Focus on facts to defeat preemption: while preemption is primarily a question of law, factual evidence about a federal agency's action or inaction can help plaintiffs defeat a motion to dismiss.

Until recently, a motion to dismiss on federal preemption grounds was rare. But efforts by the Bush administration to push preemption as a way of accomplishing its stated goal of tort "reform" have changed the legal landscape. (1) Increasingly, plaintiff lawyers are finding they must master arguments against preemption to prevail in their clients' cases.

In one of the administration's bolder moves, the FDA last year inserted language in the preamble of a new prescription drug labeling rule saying that any state tort law concerning prescription drug labeling was preempted by the rule. (2) Most recently, however, in a letter brief to a Pennsylvania district court that was hearing a challenge to the preemption claim, the FDA conceded that not all failure-to-warn cases are preempted. It argued instead that "a court must ask whether the warning sought by the plaintiff would have rendered the drug misbranded in the agency's judgment at the relevant time, or if any newwarnings proposed to be added to the warning label would have been rejected by the agency as unsubstantiated." (3)

The administration is targeting more than one area of state tort law. It is using regulatory agencies to establish the federal preemption defense across the board. For example,

   Over the past few years, the Office of the
   Comptroller of the Currency has issued a
   variety of rules that purport to preempt
   state consumer protection laws with respect
   to banking. Over the past several months,
   the National Highway Traffic Safety Administration
   [NHTSA], in conjunction with
   two notices concerning proposed safety
   standards for cars, has stated that the new
   standards would preempt state product liability
   law. And in February [2006], the Consumer
   Product Safety Commission [CPSC]
   issued a mattress flammability standard that
   purports to preempt state tort law. (4)

The preemption attack typically comes in the form of a motion to dismiss or for summary judgment. It is a win-win proposition for the defendant. If the attack fails, the defendant has lost nothing--it is simply in the same position it was before filing the motion. And if the attack succeeds, the defendant avoids having to submit to potentially damaging discovery or, more significant, any rulings on the merits of the plaintiff's claims.

This defense tactic has the added benefit of possibly obtaining a ruling in which the court transfers responsibility to adjudicate state law claims to the federal agency. For example, recently Judge Charles Breyer of the Northern District of California, accepting the FDA's statement that its approval of prescription drug labels preempts state failure-to-warn claims, stated: "The FDA is in a better position than the court to determine whether state laws that encourage manufacturers to propose defensive labels upset the FDA's careful balance of statutory objectives." (5)

Plaintiffs should still argue that federal law does not preempt their state law claims as a matter of law, but now the argument may need to be strengthened by factual evidence--of what a federal agency did or failed to do--gleaned through discovery to help plaintiffs defeat preemption claims. For example, it is appropriate to argue that a preemption motion raises factual questions on which discovery is necessary when a defendant is seeking dismissal based on "conflict preemption"--that a federal agency has allegedly considered and rejected the specific claim the plaintiff is making.

The U.S. Supreme Court, in rejecting a conflict preemption defense, held that a federal agency's consideration and rejection of a safety standard is not the same as the agency mandating a specific safety standard. (6) Accordingly, through discovery, you can obtain the evidence necessary to establish that the federal agency did not mandate a specific safety standard, and thus conflict preemption does not apply.

Defendant manufacturers usually recite factual information to convince the court that a federal agency has already fully considered the plaintiff's alleged safety risk (and not required a stronger warning or a product recall) or the plaintiff's claim of false or misleading advertising (and found it not to be so). The defense argues that any court ruling in the plaintiff's favor would conflict with the agency's "determination," and therefore the claim is preempted.

The factual information that the defense relies on in making its case for conflict preemption is fertile ground for discovery of facts showing that an agency knew of an alleged safety risk when it made its "determination," but failed to protect the public from that risk. The goal is to show that the defendant's characterization of the regulatory history is untrue and that, therefore, the agency's "determination" should be accorded no deference.

For example, a defendant's briefs and evidence in support of motions to dismiss or for summary judgment may reference specific events and dates that can help you focus discovery against both the defendant and the agency. Examining what action the agency took--or failed to take, even when its own scientists documented a safety risk--is much faster and easier than reviewing, for example, the typically massive New Drug Application for a particular drug.

Plaintiff lawyers cannot afford to wait to begin discovery until they get hit with a motion to dismiss. Aggressive efforts to obtain relevant agency documents and identify key players should begin even before filing suit, if possible.

Early in the case, study the history of the applicable regulations, particularly the dates of legislative amendments. Get to know the names of scientists who have spoken out against agency action or inaction. Research the backgrounds of key regulators, including those who have taken actions to protect the industry, and regulatory liaisons that work for the defendant company.

The good news is that the right for access to information held by government agencies has largely been successful: Many courts have issued decisions allowing the public to obtain closely held government information. The process can be confusing and time-consuming, but helpful tools are at your disposal. (7)

FOIA requests

Few attorneys regularly use the Freedom of Information Act (FOIA) in litigation. Yet the statute provides a potent tool for conducting discovery of regulatory agencies.

A thoughtful request can yield pivotal documents. For instance, in cases my firm fired on behalf of plaintiffs who suffered injury after they or their relatives took the antidepressant Prozac, we learned from documents obtained through a FOIA request that employees of Eli Lilly and Co.--the maker of Prozac--had a close and friendly relationship with certain FDA officials. We then asked for all documents concerning Prozac that were in the personal offices of each of these officials.

In response to this request, we received what would become some of the most important documents used in the Prozac litigation--some of which saved our cases from being dismissed on summary judgment. Many of these documents are still used today to demonstrate how the FDA has failed to effectively regulate the industry. For example, we provided these documents to the members of Congress who were conducting investigations and holding hearings regarding the FDA's failure to require a suicide warning for selective serotonin reuptake inhibitor (SSRI) antidepressants--such as Prozac, Paxil, and Zoloft--sooner than it did.

A common perception is that FOIA requests take too long. However, if an agency fails to respond to a FOIA request within the statutorily required time period and you have exhausted administrative remedies by appealing this failure to respond (or to adequately respond), you can rifle a FOIA lawsuit. This litigation is relatively simple and can be extremely effective in extracting documents that can incriminate the defendants. One of the best resources to help you navigate the FOIA process is Public Citizen's Web site, which provides step-by-step instructions, forms, and recommendations. (8)

Web sites

Learning to navigate an agency's Web site will lead to a wealth of information. For example, the FDA's site (www.fda.gov) includes its warning letters to companies that have violated FDA regulations--a good source of dates and names to help narrow discovery requests. (9) Other agencies--such as the Office of the Comptroller, NHTSA, and the CPSC--also provide information on their Web sites on how to make FOIA requests. (10) The agency's rules and procedures are also readily accessible online. Public information about meetings between agency officials and corporate defendants can be especially useful.

An excellent example of this is evidence my firm uncovered for a case filed against Pfizer, Inc., on behalf of parents who claimed that the label on the company's drug Zoloft at the time their teen daughter committed suicide in 2002 should have disclosed the risks of suicide and suicide-related side effects associated with its use in adolescents. FDA counsel filed an amicus brief supporting Pfizer's preemption argument by claiming that in 2002 the FDA would not have allowed the drug company to warn consumers about a link between suicidal behavior and the use of Zoloft by adolescents.

We searched the FDA's Web site and learned that less than two months before the FDA filed the brief, the agency's chief counsel, Sheldon Bradshaw, met with Jeffrey Krindler, Pfizer's vice chairman--who also acts as the company's general counsel and chief compliance officer. This type of information goes a long way in educating a judge about the politics behind preemption.

Advisory committee transcripts and slides, public testimony, expert opinions, and more are posted on agency Web sites. The key is to focus on dates of key events and names of key players and then search accordingly. Information publicly available on government Web sites can then be used to formulate discrete FOIA requests that home in on the documents that can provide evidence showing that the agency has not fully--or at least objectively--considered the safety risk your client alleges.

The Web sites of regulatory agencies in other countries are also a little-appreciated source for discovery leads--particularly in the pharmaceutical industry. (11) Many corporate defendants are multinational companies that are subject to requirements in other countries whose regulators are not as heavily influenced by the industries they regulate as U.S. agencies are.

Research of international regulatory agencies, for example, revealed that in other countries GlaxoSmithKline was already warning about the safety risks and side effects that occur when a patient stops taking its drug Paxil--while arguing in the United States that no such risks existed. (12) Imagine how difficult it would be for a drug company to argue for preemption of a state claim that a drug's label should have warned of a safety risk--on the grounds that this would be considered "misbranding" by the FDA--when that very company is warning foreign consumers about the safety risk.

Publications of institutes or organizations commissioned to research and report on public safety and other issues can provide an excellent history of government or industry conduct. These reports are often available on the Web. Examples include the Institute of Medicine's recommendations on drug safety (13) (a 2006 report on the internal structure of the FDA that describes in detail each of its recent failures in ensuring drug safety); a 2005 report on the influence of the pharmaceutical industry on the regulation of prescription drugs, issued by the United Kingdom's House of Commons Health Committee; (14) and a U.S. congressional report issued last year showing a decline in FDA enforcement activity under the Bush administration. (15)

Statements by congressional members also help demonstrate that preemption is, in fact, political. These statements are often quoted in the media and can also be found on congressional members' Web sites. In 2004, Rep. Maurice Hinchey (D-N.Y.) warned, "By attempting to shut down private suits against manufacturers of FDA-approved products, [the] FDA is removing an important layer of consumer protection: the courts. This is a position that even the most ardent advocates of tort reform have stopped short of." (16)

Depositions of agency officials

Deposing officials of agencies that have supported preemption can produce valuable information that can also help you defeat a preemption motion. The justification for depositions of FDA personnel, for example, is strengthened in cases where the FDA injects itself into private litigation by filing amicus briefs on behalf of manufacturers arguing that the cases should be preempted.

The FDA, for example, injected itself into the Paxil withdrawal litigation, which involved claims that GlaxoSmithKline was falsely advertising Paxil as "non-habit-forming." (17) To support its argument that any court decision on whether an advertisement was false or misleading is federally preempted, Glaxo asked the FDA to intervene. FDA counsel filed a motion to intervene arguing preemption.

In support of its motion, the agency included a declaration from Robert Temple, a senior FDA official. Temple argued that the FDA had reviewed the advertisement and did not believe it was false or misleading. Although the FDA initially was opposed to allowing Temple's deposition, the agency ultimately conceded without a court fight, presumably because its counsel recognized that it would be a tough fight considering that the FDA had agreed to offer factual evidence in support of the defendant. (18)

While the FDA did not inject itself into the Vioxx litigation arguing preemption, efforts by plaintiff counsel to get the deposition of an agency member set good legal precedent that can be used when you are seeking discovery to fight the conflict preemption defense. The plaintiffs' steering committee (PSC) in the Vioxx multidistrict litigation sent a letter to the FDA requesting permission to depose an FDA scientist, David Graham, because he had testified at congressional hearings and appeared in the media heavily criticizing the FDA for its failures regarding Vioxx. Depositions of FDA officials and employees are not permitted unless express permission is granted by the commissioner of the FDA. (19)

After the FDA failed to respond to the letter, the committee issued a subpoena for Graham's deposition. The agency responded by refusing to allow Graham to appear and moving to quash the subpoena on three grounds: that the United States is not considered a "person;" that, under principles of sovereign immunity, the PSC could contest the agency's refusal to comply with a deposition request only in an independent civil action brought under the Administrative Procedure Act (APA), not with a nonparty subpoena; and that independently of those two factors, "the PSC cannot satisfy the APA's arbitrary and capricious standard for setting aside an agency action." (20)

The PSC filed a countermotion to compel the testimony, and the court denied the FDA's motion, rejecting the agency's arguments. (21) Judge Eldon Fallon found that the United States is considered a "person" under federal procedural rules and that the motion to quash the subpoena was a quasi-APA action, and therefore the PSC did not have to challenge the FDA's objection with a formal APA action.

Fallon noted that the circuits were split on which standard to apply in reviewing a challenged subpoena. Some courts had used the "undue burden" standard of Rule 45. If Fallon applied that standard, the FDA would have to comply with the subpoena unless it could show that doing so would create an undue burden. If Fallon followed the lead of those circuits that had applied the standard set forth in [section]706 of the APA, the court could set aside the motion to quash if it found that the agency's refusal to allow Graham to be deposed was "arbitrary, capricious, or in excess of the FDA's authority." (22)

Applying either standard, Fallon said, would create the same result: He found that the FDA's refusal to allow the deposition was arbitrary and capricious and that the agency had failed to show that complying with the request would subject it to an undue burden. Fallon noted that Graham had testified before Congress and granted dozens of media interviews in the previous 18 months, contradicting the FDA's assertion that the deposition would have a negative effect on agency resources.

Fallon rejected the FDA's argument that the PSC already had in its possession documents that would reflect Graham's testimony, recognizing that documents are not a substitute for a deposition. He also found that allowing Graham's deposition would be in the public's interest due to the large number of people who used Vioxx. The deposition would further the objective of the FDA, which "is the protection of the public," Fallon wrote. (23)

Similar to FOIA inquiries, requests for depositions of regulatory agency personnel--regardless of the outcome--put pressure on the agency's senior officials to play by the rules and remember who their constituents are. Graham's deposition provided compelling evidence of the FDA's internal problems and why agency approval of a drug should not immunize drug companies from state tort liability. Fallon's opinion in the Vioxx litigation has greatly improved the chances of obtaining that type of testimony, and the Temple deposition illustrates that the FDA subjects itself to discovery when it intervenes in litigation. If the defendant presents factual evidence of agency conduct arguing that the agency took action that establishes conflict preemption, it will be difficult to deny plaintiffs their right to do their own discovery on this issue.

Third-party input

Given the potential danger federal preemption poses to consumer rights and safety, consumer-protection and pro-civil-justice groups--like the American Association for Justice--have been organizing and offering help to those fighting the issue in courts. (24)

Another outspoken critic of preemption is the National Conference of State Legislatures (NCSL). Soon after the FDA announced that its new rule on prescription drug labeling included language in the preamble that state tort lawsuits should be preempted, the NCSL wrote a letter to Mike Leavitt, secretary of the U.S. Department of Health and Human Services, describing the FDA's action as "an abuse of agency process and a complete disregard for our dual system of government." (25)

A Bureau of National Affairs (BNA) article discussing the wave of federal agencies asserting preemption noted that "after NHTSA issued its proposed rule on roof crush resistance for vehicles [in 2005], both the chairman and the ranking Democrat of the Senate Judiciary Committee--Sens. Arlen Specter (R-Pa.) and Patrick Leahy (D-Vt.)--wrote to NHTSA" asking for "an explanation of 'how NHTSA concluded that preemption of state law was the intent of Congress.'" (26)

As to the CPSC's final mattress flammability rule issued in February 2006, the BNA article explained that one of the agency's commissioners, Thomas Moore (a Democratic appointee), spoke out against his agency's pro-preemption position, stating: "It makes no sense to risk eliminating sources of new information that might come from private litigation. Just as litigation informs our compliance activities, so should we allow it to inform our regulatory process." (27) And Hawaii's Democratic senator, Daniel Inouye, spoke out against the CPSC's preemption assertion: "Safety advances ... moved steadily, due in part to the accountability provided by the civil justice system and state courts." (28)

Affirmations from third parties--including senators, congressional members, and federal agency commissioners--that state tort lawsuits are valuable and that preemption would harm public safety help support plaintiffs' arguments that the Bush administration is attempting to use its agencies to achieve tort "reform" to benefit industries--at the cost of consumer safety and victims' rights to compensation.

Plaintiff attorneys increasingly have to win arguments against preemption to prevail in their clients' cases, and learning to bring in and maximize factual information about a federal agency's actions can help in certain cases. Don't hesitate to make use of valuable resources such as FOIA requests, agency Web sites, and pro-consumer organizations like AAJ and the NCSL. These resources can help you weed through the massive amounts of agency documents to unveil the facts needed to defeat a preemption argument.

Notes

(1.) See Richard Frankel, Undue Deference, TRIAL 30 (Nov. 2006).

(2.) Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, 71 Fed. Reg. 3922, 3934 (Jan. 24, 2006).

(3.) FDA Amicus Curiae Ltr. Br. 11 (Sept. 21, 2006), Perry v. Novartis Pharma. Corp., 456 F. Supp. 2d 678, 685 (E.D. Pa. 2006).

(4.) Allison M. Zieve & Brian Wolfman, The FDA's Argument for Eradicating State Tort Law: Why It Is Wrong and Warrants No Deference, 34 Prod. Safety & Liab. Rep. (BNA) 308, 309 (Mar. 27, 2006).

(5.) In re Bextra & Celebrex Mktg. Sales Pracs. & Prod. Liab. Litig., 2006 WL 2374742 at *9 (N.D. Cal. Aug. 16, 2006); see also Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514, 526-32 (E.D. Pa. May 26, 2006).

(6.) Sprietsma v. Mercury Marine, 537 U.S. 51, 66-67 (2002).

(7.) See generally David Bollier, Citizen Action and Other Big Ideas: A History of Ralph Nader and the Modern Consumer Movement ch. 4 (Ctr. Study Responsive L., 1991), www.nader.org/history/bollier_chapter_4.html (last accessed Jan. 30, 2007).

(8.) See www.citizen.org. The site also has valuable information on deciding what to request--with references to articles, guides, and manuals. Click on "The Litigation Group" (in the right-hand column), then on "Freedom of Information Clearinghouse" (on the left). The AAJ Exchange posts court documents, depositions, case abstracts, and various other materials that may also help with formulating FOIA requests. Go to www.justice.org/exchange. Click on "Search the Exchange," then enter search terms, select databases, and click on "Search." Agency Web sites, too, offer instructions on submitting FOIA requests to them. (All Web sites last accessed Jan. 30, 2007.)

(9.) The FDA's Web site explains how to make a FOIA request and provides an index to the electronic reading room, a handbook for requesting information and records, and the annual FOI reports back to 1998: www.fda.gov/foi/foia2.htm (last accessed Jan. 30, 2007).

(10.) The Office of the Comptroller explains how to make a FOIA request, provides automatic access to "Popular FOIA Requests," and gives access to its annual FOIA Report at www.occ.treas.gov/foia/foia.htm; NHTSA provides similar information at www.nhtsa.dot.gov/portal/site/nhtsa/ menuitem.711d99d923a77be4ce83662ae0208a0c; the CPSC also explains how to make a FOIA request and specifically where to send it at www.cpsc.gov/library/foia/foia.html. (All Web sites last accessed Jan. 30, 2007.)

(11.) Some regulatory agencies to consider are the United Kingdom's Medicines and Healthcare products Regulatory Agency, www.mhra.gov.uk; the World Health Organization, www.who.int/research/en; and Health Canada, www.hc-sc.gc.ca/index_e.html (all last accessed Jan. 30, 2007).

(12.) See In re Paxil Prods. Liab. Litig., 296 F. Supp. 2d 1374 (M.D.L. 2003).

(13.) Inst. Med., The Future of Drug Safety: Promoting and Protecting the Health of the Public (Natl. Acads. Press, Sept. 22, 2006), http://books.nap.edu/books/0309103045/html (last accessed Jan. 30, 2007); see also Bruce M. Psaty & Sheila P. Burke, Protecting the Health of the Public--Institute of Medicine Recommendations on Drug Safety, 355 New Eng. J. Med. 1753 (Oct. 26, 2006), http://content.nejm.org/cgi/reprint/355/17/1753.pdf (last accessed Jan. 30, 2007).

(14.) H. Com. Health Comm., The Influence of the Pharmaceutical Industry vol. 1 (Mar. 22, 2005), www.publications.parliament.uk/pa/cm200405/cmselect/ cmhealth/42/42.pdf (last accessed Jan. 30, 2007).

(15.) H.R. Comm. Govt. Reform, Minority Staff, Spec. Investigations Div., Prescription for Harm: The Decline in FDA Enforcement Activity (June 26, 2006), http://oversight.house.gov/Documents/20060627101434-98349.pdf (last accessed Jan. 30, 2007).

(16.) Ltr. from Rep. Maurice Hinchey, (D-N.Y.), to Rep. Henry Bonilla, (R-Tex.), Chairman, Subcomm. on Agric., Rural Dev., FDA, and Related Agencies of the H.R. Appropriations Comm. (Aug. 5, 2004), www.house.gov/hinchey/issues/response_excounsels.pdf (last accessed Jan. 30, 2007).

(17.) In re Paxil Prods. Liab. Litig., 2002 WL 32153353 at *1 (C.D. Cal. Aug. 16, 2002).

(18.) Decl. of Robert J. Temple, In re Paxil Litig., 2002 WL 32984355 (C.D. Cal. Sept. 4, 2002).

(19.) This regulation does, however, provide the avenue by which a party can request discovery from the FDA: "A person who desires testimony from any employee may make written request therefor, verified by oath, directed to the commissioner setting forth his interest in the matter sought to be disclosed and designating the use to which such testimony will be put in the event of compliance with such request.... If it is determined by the commissioner, or any other officer or employee of the Food and Drug Administration whom he may designate to act on his behalf for the purpose, that such testimony will be in the public interest and will promote the objectives of the act and the agency, the request may be granted." 21 C.F.R. [section]20.1 (c) (2007).

(20.) In re Vioxx Prods. Liab. Litig., 235 F.R.D. 334, 337 (E.D. La. 2006).

(21.) Id. at 344.

(22.) Id.

(23.) Id. at 346.

(24.) These groups include the Center for Constitutional Litigation, Public Citizen, and Public Justice (formerly Trial Lawyers for Public Justice). AAJ has formed a Preemption Litigation Group to help plaintiff attorneys with their briefs when faced with preemption motions before the preemption issue is heard in the case. For more information, visit: www.justice.org/litgroups/ preemptionlaw/index.aspx or contact Edward Parr at [e-mail]. Declarations by respected constitutional or administrative law professors in opposition to efforts to preempt state claims are also helpful--Erwin Chemerinsky at Duke University, James O'Reilly at the University of Cincinnati, and Thomas McGarity at the University of Texas are some examples.

(25.) Ltr. from Steven J. Rauschenberger, Asst. Sen. Minority Leader (R-Ill.), and immediate past president of NCSL, to Mike Leavitt, Sec., U.S. Dept. Health & Human Servs., Food and Drug Administration Final Rule on the Requirements on Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Prescription Drug Product Labels, Docket No. 00N-1269 (Jan. 13, 2006), www.ncsl.org/programs/press/2006/060113Leavitt.htm (last accessed Jan. 30, 2007). On February 23, 2006, several congressional members sent similar letters to Leavitt opposing the FDA's assertion of federal preemption. Ltrs. from Sen. Edward M. Kennedy (D-Mass.), Sen. Christopher J. Dodd (D-Conn.), Rep. John D. Dingell (D-Mich.), Rep. Henry A. Waxman (D-Cal.), and Sen. Sherrod Brown (D-Ohio), to Michael O. Leavitt, Sec., U.S. Dept. Health & Human Servs. (Feb. 23, 2006), www.dodd.senate.gov/index.php?q=node/3381/print (last accessed Jan. 30, 2007).

(26.) Ralph Lindeman, Federalism: Agencies Move to Override State Law as Part of Federal Rulemaking Process, 66 Daily Rep. for Execs. (BNA)C-1 (Apr. 6, 2006).

(27.) Id.

(28.) Id.

KAREN BARTH MENZIES is a partner at Baum Hedlund in Los Angeles.