August 25, 1995 UNITED STATES COURT OF APPEALS
FOR THE FIRST CIRCUIT
____________________
No. 94-1291
RUSSELL VIOLETTE,
Plaintiff - Appellee,
v.
SMITH & NEPHEW DYONICS, INC.,
Defendant - Appellant.
____________________
No. 94-1334
RUSSELL VIOLETTE,
Plaintiff - Appellant,
v.
SMITH & NEPHEW DYONICS, INC.,
Defendant - Appellee.
____________________
ERRATA SHEET
The opinion of this court issued on August 7, 1995 is
amended as follows:
The coversheet should state that it is an appeal from the
United States District Court for the District of Maine.
UNITED STATES COURT OF APPEALS
FOR THE FIRST CIRCUIT
____________________
No. 94-1291
RUSSELL VIOLETTE,
Plaintiff - Appellee,
v.
SMITH & NEPHEW DYONICS, INC.,
Defendant - Appellant.
____________________
No. 94-1334
RUSSELL VIOLETTE,
Plaintiff - Appellant,
v.
SMITH & NEPHEW DYONICS, INC.,
Defendant - Appellee.
____________________
APPEAL FROM THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MAINE
[Hon. Eugene W. Beaulieu, U.S. Magistrate Judge] _____________________
____________________
Before
Boudin, Circuit Judge, _____________
Aldrich, Senior Circuit Judge, ____________________
and Young,* District Judge. ______________
_____________________
Joseph J. Leghorn, with whom Peter T. Wechsler, Warner & __________________ _________________ ________
Stackpole, Edward W. Gould and Gross, Minsky, Mogul & Singal, _________ ________________ ________________________________
P.A., were on brief for appellant Smith & Nephew Dyonics, Inc. ____
Daniel J. Popeo and Richard A. Samp on brief for Washington ________________ _______________
Legal Foundation and Allied Educational Foundation, amici curiae.
____________________
* Of the District of Massachusetts, sitting by designation.
Randall E. Smith, with whom John H. O'Neil, Jr., Smith, _________________ ____________________ ______
Elliott, Smith & Garney, P.A., were on brief for appellee Russell _____________________________
Violette.
Jeffrey R. White on brief for the Association of Trial __________________
Lawyers of America, amicus curiae.
____________________
August 7, 1995
____________________
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YOUNG, District Judge. Russell Violette ("Violette") YOUNG, District Judge. ______________
instituted this action in the Superior Court in and for Kennebec
County, Maine, seeking to recover for damage to his left wrist
allegedly caused by the improper use of a medical device manu-
factured by the defendant Smith & Nephew Dyonics, Inc.
("Dyonics"), a Massachusetts corporation. Dyonics removed to
federal court, where Violette ultimately obtained a jury verdict
in the amount of $250,000. Dyonics' appeal duly followed. It
must fail.
The relevant prior proceedings and the facts supporting
the jury's verdict, see Data General Corp. v. Grumman Sys. ___ ____________________ _____________
Support Corp., 36 F.3d 1147, 1172 (1st Cir. 1994), may be ______________
sketched briefly. In the summer of 1991, Violette experienced
numbness in his hands and consulted Dr. Robert C.G. Hottentot, an
orthopedic surgeon. Dr. Hottentot's diagnosis was carpal tunnel
syndrome, and Violette underwent a relatively new surgical
"endoscopic" procedure involving the insertion of a slotted metal
tube with a camera lens into the carpal tunnel running from the
patient's wrist to his palm. The surgeon employed the technique
developed and equipment manufactured by Dyonics known as the
ECTRA System (the "product"), which consists of an endoscope and
a set of related devices specifically designed for endoscopic
carpal ligament release. The outcome of the surgery was not as
doctor and patient had hoped -- Violette's ulnar nerve and artery
were severed, resulting in permanent injury to the nerve which
left his small and ring fingers curled up into the shape of a
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claw.
Violette's tort action against Dyonics alleged
negligence (primarily failure to warn), design defect, and breach
of warranty. In its post-removal Answer, Dyonics asserted four
affirmative defenses: 1) the product was designed and
manufactured using techniques representing the state of the art
at the time it was manufactured and sold; 2) any harm to Violette
was caused entirely by the fault of third parties for which
Dyonics cannot be held liable; 3) Dyonics provided adequate
instructions and warnings regarding the appropriate use of the
product; and 4) "Federal regulation of the subject product
preempts the present action."
With the parties' consent, the case proceeded to trial
before a United States Magistrate Judge on the failure to warn
and design defect theories, Violette having waived his breach of
warranty claim. At the close of Violette's evidence, Dyonics
moved for directed verdict, which was denied. A renewed motion
for directed verdict, made at the end of the defense case, and a
motion for judgment notwithstanding the verdict or for new trial,
made after the jury came back in Violette's favor, met with a
similar fate. Other than asserting federal preemption in its
answer, Dyonics never mentioned it again either before or during
the trial. It surfaced as an allegedly viable issue only after
the jury returned its verdict.
A. Preemption A. Preemption
The thrust of Dyonics' appeal is that provisions of the
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Federal Food, Drug and Cosmetic Act of 1938, 21 U.S.C.A. 301
et seq. (West 1972 & Supp. 1993), preempt Violette's state-law _______
products liability claims. Specifically, Dyonics points to the
Medical Device Amendments of 1976, 21 U.S.C.A. 351-60 (West
Supp. 1993), as barring the claims made in this case.1 See ___
generally Gail H. Javitt, I've Got You Under My Skin -- And I _________ ______________________________________
Can't Get Redress: An Analysis of Recent Case Law Addressing _________________________________________________________________
Preemption of Manufacturer Liability for Class III Medical _________________________________________________________________
Devices, 49 FOOD AND DRUG L.J. 553 (1994). It is simply too _______
late, however, for Dyonics to make this argument. Regardless of
its potential applicability, and we express no opinion on the
subject, Dyonics has waived the preemption issue by raising it
substantively for the first time after trial.
The question of waiver is controlled by a recent
decision of this court, Sweeney v. Westvaco Co., 926 F.2d 29, 36- _______ ____________
41 (1st Cir.), cert. denied, 502 U.S. 899 (1991). In Sweeney, we _____ ______ _______
held that the defendant waived its preemption defense by waiting
to raise it until after the jury had returned an adverse verdict.
Id. at 37. Westvaco's failure to "alert the court to the ___
____________________
1 The amendment states in part:
[N]o state . . . may establish or
continue in effect with respect to a
device intended for human use any
requirement . . . which is different
from, or in addition to, any requirement
applicable under this chapter to the
device, and . . . which relates to the
safety or effectiveness of the device. .
. .
21 U.S.C. 360k(a) (West Supp. 1993).
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problem" at any one of myriad opportunities prior to the jury
verdict led us to decline to consider the defense.
So here. An issue not presented to the trial court may
not be raised for the first time on appeal. G.D. v. Westmoreland ____ ____________
School Dist., 930 F.2d 942, 950 (1st Cir. 1991) (plaintiff cannot ____________
raise on appeal issue not articulated below); Wallace Motor ______________
Sales, Inc. v. American Motor Sales Corp., 780 F.2d 1049, 1067 ____________ ___________________________
(1st Cir. 1985). Although Dyonics pleaded preemption as an
affirmative defense in its answer, it neither developed a record
on the issue nor pressed it in any fashion before the district
court. Merely mentioning an issue in a pleading is insufficient
to carry a party's burden actually to present a claim or defense
to the district court before arguing the matter on appeal.
Cookish v. Cunningham, 787 F.2d 1, 6 (1st Cir. 1986) (per curiam) _______ __________
(allegation in pleadings insufficient to preserve issue on
appeal); Bratt v. International Business Machines Corp., 785 F.2d _____ _____________________________________
352, 362 n.1 (1st Cir. 1986) (breach of confidentiality claim
mentioned in complaint but never pressed deemed waived); Wallace _______
Motor Sales, 780 F.2d at 1067 (1st Cir. 1985) (issue raised in ___________
pleadings but not at trial was not "presented" to district court
and could not be argued on appeal) (citing In re Linda Coal and _____________________
Supply Co. v. L.H. Haberman and Son, 255 F.2d 653 [3d Cir. ___________ _______________________
1958]).
Dyonics had ample opportunity and incentive to assert
preemption below. It chose, however, neither to file a motion to
dismiss nor to press for summary judgment on the issue. In its
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Pretrial Memorandum, under the headings "Facts and Defenses" and
"Controverted Points of Law," Dyonics asserted only that the
endoscopic carpal tunnel surgery was an "accepted practice";
that it warned physicians, including Dr. Hottentot, of the
possibility of injury such as that incurred by Violette; and that
Violette's claim was barred by the "learned intermediary"
defense. There is no mention of preemption. Nor did Dyonics
assert preemption in its trial brief, its numerous motions in
limine, its two motions for directed verdict, and its motion for
judgment n.o.v. or for new trial. See Sweeney, 926 F.2d at 38. ___ _______
For whatever reason, it is plain that preemption flickered but
once, dimly, on the radar screen of this litigation and then
disappeared forever, abandoned by Dyonics, depriving the
magistrate judge of his rightful opportunity to address the
question in the first instance. To allow Dyonics to resurrect
the issue here would undermine the logic behind our refusal to
consider issues not presented below: Dyonics "cannot evade the
scrutiny of the district court . . . on appeal with a new claim
in order to create essentially a new trial." Westmoreland School ___________________
District, 930 F.2d at 950. Since this is precisely what Dyonics ________
is attempting, and as there are no exceptional or particular
circumstances requiring a detour from the traditional rule, see
id., the applicability of federal preemption is deemed waived and ___
we will not examine its applicability to this case.
No doubt recognizing the apparent applicability of
Sweeney v. Westvaco to the facts of this case, Dyonics argues _______ ________
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that, in the present circumstances, preemption is a
jurisdictional matter which cannot be waived and may be raised at
any time. It relies primarily on International Longshoremen's ____________________________
Ass'n v. Davis, 476 U.S. 380 (1986), where the Supreme Court held _____ _____
that Congress had deprived the courts of jurisdiction to decide
cases involving conduct arguably protected by the National Labor
Relations Act, and thus that the plaintiff's state-law fraud
claim was preempted despite the defendant's failure to raise the
issue until after the jury's verdict. See id. at 398; see also ___ ___ ________
Sweeney, 926 F.2d at 37-38. In Sweeney, however, we pointed out _______ _______
that the Davis principle stemmed from federal statutes involving _____
a "choice-of-forum rather than a choice-of-law question."
Sweeney, 926 F.2d at 38 (quoting Davis, 476 U.S. at 391 & n.9). _______ _____
That is, where Congress has designated another forum for the
resolution of a certain class of disputes, such as the National
Labor Relations Board in Davis, such designation deprives the _____
courts of jurisdiction to decide those cases. See Sweeney, 926 ___ _______
F.2d at 37. Where, however, the question is whether state tort
or federal statutory law controls, preemption is not
jurisdictional and is subject to the ordinary rules of appellate
adjudication, including timely presentment and waiver. See id. ___ ___
at 39. This case presents a "choice-of-law" question and thus
falls squarely within the latter category. Preemption is not
here jurisdictional, and was waived when not presented in the
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district court.2
B. The Jury Verdict B. The Jury Verdict
Violette claimed generally that the ECTRA System was
"in a defective condition unreasonably dangerous," and that
Dyonics failed to warn of the dangers associated with its
____________________
2 None of Dyonics' proffered authority addresses the question of
waiver of the preemption issue on appeal. See Kennan v. Dow ___ ______ ___
Chemical Co., 717 F. Supp. 799 (M.D. Fla. 1989); Fitzgerald v. _____________ __________
Mallinckrodt, Inc., 681 F. Supp. 404 (E.D. Mich. 1987); Ignace v. __________________ ______
International Playtex, Inc., No. 86-C-480-C, 1987 WL 93996 (W.D. ___________________________
Wis. Aug. 14, 1987). In each of those cases, the defendants were
permitted to raise the preemption issue for the first time in the
context of summary judgment -- an unremarkable result given the
liberal standard for amendments to pleadings of Fed. R. Civ. P.
15(c). As the time for amending pleadings has long passed here,
these cases are inapposite.
Nor is a recent case of ours, Mendes v. Medtronic, ______ __________
Inc., 18 F.3d 13 (1st Cir. 1994), of any assistance to Dyonics. ____
Affirming a grant of summary judgment to the defendant, we held
there that the Medical Device Amendments, 21 U.S.C. 360k,
preempted plaintiff's common law negligent failure to warn claim
against a pacemaker manufacturer because a factfinder could
impose liability on such a claim "applying standards differing
from or adding to FDA's." Id. at 19. The language of the ___
statute and its application in Mendes leave open the possibility ______
that a state may impose, establish, or continue burdens identical
to the federal standards, leading ineluctably to the conclusion
that the statute's preemptive effect is not jurisdictional. Had
Dyonics brought its preemption argument before the district court
at the proper time, like the Mendes plaintiff, this Court could ______
have reached the merits. The supplemental authorities provided
by Dyonics -- recent cases in which district courts have held
that the Medical Device Amendments preempt state tort claims --
merely serve to highlight the proper procedural context in which
preemption claims ought first be litigated. See Committee of ___ _____________
Dental Amalgam Alloy Mfrs. v. Henry, 871 F. Supp. 1278, 1285 ____________________________ _____
(S.D. Cal. 1994) (holding on summary judgment that section 360[k]
preempts California Safe Drinking Water and Toxic Enforcement Act
of 1986); Talbott v. C.R. Bard, Inc., 865 F. Supp. 37, 39-40 (D. _______ _______________
Mass. 1994) (holding on motion to dismiss that wrongful death and
other state-law causes of action preempted by section 360[k])
(appeal pending); Feldt v. Mentor Corp., No. H-93-2205, slip op. _____ ____________
at 1-2, 10 (S.D. Tex. July 11, 1994) (holding on summary judgment
that negligence and product liability claims preempted by Medical
Devices Amendments and FDA regulations).
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product. Dyonics asserts that as matter of law its product was
free from defect; that its product was unavoidably unsafe and is
therefore exempt from strict liability; that Dyonics fulfilled
its duty to warn; that Dyonics cannot be liable for a surgeon's
selection of a particular procedure; and that Violette failed to
prove the product proximately caused his injuries. Dyonics also
urges that we reverse because the magistrate judge declined to
give certain jury instructions. These arguments reflect more
hope than experience.
Maine law provides:
One who sells any goods or products in a
defective condition unreasonably
dangerous to the user or consumer or to
his property is subject to liability for
physical harm thereby caused to a person
whom the manufacturer, seller or supplier
might reasonably have expected to use,
consume or be affected by the goods, or
to his property, if the seller is engaged
in the business of selling such a product
and it is expected to and does reach the
user or consumer without significant
change in the condition in which it is
sold. This section applies although the
seller has exercised all possible care in
the preparation and sale of his product
and the user or consumer has not bought
the product from or entered into any
contractual relation with the seller.
ME. REV. STAT. ANN. tit. 14, 221 (West 1980).
Maine applies the danger/utility test to claims of
design defects -- that is, the finder of fact must weigh the
utility of the product against the danger it presents. Guiggey _______
v. Bombardier, 615 A.2d 1169, 1172 (Me. 1992); St. Germain v. __________ ___________
Husqvarna Corp., 544 A.2d 1283, 1285 (Me. 1988); Stanley v. _______________ _______
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Schiavi Mobile Homes, Inc., 462 A.2d 1144, 1148 (Me. 1983); ____________________________
Porter v. Pfizer Hosp. Prod. Group, Inc., 783 F. Supp. 1466, 1474 ______ ______________________________
(D. Me. 1992) (plaintiff cannot prevail on defective design claim
where he introduced no evidence that the utility of the design
was outweighed by the risks). This process involves an
examination of utility, risk, and the feasibility of safer
alternatives. St. Germain, 544 A.2d at 1285 (quoting Stanley, ____________ _______
462 A.2d at 1148). The jury's determination that the product was
not safely designed to carry out its intended use was supported
by the evidence, and therefore must stand.
Dr. Morton Kasdan testified that the product here was
defectively designed because it required only approximations in
the initial placement of the tube on the outside of the skin
without being able to see the ulnar nerve and artery, and that
when inserted below the carpal ligament, the knife cuts through
the ligament before the surgeon can see what is above the
ligament. Dr. Kasdan also testified that the risk involved was
enormous and that the product's use provided no benefit beyond
those available with the safer, proven, alternative technique of
open carpal tunnel surgery. Dyonics' own expert admitted that he
had participated in the development of an alternative
"extrabursal" technique which sought to minimize the risks by
moving the initial placement point and the cutting line further
from the ulnar nerve. Given such testimony, there was sufficient
competent evidence for the jury to believe and conclude that the
ECTRA System was unreasonably dangerous and of little added
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utility compared to available alternatives -- in short,
defectively designed.3
The jury's determination that Dyonics failed to provide
adequate warnings and directions is likewise supported by the
evidence. A manufacturer must provide expected users of its
product with warnings of the risks and "specific directions for
the product's safe use." Pottle v. Up-Right, Inc., 628 A.2d 672, ______ ______________
675 (Me. 1993). While the Supreme Judicial Court of Maine has
not decided the matter, the general rule regarding medical
devices (and, more frequently and by analogy, prescription drugs)
is that the manufacturer must warn the physician -- the so-called
"learned intermediary" -- and not the patient directly. See ___
____________________
3 Likewise, the evidence of an alternative safe method of
surgery defeats Dyonics' claim that its product is unavoidably
unsafe and therefore exempt from strict liability under comment k
of section 402A of the Restatement (Second) of Torts, which
requires a showing that the utility or benefit of the product
outweighs its risk of danger. See Kearl v. Lederle Lab., 218 ___ _____ ____________
Cal. Rptr. 453, 464 (Ct. App. 1985) (court must consider
availability and safety of alternative products); Belle Bonfils ______________
Memorial Blood Bank v. Hansen, 665 P.2d 118, 123 (Colo. 1983) (en ___________________ ______
banc) (manufacturer must demonstrate that the "product's benefits
could not be achieved by a substitute product or in another
manner"); Toner v. Lederle Lab., 732 P.2d 297, 306 (Idaho 1987) _____ _____________
(additional element of comment k's requirement of unavoidable
risk is that there must be "no feasible alternative design which
on balance accomplishes the subject product's purpose with a
lesser risk"); Grundberg v. Upjohn Co., 813 P.2d 89, 93 (Utah _________ ___________
1991) (same). Even if comment k accurately reflects Maine common
law -- a point we need not decide and express no opinion thereon
-- the refusal of the magistrate judge to find the product
unavoidably unsafe and exempt from strict liability was not clear
error. Salve Regina College v. Russell, 499 U.S. 225, 233 (1990) ____________________ _______
(mixed questions of fact and law are reviewed for clear error;
"deferential review" warranted when district court "better
positioned" to decide the issue); Touch v. Master Unit Die _____ _________________
Prods., Inc., 43 F.3d 754, 757 (1st Cir. 1995); ICC v. Holmes ____________ ___ ______
Transp., Inc., 983 F.2d 1122, 1128 (1st Cir. 1993). _____________
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Knowlton v. Deseret Medical, Inc., 930 F.2d 116, 120 n.2 (1st ________ ______________________
Cir. 1991) (in failure-to-warn suit against catheter
manufacturer, we noted that it "is generally accepted that in a
case involving medical products prescribed or used by a physician
or trained medical personnel, the warning runs to the physician
not the patient"); Phelps v. Sherwood Medical Indus., 836 F.2d ______ _______________________
296, 299, 302 (7th Cir. 1987) (heart catheter manufacturer has
duty to warn physicians); Brooks v. Medtronic, Inc., 750 F.2d ______ ________________
1227, 1232 (4th Cir. 1984) (pacemaker manufacturer has duty to
warn physician, not patient); Desmarais v. Dow Corning Corp., 712 _________ _________________
F. Supp. 13, 17 & n.5 (D. Conn. 1989) (manufacturer of breast
implants has duty to warn physician); cf. Garside v. Osco Drug, ___ _______ __________
Inc., 976 F.2d 77, 80 (1st Cir. 1992) (where product is a ____
prescription drug, duty to warn runs to physician). Dr. Chow,
Dyonics' ECTRA System instructor, admitted that in May of 1991,
when the equipment was purchased by Dr. Hottentot's practice, the
extrabursal technique was being taught at seminars put on by the
ECTRA faculty. Both Dr. Chow and Jan Cook, the associate product
manager for Dyonics, admitted that the extrabursal technique was
safer and easier to learn and to teach. Dr. Hottentot was not
provided with any materials referring to this safer technique or
given adequate warnings of the real potential for complications.
On this record, we conclude that the jury had sufficient basis to
find Dyonics in breach of its duty to warn.
Dyonics argues that a failure to warn claim will not
lie under Maine law where the risk of danger associated with the
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use of the product was obvious to the user, citing Lorfano v. _______
Dura Stone Steps, Inc., 569 A.2d 195, 197 (Me. 1990) ("dangers _______________________
posed by the use of steps without a handrail are patently obvious
and equally apparent to all"). A high-technology, precision
medical device is, needless to say, a far cry from a handrail.
Moreover, while a physician cannot be held liable for an adverse
outcome simply because the result could have been avoided by a
different selection as between two reasonable procedures, Roberts _______
v. Tardif, 417 A.2d 444, 448 (Me. 1980), here there was ______
sufficient evidence that use of the ECTRA System was
unreasonably dangerous without further warnings or proper
instructional materials. A jury could conclude that Dr.
Hottentot's uninformed choice of the product was not a reasonable
selection of an alternative surgical procedure, thus insulating
Dyonics from liability. Any extension of Roberts to protect a _______
manufacturer in Dyonics' position is unwarranted.
A jury verdict may be set aside "only if [it] is so
seriously mistaken, so clearly against the law or the evidence,
as to constitute a miscarriage of justice." Levesque v. Anchor ________ ______
Motor Freight,Inc., 832 F.2d 702, 703 (1st Cir. 1987). Such is __________________
not the case here.
Finally, the magistrate judge committed no error by
refusing to give two proposed jury instructions. Dyonics sought
an instruction, based on Roberts, supra, that a manufacturer of a _______ _____
medical device cannot be held liable merely because the surgeon
could have pursued an alternate course of treatment and thereby
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avoided the injury. As noted above, such an extension of Roberts _______
is unwarranted in this case. Dyonics also sought the following
instruction, citing May v. Dafoe, 611 P.2d 1275, 1278 (Wash. App. ___ _____
1980):
A manufacturer of medical products is not
responsible for the education and
training of doctors who may use its
product. The responsibility for
determining whether an individual doctor
is sufficiently skilled and trained to
use a particular product lies with the
doctor himself or herself and the
facilities where they practice.
Such instruction was unnecessary in this failure to warn-design
defect case and, in any event, the refusal to give this
instruction caused no prejudice to Dyonics since Dr. Hottentot
followed the product instructions he had been given. See Davet ___ _____
v. Maccarone, 973 F.2d 22, 26 (1st Cir. 1992) ("An error in jury _________
instructions will warrant reversal of a judgment only if the
error is determined to have been prejudicial, based on a review
of the record as a whole").
For these reasons, the Amended Judgment entered in this
action on March 17, 1994, pursuant to the jury's verdict, is
affirmed.4 ________
____________________
4 Violette also cross-appealed, requesting reversal of numerous
rulings of the magistrate judge in the event we had determined
that Dyonics was entitled to a new trial. As Dyonics is not so
entitled, there is no need to address the issues raised by the
cross-appeal, and it is dismissed as moot.
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