The Evolution of Unauthorized Agency Preemption

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The Evolution of Unauthorized Agency Preemption 

Complete immunity preemption in regulartory agencies timeline.

1997 | 2000 | 2002 | 2003 | 2004 | 2005 | 2006 | 2007 | 2008

*Denotes a key changes in the evolution of regulatory preemption in recent years.

 1997 – Margaret Porter, then Chief Counsel of the Food and Drug Administration (FDA), affirms agency’s belief that in enacting food and drug laws, Congress “did not intend to preempt state tort remedies for injury to individual consumers.”

2000 – The Supreme Court issues its decision in Geier v. Honda Motor Co., 529 U.S. 861 (2000). This was a fact-specific decision dealing with a seat belt standard issued by National Highway Traffic Safety Administration. While the Court found that the state law tort suit was preempted, it went to great lengths to show that this was a unique situation based on the intent of Congress.

*December 22, 2000 – The FDA issues its proposed rule changing the labeling requirements for prescription drugs. The preamble to the rule specifically states that the rule does not preempt State law. 65 Fed. Reg. at 81103.

March 25, 2002 – The FDA filed a brief in support of preemption in failure-to-warn cases in Dowhal v SmithKline Beecham Consumer, which challenged the FDA’s warning label on nicotine products under California’s Proposition 65. During a speech at the Washington Legal Foundation in March 2006, Dan Troy emphasized that this was the first time the FDA had filed a brief over preemption.

September 3, 2002 – The FDA filed a brief in support of Pfizer in Motus v. Pfizer, Inc, No. 02- 55372 (9th Circuit). This was the first of many briefs the agency would file in support of the pharmaceutical industry in lawsuits where the plaintiffs accused manufacturers of failing to warn of the increased risk of suicide while taking SSRI antidepressants.

September 5, 2002 – The FDA filed a brief in support of GlaxoSmithKline in In re Paxil Litigation, No. CV 01-07937. The plaintiffs sued the manufacturer over its claim that the antidepressant Paxil was non-habit forming. The FDA found this claim to be a threat to its regulation and weighed in on the side of the pharmaceutical industry.

July 18, 2003 – The FDA filed a second brief in Dowhal v. SmithKline Beecham. The lower court had agreed that the manufacturer could be held liable under California’s Proposition 65. SmithKline appealed to the California Supreme Court, prompting the agency to file its second brief in the case.

December 12, 2003 – The FDA filed its first failure-to-warn preemption brief in a medical device case with Murphree v. Pacesetter (Tenn.Cr.Ct., No. 005429-00-3).

May 14, 2004 – The FDA filed a brief in Horn v. Thoratec, No. 02-4597 (3rd Cir.), arguing that in cases where a medical device has received pre-market approval by the agency, state tort laws are preempted by the Medical Device Amendments to the Food Drug and Cosmetics Act.

*January 13, 2005 – For the first time in agency history, in the preamble to a new proposed rule regarding mattress flammability standards, the Consumer Product Safety Commission (CPSC) states that the rule preempts state tort law. Democratic CPSC Commissioner Thomas Moore issues a strong dissent. 70 Fed. Reg. at 2493. This rule takes effect March 15, 2006.

June 22, 2005 – The National Highway Traffic Safety Administration (NHTSA) issues a proposed rule regarding designated seating position that contains NHTSA’s first attempt to broadly preempt state common law claims. This rule went largely unnoticed by the public. 70 Fed. Reg. at 36101-02.

*August 19, 2005 – NHTSA issues a proposed rule on roof crush strength with a weak standard and a preamble that explicitly preempts all state law requirements and state tort law. 70 Fed. Reg. at 49223.

August 19, 2005 – NHTSA issues a proposed rule for average fuel economy standards for light trucks for 2008-11 with brief express and implied preemption language. 70 Fed. Reg. at 51457.

September 12, 2005 – NHTSA issues a proposed rule regarding rearview mirrors which seeks to preempt all state statutes, regulations, and common law. 70 Fed. Reg. at 53768-69.

September 15, 2005 – The FDA filed an amicus brief in Kallas v. Pfizer, No. 2:04CV0998 PGC (D. Utah). The FDA argued that Pfizer was not liable for the death of a 15-year old girl who shot herself while taking the anti-depressant Zoloft because the agency’s approval of the drug preempted failure-to-warn claims.

January 24, 2006 – In a complete reversal of its previous position, the FDA issues a final rule regarding prescription drug labeling, which contains a preamble that states the FDA intends its rule to preempt all state law requirements pertaining to a drug company’s obligation to warn the public of a drug’s potential side-effects. 71 Fed. Reg. at 3933-34. The labeling regulations take effect June 30, 2006.

March 29, 2006 – The FDA issues a final rule on dietary noncariogenic sweeteners with preemption language in the preamble that was not subject to notice and comment. 71 Fed. Reg. at 15563.

April 6, 2006 – NHTSA issues a final rule for average fuel economy standards for light trucks for 2008-11 with much more extensive preemption language in the preamble than was in the proposed rule. 71 Fed. Reg. at 17654-70.

May 10, 2006 – The FDA filed an amicus brief in Colacicco v. Apotex Corp., C.A. No. 05-5500- MMB (E.D. Pa.), asserting that agency approval of the drug preempted state failure-to-warn claims.

May 22, 2006 – The FDA issues a final rule on soluble dietary fiber with preemption language in the preamble that was not subject to notice or comment. 71 Fed. Reg. at 29250.

July 25, 2006 – The FDA issues a final rule on raw fruits, vegetables, and fish with preemption language in the preamble that was not subject to notice or comment. 71 Fed. Reg. at 42042.

August 1, 2006 – The FDA issues a final rule on over-the-counter nasal congestion medication with preemption language in the preamble that was not subject to notice and comment. 71 Fed Reg. at 43360.

August 29, 2006 – The FDA issued a proposed rule on skin bleaching drug products with preemption language in the preamble. 71 Fed. Reg. at 51153.

September 21, 2006 – The FDA filed an amicus brief in Perry v. Novartis Pharmaceuticals, No. 05-CV-5350 (E.D. Pa.) but did not take a position on preemption.

October 11, 2006 – The Federal Railroad Administration (FRA) issues a final rule regarding continuous welded rail with language in the preamble seeking to expand the preemption language in the Federal Rail Safety Act (FRSA) and it was not subject to notice and comment. 71 Fed. Reg. at 59690.

October 12, 2006 – The FRA issues a proposed rule regarding railroad operating standards which contains language in the preamble seeking to expand the preemption language in the FRSA to cover common law claims. 71 Fed. Reg. at 60382.

December 4, 2006 – The FDA filed its second brief in Colacicco v. Apotex Corp., No. 06-3107 (3rd Cir.) in support of preemption. The case was consolidated with a second failure-to-warn claim in an SSRI suicide lawsuit (McNellis v. Pfizer).

December 12, 2006 – The FDA includes what appears to be boilerplate preemption language in the preamble to its proposed rule regarding labeling of over-the-counter drugs. 71 Fed. Reg. at 74480-81.

December 13, 2006 – The FDA issues a final rule regarding the labeling of dietary supplements with preemption language that was not subject to notice or comment. 71 Fed. Reg. at 74790.

December 21, 2006 – The TSA issues a proposed rule regarding rail transportation security which includes preemption language in the preamble.  71 Fed. Reg. at 76878-79.

December 26, 2006 – The FDA issues a proposed rule that requires over-the-counter analgesics to include new warnings regarding potential risks which contain preemption language. 71 Fed. Reg. at 77345.

December 28, 2006 – The Department of Homeland Security (DHS) issues proposed chemical facility anti-terrorism regulations with extensive language seeking to preempt state tort law. 71 Fed. Reg. at 78292-93. DHS issues these regulations despite the short timeframe (statute requires regulations to be effective by April 4, 2007) and the fact that this preemption language was expressly rejected during the 109th Congress.

January 5, 2007 – The FDA issues a proposed rule on labeling claims regarding calcium which contain preemption language in the preamble. 72 Fed. Reg. at 516.

January 12, 2007 – The FDA issues a final rule that expanded use of the nutrient content claim “lean” on certain foods which contain preemption language in the preamble that was not subject to notice and comment. 72 Fed. Reg. at 1458.

*February 6, 2007 – NHTSA issues the first of many final rules regarding federal motor vehicle safety standards (door locks & door retention) which include boilerplate preemption language in the preamble that was not subject to notice and comment. 72 Fed. Reg. at 5397.

February 6, 2007 – The FDA issued a proposed rule on soluble fiber labeling which contains preemption language in the preamble. 72 Fed. Reg. at 52788.

March 6, 2007 – The FDA issues a final rule requiring over-the-counter dandruff products to contain a combination of 1.8% coal tar solution and 1.5 percent menthol. This rule contains preemption language in the preamble and was not subject to notice and comment. 72 Fed. Reg. at 9851.

March 29, 2007 – The FDA issues a final rule on over-the-counter laxatives with preemption language in the preamble that was not subject to notice and comment. 72 Fed. Reg. at 14673.

April 6, 2007 – NHTSA issues a final rule on electronic stability control which includes boilerplate preemption language in the preamble that was not subject to notice and comment. 72 Fed. Reg. at 17300.

April 9, 2007 – DHS issues interim final rules regarding chemical facilities, which continued to contain preemption language, despite outrage from Congress. Congress addressed this problem through the use of appropriations bills.

May 4, 2007 – NHTSA issues a final rule on head restraints which includes boilerplate preemption language in the preamble that was not subject to notice and comment. 72 Fed. Reg. at 25512.

July 12, 2007 – NHTSA issues a final rule on tire pressure monitoring which includes boilerplate preemption language in the preamble. This language was not subject to notice and comment and was not included when the earlier version of the final rule was issued two years ago. 72 Fed. Reg. at 38023-24.

July 24, 2007 – NHTSA issues a final rule on occupant crash protection which includes boilerplate preemption language in the preamble that was not subject to notice and comment. 72 Fed. Reg. at 40257.

July 27, 2007 – Congress passes legislation implementing the 9/11 Commission’s recommendations. This legislation includes anti-preemption language to clarify that the Federal Rail Safety Act (FRSA) does not preempt an individual’s right to hold a negligent railroad accountable for injuries resulting from a train derailment.

August 1, 2007 – The Federal Railroad Administration issues proposed rules regarding passenger equipment safety standards, which include a preamble with language seeking to preempt state tort law. 72 Fed. Reg. at 42036. This would essentially undo the progress that Congress made in interpreting the FRSA.

August 27, 2007 – The FDA issues a proposed rule regarding changes to the labels for sunscreen, which contains preamble language seeking to preempt state tort law. 72 Fed. Reg. at 49109.

September 4, 2007 – The FRA issues proposed rules regarding electronically controlled pneumatic brake systems, which include a preamble with language seeking to preempt state law. 72 Fed. Reg. at 50848-49.

September 5, 2007 – NHTSA issues a final rule regarding side impact protection which includes boilerplate preemption language in preamble that was not subject to notice and comment. 72 Fed. Reg. at 50905.

September 11, 2007 – NHTSA issues a final rule regarding side impact protection for electric powered vehicles which includes boilerplate preemption language in preamble that was not subject to notice and comment. 72 Fed. Reg. at 51953.

September 12, 2007 – Senate Judiciary Committee holds hearing titled: "Regulatory Preemption: Are Federal Agencies Usurping Congressional and State Authority?"

September 17, 2007 – The FDA issues an interim final rule on dietary sweeteners with preemption language in the preamble. 72 Fed. Reg. at 52788.

September 25, 2007 – NHTSA issues a proposed rule regarding changes to its occupant protection standards which includes boilerplate preemption language. 72 Fed. Reg. at 54409.

October 9, 2007 – NHTSA issues a proposed rule regarding standards for electric-powered vehicles which includes boilerplate preemption language. 72 Fed. Reg. at 57265.

October 9, 2007 – NHTSA issues a proposed rule regarding brake hoses which includes boilerplate preemption language. 72 Fed. Reg. at 57468.

November 2, 2007 – NHTSA issues a final rule regarding occupant crash protection which includes boilerplate preemption language in the preamble that was not subject to notice and comment. 72 Fed. Reg. at 62139.

November 21, 2007 – NHTSA issues a proposed rule regarding school bus passenger seating and crash protection which includes boilerplate preemption language. 72 Fed. Reg. at 65525.

November 27, 2007 – The FDA issues a proposed rule on fatty acids with preemption language in the preamble. 72 Fed. Reg. at 66116.

December 4, 2007 – NHTSA issues a final rule regarding cargo carrying capacity which includes boilerplate preemption language in the preamble that was not subject to notice and comment. 72 Fed. Reg. at 68458.

December 4, 2007 – NHTSA issues a final rule regarding lamps, reflective devices, and associated equipment which includes boilerplate preemption language in the preamble that was not subject to notice and comment. 72 Fed. Reg. at 68265.

December 19, 2007 – The FDA issues a final rule establishing new warning statements and other labeling information for over-the-counter contraceptives with preemption language in the preamble that was not subject to notice and comment. 72 Fed. Reg. at 71783.

December 20, 2007 – NHTSA issues a proposed rule regarding platform lifts for motor vehicles which includes boilerplate preemption language. 72 Fed. Reg. at 72335.

January 16, 2008 – FDA issues a proposed rule regarding supplemental applications proposing labeling changes for approved drugs, biologics, and medical devices. This rule would effectively preempt failure to warn claims despite clear congressional intent, particularly regarding drug labeling. 73 Fed. Reg. at 2848.

January 23, 2008 – NHTSA issues a proposed rule regarding child restraint systems which includes boilerplate preemption language. 73 Fed. Reg. at 3911.

January 30, 2008 – NHTSA issues a supplemental NPRM regarding roof crush resistance which continues to preempt state tort law. 73 Fed. Reg. at 5491.

February 1, 2008 – The FDA issues a final rule on skin protectant drug products with preemption language in the preamble that was not subject to notice and comment. 73 Fed. Reg. at 6016.

February 13, 2008 – The FRA issues a final rule on railroad operating rules and responds to AAJ’s comments. The FRA reiterates the language in the Railroad Preemption Clarification, which they claim renders AAJ’s comments moot. 73 Fed. Reg. 8456.

February 20, 2008 – United States Supreme Court issues decision in Riegel v. Medtronic, stating that federal law preempts medical device claims.

February 25, 2008 – The FDA issues an interim final rule on soluble fiber with preemption language in the preamble. 73 Fed. Reg. at 9944.

April 1, 2008 – The FRA/ Pipeline Hazardous Materials Safety Administration jointly issue a proposed rule to improve the crashworthiness protection of railroad tank cars designed to transport hazardous materials with preemption language in the preamble. 73 Fed. Reg. at 17852.

April 16, 2008 – The FRA/ Pipeline Hazardous Materials Safety Administration jointly issue an interim final rule enhancing rail transportation safety with preemption language in the preamble. 73 Fed. Reg. at 20755.

April 21, 2008 – NHTSA issues its proposed rule regarding average fuel economy standards for passenger cars and light trucks for 2011-15. While the rule does not expressly state that it will preempt state tort law, it clearly preempts state regulations and prohibits a state from adopting or enforcing a law or regulation related to fuel economy, which could include the use of a court order. The rule also states that the agency has decided to ignore previous court rulings that did not support the preemption of state laws on this issue. 73 Fed. Reg. at 24478-79.

May 1, 2008 – The FDA publishes its final rule regarding labeling for soluble fiber which contains preemption language. 73 Fed. Reg. at 23952. This document also includes the Administration’s first reference to the Riegel v. Medtronic decision.

May 28, 2008 – The FDA publishes its final rule regarding labeling for dietary sweeteners which contains preemption language. 73 Fed. Reg. at 30301. This document also references the Riegel v. Medtronic decision.

May 29, 2008 – The FDA publishes its proposed rule regarding requirements for pregnancy and lactation labeling which contains preemption language. 73 Fed. Reg. at 30831.

June 9, 2008 – NHTSA publishes a final rule/response to petitions for reconsideration of its earlier rule regarding side impact protection, to which AAJ had filed a petition for reconsideration. NHTSA directly responded to the petitions from several automakers, but the agency did not respond to AAJ. The same preemption language was included in this version. 73 Fed. Reg. at 32481.

June 16, 2008 – The FRA issues its final rule regarding railroad operating practices (first noticed in October 2006), which contains preemption language. 73 Fed. Reg. at 33900.

July 7, 2008 – NHTSA publishes its proposed rule regarding requirements for windshield zone intrusion which contains boilerplate preemption language. 73 Fed. Reg. at 38373.

July 7, 2008 – NHTSA publishes a final rule (with responses to petitions for reconsideration) regarding power-operated windows, partitions, and roof-panel systems. 73 Fed. Reg. at 38338.

*August 5, 2008 – NHTSA publishes a final rule on child restraint systems. The SNPRM on this issue contained boilerplate preemption language, and AAJ filed comments. For the first time in the last year and a half, NHTSA’s finally deviated from its boilerplate language preempting state tort law. Instead, the agency went back to using the language it has used prior to 2005, stating that the rule did not have any impact on State and local governments. 73 Fed. Reg. at 45357.

August 15, 2008 – The FDA issues a final rule regarding soluble fiber labeling which contains preemption language and also references the Riegel decision.  73 Fed. Reg. at 47829.

August 22, 2008 – The FDA issues a final rule regarding supplemental application used to proposed labeling changes for drugs and medical devices which continues to contain language in the preamble to preempt state law claims.  73 Fed. Reg. at 49609.  The text of the rule also may operate to preempt failure to warn claims, because the manufacturer can now argue it had no obligation to update its rule.

August 28, 2008 – NTHSA issues its revised final rule regarding lamps, reflective devices, and associated equipment.  While the agency acknowledged that AAJ filed a petition for reconsideration, the agency only decided to extend the effective date upon reconsideration.  The agency also says the boilerplate preemption language from the previous version still applies.  73 Fed. Reg. at 50730.

September 9, 2008 – Although it is after the White House’s proposed “deadline” for proposed rules, the FRA issues a proposed rule regarding incident reporting requirements, which contains a new iteration of its previous language preempting state tort law.  73 Fed. Reg. at 52519. 

September 12, 2008 – NHSTA issues a proposed rule removing the sunset provision for occupant crash requirements which contains boilerplate preemption language.  73 Fed. Reg. at 52941.

September 17, 2008 – NHTSA issues a proposed rule regarding motorcycle brake systems which contains boilerplate preemption language.  73 Fed. Reg. at 54034.

September 22, 2008 – NHTSA issues a final rule regarding electronic stability control systems which says that preemption is a matter for the courts to decide.  73 Fed. Reg. at 54536.

October 2, 2008 – NHTSA issues a proposed rule regarding motorcycle helmets which contains boilerplate preemption language.  73 Fed. Reg. at 57297.

October 8, 2008 – NHTSA issues a final rule regarding designated seating positions.  In response to comments regarding the preamble to its proposed rule, NHTSA included language in both the text and the preamble to rule regarding the preemption of State tort law.  This is the first time that any agency has taken this action.  73 Fed. Reg. at 58894.

October 16, 2008 – FRA issues a final rule regarding electronically controlled pneumatic brake systems.  FRA responds to AAJ’s comments and claims there is “no clear authorization of a common law tort action alleging a violation of those aspects of such an internal plan, rule, or standard related to the subject matter of this regulation that exceed the minimum required by the Federal regulation or order.”  73 Fed. Reg. at 61551.

October 21, 2008 – NHTSA issues a final rule regarding school bus passenger seating and crash protection which contains boilerplate preemption language.  73 Fed. Reg. at 62777-78.

October 28, 2008 – FDA issues its final rule regarding the availability of a toll-free number on product labeling to facilitate reporting of adverse events.  This rule contains an extensive preemption discussion in the preamble.  73 Fed. Reg. at 63896-97.

November 12, 2008 – NHTSA issues its final rule updating the Appendix A for its occupant crash protection standard.  It contains boilerplate preemption language.  73 Fed. Reg. at 66796.


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