Brief - When Do New Medical Devices Render Old Ones Defective? - Hansen v. Baxter Healthcare Corp., 2002 WL 93106 (Ill. 2002)
Lower Court - Hansen v. Baxter Healthcare Corporation, 309 Ill.App.3d 869, 723 N.E.2d 302, 243 Ill.Dec. 270 (Ill.App. 1999)
|||IN THE SUPREME COURT OF THE STATE OF ILLINOIS
|||Docket No. 89043-Agenda 16-March 2001
|||January 25, 2002
|||STEVEN HANSEN, SPECIAL ADM'R OF THE ESTATE OF ANDRINA HANSEN, APPELLEE
BAXTER HEALTHCARE CORPORATION, APPELLANT
|||The opinion of the court was delivered by: Justice Kilbride
|||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
|||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
|||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.
|||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.
|||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
|||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
|||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
|||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
|||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 non-delegable 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),
|||"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
|||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
|||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
|||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.
|||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.
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