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 →

Justice Sotomayor, writing for the Court, joined in full by six Justices and in part by Justices Scalia and Thomas, the U.S. Supreme Court holds that attorneys who provide bankruptcy assistance are debt-relief agencies under the bankruptcy abuse law (opinion is here) and that the BAPCPA (Bankruptcy Abuse Prevention and Consumer Protection Act) does not violate the consitution in setting limitations on advice that “debt relief agencies̶… Continue reading →

…her bit part actors will strenuously argue)… The drama has been playing out  in the Petters litigation (in the slow-motion of U.S. civil litigation as opposed to the frenzied 100 minutes or so in a movie, of course).  A bankruptcy trustee has alleged that Ritchie Capital Management and related entities (“Ritchie Capital”), investors in the Petters scampire (scam empire), “literally days before the ponzi scheme collapsed [a… Continue reading →

…Some things for defrauded clients might want to talk with a lawyer about: (1) your own “returns” (if you received any) could be someone else’s money (that is, an innocent later “investor”); under bankruptcy rules and fraudulent conveyance law, this money may be recouped from you by an appointed receiver or bankruptcy trustee, even if you are wholly innocent; (2) you will almost certainly not get 100 cents on the doll… 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 →

…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 →