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 →

…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 →

Update (July 7, 2011): A big win for plaintiffs’ class actions before the Eighth Circuit this week.  Judge Diana E. Murphy wrote the opinion, in which Judge Roger L. Wollman concurred, affirming U.S. District Court Judge Ann Montgomery’s class certification in its entirety. Judge Raymond W. Gruender dissented, arguing that the “dry plaintiffs’ class,”  that is, the class of plaintiffs whose pipes had not yet failed,… 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 →

…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 →

…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 →

…iff’s counsel brought this to the Court’s attention with a motion to enforce the settlement agreement, seeking an award of its attorneys’ fees for the expense of having to bring the motion.  U. S. Mag. Judge Raymond L. Erickson (D. Minn.) granted the motion, but not before going through the lawyer’s bill and giving it a haircut (50%). Judge Erickson had no problem with the $300/hour rate for plaintiff’s counsel but h… Continue reading →

…gued that, for national banks, the issue is only where the main office is, not where its ppob is. Eighth Circuit U.S. Court of Appeals Judge Diana Murphy dissented from the decision of her colleagues, Roger Leland Wollman and Raymond Gruender. The disagreement is a matter of interpreting a less than clear federal statute and, perhaps, the underlying policy question of whether national banks should have an easier time getting their cases into fede… Continue reading →