August 27, 2008

Celexa and Lexapro Securities Case Set for Trial

The class action In re Forest Laboratories, Inc. Securities Litigation, 1:05-cv-02827 (S.D.N.Y.), has been set for trial on November 3, 2008.

Initiated by a complaint filed in the Southern District Court of New York in March 2005, the action is being prosecuted by class representatives who claim that Forest violated federal securities laws in marketing and promoting its SSRI antidepressants, Celexa and Lexapro, and its Alzheimer’s drug, Namenda. Among other things, the lawsuit alleges that Forest deceived the investing public by hiding the risk of suicidality posed by the antidepressants to the pediatric and adolescent populations and the fact that the antidepressants failed to demonstrate efficacy in treating those populations. The case had originally been set for trial in July 2008, but that trial date was adjourned. In a June 3, 2008 order approving the parties’ class notice stipulation, the court set the trial date for November 3, 2008.

Notably, in Forest’s August 8, 2008 filing with the federal Securities and Exchange Commission, the company disclosed that the only lawsuits currently pending against it other than the securities case are the cases pending in the suicidality MDL, In re Celexa and Lexapro Products Liab. Lit., MDL No. 06-md-01736, and approximately 25 birth defects cases. http://www.sec.gov/Archives/edgar/data/38074/000003807408000019/forest10qjun08.htm

August 25, 2008

Mandatory Disclosure of Doctor-Drug Industry Payments?

The American Medical Association (AMA) is ramping up its efforts to stifle the stigma of impropriety among consumer advocates and patient groups, by proposing to add specific guidelines requiring physicians to disclose their financial ties to the pharmaceutical and medical device industry with patients.

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August 22, 2008

Independent Contractors Owed Overtime Pay?

Recently, there have been an increasing number of cases where courts have determined that independent contractors are owed overtime pay by their employer. Now at first, this seems like a contradictory statement. How can you be an independent contractor and have an employer?

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August 21, 2008

Possible Association Between Vytorin, Zocor, and Zetia and an Increased Risk of Cancer

Use of the cholesterol drugs Zocor (Simvastatin), Zetia (Ezetimibe), and Vytorin (Simvastatin + Ezetimibe) may be associated with an increased risk of some types of cancer.

On August 21, 2008, the FDA posted an alert on its website, advising that early results from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) clinical trial indicated not only that Vytorin appears to be ineffective in reducing overall cardiovascular risk, but that the drug may bring with it an increased risk of a variety of cancers, including skin cancer.

In typical fashion, the FDA’s communication, available at http://www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin_SEAS.htm, follows the language alerting of the SEAS results with language equivocating as to the accuracy of the results, stating that other larger studies have shown no link between cholesterol-lowering drugs and cancer.

Although the FDA advises that consumers should not stop taking these drugs, it does not expect final SEAS results for another 3 months and will take an additional 6 months to review those results.

If your doctor has advised you that your ingestion of a cholesterol lowering drug may have contributed to any form of cancer that you have developed and you would like to consult with an attorney, please visit our website at http://www.pbmattorneys.com, or call us directly at (888) 348-6787.

August 20, 2008

Baltimore Pharmacies Suspected of Issuing Counterfeit and Expired Drugs

On August 8, 2008, the FDA issued a warning advising consumers who filled prescriptions at two Baltimore, Maryland pharmacies that the drugs they received from the pharmacies may have been counterfeit or expired. As the warning states, many of the suspected drugs, for which neither efficacy nor safety has been established by the FDA, are used for the treatment of serious conditions.

The two Baltimore pharmacies in question are in The Medicine Shoppe chain of pharmacies: one located at 8035A Liberty Road and one at 5900 Reistertown Road.

The full warning, and a listing of the suspected drugs, is available on the FDA’s website. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01873.html If you believe that you filled a prescription for one of the listed drugs and would like to consult with an attorney to determine whether or not you have a lawsuit, please visit us at our website, http://www.pbmattorneys.com , or call us directly at (888) 348-6787.

August 18, 2008

Risk of Detached Tips Prompts FDA Recall of Boston Scientific NexStent Carotid System

On August 15, 2008, the U.S. Food and Drug Administration (FDA) announced a Class 1 Recall of Boston Scientific’s NexStent Monorail, NexStent Carotid Stent, and Monorail delivery system “because the tip of the stent-delivery system may detach during the procedure.”

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August 15, 2008

A Rise in Instances of Undeclared Ingredients in Herbal Supplements

Yet another supposed “all natural” or “herbal” supplement for erectile dysfunction contains precisely the ingredient that frequent users are intending to avoid. After an FDA lab analysis of a sample of the Viapro revealed that it contained an undeclared and potentially harmful ingredient, thio-methisosildenafil, EG Labs, LLC, announced that it is recalling all lots of its supplement product in 375mg capsules. Thio-methisosildenafil is an analog of sildenafil, which is the active chemical ingredient of several FDA-approved drugs used for Erectile Dysfunction (ED) in men to enhance sexual performance.

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August 13, 2008

Preemption Update: Wyeth v. Levine

On August 7, 2008, Respondent Diane Levine filed her brief in the United States Supreme Court in Wyeth v. Levine, 06-1249. The brief can be found here, Wyeth v. Levine, 06-1249, Brief for Respondent. For now, we’ll limit our commentary to an acknowledgment that the brief is a masterful rebuttal to Wyeth’s illusory approach at implied conflict preemption and the empty rhetoric in support of the wholesale banning of prescription drug lawsuits.

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August 11, 2008

FCC’s Slap on Comcast’s Interference with P2P Internet Connections

In an unprecedented decision, the Federal Communications Communication (FCC) recently affirmed its authority to protect a “vibrant and open Internet” by ordering Comcast to cease selective and preferential interference over some of its online subscribers, namely those customers whom share online files via peer-to-peer applications (P2P).

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August 8, 2008

Pain Pumps Only Causing More Shoulder Pain

In a 2006 presentation at an American Academy of Orthopedic Surgeons meeting, evidence was presented that showed that the anesthetics contained in pain pumps used after shoulder surgery lead to Postarthroscopic Glenohumeral Chondrolysis (PAGCL). In fact, studies now suggest that up to 63% of arthroscopic shoulder surgery patients who receive a post-operative pain pump may develop PAGCL. The condition leads to a lifetime of suffering, has no consistently successful treatment, and often results in permanent shoulder pain, loss of mobility and further surgery, specifically shoulder replacement surgery.

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July 31, 2008

Off-Label Use and the First Amendment: The Pathway to Naivety?

Daniel E. Troy, recently appointed General Counsel for GlaxoSmithKline and Former Chief Counsel for the FDA, has recently authored a letter to the editor in the New England Journal of Medicine entitled “Pharmaceutical Promotion and First Amendment Rights.”

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July 29, 2008

Preemption Update: Celexa and Lexapro Plaintiffs Enjoy Small Victory

On July 24, 2008, the Eastern District Court of Missouri rejected yet another drug manufacturer’s attempt to jettison lawsuits based on preemption. In In re: Celexa and Lexapro Prod. Liab. Litig., 4:06-md-01736 (RWS), a Multidistrict Litigation with approximately 42 cases alleging suicidal injuries caused by either Celexa or Lexapro, the defendants, Forest Laboratories, Inc. and Forest Pharmaceuticals, Inc. moved to dismiss 22 of the cases on conflict preemption grounds. The cases in question all involved plaintiffs or decedents who were over the age of 24 at the time of their suicidal event or their suicide.

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