Boulder Business Law Advisor

Democrats in the House and Senate introduced bills that would permit generic drug manufacturers the ability to revise the warning labels for generic drugs--in effect making the regulations applicable to brand name drugs applicable to generics. However, it appears that both the bills in the House and Senate bills died in committee. The bills were introduced in response to the Supreme Court's decision in Pliva v. Mensing about which we have previously written (here and here). In Mensing, the Supreme Court held that federal law preventing generic drug manufacturers from independently changing their generic drugs' warning label pre-empted state law failure-to-warn... More

The Supreme Court has agreed to take up the First Circuit's decision in Bartlett v. Mutual Pharmaceutical, Inc. which we have previously written about here and here and here.   Despite the Supreme Court's decision in Pliva v. Mensing whereby the Court held that federal regulations preventing generic drug manufacturers from independently changing their drug's labeling pre-empted state law failure-to-warn claims for injuries caused by the generic drugs, the First Circuit in Bartlett held that the generic drug manufacturer could still be liable under state law design defect claims because they could have refused to manufacture the drug in the first place:... More

We have discussed in previous posts the Supreme Court’s decision in Pliva v. Mensing which had the effect of making generic drug manufacturer “immune” from state failure-to-warn claims.  In summary, Mensing held that because federal regulations prevented a generic drug manufacturer from effectuating a change to the labeling for a particular drug, the generic drug manufacturers could not be liable for failure-to-warn claims.  The rationale runs along these lines: If a generic drug manufacturer cannot change the warning label because of federal law, how can a generic manufacturer be liable under state law for the generic drug’s label failing to... More

We discussed the First Circuit’s opinion in Bartlett v. Mutual Pharmaceutical in two previous posts (here and here). In a nutshell, in Bartlett, the First Circuit refused to find preemption under the Supreme Court’s opinion in Pliva v. Mensing for the plaintiff’s design defect claim against the generic drug manufacturer because the generic manufacturer could “…avoid defective warning lawsuits as well as design defect lawsuits by not making the drug...” in the first place. Confronted with a similar issue, the District Court for the Eastern District of Kentucky in In Re Darvocet, Darvon, and Propoxyphene Products Liability Litigation MDL reviewed the Bartlett... More

We previously wrote about the First Circuit's decision in Bartlett v. Mutual Phamaceutical Co., Inc. which refused preemption for a design defect product liability claim against a generic drug manufacturer.  In our previous post on Bartlett, we discussed the apparent frustration on the part of the First Circuit with the Supreme Court's decision in Pliva v. Mensing.  For this reason, the First Circuit was unwilling to leave the injured plaintiff in Bartlett with no avenue of remedy for her injuries from a generic drug and decided against preemption for her design defect claims. Taking a look at the Bartlett opinion again, the First... More

A number of our previous blog posts (here, here, and here) discussed the Supreme Court’s decision in Pliva v. Mensing, which held that state failure-to-warn claims against generic drug manufacturers were preempted by the Federal Food, Drug, and Cosmetic Act, particularly the 1984 Hatch-Waxman Amendments.  Our most recent post on the topic was Metz v. Wyeth in which the Middle District of Florida applied Mensing and found preemption for a number of product liability claims for recovery but did not find preemption for claims of breach of implied warranties.   Bartlett v. Mutual Pharmaceutical Co., Inc. is another recent application of Mensing--this time from the First Circuit... More

Our previous posts (here and here and here) discussed the Supreme Court’s decision in Pliva v. Mensing which largely immunized generic drug manufacturers from state law failure-to-warn claims.  In Mensing, the Court held that federal regulations preventing generic drug manufacturers from independently changing their drug's labeling preempted state law failure-to-warn claims for injuries caused by the generic drug since it was “impossible” for the generic drug manufacturers to comply with both state and federal requirements. Since Mensing, there have been a number of district court opinions finding preemption for product liability claims against generic drug manufacturers, regardless of the theory. ... More

In the wake of the Supreme Court’s Pliva v. Mensing decision (previously discussed here and here), the Sixth Circuit Court of Appeals in Smith v. Wyeth followed suit, holding that state law failure-to-warn claims against generic pharmaceutical manufacturers were pre-empted by federal law.  According to the Sixth Circuit, “[t]he plain language of the Pliva decision compels the same result here”: The Supreme Court held unequivocally…that federal law preempts state laws that impose on generic-drug manufacturers the duty to change a drug’s label, thus barring the plaintiffs’ state-law tort claims.   However, these cases are different than a straight-forward Mensing-type case in that the... More

Looking back at the transcript of the oral arguments for Pliva v. Mensing and my previous post (here), even if the Court was willing to accept that the preamble to the Hatch-Waxman amendments provided a duty for generics to “take steps” to revise the label, there was no formal process for which “steps” to take and neither the Plaintiff-Respondent nor the Government offered a legitimate one under questioning (most likely for good and obvious reason, given that it is not defined).  Neither seemingly wanted to admit that a generic manufacturer may have to “lobby” for revised labeling, however the Plaintiff-Respondent and... More

On June 23, 2011, the Supreme Court handed a stunning victory for generic drug manufacturers, effectively immunizing them from state law failure-to-warn claims.  In Pliva  v. Mensing, the Court held that federal regulations preventing generic drug manufacturers from independently changing their drug's labeling pre-empted state law failure-to-warn claims for injuries caused by the generic drugs.  According to the Court, it was “impossible” for the generic drug manufacturers to comply with both state and federal requirements. Under the Hatch-Waxman Amendments of 1984, for a generic drug manufacturer to receive FDA approval to market its drug, the manufacturer must show that the... More