Posted by Gale Burns on Tue, Dec 27, 2011 @ 03:44 PM
The Lawletter Vol 36 No 5
Jeremy Taylor, Senior Attorney, National Legal Research Group
The New York Court of Appeals recently addressed the issue of federal preemption in a case brought by bus passengers alleging that the bus in which they had been riding was defective because it did not have passenger seatbelts. See Doomes v. Best Transit Corp., N.Y. Slip Op. 07256, 2011 WL 4916002 (N.Y. Oct. 18, 2011) (subject to revision before publication). The plaintiffs were injured when the bus veered across the highway and rolled over several times after the driver fell asleep and lost control of the vehicle. The passengers brought a products liability action against the manufacturer who had completed the construction of the bus, asserting that the defendant had breached the warranty of fitness for ordinary purposes by failing to install passenger seatbelts in the bus. The bus had a seatbelt for the driver, as required by the Federal Motor Vehicle Safety Standards ("FMVSS"). The FMVSS do not, however, require passenger seatbelts in a bus. The manufacturer appealed a verdict in the plaintiffs' favor, arguing that the state law claims grounded upon the absence of passenger seatbelts were preempted by the federal regulations. The appellate division reversed the judgment in favor of the plaintiffs, and the court of appeals granted the plaintiffs leave to appeal. The court of appeals reversed the judgment of the appellate division on the question of preemption.
The court of appeals noted that state tort claims may be preempted by federal law by either express or implied preemption. As to express preemption, the court noted that preemptive intent is discerned from the plain language of a statute. Implied preemption, by contrast, may be found either when the federal legislation is so comprehensive in scope that it is inferable that Congress wished to fully occupy the field of its subject matter, or when state law conflicts with the federal law. Such a conflict may be found (1) when it is impossible for a private party to comply with both state and federal requirements, or (2) when state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress. The court found that the National Traffic and Motor Vehicle Safety Act ("the Act"), under which the FMVSS were preempted, did not expressly preempt state products liability law, because the Act's saving clause, in conjunction with the statute's preemptive provision, permitted the maintenance of common-law claims.
As to implied preemption, the court held that the plaintiffs' state law claims were not preempted under the principle of field preemption, because the Act was not intended to encompass the entire scheme of motor vehicle safety guidelines. Regarding conflict preemption, the court held that the requirement under the FMVSS for driver seatbelts in buses does not preempt claims that a bus was defective because it did not come equipped with passenger seatbelts. According to the court, the relevant regulations are "absolutely silent" as to a requirement for passenger seatbelts. Thus, it is not impossible for a bus manufacturer to comply with both the federal standard, requiring a driver's seatbelt, and the principle articulated in the plaintiffs' claims, that seatbelts should have been installed for passengers, as well.
Posted by Gale Burns on Mon, Nov 07, 2011 @ 02:44 PM
November 8, 2011
Jeremy Taylor, Senior Attorney, National Legal Research Group
The U.S. Supreme Court recently decided a case involving the issue of federal preemption of state law warning claims against manufacturers of the generic drug metoclopramide. See Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011). The plaintiffs were users of the drug who filed state court actions alleging that their long-term use of metoclopramide had caused them to suffer tardive dyskinesia. In the first case, the U.S. District Court for the Eastern District of Louisiana granted in part and denied in part the manufacturer's motion to dismiss, and the manufacturer appealed. The U.S. Court of Appeals for the Fifth Circuit affirmed. In the second case, the U.S. District Court for the District of Minnesota granted the manufacturers' motions for summary judgment, and the consumer appealed. The U.S. Court of Appeals for the Eighth Circuit reversed in part. The Supreme Court granted certiorari, and the cases were consolidated. The Court ruled that federal law preempts state laws imposing a duty on generic drug manufacturers to change a drug's label.
Following approval by the Food and Drug Administration ("FDA") of the sale of metoclopramide under a brand name, generic manufacturers began producing the drug, which is used to treat digestive disorders. The plaintiffs had been prescribed the brand-name drug but had received generic metoclopramide from their pharmacists. After having used the drug for several years, both plaintiffs developed tardive dyskinesia, a severe neurological disorder. They sued the manufacturers in state court for failing to provide adequate warnings of the dangers of the drug. The manufacturers argued that federal statutes and the FDA regulations preempted the state products liability causes of action, and they asserted that because federal law required them to use the same safety and efficacy labeling as was used in their brand-name equivalents while state law required the use of a different label, it was therefore impossible for them simultaneously to comply with both federal law and state law. The Court noted that evidence has mounted that metoclopramide can cause tardive dyskinesia. As a result, warning labels for the drug have been strengthened and amended several times. In 2004, the brand-name manufacturer requested, and the FDA approved, a label change to provide that therapy with the drug should not exceed 12 weeks. In 2009, the warning was intensified to caution that treatment with the drug can cause tardive dyskinesia, an often irreversible movement disorder.
The Court began its analysis by noting that under Louisiana and Minnesota tort law, a product manufacturer has a duty to warn about dangers in its product of which it knew or should have known. The Court then observed that the FDA's "changes being effected" ("CBE") rules permit a generic drug manufacturer to change a drug's label only when the change is made to match an updated brand-name label or to follow the FDA's instructions. The Court thus framed the potential conflict between the state tort law principles urged by the plaintiffs and the FDA regulations pertaining to manufacturers of generic drugs. The Court summarized the problem in these terms: State tort law places a duty on all drug manufacturers to label their products adequately and safely, such that the defendant manufacturers were required to use a different, stronger label than they had actually used, while federal drug regulations, as interpreted by the FDA, prevented the manufacturers from unilaterally changing their generic drugs' safety labeling. The Court further posited that federal law required the generic manufacturers to request FDA assistance in urging the brand-name manufacturer to adopt a stronger label so that the generic manufacturers of the drug could change their labels to match the stronger warning.
The Court noted that under the doctrine of conflict preemption, when state and federal law directly conflict, state law must yield. The Court observed that although an express statement on preemption in a federal law is always preferable, the lack of such a statement does not end the inquiry, and the absence of express preemption furnishes no reason not to find conflict preemption. Conflict preemption may exist when it is impossible for a private party to comply with both state and federal requirements. With the issues thus stated, the Court proceeded to find impossibility in the case at hand. According to the Court, it was not lawful under federal law for the defendant manufacturers to do what state law required of them. If they had independently changed their labels to satisfy their state law duty, they would have violated federal law, which proscribes a generic drug manufacturer from making unilateral changes to its label which cause that label to differ from that of the brand-name analog. According to the plaintiffs, however, by allowing the manufacturers' labels to remain unchanged, the manufacturers violated their state tort duties. Consequently, in the Court's view, it was impossible for the manufacturers to satisfy both state and federal law, and the state law requirements thus had to give way.
Interestingly, the Court explained that its holding did not conflict with that of Wyeth v. Levine, 555 U.S. 555 (2009), in which the Court had held that state law failure-to-warn claims against a drug manufacturer were not preempted by federal law under the theory that the manufacturer could not have modified its warning label once it had been approved by the FDA and that it was therefore impossible for the manufacturer to comply with both state law warning duties and its federal labeling duties. The Wyeth Court concluded that pursuant to FDA regulations, the manufacturer could have, without waiting for FDA approval, modified its label to add to or strengthen its warning. Despite the apparent conflict with the holding in Wyeth, the Pliva Court said that due to the different treatment given to brand-name and generic manufacturers by the FDA regulations, Wyeth was not contrary. According to the Court, the CBE regulation permitted a brand-name manufacturer, as in Wyeth, to strengthen its label unilaterally, without prior FDA approval. Accordingly, it was not impossible for the manufacturer in Wyeth to comply with both its state tort duty and the federal regulations. The Court sympathized with the Pliva plaintiffs, recognizing that from their perspective, finding preemption in the case at hand but not in Wyeth "makes little sense." The Court noted that had the plaintiffs taken the brand-name metoclopramide, their state actions would not have been preempted, while the mere fortuity of their having taken the generic equivalent foreclosed their state law remedies. According to the Court, the "unfortunate hand" dealt to consumers in the position of the plaintiffs can be remedied only by Congress and the FDA.
Posted by Gale Burns on Mon, Aug 08, 2011 @ 11:45 AM
August 4, 2011
Jeremy Taylor, Senior Attorney, National Legal Research Group
A recent decision by the West Virginia Supreme Court of Appeals addressed the doctrine of forum non conveniens in the context of the availability of an action in another state whose law was significantly less favorable to the plaintiff than that of the chosen forum. See Mace v. Mylan Pharm., Inc., No. 35710, 2011 WL 2446644 (W. Va. June 16, 2011). The plaintiff in Mace was the estate of a patient who allegedly had died from an overdose of the defendants' drug delivery apparatus, called the "Mylan Fentanyl Transdermal System." The purpose of the device was to introduce narcotic pain medication into the user's body. The patient was a resident of North Carolina at the time of her death. Her husband, as personal representative of the estate, filed suit in West Virginia against the manufacturer of the drug and related entities. The defendants were variously incorporated in West Virginia and Pennsylvania and had their headquarters in West Virginia, Vermont, and Pennsylvania.
The plaintiff alleged that the patient had been prescribed "the patch" on October 21, 2005 and had died from an overdose a mere four days later while wearing the device. The personal representative filed his action on July 1, 2008. The plaintiff set forth claims for strict products liability, negligence, breach of express warranty, and breach of implied warranty. The estate sought punitive damages based upon the defendants' "deliberate, intentional reckless and/or malicious behavior." Id. at *3. The complaint further alleged that the plaintiff had not known, and that a reasonable person under the circumstances would not have had reason to know, that "the patches" prescribed for the decedent were manufactured by Mylan until less than two years before filing the complaint. The court noted that both West Virginia and North Carolina have two-year statutes of limitations for wrongful death claims.
The defendants filed a motion to dismiss based on the doctrine of forum non conveniens. In support of their motion, the defendants argued that North Carolina was the appropriate forum because the decedent had been a resident of that state at the time of her death, she had been prescribed and had used the drug apparatus in North Carolina, and she had died there. The defendants also asserted that the cause of action arose in North Carolina and that the lawsuit's only connection with West Virginia was that two of the defendants were incorporated under West Virginia law and one defendant had its headquarters there.
In resolving the defendants' motion, the court had occasion to apply West Virginia's forum non conveniens statute. This statute provides that a West Virginia court may decline to exercise jurisdiction over a matter if it finds that in the interest of justice and for the convenience of the parties, a claim or action would be more properly heard in a forum outside the state. In making this determination, the court may consider, among other things, whether an alternate forum exists in which the claim or action might be tried.
The court noted that the principle of forum non conveniens presupposes the existence of at least two forums in which the defendant is amenable to process. According to the court, in the event that the defendant is not amenable to process in any alternate forum, dismissal on the basis of forum non conveniens is erroneous. While there is a presumption that an alternate forum "exists" if the defendant is amenable to service of process there, this presumption may be overcome if the remedy in the other forum is so clearly inadequate or unsatisfactory that it amounts to no remedy at all. In such a case, the alternate forum ceases to "exist," and dismissal on the basis of forum non conveniens is legal error.
The court decided that North Carolina did not "exist" as an alternate forum, because its law would have barred the plaintiff's claim on the basis of the statute of limitations, while the law of West Virginia allowed the claim to proceed. This was so because North Carolina does not recognize the discovery rule, under which a cause of action does not accrue, for purposes of the statute of limitations, until the plaintiff knew or should have known of the existence of his or her claim against the defendant. Because the plaintiff filed his action more than two years after his wife's death, his action would have been barred without the application of the discovery rule. Therefore, according to the court, North Carolina was not a forum in which the plaintiff could attempt to litigate his claims. The court observed that the remedy provided by North Carolina was so inadequate and unsatisfactory that it was not a remedy and that, consequently, North Carolina did not "exist" as an alternate forum. Accordingly, the trial court had erred in dismissing the plaintiff's action on the ground of forum non conveniens.
The principle articulated in Mace clearly is useful to a products liability plaintiff whom a defendant attempts to steer toward another jurisdiction having less favorable law. The effect of trying the action in the other state would have been drastic in Mace, in that the case would have been barred by the statute of limitations. Whether less onerous consequences of trying an action in an alternate forum would cause that forum to cease to "exist," so as to bar dismissal under the doctrine of forum non conveniens, is an open question. However, Mace provides a guidepost for an argument that when the law of an alternate forum raises severe obstacles to the plaintiff's cause of action, application of the doctrine of forum non conveniens is not appropriate.
Posted by Gale Burns on Tue, Apr 26, 2011 @ 12:40 PM
April 26, 2011
Jeremy Taylor, Senior Attorney, National Legal Research Group
A recent decision by a U.S. District Court in Pennsylvania combined, in an interesting way, the issues of removal of a case to federal court and of the potential responsibility under a products liability theory of the publisher of an "education monograph" containing warnings about a prescription drug. See Slater v. Hoffman-La Roche, Inc., Civ. Action No. 10-6956, 2011 WL 1087240, at *1 (E.D. Pa. Mar. 24, 2011). The plaintiff sued the manufacturer of the acne drug Accutane, alleging that the drug had caused him to develop colitis and ulcerative colitis. The plaintiff also sued the publisher of a monograph explaining the dangers of Accutane. The plaintiff was a resident of Wisconsin, the drug manufacturer was a resident of New Jersey, and the publisher of the educational monograph was a Delaware corporation with its principal place of business in Pennsylvania. Following the plaintiff's filing in Pennsylvania state court, the defendants removed the action to the federal district court. The plaintiff moved to remand the case to the state court. The court noted that unless the publisher had been fraudulently joined, the claims against it had to be remanded, in light of the rule that removal to federal court is permissible only if none of the parties in interest properly joined and served as defendants is a citizen of the state in which the action has been brought. See 28 U.S.C. § 1441(b).
Turning to the question of improper joinder, the court observed that under the doctrine of fraudulent joinder, a defendant may remove an action if it can establish that any in-state resident or nondiverse defendant was fraudulently named or joined solely to prevent removal or to defeat federal court jurisdiction. If the court determines that joinder was fraudulent in that sense, then it can dismiss the resident or nondiverse defendant and retain jurisdiction over the remainder of the case. The court explained that joinder should be found fraudulent only if the claims against the resident or nondiverse defendant are wholly insubstantial and frivolous. In making this determination, the court was tasked with deciding whether the plaintiff could state a nonfrivolous claim against the publisher of the educational monograph warning about the dangers of Accutane.
The drug manufacturer argued that the publisher had been fraudulently joined because that party was shielded from liability by Pennsylvania's learned intermediary doctrine. The learned intermediary doctrine provides that nonphysicians such as pharmacists and drug manufacturers have no independent duty to warn about the dangers and side effects of prescription drugs. The court noted, however, that the plaintiff was not arguing that the publisher had an independent duty to warn. Instead, the plaintiff's primary theory was that the publisher had voluntarily assumed a duty to exercise due care in issuing drug warnings by virtue of the fact that it had furnished written drug information to users. The drug manufacturer argued that the plaintiff had failed to cite any Pennsylvania authority imposing such a duty on pharmacies or monograph publishers.
The court rejected the drug manufacturer's argument, concluding that the plaintiff's claims against the publisher were sufficient to overcome the assertion of fraudulent joinder. The court observed that the drug manufacturer had failed to identify any Pennsylvania case law declining to impose a duty of due care on monograph publishers or pharmacies when they voluntarily undertake to provide drug warnings to patients. Citing a Massachusetts decision, the court noted that at least one state court has held that although a pharmacy has no general duty to warn, it might undertake such a duty when it provides a detailed list of warnings or it promises to furnish information to customers. The court concluded that under such authority, a Pennsylvania state court could find that the publisher of the educational monograph had assumed a duty to the plaintiff based upon its voluntary provision of the monograph containing warnings about Accutane. Because the drug manufacturer therefore failed to establish that the plaintiff's theory was wholly frivolous, the court determined that the joinder of the publisher as a defendant had not been fraudulent.
Slater furnishes a good example of the analysis applicable to the determination of fraudulent joinder, and it does so in the context of an interesting, and as yet undeveloped, point of products liability law. In light of the fact that the first response of a manufacturer sued in state court is frequently to remove the case to federal court, Slater provides guidance as to the issues that are likely to arise and how a court may approach them.
Posted by Gale Burns on Mon, Jan 17, 2011 @ 11:31 AM
January 18, 2011
Jeremy Taylor, Senior Attorney, National Legal Research Group
A recent decision by the U.S. District Court for the District of New Hampshire addressed a number of issues regarding defective design of an anti-inflammatory drug, in upholding a jury verdict of over $21 million in favor of the plaintiff. See Bartlett v. Mut. Pharm. Co., Civ. No. 08‑cv‑358‑JL, 2011 DNH 004 (D.N.H. Jan. 5, 2011). The plaintiff alleged that her use of the defendant's drug "sulindac" had caused her to suffer severe and permanent injuries, including blindness. Specifically, the plaintiff had contracted Stevens-Johnson Syndrome ("SJS"), progressing to toxic epidermal necrolysis ("TEN"), as a result of her use of sulindac. The plaintiff asserted claims of strict liability for defective design, strict liability for failure to warn, fraud, and negligence under state law. The district court granted the manufacturer's motion for summary judgment on all but the plaintiff's defective design claim, which was the sole cause of action proceeding to trial. The jury found in the plaintiff's favor and awarded her $21.06 million in compensatory damages, including $16.5 million for pain and suffering. Following the verdict, the defendant manufacturer renewed its motion for judgment as a matter of law under Federal Rule of Civil Procedure 50(b), arguing that there was insufficient evidence to support the plaintiff's claim.
The court rejected the defendant's argument that a controlled study is the only basis upon which risk may be quantified in a defective design case involving a drug. In so concluding, the court noted that in many cases involving unusual side effects, no controlled study is available. The manufacturer argued that without any evidence of the actual incidence rate of the plaintiff's injuries caused by sulindac, the jury had no reasonable manner in which to quantify the risk, for purposes of New Hampshire's risk/benefit test for defective product design. Under New Hampshire law, a product is defective in design if the magnitude of the danger outweighs the utility of the product. The court noted that under the New Hampshire risk/benefit test, a plaintiff is not required to present evidence of a safer alternative design. Rather, a product is defective in design if it does not meet the risk/utility balancing standards viewed from the perspective of the public as a whole, not just a particular subset of the public. The court held that the jury's determination that sulindac's risks outweighed its benefits was supported by sufficient evidence, including testimony by the plaintiff's expert witnesses that the drug had been confirmed to cause SJS/TEN and that the Food and Drug Administration had received 133 reports of such harm attributed to the drug in 25 years, 39 of which had resulted in death. The court also stated that under New Hampshire law, the plaintiff was not required, as part of her defective design case, to prove that the drug had any defect in design other than the fact that its risks outweighed its benefits.
As to the quantum of damages awarded by the jury, the court noted that various witnesses had testified as to the horrors of the progression of SJS to TEN caused by the defendant's drug. The court rejected the defendant's argument that such evidence should have been excluded on grounds of unfair prejudice—even though some witnesses had gone into graphic detail and some photographs shown to the jury had been unpleasant—in light of the fact that each witness had had something different to add, that the plaintiff's SJS/TEN had caused many different injuries and required treatment by many physicians, and that the plaintiff's experience, including a medically induced coma, was beyond the ken of the average juror. The court concluded that the jury's award, including $16.5 million for pain and suffering, was supported by the evidence and was not excessive. Observing that the award for pain and suffering was less than four times the plaintiff's special damages, the court noted that the plaintiff had suffered burns and lost skin over nearly two-thirds of her body, she had been in a medically induced coma for months, she had gone blind, she had lost the ability to have sexual intercourse, and she suffered from posttraumatic stress disorder.
Bartlett is noteworthy not only for the size of the award of damages, but for the fact that the court concluded that an award of such magnitude was sustainable simply on the basis of the application of the risk/benefit test from the perspective of the general public, without the necessity of proof of any other design defect in the drug and without evidence of a controlled study. This principle clearly may prove useful to plaintiffs' products liability practitioners in drug injury cases.
Posted by Gale Burns on Fri, Jan 07, 2011 @ 02:58 PM
November 9, 2010
Jeremy Taylor, Senior Attorney, National Legal Research Group
The question of federal preemption of state products liability causes of action arises frequently because preemption can be a complete defense to state tort liability. In the arena of prescription drugs, the U.S. Supreme Court, in Wyeth v. Levine, 129 S. Ct. 1187 (2009), held that a state products liability lawsuit was not preempted by the Federal Food, Drug, and Cosmetic Act ("FDCA") on the theory that under the Act, the Food and Drug Administration ("FDA") approves and controls the content of prescription drug labeling. Part of the Court's reasoning was that throughout its history, the FDCA has required drug manufacturers to remain responsible for the contents of their labels at all times. Accordingly, pursuant to the FDCA, a drug manufacturer must both create an adequate label and ensure that the warnings remain adequate for as long as a drug is on the market. The Court found no conflict between these federal requirements and state tort law that imposes a stronger warning requirement.
While the absence of federal preemption may thus assist a products liability plaintiff in maintaining an affirmative claim against a drug manufacturer, in an interesting twist, the court in Yocham v. Novartis Pharm. Corp., Civ. No. 07-1810 (JBS/AMD), 2010 WL 3502670 (D.N.J. Aug. 31, 2010), recently addressed the issue of whether a state statute providing a defense to liability in failure-to-warn cases against drug manufacturers, specifically an exception to the defense, was preempted by the FDCA. The court held that it was not and, on that basis, denied in part the defendant manufacturer's motion for summary judgment.
At the threshold, the Yocham court was tasked with determining which state's law would apply to the plaintiff's claims. Both the law of New Jersey and that of Texas were potentially applicable. The court noted that there was an actual conflict between the law of these two states because, while both New Jersey and Texas have statutes codifying a presumption that a warning approved by the FDA is adequate, in Texas the methods by which the presumption can be overcome are enumerated in the statute, while in New Jersey they are not.
In the case at hand, the sole method by which the presumption of an adequate warning could be overcome under the Texas statute was by showing that the manufacturer withheld from or misrepresented to the FDA required information that was material and relevant to the performance of the product. In addition, the Texas statute does not permit a design defect claim for prescription drugs with otherwise adequate warnings, while, in New Jersey, common-law breach of implied warranty and fraud claims is subsumed within the Products Liability Act, which creates a single, statutory cause of action for such claims. Applying the New Jersey governmental interest test, the court held that the law of Texas governed the plaintiff's claims.
The defendant manufacturer argued that under Texas law, it was entitled to the statutory defense based upon the FDA's approval of its warnings, without the exception applicable when the FDA has been misled. As the basis for its assertion that it was protected by the favorable portion of the statute without the unfavorable exception, the manufacturer argued that the exception was preempted by federal law.
The court held that a tort based exclusively on fraud against the FDA is preempted by federal law but that the exception in the Texas statute is not. The court began its analysis by noting that the Supreme Court, in Buckman v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001), had held that a state cause of action for injuries caused by misrepresentations made to the FDA is impliedly preempted by the FDCA because permitting such a state cause of action would interfere with the federal scheme of regulation. The Yocham court observed that the federal courts of appeals are split over whether the "middle case"—a traditional tort that is not exclusively based on fraud against the FDA but requires proof of such fraud as part of the tort—is preempted. Addressing the presumption against federal preemption, the court held that such a "middle case" and the Texas statute were not preempted.
The court noted that the finding of preemption in Buckman was based upon the fact that the state was not regulating in a field which states have traditionally occupied by providing for a fraud on the FDA tort. Here, by contrast, Texas imposes a duty to warn only when the injury is likely to result from the manufacturer's failure to warn, a more limited liability distinct from that in which any insufficient or incorrect information is furnished to the FDA. According to the court, the Texas statute does not regulate a drug manufacturer's interaction with the FDA but defers to FDA findings in all but exceptional circumstances in order to narrow the manufacturer's traditional tort duties. In a "stand alone" fraud on the FDA claim, the only conduct being regulated is a manufacturer's interaction with the FDA—in which a state has no traditional interest—while, when a state decides that it will defer to the FDA's findings that coincide with findings related to an overlapping but preexisting common-law duty, the matter falls at least somewhat within the sphere of traditional state interests.
This distinction between "stand alone" fraud on the FDA claims and a state statute setting forth a traditional tort with an exception to an affirmative defense affects both the applicability of the presumption against preemption, which requires at least some state interest in order to apply, and the extent of a state law's conflict with the scheme of federal regulation. According to the court, the risk that drug manufacturers will avoid submitting drugs for approval because they might be found liable for violating reporting requirements and the related risk that manufacturers will overwhelm the FDA with information for those drugs that they do choose to submit are substantially diminished when state law also requires the violation of an independent and narrower state duty to warn.
Yocham thus exemplifies the distinction in a preemption analysis between a fraud on the FDA claim and an exception to an affirmative defense arising from fraud on the FDA. In making this distinction, the Yocham court's analysis draws from many of the important, and often subtle, components of federal preemption jurisprudence in the environment of prescription drug litigation.