MEMORANDUM OF DECISION AND ORDER ON DEFENDANT MERCK &
CO., INC.'S MOTION TO DISMISS
Kenneth J. Fishman, Justice
and after ingesting finasteride, the generic equivalent of
the drug Proscar, the plaintiff, Brian Rafferty, experienced
certain side effects. He commenced this action against the
defendant Merck & Co., Inc. (" Merck"), the
manufacturer of Proscar, and against the defendant Sidney
Rubenstein, M.D., his prescribing physician, seeking damages
for the harm he suffered as a result of ingesting
finasteride. This case is before this Court on Merck's
motion to dismiss the claims against it. After hearing, and
upon review and consideration, the motion is ALLOWED
purposes of a motion to dismiss under Rule 12(b)(6), the
court must " accept as true the allegations in the
complaint and draw every reasonable inference in favor of the
plaintiff." Curtis v. Herb Chambers I-95, Inc.,
458 Mass. 674, 676, 940 N.E.2d 413 (2011).
is the manufacturer of Proscar, which the Food and Drug
Administration (" FDA") approved in 1992 for the
treatment of benign prostatic hyperplasia, i.e.,
enlarged prostate. Between 2008 and 2010, Merck changed the
label on the Proscar it sold in Sweden, the United Kingdom,
and Italy to warn that " erectile dysfunction [persists]
after discontinuation of treatment . . ." Complaint,
pars. 21-23. As of 2010, however, the Proscar label in the
United States indicated that side effects related to sexual
dysfunction could occur in a limited number of users, and
that they resolve after use of Proscar is discontinued.
August 2010, Rubenstein prescribed finasteride to Rafferty to
treat his enlarged prostate. Rubenstein did not warn Rafferty
of any side effects associated with taking finasteride. After
he started ingesting finasteride, Rafferty experienced side
effects relating to sexual dysfunction and hypogonadism,
including erectile dysfunction and decrease in libido.
Rafferty weaned himself off finasteride in October 2010, and
his symptoms ceased for approximately two weeks. Thereafter,
in late October and early November 2010, his symptoms
returned along with new symptoms. Eventually, specialists
diagnosed Rafferty with hypergonadism and androgen deficiency
which the finasteride had induced. In March 2011, Rafferty
began treatment which will continue indefinitely.
Standard of Review
party moving to dismiss pursuant to Mass.R.Civ.P. 12(b)(6)
contends that the complaint fails " to state a claim
upon which relief can be granted . . ." " While a
complaint attacked by a . . . motion to dismiss does not need
detailed factual allegations . . . a plaintiff's
obligation to provide the 'grounds' of his
'entitle[ment] to relief' requires more than labels
and conclusions . . ." Iannacchino v. Ford Motor
Co., 451 Mass. 623, 636, 888 N.E.2d 879 (2008), quoting
Bell A. Corp. v. Twombly, 550 U.S. 544, 555, 127
S.Ct. 1955, 167 L.Ed.2d 929 (2007). " Factual
allegations must be enough to raise a right to relief above
the speculative level . . . [based] on the assumption that
all the allegations in the complaint are true (even if
doubtful in fact) . . ." Id., quoting Bell
A. Corp., 550 U.S. at 555. Therefore, the pleading stage
requires " factual 'allegations plausibly suggesting
(not merely consistent with)' an entitlement to relief,
in order to 'reflect[ ] the threshold requirement of
[Fed.R.Civ.P.] 8(a)(2) that the " plain statement"
possess enough heft to " sho[w] that the pleader is
entitled to relief." '" Id., quoting
Bell A. Corp., 550 U.S. at 557.
Any person may file with the Secretary [of the FDA] an
application with respect to any drug." 21 U.S.C. §
355(b)(1). " In the case of a new brand-name drug, FDA
approval can be secured only by submitting a new-drug
application" or " NDA, " which " is a
compilation of materials that must include 'full reports
of [all clinical] investigations, ' [21 U.S.C.] §
355(b)(1)(A), relevant nonclinical studies, and 'any
other data or information relevant to an evaluation of the
safety and effectiveness of the drug product obtained or
otherwise received by the applicant from any source, ' 21
C.F.R. § § 314.50(d)(2) and (5)(iv) (2012)."
Mutual Pharm. Co., Inc. v. Bartlett, 133 S.Ct. 2466,
2470-71, 186 L.Ed.2d 607 (2013) (" Bartlett
"). " The NDA must also include 'the labeling
proposed to be used for such drug, ' 21 U.S.C. §
355(b)(1)(F); 21 C.F.R. § 314.50(c)(2)(i), and 'a
discussion of why the [drug's] benefits exceed the risks
under the conditions stated in the labeling, ' 21 C.F.R.
§ 314.50(d)(5)(viii); [21 C.F.R.] §
314.50(c)(2)(ix)." Id. at 2471. " The FDA
may approve an NDA only if it determines that the drug in
question is 'safe for use' under 'the conditions
of use prescribed, recommended, or suggested in the proposed
labeling thereof.'" Id., quoting 21 U.S.C.
this process " is both onerous and lengthy[, ] . . .
Congress passed the Drug Price Competition and Patent Term
Restoration Act of 1984 . . ., popularly known as the
'Hatch-Waxman Act[, ]'" pursuant to which "
a generic drug may be approved without the same level of
clinical testing required for approval of a new brand-name
drug, provided the generic drug is identical to the
already-approved brand-name drug in several key
respects." Id. ; see PLIVA, Inc. v.
Mensing, 564 U.S. 604, 612, 131 S.Ct. 2567, 180 L.Ed.2d
580 (2011) (" Mensing ") (" Under
this law, 'generic drugs' can gain FDA approval
simply by showing equivalence to a reference listed drug that
has already been approved by the FDA[, ] . . . [thereby]
allow[ing] manufacturers to develop generic drugs
inexpensively, without duplicating the clinical trials
already performed on the equivalent brand-name drug").
" First, the proposed generic drug must be chemically
equivalent to the approved brand-name drug: it must have the
same 'active ingredient' or 'active ingredients,
' 'route of administration, ' 'dosage form,
' and 'strength' as its brand-name
counterpart." Bartlett, 133 S.Ct. at 2471,
quoting 21 U.S.C. § 355(j)(2)(A)(ii), (iii). "
Second, a proposed generic must be 'bioequivalent' to
an approved brand-name drug[, ]" id., quoting
21 U.S.C. § 355(j)(2)(A)(iv), " [t]hat is, it must
have the same 'rate and extent of absorption' as the
brand-name drug." Id., quoting 21 U.S.C. §
355(j)(8)(B). " Third, the generic drug manufacturer
must show that 'the labeling proposed for the new drug is
the same as the labeling approved for the [approved
brand-name] drug.'" Id., quoting 21 U.S.C.
§ 355(j)(2)(A)(v). Generic drug manufacturers make this
showing by submitting an abbreviated new drug application
(" ANDA"). 21 U.S.C. § 355(j)(2).
Once a drug--whether generic or brand-name--is approved, the
manufacturer is prohibited from making any major changes to
the 'qualitative or quantitative formulation of the drug
product, including active ingredients, or in the
specifications provided in the approved
application.'" Bartlett, 133 S.Ct. at 2471,
quoting 21 C.F.R. § 314.70(b)(2)(i). " Generic
manufacturers are also prohibited from making any unilateral
changes to a drug's label." Id., citing 21
C.F.R. § 314.94(a)(8)(iii), 21 C.F.R. §
314.150(b)(10); see id. at 2476 (" [F]ederal
law prevents generic drug applications from changing their
labels"); Mensing, 564 U.S. at 617 (same).
Compare 21 C.F.R. § 314.70(c)(6)(iii) (permitting
brand-name drug manufacturers to strengthen warnings or
instructions using " changes-being-effected"
(" CBE") process; " [t]hey need only
simultaneously file a supplemental application with the
result of the Hatch-Waxman Act, then, " brand-name and
generic drug manufacturers have different federal drug
labeling duties. A brand-name manufacturer seeking new drug
approval is responsible for the accuracy and adequacy of its
label." Mensing, 564 U.S. at 613, citing 21
U.S.C. § 355(b)(1), (d). " A manufacturer seeking
generic drug approval, on the other hand, is responsible for
ensuring that its warning label is the same as the brand
name's." Id., citing 21 U.S.C. ...