (FDA Medical Products Reporting Program, 5600 Fishers Lane, Rockville, MD 20852-9787).

A “Raptiva Patient Letter” (enclosed) is being sent to patients from Genentech and Specialty Pharmacies informing them of the voluntary withdrawal. Patients are being encouraged to contact their physician to discuss transition strategies and have been advised to avoid stopping RAPTIVA abruptly. Please contact your patients promptly to discuss this matter.

Enclosed is a copy of the RAPTIVA US Prescribing Information and Medication Guide for your reference. Should you have any questions regarding the use of RAPTIVA, please call our Medical Information/Communications Department at 1-800-821-8590. For patients who may have non-clinical related questions about RAPTIVA, please direct them to call our Genentech Access Solutions call center at 1-866-480-7762.

Sincerely,

Hal Barron, M.D., FACC

Senior Vice President,

Development Chief Medical Officer Genentech, Inc. “

Copy of Letter sent to patients

“April 8, 2009
Dear RAPTIVA Patient,

Re: VOLUNTARY U.S. MARKET WITHDRAWAL OF RAPTIVA® (efalizumab)

Patient safety is a top priority for Genentech. Since September 2008, Genentech has received 3 reports of progressive multifocal leukoencephalopathy (PML), a serious and almost always fatal brain infection caused by a virus, in patients taking RAPTIVA (efalizumab). Because of the following key aspects of PML and our commitment to safety, Genentech has decided to voluntarily stop selling RAPTIVA.

Although we believe that there are many psoriasis patients who benefit from RAPTIVA, there is no way to know ahead of time who will get PML.
There is no treatment or cure for PML. People who do live with PML are severely disabled.
What You Need to Do

Do not stop your RAPTIVA treatment without first talking to your doctor. Stopping RAPTIVA may lead to serious side effects, such as severe worsening of your psoriasis and, in some cases, has led to hospitalization.

Call or make an appointment to discuss other psoriasis treatment options with your doctor as soon as possible. Pharmacies will only refill prescriptions until Monday June 8, 2009. It is important that you have enough time to plan a change to another treatment before stopping RAPTIVA.

For the limited amount of time that you may still be taking RAPTIVA, it is important that you read the Medication Guide that comes with your medication. Before each injection, read the Medication Guide, which explains serious side effects of RAPTIVA. You should discuss these side effects with your doctor.

A copy of the RAPTIVA US Prescribing Information and Medication Guide are included with this letter. This information does not take the place of talking with your doctor about your condition or treatment. Please speak to your doctor about any questions or concerns you may have. Additional information may be periodically available at www.raptiva.com.

Thank you for your prompt attention to this letter.

Sincerely,

Hal Barron, M.D., FACC Senior Vice President, Development Chief Medical Officer Genentech, Inc. “

How Much Does it Cost to File a Lawsuit and Hire a Lawyer?

Our firm handles cases on a contingency fee basis, which means there are no legal fees unless we make a recovery for you.

Is there Multi District Litigation or a Class Action Lawsuit?

Many Raptiva users are curious if there is a class action lawsuit or if cases have been transferred to Multidistrict Litigation.

At this time no class action lawsuit has been filed, and there is not an MDL. However, that may change given the potential number of victims.  Multidistrict litigation (MDL) is a federal legal procedure in which all pending civil cases of a similar type with common questions of fact that have been filed throughout the United States are transferred to one federal judge for pre-trial proceedings.  The purpose of this procedure is to speed up the process of handling complex cases in the federal court system, such as product liability suits or patent infringement cases.  By centralizing the pre-trial process, the resources of the parties, counsel and judiciary are conserved and duplicative discovery and inconsistent pretrial rulings can be avoided.

What does Statute of Limitations Mean?

Each state has a different set of guidelines which determine how long you have to file a lawsuit.  This is called a statute of limitations.  If lawsuits are not filed before the statutory deadline you may lose the right to bring a claim for compensation.  Statutes of limitations can change at any time by the actions of the legislature or courts of the particular state.  For a full review of any potential legal claims and relevant statutes of limitation related to Raptiva side effects it is important to consult with an attorney to determine how the law applies to your specific legal claims

What Should I Do Now?

If you or a loved one has experienced Raptiva complications you may have a claim against the manufacturer.  Please contact us today for a free consultation. Call toll free 1-866-777-2557 or click here to use our online contact form.  We are representing individuals in all 50 states.  This is a free, no obligation consultation.

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