NJ in Mainstream on Generic Preemption


We can't say much about it because of Dechert's involvement in the Reglan/metoclopramide litigation, but Judge Higbee has ruled on on generic preemption under Mensing.  There are two opinions.  The first, In re Reglan Litigation, No. 289, slip op. (N.J. Super. Law Div. May 4, 2012), deals with generic preemption generally.  This decision is in line with most other recent decisions.  The rulings

(1)  The 2007 FDAAA amendments made no relevant changes affecting preemption under MensingSlip op. at 7.
(2)  All the plaintiffs' claims, however designated are labeling related and are preempted.  Id. at 8-9.
(3)  To the extent that a generic defendant failed to update its labeling when required to by the FDA, warning claims based on that failure do not violate the FDA "sameness" requirement and are not preempted.  Id. at 9-10.
(4)  Claims that the generic defendants should have communicated warning changes through means (such as "Dear Doctor" letters) other than timely updates to the warnings themselves are preempted.  Id. at 10-11.
(5)  Claims that generic manufacturers should have removed their product from the market altogether do not exist under state law ("go[] beyond the duties and remedies that have ever been applied in state courts") and if they did exist would be preempted ("[t]he conflict between state and federal law would be much more pronounced if the state courts upheld a decision that an FDA-approved drug should not have been on the market").  Id. at 12.

The second, shorter, opinion, In re Reglan Litigation, No. 289, slip op. (N.J. Super. Law Div. May 4, 2012) (which we'll have to call "Reglan II" because in citation form it's identical to the first), dealt with arguments that certain generic manufacturers' status as FDA-designated "reference listed drugs" (RLD) after the branded drug left the market resulted in those defendants losing their preemption defense.  The court held that the RLD designation did not alter preemption analysis under Mensing:

"[T]his court does not find any support for plaintiffs' contention that once [a generic drug] is designated by the FDA as an RLD, it can simply take advantage of the CBE process to strengthen its label unilaterally. . . .  In fact, the FDA regulations are clear in putting the agency in charge when no [branded] holder is in the market."

Reglan II, slip op. at 3.

For more commentary, beyond what we are able to impart, see the FDA Law Blog.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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