Well, if you think that plaintiffs (or their lawyers) are just going to give up and go away, you’re a lot more optimistic than we are. We’ve seen twice before what happens when plaintiffs start to get squeezed by preemption – during the initial flowering of the preemption defense in medical device cases that was snuffed out by Medtronic v. Lohr, 518 U.S. 470 (1996), and with PMA devices currently. There’s no reason to think that history won’t repeat itself – and we owe it to our clients to be prepared for the consequences of winning.
Given the unanimous language in Lohr about tort claims that “parallel” FDA requirements not being preempted, when plaintiffs are pressed on preemption, they start adding allegations that the defendant violated the Food, Drug & Cosmetic Act (“FDCA”). We would expect that to happen once again – this time with prescription drugs as well as devices.
Here’s the legal background. Lohr held “identity of requirements claims” were not preempted. The opinion isn’t particularly helpful as to what a “parallel” claim is, since all it says about them is that the plaintiffs’ “allegations may include claims” that the defendant “violated FDA regulations.” 518 U.S. at 495. In fact, Lohr doesn’t even mention “negligence per se” – just “common law duties [that]. . .parallel federal requirements.” Id.
So we’re reduced to reading tea leaves here - but with Lohr that’s not unusual.
With respect to these rather undefined “parallel” claims, the Court in Lohr held that “[n]othing in 360k denies [a state] the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements.” 518 U.S. at 495. Such duplicative state-law causes of action were not “different from” the FDA’s requirements just because they added damages as a remedy. Id. Because it was “early” in the litigation (the defendant had raised preemption on a motion to dismiss - usually a bad move), there was “no reason. . .to preclude altogether claims that invoked common law duties that appeared to be “‘equal to, or substantially identical to, requirements imposed’ under federal law.” Id. What’s more, the four justices who dissented from other parts of the Lohr opinion agreed with this result. They took the position that the statute “does not preclude States from imposing different or additional remedies, but only different or additional requirements.” Id. at 513 (concurring and dissenting opinion).
Sure, Lohr involved express medical device preemption, but the issue of what is “different from” an FDA requirement isn’t all that far from the implied preemption question of whether there’s a “conflict” with an FDA action. So you can bet your bottom dollar violation claims are at least one place where plaintiffs will look if they find their traditional bread and butter – failure to warn claims – is being cut off by implied preemption.
So we need to be ready for it. Both practically and legally.
As a practical matter, it would be extremely helpful for our clients to be ready to refute violation claims on the facts as quickly and thoroughly as possible. In-house, drug and device companies would do well to ensure that their history and tracking files are well-organized and complete. Every opportunity to establish compliance with, for example, the FDA’s good manufacturing practices, should be taken. This kind of organization will save liability and litigation expenses many times over if effected on an ongoing basis. Document! Document! Document!
Moreover, if a manufacturer is unfortunate enough to get a warning letter, an untitled letter or a Form 483 (that’s what the FDA gives out if it spots deficiencies during a site investigation), it should take whatever steps are necessary to resolve it as quickly as possible. In a brave, new preemption world, such things might amount to breaches in the dike preventing liability. Potential defendants need to deal with them accordingly. In addition, the resolution of any regulatory violation issue needs to be documented with explicit correspondence from the FDA (letters or preserved emails) that any violation has been addressed and cured to the satisfaction of the Agency.
None of this is rocket science. It’s what we hope all our clients do anyway. But with tort liability (potentially a lot of tort liability) riding upon compliance, it would become all the more critical for companies hoping to take advantage of preemption to have all their regulatory ducks in a row.
On the legal side, it’s important for defense counsel to think about how to approach FDCA violation claims in a preemption environment. Sure, we’d love it if one or more of the Supreme Court’s opinions in pending cases were to do away with the Lohr language altogether, but we’re not holding our breath. That issue isn’t directly posed by any of the three pending cases. In Levine, as we’ve mentioned, there aren’t any allegations of violations at all. In Riegel, the violation claims were dismissed on non-preemption grounds, and aren’t before the Court. Kent involves a claim of a fraud on the agency itself, which is much different than a more simple violation claims along the lines of an accusation that you didn’t do what the FDA told you to do.
So we’re thinking about how to deal with the Lohr “parallel” violation claim problem directly.
We see two primary ways of defeating such claims (actually we see a few more, but they're all dependent upon the specific type of claim) – one that involves preemption and one that doesn’t.
The preemption angle starts with the proposition that a “violation” claim is not necessarily a “parallel” claim. Rather, the two diverge when the plaintiff’s interpretation of the relevant FDA requirement differs from how the FDA reads the same language. Wherever that happens, there should still be preemption because the plaintiff’s claim in actuality differs from the FDA’s requirement. The leading case is Kemp v. Medtronic, Inc., 231 F.3d 216, 230 (6th Cir. 2001).
Kemp concluded that the purported “violations” before it were not violations at all – but merely reflected Plaintiffs’ incorrect reading of FDA requirements. Id. at 230 (FDA “d[id] not include” Plaintiffs’ claimed requirement); 230 (Plaintiffs’ claim “at best a tenuous assertion and, at worst, an outright mischaracterization of the record”); 230 (“the record flatly contradicts plaintiffs’ position”); 231 (describing “specious nature of plaintiffs’ claim”); 231-32 (claims based upon “inapplicable” materials). In short, the court concluded that the FDA would never view the relevant regulations in the same way that the plaintiff in Kemp had twisted them in search of something to call a violation.
By misconstruing FDA requirements, the violation claims in Kemp in reality would have imposed requirements that differed from those of the FDA. Such claims are not “parallel” to any recognized FDA standard. Rather, “[t]o permit a jury to find [defendant] negligent for failing to [comply with a incorrectly stated FDA requirement] would be to impose a requirement different from and in addition to those established by the FDA.” Kemp, 231 F.3d at 230.
The rationale in Kemp, with some minor semantical tweeking, should be equally applicable to conflict preemption cases involving prescription drugs. If the plaintiff’s claim of a violation is predicated upon an interpretation of a statutory or regulatory provision, and that interpretation is contrary to how the FDA reads the same provision, that’s just as big a conflict as demanding a warning that the FDA doesn’t want the manufacturer to give. Indeed, since the conflict goes to the core of the Agency’s administrative expertise – the interpretation of its own regulations – the conflict is probably even more pronounced.
In the Kemp phony-violation situation, defense counsel also needs to consider how to get the FDA on record. There may be situations (when you’re 100% sure you’re right) in which it would be appropriate to seek an advisory opinion from the FDA on a contested regulatory interpretation under 10 C.F.R. §10.85.
The non-preemption way of challenging FDCA-violation/negligence per se claims relies upon what are entirely state-law grounds, but which operate in the context of Congress and the FDCA. The critical point is that the FDCA gives exclusive enforcement authority to the federal government. “[A]ll such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.” 21 U.S.C. §337(a). That means that nobody – not even a plaintiff – is supposed to be able to come into court claiming that somebody else violated the FDCA or any FDA regulation.
The Supreme Court in Buckman examined this part of the FDCA in the context of product liability and held that §337(a) means just what it says – no private enforcement of purported violations. This section “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions” and is “clear evidence that Congress intended that the [statute] be enforced exclusively by the Federal Government.” Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 349 n.4, 352 (2001). Yeah, we wish it wasn’t in a footnote, too. But you can’t have everything. In any event, there are plenty of other cases saying similar things about §337(a) – just shepardize this section of the statute and you’ll find them.
The Buckman rationale is critical because state law generally respects legislative intent. If the legislature did not intend for any given statute to be used in private, civil litigation, then most states do not allow violation of that statute to support a negligence per se cause of action. Since Congress plainly did not intend anyone other than the government to be able to bring FDCA violation claims, then under state law, an essential prerequisite for negligence per se is not met.
Not so fast, Herrmann. Well not so fast yourself, Bexis.
There’s a complication. It’s not a fatal one, but anybody making this argument needs to be aware of it and deal with it. Unfortunately, when our predecessors at the ALI thought about negligence per se while drafting the Restatements of Torts, they weren’t thinking about what should happen when the legislature simply didn’t want a particular statute to be used in private litigation. Maybe it was just too obvious. Thus the Restatement never firmly restated this point – that if the legislature says “don’t,” courts shouldn’t. Whatever the reason, the influential Second Restatement lists only four “purposes” that a statute has to have for a violation of it to constitute negligence per se:
(a) to protect a class of persons which includes the one whose interest is invaded, and
(b) to protect the particular interest which is invaded,
(c) to protect that interest against the kind of harm which has resulted, and
(d) to protect that interest against the particular hazard from which the harm results.
Restatement (Second) of Torts §286 (1965) (emphasis added). The Third Restatement is, if anything, even less precise on the point:
In connection with liability for defective design or inadequate instructions or warnings. . .a product’s noncompliance with an applicable product safety statute or administrative regulation renders the product defective with respect to the risks sought to be reduced by the statute or regulation[.]
Restatement (Third) of Torts: Products Liability §4 (1997).
To find anything about legislative intent, one has to delve pretty deeply into the Restatement’s comments, but such delving will be rewarded – some. Thus, when “the legislature has indicated no intention that it [a statutory provision] shall be so applied” in a tort suit, courts “treat the provision as inapplicable.” Restatement (Second) of Torts §286, comment d (1965). The Third Restatement says that legislative “purpose” is to be taken “into account in determining whether noncompliance. . .renders the product defective.” Restatement (Third) of Torts, Products Liability §4, comment d (1997).
We defense counsel need to keep the legislative purpose issue front and center. Otherwise bad things will happen. Take New York, for instance. Thirty years ago, the Second Circuit – in all of one paragraph – held that the FDCA could be used as negligence per se because it satisfied the four black-letter Restatement criteria. Ezagui v. Dow Chemical Corp., 598 F.2d 727, 733 (2d Cir. 1979). New York state law, however, has developed in precisely the way that we wanted. Where the legislature does not intend for a statute to be privately enforced, negligence per se is not a way around the lack of a private cause of action.
[W]e must, most importantly, determine the consistency of [negligence per se] with the purposes underlying the legislative scheme. For, the Legislature has both the right and the authority to select the methods to be used in effectuating its goals, as well as to choose the goals themselves.
Sheehy v. Big Flats Community Day, Inc., 541 N.E.2d 18, 21 (N.Y. 1989). While the New York Court of Appeals should eventually trump the Second Circuit when it comes to the operation of state-law negligence per se, Ezagui remains on the books to this day, and in federal courts, plaintiffs have been able to assert FDCA-based violation claims with relative impunity.
There’s already quite a bit of good law on this issue. In the FDCA context, there’s Martin v. Ortho Pharmaceutical Corp., 661 N.E.2d 352, 355-56 (Ill. 1996); Friedlander v. HMS-PEP Products, Inc., 485 S.E.2d 240, 242 (Ga. App. 1997); Osburn v. Danek Medical, Inc., 520 S.E.2d 88, 93 (N.C. App. 1999), aff’d, 542 S.E.2d 215 (N.C. 2000); In re Orthopedic Bone Screw Products Liability Litigation, 193 F.3d 781, 789-90 (3d Cir. 1999); Vanderwerf v. SmithKlineBeecham Corp., 414 F. Supp.2d 1023, 1027 (D. Kan. 2006); Hackett v. G.D. Searle & Co., 246 F. Supp.2d 591, 594 (W.D. Tex. 2002); and Blinn v. Smith & Nephew Richards, Inc., 55 F. Supp.2d 1353, 1361 (M.D. Fla. 1999). There are a number of others as well.
Moreover, in states where there’s no FDCA-specific precedent, there are cases, similar to the Sheehy case in New York, that make the legislative intent point in other contexts. Because this is a critical point we’ll provide you with one of our infamous state-by-state lists:
- Arkansas: Branscumb v. Freeman, 200 S.W.3d 411, 416-17 (Ark. 2004).
- Colorado: Brittle v. Brunetti, 750 P.2d 49, 58 (Colo. 1998); Gerrity Oil & Gas Corp. v. Magness, 946 P.2d 913, 930 (Colo. 1997); Gammill v. United States, 727 F.2d 950, 953 n.3 (10th Cir. 1984).
- Connecticut: Ward v. Greene, 839 A.2d 1259, 1272 (Conn. 2004); Gore v. People’s Savings Bank, 665 A.2d 1341, 1351-52 (Conn. 1995).
- Florida: Freehauf v. School Board of Seminole County, 623 So. 2d 761, 763 (Fla. App. 1993); White v. NCL America, Inc., 2006 WL 1042548, at *5 (S.D. Fla. March 8, 2006); Labzda v. Purdue Pharma, L.P., 292 F. Supp.2d 1326, 1355 (S.D. Fla. 2003).
- Georgia: Spivey v. Sellers, 363 S.E.2d 856, 858 (Ga. App. 1987).
- Idaho: O’Guin v. Bingham County, 72 P.3d 849, 856 (Idaho 2003).
- Illinois: Magna Trust Co. v. Illinois Central Railroad Co., 728 N.E.2d 797, 805 (Ill. App. 2000).
- Kansas: Bland v. Scott, 112 P.3d 941, 947-48 (Kan. 2005); Pullen v. West, 92 P.3d 584, 593-94 (Kan. 2004); OMI Holdings, Inc. v. Howell, 918 P.2d 1274, 1296 (Kan. 1996); Alumbaugh v. Union Pacific Railroad Co., 322 F.3d 520, 524-25 (8th Cir. 2003).
- Kentucky: T&M Jewelry, Inc. v. Hicks, 189 S.W.3d 526, 530 (Ky. 2006).
- Massachusetts: Swift v. United States, 866 F.2d 507, 509 (1st Cir. 1989).
- Missouri: Lowdermilk v. Vescovo Building & Realty Co., 91 S.W.3d 617, 629 (Mo. App. 2002); Imperial Premium Finance v. Northland Insurance Co., 861 S.W.2d 596, 599 (Mo. App. 1993).
- Nebraska: Holmes v. Circo, 244 N.W.2d 65, 69-70 (Neb. 1976).
- Nevada: Texas International Airlines, Inc. v. Bryan, 857 F. Supp. 838, 848 (D. Nev. 1981).
- New Mexico: Jaramillo v. Fisher Controls Co., 698 P.2d 887, 892 (N.M. 1985); F.D.I.C. v. Schuchmann, 235 F.3d 1217, 1223 (10th Cir. 2000); Ray v. Aztec Well Service Co., 748 F.2d 888, 890 (10th Cir. 1984).
- New York: Sheehy; Gain v. Eastern Reinforcing Service, Inc., 603 N.Y.S.2d 189, 191 (N.Y.A.D. 1993); German v. Federal Home Loan Mortgage Corp., 885 F. Supp. 537, 567 (S.D.N.Y. 1995).
- North Carolina: Hall v. Torreos, II, Inc., 626 S.E.2d 861, 869 (N.C. App. 2006), review allowed, 642 S.E.2d 248 (N.C. 2007); Williams v. City of Durham, 473 S.E.2d 665, 667 (N.C. App. 1996).
- Ohio: Hernandez v. Martin Chevrolet, Inc., 649 N.E.2d 1215, 1217 (Ohio 1995).
- Oklahoma: Gorton v. J.W. Mashburn, 995 P.2d 1114, 1117 (Okla. 1999).
- Oregon: Scovill v. City of Astoria, 921 P.2d 1312, 1316 (Or. 1996).
- Pennsylvania: Frederick L. v. Thomas, 578 F.2d 513, 517 n.8 (3d Cir. 1978).
- South Carolina: Hurst v. Sandy, 494 S.E.2d 847, 851 (S.C. App. 1997).
- Tennessee: Rains v. Bend of the River, 124 S.W.3d 580, 589-91 (Tenn. App. 2003).
- Utah: Rollins v. Petersen, 813 P.2d 1156, 1163-64 (Utah 1991).
- Wisconsin: Cooper v. Eagle River Memorial Hospital, Inc., 270 F.3d 456, 460 (7th Cir. 2001); Chapman v. Mutual Service Casualty Insurance Co., 35 F. Supp. 2d 699, 705 (E.D. Wis. 1999).
Other fertile place to search for analogous precedent are cases involving OSHA, since quite a few courts refuse to allow negligence per se for OSHA violations in light of statutory language to the effect that OSHA is not intended to affect civil litigation. E.g., Elliott v. S.D. Warren Co., 134 F.2d 1, 4 (1st Cir. 1998); Myers v. United States, 17 F.3d 890, 901 (6th Cir. 1994); Albrecht v. B&O Railroad Co., 808 F.2d 329, 332-33 (4th Cir. 1987). There are plenty of other OSHA cases, but these suffice to explain the rationale.
Also, there are cases that equate the availability of a private right of action – which the FDCA manifestly does not support – with the propriety of using a statute as the basis for negligence per se. E.g., Hoppe v. Kandiyohi County, 543 N.W.2d 635, 638 (Minn. 1996); M.H. v. State, 385 N.W.2d 533, 537 (Iowa 1986); Sierra-Bay Federal Land Bank Ass’n v. Superior Court, 277 Cal. Rptr. 753, 762 (Cal. App. 1991). This precedent also supports state-law grounds for seeking dismissal of any FDCA-based violation claim.
Finally, as we’ve blogged about before in discussing a bunch of other defences to negligence per se, this basic rationale – that Congress prohibited private enforcement of the FDCA – has frequently been raised successfully to preclude Lanham Act claims that assert thinly-disguised FDCA violation claims as some sort of false advertising. E.g., PDK Labs, Inc. v. Friedlander, 103 F.3d 1105, 1113 (2d Cir. 1997) (this persistent plaintiff tried it twice, in both state and federal court); Mylan Laboratories, Inc. v. Matkari, 7 F.3d at 1130, 1139 (4th Cir. 1993); Sandoz Pharmaceuticals v. Richardson-Vicks, 902 F.2d 222, 231 (3d Cir. 1990); Putney, Inc. v. Pfizer, Inc., 2007 WL 3047159, at *4-6 (D. Me. Oct. 17, 2007).
These decisions don’t have anything to do with preemption. Rather, they all deal with the state-law prerequisites to being able to assert a statutory violation as grounds for negligence per se. If, as we hope, the defendants prevail in the preemption cases pending before the United States Supreme Court, all of us on the defense side will need to become familiar with these less-well-known grounds for defeating state-law violation claims.
May we be so fortunate.