CHAPTER § 9.06 State Product Liability Acts' Exemption of FDA-Approved Products

• Jurisdiction: United States

§ 9.06 State Product Liability Acts' Exemption of FDA-Approved Products

In some cases, federal preemption may not be the only avenue of dismissal available to manufacturers of prescription drugs and medical devices. A number of states have enacted legislation that provides various levels of protection to manufacturers of FDA-approved products. Michigan provides the greatest protection to prescription-drug manufacturers by immunizing the manufacturers from liability for personal injuries allegedly caused by FDA-approved pharmaceuticals.⁴⁴² The Michigan statute provides only two exceptions to the grant of immunity: (1) where the manufacturer intentionally withholds certain information from, or misrepresents such information to, the FDA, and the FDA would not have approved the drug or would have withdrawn approval had it been fully informed; or (2) where the manufacturer bribes an FDA official for the purpose of obtaining approval of the drug.⁴⁴³ Although the statute has been challenged on state constitutional grounds, the Michigan Supreme Court has upheld the validity of the statute.⁴⁴⁴ As such, prescription-drug manufacturers facing liability in Michigan are armed with "an absolute defense."⁴⁴⁵ This defense has proven to be a high hurdle for plaintiffs to clear.⁴⁴⁶

Although Michigan is the only state to effectively prohibit lawsuits against manufacturers of allegedly defective drugs, a number of other states have enacted statutes that create a rebuttable presumption that a manufacturer is not liable for injuries caused by an allegedly defective product if that product has received FDA approval.⁴⁴⁷ Still other states prohibit an award of punitive damages where a drug or device has been approved by the FDA.⁴⁴⁸

One issue that has been the subject of much debate is whether Buckman preempts a plaintiff's attempt to rebut the presumptions available in Michigan and other states.⁴⁴⁹ As discussed earlier in this textbook,⁴⁵⁰ the U.S. Supreme Court in Buckman made clear that claims for purportedly withholding information from FDA—i.e., "fraud-on-the-FDA" claims—are impliedly preempted under traditional conflict preemption principles.⁴⁵¹

Several courts have found that Buckman effectively precludes plaintiffs from rebutting the presumption of immunity afforded by several of the state statutes cited above. For example, the Sixth Circuit found that preemption invalidates the "fraud-on-the-FDA" exception to Michigan's immunity statute.⁴⁵² The Fifth Circuit reached the same result with respect to a Texas statute.⁴⁵³ The Second Circuit, however, reached the opposite result in addressing the very same Michigan statute interpreted by the Sixth Circuit.⁴⁵⁴

The Supreme Court came close to resolving the issue in 2008 after granting certio-rari to resolve the split between the Second and Sixth Circuits.⁴⁵⁵ Due to Justice Rob-erts's recusal from the case, however, the Court was unable to reach a majority and the circuit split remains.⁴⁵⁶

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Notes:

^[442] Mich. Comp. Laws Ann. § 600.2946(5) ("In a product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer is not liable, if the drug was approved for safety and efficacy by the [FDA], and the drug and its labeling were in compliance with the [FDA's] approval at the time the drug left the control of the manufacturer or seller.").

^[443] Mich. Comp. Laws Ann. § 600.2946(5)(a) & (b).

^[444] See Taylor v. SmithKline Beecham Corp., 658 N.W.2d 127 (Mich. 2003) (upholding...