…s of the drug, an antibiotic. Levaquin included a warning but sometime after Schedin’s incident, the warning was changed and made more prominent (made into a “black box” warning in 2008).  Subsequent warning label changes would be a classic “subsequent remedial measure” inadmissible at trial if it were not for the fact that the label change was mandated by the FDA, U.S. District Court Judge John R. Tunheim has held. … Continue reading →

The interesting fact pattern that gives rise to the problem in this case is what are the duties of a generic drug manufacturer if, after a drug’s initial federal approval (and approval (and then mandated use) of a specific warning label), new information comes to light about potentially harmful side effects?  Can a claim be brought against the manufacturer under state law for failure to warn? Gloria Mensing took a medicine, MCP, a gene… Continue reading →

…ime will tell whether the story and the privacy breach will open up another cottage industry or whether the contagion will be contained… The named plaintiff in the (first-filed?) suit against Zynga, maker of Farmville : Nancy Graf, of St. Paul, in a suit filed in San Francisco, CA (represented by Edelson McGuire/Nassiri-Jung).  The complaint is here. … Continue reading →

…rm or illness? As a first line of defense, pharmaceuticals and device manufacturers seek protection under federal regulation but there are ways for such manufacturers to game that system (by promoting, for example, “off label” uses or, theoretically, by duping federal regulators by other means (i.e., concealing or distorting data as to efficacy or side effects)). So the FDA may afford medical companies some protection, but that protec… Continue reading →

…n that would have negatively affected levofloxacin sales in both Europe and the United States.  Over the past decade, there appears to have been increased concern about these medications and the communication of risk on their labels.  The label warnings have been increasingly emphatic.  Plaintiffs’ theories seem to be, in a nutshell, that the drug companies knew of the medicine’s risks and have steadfastly tried to understate or de-em… Continue reading →

Were you sold a flare root injection regimen for a treasured oak or multiple oaks on your property to prevent oak wilt disease, only to have your tree die from oak wilt notwithstanding the hundreds of dollars (or more) spent on flare root injection? One label on branded propiconazole says,  “Preventive application is more effective than therapeutic treatment.”  Some companies that “administer” the flare root injections d… Continue reading →

…njection regimen for a treasured oak or multiple oaks on your property to prevent oak wilt disease, only to have your tree die from oak wilt notwithstanding the hundreds of dollars (or more) spent on flare root injection? One label on branded propiconazole says,  “Preventive application is more effective than therapeutic treatment.”  Some companies that “administer” the flare root injections do so with a guaranty or warran… Continue reading →