Pharmaceutical and medical device manufacturers provide crucial health products to needy consumers. But, these beneficial products also create the potential for great harm to individuals. In order to effectively balance the benefits and risks of these products, the Food and Drug Administration (hereinafter "FDA") issues uniform marketing and manufacturing regulations.1 Specifically, the FDA derives its power to regulate from the Food, Drug, and Cosmetic Act ( hereinafter the "FDCA":), and the Medical Device Amendments of 1976, (hereinafter the "MDA").2 And, because the varying state regulation of health products sometimes creates obstacles to the FDA’s regulatory regime, American courts in appropriate instances impose the doctrine of preemption.3 Conflict, express, and field preemption protect manufacturers from conflicting state burdens and ensure that the judgment of the FDA is carried out consistently in the states.4 Recent developments in Congress and the Supreme Court, however, have served to narrow the application of these important preemption doctrines and threatened their continued vitality in drug and device litigation. Legal professionals should be aware of these critical changes to the doctrine of preemption as it concerns state based tort actions against pharmaceuticals and class III medical devices.
Wyeth v. Levine’s Impact on Conflict Preemption in Pharmaceutical Label Disputes
First, the Supreme Court’s decision in Wyeth v. Levine took the already narrow doctrine of conflict preemption and narrowed it even further in its application to pharmaceutical labels.5 A common misconception persists in the legal profession that pharmaceutical labels could garner broad protection from state laws by invoking the doctrine of preemption.6 But as case law demonstrates, the preemption doctrine is now and always has been cautiously applied. The court in Medtronic v. Lohr, said "courts should be reluctant in cavalierly implying ‘clear evidence’ of intent to immunize an entire industry from liability, even highly-regulated ones, or cavalierly implying ‘clear evidence’ of a conflict." 7 Likewise, some lower federal courts already applied conflict preemption sparingly. In Pfizer v. Cartwright, the court said "numerous federal courts who have considered this issue have determined that preemption is not appropriate."8
Yet, despite the already modest operation of the doctrine, the Supreme Court’s decision in Wyeth further diminished the application of conflict preemption to drug labels. In siding with those lower federal courts that applied conflict preemption stringently, the Wyeth court effectively directed all of the nation’s courts down a path of narrow conflict preemption analysis. Furthermore, the decision broadened the circumstances in which lower courts will have to uphold state based tort suits against pharmaceuticals.
In order to understand the court’s reasoning, we must understand the FDA’s labeling regime and how it applied to the facts of the Wyeth case. The FDCA requires all pharmaceuticals to submit labels to the FDA in its premarket approval process.9 The purpose of the process is to allow the FDA to balance the benefits and risks of pharmaceuticals marketed to the public and make the final decision on appropriate warning and usage labels.10 The labels must conform precisely to FDA standards or the manufacturer runs the risk of being subject to various penalties for misbranding and unauthorized distribution. 11A pharmaceutical company may not change its drug labels unilaterally unless new data emerges that improves knowledge about the drugs’ risks.12 In those instances, the drug companies are allowed to unilaterally strengthen warning labels pending approval by the FDA.13 This is called the "Changes Being Effected" or CBE Exception.14 The reasoning for the exception is that drug companies are in a better position to gather and analyze new data, and thus, they should be responsible for warning the public about the safety and proper use of their drugs.15 Despite placing this continued duty to warn on the manufacturer, the FDA maintains the ultimate authority over the contents of the label.16
In Wyeth, the company marketed and labeled an anti-nausea drug, phenergan, to the public.17 The label had been approved and reviewed from time to time by the FDA.18 The label on the drug included a warning about the dangers of using the IV-push method of application.19 The IV push method was known to increase the risk of aortic puncture and subsequent gangrene infection.20
Despite the warning on the package, a physicians’ aide improperly applied the drug using the IV push method and ruptured the patient’s aorta causing a gangrene infection. 21The patient subsequently had to have her arm amputated, and sued Wyeth claiming that the company was negligent under Vermont law for not providing a stronger warning label. 22The plaintiff first won her case in a Vermont court, but the case was appealed all the way to the Vermont Supreme court. 23The Vermont Supreme Court also found in favor of the plaintiff, and the Defendant appealed to the United States Supreme Court.24
From the beginning, Wyeth argued that its label met FDA standards and thus, preempted any state common law burdens.25 Typically, in order to win a conflict preemption argument the courts require defendants to demonstrate impossibility of compliance with state law and interference with Federal law.26 So, first, the defense argued that it was impossible for Wyeth to comply with both the FDA requirements and the state tort law requirements.27 Second, the defense argued that the state’s tort laws would undermine Congress’ purpose in enacting the FDCA.28 The Supreme Court rejected both arguments. 29
In dismissing the defendant’s impossibility argument, the court held that the CBE exception made it possible for Wyeth to follow both the FDA regulations and Vermont tort law.30 But, the court applied the CBE exception in a way that significantly lightened the evidentiary burden on plaintiffs and diminished the discretion of the FDA. The majority seized upon the very small amount of new information that Wyeth obtained in the years following its Phenergan label’s approval. The record showed that the plaintiff had merely offered evidence of twenty other instances where a patient suffered an amputation due to improper Phenergan administration.31 The dissent tried to point out that the FDA, in the course of studying the issue, already had information about at least five amputation cases.32 Yet, even with this information the FDA followed a course that produced the warning label exactly as it appeared when Levine’s injury occurred.33 Nevertheless, the majority in Wyeth found the plaintiff’s evidence adequate and hinted that even less may be enough to compel a label change. The majority, interpreting FDA regulations, declared that new information means not only new data but new understanding of old data in light of continued experience.34 This analysis of the manufacturer’s duty practically allows plaintiffs to argue for a duty to change a warning label without showing any real emerging data. It also puts companies in the precarious position of deciding whether to risk a misbranding and unauthorized distribution judgment on the one hand or state law liability on the other.35
The court also observed that the FDA cannot always adequately complete its mission due to limited funding, and staffing.36 In making this observation, the court implied that companies cannot always rely on the FDA’s judgment when analyzing data. Thus, in the future, defendant companies will have to show substantial evidence to demonstrate that the FDA carefully considered data when passing judgment on appropriate warning labels. The majority, repeating the Vermont trial court, said it was looking for "more than passing judgment." 37 In response, the dissent pointed out that the FDA had thoruoghly considered which adjustments should be added to the warning label. The evidence offered by the dissent included nearly fifty years worth of meetings, conferences, applications, and reports discussing the data related to the risks of Phenergan.38
In another drug warning label case, Colacicco v. Apotex,, the FDA offered similar evidence to that offered by the defendants in the Wyeth case.39 In Colacicco, the court held that the state imposed burdens were preempted because the FDA showed memos, meetings, reports, studies, and publicly announced opinions that precluded the need for a stronger warning label on SSRI drugs.40 Yet, all these facts failed to convince the Wyeth court that the Phenergan label had been considered carefully. The court’s analysis foreshadows future instances where the FDA may review and reject an application for a stronger warning but still not save the manufacturer from state law liability. Basically, drug manufacturers must now prove that the FDA has offered a thorough and sound perspective on the potential risks of drugs.
Second, the court found that Vermont’s laws did not obstruct the accomplishment of Congress’ purpose in enacting the FDCA.41 Here again the court reached this decision in a way that narrowed the scope of conflict preemption. The majority started by diminishing the FDA’s role in prescribing appropriate standards through agency statements.42 Agency statements about preemption do not give rise to express preemption as when Congress clearly declares its intent to regulate an area of law exclusively. However, courts typically treat agency statements as evidence of whether or not a conflict exists between state and federal law.43
The Wyeth majority acknowledged that the court usually gives "some weight" to statements made by Federal agencies.44 When considering these agency statements, the court looks for "thoroughness, consistency, and persuasiveness."45 In 2006, the FDA stated in the preamble to a newly issued regulation that "FDA approval of labeling . . . preempts conflicting or contrary state law."46 But, upon comparing this preamble statement to past FDA statements about state tort law, the majority determined that the FDA spoke inconsistently. Thus, the majority largely ignored the preamble statement and rendered it irrelevant for future preemption analysis.47 Regardless, future defendants may still have a chance of showing preemptive intent if they can find statements similar to the FDA’s 1986 official regulations of OTC drugs. That 1986 regulation clearly said "this final rule preempts State and local law."48 The Caraker v. Sandoz court used this regulation as an example of an agency statement that would require preemption.49 The Caraker court reasoned that statements in official regulations carry more weight than statements included in a regulation’s preamble.50 Still, considering the Wyeth court’s concerns about the FDA’s limitations, even clearly worded official regulations may not guarantee a finding of preemption in the future.
After considering the importance or lack thereof given to the agency’s statements in the 2006 preamble, the court tried to determine whether any other facts could lead to conflict preemption. The court had to ask whether the Vermont Supreme Court’s ruling created a regulatory scheme that conflicted with the Federal scheme. The dissent argued that the Vermont court’s decision imposed a standard different from and in conflict with the standards set by the FDA. Basically, the dissent interpreted the Vermont decision to mean that the FDA’s analysis was inadequate, and thus, Wyeth’s label should have contraindicated the use of IV-push distribution altogether.51 But, such a standard clearly conflicted with the FDA’s continued and consistent failure to contraindicate IV-push.52 However, the majority interpreted the Vermont decision differently. The majority argued that the Vermont Supreme Court merely imposed a general duty to include a stronger warning label.53 In interpreting the Vermont decision in that manner, the majority never really answered whether it agreed with the Vermont court that such a direct conflict of standards could be tolerated in instances of inadequate FDA oversight. So, potentially, the door may be opened for future courts to limit the doctrine of conflict preemption even further.
The defense countered that even if the Vermont court was merely imposing a general duty to strengthen the warning label, its holding still conflicted with the FDA’s prescribed regulations.54 To further support its position, the defense turned to the precedent set in the Geier v American Honda Motor Company case.55
The Geier decision, although based on a different statute, offered some relevant parallels to the facts of the Wyeth case.56 In Geier, an injured plaintiff sued on the theory that the defendant car maker had a duty under state law to provide airbags in its automobiles.57 The court found that this burden conflicted with the standards set by the Transportation Security Administration, hereinafter TSA.58 The TSA mandated that manufacturers could choose from a variety of restraint devices and slowly introduce them into the market.59 The Geier court found that by imposing a different standard, the state undermined the TSA’s scheme of regulation.60 The defendants in Wyeth tried to argue that the Vermont decision conflicted with the FDA’s requirements in a manner similar to that presented in the Geier case.61
But, here again, the majority narrowed the application of Geier. The majority distinguished Geier in a number of ways, but two of the distinctions are particularly important. First, as discussed previously, the majority argued that the TSA in Geier gave more consideration to the safety issues involved with airbags than the FDA gave to Phenergan warning labels.62 Second, the majority pointed out that in Geier, the state imposed a specific burden that directly conflicted with a federal requirement, whereas, in Wyeth, the state merely imposed the general burden of strengthening a warning label.63 In the majority’s view, this general requirement merely served as complement to the Federal scheme.64
Consequently, Wyeth significantly changed the dynamic of conflict preemption in state tort actions. In the future, defendant drug makers will have to show abundant evidence of the FDA’s consistent involvement in and analysis of drug warning labels. Companies will have to vigilantly and rigorously analyze new data in order to tread a careful course between misbranding and state law liability. Finally, defendants should be aware of the potential that some instances of even blatantly conflicting state requirements may not give rise to preemption.
Developments in Class III Medical Device Regulation and Litigation
Class III medical devices also face the prospect of state based tort litigation minus effective preemption protection. Medical device manufacturers face this challenge despite standing on seemingly firm preemption ground. Medical device regulation poses a question of express preemption as opposed to conflict preemption. Medical device manufacturers draw on the doctrine of express preemption as stated clearly in the Medical Device Amendments to the FDCA. The amendment states that a State shall not "establish or continue in effect with respect to a device intended for human use any requirement—… (1) which is different from, or in addition to, any requirement applicable under [federal law] to the device, and … (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under relevant federal law."65 This clear language led the Supreme to court to decide 8-1 in favor of the manufacturer Medtronic on the issue of preemption in the recent case of Riegel v. Medtronic.66 In that case, a patient’s estate sued the manufacturer after an improperly placed heart catheter malfunctioned and killed the patient.67 The device met all Federal safety requirements, and since the MDA statute expressly preempted the regulation of medical devices, the court found in favor of the defendant manufacturer. 68
Because the type of device at issue in Riegel was afforded strong protection from the application of express preemption, many in the legal and policy-making profession assumed that the law allowed medical devices in general too much protection.69 Assuming the need existed for more consumer protection, policy-makers drafted new legislation known as the Medical Device Safety Act to change the language of the 1976 Medical device amendment.70 The legislation is still pending but seems to have strong support in Congress.71 The bill would change the MDA amendment to say "No Effect on Liability Under State Law- Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State."72
While the tragic outcomes of some medical device cases have convinced many policy-makers to believe that the need exists for this new legislation, the realities of medical device regulation paint a different picture. As with pharmaceuticals, the preemption protection for medical devices is quite narrow and now, possibly narrowing even more.
Again, it is important to understand the regulatory regime. Medical Devices, governed by the 1976 Amendment, are divided into categories. Classes III devices are those with great potential for both harm and health benefits to society.73 Unlike class I and II, Class III devices undergo a very rigorous PMA or premarket approval process.74 These devices must conform precisely to specific requirements and labeling by the FDA.75 Class III devices consist of products like heart valves, catheters, etc.76 In contrast, class I and II consist of products such as bandages, examination gloves, hearing aids, etc.77 As rigorous as the process is for Class III devices, the FDA allows exceptions for products to remain on the market until grandfathered in, or in the case of "substantially equivalent" devices, manufactures may continue to market products that bear a significant resemblance to other already approved products.78 In order to market "substantially equivalent" devices, manufactures may meet lower burdens to demonstrate a product’s equivalence to an already approved product.79
This exception allows for the sale and distribution of highly demanded medical devices while the FDA completes its review process.
This exception also becomes extremely important in Class III device regulation because very few devices actually undergo the normal PMA process. As of 1996, most of the medical devices that made it to the market did not go through the normal PMA process. The rest, approximately 98%, followed the "substantially equivalent" exception. 80 This exception raised the question of whether express preemption applied to the "substantially equivalent" devices. In Medtronic v. Lohr, the court found that "substantially equivalent" devices that enter the market through the aforementioned exception should not receive the same preemption protection as regular class III devices.81 The court reasoned that since the PMA process for class III devices imposed very specific and thorough requirements on manufacturers, state laws were more likely to conflict with those regulations. "Substantially equivalent" devices, on the other hand, are not subject to the same specific requirements before entering the market, and thus, should not receive as much protection from state regulation. 82The Lohr decision basically limited express preemption protection only to those devices that undergo the rigorous PMA process. So clearly, the Lohr decision demonstrates that express preemption for medical devices is already very narrow.
Yet, many scholars still continue to call for Congress and the courts to narrow preemption even further.83 Because, HR 1346 will likely pass Congress, medical device manufacturers will no longer benefit from the express preemption protection granted by the 1976 MDA. Like pharmaceutical manufacturers, medical device manufacturers will have to resort to conflict preemption. But, as has been shown, the application of conflict preemption continues to diminish. Thus, Medical device manufacturers will have to seek extensive involvement from the FDA in its PMA process and aggressively respond to emerging data about device risks. Ultimately, both pharmaceutical and medical device manufacturers will have to walk a careful line between FDA regulation and state tort law.
1 See Wyeth v. Levine, No. 06-1249, slip op. at 23 (March 4, 2009) (dissenting opinion).
2 E.g., 21 U.S.C.A. § 301 (West 1999); 21 U.S.C.A. § 360 (West 1999).
3 Caraker v. Sandoz, 172 F. Supp. 2d. 1018, 1030 (S.D. Ill 2001); See also Lousiana Public Service Commission v. F.C.C., 476 U.S. 355, 368-69 (1986).
4 Lousiana Public Service Commission v. F.C.C., 476 U.S. 355, 368-69 (1986); see also Michelle H. Lyu, House Subcommittee Holds Hearing to Overturn Riegel: H.R. 1316, the "Medical Device Safety Act of 2009" (2009), http://www.lifescienceslegalupdate.com/tags/hr-1346/.
5 See Wyeth v. Levine, No. 06-1249, slip op. (March 4, 2009) (opinion of the court).
6 See Leonard H. Glantz, J.D. & George J. Annas, J.D., M.P.H., The FDA, Preemption, and the Supreme Court 358 New Eng. J. Med. 1883-1885 (2008), http://content.nejm.org/cgi/content/full/358/18/1883.
7 Medronic v. Lohr, 518 U.S. 470, 485 (1996).
8 Cartwright v. Pfizer, 369 F. Supp. 2d 876, 884 (E.D. Texas 2005).
9 21 U.S.C.A. 355(a) (West 1999); 21 U.S.C.A. 355(b)(1)(F) (West 1999).
10 See Wyeth v. Levine, No. 06-1249, slip op. at 23 (March 4, 2009) (dissenting opinion).
11 21 U.S.C.A. § 352(f) (West 1999).
12 21 C.F.R. §§ 314.70(c)(6)(iii)(A)(C) (2008).
13 See 21 C.F.R. §§ 314 (2008).
14 Wyeth v. Levine, No. 06-1249, slip op. at 11 (March 4, 2009) (opinion of the court).
15 Id. at 22.
16 Id. at 15.
17 Id. at 1.
18 Id. at 4-5.
19 Wyeth v. Levine, No. 06-1249, slip op. at 14-17 (March 4, 2009) (dissenting opinion).
20 Wyeth v. Levine, No. 06-1249, slip op. at 2-3 (March 4, 2009) (opinion of the court).
21 Id. at 2-3.
22 Id. at 2-3.
23 Id. at 5-6
24 Id. at 5-6.
25 Id. at 3-4.
26 Cartwright v. Pfizer, 369 F. Supp. 2d 876, 881 (E.D. Texas 2005).
27 Wyeth v. Levine, No. 06-1249, slip op. at 6-7 (March 4, 2009) (opinion of the court).
28 Id. at 6-7.
29 Wyeth v. Levine, No. 06-1249, slip op. at 1 (March 4, 2009) (syllabus).
30 Wyeth v. Levine, No. 06-1249, slip op. at 11-16 (March 4, 2009) (opinion of the court).
31 Id at 5.
32 Wyeth v. Levine, No. 06-1249, slip op. at 10 (March 4, 2009) (dissenting opinion).
33 Id. at 10.
34 Wyeth v. Levine, No. 06-1249, slip op. at 12 (March 4, 2009) (opinion of the court); 73 Fed. Reg. 49609 (2008).
35 Colacicco v. Apotex, Inc., 432 Fed Supp. 514, 526-27 (E.D. Pa. 2006) (Discussing the FDA’s amicus brief that declares that companies failing to follow precise label guidelines as approved by the agency are subject to misbranding penalties).
36 Wyeth v. Levine, No. 06-1249, slip op. at 22 (March 4, 2009) (opinion of the court).
37 Id. at 3.
38 Wyeth v. Levine, No. 06-1249, slip op. at 9-18 (March 4, 2009) (dissenting opinion).
39 Colacicco v. Apotex, Inc., 432 Fed Supp. 514, 527-28 (E.D. Pa. 2006).
40 Id. at 527-28.
41 Wyeth v. Levine, No. 06-1249, slip op. at 17 (
March 4, 2009
) (opinion of the court).
42 Id. at 20.
43 Id. at 20.
44 Id. at 20.
45 Id. at 20.
46 71 Fed. Reg. 3922, 3934-35 (2006).
47 Wyeth v. Levine, No. 06-1249, slip op. at 20-22 (March 4, 2009) (opinion of the court) (discussing the history of the FDA and how the relatively recent preamble declaration is as at odds with previous statements that acknowledged the benefits of state tort law).
48 51 Fed. Reg. 8180, 8181 (1986).
49 Caraker v. Sandoz Pharmaceutical Corp., 172 Fed. Supp. 2d 1018, 1035-36 (S.D. Ill. 2001).
50 Id. at 1035-36.
51 Wyeth v. Levine, No. 06-1249, slip op. at 8 (March 4, 2009) (dissenting opinion) ("through a state tort suit, respondent attempted to deem IV push ‘unsafe’ and ‘inneffective’").
52 Id. at 3 (Discussing the FDA’s many decades long determinations of appropriate warning labels as regards IV-push distribution of Phenergan).
53 Wyeth v. Levine, No. 06-1249, slip op. at 8 (March 4, 2009) (opinion of the court).
54 Wyeth v. Levine, No. 06-1249, slip op. at 18-19 (March 4, 2009) (dissenting opinion).
55 Id. at 6-7.; See Geier v. American Honda Motor Co., 529 US 861.
56 See Geier v. American Honda Motor Company, 529 U.S. 861 (2000).
57 Geier v. American Honda Motor Company, 529 U.S. 861, 865 (2000).
58 Id. at 867.
59 Id. at 875.
60 Id. at 867.
61 Wyeth v. Levine, No. 06-1249, slip op. at 23 (March 4, 2009) (opinion of the court); Wyeth v. Levine, No. 06-1249, slip op. at 8 (March 4, 2009) (dissenting opinion).
62 See Wyeth v. Levine, No. 06-1249, slip op. at 24 (March 4, 2009) (opinion of the court) (discussing the TSA’s thorough formal rulemaking and records used in promulgating airbag regulations in the Geier case).
63 Id. at 24-25.
64 Id. at 24-25.
65 21 U.S.C.A. § 360k(a) (West 1999).
66 Riegel v. Medtronic, No. 06-179, slip op. at 1(February 20, 2008) (opinion of the court).
67 Id. at 1.
68 Id. at 1.
69 Barnaby J. Feder, Medical Device Ruling Redraws Line on Lawsuits, N. Y. Times, February 22, 2008, http://www.nytimes.com/2008/02/22/business/22device.html.
70 Medical Device Safety Act, H.R. 1346, 111th Cong. (2009-10).
71 See U.S. House of Representatives, Committee on Energy and Commerce Health Leaders Introduce Legislation Reversing Supreme Court’s Medical Device Decision (2009), http://energycommerce.house.gov/index.php? option=com_content&task=view&id=1518.
72 Medical Device Safety Act, H.R. 1346, 111th Cong. (2009-10).
73 21 U.S.C.A. § 360c (a)(1)(C) (West 1999).
74 21 U.S.C.A. § 360c (a)(1)(C) (1999); 21 U.S.C.A. § 360e (d)(2) (West 1999).
75 21 U.S.C.A. § 360e (d)(2) (West 1999).
76 Medronic v. Lohr, 518 U.S. 470, 477 (1996); Riegel v. Medtronic, No. 06-179, slip op. at 2-3(February 20, 2008) (Brief for Petitioners); Riegel v. Medtronic, No. 06-179, slip op. at 3(February 20, 2008) (opinion of the court) .
77 Riegel v. Medtronic, No. 06-179, slip op. at 3(February 20, 2008) (opinion of the court).
78 21 U.S.C.A. § 360e(b)(1)(A) (West 1999); Medronic v. Lohr, 518 U.S. 470, 478-79 (1996).
79 U.S.C.A. § 360e(b)(1)(A) (West 1999); 21 U.S.C.A. § 360(b)(1)(B) (West 1999); 21 C.F.R. § 814.1(c)(1) (2008).
80 H.R. Rep. No. 101-808, p.14 (1990) (discussing how the vast majority of devices did not enter the market through the normal PMA process); Medronic v. Lohr, 518 U.S. 470, 478-79 (1996).
81 See Medtronic v. Lohr, 518 U.S. 470 (1996).
82 Medronic v. Lohr, 518 U.S. 470, 499-500 (1996) (discussing how specific requirements within regulations raise the prospects for preemption. Also discussing how the exceptions applied to substantially equivalent devices under 21 U.S.C. § 360(k) do not impose requirements specific enough to defeat complimentary state requirements).
83 See Barry Meier, Lawmakers Seek to ReturnRight to Sue Device Makers, N.Y. Times, February 19 2009, http://www.nytimes.com/2009/02/20/business/20device.html
Brian Michael Krause, Licensed Attorney, B.A. Humanities, Bob Jones University, 2002, J.D. Northern Illinois University School of Law, 2008.