The Supreme Court's Latest Ruling on Drug Liability and its Implications for Future Failure-to-Warn Litigation

Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019).

J. Greenwald , “High Court Hands Win to Drugmakers in Preemption Case,” Business Insurance, May 28, 2019, available at <https://www.businessinsurance.com/article/20190528/NEWS06/912328657/High-court-hands-win-to-drugmakers-in-preemption-case> (last visited November 19, 2019).

B. Wolfman , “Supreme Court strongly reaffirms 2009 no-preemption decision in Wyeth v. Levine,” Public Citizen Consumer Law & Policy Blog, May 20, 2019, available at <https://pubcit.typepad.com/clpblog/2019/05/supreme-court-strongly-reaffirms-earlier-no-preemption-decision-in-wyeth-v-levine.html> (last visited November 19, 2019).

T. Neilan , “Merck Pulls Vioxx Painkiller From Market, and Stock Plunges,” The New York Times, September 30, 2004, available at <https://www.nytimes.com/2004/09/30/business/merck-pulls-vioxx-painkiller-from-market-and-stock-plunges.html> (last visited November 19, 2019).

Merck, 139 S. Ct. at 1675.

Id. at 1674.

Id. at 1678.

Wyeth v. Levine, 555 U.S. 555, 575 (2009).

G.J. Annas , “Good Law from Tragic Facts — Congress, the FDA, and preemption,” New England Journal of Medicine 361, no. 12 (2009):1206-1211.

Wyeth, 555 U.S. at 571.

Merck, 139 S. Ct. at 1678 (emphasis added).

Id. at 1680.

Id. at 1679.

Wyeth, 555 U.S. at 570-71.

In our view, this central holding of the Merck decision represents a major victory for patients and a major defeat for drug manufacturers. As noted above, a separate portion of Merck decided a procedural issue: should the question of whether preemption applies in a given case be decided by a judge or a jury? Merck held that the question should be decided by a judge, not a jury. Merck, 139 S. Ct. at 1680. This outcome permits judges to dismiss some failure-to-warn lawsuits prior to trial, and it may favor industry to the extent that juries are more likely than judges to side with a sympathetic plaintiff. However, we believe the import of Merck's central holding on the legal standard for preemption outweighs the import of the procedural judge-versus-jury question, and we therefore disagree that Merck represents a victory for industry, on the whole.

21 C.F.R. § 314.70(c).

Merck, 139 S. Ct. at 1673. 21 C.F.R. § 314.70(c) sets the 30 day deadline for FDA review of CBE labeling changes.

S.B. Dusetzina , A.S. Higashi , E.R. Dorsey , R. Conti , H.A. Huskamp , S. Zhu , C.F. Garfield , and G.C. Alexander , “Impact of FDA Drug Risk Communications on Health Care Utilization and Health Behaviors: A Systematic Review,” Medical Care 50, no. 6 (2012): 466-478.

A.S. Kesselheim , D.L. Darby , D.M. Studdert , R.J. Glynn , R.L. Levin , and J. Avorn , “False Claims Act Prosecution Did Not Deter Off-label Drug Use in the Case of Neurontin,” Health Affairs 30, no. 12 (2011): 2318-2327.

A.C. Egilman , A.S. Kesselheim , H.M. Krumholz , J.S. Ross , J. Kim , and A. Kapczynski , “Confidentiality Orders and Public Interest in Drug and Medical Device Litigation,” JAMA Internal Medicine, published online October 28, 2019. doi: https://doi.org/10.1001/jamainternmed.2019.5161.

H.M. Krumholz , J.S. Ross , A.H. Presler , and D.S. Egilman , “What Have We Learnt from Vioxx?” BMJ 334 (2007): 120–123.

J.N. Jureidini , L.B. McHenry , and P.R. Mansfield , “Clinical Trials and Drug Promotion: Selective Reporting of Study 329,” International Journal of Risk & Safety in Medicine 20 (2008): 73-81.

A.S. Kesselheim , B. Wang , J. M Franklin , and J.J. Darrow , “Trends in Utilization of FDA Expedited Drug Development and Approval Programs, 1987-2014: Cohort Study,” BMJ 351 (2015): h4633.

N.S. Downing , N.D. Shah , J.A. Aminawung , A.M. Pease , J.-D. Zeitoun , H.M. Krumholz , and J.S. Ross , “Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010,” JAMA 317, no. 18 (2017): 1854–1863.

E. Pinnow , S. Amr , S.M. Bentzen , S. Brajovic , L. Hungerford , D.M. St. George , and G. Dal Pan , “Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved by the Food and Drug Administration Between 2002 and 2014,” Clinical Pharmacology & Therapeutics, 104, no. 2 (2017): 390-400.

FDA, Step 5: FDA Post-Marketing Drug Safety Monitoring, Jan. 4, 2018, available at <https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405579.htm> (last visited November 19, 2019).

See PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011).

Association for Accessible Medicines, 2018 Generic Drug Access & Savings Report, available at <https://accessiblemeds.org/resources/blog/2018-generic-drug-access-and-savings-report> (last visited November 19, 2019).

For a recent court decision, see In re Zimmer (Nexgen Knee Implant Products Liability Litigation), 884 F.3d 746 (7th Cir. 2018).

J. Avorn and W. Shrank , “Highlights and a Hidden Hazard — the FDA's New Labeling Regulations,” New England Journal of Medicine 354, no. 23 (2006): 2409-2411.