Pharma Use of FDA Approval as a Shield Against State Tort Liability: How Does the Shield Stand Today?

The purpose behind the U.S. Food and Drug Administration’s (“FDA”) power to regulate pharmaceuticals is at odds with pharmaceutical companies’ use of FDA approval shields against state tort liability.

The FDA was given regulatory power under the 1938 Food, Drug, and Cosmetic Act, to prevent public harm from mislabeled drugs. [1] As a measure against mislabeling, the FDA requires pharmaceutical companies to complete a New Drug Application (“NDA) to introduce a drug to the consumer market. [2] The FDA itself does not test the “new drugs,” but relies on pharmaceutical companies to submit their own scientific test results as a part of the NDA. [3] To protect FDA’s regulatory power, the Supreme Court in Buckman determined that state “fraud-on-the-FDA” claims were preempted by federal law because they conflicted with the FDA’s ability to police fraud on its own. [4] In effect, some federal courts have broadly interpreted the opinion in Buckman to mean that FDA approval of NDAs acts as a complete shield for pharmaceutical companies against state tort liability. [5] While the purpose of the FDA’s power to regulate is to protect the public from dangerous food and drugs, the “FDA Shield” interferes with recognized state power to use common law tort claims to protect the health and safety of their citizens.

In Desiano v. Warner-Lambert & Co., the Second Circuit of the United States Court of Appeals interpreted the FDA shield in Buckman as a narrow application of immunity for pharmaceutical companies in state tort suits. [6] The Second Circuit reasoned that Buckman’s preemption of state tort claims applied only to claims that form liability solely on the grounds of fraud against the FDA. [7] The Second Circuit acknowledged that the role of “state regulation [in] matters of health and safety” should only be restricted if it interferes with statutory duties of federal agencies. [8] Essentially, the decision upheld the ability of consumers to make product liability claims against pharmaceutical companies in state court as long as the claim was based on state common law.  Nonetheless, pharmaceutical liability at the state level is still an issue among federal courts.

The decision in Desiano was controversial because it conflicted with the Sixth Circuit’s interpretation of Buckman in Garcia v. Wyeth-Ayerst Labs, 385 F.3d 961 (6th Cir. 2004). Since the Desiano and Garcia decisions disagreed about the tension between federal agency duties and Michigan’s pharmaceutical immunity statute, it is essential to know which authority controls for future litigation.  It was expected that the Supreme Court was to clear the discrepancy when it issued a writ of certiorari for an appeal of Desiano, but the Court simply affirmed the judgment with no written opinion. [9].

Without clarification from the Supreme Court, a degree of uncertainty still lingers among the Circuits on the particular issue. Desiano, at least, recognized the utility of permitting drugmakers to be accountable for consumer injuries at the state level. [10] Legal accountability is a large step for many consumers injured by defective drugs.

FDA processes and uncertainties within the judicial system are the subject of much legal ambiguity.  Consumers rely on legal accountability to protect from dangerous and fraudulently advertised pharmaceuticals.  While the FDA’s regulatory power was created with the intent to protect the public, the FDA’s drug application processes are susceptible to allowing situations where consumers are exposed to dangerous products.  Pharmaceutical companies submit their own scientific studies for new drugs to the FDA.  The bias of the self-submitted scientific studies can become obvious when profit projections for particular drugs become a part of the logical analysis.  In addition, FDA approval shields remove accountability from pharmaceutical companies.  If pharmaceutical companies are not forced to compensate for consumer injuries, it is hard to imagine who can be held responsible for damages caused by incomplete or misleading scientific research.  It seems unjust to force a consumer to pay for injuries caused by misleading information. Overall, it is unclear how the FDA approval shield stands in today’s legal system.  But it can certainly be argued that clarification is needed.


[1] About FDA, U.S Food and Drug Administration,

[2] How Drugs are Developed and Approved, U.S Food and Drug Administration,

[3] Id.

[4] Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001).

[5] Desiano v. Warner-Lambert & Co., 467 F.3d 85, 88 (2d Cir. 2006).

[6] Id.

[7] Id. at 98.

[8] Id.

[9] Warner-Lambert & Co. v. Kent, 552 U.S. 440 (2008), see also Bruce Patsner, Does FDA Approval of a Drug Completely Shield the Pharmaceutical Manufacturer from Tort Liability in State Court? U.S. Supreme Court to Decide (2007),

[10] Desiano, 467 F.3d at 96.