Supreme Judicial Court of Massachusetts, Middlesex
Heard: November 6, 2017.
action commenced in the Superior Court Department on October
10, 2013. A motion to dismiss was heard by Kenneth J.
Fishman, J., and entry of separate and final judgment was
ordered by him.
Supreme Judicial Court on its own initiative transferred the
case from the Appeals Court.
E. Smith-Lee for the plaintiff.
Richard L. Neumeier (Aaron Rice, of Mississippi, & David
L. Johnson, of Tennessee, also present) for Merck & Co.,
following submitted briefs for amici curiae:
Michael X. Imbroscio & Gregory L. Halperin, of the
District of Columbia, & Paul W. Schmidt for
Pharmaceutical Research and Manufacturers of America &
C. Fleming & Tyler L. Sparrow for International
Association of Defense Counsel.
F. Young, Jr., of Virginia, & David R. Greiger &
Richard G. Baldwin for Product Liability Advisory Council,
K. Shanmugam, Allison Jones Rushing, & Connor S.
Sullivan, of the District of Columbia, & Jennifer G.
Wicht for Chamber of Commerce of the United States of
Lawrence G. Cetrulo, Kyle E. Bjornlund, Elizabeth S. Dillon,
& Brian D. Fishman for Massachusetts Defense Lawyers
Present: Gants, C.J., Gaziano, Budd, & Cypher, JJ.
Federal law, a manufacturer of a generic drug must provide
its users with a warning label that is identical to the label
of the brand-name counterpart. See PLIVA, Inc.
v. Mensing, 564 U.S. 604, 613 (2011)
(PLIVA). The issue on appeal is whether a plaintiff
who alleges that he was injured from his use of a generic
drug, because of a failure to warn of the drug's side
effects, may bring a common-law general negligence claim and
a statutory claim under G. L. c. 93A against the brand-name
drug manufacturer that created the warning label. Applying
our general principles of tort law and as a matter of public
policy, we conclude that the plaintiff may not bring a
negligence claim against the brand-name manufacturer for a
failure to warn. We further conclude that the plaintiff, if
he were to amend his complaint, and if the amended
allegations would so warrant, may bring a common-law
recklessness claim against the brand-name manufacturer if it
intentionally failed to update the label on its drug, knowing
or having reason to know of an unreasonable risk of death or
grave bodily injury associated with its use. We also conclude
that a plaintiff who is injured by a generic drug due to a
failure to warn cannot bring a claim under G. L. c. 93A,
§ 9, against a brand-name manufacturer that did not
advertise, offer to sell, or sell that drug because such
failure did not occur in the conduct of "trade or
commerce" as defined in § 1 (b).
the Federal Food, Drug, and Cosmetic Act (act), 21 U.S.C.
§§ 301 et seq. (2012), drug manufacturers may not
market drugs in interstate commerce without the approval of
the United States Food and Drug Administration (FDA). 21
U.S.C. § 355(a). As such, a manufacturer that seeks to
market a new brand-name drug must submit a new drug
application, showing that the drug is safe and effective. See
21 U.S.C. § 355(b)(1); 21 C.F.R. §
314.50(d)(5)(iv)-(vi) (2017). As part of the new drug
application, the manufacturer must also show that the
proposed warning label for the drug is accurate and adequate.
See 21 U.S.C. § 355(b)(1), (d); 21 C.F.R. §
314.50(c)(2)(i), (d)(5)(v), (d)(5)(viii) (2017). The process
of obtaining FDA approval is "both onerous and lengthy,
" requiring manufacturers to expend significant time and
resources. Mutual Pharm. Co., v. Bartlett,
570 U.S. 472, 476 (2013).
the same process was required for generic drugs. See
PLIVA, 564 U.S. at 612. This changed in 1984, when
Congress enacted the Drug Price Competition and Patent Term
Restoration Act, commonly known as the Hatch-Waxman
amendments to the act. See Id. The purpose of the
amendments was twofold: to improve the affordability of
prescription drugs while also encouraging innovation and
investment in new drugs. See Abbott Labs, v.
Young, 920 F.2d 984, 985 (D.C. Cir. 1990), cert, denied,
502 U.S. 819 (1991), citing H.R. Rep. No. 98-857, 98th Cong.,
2nd Sess., pt. 1, at 14-15 (1984), reprinted in 1984
U.S.C.C.A.N. 2647, 2648 (House Report). In striking a balance
between these competing goals, Congress made two significant
changes to the existing regulatory scheme.
the amendments established a simpler and speedier approval
process for generic drugs. See 21 U.S.C. § 355 (j) . A
manufacturer now seeking to market a generic version of an
approved brand-name drug need only submit an abbreviated
new-drug application, indicating that the generic drug is
equivalent to its brand-name counterpart in certain key
respects. 21 U.S.C. § 355(j)(2)(A). Specifically, the
manufacturer must show that the proposed generic drug has the
same active ingredients, route of administration, dosage
form, and strength as the approved brand-name drug. 21 U.S.C.
§ 355(j)(2)(A)(ii)-(iii). It also must show that the
generic drug is "bioequivalent" to the brand-name
drug, 21 U.S.C. § 355(j)(2)(A)(iv), meaning that it has
the same rate and extent of absorption. 21 U.S.C. §
355(j)(8)(B). Finally, it must show that the proposed warning
label for the generic drug is the same as the labeling
approved for the brand-name drug. 21 U.S.C. §
355(j)(2)(A)(v). As a result, generic manufacturers can bring
their drugs to market much less expensively and can therefore
make these lower-cost alternatives more widely available to
consumers. See PLIVA, 564 U.S. at 612.
in order to safeguard the interests of brand-name
manufacturers and incentivize continued innovation, the
amendments also authorized the FDA to extend the length of
its patent terms to offset delays caused by the FDA's
regulatory review. See 35 U.S.C. § 156 (2012). See also
House Report, supra at 15. For patents issued after
the amendments were enacted, patent terms can now be extended
for up to five years, depending on the length of the review
period, thereby allowing brand-name manufacturers to enjoy a
monopoly over their newly developed drugs for a longer period
of time. 35 U.S.C. § 156(a), (c), (g)(6)(A).
feature of the current regulatory scheme is that it imposes
different labeling responsibilities on brand-name
manufacturers and generic manufacturers. See PLIVA,
564 U.S. at 613. A manufacturer of a brand-name drug must
ensure that its label is accurate and adequate. See 21 U.S.C.
§ 355(b)(1), (d). In contrast, a manufacturer of a
generic drug must ensure only that its label is identical to
the label of the brand-name counterpart. See 21 U.S.C. §
355(j)(2)(A)(v), (j)(4)(G). See also PLIVA,
supra. Furthermore, although all drug manufacturers
are required to continue to monitor the safety of their
products after approval, 21 C.F.R. §§ 314.80,
314.81, 314.98 (2017), only brand-name manufacturers have the
power to change the contents of their labels without FDA
approval. Under FDA regulations, a manufacturer may, through
a process known as "changes being effected, "
"add or strengthen" a warning on its label by
filing a simultaneous application with the FDA, without
waiting for the agency's approval. 21 C.F.R. §
314.70(c)(3), (c)(6)(iii)(A) (2017). This process is not
available to generic manufacturers that, pursuant to their
"ongoing [F]ederal duty of 'sameness, '"
may change a label only when necessary to match an updated
brand-name label or to follow FDA instructions.
PLIVA, supra at 613, 614-615. See 21 C.F.R.
§ 314.150(b)(10) (2017) (FDA approval for generic drug
may be withdrawn if label is "no longer consistent"
with brand-name label).
allocation of labeling responsibilities under Federal law has
proved difficult to reconcile with the duties required of
generic drug manufacturers under State tort law. Many States,
including this one, impose on manufacturers a duty to warn
consumers of dangers arising from the use of their products
where the manufacturers know or should have known of the
dangers. See PLIVA, 564 U.S. at 611; Mitchell v.
Sky Climber, Inc., 396 Mass. 629, 631 (1986) . Under
Federal regulations, however, manufacturers of generic drugs
-- because they lack the power to change the warning labels
on their products unilaterally -- cannot independently fulfil
these State law duties. For this reason, in PLIVA,
564 U.S. at 608-609, the United States Supreme Court held
that State tort law claims against generic manufacturers
arising out of a failure to warn are preempted by Federal
drug regulations. See Mutual Pharm. Co., 570 U.S. at
476 ("[S]tate-law design-defect claims that turn on the
adequacy of a drug's warnings are pre-empted by [F]ederal
law under PLIVA"). The practical consequence is
that a consumer who suffers injury arising from an inaccurate
or inadequate drug warning label can sue the manufacturer for
damages caused by his or her injury only if the consumer
ingested a brand-name version of the drug -- but not if the
consumer ingested the generic version. See PLIVA,
supra at 625.
summarize the facts as stated in the plaintiff's
complaint. Merck & Co., Inc. (Merck), is the manufacturer
of Proscar, an FDA-approved, brand-name version of the drug
finasteride. Finasteride is used to treat benign prostatic
hyperplasia in persons with an enlarged prostate.
August, 2010, Brian Rafferty was prescribed finasteride by
his physician to treat an enlarged prostate. Shortly after he
started taking finasteride, Rafferty began to experience side
effects causing sexual dysfunction, including erectile
dysfunction and decrease in libido. In October, 2010,
Rafferty weaned himself off of the drug but the side effects
continued and even worsened. He was eventually diagnosed with
hypogodanism and androgen deficiency allegedly induced by the
finasteride, and is now undergoing treatment that, according
to his physicians, may continue indefinitely.
undisputed that Rafferty ingested the generic version of
finasteride, not Merck's brand-name version Proscar. At
the time that Rafferty was prescribed the finasteride, the
product label warned of the potential for side effects
related to sexual dysfunction, but represented that these
side effects would resolve after discontinued use of the