Medicolegal Review: Perinatal Effexor Lawsuits and Legal Strategies Adverse to Prescribing Obstetric Providers
19 December 2017
12 October 2018
19 March 2019 (online)
Objectives This study was aimed to familiarize obstetricians with the legal environment surrounding Effexor lawsuits and emphasize the importance of documenting informed consent in the medical records when prescribing a medication that is being targeted for litigation.
Study Design We used the LexisNexis legal search engine to review legal documents from Effexor-related cases and also used Google to search for Effexor-related lawsuits online, further researching these cases via publically available court records from district clerk offices. Finally, we conducted a year-by-year literature review from 1993 to 2017 to establish the history and evolution of scientific studies surrounding Effexor use during pregnancy.
Results Litigation involving Effexor typically arises due to congenital cardiac birth defects in the neonate allegedly associated with maternal Effexor use in pregnancy. Medication manufacturers have employed a legal strategy termed the learned intermediary doctrine in an attempt to shift liability away from themselves and on to prescribing obstetricians. Manufacturers claim they adequately inform obstetricians of the risks and benefits of prescribing their product and it is the duty of the obstetrician to relay those risks and benefits to their patients.
Conclusion To reduce the risk of liability exposure, obstetricians must adequately document informed consent in the medical records when prescribing medications to their pregnant patients.
- 1 ACOG Committee on Practice Bulletins--Obstetrics. ACOG Practice Bulletin: Clinical management guidelines for obstetrician-gynecologists number 92, April 2008 (replaces practice bulletin number 87, November 2007). Use of psychiatric medications during pregnancy and lactation. Obstet Gynecol 2008; 111 (04) 1001-1020
- 2 Wyeth Pharmaceuticals I. Effexor XR (venlafaxine hydrochloride) extended-release capsules. 2004; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s059,020699s100lbl.pdf . Accessed March 13, 2019
- 3 US Food and Drug Administration. FDA adverse event reporting system (FAERS). Available from: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ . Accessed December 14, 2017
- 4 Einarson A, Fatoye B, Sarkar M. , et al. Pregnancy outcome following gestational exposure to venlafaxine: a multicenter prospective controlled study. Am J Psychiatry 2001; 158 (10) 1728-1730
- 5 Wyeth Pharmaceuticals, Inc. EFFEXOR–venlafaxine hydrochloride tablet. 2008; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020151s051lbl.pdf . Accessed December 8, 2017
- 6 Hostetter A, Ritchie JC, Stowe ZN. Amniotic fluid and umbilical cord blood concentrations of antidepressants in three women. Biol Psychiatry 2000; 48 (10) 1032-1034
- 7 Polen KN, Rasmussen SA, Riehle-Colarusso T, Reefhuis J. ; National Birth Defects Prevention Study. Association between reported venlafaxine use in early pregnancy and birth defects, national birth defects prevention study, 1997-2007. Birth Defects Res A Clin Mol Teratol 2013; 97 (01) 28-35
- 8 A.S. v. Pfizer, Inc., Case No.: 1:13-cv-00524 - LJO - JLT (United States District Court, E.D. California 2013). Available from: https://casetext.com/case/as-v-pfizer . Accessed March 13, 2019
- 9 Emeigh J. Butte parents suing drug company over daughter's birth defects. 2012. Available from: http://billingsgazette.com/news/state-and-regional/montana/butte-parents-suing-drug-company-over-daughter-s-birth-defects/article_ac18a92f-f5ea-50c3-b7c8-c2b3d6b691d1.html . Accessed October 29, 2018
- 10 Friedman RJ. Take two of these and sue me in the morning: efficacy of the learned intermediary doctrine in prescription drug failure to warn cases. St Thomas Law Rev 2010; 22 (02) 276-293
- 11 Ackermann v Wyeth, 526 F3d 203 (United States Court of Appeals, Fifth Circuit 2008)
- 12 Strayhorn v Wyeth, 887 F Supp 2d 799 (United States District Court, W.D. Tennessee, Western Division 2012)
- 13 Simon v Wyeth, 989 A2d 356 (Superior Court of Pennsylvania 2009)
- 14 Miller v. Pfizer, 196 F. Supp. 2d 1095(United States District Court for the District of Kansas, 2002)
- 15 Brumley v Pfizer, 149 F Supp 2d 305 (U.S. District Court for the Southern District of Texas 2001)
- 16 Kapp MB. Patient autonomy in the age of consumer-driven health care: informed consent and informed choice. J Leg Med 2007; 28 (01) 91-117
- 17 McNichols v Johnson & Johnson, 461 F. Supp. 2d 736 (S.D. Ill. 2006). Available from: https://casetext.com/case/mcnichols-v-johnson-johnson . Accessed March 13, 2019
- 18 Bérard A, Sheehy O, Zhao JP, Vinet É, Bernatsky S, Abrahamowicz M. SSRI and SNRI use during pregnancy and the risk of persistent pulmonary hypertension of the newborn. Br J Clin Pharmacol 2017; 83 (05) 1126-1133
- 19 Huybrechts KF, Palmsten K, Avorn J. , et al. Antidepressant use in pregnancy and the risk of cardiac defects. N Engl J Med 2014; 370 (25) 2397-2407