Posted On: 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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Posted On: 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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Posted On: July 24, 2008

Preemption Update: Tucker v. GlaxoSmithKline (the Court That Finally Got It Right)

No doubt the Plaintiff’s attorneys in Tucker v. SmithKline Beecham, d/b/a GlaxoSmithKline, 04-cv-01748 (DFH/WTL), S.D. Ind. (Indianapolis Division) are breathing a huge sigh of relief. On July 18, 2008, Chief Judge David Hamilton reopened the case by granting the Plaintiff’s motion for reconsideration, effectively reversing the court’s prior grant of summary judgment on preemption grounds. Perhaps even more remarkable than the 180-degree-turn of events is the depth of this particular jurist’s understanding of the preemption issue in the context of SSRI litigation – specifically, in the context of Paxil suicide cases – and the utter frankness of the opinion. Tucker v. GSK, Slip opinion (S.D. Ind. July 18, 2008) At last, someone gets it.

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Posted On: July 22, 2008

Vytorin’s Impotence -- Second Round of Clinical Trials Show Lack of Efficacy

The Associated Press is reporting Schering-Plough and Merck's recent clinical trial fiasco involving their highly touted anti-cholesterol pill Vytorin, whereby a “European study in patients with heart valve disease found the drug didn't prevent worsening of the disease or lower the need for valve surgery.”

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Posted On: July 10, 2008

Preemption Update: Presumption Against Preemption Under Attack by Wyeth

As plaintiffs’ attorneys and defense attorneys representing pharmaceutical manufacturers await the filing of the respondent-plaintiff’s merit brief in Wyeth v. Levine, No. 06-1249 it is useful to take note of one of the salient features of Wyeth’s brief, filed in May 2008.

Wyeth apparently appreciates the elephant in the room: that if the High Court applies the longstanding presumption against preemption, Wyeth faces a decidedly uphill battle to conjure an implied conflict to warrant preemption. And so Wyeth begins its brief by attacking the very applicability of the presumption. To make its point, Wyeth insists, inter alia, that while the presumption against preemption is applicable in “express” and “field” preemption cases, it has no similar applicability in a case where, as in Levine and in almost all prescription-drug, failure-to-warn cases, the only category of preemption urged by the defendant drug company is implied “conflict” preemption.

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Posted On: July 9, 2008

Cholesterol Screening for Children as Early as Age 2?

The American Academy of Pediatrics is now recommending cholesterol screening of children and adolescents, starting as early as the age of 2 and no later than the age of 10, especially if they come from families with a history of high cholesterol or heart attacks before 55 for men and 65 for women.

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Posted On: July 8, 2008

Levaquin --- The New Reality, A Black Box Warning

The FDA has now issued a Black Box Warning to healthcare professionals setting forth the "increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use."

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Posted On: July 7, 2008

Pigford: African American Farmer's Discrimination Lawsuit

On May 27, 2008, the law firm of Pogust, Braslow, & Millrood, filed suit on behalf of hundreds of African American farmers, alleging discrimination by the United States Department of Agriculture (USDA), in the application, processing, and distribution of farm loans. An additional 150 discrimination claims were filed by the law firm on May 30, 2008.

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Posted On: July 5, 2008

Neurontin and Suicide: The FDA’s Big Gamble

On January 31, 2008, the FDA issued a warning to Health Care Professionals of an “increased risk of patients having suicidal thoughts and behaviours as a result of taking antiepileptic drugs for epilepsy, bipolar disorder, migraines, and other conditions.”

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Posted On: July 3, 2008

Levaquin’s Achilles Heel: Tendon Ruptures

The current labeling for Levaquin presently warns that “ruptures of the shoulder, hand, Achilles tendon, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including levofloxacin.”

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Posted On: July 1, 2008

Depo-Provera -- The Onset of Osteoporosis?

On November 18, 2004, Pfizer, Inc., the manufacturer of Depo-Provera, a contraceptive injection, issued a warning to Health Care Professionals that “women who use Depo-Provera Contraceptive Injection may lose significant bone mineral density.”

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