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HTMLPublic Statements Made by Pharmaceutical and Biotech Company Executives May Raise FDA's Hackles if They Do Not Meet Basic Requirements for Promotional Communications
Joanne S. Hawana; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
June 26, 2015, previously published on June 23, 2015
For players in the highly regulated pharmaceutical and health care industries, it is common knowledge that manufacturers and distributors of FDA-regulated products are required to promote their products in compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and FDA’s...

 

HTMLFederal Judge Makes Important Ruling in Xarelto Lawsuits
Waters Kraus LLP;
Legal Alert/Article
June 17, 2015, previously published on June 1, 2015
As the number of Xarelto lawsuits rises due to the drug’s link to uncontrollable bleeding in patients, cases filed in federal court have been assigned to a single judge in the Eastern District of Louisiana — Judge Eldon Fallon. In May 2015, Judge Fallon ordered lawyers in the Xarelto...

 

HTMLWhat’s Really in Your Supplements?
Selina A. Billington; Wilson Elser Moskowitz Edelman & Dicker LLP;
Legal Alert/Article
April 15, 2015, previously published on March 16, 2015
New York State Attorney General’s Investigation Has Sparked a Coalition of State Attorneys General Against Herbal Supplement Manufacturers: What does this mean for the industry as a whole in terms of product liability exposure?

 

HTMLJ&J and Bayer Launch New Xarelto Study
Waters Kraus LLP;
Legal Alert/Article
April 7, 2015, previously published on March 20, 2015
Johnson & Johnson and Bayer are reportedly seeking additional Food and Drug Administration (FDA) approval for Xarelto, the companies’ lucrative blood thinner that many lawsuits claim can cause injuries and death from uncontrollable bleeding.

 

HTMLStates with Medical Marijuana See Falling Opioid Death Rate
Stephen J. Burg; Burg Simpson Eldredge Hersh & Jardine, P.C.;
Legal Alert/Article
March 25, 2015, previously published on January 23, 2015
Researchers from the University of Pennsylvania and Philadelphia Veterans Affairs Medical Center discovered the number of opioid overdoses decreased overtime in states with legalized marijuana.

 

HTMLFDA Establishes the Office of Pharmaceutical Quality
Duane Morris LLP;
Legal Alert/Article
March 3, 2015, previously published on February 23, 2015
In a press conference earlier this year, Dr. Janet Woodcock, head of the U.S. Food and Drug Administration's (FDA) pharmaceutical division, stated that the FDA has been working on "establish[ing] consistent quality standards for all drugs, whether brand name or generic" over the past 10...

 

HTMLFDA Publishes Second Draft Guidance for Further Clarification of Drug Supply Chain Security Act
Carolyn A. Alenci, Frederick R. Ball; Duane Morris LLP;
Legal Alert/Article
December 10, 2014, previously published on November 17, 2014
Earlier this year, the U.S. Food and Drug Administration (FDA) requested information and commentary for the implementation of the Drug Supply Chain Security Act (DSCSA) that in part "establishes a Federal system for tracing prescription drug products through the pharmaceutical distribution...

 

HTMLFailure-to-Update Claims Against Generic Manufacturers Remain Viable
Laura J. Gust; Baker Sterchi Cowden & Rice, L.L.C.;
Legal Alert/Article
November 12, 2014, previously published on October 16, 2014
In Franzman v. Wyeth, Inc., et al., case number ED100312, the Missouri Court of Appeals for the Eastern District recently reversed the trial court’s judgment in favor of the manufacturers of the generic form of Reglan (the “Generic Defendants”) on the portion of Franzman’s...

 

HTMLFlorida Court Says, “No Phishing Expeditions Allowed on a Plaintiff’s Facebook Page”
Sean M. McDonough; Wilson Elser Moskowitz Edelman & Dicker LLP;
Legal Alert/Article
November 8, 2014, previously published on April 15, 2014
While it is true that social media has become one of the main sources for discovery in personal injury litigation, the basic tenets of discovery that apply to the standard document requests, also apply to this new technological source of information. The question of whether a demand for any and all...

 

HTMLWeeks II: Alabama bucks the trend and accepts the Innovator-Liability Theory
Laura J. Gust; Baker Sterchi Cowden & Rice, L.L.C.;
Legal Alert/Article
October 31, 2014, previously published on October 10, 2014
On August 15th, the Alabama Supreme Court endorsed the theory of “innovator liability” and held for the second time in Wyeth, Inc. v. Weeks, 2014 Ala. LEXIS 109 (Ala. Aug. 15, 2014), that a plaintiff who took only the generic version of the heartburn medication Reglan could still make a...

 


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