367
Chapter 22
Warranties and
Product Liability
Case 22.1
198 N.E.2d 309
Priscilla D. WEBSTER
v.
BLUE SHIP TEA ROOM, INC.
Supreme Judicial Court of Massachusetts, Suffolk.
Argued April 6, 1964.
Decided May 4, 1964.
REARDON, Justice.
This is a case which by its nature evokes earnest study not only of the law but also of the culinary traditions of the Commonwealth
which bear so heavily upon its outcome. It is an action to recover damages for personal injuries sustained by reason of a breach of
implied warranty of food served by the defendant in its restaurant. An auditor, whose findings of fact were not to be final, found for
the plaintiff. On a retrial in the Superior Court before a judge and jury, in which the plaintiff testified, the jury returned a verdict for
368 CASE PRINTOUTS TO ACCOMPANY BUSINESS LAW
This restaurant, which the plaintiff characterized as “quaint,’ was located in Boston “on the third floor of an old building on T Wharf
which overlooks the ocean.’ The plaintiff, who had been born and brought up in New England (a fact of some consequence), or-
dered clam chowder and crabmeat salad. Within a few minutes she received tidings to the effect that “there was no more clam
chowder,’ whereupon she ordered a cup of fish chowder.
This misadventure led to two esophagoscopies at the Massachusetts General Hospital, in the second of which, on April 27, 1959, a
fish bone was found and removed. The sequence of events produced injury to the plaintiff which was not insubstantial. We must
decide whether a fish bone lurking in a fish chowder, about the ingredients of which there is no other complaint, constitutes a
breach of implied warranty under applicable provisions of the Uniform Commercial Code,1 the annotations to which are not helpful
on this point. As the judge put it in his charge, “Was the fish chowder fit to be eaten and wholesome? * * * (N)obody is claiming that
1. “(1) Unless excluded or modified by section 2-316, a warranty that the goods shall be merchantable is implied in a contract for
their sale if the seller is a merchant with respect to goods of that kind. Under this section the serving for value of food or drink to be
consumed either on the premises or elsewhere is a sale. (2) Goods to be merchantable must at least be such as * * * (c) are fit for
403), and to certain other cases, here and elsewhere, serving to bolster her contention of breach of warranty. The defendant as-
serts that here was a native New Englander eating fish chowder in a “quaint’ Boston dining place where she had been before; that
“(f)ish chowder, as it is served and enjoyed by New Englanders, is a hearty dish, originally designed to satisfy the appetites of our
seamen and fishermen’; that “(t)his court knows well that we are not talking of some insipid broth as is customarily served to con-
valescents.’
uted by the fishermen themselves, each of whom in return receives his share of the prepared dish. The Breton fishermen probably
carried the custom to Newfoundland, long famous for its chowder, whence it has spread to Nova Scotia, New Brunswick, and New
England.’ A New English Dictionary (MacMillan and Co., 1893) p. 386. Our literature over the years abounds in references not only
CHAPTER 22: WARRANTIES AND PRODUCT LIABILITY 369
to the delights of chowder but also to its manufacture. A namesake of the plaintiff, Daniel Webster, had a recipe for fish chowder
2. “Take a cod of ten pounds, well cleaned, leaving on the skin. Cut into pieces one and a half pounds thick, preserving the head
whole. Take one and a half pounds of clear, fat salt pork, cut in thin slices. Do the same with twelve potatoes. Take the largest pot
you have. Fry out the pork first, then take out the pieces of pork, leaving in the drippings. Add to that three parts of water, a layer of
3. Atwood, Receipts for Cooking Fish (Avery & Doten, Plymouth, 1896) p. 8.
Thus, we consider a dish which for many long years, if well made, has been made generally as outlined above. It is not too much
to say that a person sitting down in New England to consume a good New England fish chowder embarks on a gustatory adven-
ture which may entail the removal of some fish bones from his bowl as he proceeds. We are not inclined to tamper with age old
recipes by any amendment reflecting the plaintiff’s view of the effect of the Uniform Commercial Code upon them. We are aware of
Case 22.2
U.S.Vt.,2009.
129 S.Ct. 1187, 173 L.Ed.2d 51, 77 USLW 4165, Prod.Liab.Rep. (CCH) P 18,176, 09 Cal. Daily
Op. Serv. 2644, 2009 Daily Journal D.A.R. 3199, 21 Fla. L. Weekly Fed. S 675
Supreme Court of the United States
and when it later approved changes in the drug’s labeling. The question we must decide is whether the FDA’s approvals provide
Wyeth with a complete defense to Levine’s tort claims. We conclude that they do not.
I
Phenergan is Wyeth’s brand name for promethazine hydrochloride, an antihistamine used to treat nausea. The injectable form of
Phenergan can be administered intramuscularly or intravenously, and it can be administered intravenously through either the “IV–
push” method, whereby the drug is injected directly into a patient’s vein, or the “IV–drip” method, whereby the drug is introduced
After settling claims against the health center and clinician, Levine brought an action for damages against Wyeth, relying on com-
mon-law negligence and strict-liability theories. Although Phenergan’s labeling warned of the danger of gangrene and amputation
following inadvertent intra-arterial injection,FN1 Levine alleged that *1192 the labeling was defective because it failed to instruct cli-
nicians to use the IV-drip method of intravenous administration instead of the higher risk IV-push method. More broadly, she al-
leged that Phenergan is not reasonably safe for intravenous administration because the foreseeable risks of gangrene and loss of
limb are great in relation to the drug’s therapeutic benefits. App. 14-15.
Wyeth filed a motion for summary judgment, arguing that Levine’s failure-to-warn claims were pre-empted by federal law. The court
found no merit in either Wyeth’s field pre-emption argument, which it has since abandoned, or its conflict pre-emption argument.
With respect to the contention that there was an “actual conflict between a specific FDA order,”
id.,
at 21, and Levine’s failure-to–
warn action, the court reviewed the sparse correspondence between Wyeth and the FDA about Phenergan’s labeling and found no
evidence that Wyeth had “earnestly attempted” to strengthen the intra–arterial injection warning or that the FDA had “specifically
The trial record also contains correspondence between Wyeth and the FDA discussing Phenergan’s label. The FDA first approved
injectable Phenergan in 1955. In 1973 and 1976, Wyeth submitted supplemental new drug applications, which the agency ap-
proved after proposing labeling changes. Wyeth submitted a third supplemental application in 1981 in response to a new FDA rule
governing drug labels. Over the next 17 years, Wyeth and the FDA intermittently corresponded about Phenergan’s label. The most
notable activity occurred in 1987, when the FDA suggested different warnings about the risk of arterial exposure, and in 1988,
a result of inadequate warnings and instructions, and that no intervening cause had broken the causal connection between the
product defects and the plaintiff’s injury.
Id
., at 233-235. It awarded total damages of $7,400,000, which the court reduced to ac-
count for Levine’s earlier settlement with the health center and clinician.
Id.,
at 235-236.
On August 3, 2004, the trial court filed a comprehensive opinion denying Wyeth’s motion for judgment as a matter of law. After
making findings of fact based on the trial record (supplemented by one letter that Wyeth found after the trial), the court rejected
Reiber argued that the jury’s verdict conflicted with federal law because it was inconsistent with the FDA’s conclusion that intrave-
nous administration of Phenergan was safe and effective.
The importance of the pre-emption issue, coupled with the fact that the FDA has changed its position on state tort law and now
endorses the views expressed in Chief Justice Reiber’s dissent, persuaded us to grant Wyeth’s petition for certiorari. 552 U.S. —-,
128 S.Ct. 1118, 169 L.Ed.2d 845 (2008). The question presented by the petition is whether the FDA’s drug labeling judgments
warning about the risks of the IV-push method of administering the drug. The record contains evidence that the physician assistant
administered a greater dose than the label prescribed, that she may have inadvertently injected the drug into an artery rather than
a vein, and that she continued to inject the drug after Levine complained of pain. Nevertheless, the jury rejected Wyeth’s argument
that the clinician’s conduct was an intervening cause that absolved it of liability. See App. 234 (jury verdict), 252-254. In finding
Wyeth negligent as well as strictly liable, the jury also determined that Levine’s injury was foreseeable. That the inadequate label
was both a but-for and proximate cause of Levine’s injury is supported by the record and no longer challenged by Wyeth.FN2
FN2. The dissent nonetheless suggests that physician malpractice was the exclusive cause of Levine’s injury. See,
e.g.,
post,
at 1217 (opinion of ALITO, J.) (“[I]t is unclear how a ‘stronger’ warning could have helped respondent”);
post,
at
1225 – 1227 (suggesting that the physician assistant’s conduct was the sole cause of the injury). The dissent’s frustration
with the jury’s verdict does not put the merits of Levine’s tort claim before us, nor does it change the question we must de-
cide-whether federal law pre-empts Levine’s state-law claims.
FN3. Wyeth argues that the presumption against pre-emption should not apply to this case because the Federal Govern-
ment has regulated drug labeling for more than a century. That argument misunderstands the principle: We rely on the
presumption because respect for the States as “independent sovereigns in our federal system” leads us to assume that
“Congress does not cavalierly pre-empt state-law causes of action.”
Medtronic, Inc. v. Lohr,
518 U.S. 470, 485, 116 S.Ct.
CHAPTER 22: WARRANTIES AND PRODUCT LIABILITY 373
In order to identify the “purpose of Congress,” it is appropriate to briefly review the history of federal regulation of drugs and drug
labeling. In 1906, Congress enacted its first significant public health law, the Federal Food and Drugs Act, ch. 3915, 34 Stat. 768.
The Act, which prohibited the manufacture or interstate shipment of adulterated or misbranded drugs, supplemented the protection
for consumers already provided by state regulation and common-law liability. In the 1930’s, Congress became increasingly con-
cerned about unsafe drugs and fraudulent marketing, and it enacted the Federal Food, Drug, and Cosmetic Act (FDCA), ch. 675,
tions of use prescribed, recommended, or suggested in the proposed labeling.” § 102(d),
id.,
at 781.
As it enlarged the FDA’s powers to “protect the public health” and “assure the safety, effectiveness, and reliability of *1196
drugs,”
id.,
at 780, Congress took care to preserve state law. The 1962 amendments added a saving clause, indicating that a provi-
sion of state law would only be invalidated upon a “direct and positive conflict” with the FDCA. § 202,
id.,
at 793. Consistent with
that provision, state common-law suits “continued unabated despite … FDA regulation.”
Riegel v. Medtronic, Inc.,
552 U.S. —-, —-,
(2007) (as passed) (proposing new § 506D). Instead, it adopted a rule of construction to make it clear that manufacturers remain
responsible for updating their labels. See 121 Stat. 925-926.
III
[5] Wyeth first argues that Levine’s state-law claims are pre-empted because it is impossible for it to comply with both the state-law
duties underlying those claims and its federal labeling duties. See
de la Cuesta,
458 U.S., at 153, 102 S.Ct. 3014. The FDA’s pre-
market approval of a new drug application includes the approval of the exact text in the proposed label. See 21 U.S.C. § 355; 21
Phenergan’s label only in response to new information that the FDA had not considered. And it maintains that Levine has not
pointed to any such information concerning the risks of IV-push administration. Thus, Wyeth insists, it was impossible for it to dis-
charge its state-law obligation to provide a stronger warning about IV-push administration without violating federal law. Wyeth’s
argument misapprehends both the federal drug regulatory scheme and its burden in establishing a pre-emption defense.
We need not decide whether the 2008 CBE regulation is consistent with the FDCA and the previous version of the *1197 regula-
FN4. Levine also introduced evidence that Pfizer had withdrawn Vistaril, another antinausea drug, from intravenous use
several decades earlier because its intravenous injection had resulted in gangrene and amputations. See App. 79.
Wyeth argues that if it had unilaterally added such a warning, it would have violated federal law governing unauthorized distribution
and misbranding. Its argument that a change in Phenergan’s labeling would have subjected it to liability for unauthorized distribu-
tion rests on the assumption that this labeling change would have rendered Phenergan a new drug lacking an effective application.
bears primary responsibility for drug labeling. Yet through many amendments to the FDCA and to FDA regulations, it has remained
a central premise of federal drug regulation that the *1198 manufacturer bears responsibility for the content of its label at all times.
It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the
market. See,
e.g
., 21 CFR § 201.80(e) (requiring a manufacturer to revise its label “to include a warning as soon as there is rea-
sonable evidence of an association of a serious hazard with a drug”); § 314.80(b) (placing responsibility for postmarketing surveil-
CHAPTER 22: WARRANTIES AND PRODUCT LIABILITY 375
Of course, the FDA retains authority to reject labeling changes made pursuant to the CBE regulation in its review of the manufac-
turer’s supplemental application, just as it retains such authority in reviewing all supplemental applications. But absent clear evi-
dence that the FDA would not have approved a change to Phenergan’s label, we will not conclude that it was impossible for Wyeth
to comply with both federal and state requirements.
FN5. The record would not, in any event, support such an argument. In 1988, Wyeth did propose different language for
Phenergan’s warning about intra-arterial injection, adapted from revisions the FDA proposed in 1987. See App. 339-341,
311-312. When the FDA approved Wyeth’s application, it instructed Wyeth to retain the wording in its current label. During
the trial court proceedings, Levine indicated that the language proposed in 1988 would have more strongly warned
FN6. The dissent’s suggestion that the FDA intended to prohibit Wyeth from strengthening its warning does not fairly re-
flect the record. The dissent creatively paraphrases a few FDA orders-for instance by conflating warnings about IV-push
administration and intra-arterial injection, see,
e.g., post,
at 1222, 1223 – 1224, 1225 – 1226-to suggest greater agency at-
tention to the question, and it undertakes a study of Phenergan’s labeling that is more elaborate than any FDA order. But
even the dissent’s account does not support the conclusion that the FDA would have prohibited Wyeth from adding a
FN7. Although the first version of the bill that became the FDCA would have provided a federal cause of action for dam-
ages for injured consumers, see H.R. 6110, 73d Cong., 1st Sess., § 25 (1933) (as introduced), witnesses testified that
such a right of action was unnecessary because common-law claims were already available under state law. See Hear-
ings on S.1944 before a Subcommittee of the Senate Committee on Commerce, 73d Cong., 2d Sess., 400 (1933) (state-
FN8. In 1997, Congress pre-empted certain state requirements concerning over-the-counter medications and cosmetics
but expressly preserved product liability actions. See 21 U.S.C. §§ 379r(e), 379s(d) (“Nothing in this section shall be con-
strued to modify or otherwise affect any action or the liability of any person under the product liability law of any State”).
3935.
This Court has recognized that an agency regulation with the force of law can pre-empt conflicting state requirements. See,
e.g.,
Geier v. American Honda Motor Co.,
529 U.S. 861, 120 S.Ct. 1913, 146 L.Ed.2d 914 (2000);
Hillsborough County v. Automated
FN9. For similar examples, see 47 U.S.C. §§ 253(a), (d) (2000 ed.) (authorizing the Federal Communications Commis-
sion to pre-empt “any [state] statute, regulation, or legal requirement” that “may prohibit or have the effect of prohibiting
the ability of any entity to provide any interstate or intrastate telecommunications service”); 30 U.S.C. § 1254(g) (2006 ed.)
(pre-empting any statute that conflicts with “the purposes and the requirements of this chapter” and permitting the Secre-
tary of the Interior to “set forth any State law or regulation which is preempted and superseded”); and 49 U.S.C. § 5125(d)
U.S., at 883, 120 S.Ct. 1913;
Lohr,
518 U.S., at 495-496, 116 S.Ct. 2240. The weight we accord the agency’s explanation of state
law’s impact on the federal scheme depends on its thoroughness, consistency, and persuasiveness. Cf.
United States v. Mead
Corp.,
533 U.S. 218, 234-235, 121 S.Ct. 2164, 150 L.Ed.2d 292 (2001);
Skidmore v. Swift & Co.,
323 U.S. 134, 140, 65 S.Ct. 161,
89 L.Ed. 124 (1944).
Under this standard, the FDA’s 2006 preamble does not merit deference. When the FDA issued its notice of proposed rulemaking
FN10. See also 44 Fed.Reg. 37437 (1979) (“It is not the intent of the FDA to influence the civil tort liability of the manufac-
turer”); 59 Fed.Reg. 3948 (1994) (“[P]roduct liability plays an important role in consumer protection”); Porter, The
Lohr
Decision: FDA Perspective and Position, 52 Food & Drug L.J. 7, 10 (1997) (former chief counsel to the FDA stating
FN11. In 1955, the same year that the agency approved Wyeth’s Phenergan application, an FDA advisory committee is-
sued a report finding “conclusively” that “the budget and staff of the Food and Drug Administration are inadequate to per-
mit the discharge of its existing responsibilities for the protection of the American public.” Citizens Advisory Committee on
the FDA, Report to the Secretary of Health, Education, and Welfare, H.R. Doc. No. 227, 84th Cong., 1st Sess., 53. Three
recent studies have reached similar conclusions. See FDA Science Board, Report of the Subcommittee on Science and
FN12. See generally Brief for Former FDA Commissioners Drs. Donald Kennedy and David Kessler as
Amici Curiae;
see
also Kessler & Vladeck, A Critical Examination of the FDA’s Efforts To Preempt Failure-To-Warn Claims, 96 Geo. L.J.
461, 463 (2008);
Bates v. Dow Agrosciences LLC,
544 U.S. 431, 451, 125 S.Ct. 1788, 161 L.Ed.2d 687 (2005) (noting
that state tort suits “can serve as a catalyst” by aiding in the exposure of new dangers and prompting a manufacturer or
the federal agency to decide that a revised label is required).
FN13. The United States’
amicus
brief is similarly undeserving of deference. Unlike the Government’s brief in
Geier v.
American Honda Motor Co.,
529 U.S. 861, 120 S.Ct. 1913, 146 L.Ed.2d 914 (2000), which explained the effects of state
FN14. Wyeth’s more specific contention-that this case resembles
Geier
because the FDA determined that no additional
warning on IV-push administration was needed, thereby setting a ceiling on Phenergan’s label-is belied by the record. As
we have discussed, the FDA did not consider and reject a stronger warning against IV-push injection of Phenergan. See
also App. 249-250 (“[A] tort case is unlikely to obstruct the regulatory process when the record shows that the FDA has
Case 22.3
Colo.,2010.
Boles v. Sun Ergoline, Inc.
223 P.3d 724
Supreme Court of Colorado,
En Banc.
Savannah BOLES, Petitioner
v.
SUN ERGOLINE, INC., a Delaware corporation, Respondent.
No. 08SC970.
Feb. 8, 2010.
Justice COATS delivered the Opinion of the Court.
Boles petitioned for review of the court of appeals’ unpublished opinion affirming a summary judgment in favor of Sun
Ergoline, the manufacturer of a tanning booth in which she was injured. The district court found that Boles’s strict
products liability claim was barred by a release she signed as a condition of using the tanning facilities. On direct ap-
I.
Savannah Boles brought suit against Sun Ergoline, Inc., asserting a strict products liability claim for personal injury.FN1
Sun Ergoline moved for summary judgment, countering that Boles’s claim was barred by a release she signed prior to
using its product. The trial court agreed and granted Sun Ergoline’s motion on the basis of the following undisputed
facts.
FN1. By the time of the third and final amended complaint, this was the only claim remaining against Sun Er-
goline. Boles also asserted a number of other claims against other parties at various points in the litigation
process.
FN2. The exhaust fan assembly, (including the fan guard that allowed Boles fingers to contact the fan), was
manufactured by a different company, with whom Boles settled.
lo.1981), as the district court had also done, and found no violation of public policy.
We granted Boles’s petition for a writ of certiorari challenging the court of appeals’ determination that the exculpatory
agreement barred her strict products liability claim.
II.
and (4) whether the intention of the parties is expressed in clear and unambiguous language.”).
[2] We designed the
Jones
factors to ensure that agreements to release a party from liability for its simple negligence,
although not void as against public policy in every instance, are closely scrutinized for particular circumstances or
context that might nevertheless render them invalid.
See Chadwick v. Colt Ross Outfitters, Inc.,
100 P.3d 465, 468
–406, C.R.S. (2009) (general provisions); §§ 13–21-501 to –505, C.R.S. (2009) (firearms and ammunition); § 13–22–
104, C.R.S. (2009) (medical transplants and transfusions). It has never, however, fundamentally altered the nature of,
or rationale for, a strict products liability claim.