United States: Parallel Claims, The First Amendment And FDA's Permissive View Of Private Enforcement

Last Updated: September 25 2015
Article by Michael A. Walsh

The tracks of "parallel claims" are often federal claims treated as parallel state law claims when viewed by a court through a lens focused on providing a remedy. With the circuit courts divided on how to define "parallel claims," the government has been flip-flopping from its previous view favoring preemp­tion to a permissive view favoring private enforcement of the Food Drug and Cos­metic Act (FDCA). The Supreme Court has had a number of opportunities to add clar­ity to the confusion, but neglected to do so most notably in Stengel v. Medtronic, 2013 U.S. App. Lexis 621 (9th Cir. Jan. 10, 2013), cert. denied (U.S. June 23, 2014). The Court invited the government to weigh in on the issue in Stengel and the government's position supported the purported paral­lel claim while recognizing the disarray in the lower courts applying the parallel claim doctrine. The government's permis­sive view of private claims under the FDCA has been advanced more recently in two cases, Allergan et al. v. Athena, 738 F.3d 1350 (Fed. Cir. 2013), cert. denied (No. 13-1286) (June 29, 2015) and Amarin v. FDA, 1:15-cv-03588-PAE, Doc. 73 (S.D.N.Y. Aug. 7, 2015). In these two cases there has been a further shifting of a tectonic plate and the bedrock upon which preemption rests has undergone a seismic shift that has yet to be fully realized. In Allergan v Athena the issue was whether the FDA is the sole arbiter of deciding whether con­duct and statements render a product a new drug. Both of these cases were brought by manufacturers and the holdings in both are double edged swords. In Amarin v FDA, the government suffered a devastating blow to the untenable position it has taken con­cerning the landmark First Amendment ruling in U.S. v. Caronia, 703 F.3d 149 (2d Cir. 2012), upholding the First Amendment prohibition of the power to regulate truth­ful speech concerning approved products.

Before defense counsel and manufacturers applaud too loudly, we might consider that the sword that cut the FDA's power to crim­inalize truthful speech in both Caronia and Amarin has two sides and the second side may cut deeper and create a duty to speak. The sharper edge of the sword may well be to undercut reliance on the FDA as the sole arbiter of claims arising under the FDCA. Indeed, reliance on the FDA's pri­mary jurisdiction and discretion to control manufacturer's communications has been the bulwark of preemption defense for fail­ure to warn claims. Where the FDA's power is limited, so too is the preemption defense.

The Birth of Parallel Claims—A Brief History

Three Supreme Court cases form the foun­dation for federal preemption and parallel claims for medical devices under the FDCA. See Medtronic Inc. v. Lohr, 518 U.S. 470 (1996); Buckman v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001); Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). Another trio of Supreme Court cases addresses preemp­tion in the context of approved drugs. See Wyeth v. Levine, 555 U.S. 555 (2009); Pliva Inc. v. Mensing, 131 S. Ct. 2567 (2011); Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013).

In Lohr, the Supreme Court held that the FDCA does not preempt "a traditional dam­ages remedy for violations of common-law duties when those duties parallel federal re­quirements." Lohr, 518 U.S. at 495. Buckman purports to refine the issue, allowing tort claims when plaintiffs are "relying on tradi­tional state tort law" but not when the FDCA "is a critical element in their case." Buck­man, 531 U.S. at 353. In Riegel, the Court established a two-prong test for determin­ing if a state-law tort claim could proceed: (1) has the FDA established applicable "re­quirements"? and (2) does the state law at issue create a requirement related to safety or effectiveness that is "different from or in addition to the federal requirement?" Rie­gel, 552 U.S. at 322. Despite these Court rul­ings, the precise contours defining "parallel claims" remain uncertain.

In the confusion that has followed, courts have reached various conclusions, and the government has morphed from being possessive of claims under the FDCA to being permissive of state claims under the FDCA. Further muddling the paral­lel claim landscape are three circuit court opinions that permitted state law tort claims for conduct under the FDCA. See Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), cert. denied, 132 S. Ct. 498 (2011); Hughes v. Boston Scientific, 631 F.3d 762 (5th Cir. 2011); Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc).

In Bausch v. Stryker Corp., the Sev­enth Circuit focused on the violation of federal law as supporting the state law claim and reversed the trial court dis­missal on preemption grounds. 630 F.3d at 546. The court was befuddled that Con­gress would leave a plaintiff without a rem­edy. Accusing the defendant of attempting to stretch the bounds of preemption, the court tore the fabric of preemption, con­cluding that preemption "protection does not apply where the patient can prove that she was hurt by the manufacturer's viola­tion of federal law." Id. at 549–50. Accord­ingly, the Seventh Circuit held that "the [Supreme] Court's opinions in Lohr and Riegel expressly left the door open for state law claims based on violations of federal law." Id. at 550. In reaching this decision, the court relied on the following expla­nation of the distinction provided by the Supreme Court in Lohr based on "the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements." The Court observed that a state law claim does not trample preemption consider­ations because "[t]he presence of a damages remedy does not amount to the additional or different 'requirement' that is necessary under the statute; rather, it merely pro­vides another reason for manufacturers to comply with identical existing 'require­ments' under federal law." Lohr, 518 U.S. at 495 (reversing dismissal of complaint). Thus, determining whether the plaintiff is enforcing the FDCA or pursuing a state law claim premised on a violation of the FDCA is a distinction with a difference.

The court in Bausch also discussed Rie­gel at length, remarking that section 360k preempted the state requirements implicit in the Riegel case's common law claims that were different from or in addition to the federal requirements. Bausch, 630 F.3d at 552. The court observed that "§360k does not prevent a State from providing a dam­ages remedy for claims premised on a vio­lation of FDA regulations; the state duties in such a case 'parallel,' rather than add to, federal requirements." Id.

Bausch is not without its critics. For example, the district court in Hafer v. Medtronic, Inc., No. 2:13-cv-02340, slip op. (W.D. Tenn. Apr. 13, 2015), expressly rejected Bausch, taking issue with the idea that a violation of federal law removes pre­emption concerns. Id. at fn. 6.

In Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011), the court held that the plaintiff's state-law failure-to-warn claim was not preempted "to the extent that this claim is predicated on Boston Scien­tific's failure to comply with the applica­ble federal statutes and regulations." Id. at 764. The Fifth Circuit stated that Riegel and Lohr "make clear" that a manufacturer is not protected from state tort liability when the claim is based on the manufacturer's violation of federal requirements. Id. at 767.

The Fifth Circuit found that state law product liability claims that purport to impose liability despite compliance with the FDA design and manufacturing spec­ifications, as approved by the FDA during the premarket approval (PMA) process, seek to impose different or additional state duties and the federal law expressly pre­empts them. Id. at 769. However, the court reached a different conclusion about the state law claims based on a failure to com­ply with federal regulations. Id. The court reasoned that "§360k does not prevent a State from providing a damages remedy for claims premised on violation of FDA regu­lations." Id. at 769. According to the court, the state duties that "parallel" the federal requirements were "accurately report[ing] serious injuries and malfunctions of the [Hysteroscopic Thermal Ablation] device as required by the FDA's [Medical Device Reporting] regulations." Hughes, 631 F.3d at 770.

In Bass v. Stryker, 669 F.3d 501 (5th Cir. 2012), the court further defined the necessity of pleading a violation of federal law to avoid preemption. In that case, the plaintiff claimed that a hip replacement product malfunctioned and caused injury, alleging a variety of state law claims. The court explained that the FDA need not have found a violation but that "the cause of action survived where the plaintiff pro­vided expert testimony showing that the medical device manufacturer had "vio­lated the plain text of the [Medical Device Reporting] regulations." Id. at 509–10 (cita­tions omitted).

The court in Bass went on to state that if "a plaintiff pleads that a manufacturer of a Class III medical device failed to comply with either the specific processes and proce­dures that were approved by the FDA or the CGMPs [Current Good Manufacturing Pro­cess Guidelines] themselves and that this failure caused the injury, the plaintiff will have pleaded a parallel claim." Id. at 512.

Nonetheless, while the court permit­ted claims premised on violations of good manufacturing processes, the FDA had cited the defendant for the same conduct that plaintiff was suing for. Id. at 513.

The Government's Jagged Parallel Line

In Stengel v. Medtronic, 2013 U.S. App. Lexis 621 (9th Cir. Jan. 10, 2013), cert. denied (U.S. June 23, 2014) (No. 1 2-1351), the plaintiffs sued under state law claim­ing that the defendant's product caused a granuloma and rendered one plaintiff per­manently paraplegic after it was implanted in 2005. The label did not warn of certain adverse events that were not known at the time that the FDA cleared the product originally, and they only became known after the product was on the market. Id. at *6. According to the Stengels, the FDA discovered the risks, and discovered that Medtronic already knew about them, when it inspected a Medtronic facility in late 2006 and early 2007. Id. The FDA sent a warning letter in July 2007, stating that Medtronic had "misbranded" its Class III device by concealing known risks, in violation of 21 C.F.R. §§803.50(a)(1), and 806.10(a)(1). Id. In response to the FDA's warning let­ter, in early 2008, Medtronic sent a Medi­cal Device Correction letter to doctors and shortly after recalled the device. Id.

The district court granted Medtronic's motion to dismiss on preemption grounds. See id. at *25. After an en banc review, the Ninth Circuit reversed, finding that the Medical Device Amendments (MDA) to the FDCA did not preempt a state law claim in which the state law duty of care "parallels" a federal law duty imposed by the MDA. See id. Citing Riegel, the Ninth Circuit found that the claims were par­allel to the federal requirement and not preempted, holding that "§360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations." Stengel, 2013 U.S. App. Lexis 62, at *15.

The court found that the ambiguity in the term "requirement" did not signal the intent of Congress to deprive the states of taking roles in protecting consumers from the dangers inherent in many medi­cal devices. To find a remedy for the Sten­gels, the court observed that "[t]he whole modern law of negligence, with its many developments, enforces the duty of fel­low-citizens to observe in varying cir­cumstances an appropriate measure of prudence to avoid causing harm to one another." Id. at *22–23 (citations omitted).

The court found that Arizona law con­templates a warning to a third party such as the FDA and that "[u]nder Arizona law, a warning to a third party satisfies a man­ufacturer's duty if, given the nature of the warning and the relationship of the third party, there is 'reasonable assurance' that the information will reach those whose safety depends on their having it." Id. at *23–24.

What was at issue in Stengel was the scope of the "parallel duty" exception to federal preemption of tort claims for FDA-approved medical products. More pre­cisely, whenever a device-specific federal duty constitutes a federal "requirement" under §360k(a) and a state law duty paral­lels that "requirement," is the parallel duty exception limited to device-specific fed­eral duties, or does it extend to the gener­ally applicable federal reporting duty, such as the one at issue in Stengel?

The Government's New Approach (or the Emperor Parades His New Clothes)

In its brief to the Supreme Court in Stengel, the government took a very different view than in previous cases, stating that preemp­tion extends to device-specific claims but does not apply to claims that are not based on the FDA's device-specific requirements. The government stated that it is a "mis­taken premise that general federal require­ments ordinarily do have preemptive effect under Section 360k(a)." Gov't Br. at 24–25. The government asserted that Stengel is not an appropriate vehicle to decide the scope of parallel claims and that Supreme Court review was unnecessary. See id. at 36. In addition, the government stated that the circuit courts are consistent but wrong and any "tension" with Buckman is based on the Ninth Circuit's "unnecessary reliance on a tortuous theory of causation." See Gov't Br. at 37. Thus, according to the government, the Stengel's failure to warn claims were not preempted, but for reasons different from those relied on by the lower courts:

Section 360k(a) does not preempt respondents' straightforward claim that petitioner should have brought new safety information to physicians' attention through a CBE [changes being effected] revision to the device's label­ing, because such a claim implicates no preemptive device-specific federal requirement. As for implied preemp­tion, such a claim does not implicate Buckman; rather it closely resembles the claim against the brand-name prescrip­tion drug manufacturer that Wyeth held was not impliedly preempted.

Id. at 14–15.

The court of appeals' conclusion that respondents' failure-to-warn claim is not expressly preempted is correct, but for a different and more basic reason than the court identified: the federal requirements relevant to respondents' claim are not device-specific, and there­fore they do not have preemptive effect under Section 360k(a).

Id. at 16.

According to the government, to have preemptive force under §360k(a), a federal requirement ordinarily must be not only device-specific, but also relevant to the as­serted state claim. Id. at 18. In the govern­ment's newly formed view, a claim against a device manufacturer is viable if the plaintiff is "suing for conduct that violates the FDCA (or else his claim is expressly preempted by [Section] 360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly pre­empted under Buckman)." Id. at 38.

In response to the government's newly minted approach to preemption, the de­fendant pointed out that the government "once shared the view that Section 360k(a) generally preempts a state requirement that is different from, or in addition to a fed­eral requirement." See Medtronic Supple­mental Br. at 9. Moreover, the government took an extreme position that "every court of appeals is wrong" yet still maintained that the Supreme Court's guidance was not needed. Id. at 1.

Medtronic highlighted the dilemma, suggesting that if a state law duty "derived from highly generalized tort-law princi­ples in the Restatement (Second) of Torts" was deemed sufficiently independent to escape preemption, states could freely cir­cumvent §337(a) at will. Id. at 5. The de­fendant pointed out that the government's new approach to preemption contradicted its previous position that "plaintiffs can­not evade Buckman by camouflaging fed­eral-law claims in state-law clothes." Id. Questioning whether the government's shifting position should receive deference, the manufacturer stated that the govern­ment's "views deserve no deference when, as here, it fails even to acknowledge, much less explain, its departure from prior posi­tions." Id. at 6.

On June 23, 2014, the Supreme Court denied certiorari in Stengel, leaving intact the Ninth Circuit's reversal of the dis­trict court decision denying the plaintiffs' motion to amend the complaint to assert a parallel state law failure to warn claim. The case was remanded to the district court to determine whether the plaintiffs should be permitted to further amend their com­plaint in light of the Ninth Circuit's view of parallel state law claims.

The saga in Stengel continued and fol­lowed a tortured course. During the pen­dency of the action, the Stengels divorced, and then then Mr. Stengel died. The ex- Mrs. Stengel attempted to step in as the plaintiff but procedural errors were made, and her claims were dismissed. The court allowed an amendment to add the dece­dent's son, and he filed an amended com­plaint purporting to follow the blueprint provided by the Ninth Circuit.

Three Infuse Bone Graft Cases After Stengel with Similar Results

In Beavers–Gabriel v. Medtronic, Inc., 2015 U.S. Dist. Lexis 2522 (D Hawaii Jan. 9, 2015), it was alleged that Medtronic promoted the device for an off-label purpose, hid the side effects, and induced the implanting physician "to use the Infuse Device in an off-label manner by Medtronic's false rep­resentations and omissions." Id. at *4. The court cited Stengel, noting that the negli­gence claim "is a state-law claim that is in­dependent of the FDA's pre-market approval process" and "rests on a state-law duty that parallels a federal-law duty under the [Med­ical Device Amendments]...." Similar to Arizona law, Hawaii law imposes a general duty of reasonable care on product manu­facturers and recognizes a cause of action for failure to warn. Id at *34–35.

The court in Beavers chided the de­fendant, stating: "Defendants largely ignore Stengel and instead attempt to recast Plain­tiff's failure-to-warn claims as boiling down to a challenge of the FDA labeling." Id at *35. The court concluded:

"[The p]laintiff is not challenging the labeling of the Infuse Device [a claim the court dismissed without leave to amend], but rather is asserting a straightforward Stengel claim—that Defendants failed to provide required information to the FDA, which, if Dr. Graham was aware of, would have affected his decision to use the Infuse Device for Plaintiff's surgery."

Id. at *37 (emphasis added). See also Gaross v. Medtronic, Inc., 2015 U.S. Dist. LEXIS 6675 (Jan. 21, 2015); Buccelli v. Medtronic, Inc., No. 2014-cv-001667, slip op. (Cir. Ct. Sarasota, Fla. Jan. 27, 2015).

Highlighting the confusion in the courts concerning purported parallel claims, cases at odds with Stengel also abound, particularly concerning off-label promo­tion. See Caplinger v. Medtronic, 2015 U.S. App. Lexis 6630 (10th Cir. April 21, 2015) (finding no parallel claim and concluding that the state law off-label claim was pre­empted); Otis-Wisher v. Medtronic, 2015 U.S. App. Lexis 9565, at *2 (2d Cir. June 9, 2015) ("the weight of authority both in this Circuit and elsewhere casts doubts on the viability of such [off-label] claims"); Hafer v. Medtronic, Inc., No. 2:13-cv-02340, slip op. (W.D. Tenn. Apr. 13, 2015) (dismissing 141 cases and granting leave to re-plead, but nonetheless finding "[t]o the extent that this claim is based on allegations that Medtronic made misrepresentations and omissions in promoting off-label use of the Infuse® device, the Court finds this claim is neither expressly nor impliedly preempted."). Id. at 9.

In Byrnes v. Small, 2015 U.S. Dist. Lexis 33555 (MD Fla. Mar. 18, 2015), a case fol­lowing the path of Stengel, the court noted the confusion in the case law addressing parallel claims:

Many courts have addressed issues that are nearly-identical, if not identical, to the ones currently before this Court. Many have reached conclusions that differ in a multitude of ways, and can­not be reconciled easily, if at all. Hav­ing conducted an exhaustive review of those opinions and the reasoning behind them, the Court has applied the general principle that claims premised on voluntary, affirmative falsehoods are not preempted.

Id. at *26.

Off-Label Parallel Claims and Who Decides if a Product Requires Regulatory Approval?

The FDA suggested that it would meet in the summer of 2015 to hear public com­ments on whether it will loosen the reins on what it considers impermissible conduct rendering a product a new drug requir­ing regulatory approval. Perhaps the FDA had had its fill after reaping in over $12 billion in penalties. More likely, the land­mark decision in U.S. v. Caronia, 703 F.3d 149 (2d Cir. 2012), was the watershed deci­sion that most commentators, except the FDA and former government lawyers, said it was. Further fueling the flames, Con­gress is advancing the "Cures Act" with a provision that will reshape how the gov­ernment regulates manufacturers' con­duct concerning off-label and new uses for approved products. In addition, the gov­ernment's regime for limiting communica­tion of scientific and medical information, for uses beyond those in the approved labeling has been challenged in Citizen's petitions. Docket Nos. FDA-2011-P-0512 and FDA-2013-P-1079). As the FDA has wrangled over how to fashion appropriate rules, the FDA has had its ability to con­sider promotional conduct as violating the FDCA significantly curtailed in Amarin v. FDA, 1:15-cv-03588-PAE, Doc. 73 (S.D.N.Y. Aug. 7, 2015).

While it is unclear what form any new rule by the FDA may take, what is emerg­ing is an erosion of the primacy of the FDA to determine whether statements or con­duct render a product "new" for regula­tory approval or clearance purposes. This erosion allows room for courts and juries to decide. Indeed, the firestorm of con­troversy about whether communications or failing to communicate may have vio­lated the FDCA demonstrates that the gov­ernment seems uncertain about the scope of conduct it may prohibit. If anything is clear, it is that unleashing determinations under state law for claims under the FDCA will only aggravate the maelstrom.

As the parallel claim brouhaha contin­ues, courts continue to contort decision making to draw a straight line from the spaghetti bowl of cases applying federal preemption to state law parallel claims, particularly for off-label promotion. For example, in Caplinger v. Medtronic, 2015 U.S. App. Lexis 6630 (10th Cir. April 21, 2015), the Tenth Circuit observed that off-label promotion claims concerning Medtronic's Infuse Device did not war­rant delving into the FDCA or FDA reg­ulations to craft a cognizable claim that would avoid the constraints of murky but overwhelming Supreme Court preemption precedent. While affirming the lower court dismissal of the complaint on preemp­tion grounds, the court wrestled with the morass of Supreme Court "parallel claim" preemption precedent and whether a state tort claim could survive the supremacy clause. Id. at *8.

Recognizing the confusion in the courts, the Tenth Circuit Court has stated that it is "no easy task" to fathom the Supreme Court dictates and went on to suggest that the Supreme Court needed to clarify them. Id. at *12–13 (citations omitted).

Musing on the plaintiff's inability to fashion a cognizable claim, the court sug­gested that a plaintiff might scour the 593 pages of FDA regulations, and "lurking in there somewhere might be some answer to the apparent conundrum of how a plaintiff might use state law to require more label warnings that federal law seems to pro­hibit." Id. at *18.

The Caplinger case is not notable merely because plaintiff failed to frame a cogniza­ble cause of action. What is more troubling about this case is how the court recognized the trend adopted by plaintiffs to rely on an "off-label promotion" claim to circum­vent preemption. The court observed: "In not a single one of its many and involved encounters with the MDA has the Supreme Court so much as hinted at this [off-label promotion] alternative path around pre­emption. But Ms. Caplinger says its past obscurity shouldn't stop us from recogniz­ing it now." Id. at *23.

The Tenth Circuit conflated an off-label use by a physician practicing medicine with marketing an unapproved device by a manufacturer. The court was concerned about stifling innovation or limiting life­saving therapy, which are consistent with Supreme Court rulings and positions that the FDA has taken. Id. at *29–30. The court was correct perhaps for the wrong reason. The preemption provided under §360k does not reference off-label in an effort to pro­tect innovation but because clearance is premised solely on specific approved uses.

The road ahead is not nearly as clear as the Tenth Circuit may surmise because what §360k and §396 tell us is that irre­spective of any "use" that differs from the approved labeled use, when the FDA seeks enforcement against manufactur­ers for purported "off-label promotion," it penalizes manufacturers for marketing an unapproved new device. Section 396 prohibits the FDA from exerting author­ity over physicians "using" a device off label, but the prohibition does not expressly extend to "promotion" by manufactur­ers. What the court and the plaintiff did not address is that a "use" is relegated to the realm of medical judgment, whereas a device is a "new device" is the realm of FDA, and deciding this issue up until now has rightfully been the sole responsibility of the FDA.

As in most purported "off-label" tort cases, the defendant in Caplinger was saved by the inability of the plaintiff to articulate facts sufficient to support a parallel claim for off-label promotional conduct. The FDCA is not a work crafted with precision, nor are the Supreme Court opinions allow­ing for a state law tort claim to "parallel" the FDCA. Until and unless the Supreme Court or Congress take a good hard look at the underlying policy considerations sur­rounding off-label use for approved prod­ucts, the "conundrum" noted by the Tenth Circuit in Caplinger will continue. The result for the manufacturer in Caplinger was good, but the Tenth Circuit's opinion does not put the preemption issue to rest. Instead, it portends more litigation.

Allergan v. Athena: Winning the Battle to Lose the War

In June 2015 industry received the final word on a self-inflicted wound when the Supreme Court denied the petition for cer­tiorari in Allergan et al. v. Athena, 738 F.3d 1350 (Fed. Cir. 2013), cert. denied (No. 13-1286) (June 29, 2015), leaving intact a circuit court opinion that could reshape the landscape for off-label claims purport­ing to parallel the FDCA. In Allergan, the claims involved California's Unfair Com­petition Law (UCL). Cal. Bus. & Prof. Code §17200 et seq. Allergan marketed an FDA-approved drug, and Athena was marketing a cosmetic. Both products were similarly formulated and were used for the same purpose. See id. at 1353. Allergan claimed that Athena violated the FDCA by market­ing a cosmetic as a drug. See id. The court of appeals agreed with the district court's grant of summary judgment finding that Athena violated the UCL by "marketing, distributing and selling, without regu­latory approval, products that qualify as drugs." Id. at 1352.

As is true in many states, California's Health Code (the California FDCA) mir­rors and incorporates various provisions of the federal FDCA. The Federal Circuit reasoned its way around the doctrines of primary jurisdiction and preemption, con­cluding that references in the complaint to the FDCA were merely "referential." See id. at 1354, 1357–58. Athena argued that Aller­gan's claims exist because of the FDCA and required deference to a determination by the FDA concerning whether Athena mar­keted a drug or a cosmetic. See id. at 1355. Allergan argued that its state law claims merely "parallel" federal law and rely on a violation of the California FDCA. See id.

The Federal Circuit agreed with Aller­gan that the FDCA does not by implication preempt UCL claims when the claims rely on the California FDCA and not the federal FDCA. See id. at 1357–58. Citing Buckman, the Federal Circuit acknowledged "the his­toric primacy of state regulation on mat­ters of health and safety," Buckman, 531 U.S. at 348 (finding the "fact that the Cali­fornia Health Code parallels certain FDCA provisions does not mean that it does not implicate an historic state power that may be vindicated under state law tort princi­ples."). See Allergan, 738 F.3d at 1355.

The definition of a "drug" under the California FDCA mirrors that of the fed­eral FDCA, and whether a substance is a drug is determined by the manufactur­er's "intended use." The term "intended use" is only defined under the FDA regu­lations, and not under California state law. Under the federal scheme, the FDA applies its expertise to determine a manufactur­er's "intended use" of a product. To make this determination, the FDA looks to "such persons' expressions [as] may be shown by the circumstances surrounding the dis­tribution of the article, including labeling claims, advertising matter, or oral or writ­ten statements by such persons or their representatives." 28 C.F.R. §201.128. His­torically, and as demonstrated by the reg­ulatory record and government positions in Allergan and Amarin, infra, the exper­tise FDA brings to bear to make this deter­mination demands deference and preempts any purported "parallel" state law assess­ment. The alchemy at play in the Federal Circuit's analysis in Allergan was that the FDA regulation on "intended use" does not have a "parallel" under state law but was borrowed by the Federal Circuit Court to hold together the court's reasoning to allow Allergan's claims to proceed.

After Athena sought certiorari, the Supreme Court invited the solicitor gen­eral to file a brief expressing the views of the government. In all material respects, the California law mirrors federal law, but neither law states who should decide whether a product is a cosmetic that is not subject to FDA approval or a drug that is subject to approval by the FDA. In Allergan the trial court broke new ground and con­cluded: "RevitaLash Advanced was a new drug that required approval under Califor­nia law based on, among other facts, peti­tioner's marketing claims about eyelash growth and petitioner's strategy of pro­moting its various formulations of Revi­taLash through comparison of the product to Latisse."

Allergan questioned whether the FDA has exclusive authority to determine a product's regulatory classification. Deter­mining a product's regulatory status is dif­ficult and complex, but it is fundamental to whether a manufacturer's conduct violates the FDCA for promoting a drug without FDA approval. Even those well versed in the complexities of FDA practice often wrangle with the FDA over whether a product is a food, a supplement, a cosmetic, a device, a drug, or a combination product.

The Pen Is Mightier (Only When the Government Doesn't Have Its Sword)

In Allergan, the government demonstrates that its powers of reasoning and persua­sion are far mightier when it is wielding the sword of criminal sanctions. In May 2015, the solicitor general expressed the government's views on whether the FDA or state court juries decide the regulatory status of FDA-regulated products. The gov­ernment's position, while consistent with its recent pro-plaintiff approach to allow­ing litigants to enforce the FDCA, breaks dangerous new ground by inviting state courts to decide a product's drug classifi­cation status, and adopting this position significantly blurs the lines between state law claims and claims seeking to enforce the FDCA.

It is important to note that Allergan involved no FDA action, no record of reg­ulatory communications between the manufacturer and the FDA, and no deter­mination regarding an FDA classification. Commenting in the brief, the government states that "[Allergan's] claim does not sup­plant any regulatory determination by FDA regarding the product's status as a cosmetic or a new drug." Gov't Br. at 11. The govern­ment does not state whether the analysis would be the same and would result in a viable parallel state law claim had the FDA reviewed the matter and not taken regu­latory action for failure to file a new drug application. The government does, at least, nod in approval to preemption when the FDA was aware of a new use or off-label use. See Gov't Br. at 20, citing Perez v. Nidek, 711 F.3d 1109 (9th Cir. 2013). The govern­ment suggests that if the state attempted to impose criminal sanctions, that circum­ stance "might alter the preemption calcu­lus." See Gov't Br. at 15, n. 5.

In the view of the government, when FDA has not determined whether a prod­uct is a drug subject to FDA approval, the states have the freedom to decide a regula­tory classification as they see fit. To support this position, the government cites Wyeth v. Levine, 555 U.S. 555 (2009), stating:

This Court has concluded, however, that "Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness, and that FDA has traditionally regarded state law as a complementary form of drug regulation," Indeed, Congress specified, when enacting the modern drug pre-approval regime, that the FDCA does not "invalidat[e] any provision of State law which would be valid in the absence of such amendments unless there is a direct and positive conflict between such amendments and such provision of State law."

Id. at 575, 578–79.

Despite the FDA's $1.3 billion budget and 15,000 employees, the government states that allowing state juries to decide the reg­ulatory status of FDA-regulated products does not compromise the FDA's objectives. The FDA leaps to allow state enforcement of the FDCA by bemoaning its limited resources and inability to "police" the mar­ketplace of unapproved products. Gov't Br, at 13–14.

Whether a new drug is safe and effec­tive for its intended use presupposes that the product has been classified as a new drug. This is no minor speed bump in the analysis, and the government skips past the crux of the issue by parroting that the lower courts concluded that the prod­uct was a new drug. The potential effect of the government's position to allow a state jury to decide FDA regulatory classifica­tion is important. Permitting a state jury to decide if claims perceived by a plaintiff render a product a new drug or a device under the FDCA and then allowing the plaintiff to sue the manufacturer for fail­ing to obtain regulatory approval or clear­ance is the definition of the purported "tort of off-label promotion." Off-label pro­motion posits that when a manufacturer promotes a drug for a "new use," it is pro­moting an unapproved new drug, and there is no label sufficient under the law to warn of the risks of an unapproved new drug or device. Until or unless the FDA approves a new use and labeling, the new use or the new drug would have insufficient warn­ings, and this would subject the manufac­turer to potential tort liability. Because the solicitor general urged the Court to decline the cert petition in Allergan and the Court did, it appears that the Court may have sided with the government position. It now appears that the FDA alone may not have primary jurisdiction to decide whether a product's intended use is that of a drug, increasing the allowable claims for prod­ucts—whether approved by the FDA or not.

The government's position in Aller­gan is important not merely because it permissively allows state law to establish product classifications for drugs, but also because little, if any, principled basis exists to distinguish this case from any other off-label drug or device promotion case. In its response to the government's brief, Athena filed a supplemental brief hitting the nail on the head in stating: "It is one thing for the Government to sanction pri­vate claims—fraud, negligence, failure to warn—that are "based on traditional state tort law that predates the FDCA...." It is quite another thing for the Government to invite private claims like this one." Supple­mental Br. for Petitioner at 1.

What Athena pointed out and the gov­ernment failed to address is whether the FDA would have determined the product at issue to be a new drug. Assuming that the FDA later evaluates this product and con­cludes that the product is a cosmetic, would it defer to the state court determination that is a drug? What if another state deter­mines that the product is a medical device and yet another state decides that the prod­uct is a cosmetic? When the FDA, as here, does not take regulatory action, that inac­tion means that the product is not subject to approval or clearance. The government failed to address the heart of the issue.

Unfettered Discretion: The FDA's Unapproved Voodoo Elixir

There is no clearer example of the com­plexity of applying the FDCA to determine a product classification as a new drug than in Amarin v. FDA, 1:15-cv-03588 (S.D.N.Y. filed May 7, 2015). In Amarin, the FDA provided an ample description of the expertise it applies demonstrating that the FDA should determine a product classification. The FDA details the unique expertise and complexity of the analy­sis that it uses when considering whether the information that a manufacturer con­veys rises to the level of requiring new drug approval.

Amarin is the first significant post Caro­nia case to consider whether FDA would retain its stranglehold on what informa­tion a manufacturer could and perhaps should disseminate. FDA wagered every­thing and lost on its misguided strategy not to appeal Caronia on the hope that the trial court would accept its voodoo logic and avoid tackling an issue that threat­ens to upend FDA's regulatory framework:

[Amarin's] legal arguments strike at the very heart of the new drug approval pro­cess, and a court decision in Plaintiffs' favor has the potential to establish prec­edent that would return the country to the pre-1962 era when companies were not required to prove that their drugs were safe and effective for each of their intended uses.

FDA Br. (Dkt. 53 filed June 23, 2015) at 3. With a couple notable exceptions, this argument had worked for the FDA for the better part of 50 years, but on August 7, 2015, the court ruled in Amarin's favor.

Proving that life is often stranger than fiction, it is perhaps more than a coinci­ dence that the death of Frances Oldham Kelsey on August 7, 2015, coincides with the Court's opinion in Amarin. Ms. Kelsey is generally credited with the federal reg­ulatory changes in 1962 that required evi­dence of efficacy before a product could be marketed. Those changes were precipitated by the use of thalidomide for nausea dur­ing pregnancy but produced profound de­formities in developing fetuses. The Court in Amarin detailed the widespread use of products for indications, dosages, durations or in combinations not in the approved la­bel and that this widespread off-label use is often recognized as the standard of care in medicine and acknowledged by the Su­preme Court. Amarin, supra, at 5–9.

Give that the terms "promotion," "adver­tising" and "off-label" are not defined in the FDCA it is little surprise that the entire issue has been a muddled mess allowing the FDA to define the terms as it threatened manu­facturers with criminal and civil penalties. The FDA's position as supreme arbiter to ren­der the dissemination of truthful scientific and medical content criminal conduct has waned and Amarin may represent the end of the FDA era of exacting huge penalties from FDA-regulated industry. If a manufacturer cannot be prohibited from disseminating truthful scientific information concern­ing its products, state law may step in to fill the void and find a state law duty to provide more information. Under Caronia and Am­arin such a state law duty might not be sub­ject to federal preemption and may be a more pernicious threat than federal enforcement.

Highlighting the Second circuit opin­ion in Caronia the district court in Ama­rin rejected the government's rewriting of Caronia holding: "Where the speech at is­sue consists of truthful and non-misleading speech promoting the off-label use of an FDA-approved drug, such speech, under Caronia, cannot be the act upon which an action for misbranding is based." Id at 49.

If anything is clear from the FDA's posi­tions in Allergan and Amarin, it is that de­termining a product's classification should remain solely within the FDA's purview. It is strange indeed that delivering a pathway around preemption may have come from manufacturers themselves. Leaving the de­cision of whether a manufacture's conduct renders a product a new drug or device and whether sufficient truthful information was provided to the ipse dixit of state court ju­ries is an invitation for patchwork determi­nations and litigation chaos.

Conclusion

The Supreme Court is refusing or neglect­ing to take the opportunity to bring clarity to parallel claims for FDA-regulated indus­try. Unless or until the Supreme Court or Congress brings clarity to limit state law claims for conduct under the FDCA, courts may follow the government's per­missive approach to parallel claims, imper­iling manufacturers.

As for Amarin, due process, defer­ence and First Amendment challenges have been a gathering storm over the FDA's stronghold of truthful scientific and medical information. As the deluge is realized, the chaos that ensues may be self-inflicted

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Michael A. Walsh
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