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 #2:  (Sept. 2010) Third-party Maslon Borman Edelman & Brand is apparently out of the case.] [UPDATE: (July, 2010)  Originally commented on in early June in light of the apparent secrecy of the case, this case was “all sealed up” but now somewhat less so in light of last week’s order by U.S. Mag. Judge Janie Mayeron (D. Minn.).  Plaintiff has now filed redacted unsealed pleadings here.   Defendants and third-party defendants’ “Joint a… Continue reading →

Update (July 27, 2011):  Chief Technology Officer Mark Lanterman’s declaration in response to the opposition’s claim that discovery responses ordered by the Court would cost $36,000,000 was filed yesterday in this discovery dispute before U.S. Mag. Judge Janie S. Mayeron (D. Minn.). In a nutshell, Lanterman suggests that the opposing tech, Jeff Stoneking, made numerous unwarranted assumptions regarding the data ordered to be provide… 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 →

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 →

…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 →

…ts sought to be unsealed go to the heart of this lawsuit and it is inconvenient and unwarranted to have to treat them as secret, now years after the grand jury proceedings. The issue to be decided by U.S. District Court Judge Janie S. Mayeron, in the first instance, at least, plumbs depths of criminal procedure deeper than this Minnesota civil litigator has ever swam so I make no prediction as to outcome. This is just another chapter in the Heims… Continue reading →

…ng for punitive damages claim going forward against Defendant Gonzalez but not his employer, SMS, which has also already been covered. Now plaintiff’s counsel is taking another run for punitives, objecting to Mag. Judge Janie S. Mayeron’s denial of punitives against SMS by appeal to U.S. District Court Judge Ann D. Montgomer (D. Minn.).   The legal standard for granting leave to amend to add a claim for punitive damages under Minnesot… Continue reading →

When do employers have to pay for the intentional wrong doing of employees?  When should employers be subject to punitive damages for alleged wrong-doing of an employee?  (A related recent post, by the way, is here.) Thanks to ML Guest Poster/Contributor Employment Attorney T.J. Conley for the following commentary: A decision last week by U.S. Magistrate Judge Janie Mayeron offers an excellent analysis of the appropriate standards used in evalua… Continue reading →