This guest post was written by Paul B. Kerrigan. Mr. Kerrigan is a partner resident in the Philadelphia office of Reed Smith LLP. This post is entirely his work. It, of course, represents only his views and not the views of his clients or firm.
Following passage by Congress in September 2007 of the Food and Drug Administration Amendments Act of 2007, P.L. 110-85 (the “2007 Act”), one of the most intriguing questions being asked in Washington (and elsewhere) is what effect, if any, will the 2007 Act and its “Rule of Construction” have on preemption jurisprudence in prescription drug cases when it becomes effective in March 2008.
The statute itself provides scant guidance for predicting how courts will interpret and apply the new law. In that respect, the 2007 Act is an unfortunate but not infrequent example of the legislative process providing less clarity and more uncertainty. Despite (or perhaps because of) the statutory ambiguity, individual members of Congress were undeterred from providing trenchant sound bites for both sides of the preemption debate in the days preceding passage of the 2007 Act.
Depending upon which member of Congress rose to speak on September 19-20, 2007, the 2007 Act either “clarified” Congressional intent that the Federal Food, Drug and Cosmetic Act (the “Act”) does not preempt state tort law on the adequacy of prescription drug warnings, or it left intact the views expressed by the U.S. Food and Drug Administration (“FDA”) that the Agency is the ultimate arbiter of the form and content of safety information about prescription drugs. See The Final Labeling Rule – Requirements on Content and Format of Labeling for Human Prescription Drugs and Biological Products, 71 Fed. Reg. 3922-3997 (FDA Jan. 24, 2006).
Significantly, members of Congress did not publicly comment on what was absent from the 2007 Act – the express anti-preemption language found in “Discussion Drafts” of H.R. 2900, the original House bill that was reconciled with S. 1082 to become H.R. 3580 and, ultimately, the 2007 Act. The House deleted this language prior to passage of H.R. 2900 and the language is not part of the law enacted by Congress and approved by President Bush. See P.L. 110-85. Despite the explicit rejection of such language, remarks by some Congressional opponents of preemption seemed more apropos to the draft legislation that contained the anti-preemption proviso rather than to the statute from which such language had been deleted.
Several members of Congress stated that the 2007 Act expressly preserved what they considered to be the “balance of responsibility” between FDA and pharmaceutical companies to ensure full disclosure of health risks to consumers at the earliest possible moment. In their view, section 901 of the 2007 Act unequivocally endorses this shared responsibility because it endows FDA with new authority to require manufacturers to update product labeling, while the Rule of Construction preserves the manufacturers’ responsibility to update package labeling in the face of a newly-discovered risk through the existing “changes being effected” (“CBE”) system. For these members of Congress, the 2007 Act leaves intact state law requirements and remedies, including product liability lawsuits, which are regarded as being akin to a private regulatory mechanism to hold manufacturers accountable if they do not provide prompt and adequate warnings of a prescriptions drug’s risks.
Even though Sen. Kennedy (D-Mass.) concedes that the 2007 Act “provides FDA with additional resources and authority to better able to step in when a company fails to live up to these responsibilities [to update product labeling],” this improved and expanded FDA oversight of post-market drug safety “does not undermine or preempt the efforts by injured patients to seek redress under State product liability law.” Cong. Rec. S11833 (Sept. 20, 2007). Sen. Leahy (D-Vt.) shares his colleague’s view and strongly criticized the “regulatory preemption model” that he claimed the Bush Administration was using to shield corporations from liability – a model he found “especially troubling” in the area of pharmaceutical drugs.” Cong. Rec. S11834 (Sept. 20, 2007). Sen. Leahy left no doubt about his views on preemption under the 2007 Act when he said “[t]he legislation we are set to pass today contains a ‘rule of construction’ making clear that Congress has again decided that we are not preempting State law regarding the responsibility of drug manufacturers to immediately notify consumers of dangers without waiting for the FDA to act.” Id. (emphasis added).
To be sure, the opinions of Sen. Kennedy and Sen. Leahy did not receive unanimous acclamation. Sen. Coburn (R-Ok.) expressed a diametrically opposite view about the purpose of the 2007 Act and Congressional intent in enacting the legislation. He stated:
This bill ensures that the FDA has broad and exhaustive authority to make sure drug companies are doing the right and scientifically-justified thing when it comes to drug safety and labeling of their drugs. This authority is placed rightly in the hands of highly-trained scientists at the FDA. It is clear that Congress relies on the scientists of the FDA to assess safety risks and drug labeling and this should be squarely and solely the FDA’s role – that is why we have spent months and months trying to get the issue of drug safety right.
* * * * *
The newly expanded role of the FDA does and should preempt State law when it comes to drug safety and labeling.
Cong. Rec. S11839 (Sept. 20, 2007 (emphasis added). In addition, Sen. Hatch (R-Utah) praised the legislation because it establishes “a new and enhanced mechanism for the prompt consideration of new safety-related information and sets forth strict timelines for evaluation of such data.” The Utah Republican added that the “new procedure is designed . . . to ensure that FDA is the ultimate authority in making certain that drug labels convey safe information in a clear and consistent way.” Cong. Rec. S11835 (Sept. 20, 2007) (emphasis added).
But remarks by individual members of Congress often remind us that there are “two sides of the aisle” in our federal legislative bodies. For example, Rep. Green (D-Tx.) supported passage of the 2007 Act because the Rule of Construction makes it “perfectly clear” that all prescription drug lawsuits based on failure to warn are not preempted.” Cong. Rec. H10598 (Sept. 19, 2007) (emphasis added). In contrast, Sen. Enzi (R. Wyo.) was deeply concerned about provisions in the 2007 Act relating to labeling changes and liability of prescription drug manufacturers. He worried that “we do not fully understand the implications of [the] language [in the Rule of Construction]. [It] was part of the House-passed language and not something the Senate fully debated.” Cong. Rec. S11833 (Sept. 20, 2007) (emphasis added).
Given these conflicting remarks, one might reasonably wonder whether Messrs. Kennedy, Leahy, Coburn, Hatch, and Greene all read the final version of the legislation. Nor is it difficult to understand why statements by individual legislators rarely carry the day when courts find it necessary to review the legislative history. Basic principles of statutory construction dictate that, “when the statute’s language is plain, the sole function of the courts – at least where the disposition required by the text is not absurd – is to enforce it according to its terms.” Lamie v. United States, 520 U.S. 1, 6 (1997). See also United States v. Gonzalez, 520 U.S. 1, 6 (1997) (“there is no reason to resort to legislative history” when a “straightforward statutory command” exists particularly where “the legislative history only muddies the waters.”); Thornburg v. Gingles, 478 U.S. 30, 44 (1986) (committee reports are “the authoritative source for legislative intent”). The House Report on the 2007 Act does not say anything about the Rule of Construction. The Senate did not issue a report. And, it is not entirely clear that Congress used the traditional process of convening a conference committee to reconcile the differences between H.R. 2900 and S. 1082. Compare OMB Watch, Congress Expands FDA User Fee Program, Reforms Drug Safety Process, Sept. 25, 2007 (“[n]egotiations between the two chambers stalled and Congress did not form a conference committee to reconcile the two bills. Because of the need to finalize the legislation by Sept. 30, Rep. John Dingell (D. Mich.) introduced Sept. 19 the Food and Drug Administration Amendments Act of 2007 (H.R. 3508), which was based on the two bills.”) and Cong. Rec. H10594, Sept. 19, 2007 (Rep. Dingell stating that “[s]ince July, bipartisan meetings have been held frequently between House Energy and Commerce Committee and the Senate Committee on Health, Education, Labor, and Pensions to reconcile the differences between these two bills.”).
Rule of Construction
So, what’s all the hullabaloo about the Rule of Construction? Tucked away in section 901(a) of the 2007 Act, the Rule will likely draw close scrutiny from the preemption bar. Section 901(a) creates a new sub-section (o) to Section 505 of the Act (21 U.S.C. §355) dealing with Post Market Studies and Clinical Trials Regarding Human Drugs, Labeling, and Risk Evaluation and Mitigation Strategies. Generally, this section gives broad and comprehensive new powers to FDA over prescription drugs, especially in the product’s post-marketing period, but then imposes on drug manufacturers the obligations under existing law to make appropriate and necessary changes to safety information in package labels. Section (o)(4)(I) provides as follows:
RULE OF CONSTRUCTION – This paragraph shall not be construed to affect the responsibility of the responsible person or holder of the approved application under section 505(j) to maintain its label in accordance with existing requirements, including subpart B of part 201 and sections 314.70 and 601.12 of title 21, Code of Federal Regulations (or any successor regulations).
H.R. 3580, Title IX, §901(o)(4)(I) (2007).
Perhaps the only true thing that might be said to date about the 2007 Act and its Rule of Construction is that they have not quieted the preemption debate about prescription drug warnings and probably will not do so until their content is explained by judicial interpretation.
S. 1082 and H.R. 2900 become H.R. 3580
The impetus for Congressional consideration of this legislation was the expiration on September 30, 2007 of the Prescription Drug User Fee Act (“PDUFA”). Although the law eventually passed by Congress is far more comprehensive than simply reauthorizing “user fees,” the 2007 Act is sometimes referred to as the PDUFA Reauthorization Package.
The Senate was the first body to consider the legislation, passing on May 9, 2007 the FDA Revitalization Act (S. 1082) by a vote of 93-1. Initially, the House considered nine separate bills that ultimately were consolidated into the Food and Drug Administration Amendments Act of 2007 (H.R. 2900), which passed on July 11, 2007 by a vote of 403-16.
The compromise bill emerged on September 19, 2007 as the Food and Drug Administration Amendments Act of 2007 (H.R. 3508) and passed the House that same day by a vote of 405-7. The Senate approved the measure the next day by unanimous consent and President Bush signed the 2007 Act into law on September 27, 2007.
While S.1082 re-authorized the user fee program, it did much more. Section 208 of S.1082 essentially eliminated the “changes being effected system” under the Act by requiring FDA approval for all labeling changes, whether initiated by the Agency or the manufacturer, and establishing an “accelerated” process for considering them. Sen. Kennedy endorsed this version of the Senate bill despite the likelihood that language in an amendment proposed by Sen. Burr (R-N.C.) would be interpreted as requiring FDA to review and approve all labeling changes.
Sen. Kennedy accepted the Burr amendment because the provision added to FDA’s authority. Undoubtedly, it did, but it also did much more — it strengthened the preemption defense in prescription drug cases by essentially eliminating the CBE system which, according to The Pharmaceutical Research and Manufacturers of America, “doesn’t really exist in practice.” The Pink Sheet, “Preemption Remains Conference Issue in FDA Bill as Both Sides Declare Victory,” Vol. 69, No. 30, July 23, 2007.
Perhaps sensing the consequences of his support for the Burr Amendment, Sen. Kennedy tried to establish a much different legislative intent for the bill that he sponsored during a floor speech on May 9, 2007, the day the Senate passed S. 1082. Despite the language of the Burr Amendment, Sen. Kennedy wanted to have it both ways:
“[w]e do not intend to alter existing state law duties imposed on the holder of an approved drug application to obtain and disclose information regarding drug safety hazards either before or after the drug receives FDA approved labeling. Nor are we expressing a belief that the regulatory scheme embodied in the bill is comprehensive enough to preempt the field or every aspect of State tort law. FDA’s approved label has always been understood to be the minimum requirement necessary for approval. In providing the FDA with new tools and enhanced authority to determine drug safety, we do not intend to convert this minimum requirement into a maximum.”
Cong. Rec. S5764 (May 9, 2007) (emphasis added).
As approved, the Senate bill added a section 506D to the Act entitled “Safety Labeling Changes” to be inserted after 21 U.S.C. §356c. It required FDA and drug manufacturers to notify each other if either became “aware of new safety information that … should be included in the labeling of the drug.” Thereafter, discussions would ensue between FDA and the drug maker to determine whether a “safety labeling change” is appropriate. See S. 1082, Title II, §208 at pp. 107-117 (2007).
These discussions to review possible labeling supplements would occur on a normal or accelerated process, with the accelerated process limited to 45 days. Upon expiration of the 45-day period, the Senate bill would require FDA, “on the next calendar day,” to request in writing that the manufacturer make any safety labeling change that FDA determines to be necessary or to notify the manufacturer that no change is “necessary or appropriate.” If FDA fails to act within the prescribed period or the manufacturer does not agree to adopt FDA recommendations, either the manufacturer or FDA could refer the matter to a Drug Safety Oversight Board (the “Board”), which has 45 days in which to make a recommendation. Id.
After the Board issues its recommendation, FDA must issue an order within 20 days, either requiring the manufacturer to make necessary and appropriate safety labeling changes or determining that no safety labeling change is required. Should FDA fail to act, the Board’s written recommendation will be considered the order of the Secretary of Health and Human Services. If the manufacturer fails to comply with the order of FDA or the Board’s recommendation within 10 days of receipt, the drug at issue may be misbranded. Id.
It did not take very long following Senate approval of S. 1082 for the plaintiffs’ bar to recognize that preemption advocates had achieved a significant legislative victory. To complement FDA statements in the Final Labeling Rule that the Agency is the ultimate arbiter of the form and content of safety information for prescription drugs, the Senate had now passed a law requiring FDA approval of all label changes – effectively eliminating the CBE system, which the plaintiffs’ bar frequently invokes to counter the preemption defense in prescription drug cases since FDA’s publication of the Final Labeling Rule in January 2006. But the plaintiffs’ bar worked very quickly to undo what was now a double-barreled argument for preemption.
By the time the House Subcommittee on Health held a hearing on June 12, 2007 to consider its version of the new legislation, Health Subcommittee Chairman Rep. Frank Pallone (D-N.J) had already circulated “Discussion Drafts” of what would become H.R. 2900. These “Discussion Drafts” contained language that would expressly eliminate the preemption defense in prescription drug actions. Each of the “Discussion Drafts” circulated by Rep. Pallone contained the following language:
Sec. 6. RULE OF CONSTRUCTION REGARDING FEDERAL PREEMPTION
Nothing in this Act or the amendments made by this Act may be construed as having any legal effect on any cause of action for damages under the law of any State (including statutes, regulations, and common law).
The American Institute for Justice, formerly known as the Association of Trial Lawyers of America, claimed in an e-mail to members that its lobbyists were responsible for the inclusion of the anti-preemption language. The e-mail stated:
“This week, our Public Affairs Department worked hard to get a provision in a draft drug safety legislation which could prevent drug companies from using the FDA as a shield against accountability for the harm they cause – and we were successful.”
Young, Jeffrey, The Hill, “Trial lawyers win on suit provision threatens FDA Bill,” June 15, 2007. See, e.g., H.R. ____ To Amend the Federal Food, Drug and Cosmetic Act to improve drug safety and for other purposes (House Energy Committee Discussion Draft), §6 at p. 58 (June 6, 2007).
This is definitely anti-preemption language. Similar language in the Occupational Safety and Health Act (“OSHA”) reads:
“Nothing in this chapter shall be construed . . . to enlarge or diminish or affect in any other manner the common law or statutory rights, duties, or liabilities of employers and employees under any law with respect to injuries, diseases, or death of employees arising out of, or in the course of, employment.”
29 U.S.C. §653(b)(4). The OSHA law has been interpreted as restricting preemptive effects of OSHA regulations in tort suits. See, e.g., Lindsey v. Caterpillar, Inc., 480 F.3d 202, 209 (3d Cir. 2007); Pedraza v. Shell Oil Co., 942 F.2d 48, 53 (1st Cir. 1991); and In re Welding Fume Products Liability Litigation, 364 F.Supp. 2d 669, 686 (N.D. Ohio 2005).
At the June 12, 2007 hearing, the Health Subcommittee heard testimony by Randall Lutter, Ph.D., FDA’s Deputy Commissioner for Policy, who expressed the Agency’s concerns with the new language eliminating FDA’s preemption authority.
“[W]e are concerned about new language on preemption in the discussion drafts, which states that nothing in the Act may be construed as having any legal effect on actions for damages under state law (including statutes, regulations, and common law). This language appears in each of the draft bills and relates to both drugs and devices.
With respect to drugs, FDA is the expert federal public health agency charged with ensuring that drugs are safe and effective and that the labeling adequately informs users of the drugs’ risk and benefits. FDA . . . provides formal, authoritative conclusions under which drugs can be used safely and effectively. * * * We believe that State law actions that can conflict with the Agency’s conclusions and frustrate the Agency’s implementation of its public health mandate should not be endorsed in federal laws.”
Statement of Randall Lutter, Ph.D., Deputy Commissioner for Policy, Food and Drug Administration, Before the Subcommittee on Health Committee on Energy and Commerce, U. S. House of Representatives (June 12, 2007) (emphasis added). An FDAnews Marketing and Sales Bulletin dated June 14, 2007 quotes Dr. Lutter as saying that “[t]he best way to ensure safety of the medical process is to ensure there is a single authoritative voice,” and explaining that the House drafts would essentially formalize a collection of state actions that could be contradictory to FDA’s regulations. FDANEWS, “FDA Raises Concerns with House PDUFA Draft Legislation,” Vol. 2 No. 24, June 14, 2007 (emphasis added); see also The Food & Drug Letter, “Debate Over Preemption Provision in FDAAA Continues,” Vol. No. 781 (Sept. 28, 2007).
Despite the inclusion of obvious anti-preemption language in the draft legislation, a spokeswoman for the Health Subcommittee explained that Democrats were not trying to roll back preemption. “We are not attempting to change the status quo on preemption,” she said. Instead, the Democrats want to forestall the expansion of federal preemption into new areas of drug and device law. Young, Jeffrey, The Hill, “Trial lawyers win on suit provision threatens FDA Bill,” June 15, 2007 (emphasis added).
Apparently, Dr. Lutter’s comments did not go unheeded. The Health Subcommittee postponed its scheduled June 14, 2007 markup of H.R. 2900 until June 19, 2007 “to allow for further negotiation on preemption and other issues.” The Pink Sheet, “Negotiations Preempt Subcommittee Markup,” Vol. 69 No. 25, June 18, 2007. Significantly, the anti-preemption language found in the draft discussions was not included in the bills presented at the June 19, 2007 Health Subcommittee markup, and the House Committee on Energy and Commerce did not re-insert the language when it marked up H.R. 2900 on June 21, 2007. H.R. 2900 was introduced in the House on June 28, 2007 and passed on July 11, 2007 by a vote of 403-16.
In the House version, FDA also had authority to compel changes in labeling to reflect new safety information within specified time periods but, significantly, the House bill did not require FDA approval of all changes in package labeling for prescription drugs, as did the Senate version. Thus, the Rule of Construction in H.R. 2900 arguably left intact the responsibility of drug manufacturers to maintain their labels in accordance with existing requirements, including Subpart B and section 314.70 of title 21, Code of Federal Regulations (or any successor regulations). See H.R. 2900, Title IX, §901(o)(4)(I).
Eventually, the Senate and House bills were reconciled in H.R. 3580 and received Congressional approval. The “reconciliation” process produced the following issues that could be significant in the preemption debate about prescription drug warnings:
- FDA has new and expansive powers to regulate prescription drug safety information in the post-marketing period and, for the first time, FDA is not limited to the “nuclear option” of pulling a drug from the market but, instead, can compel drug makers to make FDA-initiated changes to package labeling and impose civil and criminal penalties for non-compliance;
- The “reconciliation” process eliminated the Senate bill’s provision that manufacturers could not make any label change without prior FDA approval; and
- The Rule of Construction qualifies the sweeping and expansive regulatory authority given FDA over prescription drug warnings in section 901(a) by leaving intact the manufacturers’ responsibility under the “changes being effected” system to initiate label changes for new safety information.
PREEMPTION OF PRESCRIPTION DRUG WARNINGS
So – what does all of this mean for preemption of state product liability lawsuits alleging inadequate warnings for prescription drugs?
The new law significantly expands FDA’s power on labeling issues because the Agency can now compel manufacturers to make changes it deems necessary and appropriate to provide new safety information. Rep. Waxman (D-Cal.) highlighted the significance of this change:
“Mr. Speaker, the legislation poised [sic] to pass today provides FDA, for the first time, critical tools that the Agency has been desperately lacking in its efforts to protect the American public from unsafe drugs.”
Cong. Rec. H10598 (Sept. 19, 2007). (emphasis added).
However, the House excised the Senate’s key provision on labeling that likely would have been interpreted as a de facto endorsement of preemption in prescription drug cases – i.e., pharmaceutical companies could make no change to package labeling without prior approval by FDA. The House further muddied the preemption waters by then enacting its version of the Rule of Construction which, to be sure, will be invoked by the plaintiffs’ bar as re-affirming the CBE system in an effort to weaken drug manufacturers’ reliance on the Final Labeling Rule as a basis for preemption.
The rejection of explicit anti-preemption language in House drafts of the 2007 Act, coupled with the significant expansion of FDA power to regulate post-market prescription drug warnings – taken together – significantly weaken any argument that the Rule of Construction somehow “trumps” the 1996 Final Labeling Rule and eliminates the preemption defense in prescription drug cases. In fact, such a scenario was expressly discussed and rejected by Sen. Coburn (R-Ok.) in his remarks prior to passage of the legislation:
“I want to specifically comment on language in H.R. 3580 [the 2007 Act] that includes a new mechanism to further encourage the timely and accurate communication of new safety information on prescription drug labels. That mechanism reiterates the FDA’s primacy in determining the content of prescription drug labeling, including through the new power to command a safety labeling change. New section 505(o)(4)(I) also makes clear that this enhanced safety labeling mechanism does not affect the obligation of a company to maintain a drug product’s labeling in accordance with FDA’s regulations, including 21 C.F.R. Sec. 314.70 . . . Nothing in this rule of construction changes that obligation or FDA’s ultimate authority over drug labeling; nor is it intended to change the legal landscape in this area. That is because there is an overriding federal interest in ensuring that the FDA, as the public health body charged with making these complex and difficult scientific judgments, be the ultimate arbiter of how safety information is conveyed.”
Cong. Rec. S.11849 Sept. 20. 2007. (emphasis added).
Although FDA now has unilateral authority to compel changes in the form and content of prescription drug labeling, the 2007 Act leaves intact the CBE system that existed when FDA published the Final Labeling Rule in the Federal Register on January 24, 2006. While Congress did not eliminate the regulatory framework for company-initiated changes to package labels that existed when the Final Labeling Rule was published, it certainly had the opportunity to expressly repudiate the views expressed by FDA in that document and, significantly, it did not expressly do so in the 2007 Act.
In fact, an interpretation of the Rule as maintaining the regulatory “status quo” finds support in both the language of the Rule and remarks by Sen. Kennedy, who sponsored the legislation. In this regard, the Rule could be construed as a “savings clause” that preserves the regulatory status quo and deters preemption advocates from interpreting the 2007 Act as evidence that Congress, by giving FDA broad and unprecedented authority over prescription drugs in the post-marketing period, intended to extend FDA regulatory supremacy beyond its existing scope. Sen. Kennedy’s remarks support such an interpretation. He said:
“Congress has stated very clearly in the legislation that we do not intend the new authority being given to FDA to preempt common law liability for a drug company’s failure to warn its customers of health risks.”
Cong. Rec. S.11833 (Sept, 20, 2007). (emphasis added).
Undoubtedly, the plaintiffs’ bar will attempt to persuade courts that the Rule of Construction demonstrates Congressional intent to thwart drug manufacturers’ reliance on the preemption defense. In response, pharmaceutical companies can forcefully argue that: 1) Congress rejected the explicit anti-preemption language sought by the plaintiffs’ bar and did not disavow FDA views expressed in the Final Labeling Rule; 2) the language of the Rule of Construction is, at best, inconclusive, as evidenced by conflicting Congressional opinions about the preemptive effect of the Act of 2007; and 3) the advertent purpose of the 2007 Act was to give FDA new and sweeping regulatory power in the collection and dissemination of drug safety information during the post-marketing period. All of these factors portend Congressional support for FDA primacy in regulating prescription drug warnings.
Notwithstanding these and many other words that will be written about the 2007 Act, a prediction today about its effect on preemption jurisprudence for prescription drugs has but one certainty – the 2007 Act did not provide an unequivocal answer for either side of the debate. Rather, it will be left to the courts, perhaps on a case-by-case or product-by-product basis, ultimately to determine whether company-initiated warnings pursuant to the “changes being effected” regulations provide a basis for product liability suits under state law when FDA has concluded that “the determination whether labeling revisions are necessary is, in the end, squarely and solely FDA’s under the Act.” Requirements on Content and Format of Labeling for Human Prescription Drugs and Biological Products, 71 Fed. Reg. at 3934 (FDA Jan. 24, 2006). (emphasis added).
The Supreme Court may have an opportunity to address this question should it grant certiorari and take up the case of Levine v. Wyeth, 2006 Vt. LEXIS 306 (October 27, 2006). It has invited the Solicitor General to file a brief expressing the views of the United States, and it is generally believed that such a brief will be filed soon.
Developments in this case will be closely watched. If the Supreme Court decides to hear the Levine case, this observer will be interested to see whether the Court considers the jury verdict in favor of plaintiff Diana Levine to be a state requirement for additional or stronger product warnings or, instead, a prohibition on an approved and indicated use for a prescription drug.