A former farm worker named Enrique Rubio may just be the right “David” to take down “Goliath” chemical company Monsanto. Rubio filed suit against the manufacturer of Roundup® early last week, claiming that the company’s infamous herbicide is the cause of his bone cancer and inability to work. Roundup’s® safety has been hotly debated for years among scientists, environmental activists and those concerned with human health. Rubio’s suit, if successful, may put an end to…

[By Staff Writer Jay Belle Isle] In a letter dated July 13, the FDA issued serious warning to C. R. Bard Inc. due to multiple violations. The company has been given fifteen business days to respond to the letter or else it may face “seizure, injunction and civil money penalties.” The warning is based on inspections of Bard’s Queensbury, NY and Tempe, AZ manufacturing facilities and is focused on Bard’s Recovery Cone Removal System, Models…

U.S. District Judge Cynthia Rufe or the Eastern District of Pennsylvania made the only call she could on Tuesday: the postponement of Daubert hearing in Zoloft birth defects case until September. The multidistrict litigation (MDL) against Pfizer, claiming its popular antidepressant, Zoloft causes birth defects, came to a halt as the plaintiffs’ expert was disqualified due to errors in the article upon which he was basing his argument in the plaintiffs’ favor. The postponement came…

Recently, Reuters reported that “Drug companies generally don’t disclose all the reasons new medicines fail to win U.S. marketing approval, even though regulators often reject treatments over concerns about safety or effectiveness”. Reporter Lisa Rapaport quotes Dr. Peter Lurie, FDA associate commissioner for public health strategy and analysis, saying “‘Only a minority of the press releases clearly stated that receipt of a complete response letter meant that marketing could not commence, and most findings associating…

In an unpublished opinion file on April 9, the Court of Appeals for the 5th Circuit affirmed a previous decision in one of the Reglan generics cases, Whitener v. Pliva, Inc. This ruling upholds the district court’s grant of summary judgment in favor of the defendant drug companies on the grounds that the defendants performed no off-label promotional activities. Lindsey and Joshua Whitener’s son was born prematurely and with severe birth defects after Mrs. Whitener…

On Tuesday March 3rd, the United States Food and Drug Administration required that manufacturers of testosterone supplements (or, Low-T drugs)  include warnings on packaging for the increased risk for heart attack and stroke linked to these drugs. In years past, a great many peer-reviewed scientific studies had demonstrated that men using Low-T drugs were at dramatically higher risk for heart attack and stroke.  Finally, this work has led the FDA to require a warning …

Last week, the pharmaceutical company, Takeda, was ordered to pay $1.3 million in punitive damages to a former Philadelphia schoolteacher who “argued the drugmaker’s Actos diabetes medicine caused his bladder cancer”, Japan Times writes. Only a few days earlier, that man was awarded over $2.3 million in compensatory damages. According to that Japan Times article, this was the “fifth Actos patient to convince a jury that Takeda’s former top-selling drug causes bladder cancer. Last…