STEP Section Winter/Spring 2011 Newsletter

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Newsletter | Vol. 18, No. 2, Winter/Spring 2011

Endowed by David S. Shrager

How to Win a RICO Case against Pharmaceutical Giants for Fraudulent Off-Label Marketing

By Thomas M. Greene, Boston, MA

Off-label promotion occurs when pharmaceutical companies promote prescription drugs for uses that have not been approved by the U.S. Food & Drug Administration (FDA). When drugs have been subject to the FDA review process, the FDA critically reviews the scientific evidence submitted by the drug company to ensure that the drug is both safe and effective for the proposed use. The FDA approved label sets forth the precise parameters of the drug’s proven safety and efficacy. When drug companies subvert FDA review by obtaining approval for one use but then promote it for a different (and often more lucrative), alternative use, there can be no assurance that the medication is either safe or effective for the unapproved use. Because neither the FDA nor any other non-interested organization has comprehensively reviewed the medical evidence and supporting data, there also can be no assurance that medical articles that tout the benefits of an off-label use describe the research accurately. Nor is there any assurance that the results of all relevant clinical trials have been made public. When engaged in off-label marketing, pharmaceutical giants may weave a tangled web of half-truths, omissions, and outright untruths. As a result, drug purchasers, including health insurers and consumers, may spend huge amounts on worthless and possibly dangerous drugs.

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Section Leadership

Esther E. Berezofsky
Cherry Hill, NJ

Yvonne M. Flaherty
Minneapolis, MN

First Vice Chair
Jeffrey A. Bowersox
Lake Oswego, OR

Second Vice Chair
Wendy R. Fleishman
New York, NY

Immediate Past Chair
Gerson H. Smoger
Oakland, CA

AAJ Annual Convention
2011 Annual Convention

Jul 9, 2011 - Jul 13, 2011
Hilton New York and Sheraton New York
New York City, NY

To learn more and register, click here

Reglan/Metoclopramide Litigation Update

By William B. Curtis and Javier Gonzalez, Dallas, TX

Reglan, or its generic equivalent, metoclopramide (MCP), is a dopamine antagonist/neuroleptic1 drug indicated for patients with gastroesophageal reflux (GERD), diabetic gastroparesis, to prevent nausea and vomiting associated with chemotherapy or post operatively, and to aid in other limited medical procedures. Although Reglan is only indicated for short-term use (4 to 12 weeks), the medical conditions are all long-term problems.  This creates an issue because the risks of serious side effects increase dramatically after 12 weeks of use. Most notable of these side effects are Tardive Dyskinesia (TD), which can include involuntary movements of limbs and facial grimacing, torticollis, rhythmic protrusion of the tongue, bulbar speech, dystonic reactions, tremors, akathisia, and other abnormal movements. In certain cases, these symptoms can be irreversible and there is no widely effective treatment at this time.

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Sign Up Now: Women Trial Lawyers Caucus Lobby Days—May 25-26, 2011!

By AAJ Public Affairs

Come join women from around the country for Women Trial Lawyers Caucus Lobby Days! With the recent change in leadership in the U.S. House of Representatives, we know what’s coming and we’ve already seen it start: numerous attacks on the civil justice system and countless fights to protect your clients’ rights. Who better to persuade a bunch of legislators than a group of dynamic women, in force! This event is an incredibly effective way to communicate with elected officials and a terrific opportunity to put a fresh face on the civil justice system, while allowing you the opportunity to network with other women trial lawyers. 

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Fluoridegate and Fluoride Litigation: What Law Firms Need to Know About Fluoride Toxic Tort Actions

By Chris Nidel, Rockville, MD & Daniel G. Stockin, Ellijay, GA

You have probably heard the recent news in the media about fluoride risks; a growing “Fluoridegate” scandal; cities dropping their longstanding policy of water fluoridation; and concerns about fluoride harm to kidneys, bones, thyroid glands, and teeth. For decades, Americans have heard of a long-simmering controversy over the whole-body safety of ingested fluorides. Now government agencies and private sector groups are admitting concerns about the impact to the body from fluorides in numerous consumer products. including water, beverages, foods made with fluoridated water or containing fluoride fumigant residues, and oral care products.

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New and Newly Updated Litigation Packets from the AAJ Exchange: DePuy Hip Implant and Reglan/Metoclopramide

By AAJ Exchange

The AAJ Exchange’s newly updated Litigation Packet, DePuy Hip Implant, educates members on the recall of the popular metal-on-metal hip implants and litigation surrounding the recall.

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AAJ's Jazz Fest Seminar: Litigating Auto Collision Cases

By AAJ Education

AAJ’s annual Jazz Fest Seminar: Litigating Auto Collision Cases combines a highly skilled faculty and a convenient program format. The faculty of experienced trial lawyers will cover important topics in collision cases, and provide you with litigation strategies for winning your clients’ cases. The program features three days of morning sessions, allowing you to enjoy the New Orleans Jazz and Heritage Festival in the afternoons and evenings.

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