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SJC-12347

BRIAN RAFFERTY vs. MERCK & CO., INC., & another.1

Middlesex. November 6, 2017. - March 16, 2018.

Present: Gants, C.J., Gaziano, Budd, & Cypher, JJ.

Negligence, Pharmaceutical manufacturer, Adequacy of warning, 

Duty to warn, Standard of care. Actionable tort. Public 

Policy. Consumer Protection Act, Unfair or deceptive act, 

Trade or commerce. Practice, Civil, Motion to dismiss.

Civil 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.

The Supreme Judicial Court on its own initiative 

transferred the case from the Appeals Court.

Emily E. Smith-Lee for the plaintiff.

Richard L. Neumeier (Aaron Rice, of Mississippi, & David L. 

Johnson, of Tennessee, also present) for Merck & Co., Inc.

The 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 & others.

 

1 Sidney Rubenstein.
2

Mark C. Fleming & Tyler L. Sparrow for International 

Association of Defense Counsel.

Hugh F. Young, Jr., of Virginia, & David R. Greiger & 

Richard G. Baldwin for Product Liability Advisory Council, Inc.

Kannon 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 America.

Lawrence G. Cetrulo, Kyle E. Bjornlund, Elizabeth S. 

Dillon, & Brian D. Fishman for Massachusetts Defense Lawyers 

Association.

GANTS, C.J. Under 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 
3

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).2

Background. 1. Regulatory background. Under 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 

 

2 We acknowledge the amicus briefs submitted in support of 

Merck & Co., Inc., by the Pharmaceutical Research and 

Manufacturers of America, the American Tort Reform Association, 

and the National Association of Manufacturers; the International 

Association of Defense Counsel; the Product Liability Advisory 

Council, Inc.; the Chamber of Commerce of the United States of 

America; and the Massachusetts Defense Lawyers Association.
4

"both onerous and lengthy," requiring manufacturers to expend 

significant time and resources. Mutual Pharm. Co., v. Bartlett, 

570 U.S. 472, 476 (2013).

Originally, 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. 

First, 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 newdrug 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, 
5

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. 

Second, 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).
6

A key 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).3 This process is not available to generic manufacturers 

that, pursuant to their "ongoing [F]ederal duty of 'sameness,'" 

 

3 The United States Food and Drug Administration (FDA) 

retains the authority to disapprove any labeling changes made 

through the "changes being effected" process, in which case it 

may order the manufacturer to cease distribution of the drug 

with the disapproved label change. See 21 C.F.R. 

§ 314.70(c)(3), (7) (2017). See also Wyeth v. Levine, 555 U.S. 

555, 571 (2009).
7

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).

This 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 
8

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.

2. Plaintiff's claims. We 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.

In 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.

It is 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 
9

resolve after discontinued use of the drug. As required under 

Federal law, this generic label conformed to Merck's label for 

Proscar.

Rafferty alleged that by the time he was prescribed 

finasteride, several reports and studies had already emerged 

suggesting that those side effects could in fact persist even 

after discontinued use. He also alleged that, starting in 2008, 

Merck changed the label for Proscar in certain foreign markets, 

including Sweden, the United Kingdom, and Italy, to include a 

warning about persistent erectile dysfunction. Nevertheless, as 

of 2010, when Rafferty ingested finasteride, Merck had not 

changed its label for Proscar in the United States to include 

this warning.

In 2013, Rafferty commenced an action against Merck in the 

Massachusetts Superior Court, asserting claims of negligence for 

failure to warn, and a violation of G. L. c. 93A, § 9.4 Crucial 

to Rafferty's negligence claim was his contention that, although 

he had never ingested Merck's brand-name version of finasteride, 

Merck nevertheless owed him a duty to warn of its dangers 

because, under Federal law, Merck controlled the label on the 

generic version that Rafferty did ingest. The case was removed 

 

4 Rafferty also sued his prescribing physician for negligent 

failure to obtain informed consent. He later voluntarily 

dismissed the claim against the physician.
10

to Federal court but subsequently remanded to the Superior 

Court. 

Merck filed a motion to dismiss the complaint, and the 

judge allowed the motion. With respect to Rafferty's negligence 

claim, the judge ruled that Merck owed no duty of care to 

Rafferty. The judge relied on "two well-established . . . 

principles" of Massachusetts products liability law: first, 

that "[a] plaintiff who sues a particular manufacturer for 

product liability generally must be able to prove that the 

[product] which it is claimed caused the injury can be traced to 

that specific manufacturer," Mathers v. Midland-Ross Corp., 403 

Mass. 688, 691 (1989); and second, that a manufacturer cannot be 

held liable "for failure to warn of risks created solely in the 

use or misuse of the product of another manufacturer" (emphasis 

added). Mitchell, 396 Mass. at 631. Because Merck did not 

manufacture the finasteride that allegedly caused Rafferty's 

injury, the judge concluded that Merck could not be held liable 

for his injuries. The judge, quoting the Iowa Supreme Court 

opinion in Huck v. Wyeth, Inc., 850 N.W.2d 353, 376-377 (Iowa 

2014), cert. denied, 135 S. Ct. 1699 (2015), declared that 

imposing liability on Merck for an injury caused by a 

competitor's product would not only disturb the balance struck 

between brand-name and generic manufacturers in the Hatch-Waxman 

amendments -- which courts are not "institutionally qualified" 
11

to second-guess -- but also run contrary to the fundamental 

principle of tort law that "[l]iability generally follows 

control." Id. at 378. Similarly, with respect to Rafferty's 

c. 93A claim, the judge concluded that there could be no 

violation of the consumer protection statute where there was no 

duty of care owed to the consumer.

After the judge dismissed both claims, a final judgment 

entered in favor of Merck. Rafferty now appeals from that final 

judgment and from the judge's decision allowing Merck's motion 

to dismiss. We transferred this case from the Appeals Court on 

our own motion.

Discussion. We review a judge's decision to dismiss a 

claim de novo, accepting as true the allegations in the 

complaint and drawing every reasonable inference in favor of the 

plaintiff. See Curtis v. Herb Chambers I-95, Inc., 458 Mass. 

674, 676 (2011). Our task is to "consider whether the factual 

allegations in the complaint are sufficient, as a matter of law, 

to state a recognized cause of action or claim, and whether such 

allegations plausibly suggest an entitlement to relief." 

Dartmouth v. Greater New Bedford Regional Vocational Tech. High 

Sch. Dist., 461 Mass. 366, 374 (2012). Here, Rafferty has 

asserted two claims, the first for negligence based on failure 

to warn, and the second for a violation of c. 93A. We address 

each of these claims in turn.
12

1. Negligence claim. "To recover for negligence, a 

plaintiff must show 'the existence of an act or omission in 

violation of a . . . duty owed to the plaintiff[] by the 

defendant.'" Cottam v. CVS Pharmacy, 436 Mass. 316, 320 (2002), 

quoting Dinsky v. Framingham, 386 Mass. 801, 804 (1982). The 

existence of a duty is a question of law for the courts. 

Cottam, supra at 321. Here, the question is whether Merck, as 

the brand-name manufacturer of finasteride, owed a duty to warn 

to those, like Rafferty, who ingested the generic version of the 

drug.

Typically, where a consumer is injured by a product, our 

law holds the manufacturer or seller responsible under a theory 

of products liability. See, e.g., H.P. Hood & Sons, Inc. v. 

Ford Motor Co., 370 Mass. 69, 75 (1976). But Rafferty concedes, 

as he must under our prevailing law, that Merck owes him no duty 

to warn under the law of products liability. As noted by the 

judge, a manufacturer may be found liable for a failure to warn 

only where the product that caused the injury was made by that 

manufacturer; its duty of care extends only to users of its own 

product. See Mathers, 403 Mass. at 691; Mitchell, 396 Mass. at 

631. This principle was applied in Carrier v. Riddell, Inc., 

721 F.2d 867, 868 (1st Cir. 1983), where the plaintiff, a high 

school football player, suffered a severe spinal injury playing 

football and sued the defendant, a helmet manufacturer, claiming 
13

that it negligently failed to warn his team that helmets offer 

little protection to a player's neck and spine. When the 

plaintiff learned in discovery that the helmet he wore was made 

by another manufacturer, not the defendant, the plaintiff 

continued to press his claim, arguing that his teammates wore 

helmets made by the defendant manufacturer and that, if it had 

provided a general warning about a helmet's limitations, he 

would have heard that warning and taken additional precautions 

that would have prevented his injury. Id. In an opinion 

written by now United States Supreme Court Justice Stephen 

Breyer, the United States Court of Appeals for the First 

Circuit, applying Massachusetts law, held that the defendant

manufacturer could not be liable for failing to warn the

plaintiff. Id. at 870. The court reasoned, "In the absence of 

some special circumstance one would expect a purchaser or a user 

of a product to rely for warnings upon the maker of the product 

they buy or use, not upon the maker of another, similar 

product." Id. at 869. As a general principle of products 

liability law, the court concluded that a manufacturer's "duty 

of care runs to those who buy or use the product itself, not a 

different [manufacturer's] product." Id.

Here, however, Rafferty did not bring a products liability 

claim and does not contend that Merck owed him a duty to warn as 

a manufacturer. Instead, he has brought a general negligence 
14

claim, relying on "a general principle of tort law" that we 

articulated in Jupin v. Kask, 447 Mass. 141, 147 (2006), quoting 

Remy v. MacDonald, 440 Mass. 675, 677 (2004). In Jupin, supra,

we declared:

"'[E]very actor has a duty to exercise reasonable care to 

avoid physical harm to others.' . . . A precondition to 

this duty is, of course, that the risk of harm to another

be recognizable or foreseeable to the actor. . . .

Consequently, with some important exceptions, 'a defendant 

owes a duty of care to all persons who are foreseeably 

endangered by his conduct, with respect to all risks which 

make the conduct unreasonably dangerous.'" (Citations 

omitted.)

Applying this "general principle," id., we held in Jupin

that a homeowner who stores firearms on his or her property has 

a duty of reasonable care to ensure that those firearms are 

properly secured, and that that duty was owed to, among others, 

a law enforcement officer shot by a person granted unsupervised

access, because he was a "foreseeable victim" of the improper 

storage. Id. at 143. Under that same principle, we also have 

held, for example, that a limousine driver who discharges an 

intoxicated passenger, knowing that that passenger is likely to 

drive while intoxicated, owes a duty of reasonable care to those 

who are foreseeably endangered by the passenger's drunk driving. 

Commerce Ins. Co. v. Ultimate Livery Serv., Inc., 452 Mass. 639, 

649-651 (2008). Similarly, we have held that an attorney owes a 

duty of reasonable care to nonclients, absent a conflict with a 
15

client's interest, if he or she knows or should know that the 

nonclient will rely on the attorney's advice, see Lamare v. 

Basbanes, 418 Mass. 274, 276 (1994), and that an accountant owes 

a duty of reasonable care to third parties if the accountant

knows that they will rely on the audit he or she prepares. 

Nycal Corp. v. KPMG Peat Marwick, LLP, 426 Mass. 491, 495-498

(1998).

At the same time, we recognized in Jupin that, even where 

the requirements of negligence are satisfied, there may 

nevertheless be a public policy justification for declining to 

impose a duty of care where "the imposition of a precautionary 

duty is deemed to be either inadvisable or unworkable." Jupin,

447 Mass. at 150-151, quoting Remy, 440 Mass. at 677. "The 

concept of 'duty' . . . 'is not sacrosanct in itself, but is

only an expression of the sum total of . . . considerations of 

policy which lead the law to say that the plaintiff is entitled 

to protection.'" Luoni v. Berube, 431 Mass. 729, 735 (2000), 

quoting W.L. Prosser & W.P. Keeton, Torts § 53, at 358 (5th ed. 

1984). Thus, the existence of duty is ultimately determined 

with "reference to existing social values and customs and 

appropriate social policy." Cremins v. Clancy, 415 Mass. 289, 

292 (1993). This approach comports with the one taken by the

Restatement (Third) of Torts, which provides:
16

"(a) An actor ordinarily has a duty to exercise reasonable 

care when the actor's conduct creates a risk of physical 

harm.

"(b) In exceptional cases, when an articulated 

countervailing principle or policy warrants denying or 

limiting liability in a particular class of cases, a court 

may decide that the defendant has no duty or that the 

ordinary duty of reasonable care requires modification."

Restatement (Third) of Torts: Liability for Physical and

Emotional Harm § 7 (2010).

Merck contends that, where a plaintiff alleges injury 

caused by a product arising from a failure to warn, we should 

limit the duty to warn to the manufacturer of that particular 

product, regardless of whether the claim is framed as a products 

liability claim or, as here, as a general negligence claim. It

is true that, in the vast majority of such cases, the duty to 

warn would be limited to the manufacturer of the product -- even 

if the plaintiff were to bring a general negligence claim --

because the risk of harm arising from an inadequate warning 

would be foreseeable to a manufacturer only with respect to

users of its own product, not the users of another product. 

Where the product causing the injury carries its own warning, 

one would expect the plaintiff to rely on that warning, not on 

the warning given for another product. Moreover, apart from any 

duty arising from the risk of foreseeable injury, only in rare 
17

cases could a plaintiff contend that his or her injury was 

caused by the inadequate warning given for another product. 

But this case presents an exception to the usual pattern.

Because the Hatch-Waxman amendments to the act require that the 

warning label of a generic drug be identical to the warning 

label of its brand-name counterpart, and because the United 

States Supreme Court in PLIVA, 564 U.S. at 614-615, interpreted 

the resulting regulatory scheme to forbid a generic drug 

manufacturer from independently revising its warning labels, 

duty to warn claims involving generic drugs are potentially 

viable as general negligence claims, although not as products 

liability claims. With generic drugs, it is not merely 

foreseeable but certain that the warning label provided by the 

brand-name manufacturer will be identical to the warning label 

provided by the generic manufacturer, and moreover that it will 

be relied on, not only by users of its own product, but also by 

users of the generic product. Unlike in Carrier, 721 F.2d at 

869, where the defendant manufacturer exercised no control 

whatsoever over the warnings attached to another manufacturer's 

product, Federal labeling requirements for generic drugs present

precisely the kind of "special circumstance" where a consumer 

would rely on the warnings created by someone other than the 

manufacturer of the product causing the injury, because those 

will be identical to (and inseparable from) the warnings 
18

provided by the generic manufacturer. Where a brand-name drug 

manufacturer provides an inadequate warning for its own product, 

it knows or should know that it puts at risk not only the users 

of its own product, but also the users of the generic product. 

Consequently, this is the rare (perhaps the only) type of case 

involving a manufactured product where the requirements of 

general negligence may be satisfied even where the requirements 

of products liability are not. 

However, as noted earlier, even where the requirements of 

general negligence are satisfied, we must still consider as a 

matter of public policy whether the imposition of a duty is 

"inadvisable or unworkable," see Jupin, 447 Mass. at 151, 

quoting Remy, 440 Mass. at 677, or, in the words of the 

Restatement (Third) of Torts, supra at § 7, whether this is an 

"exceptional case[]" where a "countervailing principle or policy 

warrants denying or limiting liability" in this class of cases. 

"Public policy favors the development and marketing of new 

and more efficacious drugs." Payton v. Abbott Labs, 386 Mass. 

540, 573 (1982). Therefore, we must carefully consider whether 

the imposition of general negligence liability on brand-name 

manufacturers for injuries suffered by generic drug consumers 

arising from a failure to warn would materially diminish the 

development and marketing of new drugs. 
19

Inevitably, imposing on brand-name manufacturers a duty to 

warn generic drug consumers would add to the manufacturer's 

costs. Where there is a duty to warn, negligence may be found 

where there is a failure "to exercise reasonable care in warning 

potential users of hazards associated with use of the product." 

Laaperi v. Sears, Roebuck & Co., 787 F.2d 726, 729 (1st Cir. 

1986) (applying Massachusetts law). "The common law duty to 

warn . . . necessitates a warning 'comprehensible to the average 

user and . . . convey[ing] a fair indication of the nature and 

extent of the danger to the mind of a reasonably prudent 

person.'" MacDonald v. Ortho Pharm. Corp., 394 Mass. 131, 140, 

cert. denied., 474 U.S. 920 (1985), quoting Ortho Pharm. Corp. 

v. Chapman, 180 Ind. App. 33, 49 (1979). "Whether a particular 

warning measures up to this standard is almost always an issue 

to be resolved by a jury; few questions are 'more appropriately 

left to a common sense lay judgment than that of whether a 

written warning gets its message across to an average person.'" 

MacDonald, supra, quoting Ferebee v. Chevron Chem. Co., 552 F. 

Supp. 1293, 1304 (D.D.C. 1982). The breadth and uncertain scope 

of this standard for a negligent failure to warn means that, 

where a consumer suffers injury from a generic drug, there would 

be broad latitude to bring a failure to warn claim and great 

difficulty in defeating it before trial. As a result, brandname manufacturers faced with failure to warn claims would bear 
20

the significant cost not only of compensating injured consumers, 

but also of litigating their claims, meritorious or not.

Where failure to warn claims are brought by consumers of a 

manufacturer's own product, "the risk of injury can be insured 

by the manufacturer and distributed among the public as a cost 

of doing business." Escola v. Coca Cola Bottling Co. of Fresno, 

24 Cal. 2d 453, 462 (1944) (Traynor, J., concurring). The cost 

of litigation and of damage awards or settlements is in this 

sense treated as "a cost of production." Restatement (Second) 

of Torts § 402A comment c (1965). But if consumers of generic 

drugs were allowed to recover damages for a brand-name 

manufacturer's negligent failure to warn, it would be far more 

difficult for the manufacturer to shoulder these costs, for 

three reasons. 

First, these costs would not be incurred until after the 

brand-name manufacturer's patent monopoly expires and generic 

competitors enter the market, at which point the brand-name 

manufacturer will have suffered a precipitous decline in sales

of its product. When there is such competition, generic 

manufacturers command approximately ninety per cent of the 

market, see Association for Accessible Medicines, Generic Drug 

Access & Savings in the U.S. 16 (2017), in part because many 

States, including Massachusetts, have enacted laws that 

authorize or even require pharmacists to substitute generic 
21

drugs when filling prescriptions for brand-name drugs. See, 

e.g., G. L. c. 112, § 12D (requiring generic substitution unless 

prescribing physician indicates "no substitution"). See also 

PLIVA, 564 U.S. at 628 (Sotomayor, J., dissenting); Grabowski,

Long, Mortimer, & Boyo, Updated Trends in US Brand-Name and 

Generic Drug Competition, 19 J. Med. Econ. 836, 840 (2016) 

(brand-name drugs facing generic competition between 2013 and 

2014 saw market share by volume fall to average of twelve per 

cent within first year). 

Second, because prices drop with generic drug competition, 

the sales of generic drugs may exceed the sales generated during 

the patent monopoly period, and may even continue indefinitely, 

long after the brand-name manufacturer has moved on to focus on 

other patented products. See United States Department of Health 

and Human Services, Office of the Assistant Secretary for 

Planning and Evaluation, Issue Brief: Understanding Recent 

Trends in Generic Drug Prices 1-2 (Jan. 27, 2016).

Third, because the United States Supreme Court in PLIVA, 

564 U.S. at 624, ruled that Federal preemption bars any generic 

drug consumer from bringing a failure to warn claim against any 

generic manufacturer, all such claims would be brought only

against the brand-name manufacturer that drafted the warning 

label, leaving the brand-name manufacturer without any ability 
22

to share the costs of litigation, or of a damage award or 

settlement, with the generic manufacturer. 

Therefore, although brand-name manufacturers are in the 

best position, because of their Federal labeling 

responsibilities, to prevent an injury arising from the 

inaccurate or inadequate warning on a generic drug, they are not 

in the best position to bear its costs. To recognize negligence 

liability here would impose on brand-name manufacturers an 

additional "cost of production" for products that, in reality, 

they no longer produce. Restatement (Second) of Torts, supra at 

§ 402A comment c.

These additional costs, and the uncertainty regarding their 

scope and duration, would inevitably affect to some degree the 

financial incentives to invest in the research and development 

of new drugs. Having said that, it is difficult to accurately 

assess whether, and to what extent, this would have a chilling 

effect on drug innovation. See S. Garber, RAND Institute for 

Civil Justice, Economic Effects of Product Liability and Other 

Litigation Involving the Safety and Effectiveness of 

Pharmaceuticals 55-56, 58, 62 (2013) (some evidence that 

expanded products liability has discouraged drug innovation, but 

"there is no reliable empirical basis for estimating in dollar 

terms the social costs or benefits of liability-induced . . . 

price increases, or effects on product safety, effectiveness, or 
23

innovation"). We realize that bringing a new drug to market is 

already a long, expensive, and risky process; studies have shown 

that, on average, the process of developing and obtaining FDA 

approval for a new drug takes ten to fifteen years and costs 

$2.6 billion, and only a small fraction of compounds under 

development are ever approved. See Pharmaceutical Research and

Manufacturers of America, Biopharmaceuticals in Perspective 29 

(2017). See also United States Department of Health and Human 

Services, Report to Congress, Prescription Drugs: Innovation, 

Spending, and Patient Access 25-36 (Dec. 7, 2016). Given that 

the costs of research and development are already so high and 

the odds of FDA approval so low, it is far from clear whether 

the development of any new drug would be prevented merely 

because of the incremental costs that would arise from the 

imposition of a duty to warn generic drug consumers. 

Meanwhile, imposing such a duty on brand-name manufacturers 

would have undeniable benefits. We can be confident that, if 

brand-name manufacturers owed generic drug consumers a duty to 

warn, they would have a greater financial incentive to revise 

their warnings through the change being effected process where 

new information demonstrates the need to do so, in order to 

prevent failure to warn suits. Without such a duty, the only 

threat of a failure to warn suit would be from consumers of the

brand-name drug who, once the patent has expired and generic 
24

drugs enter the market, might comprise as little as ten per cent 

or less of the market for such drugs. As a result, no one --

neither the generic manufacturer nor the brand-name manufacturer 

-- would have a complete incentive to maintain safe labels for 

the overwhelming share of prescription drugs dispensed. State 

tort law always has been an important source of consumer 

protection with respect to prescription drugs, "provid[ing] 

incentives for drug manufacturers to disclose safety risks 

promptly." Wyeth v. Levine, 555 U.S. 555, 579 (2009). See 

Kessler & Vladeck, A Critical Examination of the FDA's Efforts 

to Preempt Failure-to-Warn Claims, 96 Geo. L.J. 461, 483, 491-

495 (2008). If generic drug consumers could not sue drug 

manufacturers for a failure to warn, they would be denied an 

important safeguard against future injuries.

We also recognize that, if we were to shield brand-name 

manufacturers entirely from liability for the failure to warn 

generic drug consumers, we would leave those consumers with no 

chance of obtaining compensation for their injuries because

generic manufacturers are already immune from State law claims. 

In PLIVA, 564 U.S. at 625, the United States Supreme Court 

recognized "the unfortunate hand that [F]ederal drug regulation 

has dealt" generic drug consumers, whose claims against 

manufacturers are barred only because they ingested generic 

rather than brand-name drugs. See id. at 643 (Sotomayor, J., 
25

dissenting) ("[Under PLIVA,] a drug consumer's right to 

compensation for inadequate warnings now turns on the 

happenstance of whether her pharmacist filled her prescription 

with a brand-name drug or a generic"). Were we also to bar 

their claims against brand-name manufacturers, we would only 

exacerbate the unfairness of this regulatory scheme. Such a 

result would be especially troubling given that, as discussed, 

generic drugs represent close to ninety per cent of the 

prescription drug market, and many drug consumers do not even 

have a choice under State generic substitution laws whether they 

receive a brand-name or generic drug when they fill a 

prescription. See PLIVA, supra at 628 (Sotomayor, J., 

dissenting). The widespread use of generic drugs means that, if 

we decline to impose any liability on brand-name manufacturers, 

countless consumers would be left without a remedy. 

The need to deter failures to warn, and to compensate for 

the resulting harm, is especially urgent where the failure is 

not merely inadvertent and the risk of harm is most serious. In 

other types of cases where we have circumscribed liability for 

public policy reasons, we have nevertheless consistently 

recognized that there is a certain core duty -- a certain 

irreducible minimum duty of care, owed to all persons -- that as 

a matter of public policy cannot be abrogated: that is, the 

duty not to intentionally or recklessly cause harm to others. 
26

For instance, we have long held in premises liability cases that 

a landowner owes no duty of reasonable care to a trespasser, 

Schofield v. Merrill, 386 Mass. 244, 245-246 (1982), based on 

the rationale that landowners should not be "bound to protect or 

provide safeguards for wrongdoers." Sweeny v. Old Colony & 

Newport R.R. Co., 10 Allen 368, 372 (1865). Yet, we have held 

that a landowner still owes a trespasser a duty to "refrain from 

wilful, wanton[,] or reckless disregard for the trespasser's 

safety." Schofield, supra at 245-246. And in cases involving 

contractual waivers, we have hewed to "the well-established 

principle of contract law" that "while a party may contract 

against liability for harm caused by its negligence, it may not 

do so with respect to its gross negligence" or, for that matter, 

its reckless or intentional conduct. Maryland Cas. Co. v. NSTAR 

Elec. Co., 471 Mass. 416, 422 (2015), quoting Zavras v. Capeway 

Rovers Motorcycle Club, Inc., 44 Mass. App. Ct. 17, 19 (1997). 

See Sharon v. Newton, 437 Mass. 99, 110 n.12 (2002) 

(distinguishing waivers for ordinary negligence from waivers for 

"gross negligence, or reckless or intentional conduct"); 

Restatement (Second) of Contracts § 195(1), at 65 (1981) ("A 

term exempting a party from tort liability for harm caused 

intentionally or recklessly is unenforceable on grounds of 

public policy"). 
27

We have applied this same reasoning in many other types of 

cases where we have tolerated ordinary negligence but drawn the 

line at recklessness. In defamation cases, a plaintiff who is a 

public officer or a public figure cannot recover damages on 

proof of the defendant's negligence, but can recover if the 

defendant acted with "actual malice," meaning wilful or reckless 

disregard of the truth. See Stone v. Essex County Newspapers, 

Inc., 367 Mass. 849, 851 (1975). See also New York Times Co. v. 

Sullivan, 376 U.S. 254, 279-280 (1964). In cases involving 

bailments, the traditional rule has been that where bailments 

are for the sole benefit of the bailor, the bailee is not liable 

for ordinary negligence but can be liable for gross negligence. 

See Altman v. Aronson, 231 Mass. 588, 590 (1919), quoting Foster

v. Essex Bank, 17 Mass. 479, 498-499, 507 (1821). Similarly, in 

cases involving sporting events, we have held that athletes and 

coaches cannot be liable for injuries caused by their 

negligence, but will be held liable if they act in "reckless 

disregard of safety." Gauvin v. Clark, 404 Mass. 450, 454 

(1989). See Kavanagh v. Trustees of Boston Univ., 440 Mass.

195, 204-205 (2003). 

In enacting statutes, the Legislature, too, has 

distinguished between ordinary negligence and reckless conduct, 

granting immunity or indemnification in some situations in 

claims of negligence but not in claims of recklessness. See, 
28

e.g., G. L. c. 21, § 17C (landowner who makes land open to 

public for recreational use free of charge not liable for 

personal injuries "in the absence of wilful, wanton, or reckless 

conduct"); G. L. c. 229, § 2 (railroads not liable for 

negligence in causing death of trespasser but liable for 

reckless conduct). See also G. L. c. 258, § 9 (public employees 

may not be indemnified for civil rights violations if employee 

"acted in a grossly negligent, willful[,] or malicious manner); 

G. L. c. 258, § 9A (police officers may not be indemnified for 

violations of Federal or State law if officer "acted in a 

wilful, wanton, or malicious manner").

Implicit in both our common and statutory law, then, is a 

longstanding public policy that, although we may be willing in 

certain circumstances to excuse ordinary negligence, we will not 

tolerate the reckless disregard of the safety of others. 

Having weighed these considerations, we conclude as a 

matter of public policy that allowing a generic drug consumer to 

bring a general negligence claim for failure to warn against a 

brand-name manufacturer poses too great a risk of chilling drug 

innovation, contrary to the public policy goals embodied in the 

Hatch-Waxman amendments. But we also conclude that public 

policy is not served if generic drug consumers have no remedy 

for the failure of a brand-name manufacturer to warn in cases 

where such failure exceeds ordinary negligence, and rises to the 
29

level of recklessness. In cases where, for instance, a brandname manufacturer learns that its drug is repeatedly causing 

death or serious injury, or causes birth defects when used by 

pregnant mothers, and still fails to warn consumers of this 

danger, public policy does not dictate that these consumers be 

left with no remedy when those risks are realized, or that the 

manufacturer have little financial incentive to reveal these 

risks. We therefore hold that a brand-name manufacturer that

controls the contents of the label on a generic drug owes a duty 

to consumers of that generic drug not to act in reckless 

disregard of an unreasonable risk of death or grave bodily 

injury. This recklessness standard strikes the most appropriate 

balance between competing public policy interests, limiting 

liability for brand-name manufacturers while also providing 

remedies for the most serious injuries and deterring the most 

dangerous forms of conduct. 

Under our common law, a defendant's conduct is in reckless 

disregard of the safety of another where

"he does an act or intentionally fails to do an act which 

it is his duty to the other to do, knowing or having reason 

to know of facts which would lead a reasonable man to 

realize, not only that his conduct creates an unreasonable 

risk of physical harm to another, but also that such risk 

is substantially greater than that which is necessary to 

make his conduct negligent."
30

Boyd v. National R.R. Passenger Corp., 446 Mass. 540, 546 

(2006), quoting Restatement (Second) of Torts, supra at § 500, 

at 587.

Recklessness is distinguishable from negligence in two key 

respects. See Manning v. Nobile, 411 Mass. 382, 387-388 (1991). 

First, the reckless conduct must be intended. "While negligence 

may result from 'inadvertence, incompetence, . . . or a failure 

to take [adequate] precautions,' recklessness 'requires a 

conscious choice of a course of action, either with knowledge of 

the serious danger to others involved in it or with knowledge of 

facts which would disclose this danger to any reasonable man.'" 

Boyd, 446 Mass. at 547, quoting Restatement (Second) of Torts, 

supra at § 500 comment g, at 590. Importantly, only the conduct 

need be intended; the resulting harm need not be. Boyd, supra

at 548. 

Second, reckless conduct must involve a substantially 

greater risk than is required for ordinary negligence. 

"Reckless failure to act involves an intentional or unreasonable 

disregard of a risk that presents a high degree of probability 

that substantial harm will result to another." Sandler v. 

Commonwealth, 419 Mass. 334, 336 (1995). "The risk of death or 

grave bodily injury must be known or reasonably apparent, and 

the harm must be a probable consequence of the defendant's 

election to run that risk or of his failure reasonably to 
31

recognize it." Id. The difference between recklessness and 

mere negligence is therefore not only "a difference in degree 

but also a difference in kind." Id. at 337. 

Under this standard, a brand-name manufacturer that

intentionally fails to update the label on its drug to warn of

an unreasonable risk of death or grave bodily injury, where the 

manufacturer knows of this risk or knows of facts that would 

disclose this risk to any reasonable person, will be held 

responsible for the resulting harm.

We acknowledge that, by imposing on brand-name 

manufacturers any duty to warn generic consumers, we find 

ourselves in the minority of courts that have decided this 

issue. We also are the only court to limit the scope of 

liability arising under this duty to reckless disregard of the 

risk of death or grave bodily injury. As Merck has repeatedly 

reminded us, most courts have held that brand-name manufacturers 

owe no duty to generic drug consumers who have been injured by 

inaccurate or inadequate labels. See, e.g., Johnson v. Teva 

Pharms. USA, Inc., 758 F.3d 605, 616 (5th Cir. 2014); Guarino v. 

Wyeth, LLC, 719 F.3d 1245, 1250-1253 (11th Cir. 2013); Smith v. 

Wyeth, Inc., 657 F.3d 420, 424 (6th Cir. 2011), cert. denied, 

566 U.S. 974 (2012); Mensing v. Wyeth, Inc., 588 F.3d 603, 613-

614 (8th Cir. 2009), vacated on other grounds, 564 U.S. 604, and 

revised, 658 F.3d 867 (2011); Foster v. American Home Prods. 
32

Corp., 29 F.3d 165, 171 (4th Cir. 1994); Huck, 850 N.W.2d at

378.5 We note that many of these decisions are distinguishable, 

some because they were resolved under the products liability 

statutes of other States, see Johnson, supra at 615-616 

(applying Louisiana Products Liability Act); Smith, supra at 

423-424 (applying Kentucky Products Liability Act), and others 

because they were issued by Federal courts that are constrained 

in their interpretation of State law in the absence of clear 

guidance from State appellate courts. See Guarino, supra at 

1251 ("[C]onsiderations of comity and federalism counsel that we 

proceed gingerly when venturing into uncharted waters of [S]tate 

substantive law"). Further, to the extent that several of these 

decisions predate the United States Supreme Court's decision in 

PLIVA, 564 U.S. at 613, 624, we find them less persuasive 

because they failed to consider the Federal preemption of State 

tort law claims against generic manufacturers and the unique 

remedial gap that this has created.6 

 

5 Only a few courts have held otherwise. See Wyeth, Inc. v. 

Weeks, 159 So. 3d 649, 676 (Ala. 2014), superseded by statute, 

Ala. Code § 6-5-530(a); Conte v. Wyeth, Inc., 168 Cal. App. 4th 

89, 114 (2008). See also Kellogg v. Wyeth, 762 F. Supp. 2d 694, 

706 (D. Vt. 2010).

6 For example, in Foster v. American Home Prods. Corp., 29 

F.3d 165, 169-171 (4th Cir. 1994), the United States Court of 

Appeals for the Fourth Circuit held that a brand-name 

manufacturer owed no duty to a generic drug consumer based in 

part on the premise that generic manufacturers have some control 

over the contents of their labels and can therefore be held 
33

We also conclude that, by limiting liability to 

circumstances where there has been reckless disregard of an 

unreasonable risk of death or grave bodily injury, we adequately 

address the many policy concerns that have led other courts to 

deny liability altogether. See, e.g., Huck, 850 N.W.2d at 376-

380. First, our ruling does not undo the careful balance struck 

in the Hatch-Waxman amendments by imposing unwarranted new 

burdens on brand-name manufacturers. We emphasize that, 

although we limit the brand-name manufacturer's duty to warn 

generic drug consumers, we do not limit its duty to warn its own 

customers; as to them, brand-name manufacturers still owe a duty 

to "exercise reasonable care in warning [them] of hazards 

associated with use of [their] product." Laaperi, 787 F.2d at 

729. In addition to this common-law duty they already owe to 

their own customers, brand-name manufacturers also have a duty 

under the act to ensure that the labels on their products are 

accurate and adequate. 21 U.S.C. § 355(b)(1), (d). FDA 

regulations impose on all drug manufacturers, both brand-name 

and generic, an ongoing obligation to monitor a drug's risks and 

report any adverse drug experiences that may not be indicated by 

the drug's label. 21 C.F.R. §§ 314.80, 314.81, 314.98. Drug

 

liable for negligent failure to warn. This premise is obviously 

no longer true in light of the United States Supreme Court's 

decision in PLIVA, Inc. v. Mensing, 564 U.S. 604, 613, 624 

(2011).
34

manufacturers also have a regulatory obligation to revise their 

labeling "to include a warning about a clinically significant 

hazard as soon as there is reasonable evidence." 21 C.F.R. §

201.57(c)(6)(i) (2017). See 21 C.F.R. § 201.80(e) (2017). To 

avoid liability for recklessness toward generic drug consumers, 

a brand-name manufacturer need only fulfil those obligations it 

already has towards its own customers. Cf. Coombes v. Florio, 

450 Mass. 182, 191 (2007) (Ireland, J., concurring) (extension 

of doctor's duty to warn to nonpatients "d[id] not impose a 

heavy burden" where it "require[d] nothing . . . not already 

required by his duty to his patient"). 

Second, to the extent that our decision makes investments 

in new drugs any "riskier" -- by exposing manufacturers to 

additional liability -- we expect that this marginal risk will 

not materially chill innovation or increase drug prices. After 

all, what drug manufacturer, when deciding whether to invest in 

a new drug or in setting prices during its patent monopoly, 

would factor in substantial liability costs that might be 

incurred after its patent expires, premised on the probability 

that it will act in reckless disregard of an unreasonable risk 

of death or grave bodily injury?

Third, we do not believe that by recognizing liability for 

recklessness we overstep our bounds and intrude into matters for 

which "courts are not institutionally qualified." Huck, 850 
35

N.W.2d at 377. In enacting the Hatch-Waxman amendments, 

Congress has determined that public health and safety is best 

served by a particular allocation of labeling responsibilities 

between brand-name and generic manufacturers. We cannot (nor do 

we seek to) disturb that allocation. Congress recognized and 

expected that its Federal regulatory scheme would be 

supplemented with traditional State law remedies. When Congress 

enacted the act, it rejected an earlier draft that would have 

provided a Federal cause of action for injured consumers, 

"[e]vidently, [because] it determined that [State law] provided 

appropriate relief." Wyeth, 555 U.S. at 574 & n.7. 

Fourth, our decision does not subvert the fundamental 

principles of tort law. On the contrary, it is fully consistent 

with them. As earlier noted, the relief we provide, limited to 

reckless disregard of an unreasonable risk of death or grave 

bodily injury, is coextensive with the irreducible minimum duty 

of care that as a matter of public policy cannot be abrogated, 

even where a trespasser invades a person's property or when the 

parties contractually agree to a waiver of liability.

In this case, the question whether Rafferty has stated a 

failure to warn claim that meets the standard of a reckless 

disregard of an unreasonable risk of death or grave bodily 

injury must be determined by a trial judge. Because Merck owed 

Rafferty a limited duty to warn, and because Rafferty, to state 
36

a claim that falls within this limited duty, must allege facts 

supporting a finding that Merck acted recklessly, not just 

negligently, we vacate the dismissal of this claim and remand 

the case to the Superior Court. We direct the court to grant 

leave to Rafferty to amend his complaint if he believes that he 

can state facts sufficient to support such a claim. Cf. Cheney

v. Automatic Sprinkler Corp. of Am., 377 Mass. 141, 150 (1979) 

(plaintiff given opportunity to amend complaint where court "for 

the first time . . . [indicated] the relevant considerations" 

for his claim).

2. Chapter 93A claim. To state a claim under the consumer 

protection statute, G. L. c. 93A, § 9, a plaintiff must allege

facts sufficient to establish four elements: first, that the 

defendant has committed an unfair or deceptive act or practice; 

second, that the unfair or deceptive act or practice occurred

"in the conduct of any trade or commerce;" third, that the 

plaintiff suffered an injury; and fourth, that the defendant's 

unfair or deceptive conduct was a cause of the injury. 

See G. L. c. 93A, § 2 (a); Herman v. Admit One Ticket Agency 

LLC, 454 Mass. 611, 615-616 (2009).

Under § 2, "unfair or deceptive acts or practices" are 

"declared unlawful" only where they occur "in the conduct of any 

trade or commerce." "Trade" and "commerce" are defined in 

§ 1 (b) to include "the advertising, the offering for sale, 
37

. . . the sale, . . . or distribution of any services and any 

property, tangible or intangible, . . . and any other article, 

commodity, or thing of value wherever situate, and shall include 

any trade or commerce directly or indirectly affecting the 

people of this [C]ommonwealth." 

To satisfy the "trade or commerce" requirement in a failure 

to warn claim under G. L. c. 93A, § 9, a plaintiff need not have 

purchased the product directly from the defendant. See Kattar

v. Demoulas, 433 Mass. 1, 14-15 (2000) ("Parties need not be in 

privity for their actions to come within the reach of c. 93A"). 

It suffices that the plaintiff used the product, even if it was 

sold to another, and was injured as a result of the defendant's 

failure to warn. See Maillet v. ATF-Davidson, Co., 407 Mass. 

185, 190 (1990) (injured printing press operator could sue 

manufacturer of printing press purchased by his employer, even 

though he was "neither a consumer nor in privity with the 

defendant"). See also Ciardi v. F. Hoffmann-La Roche, Ltd., 436 

Mass. 53, 65 (2002) (indirect purchaser of product could assert 

c. 93A claim for unfair competition against manufacturer of that 

product, notwithstanding lack of privity, because she "alleged a 

connection between herself and the defendants, albeit an 

indirect one, as parties to consumer transactions").7 

 

7 It is important to distinguish between claims brought 

under G. L. c. 93A, § 9, typically by consumers against 
38

Here, however, Rafferty does not allege that he used 

Merck's brand-name drug. Rather, he alleges that he suffered 

injury from the use of a drug that Merck did not advertise, 

offer to sell, or sell. Although c. 93A does not require 

privity, it is limited "only to actions taken in the course of

'trade or commerce'" (emphasis added). Morrison v. Toys "R" Us, 

Inc., Mass., 441 Mass. 451, 457 (2004). In this context,

Merck's alleged unfair and deceptive action -- that is, its 

failure to warn Rafferty of the side effects of the drug -- was 

not taken in the course of "any trade or commerce" because it 

was not taken in the course of the advertising, offer to sell, 

or sale of any Merck product. Of course, if one of Merck's own 

consumers was injured from Merck's brand-name version of the 

drug as a result of its failure to warn, that failure would have 

been in the course of Merck's sale of its own product, and 

therefore "in the conduct of any trade or commerce." G. L. 

c. 93A, § 2 (a). But where the failure to warn is with respect 

to a drug that Merck has never advertised, offered to sell, or 

sold, it would stretch the limits of c. 93A to hold that such 

 

businesses, and claims brought under § 11, typically by 

businesses against other businesses. Unlike claims under § 9, 

claims under § 11 require not only that the defendant's conduct 

occur in "trade or commerce" but also that there be a commercial 

transaction between the parties. See Linkage Corp. v. Trustees 

of Boston Univ., 425 Mass. 1, 22-23, cert. denied, 522 U.S. 1015 

(1997).
39

failure occurred "in the conduct of any trade or commerce." Id. 

We therefore conclude that Rafferty has failed to allege 

sufficient facts to state a claim under c. 93A, § 9.

Conclusion. For the reasons stated above, the order 

dismissing Rafferty's common-law claim is vacated and the case 

is remanded to the Superior Court, with instructions that 

Rafferty be granted leave to amend his complaint within thirty 

days of the date of the rescript. The order dismissing 

Rafferty's c. 93A claim is affirmed.

So ordered.