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Things are not looking good for generic drug product liability plaintiffs after Bartlett.  In New Jersey, Judge Higbee – whom nobody would claim to be a pro-defense judge – has dismissed (on a motion to strike, which is a pleadings-based procedural posture) all claims against generic manufacturers of Isotretinoin (the generic form of Accutane).  This happened a couple of weeks ago, but now we have the Westlaw citation for you.  In In re Isotretinoin Litigation, No. ATL-L-1321-09, 2013 WL 3483813 (N.J. Super. Law Div. June 28, 2013), the court rejected the following claims for the following preemption-reasons:

  • All state law warning claims, including implied warranty, common law fraud, fraudulent concealment, and negligent misrepresentation, are preempted.  Moreover, warnings are the crux of all plaintiff’s allegations.  2013 WL 3483813, at *4, 6-7, 8.
  • The 2007 FDAAA legislation made no changes to the FDCA with respect to generic drugs that could affect the generic preemption analysis.  Id. at *4.
  • Generic manufacturers cannot change the designs of their products, so design defect claims are preempted.  Id. at *5-6.
  • Under Bartlett, where a manufacturer cannot change its design or label, risk/utility-based design claims are preempted.  Id. at *4-5.
  • Claims that defendants should have communicated with physicians through “Dear Doctor” letters are warning claims and thus are preempted.  Id. at *6.
  • The logic of Mensing requires of claims based on assertions that a generic manufacturer should have approached the pertinent innovator manufacturer and requested a label change , since that is as “speculative” as the “take steps” argument concerning approaching the FDA in MensingId. at *7-8.
  • Wrongful marketing claims that generic manufacturers had a duty to cease selling their product do not exist (“goes beyond the duties and remedies that have ever been applied in state court”) under state law and are directly preempted by BartlettId. at *7.
  • Claims of inadequate post-marketing pharmacovigilance are preempted as a disguised form of warning claim.  Id. at *8.

There is one caveat to Isotretinoin, there were no allegations or evidence that the relevant warnings were ever not updated in a timely fashion.  Id. at *2 (rejecting difference in colour and, identification of risk management systems, and program registries as immaterial)  Rather, at all times, the warnings about the risks at issue (and as far as we know all of the warnings) were the same as those required by the FDA for the branded product.  Id.  So this decision is not a rejection (or allowance) of duty to update claims.

We view the ruling on the “approach the innovator manufacturer” claim as having the most long-term significance.  The FDA – for reasons that we both agree with (the divergent preemption rationales for generic and innovator drugs make no practical sense) and don’t agree with (here comes yet another FDA flip-flop as the agency responds “how high” when the plaintiffs’ bar says “jump”) – is going to take a stab at changing its regulations to authorize generic warning changes without pre-approval.  Authorizing such a change directly on the present Hatch-Waxman language likely put the Agency cross-wise with the statute (and with little basis after this flip-flop for claiming judicial deference), so some sort of formal procedure along the lines of “approach the innovator manufacturer” was a possible alternative that might at least pass administrative muster.  We don’t like the “approach” approach because it would open the door to innovators being harassed and forced to take un-economic actions on drugs they no longer sell by generic manufacturers seeking to avoid liability.  But with preemption being the underlying driver for this FDA initiative (belying prior FDA protestations of not intending to affect common-law litigation), the failure of the “approach” approach to alter the preemption result under Mensing/Bartlett should help remove option from the table.