Case Title: Hansen v. Baxter Healthcare Corp.

Citation: 

Docket Number: 89043

State: illinois

Court: Illinois Supreme Court

Date: 2002-01-25T00:00:00Z

Document:
Docket No. 89043-Agenda 16-March 2001.
STEVEN HANSEN, Special Adm'r of the Estate of Andrina
Hansen, Appellee, v. 
 BAXTER HEALTHCARE CORPORATION, Appellant.
Opinion filed January 25, 2002.
	JUSTICE KILBRIDE delivered the opinion of the court:
	Plaintiff's decedent, Andrina Hansen, suffered an air
embolism because an intravenous (IV) tube became detached from
a catheter inserted into her jugular vein. The embolism caused
brain damage and paralysis; Andrina died a little more than four
years later.
	The administrator of Andrina's estate filed medical
malpractice claims, in the circuit court of Cook County, against
the hospital and one of her treating nurses. He later added survival
and wrongful-death claims based on a products liability theory
against the manufacturer of the IV tube and connecting devices,
Baxter Healthcare Corporation (Baxter). Shortly before trial, the
plaintiff settled all claims against the medical malpractice
defendants for a total of $2,880,000. The administrator then filed
an amended complaint against Baxter alleging products liability
and negligence theories.
	Following trial, plaintiff dismissed the negligence claims and
the matter was submitted to the jury on only the products liability
theory. The jury awarded plaintiff $18,047,000. The award was
reduced by a partial setoff of the amounts paid by the settling
defendants.
	 On appeal, the appellate court found that the evidence was
sufficient to justify the verdict based on a defective-design theory.
The appellate court further found that the jury's verdict could not
be sustained on the theory that Baxter breached its duty to warn of
its products' inherent dangers. However, because the jury reached
a general verdict, unchecked by any inconsistent answers to
special interrogatories, the appellate court refused to disturb the
verdict except to reduce the judgment amount by the full amount
of the settlements. 309 Ill. App. 3d 869.
	Baxter appeals to this court, primarily arguing that the
appellate court erred in finding that the jury's verdict could be
supported under a defective-design theory. Plaintiff cross-appeals,
arguing that we should reverse the appellate court's finding that
Baxter had no duty to warn the medical profession of dangers
inherent in its product. We affirm the judgment of the appellate
court.

BACKGROUND
	Baxter designs, manufactures and distributes IV tubing sets to
hospitals nationwide. These IV sets are prescription medical
devices used to deliver fluids, such as blood products, medicines,
or nutrients. An IV set consists of tubing and a connector, allowing
it to be attached to other sections of tubing or to a catheter inserted
into a patient's venous system.
	There are two types of connectors: "friction-fit" and "Luer-lock." The friction-fit type consists of two mating tapered fittings.
A medical professional must push the ends of the two fittings
together with sufficient force to maintain a leak-proof connection.
The Luer-lock type is similar to a friction-fit connector but also
has a threaded collar that screws onto the hub of the catheter. In its
patent application, Baxter stated that the Luer-lock was designed
to overcome the problem of inadvertent disconnection that occurs
with friction-fit connectors. Baxter continued to distribute both
friction-fit and Luer-lock connectors to hospitals.
	In March 1991, Andrina was admitted to Mt. Sinai Hospital
for treatment of stomach ulcers. Following successful surgery,
fluids were administered intravenously to Andrina through her
jugular vein. This procedure is known as a "central line"
application. Unfortunately, the Baxter friction-fit connector used
to connect the IV tube to a catheter came apart, causing Andrina
to suffer a seizure. She also suffered an air embolism resulting in
brain damage, paralysis and, ultimately, death.
	The administrator's complaint alleged, inter alia, that: (1) the
tubing was unreasonably dangerous because it was designed,
manufactured, and sold without a Luer-lock connection; (2) the
friction-fit connection failed when the product was used in a
reasonably foreseeable manner; and (3) Baxter failed to warn of
the likelihood of unintentional disconnection and the need to use
tubing equipped with the Luer-locking device.
	At trial, plaintiff called Baxter employees as adverse
witnesses to establish the propensity of the friction-fit connectors
to disconnect unintentionally and to prove that Luer-locking
devices provided a more secure connection. According to
Margaret Foss, a registered nurse and Baxter vice-president,
Baxter was aware at the time Andrina was injured that friction-fit
connectors sometimes failed due to patient movement. Foss
admitted that this could cause air embolisms in central line
applications. She conceded that friction-fit connectors were
inadequate for central line use and that, in such instances, medical
professionals should use Luer-locks. She testified, however, that
Baxter did not encourage sales representatives to recommend
Luer-locks for central line applications. Instead, Baxter simply
made both products available to its customers.
	Baxter's sales representatives provided similar testimony. For
example, one representative admitted that she knew prior to
Andrina's injury that friction-fit IV sets could unintentionally
disconnect and should not be used in central line applications.
	Birenda Lal, Baxter's chief engineer in charge of the IV
product line, was called as an adverse witness. He testified that
friction-fit connectors could accidentally disconnect. He also
stated that friction-fit connectors were being used in central lines
and agreed that an air embolism could result if they became
disconnected. For this reason, he recommended using Luer-locks
in central line applications. He added, however, that Baxter did not
advise hospitals to use one product or the other, and Baxter had
not developed and marketed Luer-locks to prevent accidental
disconnections or to increase patient safety. Rather, the Luer-lock
mechanism was a competitive response to industry demands. Lal
testified that adding Luer-locks to all connectors was technically
feasible and would add between three and five cents to the cost of
each unit. He believed that Baxter would put locking collars on all
their connectors if customers demanded it.
	Neil Sheehan testified as plaintiff's expert witness without
objection. Sheehan is a mechanical engineer and had worked for
several companies that developed and sold IV components.
Sheehan had personally designed and, in some cases, patented
medical devices, including IV equipment. He explained that the
main problem with using a friction-fit connector was that the
amount of force needed to disconnect it depended on several
factors, including (1) the force used to connect it; (2) its
composition; (3) the method used to sterilize it; and (4) variations
in molding. Thus, the strength of the connection varied as different
persons used different friction-fit connectors at different times.
Generally, however, if the connection was made with less force,
it was more likely to fail.
	 Sheehan also described the technical aspects of the Luer-lock.
He stated that a Luer-lock prevents the accidental disconnection of
IV lines and that it is four to five times stronger than a friction-fit.
In order to disconnect a Luer-lock without unscrewing it, the
components would have to be pulled apart with great force until
the threads on one component tore. Sheehan testified that air
embolisms can be avoided by using Luer-locks and that Luer-locks
should always be used in central line applications. In his opinion,
the friction-fit connector became obsolete once the Luer-lock
became available.
	In addition, Sheehan stated that is was foreseeable that
friction-fit connectors might be used in a central line application.
He opined, however, that a friction-fit connection was not a safe
design in any application and that it was especially hazardous
when used in a central vein. He also believed that if medical
personnel had used a Luer-lock connector, Andrina's injury would
have been prevented.
	Dr. William Schumer, chief of surgery at Mt. Sinai Hospital,
testified that decisions regarding the purchase of medical supplies
were made by a nursing products committee. He said that Luer-locks were not used at Mt. Sinai prior to the incident, and he
believed that most hospitals did not use them at that time. He
stated that he assumed friction-fit connectors were safe because
they were readily available in the market.
	The chair of the nursing products committee at Mt. Sinai
testified that the hospital staff relied on product manufacturers to
advise them of the appropriate uses for their products.
	The nurse responsible for the actual purchase and distribution
of medical supplies at Mt. Sinai stated that at the time of
Andrina's injury she did not know the difference between a
friction-fit connector and a Luer-lock connector. She also noted
that at that time she did not know that friction-fits should not be
used in central line applications.
	Dr. Ricky Maddox, a second-year resident in general surgery
at Mt. Sinai at the time of Andrina's operation, testified that he
placed the catheter in Andrina's jugular vein. Although he knew
about using friction-fit connectors on IV tubing, he was unfamiliar
with Luer-lock connectors. He did not learn of them until after
Andrina was injured, when they began to be used exclusively at
Mt. Sinai Hospital.
	 Dr. Henry Roztoczynski, Andrina's surgeon, testified that he
was aware that friction-fit connectors could unintentionally
disconnect and that Luer-lock connectors were safe to use in
central lines. He never mentioned Luer-lock connectors to his
colleagues at Mt. Sinai and did not advocate their use prior to the
incident involving Andrina.
	Dr. Norbert Strohmayer, was a fifth-year surgical resident
when he assisted Dr. Roztoczynski with Andrina's surgery. He
testified that he was familiar with both friction-fit and Luer-lock
connectors. He was unaware of the requisite force necessary to
disconnect friction-fit connectors and could not specifically recall
one coming apart. He was also unaware of any literature
describing the frequency of accidental disconnection, although he
read several well-known medical journals. He agreed that the
unintentional disconnection of an IV device could have adverse
effects in any application and is "never a good idea." He
acknowledged that Luer-lock connectors were less likely to fail
due to a patient's movement.
	In its case in chief, Baxter presented testimony from two
expert witnesses. First, William McVay, a "medical device
consultant" with a degree in mechanical engineering, testified as
an expert witness. He agreed that only Luer-locks should be used
in central line applications. McVay acknowledged that Baxter was
aware of the dangers of using friction-fit connectors in central
lines but believed that Baxter was not obliged to reveal this
information.
	Next, Kathleen Medica, a registered nurse with a master's
degree, testified as an expert witness for Baxter. In her opinion, a
friction-fit connector was much more likely to fail than a Luer-lock, although she did not know whether this was a well-known
complication in the field. She acknowledged that some nurses may
never have had the experience of a friction-fit coming apart.
	After hearing the evidence, the jury returned a general verdict
for the decedent's estate. No special interrogatories were requested
or submitted to the jury. The trial court denied Baxter's post-trial
motion seeking judgment notwithstanding the verdict or a new
trial. Baxter then appealed.
	Relying on the learned intermediary doctrine, the appellate
court found that Baxter was not obliged to warn Andrina's health-care providers of the risks associated with friction-fit connectors
because they already knew that such risks existed. 309 Ill. App. 3d
at 882. The court found, however, that the evidence sufficiently
supported the verdict based on the theory of defective design. 309
Ill. App. 3d at 883. The court affirmed the judgment but reduced
the award by the full settlement amount. We granted Baxter's
petition for leave to appeal. 177 Ill. 2d R. 315.

ANALYSIS
	Baxter argues that the appellate court erred in (1) holding that
the patient, rather than the prescribing physician, is the "ordinary
consumer" of prescription medical products; (2) finding that the
connector was defective based on Sheehan's expert opinion
testimony since he was an engineer and had no medical training;
(3) performing its proximate cause analysis; and (4) applying risk-benefit analysis in determining whether the friction-fit connector
was unreasonably dangerous due to a defect in its design.
	Plaintiff argues that Baxter has waived the last three of these
arguments. Therefore, we will first determine whether waiver
applies here.

A. Waiver
	Baxter argues that the appellate court erred in finding a
prescription medical product defective without expert medical
testimony on its proper uses. On that issue, plaintiff offered only
the testimony of Neil Sheehan, who is a mechanical engineer and
lacks medical training.
	We agree that Baxter failed to preserve this issue for review.
At trial, Baxter did not challenge Sheehan's qualifications to
testify or the sufficiency of his testimony to support plaintiff's
burden of proof. Baxter also failed to raise this issue in the
appellate court and raised it for the first time in its petition for
leave to appeal before this court. In Daniels v. Anderson, 162 Ill. 2d 47 (1994), we held that parties may not raise arguments for the
first time on appeal. To do so weakens the adversarial process and
would likely prejudice the other party, who did not present
relevant evidence and argument on that issue at trial. Daniels, 162 Ill. 2d  at 59. Baxter offers no persuasive reason to depart from the
waiver doctrine in this case.
	Baxter also argues that the appellate court erred in performing
a proximate cause analysis. Plaintiff contends that Baxter failed to
raise this argument in its petition for leave to appeal and therefore
should be foreclosed from raising it now.
	Again, we agree with plaintiff. Supreme Court Rule 315(b)
provides that a party's petition for leave to appeal "shall contain
*** (3) a statement of the points relied upon for reversal of the
judgment of the Appellate Court." 177 Ill. 2d R. 315(b)(3). Failure
to raise an argument in the petition for leave to appeal may be
deemed a waiver of that argument. Federal Deposit Insurance
Corp. v. O'Malley, 163 Ill. 2d 130, 154 (1994). Adherence to the
rule is not a jurisdictional prerequisite to our review of an issue; it
is a principle of administrative convenience. Dineen v. City of
Chicago, 125 Ill. 2d 248, 265 (1988). Here, the issue of proximate
cause was thoroughly and thoughtfully discussed in the appellate
court's opinion and it need not be repeated here. We find no
sufficient justification to overlook the administrative requirements
of Rule 315 in this instance.
	Finally, we examine whether Baxter has waived its argument
that the appellate court erred in applying the risk-benefit test in
analyzing whether the friction-fit connector was unreasonably
dangerous by reason of a defective design. We conclude that it has
not. Although Baxter did not expressly designate this point as a
separate argument in its petition for leave to appeal, it did argue
that the appellate court's decision is contrary to a body of
precedent prohibiting a finding of liability solely on the existence
of an alternative design. Thus, the application of the risk-benefit
test is inextricably intertwined with any fair analysis of the
elements of plaintiff's defective design case. For that reason we
will consider the merits of Baxter's argument on this issue.

B. Duty To Warn
	We first address whether Baxter had a duty to warn of dangers
inherent in the friction-fit connector. For the reasons that follow,
we conclude that it did.
	Generally, the manufacturer of a prescription medical device
has a duty to warn prescribing physicians or other health
professionals who may prescribe the device of the product's
known dangerous propensities. Kirk v. Michael Reese Hospital &
Medical Center, 117 Ill. 2d 507, 517 (1987). Likewise, physicians,
using their medical judgment, have a duty to convey the warnings
to their patients. Kirk, 117 Ill. 2d  at 517. The duty to warn the
health-care professional, rather than the ultimate consumer or
patient, is an expression of the "learned intermediary" doctrine. A
corollary of that doctrine is the principle that a prescription
medical device manufacturer need not provide a warning of risks
already known to the medical community. Proctor v. Davis, 291
Ill. App. 3d 265, 277 (1997). In this case, the appellate court held
that Baxter had no duty to warn Mt. Sinai Hospital's doctors about
the risks of disconnection of the friction-fit device because the
medical community was already aware of those risks. 309 Ill. App.
3d at 882.
	In plaintiff's request for cross-relief in this court, he argues
that the appellate court erred by finding that Baxter had no duty to
warn as a matter of law because health-care providers already
knew of the dangers associated with friction-fit connectors and the
need to use Luer-locks. Plaintiff asserts that since there is
conflicting evidence concerning the comparative knowledge of
Baxter and the medical community about this peril, the jury was
properly allowed to decide this issue.
	We agree that the record contains sufficient conflicting
evidence to raise factual questions concerning the comparative
knowledge of Baxter and that of the medical community
concerning both the danger of using friction-fits in central lines
and the need to use only Luer-locks in these applications. The
record indicates that Baxter's employees knew of the inherent
dangers of friction-fits and that Baxter's patent indicates that Luer-locks were designed to avoid accidental disconnections. For
example, both Baxter's chief engineer, Birenda Lal, and its expert
medical device consultant, William McVay, knew that only Luer-locks should be used on central lines because they are less likely
to come apart.
	In contrast, the testimony from persons on the medical staff at
Mt. Sinai shows that they had significantly less knowledge. The
chairperson of the nursing products committee testified that
hospital staff relied on product manufacturers to advise them
regarding the appropriate uses of a product. The nurse responsible
for the actual purchase and distribution of medical supplies at Mt.
Sinai testified that, in March 1991, she did not know the difference
between a friction-fit connector and a Luer-lock and that she did
not know that friction-fit connectors should not be used in central
lines.
	Morever, Dr. Norbert Strohmayer, the fifth-year resident who
assisted at Andrina's surgery, was unaware of any literature
describing the frequency of unintentional separation with friction-fit connectors, despite reading and subscribing to several well-known medical journals. He was also unaware of the force
necessary to disconnect a friction-fit connector.
	In addition, Dr. Ricky Maddox, who actually placed the
catheter in Andrina's jugular vein, stated that he was unfamiliar
with Luer-lock connectors and did not learn about them until after
the incident. Thus, he could not have known that friction-fit
connectors should never be used in central line applications.
	In Proctor v. Davis, 291 Ill. App. 3d 265 (1997), the appellate
court held that a drug manufacturer that only shared information
about its product's toxicity with its own employees breached its
duty to warn the medical community because without this
information, doctors could not provide appropriate and
comprehensive medical advice for their patients. This prevented
them from functioning as "learned intermediaries" to protect their
patients' best medical interests. The court said, "Doctors who have
not been sufficiently warned of the harmful effects of a drug
cannot be considered 'learned intermediaries' and the adequacy of
warnings is a question of fact, not law, for the jury to determine,
as it did in the instant case." (Emphasis added.) Proctor, 291 Ill.
App. 3d at 283.
	In the instant case, Baxter gave the medical community no
warning at all about the need to use Luer-locks in central line
applications. Thus, this issue was properly submitted to the jury.
The jury's general verdict for plaintiff could have been reasonably
based on a finding that Baxter's knowledge with respect to the use
of friction-fit connectors was superior to that of the medical
community and thus Baxter breached its duty to warn. The
evidence does not so strongly favor Baxter that the jury's
conclusion cannot stand and therefore we will not disturb it on
appeal. See Pedrick v. Peoria & Eastern R.R. Co., 37 Ill. 2d 494,
510 (1967). The appellate court erred by holding otherwise.

C. Design Defect
	We next consider whether the jury's verdict can be supported
under a design-defect theory. We find that it can.
	A manufacturer has a nondelegable duty to produce a product
that is reasonably safe for all intended uses. Doser v. Savage
Manufacturing & Sales, Inc., 142 Ill. 2d 176, 189 (1990). In
Lamkin v. Towner, 138 Ill. 2d 510, 529 (1990), we said:
			"A plaintiff may demonstrate that a product is defective
in design, so as to subject a retailer and a manufacturer to
strict liability for resulting injuries, in one of two ways: (l)
by introducing evidence that the product failed to perform
as safely as an ordinary consumer would expect when
used in an intended or reasonably foreseeable manner or
(2) by introducing evidence that the product's design
proximately caused his injury and the defendant fails to
prove that on balance the benefits of the challenged
design outweigh the risk of danger inherent in such
designs."
The first way is commonly referred to as the consumer expectation
test. The second is called the risk-utility or risk-benefit test. The
appellate court held that under either test, the evidence justified a
finding of defective design. We agree.

1. The Consumer Expectation Test
	In affirming the jury's verdict, the appellate court held that it
was not against the manifest weight of the evidence for the jury to
find that the friction-fit device failed to meet Andrina's reasonable
expectation that it would function properly. 309 Ill. App. 3d at
884.
	Baxter contends that the health-care professional (rather than
the patient) should be deemed "the consumer" for purposes of the
consumer expectation test. This approach, Baxter argues, is
consistent with the traditional application of the learned
intermediary doctrine. Baxter further argues that this is true
because, in the case of a prescription medical device, the patient
has no more independent ability to assess the product's risks or
benefits than to appreciate or assess the warnings as to its use.
Thus, under the consumer expectation test, the issue is whether the
product is more dangerous than expected by the ordinary learned
intermediary.
	 Neither Baxter nor its amicus, the Product Liability Advisory
Council, has cited any Illinois authority in support of this
argument. Baxter refers us to Shanks v. Upjohn Co., 835 P.2d 1189 (Alaska 1992). In that case, the court concluded that a
prescription drug is defectively designed and imposes strict
liability on its manufacturer if it fails to perform as safely as an
ordinary doctor would expect, when used by the patient in an
intended and reasonably foreseeable manner. Shanks, 835 P.2d  at
1195. In a footnote, the court observed:
			"With certain types of prescription drugs, the role of the
doctor in the decision to use a specific product is
significantly reduced. Examples of such atypical
prescription products include contraceptives, where the
patient initiates and directs the usage, drugs administered
in a clinical setting with little or no physician
involvement, or drugs marketed under a strategy designed
to appeal directly to the consuming public. These are
areas where courts have held that manufacturers have a
duty to warn patients directly. In strict liability design
cases involving such products, it may be appropriate to
apply the 'ordinary consumer expectation' test rather than
the 'ordinary doctor expectation test.' " Shanks, 835 P.2d 
at 1195 n.7.
	In the case before us, the evidence showed that the decision
to purchase friction-fit connectors was made exclusively by the
nursing products committee at Mt. Sinai. The chairperson of that
committee testified that the hospital staff relied on the product
manufacturer to advise them of the proper uses for the product.
The person who actually purchased the friction-fit connectors from
Baxter's sales representative was not a physician and did not know
that those devices should not be used in central line applications.
Since the purchase of the product had little physician involvement,
it would appear that the facts in this case are similar to those
described in the Shanks footnote. In such cases, the application of
the "ordinary consumer" expectation test, rather than the "ordinary
physician" expectation test, is appropriate.
	Moreover, in Haudrich v. Howmedica, Inc., 169 Ill. 2d 525
(1996), plaintiff sought recovery on a strict liability theory against
the manufacturer of a knee prosthesis that failed prematurely,
causing personal injuries. The evidence was conflicting as to
whether the device failed because of a design defect, a
manufacturing defect, or both. In any event, this court held that the
evidence was sufficient to support a finding that the plaintiff was
injured by an unreasonably dangerous condition of the knee
device. The court stated: "sufficient evidence was presented to
support a finding that the device failed to perform in a manner
reasonably expected in light of its nature and intended function
and subjected the plaintiff to an unreasonable risk of harm beyond
that contemplated by an ordinary person." (Emphasis added.)
Haudrich, 169 Ill. 2d  at 542. Although the Haudrich court was not
presented with the argument that the contemplation of the doctors,
rather than the patient, should be controlling, that case clearly used
the "ordinary person" standard in applying the consumer
expectation test.
	Andrina, who was conscious after surgery, could have
reasonably expected that her IV catheter connection, if properly
designed and manufactured, would be safe to use for its intended
purpose. She was the person who would be harmed if the device
failed. The expert testimony adduced at trial was sufficient to
establish that the design of the device was defective and that this
defective design caused her injury. Thus, we agree with the
appellate court's conclusion that the jury's decision did not
contradict the manifest weight of the evidence.

2. The Risk-Utility Test
	Baxter also argues that the appellate court erred in finding that
the jury's verdict could be supported under the risk-utility test. The
appellate court held that the record supported a finding that a
connector existed that would prevent foreseeable harm without
hindering its function or significantly increasing its price. Hansen,
309 Ill. App. 3d at 884.
	We disagree with Baxter on this point. As this court held in
Kerns v. Engelke, 76 Ill. 2d 154, 162-63 (1979), a plaintiff may
demonstrate that a product is unreasonably dangerous because of
a design defect by presenting evidence of an alternative design that
would have prevented the injury and was feasible in terms of cost,
practicality and technological possibility. The record in this case
contains sufficient evidence to establish that the Luer-lock collar
was designed to, and would have, prevented an unintentional
disconnection at a cost of between three and five cents per unit.
This record is sufficient to sustain a finding of unreasonable
dangerousness under a risk-utility analysis.
	Baxter argues, however, that a risk-utility analysis is
inappropriate in this case because the device in question is simple
and because the risks are well-known to the medical community
that uses the device.
	Baxter cites Scoby v. Vulcan-Hart Corp., 211 Ill. App. 3d 106
(1991), in support of its argument. In that case, the appellate court
reviewed a grant of summary judgment by the trial court in favor
of the defendant manufacturer of a deep-fat fryer used in a
restaurant. Plaintiff was a cook who was burned when he slipped
and lost his balance, causing his arm to be submersed in hot oil.
Plaintiff claimed the injury could have been prevented if the fryer
had been equipped either with a simmer cover or a tank cover. The
manufacturer offered each protective cover as a separate product.
The parties stipulated that the purpose of the simmer cover was to
trap moisture in the product being cooked, and that the purpose of
the tank cover was to prevent vermin from getting into the jelled
cooking oil after it had cooled. Neither cover was developed or
marketed as a safety device. In affirming the trial court's decision,
the appellate court remarked:
			"We do not deem that Lamkin or other cases applying
aspects of the danger-utility test intend that all
manufacturers of products described above should be
subject to liability depending upon a trier of fact's
balancing under that test, when suit is brought by one
injured by such a product. Somewhere, a line must be
drawn beyond which the danger-utility test cannot be
applied. Considering not only the obvious nature of any
danger here but, also, the simple nature of the mechanism
involved, we conclude the circuit court properly applied
only the consumer-user contemplation test." Scoby, 211
Ill. App. 3d at 112.
	That conclusion is not compelled by the facts in this case.
Baxter's patent application stated that the Luer-lock was designed
to overcome the problem of inadvertent disconnection of the
friction-fit. Thus, it is reasonable to infer that Baxter, unlike the
manufacturer in Scoby, developed and marketed its product as a
safety device. As plaintiff's expert Neil Sheehan testified, the
likelihood of disconnection of a friction-fit device is dependent on
several variables, including the force applied to engage it,
differences in molding and differences in sterilization procedures.
Sheehan further opined that the friction-fit connectors became
obsolete once the Luer-lock was invented.
	 Even though the doctors assumed the friction-fit device was
safe to use in central line applications, the reasonable conclusion
is that the danger in the friction-fit was not obvious, nor was the
mechanism simple. There can be no rational comparison between
this device and a kettle of boiling oil. Thus, Scoby is inapposite.
We believe the analysis of the appellate court was correct on this
issue and we hold that the jury's decision against Baxter based on
application of the risk-utility test was not against the manifest
weight of the evidence.
	Baxter also argues that if the risk-utility test is to be applied
in the defective design analysis, then we should apply the standard
defined by the new Restatement (Third) of Torts. That standard
would allow a finding of unreasonably dangerous design only if
reasonable health-care providers, knowing the foreseeable risks
and therapeutic benefits, would not prescribe the device for any
class of patients. Restatement (Third) of Torts: Product Liability
§6 (1998).
	Baxter did not argue this point in the trial court and it was
asserted for the first time in Baxter's reply brief in the appellate
court. The appellate court, however, made no reference to this
argument in its opinion. Application of the Restatement (Third) of
Torts standard would apparently require expert medical testimony
to establish whether reasonable health-care providers, knowing the
foreseeable risks and therapeutic benefits of the friction-fit device,
would prescribe it for any class of patient. No such expert medical
testimony was proffered by either party. We have already held that
Baxter waived the argument that it was error to rely on the
testimony of a mechanical engineer with no medical training or
expertise and, thus, there is no evidentiary basis for the application
of the Restatement (Third) of Torts standard. We decline,
therefore, to address this issue We do not foreclose the
consideration of the Restatement (Third) of Torts standard in
another case where it is raised at trial and is appropriately briefed
and argued.

CONCLUSION
	We disagree with the appellate court's conclusion that, under
the learned intermediary doctrine, Baxter had no duty to warn of
the inherent dangers associated with friction-fit locks. We find that
the duty to warn was properly submitted to a jury and that the
jury's verdict does not contradict the manifest weight of the
evidence. We agree with the appellate court's conclusion that the
defective-design theory was properly submitted to a jury and that
the verdict does not contradict the manifest weight of the evidence.
	Therefore, for the reasons stated, we affirm the judgment of
the appellate court, which affirmed the judgment of the circuit
court as modified.
Appellate court judgment affirmed.