enforcement litigation and compliance washington, dc december 9-10, 2015 litigation and settlements...

Enforcement Litigation and Compliance

Washington, DC

December 9-10, 2015

Litigation and Settlements

Dale J. Giali, Partner, Mayer Brown LLP

Eric Gotting, Partner, Keller and Heckman LLP

Daniel Jarcho, Partner, Alston & Bird LLP

Lynn Tyler, Partner, Barnes & Thornburg

Moderated by Daniel Kracov, Partner, Arnold & Porter LLP

Consumer Class Actions Challenging Food Labels

Based on Alleged

Regulatory Violations

Dale J. Giali

Consumer Class Actions Based on Alleged Regulatory Violations

The Topic

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Consumer Class Actions Based on Alleged Regulatory Violations

Class action lawyers want to sue on behalf of consumers for alleged technical violations of the FDCA labeling rules, but (of course) they want to avoid altogether the tough work of showing that a consumer was deceived, relied on the challenged labeling statement, or was injured by the challenged labeling statement.

In numerous different ways -- all of which relying on highly technical violations of the food labeling laws themselves -- consumer class action lawyers have tried to argue they don’t have to allege/show deception, reliance, or injury.

Example: “0g Trans Fat” on PDP without an additional statement under 21 C.F.R. § 101.13(h)(1) referring consumers to the Nutrition Facts box for additional information about high levels of fat, total fat, sodium or cholesterol.

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Consumer Class Actions Based on Alleged Regulatory Violations

Executive Summary

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Consumer Class Actions Based on Alleged Regulatory Violations After a lot of motion practice, courts have rejected plaintiffs’ efforts to proceed without

alleging/showing deception, reliance and injury.

Food companies cannot be held strictly liable to consumers for misbranding -- there must be deception/reliance (after all, without deception/reliance, a consumer got exactly what she paid for).

Alleged technical violations of the FDCA are not synonymous with deception/reliance -- consumers don’t necessarily think like FDA.

Food companies are not liable for not disclosing their own misbranding.

Consumers are not somehow damaged (i.e., subject to arrest) for holding misbranded food.

If consumers are able to allege and show material reliance on a deceptive label they are entitled (at most) to the incremental price premium (if any) associated with the specific deceptive statement (and certainly not a full refund of the purchase price).

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Consumer Class Actions Based on Alleged Regulatory Violations

The Basics

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Consumer Class Actions Based on Alleged Regulatory Violations

Congress set up comprehensive uniform food labeling system. FDCA (21 U.S.C. §§ 301, et seq.), NLEA (Public Law 101-535, 104 Stat. 2352, Nov. 8, 1990), and the implementing regulations promulgated thereunder (21 C.F.R. § 1.1, et seq., § 101, et seq.).

No private right of action under FDCA -- Congress vested exclusive enforcement authority to the government. 21 U.S.C. § 337(a); see Buckman Co. v.

Plaintiffs’ Legal Comm., 531 U.S. 341 (2001); Fiedler v. Clark, 714 F.2d 77, 79 (9th Cir. 1983). Moreover, a violation cannot be a predicate to support violation of consumer protection laws.

And, no state “may directly or indirectly establish… any requirement for the labeling of food of the type” covered by certain of the food labeling laws “that is not identical to the [federal] requirement.” 21 U.S.C. § 343-1.

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Consumer Class Actions Based on Alleged Regulatory Violations

But, many states have baby FDCAs.

California has the Sherman Food Drug and Cosmetic Law. Cal. Health & Safety § 109875, et seq.

The Sherman Law expressly incorporates the FDCA and federal regulations as the law of California. Cal. Health & Safety § 110100.

However, no private right of action under the Sherman Law either.

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Consumer Class Actions Based on Alleged Regulatory Violations

Arguments Consumer Class Action Lawyers Make to Exploit

Technical Labeling Regs and Avoid Having to Allege/Show Deception, Reliance & Injury

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Consumer Class Actions Based on Alleged Regulatory Violations

Mere violation of the FDCA is enough to show deception -- if it’s good enough to support an FDA warning letter, it’s good enough to support a consumer class action for deception.

Deception/reliance are not even needed -- the “unlawful” prong of California’s Unfair Competition Law (Cal. Bus. & Prof. Code §17200) allows for “strict liability” enforcement of the Sherman Law, which incorporates the FDCA.

Consumers rely on non-disclosure of a product’s misbranding. Injury can be presumed -- Misbranded food can’t be sold and is legally worthless.

Injury can be presumed -- Because it’s unlawful under the Sherman Law to “hold” a misbranded product, consumers are injured for merely holding a misbranded product because they are in jeopardy of criminal sanction. Cal. Health & Safety § 110760.

In any event, injury need not be calculated precisely -- Plaintiffs are entitled to “non-restitutionary disgorgement” -- otherwise known as a full refund -- so there is no need to show actual damage or a “price premium” associated with the challenged labeling statement.

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Consumer Class Actions Based on Alleged Regulatory Violations

The Courts’ Treatment

of the Arguments

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Consumer Class Actions Based on Alleged Regulatory Violations

Under FDCA and Sherman Law, a food is misbranded if “its labeling is false or misleading in any particular.” Cal. Health & Safety Law §§ 110660, 110705; 21 U.S.C. § 343.

“A consumer’s burden of pleading causation in a UCL action . . . hinge[s] on the nature of the alleged wrongdoing rather than the specific prong of the UCL the consumer invokes.” Durell v. Sharp Healthcare, 108 Cal. App. 4th 1350 (2010).

When plaintiffs allege unlawful conduct predicated on violations of statutes that “simply codify prohibitions against certain specific types of misrepresentations,” their claims must be treated as fraud claims. Kwikset v. Super. Ct., 51 Cal. 4th 310, 326 n.9 (2011).

And when “[t]he theory of the case is that [the defendant] engaged in misrepresentations and deceived consumers,” it must be pleaded as such (id.), including by satisfying the UCL’s “actual reliance requirement” regardless of the UCL prong that the plaintiffs invoke. In re Tobacco II Cases, 46 Cal. 4th 298 at 306),; see also Park v. Welch Foods, Inc., 2013 WL 5405318, at *4 (N.D. Cal. Sept. 26, 2013).

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Consumer Class Actions Based on Alleged Regulatory Violations

So, misbranding is not synonymous with deception or reliance. Delacruz v. Cytosport, Inc., 2012 WL 2563857, at *4, *8 (N.D. Cal. June 28, 2012); Mason v. Coca-Cola Co., 774 F. Supp. 2d 699, 705 (D.N.J. 2011).

And, a plaintiff may not allege that “misbranded food products are unlawful by nature and therefore actionable.” “Holding for [plaintiffs] on this point would be an affront to state and federal standing rules” because “[f]ederal standing requires an injury, and California law requires UCL plaintiffs to plead injury and reliance.” Wilson v. Frito-Lay N. Am., Inc., 961 F. Supp. 2d 1134, 1144-45 (N.D. Cal. 2013); see also Victor v. R.C. Bigelow, Inc., 2014 WL 1028881, at *16-17 (N.D. Cal. Mar. 14, 2014); Bishop v. 7-Eleven, Inc., 2014 WL 1620946, *4-6 (N.D. Cal. Apr. 21, 2014); Thomas v. Costco Wholesale Corp., 2014 WL 1323192, at *5-6 (N.D. Cal. Mar. 31, 2014)

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Consumer Class Actions Based on Alleged Regulatory Violations

“Establishing that a defendant violated a law only accomplishes half of a plaintiff’s burden in a UCL unlawful prong action.” If plaintiffs could “make out a violation of the FDCA or the Sherman Laws, plaintiffs would then be required to prove that they were injured ‘as a result of’ defendants’ law-violating conduct.” In re Actimmune Marketing Litigation, 2010 2010 WL 3463491, at *7 (N.D. Cal. Sept. 1, 2010) (emphasis added).

A consumer is not entitled to a full refund of the purchase price -- she is entitled to the incremental increase in price of the product associated with the challenged labeling statement (price premium). Trazo v. Nestlé USA, Inc., -- F. Supp. 3d --, 2105 WL 4196973 (N.D. Cal. July 10, 2015).

Food company has no duty to disclose the alleged “illegality” of its own products. Brazil v. Dole Food Co., Inc., 2013 WL 5312418 (N.D. Cal. Sept. 23, 2013); Swearingen v. Amazon Pres. Partners, Inc., 2014 WL 1100944, at *3 (N.D. Cal. Mar. 18, 2014); Gitson v. Trader Joe’s Co., 2014 WL 1048640, at *12 (N.D. Cal. Mar. 14, 2014).

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Consumer Class Actions Based on Alleged Regulatory Violations

Other Relevant Representative Legal Authorities:

De Keczer v. Tetley USA, Inc., 2014 WL 4288547, at *8-9 (N.D. Cal. Aug. 28, 2014)

Figy v. Frito-Lay N. Am., Inc., 2014 WL 3953755, at *8-9 (N.D. Cal. Aug. 12, 2014)

Swearingen v. Pac. Foods of Or., Inc., 2014 WL 3767052, at *2 (N.D. Cal. July 31, 2014)

Leonhart v. Nature's Path Foods, Inc., 2014 WL 1338161, at at *8 (N.D. Cal. Mar. 31, 2014)

Figy v. Amy’s Kitchen, Inc., 2013 WL 6169503 (N.D. Cal. Nov. 25, 2013)

Gitson v. Trader Joe’s Co., No. 3:13cv1333, Dkt. No. 139 (N.D. Cal. Dec. 1, 2015)

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Recent Tobacco Decisionsand On-Going Litigation

Eric P. GottingKeller and Heckman LLP

1001 G Street, NW Suite 500 West

Washington, DC 20001

Overview

• Chicago’s Flavoring Ban

• FDA’s Substantial Equivalence Guidance

• Indiana’s E-Liquid Manufacturing Requirements

Flavoring Bans• Local Ordinances

– New York City (N.Y.C. Admin. Code§17-715)– Providence (Providence, R.I., Code of Ordinances §14-309)– Chicago (Chi., Ill., Code §4-64-098)

• Proposed State Legislation– Vermont HB 59 (bans flavored liquid nicotine except menthol)– Virginia SB 1068 (bans candy flavored liquid nicotine)

Chicago Flavoring Ordinance• Adopted in 2013

• Prohibits the sale of “flavored tobacco products,” “samples of such products,” and “accessories” within 500 feet of a school

– “Flavored tobacco product” means “any tobacco product that contains a constituent that imparts a characterizing flavor”

– “Characterizing flavor” defined as a “distinguishable taste or aroma, other than the taste or aroma of tobacco, including” menthol, vanilla, any candy, any dessert…

• Does not apply to “retail tobacco stores” (80% or more revenue from tobacco product sales)

Preemption Lawsuit• Indep. Gas & Serv. Ass’n v. Chicago, 2015 WL 4038743 (N.D. Ill 2015)

– Filed by gas service station association and a convenience store

• Plaintiffs’ Argument – Preempted under the Family Smoking Prevention and Tobacco Control Act (“TBC”)

– TBC’s “Tobacco Product Standard” (21 U.S.C. §387g)• Bans “characterizing flavors” other than tobacco or menthol in cigarettes

– TBC’s Preemption Clause (21 U.S.C. §387p)• Prohibits state or local laws that are “different from, or in addition to” any federal requirement relating

to, among other things, “tobacco product standards”

– In essence, a tobacco product standard disguised as a sales restriction

Federal District Court Decision

• No preemption under TCA– Preservation Clause (21 U.S.C. §387p)

• States and localities may adopt regulations that are “in addition to, or more stringent than” any federal requirement, including one “relating to or prohibiting the sale” of tobacco products

– Exemption Clause (21 U.S.C. §387p)• Preemption clause does not prohibit states and localities from adopting “requirements

related to the sale, distribution, possession…of tobacco products”

– In short, sales restrictions or prohibitions ≠ tobacco product standards

Substantial Equivalence• Substantial Equivalence – A new tobacco product (i) has the same

characteristics as a predicate product or (ii) has different characteristics but does not raise different questions of public health. (21 U.S.C. §387j(a)(3))

• New Tobacco Product – Tobacco product that was not commercially marketed in the U.S. as of February 15, 2007 or any modification to a product commercially marketed after that date. (21 U.S.C. §387j(a)(1))

• Predicate Product – A tobacco product commercially marketed as of February 15, 2007 or another product previously determined by FDA to be substantially equivalent. (21 U.S.C. §387e(j)(1))

FDA Guidance• Demonstrating the Substantial Equivalence of a New Tobacco Product:

Responses to Frequently Asked Questions (September 2015)– Streamlined substantial equivalence reports

• Changes in labels (Same Characteristics SE Report)

• Changes in quantity (Product Quantity Change SE Report)

• Does a label change result in a new tobacco product?– Yes, if a consumer would likely perceive the product as “new”

• Does a change in quantity of product result in a new tobacco product?– Yes, because it is a modification to the product (e.g., amounts of ingredients or

materials)

Challenge to FDA Guidance• Philip Morris USA Inc., et al. v. FDA, et al. (D.D.C. 2015)

– Violates Administrative Procedure Act (“APA”)• TCA limits FDA approval of labels

• Substantial equivalence turns on characteristics, not labels

• Change in quantity in the package is not a change in characteristics

– Violates First Amendment• Prior restraint on labeling

• Violates Central Hudson “intermediate scrutiny” test

– Void for Vagueness• How to apply consumer test?

E-Vapor Industry and Regulation• E-Vapor Industry

– Introduced into US in 2007

– $3.5 billion in 2015 sales

– 24 million US consumers

• Electronic Cigarettes– Closed systems (non-refillable devices)

– Open systems (refillable devices)

• E-Liquid– Liquid nicotine, flavorings, base (e.g., propylene glycol)

• State and local regulation– Age restrictions, sales and use location restrictions, child-proof packaging requirements

Indiana Statute• E-liquid manufacturers must obtain an Indiana permit

• Applies to manufacturers across US and globe

• Imposes manufacturing requirements– Security system– Clean room (compliant with Indiana Kitchen Code)– On-site audits and inspections by Indiana officials

• Only applies to e-liquid used in open systems– Closed systems are exempt

Challenge to Indiana Statute• Legato Vapors, et al. v. Cook, et al. (D. Ind. 2015)

– Filed by e-liquid manufacturers and retailers

• Plaintiffs’ Arguments– Violates Commerce Clause (extraterritorial regulation)– Violates Due Process Clause (single security firm)– Violates Commerce Clause (undue burdens on interstate commerce)– Violates Equal Protection Clause (only applies to open systems)

Thank You!

Eric P. Gotting

Keller and Heckman LLP

1001 G Street, NW

Suite 500W

Washington, DC 20001

gotting@khlaw.com

Enforcement, Litigation and Compliance Conference

Daniel G. JarchoAlston & Bird LLP

daniel.jarcho@alston.com

December 10, 2015

FDA’s New Assertion ofRegulatory Authority

OverLaboratory-Developed

Tests

A Broader Issue: FDA’s Assertion of New

Regulatory Authority and

Potential Litigation Responses

Laboratory-Developed Tests• Diagnostic tests developed, validated and performed by

laboratory professionals within a single clinical laboratory.• Tests use reagents to provide clinical diagnostic results.• No physical “product” or “test kit” is created – test is arguably a

“service” that follows specific protocols.

FDA’s October 2014 “Draft Guidances”

• Risk-based framework for regulating LDTs as devices.• Within specified time frames after “Draft Guidances” are

finalized:

– Notification to FDA (for purposes of classification) in lieu of registration and listing.

– MDR reporting as device manufacturers.– PMA approval or 510(k) clearance for Class III and 510(k)

clearance for Class II.– Quality System Regulation compliance for Class III and

Class II.

• Comments on “Draft Guidances” completed in February 2015.

• FDA has indicated Guidances will be finalized in early 2016.

ISSUE #1:Does FDA Have Statutory Authority to Regulate?

• A device is a physical article:

– “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article…” 21 U.S.C. § 321(h).

• LDTs use in vitro reagents, but is the use of a device itself a device?

ISSUE #2:Will the Final Guidance be a “Rule” That Can be

Challenged Through Litigation?

• Has FDA had the regulatory authority all along but never previously used it?

• “FDA believes the policy of general enforcement discretion towards LDTs is no longer appropriate.”

• Individual FDA enforcement decisions generally are not subject to judicial review (Heckler v. Chaney, 470 U.S. 821 (1985)).

• Is FDA asserting a new authority never previously claimed (since 1976) and imposing new generally-applicable legal requirements?

• A “rule” includes “an agency statement of general . . . applicability and future effect designed to implement, interpret, or prescribe law or policy . . . ” 5 U.S.C. §551(4).

• A “rule” may be subject to judicial review.

ISSUE #3:Has FDA Satisfied Applicable Notice and

Comment Requirements?

• Will the Final Guidance be a “legislative rule” subject to notice and comment requirements?

• Will the agency’s acceptance of comments on the “Draft Guidance” suffice?

Questions?

Amarin And Other Important 2015 Drug Cases

Lynn C. TylerBarnes & Thornburg LLP

FDLI Enforcement, Litigation, and Compliance ConferenceDecember 10, 2015

Amarin Pharma, Inc. v. FDA, No. 15 Civ. 3588 (PAE), 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015)

• The dispute concerned proposed truthful and non-misleading, but off-label promotion, of an Amarin drug, Vascepa®.

• Citing Amarin’s First Amendment rights, the court issued a preliminary injunction authorizing Amarin to make several specific statements or disclosures to doctors and to disseminate 13 scientific publications concerning Vascepa®.

Facts

• FDA previously approved Vascepa® as an adjunct to diet to reduce triglyceride levels in patients with severe (≥ 500 mg/dL) hypertriglyceridemia.

• This approval was based on a single phase 3 clinical trial conducted in patients with “very high” triglycerides pursuant to an agreement with FDA.

Facts

• After Vascepa®’s approval, Amarin learned that physicians were also using it to treat patients with “persistently high” triglycerides (≥ 200 and ≤ 500 mg/dL) and planned to seek approval for its use in this expanded patient population.

• Similar to its approach with the initial indication, Amarin designed a single phase 3 clinical trial to examine the effect of Vascepa® on triglyceride levels among statin-treated patients with persistently high triglycerides (the ANCHOR trial) and entered into another agreement with FDA.

Facts• Amarin also agreed to conduct a cardiovascular

outcomes trial (the REDUCE-IT trial) to study whether Vascepa® would be effective in reducing cardiovascular events.

• Amarin completed the ANCHOR study and believed it had satisfied all of FDA’s requirements to obtain approval of Vascepa® for persistently high triglycerides.

• Amarin submitted a supplemental NDA (sNDA) for the persistently high triglyceride indication in February, 2013, and anticipated a timely approval.

Facts• Instead of approving the sNDA, however, FDA convened an

Advisory Committee. • After the FDA and Amarin had agreed to the ANCHOR and

REDUCE-IT trials, several cardiovascular outcomes studies had called into question whether a reduction in triglyceride levels would translate into a reduction in cardiovascular events.

• Accordingly, FDA asked the Advisory Committee whether Vascepa®’s triglyceride lowering effect was sufficient to approve the drug for use in patients with persistently high triglycerides.

• The Advisory Committee voted against approval of Vascepa® and FDA declined to approve it.

Facts

• According to Amarin, when FDA conveyed its decision to Amarin FDA stated that “any effort by Amarin to market Vascepa® for the proposed supplemental use could constitute ‘misbrand[ing] under the Federal Food, Drug, and Cosmetic Act [(FDCA)].’”

Procedure

• Amarin filed its complaint with the court and sought the preliminary injunction authorizing the specific statements or disclosures and the dissemination of the scientific articles mentioned above.

Ruling

• In ruling for Amarin, the court relied heavily on the relatively recent decision in United States v. Caronia, 703 F.3d 149 (2d Cir. 2012).

• In Caronia, the Second Circuit reversed the criminal conviction of a pharmaceutical sales representative for the off-label promotion of a prescription pharmaceutical based on the First Amendment.

Ruling

• The Caronia court summarized its decision as follows: “We construe the misbranding provisions of the FDCA as not prohibiting and criminalizing the truthful off-label promotion of FDA approved prescription drugs…. We conclude simply that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.”

Ruling

• FDA argued for a narrow interpretation of Caronia, limited to its facts, and for the position that it could pursue Amarin for off-label promotion by analogy to other crimes, such as jury tampering, blackmail, and insider trading, where speech constitutes the criminal act.

• The Amarin court rejected those arguments, however, and concluded “[w]here 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.”

• In other words, “if the speech at issue is found truthful and non-misleading, under Caronia, it may not serve as the basis for a misbranding action.”

Ruling

• With respect to the 13 scientific publications, the court observed that the FDA did not claim that they were, individually or collectively, false or misleading and therefore approved their distribution.

• Amarin sought to disseminate a summary of the ANCHOR trial. Again the court stated that the FDA did not argue that the summary is false or misleading, and the court found the summary is “studiously neutral” and approved its distribution.

Ruling• Amarin also sought to make certain specific “statements”

and “disclosures.”• The court stated that the FDA agreed with two of the

statements and four of the disclosures, and the court found they were truthful and not misleading.

• Amarin agreed to the FDA’s proposal to disclose any potential financial or affiliation biases between itself and the people who conducted the ANCHOR study.

• The court then discussed at some length two disputed disclosures and one disputed statement and, after revising the disclosures somewhat, authorized Amarin to make them.

Court’s Caution

• [T]he Court notes that Vascepa’s unusual and extensive regulatory history makes it realistic to determine, at this early stage, the truthfulness of Amarin’s proposed statements regarding its off-label use.

• Here, the FDA has already reviewed the off-label use at issue. • [FDA] approved the ANCHOR study, which tested Vascepa’s

effectiveness in reducing triglyceride levels among patients with persistently high triglycerides.

• And it has confirmed in writing, including in the CRL [Combined Response Letter], that Vascepa has proven effective in doing so.

• Amarin has thus been able to base its proposed communications about Vascepa almost entirely on statements by the FDA itself (emphasis added).

Court’s Caution, Part Deux

• Although the FDA cannot require a manufacturer to choreograph its truthful promotional speech to conform to the agency’s specifications, there is practical wisdom to much of the FDA’s guidance, including that a manufacturer vet and script in advance its statements about a drug’s off-label use.

• A manufacturer that leaves its sales force at liberty to converse unscripted with doctors about off-label use of an approved drug invites a misbranding action if false or misleading (e.g., one-sided or incomplete) representations result.

• Caronia leaves the FDA free to act against such lapses. A manufacturer may also conclude that it is prudent to consult with the FDA before promoting off-label use.

Court’s Caution, Part Trois

• The Court has held that Amarin’s proposed communications, as modified herein, are presently truthful and non-misleading.

• But the dynamic nature of science and medicine is that knowledge is ever-advancing.

• A statement that is fair and balanced today may become incomplete or otherwise misleading in the future as new studies are done and new data is acquired.

• The Court’s approval today of these communications is based on the present record.

• Amarin bears the responsibility, going forward, of assuring that its communications to doctors regarding off-label use of Vascepa® remain truthful and non-misleading (emphasis added).

Anyone see a trend?

• Washington Legal Foundation v. Henney, 13 F. Supp. 2d 51 (D.D.C. 1998), appeal dismissed, judgment vacated in part, 202 F.3d 331 (D.C. Cir. 2000).

• Thompson v. W. States Med.Ctr., 535 U.S. 357 (2002).

• Sorrell v. IMS Health, Inc., 564 U.S. (2011).

• U.S. v. Caronia, 703 F.3d 149 (2d Cir. 2012).

• Amarin

Open Issues

• Who has the burden of proof on truthfulness?• What evidence is required to satisfy the burden?

Other cases of interest

• Amarin Pharmaceuticals Ireland Ltd. v. FDA, Civil Action No. 14–cv–00324 (RDM), 2015 WL 3407061 (D.D.C. May 28, 2015) (setting aside FDA decision that VASCEPA® not entitled to five year NCE exclusivity because its active ingredient was a component of mixture that is an active ingredient of a previously-approved drug).

Other cases of interest

• Amgen, Inc. v. Sandoz, Inc., 794 F.3d 1347 (Fed. Cir. 2015) (patent litigation provisions of Biosimilar Price Competition and Innovation Act are optional; FDA approval required before effective notice of commercial marketing can be given).

• Eisai, Inc. v. FDA, Civil Action No. 14-cv-1346, 2015 WL 5728882 (D.D.C. Sept. 30, 2015) (exclusivity period for a new drug begins when the FDA issues its letter approving the drug, even if the drug’s manufacturer must await DEA’s scheduling determination before it can bring the drug to market).

Other cases of interest

• Mallinckrodt Inc. v. FDA, Civil Action No. DKC 14-3607 (D. Md. July 29, 2015) (dismissing three claims and entering summary judgment on two claims under APA and 5th Amendment challenging FDA’s downgrade of therapeutic equivalence rating).

• Otsuka Pharmaceutical Co. Ltd. v. Burwell, Case No. GJH-15-852, 2015 U.S. Dist. LEXIS 68230 (D. Md. May 27, 2015) (upholding FDA authority to carve out an indication or other information from ANDA labeling when that indication or information is protected by orphan drug exclusivity as long as the ANDA with that carved out label remains safe and effective for the remaining non-protected conditions of use)

Other cases of interest

• Ouellette v. Mills, 91 F. Supp. 3d 1 (D. Me. 2015) (Amendment to Maine Pharmacy Act permitting importation of drug products into the U.S. from licensed retail pharmacies located in certain foreign countries is pre-empted by FDCA).

• Spectrum Pharmaceuticals, Inc. v. Burwell, Civil Action No. 15-631 (RCL), 2015 U.S. Dist. LEXIS 73218 (D.D.C. May 27, 2015) (upholding FDA’s authority to approve a generic drug in a strength that is appropriate only for an indication that has been “carved out” based on the reference listed drug’s Orphan Drug Act exclusivity).

Other cases of interest

• United States v. Bayer Corp., Civil Action No. 07–01(JLL), 2015 WL 5822595 (D.N.J. Sept. 24, 2015) (Court finds Bayer had “competent and reliable scientific evidence” as required by earlier consent decree to support claims for Philips Colon Health probiotic dietary supplement).

• In U.S. ex rel. Campie v. Gilead Sciences, Inc., Case No. C–11–0941 EMC, 2015 WL 106255 (N.D. Cal. Jan. 7, 2015) (dismissing False Claims Act case for failure to state a claim when based on alleged violations of FDA cGMP regulations). 

Other cases of interest

• Veloxis Pharmaceuticals, Inc. v. FDA, Civil Action No. 14–2126 (RBW), 2015 WL 3750672 (June 12, 2015) (FDA’s decision to delay final approval of Envarsus XR for the prophylaxis of organ rejection in de novo kidney transplant patients until expiration of three year exclusivity of Astellas’ Astragraf XL was neither arbitrary and capricious nor in excess of the FDA’s statutory authority).