Rafferty v. Merck & Co., Inc.

Decision Date23 May 2016
Docket NumberMICV2013-04459
PartiesBrian Rafferty v. Merck & Co., Inc. et al. [1] No. 133690
CourtMassachusetts Superior Court

Kenneth J. Fishman, Justice

During 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 .


For 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).

Merck 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.

In 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.

I. Standard of Review

A 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.

II. Legal Framework

" 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. § 355(d).

As 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 FDA").

As a 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. § 355(j)(2)(A)(v), 21 U.S.C. § 355(j)(4)(G), 21 C.F.R. § 314.94(a)(8), 21 C.F.R. § 314.127(a)(7).

The two recent United States Supreme Court decisions cited above confirmed these differing duties. First, in Mensing, the question before the Court was " whether federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus preempt, . . . state-law [product liability] claims." 564 U.S. at 609. Under the state laws at issue, " all drug manufacturers [have a duty] to adequately and safely label their products." Id. at 617. Federal drug regulations, however, prevent generic drug manufacturers " from independently changing their generic drugs' safety labels." Id. Federal law pre-empts state law " where it is impossible for a private party to comply with both state and federal requirements." Id. at 618 (citation omitted). The Court found impossibility in Mensing because " [i]t was not lawful under federal law for the [generic] [m]anufacturers to do what state law required of them . . . [and if they] had independently changed their labels to satisfy their state-law duty, they would have violated federal law." Id. The Court therefore concluded that the federal drug regulations pre-empted the plaintiffs' state tort-law claims alleging that the generic manufacturers had failed to provide adequate warning labels. Id. at 608-09, 618.

Second in Bartlett, the Court " decide[d] whether federal law pre-empt[ed] the [state law] design-defect claim . . . [which] impose[d] a duty on manufacturers to ensure that the drugs they market are not...

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