Irizarry-Casiano v. Novartis Pharmaceuticals Corporation et al
Filing
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MEMORANDUM OPINION: Denying 17 Motion to Dismiss. Signed by Judge Gustavo A. Gelpi on 6/27/13. (CL) Modified on 6/27/2013 as to title (er).
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IN THE UNITED STATES DISTRICT COURT
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FOR THE DISTRICT OF PUERTO RICO
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LILLIAM IRIZARRY-CASIANO,
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Plaintiff,
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v.
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NOVARTIS PHARMACEUTICALS
CORPORATION, et al.,
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Defendants.
Civil No. 13-1051 (GAG)
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MEMORANDUM OPINION
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Plaintiff alleges she was stricken with glaucoma and carpal tunnel from using Defendant's
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product, Reclast, and that Defendant “did not warn that Reclast was not for people [such as Plaintiff]
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suffering from” calcium deficiency. (Docket No. 16 at 4.) To succeed in a products liability suit
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in Puerto Rico, a plaintiff must demonstrate that "there were no warnings or instructions, or those
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provided were inadequate," and that the "absence of adequate warnings or instructions was the
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proximate cause of plaintiff's injury." Cruz-Vargas v. R.J. Reynolds Tobacco Co., 348 F.3d 271,
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276 (1st Cir. 2003).
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Plaintiff alleges, “Had [D]efendant properly labeled the product, the same would have not
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been prescribed to [Plaintiff] and she would have not” suffered glaucoma or carpal tunnel. (Docket
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No. 16 at 4.) The FDA, to wit, warns against its use by those with low calcium and that it can cause
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bone, joint, or muscle pain. (See Docket No. 13.) Plaintiff, furthermore, cites websites whose
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credibility the court cannot weigh at this stage. (Id.) Plaintiff satisfies her burden of pleading that
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the label or package insert insufficiently warned users of the FDA’s admonishments. Because the
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motion to dismiss and sur-reply fail to discuss the specifics of the warning's adequacy on the label
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Civil No. 13-1051 (GAG)
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or in the drug's package insert, this issue requires resolution of factual issues beyond the court's
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current grasp.
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This issue may not require extensive discovery. “A prescription drug manufacturer has a
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duty to adequately warn prescribing physicians of the hazards posed by the use of its drugs.”
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Guevara, 845 F.2d at 366. Furthermore, “The warning is directed not to the ultimate user but to the
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doctor prescribing the drug, who must then ‘take into account the propensities of the drug and the
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susceptibilities of the patient and make an informed decision.’” Id. (citation omitted). The First
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Circuit has determined that, as a matter of law, when the Physician’s Desk Reference and package
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insert that comes with a drug warn physicians not to give the drug to persons with certain
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sensitivities, then a warning is adequate. See id. Resolving this issue turns on the contents of the
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warning, which the court does not presently have. For now, Plaintiff’s statement that Defendant
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failed to properly warn the label to tip off a doctor that a calcium-deficient might suffer potential
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dangers of Reclast’s side-effects. Therefore, Defendant’s motion to dismiss at Docket No. 17 is
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DENIED.
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SO ORDERED.
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In San Juan, Puerto Rico this 27th day of June, 2013.
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/S/ Gustavo A. Gelpí
GUSTAVO A. GELPI
United States District Judge
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