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89 Tul. L. Rev. 959 (2014-2015)

handle is hein.journals/tulr89 and id is 1017 raw text is: 





Post-Mensing Immunity Under the Louisiana Products
Liability Act: Johnson v Teva Pharmaceuticals USA, Inc.,
and Its Implications for Louisiana Law

I.   O VERV IEW .................................................................................... 959
II.  B ACKGROUND    ............................................................................. 960
III. THE  COURT'S D  ECISION .............................................................. 965
IV   A N ALY SIS  ..................................................................................... 968

I.   OVERVIEW
     Under the duty of sameness, manufacturers of generic drugs
are required by federal law to design and label their products the same
at all times as the corresponding brand-name drug[s].' Federal law
thus requires the composition of metoclopramide, a generic drug used
to treat digestive issues, to be identical to that of Reglan, its brand-
name counterpart. Likewise, any warning labels associated with
metoclopramide (including Dear Doctor warning letters and the
Physicians'Desk Reference) must strictly mirror those disseminated in
association with Reglan.2 Considering that approximately 80% of all
prescriptions filled in the United States are filled with generic drugs,3
and that under current United States Court of Appeals for the Fifth
Circuit precedent, brand-name manufacturers cannot be liable for
injuries caused by generic versions of their drugs that they did not
manufacture, the duty of sameness has the potential effect of placing a
significant population of plaintiffs injured by the use of a generic drug
up against two immunized defendants.4 If a generic manufacturer is
not at liberty' to alter the composition or labeling of a potentially
dangerous or inadequately labeled drug, and the brand-name
manufacturer who created the drug (and its warning labels) owes no


    1.   Johnson v, Teva Pharm. USA, Inc., 758 E3d 605, 611 (5th Cir. 2014) (quoting
PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2578 (2011)).
    2.   Dear Doctor letters are communications issued by drug manufacturers to alert
health care providers to any risks associated with a drug and are considered labeling. See
NDAs: Dear Health Care Professional Letters, U.S. FOOD & DRUG ADMIN. (July 2, 2003),
http://www.fda.gov/downloads/aboutfda/centersoffices/offlceofinedicalproductsandtobacco/c
der/manualofpoliciesprocedures/ucm082012.pdf
    3.   Johnson, 758 E3d at 618 (Dennis, J., concurring in part, dissenting in part).
    4.   Id. at 615-16 (majority opinion).
    5.   Id. at 612.
                                959

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