Murthy v. Abbott Laboratories
2012 U.S. Dist. LEXIS 29683
S.D. Tex.2012Background
- Murthy participated in Abbott's HERO clinical trial and received Humira infusions for RA.
- Murthy signed a pre-trial Consent to Participate; doctor signed as 'Person Explaining Authorization'; warning about cancer risks discussed in the document.
- Murthy developed Stage III lymphoma after trial participation and stopped Humira on medical instruction.
- Plaintiff alleges FDA labeling was incomplete/misleading about lymphoma risk and that Abbott improperly marketed Humira, including a video and physician compensation.
- Abbott moved to dismiss all claims except contract; court applies Texas law and addresses learned intermediary doctrine and § 82.007.
- Court ultimately holds only Murthy's breach of contract claim survives; other claims barred or dismissed, with contract relate-back allowing tolling.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Does § 82.007 bar failure-to-warn claims? | Murthy argues § 82.007 does not bar direct warning claims and can be rebutted. | Abbott argues presumption applies and § 82.007(b)(1) preempts or is exclusive. | § 82.007(a) preempts/warns bar failure-to-warn claims to extent applicable. |
| Does learned intermediary doctrine apply to Murthy's failure-to-warn claims here? | Murthy contends direct marketing and physician compensation undermine intermediary. | Abbott argues intermediary doctrine should shield manufacturer if physician warned. | Learned intermediary not fully dispositive; issues require further fact-finding, but claims dismissed under § 82.007(a). |
| Are Murthy's contract claims time-barred, or do tolling/relation-back save them? | Murthy contends discovery/tolling and relation-back save contract claim. | Abbott argues statute of limitations/tolling do not save contract claim; but argues b)(1) preemption issue. | Contract claim relates back and is not time-barred; fraudulent concealment/discovery rules do not toll. |
Key Cases Cited
- Twombly v. Bell Atl. Corp., 550 U.S. 544 (Supreme Court 2007) (pleading must state claims plausibly, not merely conclusory)
- Ashcroft v. Iqbal, 129 S. Ct. 1937 (U.S. 2009) (pleading must show facial plausibility)
- Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372 (5th Cir. 2012) (preemption of § 82.007(b)(1) unless FDA finds fraud)
- Centocor, Inc. v. Hamilton, 310 S.W.3d 476 (Tex.App.-Corpus Christi 2010) (DTCA exception to learned intermediary doctrine discussed)
- Ackermann v. Wyeth Pharmaceuticals, 526 F.3d 203 (5th Cir. 2008) (learned intermediary doctrine foundations and scope)
- Wyeth-Ayerst Laboratories Co. v. Gravis, 28 S.W.3d 87 (Tex.App.-Texarkana 2000) (doctor as intermediary between manufacturer and patient)
- Reyes v. Wyeth Labs., 498 F.2d 1264 (5th Cir. 1974) (exception to learned intermediary when physician is not intermediary)
- Pustejovsky v. Pliva, Inc., 623 F.3d 271 (5th Cir. 2010) (grounds for warning adequacy in drug cases)
- McNeil v. Wyeth, 462 F.3d 364 (5th Cir. 2006) (warning adequacy question in prescription drug cases)