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 →

… enhanced warning. Judge Tunheim analyzed the evidence under Fed. R. Evid. 407 (regarding subsequent remedial measures), Fed. R. Evid. 403 (balancing probative value against risk of prejudicial effect), and also under federal preemption.  Defendants had also challenged the evidence as irrelevant to Mr. Schedin’s claims, a position that Judge Tunheim’s order rejected only implicitly. … 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 →

…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 →

…e not surprising that Medtronic and plaintiffs’ counsel settled the Sprint Fidelis litigation for $268 million under the ominous shadow of a pending decision by the U.S. Court of Appeals on the critical issue of federal preemption of state law claims. What is surprising is that the U.S. Court of Appeals for the Eighth Circuit today rejected a joint motion to stay issuance of opinion.  The Eighth Circuit docket reports that U.S. Court of App… Continue reading →