Download Slides - Food and Drug Law Institute

Litigation and Settlements
Dale J. Giali, Partner, Mayer Brown LLP
Eric Gotting, Partner, Keller and Heckman LLP
Enforcement
Litigation and
Compliance
Daniel Jarcho, Partner, Alston & Bird LLP
Lynn Tyler, Partner, Barnes & Thornburg
Washington, DC
December 9-10, 2015
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
3
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
5
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 Decisions
and On-Going Litigation
Eric P. Gotting
Keller 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)
•
–
TBC’s Preemption Clause (21 U.S.C. §387p)
•
–
Bans “characterizing flavors” other than tobacco or menthol in cigarettes
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
–
–
–
•
Electronic Cigarettes
–
–
•
Closed systems (non-refillable devices)
Open systems (refillable devices)
E-Liquid
–
•
Introduced into US in 2007
$3.5 billion in 2015 sales
24 million US consumers
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
[email protected]
Enforcement,
Litigation and
Compliance
Conference
Daniel G. Jarcho
Alston & Bird LLP
[email protected]
December 10, 2015
FDA’s New Assertion of
Regulatory Authority
Over
Laboratory-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.
•
2015.
Comments on “Draft Guidances” completed in February
•
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.
• 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. Tyler
Barnes & Thornburg LLP
FDLI Enforcement, Litigation, and Compliance Conference
December 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 statintreated 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, offlabel 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 nonmisleading 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 nonmisleading, 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 previouslyapproved 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 nonprotected 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).