Chapter 4.F.3: Drugs, Devices, and Products Liability

Supplemental Bibliography

Notes: Products Liability for Defective Drugs and Devices

Note 1. Mass Torts

On mass torts, see Frank M. McClellan, The Vioxx Litigation: A Critical Look at Trial Tactics, the Tort System, and the Roles of Lawyers in Mass Tort Litigation, 57 DePaul L. Rev. 509 (2008); Jonathan Van O’Steen, The FDA Defense: Vioxx and the Argument Against Federal Preemption of State Claims for Injuries Resulting from Defective Drugs, 48 Ariz. L. Rev. 67 (2006); Michael D. Green, Bendectin and Birth Defects: The Challenges of Mass Toxic Substances Litigation (1996).

Note 4. The Learned Intermediary Doctrine

On the learned intermediary rule and DTC exceptions, see 57 A.L.R.5th 1 (Originally published in 1998); Note, 48 Jurimetrics J. 285 (2008); Richard C. Ausness, Will More Aggressive Marketing Practices Lead to Greater Tort Liability for Prescription Drug Manufacturers?, 37 Wake Forest L. Rev. 97 (2002); Jack Karns, Direct Advertising of Prescription Drugs: The Duty to Warn and the Learned Intermediary Rule, 3 DePaul J. Health Care L. 273 (2000).

Note 6. Computerized Medicine and Artificial Intelligence

For analysis of developing issues in AI and products liability, see Frank Griffin, Artificial Intelligence and Liability in Health Care, 31 Health Matrix 65 (2021); Benny Chan Applying a Common Enterprise Theory of Liability to Clinical AI Systems. 47 Am. J. L. & Med. 351 (2021); Gary E. Marchant and Lucille M. Tournas, AI Health Care Liability: From Research Trials to Court Trials, 18 J. Health Life Sci. L 25 (2019);  Karni A. Chagal-Feferkorn, Am I an Algorithm or a Product? When Products Liability Should Apply to Algorithmic Decision-Makers, 30 Stanford. L. & Pol’y Rev. 61 (2019).

Note 7. Federal Preemption

For more on FDCA preemption of state law products liability claims, see J. David Prince, The Puzzle of Parallel Claims, Preemption, and Pleading the Particulars, 39 Wm. Mitchell L. Rev. 1034 (2013); Richard Epstein, What Tort Theory Tells Us About Federal Preemption: The Tragic Saga of Wyeth v. Levine, 65 N.Y.U. Ann. Surv. Am. L. 485 (2010); Richard L. Cupp, Jr., Preemption’s Rise (and Bit of a Fall) as Products Liability Reform, 74 Bklyn. L. Rev. 727 (2009); Symposium, 32 Hamline L. Rev. 657 (2009); Catherine M. Sharkey, What Riegel Portends for FDA Preemption of State Law Products Liability Claims, 103 Nw. U. L. Rev. 437 (2009); Mary J. Davis, The Battle over Implied Preemption: Products Liability and the FDA, 48 B.C. L. Rev. 1089 (2007); William Dreier, Liability for Drug Advertising, Warnings, and Frauds, 58 Rutgers L. Rev. 615 (2006); Richard Ausness, Should the Courts Defer to the FDA’s New Interpretation of the Medical Device Amendments?, 80 Tul. L. Rev. 727 (2006); Annot., 98 A.L.R. Fed. 124 (1990).
 

Supplemental Substantive Materials

Review Problem: Products Liability

Based on what you’ve learned in this chapter, how would you evaluate the potential liability of the manufacturer and/or the physician in each of the following situations? What public policy perspectives would support liability or nonliability in each situation?

  1. To treat a patient with cardiac arrhythmia, physician surgically implants a pacemaker that uses electrical pulses to regulate the patient’s heartbeat. Before surgery, the physician fails to ascertain that the pacemaker is fully functional. During the patient’s recovery in the hospital, the pacemaker malfunctions and the patient suffers a cardiac arrest.
  2. With FDA approval, a manufacturer markets a powerful new chemotherapy drug for treatment of kidney cancer. The package insert warns that the drug is not intended to be used for treatment of any other cancer. A physician treating a patient with pancreatic cancer (which has an extremely dim prognosis using standard treatments) decides to use the new drug off-label. The physician secures generic, routine informed consent from the patient (“We’ll be treating you with various chemical agents that have a significant risk of toxic side effects, including death”), but does not tell the patient that the drug is not intended for pancreatic cancer. The drug’s toxic effects kill the patient. 
  3. Korkafine is a widely used over-the-counter drug for allergies that the manufacturer markets under the brand name Snuffle. Manufacturer advertises Snuffle both to the public and also directly to physicians (since many people consult physicians about their allergies). After five years on the market, it is discovered that patients who take korkafine and also regularly eat blueberries can occasionally suffer mild hair loss due to a bizarre chemical reaction. After some deliberation, the FDA allows the drug to remain on the market as long as the manufacturer adds a new warning to the package and in any written promotional materials. Three years later, a 65-year old blueberry farmer who uses Snuffle to combat seasonal allergies every spring (on his doctor’s recommendation) sues the manufacturer when he begins to experience significant hair loss.