For sufferers of the side-effects of dangerous drugs and medical devices, the journey to justice and seeking compensation for injuries is not always a straightforward one. Unfortunately, some claims for injury can be thwarted at the very outset due to a complex legal policy enshrined in Article VI of the U.S. Constitution – the “Supremacy Clause”. Known as the “Preemption Doctrine” it shields some manufacturers of approved drugs and devices from liability arising from the claims of victims.
What is Preemption?
“Preemption” describes the legal basis for dismissal of a claim under state law where the courts hold that federal law reigns supreme and invalidates state law. In essence, where state laws run contrary to or otherwise interfere with federal law, the federal will preempt the state law thereby excluding those claims.
How Does Preemption Apply to Drug and Device Manufacturers?
Prescription Drugs and Medical Devices are regulated under a federal law known as the Food, Drug and Cosmetic Act (FDCA). The U.S. Food and Drug Administration (FDA) is charged with primary enforcement responsibility and to regulate drug and device manufacturers under the FDCA. To that end, the FDA has created an elaborate “pre-market approval” process designed to examine the safety and effectiveness of drugs and medical technology covered by the law. Over the past two decades, the existence of the FDCA has been used by drug and device manufacturers to argue that they cannot be sued on claims arising under state law.
When Does Preemption Become a Factor?
Preemption usually crops up as a defense by drug and device manufacturers against claims for injury made under state law. Manufacturers will point to the state law claims and say that because their products are regulated by the FDA and have gone through the federal “pre-market approval” process, they should be shielded from state law claims. And sometimes this strategy works – preemption does prevent some sufferers from mounting an effective case in court. But as the U.S. Supreme Court has ruled over the past two decades, preemption can’t stop every drug and device case and that is an important distinction for sufferers of side effects from dangerous drugs and devices.
Medical Device Lawsuits and Preemption
The FDCA sets down a detailed set of rules and standards which are designed to ensure that approved medical devices are safe and effective (the pre-market approval process). Part of the pre-market approval process involves certification and testing to make certain each submitted device meets minimum requirements before it is marketed to consumers and the healthcare industry in the United States. It goes without saying that the medical device pre-market approval process is rigorous, detailed and lengthy. Furthermore, the FDCA creates an explicit preemption rule for medical devices which have done through pre-market approval.
However, not every medical device is subjected to this rigorous process. Many medical devices on the market today and which have been implanted in patients throughout the United States can bypass the more detailed pre-market process and opt instead for the “Pre-Market Notification” or Section 510(k) Process. Essentially, these devices can avoid layers of FDA scrutiny and go straight into use.
With this in mind, the U.S. Supreme Court has made at least two critical rulings about the preemption defense and its use:
510(k) Approval Does Not Shield the Manufacturer – Medtronic v. Lohr:
In 1990, Lora Lohr’s Medtronic pacemaker failed, allegedly according to a defect. Lohr and her spouse filed a Florida state-court suit, alleging both negligence and strict-liability claims. The device at the center of Lohr’s claims made it to market through the markedly less rigorous 510(k) process. The state court dismissed Lohr’s claims ruling they were preempted. However, on appeal in 1996, the U.S. Supreme Court reversed the lower court and established that medical devices that go through the 510(k) process, instead of the more rigorous pre-market process, cannot hide behind a preemption defense.
Premarket Approval Preempts – Riegel v. Medtronic:
During Charles Riegel’s angioplasty, his surgeon used an Evergreen Balloon Catheter to dilate his coronary artery. The catheter burst, causing extreme complications. Riegel sued the manufacturer, Medtronic, for negligence in the design, manufacture, and labeling of the device. Lower courts agreed with Medtronic that the corporation was shielded from Riegel’s state claims because the device in question was subjected to the more rigorous pre-market approval process and therefore enjoyed an explicit preemption defense under the federal law. The U.S. Supreme Court later affirmed this ruling.
Pharmaceutical Drugs and Preemption
Under the FDCA and subsequent amendments to the law, drug manufacturers have to file a New Drug Application (NDA) with the FDA before marketing a new drug. This NDA must contain detailed information about the drug’s composition, safety and effectiveness. The FDA will not approve a new drug if it finds that the drug is unsafe or ineffective – for use under the conditions prescribed, recommended or suggested on the label. Once approved, drug manufacturers must continue to monitor and report anything about the drug’s use which would compromise its safety, effectiveness or labeling.
Under the FDCA and subsequent amendments to the law, drug manufacturers have to file a New Drug Application (NDA) with the FDA before marketing a new drug. This NDA must contain detailed information about the drug’s composition, safety and effectiveness. The FDA will not approve a new drug if it finds that the drug is unsafe or ineffective – for use under the conditions prescribed, recommended or suggested on the label. Once approved, drug manufacturers must continue to monitor and report anything about the drug’s use which would compromise its safety, effectiveness or labeling.
Unlike medical devices, however, drugs do not enjoy an explicit presumption of preemption under the FDCA. And this has led to a range of divergent court opinions over the years.
Approved Drug Label Does Not Shield the Manufacturer – Wyeth v. Levine
Diane Levine had Phenergan, a drug made by Wyeth and used to prevent allergies and motion sickness, intravenously injected into her arm, and complications arising from the injection eventually led to the amputation of her arm. Ms. Levine sued Wyeth asserting that the company failed to include a warning label describing the possible arterial injuries that could occur from negligent injection of the drug. Wyeth argued that because their warning label had been deemed acceptable by the FDA, a federal agency, any Vermont state regulations making the label insufficient were preempted by the federal approval. The U.S. Supreme Court agreed with Ms. Levine asserting that the Wyeth bore ultimate responsibility for the content of its labels – at all times. The Court also rejected Wyeth’s preemption argument and reasoned that Congress did not intend to preempt state-law in failure to warn actions when it created the FDCA.
Generic Drugs Distinguished from Brand-Name Drugs – PLIVA v. Mensing
Gladys Mensing took the drug metoclopramide for four years to help fight diabetic gastroparesis. She filed a lawsuit against the generic drug’s manufacturers and distributors, contending that the drug gave her a severe neurological movement disorder, tardive dyskinesia, but none of the generic drug’s manufacturers and distributors made any effort to include warnings on the label. The manufacturers of this generic labeled drug claimed that Ms. Mensing’s claims were preempted under federal law. A lower court and the U.S. Supreme Court agreed with the drug manufacturers on the basis that generic drugs are manufactured under a label submitted by another manufacturer. To require generic drug manufacturers to change that label would result in a violation of federal law. A subsequent case: Mutual Pharmaceutical v. Bartlett extended this preemption shield on generic drugs further by also preempting claims other than “Failure to Warn”.
Sources Cited (13)
1. “Preemption of Drug and Medical Device Claims: A Legal Overview”, Congressional Research Service Report, September 2013. https://www.everycrsreport.com/reports/R43218.html#_Toc366593212
2. “Federal Preemption 19”, Richard A. Epstein and Michael S. Greve (2007).
3. “Unmasking the Presumption in Favor of Preemption”, Mary J. Davis, 53 S.C. L. Rev. 967 (2002) https://uknowledge.uky.edu/cgi/viewcontent.cgi?article=1270&context=law_facpub
4. “The Tort Liability Insurance System and Federalism: Everything in its Own Time”, Roger C. Henderson, 38 Ariz. Law Review 953 (1996). https://heinonline.org/HOL/LandingPage?handle=hein.journals/arz38&div=48&id=&page=
5. “Economic Analysis of Accident Law 298”, Steven Shavell (1987). https://www.jstor.org/stable/j.ctvjghx2b
6. “The Economic Structure of Tort Law 9-12”, William M. Landes & Richard A. Posner (1987). https://digitalcommons.law.yale.edu/cgi/viewcontent.cgi?article=5216&context=fss_papers
7. “Orphan Drugs: The Question of Products Liability”, Susan F. Scharf, 10 Am.J.L. and Med. 491 (1985). https://heinonline.org/HOL/LandingPage?handle=hein.journals/amlmed10&div=34&id=&page=
8. “The Products Liability Resource Manual 135”, James T. O’Reilly and Nancy C. Cody (1993).
9. “The Fall of the Citadel (Strict Liability to the Consumer)”, William L. Prosser, 50 Minn. L. Rev. 791 (1966). https://scholarship.law.umn.edu/cgi/viewcontent.cgi?article=3558&context=mlr
10. “The Battle of Implied Preemption: Products Liability and the FDA”, Mary J. Davis, 48 B.C. Law Rev. 1089 (2007). https://uknowledge.uky.edu/law_facpub/44/
11. “Federalism in Action: FDA Regulatory Preemption in Pharmaceutical Cases in State Versus Federal Courts”, Catherine M. Sharkey, 15 J.L. & Pol’y (2007). https://brooklynworks.brooklaw.edu/jlp/vol15/iss3/19/?utm_source=brooklynworks.brooklaw.edu%2Fjlp%2Fvol15%2Fiss3%2F19&utm_medium=PDF&utm_campaign=PDFCoverPages
12. “Does the U.S. Constitution Constrain State Products Liability Doctine?”, Lars Noah, 92 Temple L. Rev. (2019). https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3238093
13. “A Shift in the Preemption Landscape?”, Douglas G. Smith, Tennesee Law Review (2019). https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3406918
Tracy Everhart
Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.