Case Title: Rafferty v. Merck & Co., Inc.

Citation: 

Docket Number: SJC-12347

State: massachusetts

Court: Massachusetts Supreme Court

Date: 2018-03-16T00:00:00Z

Document:
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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 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, 
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, brand-
name 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 brand-
name 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.