Title: RICHARD DEAN ROHDE V. SMITHS MEDICAL, d/b/a SIMS DELTEC, INCL, A Minnesota Corporation

State: wyoming

Issuer: Wyoming Supreme Court

Document:

RICHARD DEAN ROHDE V. SMITHS MEDICAL, d/b/a SIMS DELTEC, INCL, A Minnesota Corporation2007 WY 134165 P.3d 433Case Number: 06-213Decided: 08/22/2007
APRIL 
TERM, A.D. 2007

 
 
RICHARD 
DEAN ROHDE,

 
 
Appellant

(Plaintiff),

 
 
v.

 
 
SMITHS 
MEDICAL, d/b/a

SIMS 
DELTEC, INC., A Minnesota

Corporation,

 
 
Appellee

(Defendant).

 
 
Appeal 
from the DistrictCourtofTetonCounty

The 
Honorable Nancy J. Guthrie, Judge

 
 
Representing 
Appellant:

Katherine 
L. Mead and Bradford S. Mead of Mead & Mead, Jackson, Wyoming.  
Argument by Ms. Mead.

 
 
Representing 
Appellee:

Richard 
A. Mincer of Hirst & Applegate, Cheyenne, 
Wyoming; Michelle L. Rognlien of Bowman and 
Brooke, LLP, Minneapolis, 
Minnesota.  Argument by Mr. Mincer.                       

            

Before 
VOIGT, C.J., and GOLDEN, HILL, KITE, and BURKE, JJ.

 
 
KITE, 
Justice.

 
 
[¶1]      Mr. Rohde sued 
Smiths Medical d/b/a Sims Deltec, Inc. (Smiths Medical), the manufacturer of a 
venous access device which fractured after it was inserted into his chest to 
administer chemotherapy treatment, claiming the device was defective.  The district court granted summary 
judgment in favor of Smiths Medical because Mr. Rohde did not present evidence 
ruling out reasonable secondary causes of the fracture so as to establish that 
the device was defective under the inference of defect rule.    

 
 
[¶2]      We affirm.  

 
 
ISSUES

 
 
[¶3]      Mr. Rohde 
articulated a single issue in his opening brief:1

 
 

I.                    
Did 
the trial court err when it held that the inference of defect rule is 
inapplicable to the case at bar?

 
 
Smiths 
Medical restated the appellate issue as:

 
 
            
In this products liability case, did the District Court correctly grant 
summary judgment for Appellee Smiths Medical where Appellant Richard Rohde 
failed to produce any evidence of a defect in the design or manufacture of, or 
warnings related to, the PORT-A-CATH® medical device at issue? 

 
 
FACTS

 
 
[¶4]      In March 2001, 
Mr. Rohde was diagnosed with Hodgkin's lymphoma.2  He underwent chemotherapy treatment 
which was initially administered through a vein in his arm.  In July 2001, Mr. Rohde's oncologist, 
Banu Symington, M.D., recommended that he have a venous access device implanted 
to facilitate his chemotherapy treatments.  
On July 20, 2001, P. George Poore, M.D., a vascular surgeon at 
St. John'sHospital in Jackson, Wyoming, implanted a Port-A-Cath venous access 
device manufactured by Smiths Medical in Mr. Rohde's upper chest between his 
clavicle and first rib.     

 
 
[¶5]      The Port-A-Cath 
is designed to be implanted completely under the skin, usually in the chest or 
arm. Catheter tubing is inserted into the patient's blood system and attached to 
a portal consisting of a small metal chamber sealed at the top with a silicone 
septum.  It allows medications or 
fluids to be delivered directly into the bloodstream by injection through the 
skin and into the portal.     

 
 
[¶6]      Smiths Medical 
provided physicians with instructions for the Port-A-Cath which stated that 
there was a risk the device could fracture as a result of compression between 
the clavicle and first rib.  Dr. 
Poore advised Mr. Rohde of some risks associated with the implantation, but did 
not tell him there was a risk that the device could fracture while implanted in 
his body because the doctor believed the risk was so slight.  Dr. Poore examined the Port-A-Cath prior 
to implantation in Mr. Rohde's chest and did not notice any defects.  Dr. Poore's surgical records indicated 
that he had some minor difficulty implanting the device because Mr. Rohde had a 
large clavicle and his tissue was resistant to the needle used in the 
procedure.  Despite those 
difficulties, Dr. Poore was able to successfully implant the Port-A-Cath and 
determined it was working properly.    

 
 
[¶7]      Over the next 
several months, Mr. Rohde received chemotherapy treatments utilizing the 
Port-A-Cath device.  It seemed to 
work properly, although Mr. Rohde had to lie on his back while receiving the 
treatments in order for the device to work.  In the fall of 2001, Dr. Symington 
decided that Mr. Rohde could cease chemotherapy treatments.  She recommended, however, that the 
Port-A-Cath remain in place because there was "a very high likelihood" that Mr. 
Rohde's cancer would return within the next year or two, necessitating further 
treatment.  She directed Mr. Rohde 
to have the Port-A-Cath flushed periodically to guard against the formation of 
blood clots.    

 
 
[¶8]      In November 2001, 
Mr. Rohde began experiencing pain during and after flushing of the 
Port-A-Cath.  He treated the pain 
with a heating pad and ice therapy.  
On December 4, 2001, Mr. Rohde complained of pain during the flushing 
process.  Dr. Symington suspected a 
blood clot had formed and ordered a venous dye study to check for a clot.  Although she intended for the dye to be 
administered through the Port-A-Cath to test its patency, the doctor performing 
the procedure inserted the dye through Mr. Rohde's veins; consequently, the 
Port-A-Cath was not tested at that time.  
The venous dye study did not reveal a blood clot.      

 
 
[¶9]      On January 17, 
2002, Mr. Rohde began to bleed from the Port-A-Cath.  Medical tests revealed that a six to 
seven centimeter section of the catheter tubing had fractured off from the 
remainder of the Port-A-Cath and migrated through Mr. Rohde's heart to his 
pulmonary artery.  Thomas 
Cunningham, M.D., an interventional radiologist, retrieved the fragment from Mr. 
Rohde's pulmonary artery.  Before 
discarding the broken piece, Dr. Cunningham looked at it and noticed that, 
although one end looked normal and smooth, the other end had a slightly 
irregular or jagged edge.  Dr. Poore 
subsequently removed the remainder of the Port-A-Cath from Mr. Rohde's chest and 
discarded it.  While examining that 
piece, Dr. Poore noted that, other than the fact it was shorter, it looked 
essentially the same as when he implanted it.   

 
 
[¶10]   In 2004, Mr. Rohde sued St. John's Medical 
Center,3 Dr. Poore4 and Smiths Medical.  Mr. Rohde claimed Smiths Medical was 
strictly liable for the injuries he incurred because the Port-A-Cath 
fractured.  He asserted the 
Port-A-Cath was defective and Smiths Medical had failed to adequately warn about 
the risk of fracture of the device.    

 
 
[¶11]   After extensive discovery, Smiths 
Medical filed a motion for summary judgment and submitted testimony and exhibits 
indicating there was no evidence of a defect in the Port-A-Cath and Smiths 
Medical had adequately warned Mr. Rohde's physicians about the risks associated 
with the Port-A-Cath, including the possibility of fracture.  In response, Mr. Rohde did not present 
any evidence to establish a specific defect in the Port-A-Cath, but asserted the 
court should allow his strict liability claim to proceed under the inference of 
defect rule recognized in Sims v. General 
Motors Corp., 751 P.2d 357 (Wyo. 1988).  Specifically, Mr. Rohde argued that he 
was entitled to an inference the Port-A-Cath was defective simply because it 
fractured while implanted in his body.  
Although he asserted that Dr. Poore did not warn him about the risk of 
fracture, he did not respond to Smiths Medical's argument regarding the adequacy 
of the warnings it provided to physicians about the risk.5    

 
 
[¶12]   In reply to Mr. Rohde's inference 
of defect argument, Smiths Medical asserted that to qualify for an inference 
that the Port-A-Cath was defective under Sims, Mr. Rohde was required to show 
that a malfunction occurred with normal use and there were no reasonable 
secondary causes of the malfunction.  
The manufacturer maintained the evidence showed that compression between 
the clavicle and first rib, a known risk, was a reasonable secondary cause of 
the fracture of Mr. Rohde's Port-A-Cath.  
In particular, Smiths Medical relied upon the opinion of Dr. Poore's 
expert witness, Michael Fenoglio, M.D., that Mr. Rohde's Port-A-Cath broke 
because of clavicle/first rib compression exacerbated by his weight gain after 
the device was implanted.  Mr. Rohde 
failed to offer any evidence showing that the fracture occurred for some other 
reason or to counter, in any way, Smiths Medical's showing that compression was 
a reasonable secondary cause of the fracture of his Port-A-Cath.    

 
 
[¶13]   The district court rejected Mr. 
Rohde's inference of defect argument because he failed to present evidence to 
counter that offered by Smiths Medical.  
The court also ruled that fracture was an inherent risk associated with 
use of the Port-A-Cath and Smiths Medical warned physicians about that 
risk.  On appeal, Mr. Rohde contests 
the district court's refusal to allow his products liability claim to proceed 
under the inference of defect rule.        

 
 
STANDARD 
OF REVIEW

 
 
[¶14]   W.R.C.P. 56(c) governs summary 
judgment and states that a motion for summary judgment should be granted "if the 
pleadings, depositions, answers to interrogatories, and admissions on file, 
together with the affidavits, if any, show that there is no genuine issue as to 
any material fact and that the moving party is entitled to a judgment as a 
matter of law."

   

[¶15]   Our standard for reviewing the 
district court's decision to grant a summary judgment is de novo.  We evaluate the propriety of a summary 
judgment by employing the same standards and examining the same material as the 
district court.   We consider 
the record in the light most favorable to the party opposing the motion, 
affording to that party the benefit of all favorable inferences that may be 
drawn from the record.  If upon 
review of the record, doubt exists about the presence of issues of material 
fact, that doubt must be resolved against the party seeking summary 
judgment.  A genuine issue of 
material fact exists when a disputed fact, if proven, would establish or refute 
an essential element of a cause of action or a defense that a party has 
asserted.  Cook v. Shoshone First Bank, 2006 WY 13, 
¶ 11, 126 P.3d 886, 889 (Wyo. 2006); Linton v. E.C. Cates Agency, Inc., 2005 
WY 63, ¶¶ 6-7, 113 P.3d 26, 28 (Wyo. 2005).

 
 
DISCUSSION 

 
 
[¶16]   
Mr. Rohde claims the district court erred when it granted summary 
judgment on his claim that Smiths Medical was strictly liable for the injury he 
suffered as a result of the Port-A-Cath's fracture.  He argues the district court erroneously 
refused to apply the inference of defect rule to allow his claim to 
proceed.  In order to establish the 
proper context for our discussion of Mr. Rohde's argument, we will briefly 
review the law of products liability in this state.

 
 
[¶17]   In Ogle v. Caterpillar Tractor Co., 716 P.2d 334, 342-44 (Wyo. 1986), we recognized that in cases involving defective 
products, causes of action in negligence and/or for breach of warranty may not 
be adequate to provide recompense to an injured party.  This Court, therefore, recognized a 
cause of action, based upon the Restatement (Second) of Torts § 402A (1965), for 
strict liability in favor of a party injured by a defective product.   Ogle, 716 P.2d  at 341-42.  Section 402A 
states:

 
 
402A. Special Liability of Seller of Product for 
Physical Harm to User or Consumer

 
 
            
(1) One who sells any product 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 the ultimate user or consumer, or to his 
property, if

 
 

(a)     
the 
seller is engaged in the business of selling such a product, 
and

 
 
(b) it 
is expected to and does reach the user or consumer without substantial change in 
the condition in which it is sold.

 
 
            
            
(2) The rule stated in Subsection (1) applies 
although

 
 

(a)   the 
seller has exercised all possible care in the preparation and sale of his 
product, and

 
 
(b) the 
user or consumer has not bought the product from or entered into any contractual 
relation with the seller.

 
 

Id.

 
 
[¶18]   In accordance with § 402A, we adopted the following elements of a 
strict liability claim in Wyoming:

 
 
(1) that 
the sellers were engaged in the business of selling the product that caused the 
harm;

 
 
(2)  that the product was defective when 
sold;

 
 
(3) that 
the product was unreasonably dangerous to the user or 
consumer;

 
 
(4) that 
the product was intended to and did reach the consumer without substantial 
change in the condition in which it was sold;  and

 
 
(5) that 
the product caused physical harm to the plaintiff/consumer.  

 
 

Id. at 
344.  As the strict liability 
elements demonstrate, a plaintiff must show the product was defective when the 
seller sold it.  Campbell v. Studer, Inc., 970 P.2d 389, 392 
(Wyo. 1998); McLaughlin v. Michelin Tire Corp., 778 P.2d 59, 64 (Wyo. 1989).  Stated generally, a "defective product" 
is one which is "not reasonably safe" or is "unreasonably dangerous" to the user 
or consumer.  Campbell, 970 P.2d  at 392, quoting McLaughlin, 778 P.2d  at 64.   In contrast, "[i]f a product is 
safe for normal handling and consumption, it is not defective."  Campbell, 970 P.2d  at 392.  It is not enough to show that an injury 
occurred during use of the product to establish it was defective.  Id. 
at 394.  Instead, a plaintiff must 
show a defect in the product, which he may do either by presenting evidence of a 
specific defect or by inference.  Sims, 751 P.2d  at 360-61.  
  

  

[¶19]   The inference of defect rule was 
recognized by this Court in Sims.  Restatement (Second) of Torts § 402A, 
cmt (g) provides the basis of the inference of defect rule.  We explained in Sims:

 
 
As 
stated in comment g of section 402A, supra:

 
 
"The 
seller is not liable when he delivers the product in a safe condition, and 
subsequent mishandling or other causes make it harmful by the time it is 
consumed.  The burden of proof that 
the product was in a defective condition at the time that it left the hands of 
the particular seller is upon the injured plaintiff;  and unless evidence can be produced 
which will support the conclusion that it was then defective, the burden is not 
sustained."  

 
 
            
From the language in comment g, it is clear that section 402A, supra, 
applies only when the product is shown to have been unreasonably dangerous at 
the time it left the seller's hands.  
There is, however, an inference that a product was defective at the time 
it left the seller's hands if a prima facie case can be presented that there was 
no abnormal use of the product or that there were no reasonable secondary causes 
for the defect.  In Valentine v. Ormsbee Exploration 
Corporation, Wyo., 665 P.2d 452, 462 (1983), we quoted with approval the 
rule set out in Tweedy v. Wright Ford 
Sales, Inc., 64 Ill. 2d 570, 2 Ill. Dec. 282, 285, 357 N.E.2d 449, 452 
(1976):

 
 
"A prima 
facie case that a product was defective and that the defect existed when it left 
the manufacturer's control is made by proof that in the absence of abnormal use 
or reasonable secondary causes the product failed to perform in the manner 
reasonably to be expected in light of [its] nature and intended function.'"  (Emphasis added.)

 
 

Id. at 
360-61.  In Sims, we rejected the plaintiffs' 
contention that mere proof of a product malfunction was sufficient to create an 
inference that the product was defective.  
Instead, the plaintiff has the "additional burden to present evidence 
that there was no abnormal use and no reasonable secondary causes for the 
malfunction."  Id. at 361.  

 
 
[¶20]   Apparently unable to present 
evidence of a specific defect in the Port-A-Cath, Mr. Rohde attempted to prove 
the device was defective using the inference of defect rule.  He claimed he was entitled to an 
inference that the Port-A-Cath was defective because it fractured while 
implanted in his body.  Relying on 
Sims, Smiths Medical maintained Mr. 
Rohde was not entitled to an inference of defect because compression between the 
clavicle and first rib, compounded by Mr. Rohde's weight gain after 
implantation, was a reasonable secondary cause of the fracture.6    

 
 
[¶21]   The risk of clavicle/first rib 
compression was outlined in the literature supplied to physicians who used the 
device.  The Instructions for Use of 
the Port-A-Cath stated in relevant part:

 
 

WARNING:  When 
introducing the catheter percutaneously into the subclavian vein, there is a 
risk that it may be placed too medially near the angle between the clavicle and 
first rib.  This could increase the 
inherent risk of compression of the catheter, which may result in damage, 
rupture, drug extravasation, or catheter fragmentation with possible 
embolization.

 
 
In 
support of its claim that clavicle/first rib compression was a reasonable 
secondary cause of the fracture of Mr. Rohde's Port-A-Cath, Smiths Medical 
pointed to the testimony of Dr. Poore's expert witness, Michael Fenoglio, 
M.D.  Dr. Fenoglio stated, although 
he could not be absolutely certain that the Port-A-Cath fractured because of the 
compression, he believed that is what happened in Mr. Rohde's case:  

 
 
Q.        
Okay.  Based on your 
knowledge of Mr. Rohde's weight gain from the time he had the device implanted 
to the time it was discovered that it fractured, and based on Mr. Rohde's 
clavicle size and the placement in Mr. Rohde of the device near the clavicle and 
first rib, and your understanding of how things shift particularly in an obese 
patient, is it reasonable in your mind to assume that the device fractured  the 
catheter fractured because of the interaction between the clavicle and the first 
rib?

 
 
[Objection]

 
 

A.                 
I 
personally think that's probably what happened, but I can't say with 100 percent 
certainty that that's what happened.  
But that's my opinion because of the weight gain, because of the 
shifting, because of the movements that happened.  

 
 
[¶22]   Mr. Rohde did not present any 
evidence to the district court to counter Smiths Medical's showing that 
compression was a reasonable secondary cause of the Port-A-Cath's fracture.  Thus, he failed to meet his burden to 
discount reasonable secondary causes of the product's malfunction as required by 
Sims.  Indeed, Mr. Rohde does not seriously 
contest the district court's ruling that he did not meet his burden under the 
inference of defect rule as set out in Sims.  
He suggests, instead, that this Court should modify the inference of 
defect rule to relieve product liability plaintiffs of the burden of showing no 
reasonable secondary causes for a product's failure.  In making this argument, he relies on 
two Illinois cases which, he claims, have relaxed the requirements for showing a 
defect using the inference of defect rule:  
Weedon v. Pfizer, Inc., 773 N.E.2d 720 (Ill. Ct. App. 2002); Tweedy 
v. Wright Ford Sales, Inc., 357 N.E.2d 449 (Ill. 1976).    

 
 
[¶23]   The facts in Weedon are very similar to the case at 
bar.  Mr. Weedon had a Lifeporte 
implanted in his chest to aid in the administration of chemotherapy treatments 
for his Hodgkin's disease.  Weedon, 773 N.E.2d  at 722.  The site of the venous access device 
became inflamed and Mr. Weedon's physicians decided to remove (explant) the 
device.  After explantation, the 
area in Mr. Weedon's chest where the device had been located continued to 
deteriorate, resulting in a large hole in his chest.  Id.  

 
 
[¶24]   Like Mr. Rohde, the plaintiff in Weedon did not present any evidence of a 
specific defect in the device.  
Id.  He attempted, however, to establish a 
defect by circumstantial evidence.  
Id. at 722-23, citing Doyle v. White Metal Rolling & Stamping 
Corp., 618 N.E.2d 909 (Ill. Ct. App. 1993).  In particular, he maintained that the 
device had improperly leaked or "extravasated," allowing the chemotherapy drugs 
to come into contact with the tissues in his chest, causing his injuries.  The defendants suggested that Mr. 
Weedon's injuries were caused by infection, rather than leakage from the venous 
access device, or if the product leaked, it was because of a medical mistake 
rather than a defect in the device.  
Weedon, 773 N.E.2d  at 
725-31.  The district court agreed 
with the defendants and granted summary judgment in their favor.  Id. at 721.  

 
 
[¶25]   On appeal, Mr. Weedon argued the 
district court should not have granted summary judgment in favor of the 
manufacturers because he had presented evidence which tended to negate other 
reasonable causes of his injury.  
Id. at 725.  The court of appeals agreed with Mr. 
Weedon because he had offered ample deposition testimony indicating that medical 
tests had shown he was not suffering from an infection and the cause of his 
injuries was leakage or extravasation from the venous access device.  Id. at 725-730.  Moreover, there was evidence ruling out 
medical mistake as a cause of the extravasation.  Id. at 730.  The court of appeals reversed the 
summary judgment in favor of the defendant manufacturers, finding Mr. Weedon's 
evidence was sufficient to raise genuine issues of material fact about the cause 
of his injuries and/or malfunction of the product.  Id. at 731.   

 
 
[¶26]   We note an analytical difference 
between Weedon and our 
precedent.  The court in Weedon considered other causes of the plaintiff's injuries.  Our law, as expressed in Sims and consistent with Restatement 
(Second) of Torts § 402A, comment g, requires the plaintiff to show he is 
entitled to an inference that the product was defective because there are no 
other reasonable causes for the product's 
failure.  Other causes of the 
plaintiff's injuries should be analyzed in determining whether the product's 
defect was the proximate cause of the injuries (the fifth element of a strict 
liability claim), not in determining whether the product was defective (the 
second element of a strict liability claim).  Despite the difference between 
Wyoming law and the analysis employed in Weedon, the Illinois court of appeals 
still required Mr. Weedon to offer evidence to counter the other causes 
championed by the manufacturers.  
Thus, the Weedon decision does 
not support Mr. Rohde's argument that he should be relieved of the burden of 
presenting evidence to refute the secondary cause identified by Smiths 
Medical.  

 
 
[¶27]   Likewise, in Tweedy the court held the plaintiff 
established a prima facie case that a 
product was defective by presenting "proof that in the absence of abnormal use 
or reasonable secondary causes the product failed to perform in the manner 
reasonably to be expected in light of (its) nature and intended function.'"  Tweedy, 357 N.E.2d  at 452.  In other words, in order to qualify for 
an inference that the product was defective, the plaintiff was required to offer 
evidence discounting other causes of the product's failure.  Consequently, the Illinois cases cited by 
Mr. Rohde simply do not support a relaxation of the Sims requirements for establishing an 
inference of defect.      

 
 
[¶28]   Mr. Rohde also suggests that 
products liability plaintiffs should not be required to present evidence that 
secondary causes did not cause the product's malfunction because, in any given 
case, there are innumerable possible causes and it is unduly burdensome for 
plaintiffs to disprove all of them.   
He claims it should be enough to establish that the device malfunctioned 
and did not, therefore, perform "in a manner reasonably to be expected in light 
of its nature and intended use."  We 
believe Mr. Rohde overstates the burden imposed on plaintiffs by the inference 
of defect rule.  In this case, 
Smiths Medical presented evidence of a reasonable secondary cause of the 
Port-A-Cath's fracture, i.e. clavicle/first rib compression.  Mr. Rohde was not required to disprove 
numerous or vague secondary causes.  
Instead, his burden, at the summary judgment stage, was simply to present 
evidence to establish a material issue of fact on the reasonable secondary cause 
advanced by Smiths Medical.  He did 
not present any evidence to satisfy that burden.  

 
 
[¶29]   We recognize it may have been 
difficult for Mr. Rohde to meet the challenge of showing a specific defect given 
the unfortunate fact that the device was discarded after it was removed.  Nevertheless, if the Port-A-Cath was 
defectively designed making it prone to fracture then, presumably, he could have 
located an expert to analyze the design and provide his opinion on such a 
specific defect.  In the 
alternative, Mr. Rohde could have qualified for an inference of defect by 
presenting expert evidence to discount the other causes of the fracture 
identified by Smiths Medical.  Mr. 
Rohde's failure to meet his burden to establish a specific defect or an 
inference of defect in accordance with Sims does not justify expanding the 
inference of defect rule to allow a plaintiff to proceed to trial simply because 
the product failed.  Such a holding 
would unduly expand product liability jurisprudence without justification.  We, therefore, conclude the district 
court properly granted summary judgment in favor of Smiths Medical on Mr. 
Rohde's claim that the Port-A-Cath was defective.    

 
 
[¶30]   We turn now to a different argument 
raised by Mr. Rohde.  In his 
statement of the issue on appeal, he only contested the district court's refusal 
to apply the inference of defect rule in his case.  He did not articulate an issue regarding 
the summary judgment on his failure to warn claim.  Nevertheless, he attempts to dovetail an 
issue about the warnings into his appellate argument, stating the warnings do 
not "immunize [Smiths Medical] from liability for a defective product" and 
arguing there are genuine issues of material fact about the adequacy of Smiths 
Medical's warnings about the Port-A-Cath.    

 
 
[¶31]   Mr. Rohde's argument improperly 
blends two distinct theories of strict liability:  1) a defect in the product itself; and 
2) failure to warn about an inherent risk of a non-defective product.  An American Law Report annotation 
explains the difference between the theories:

 
 
            
In the field of products liability, the doctrine of strict liability in 
tort generally imposes liability upon the supplier of a defective product for 
injury caused thereby, without requiring proof of negligence, and 
notwithstanding lack of reliance on warranty.  As expressed in §402A of the Restatement 
of Torts (the version of strict liability adopted in many jurisdictions), such 
liability attaches with respect to injury caused by any product in a defective 
condition unreasonably dangerous to the user or consumer or to his 
property.  However, notwithstanding 
the requirement that the product be in a defective condition unreasonably 
dangerous to the user or the consumer, it is apparently recognized in all 
jurisdictions which have adopted the doctrine of strict liability in tort, that 
the doctrine applies even though the product is flawlessly manufactured and 
designed but is nevertheless dangerous or likely to cause harm unless properly 
used.  In such cases the doctrine is 
invoked, under the appropriate circumstances, if there is a failure to warn or 
instruct as to possible danger, with many of the courts which have adopted the 
Restatement language of the doctrine stating that the particular product is in a 
"defective condition unreasonably dangerous" by virtue of the absence of 
adequate warning or instruction.

 
 
            
Although liability arising from faulty manufacture or design and 
liability arising out of failure to warn of danger are covered under the same 
rule, the two categories are conceptually different.  Fault in production or design is 
something over which a manufacturer has control, while the danger for which 
warning is required is one generally caused by a failure of scientific or 
technological knowledge to provide a safe product.  In the case of the former, the 
manufacturer can at least theoretically produce a fault-free product.  In the case of the latter, the danger is 
not in the manufacture but in the product itself, and its availability is deemed 
beneficial notwithstanding the presence of danger.  Furthermore, since almost every product 
would appear to have some potential for inflicting harm, and since it would 
appear that instructions and warnings could not reasonably be required in the 
marketing of every product, a rule as to standards of conduct must be applied in 
determining the circumstances under which a warning or instruction is required 
so as to keep the product from being considered "defective" without the 
warning.   

 
 
Allan E. 
Korpela, LL.B., Failure to Warn as Basis of Liability Under Doctrine of Strict 
Liability in Tort, 53 A.L.R.3d 239, 243, § 2[a] (1973) (hereinafter 
Annotation).  

 
 
[¶32]   Thus, if the product itself is not 
defective but may be unreasonably dangerous if it is used improperly, a 
plaintiff may show a "defect" by establishing that the manufacturer failed to 
warn about dangers associated with the product.  See, e.g., Jacobs v. Dista Products Co., 693 F. Supp. 1029 (D. Wyo. 1988) (considering a claim that defendant manufacturer 
failed to adequately warn about the dangers of a prescription drug); Braaten v. Saberhagen Holdings, 151 P.3d 1010 (Wash. Ct. App. 2007); Hurley v. 
Heart Physicians, P.C., 898 A.2d 777 (Conn. 2006).  Unlike traditional strict liability 
claims, a claim for failure to provide adequate warnings incorporates some 
negligence components in determining whether a warning is necessary and/or 
whether the warnings provided were adequate.  See, Annotation, 53 A.L.R.3d at 243, § 
2[a].  The efficacy and adequacy of 
the warnings Smiths Medical supplied to Port-A-Cath users was not, however, 
implicated under Mr. Rohde's "inference of defect" theory. 

 
 
[¶33]   We realize that Mr. Rohde alleged 
in his complaint that Smiths Medical was strictly liable because it did not 
adequately warn of the dangers associated with using the Port-A-Cath.  Smiths Medical moved for summary 
judgment on the failure to warn claim, maintaining that it adequately warned Mr. 
Rohde's physicians about the risk of fracture.  Smiths Medical submitted, as evidence, 
the warnings contained in the Port-A-Cath's instructions for use and the 
deposition testimony of one of its employees who stated that the warnings 
accompanied the product.  Smiths 
Medical argued that it was entitled to summary judgment because Mr. Rohde had 
"proffered no evidence that the Instructions for Use [were] in any way defective 
or insufficient."  In reply, Mr. 
Rohde stated that Dr. Poore did not warn him about the risk of fracture,7 but he did not point to any 
evidence or present any argument that the warnings provided by Smiths Medical to 
Dr. Poore were inadequate.  

   

[¶34]   The district court granted summary 
judgment in favor of Smiths Medical on Mr. Rohde's failure to warn claim.  Obviously, on the record before us, the 
district court's decision was proper since Mr. Rohde failed to present any 
evidence or, for that matter, any argument that a genuine issue of material fact 
existed on the adequacy of Smiths Medical's warnings about the risk of fracture. 

 
 
CONCLUSION

 
 
[¶35]   
Smiths Medical was entitled to a summary judgment on Mr. Rohde's 
claim that the Port-A-Cath was defective because he failed to fulfill his 
obligation, under the inference of defect rule, to present evidence creating a 
material issue of fact on whether there were reasonable secondary causes of the 
Port-A-Cath's failure.  Moreover, 
the district court properly granted summary judgment on Mr. Rohde's failure to 
warn claim because he presented no evidence that the warnings provided by Smiths 
Medical were inadequate.  
Consequently, we affirm.  

 
 
FOOTNOTES

 
 

1Mr. 
Rohde states other issues in his reply brief.  We do not need to address those issues 
to decide this case.

  

2Hodgkin's 
lymphoma is commonly known as Hodgkin's disease, and it is a cancer of the lymph 
system.  Webster's Third New International 
Dictionary 1076 (2002).

 
 

3Mr. 
Rohde voluntarily dismissed St. 
John'sMedicalCenter from the action 
before it answered the complaint.

  

4Dr. 
Poore filed a motion for summary judgment, and, after discovery, Mr. Rohde 
decided not to contest the doctor's motion.  Consequently, the district court granted 
summary judgment in favor of Dr. Poore.

     

5The 
"learned intermediary" principle generally states that a manufacturer has a duty 
to adequately warn medical professionals about risks associated with use of 
healthcare products.  So long as it 
complies with that obligation, the manufacturer may rely on medical 
professionals, as learned intermediaries, to properly warn their patients of the 
risks.   See, e.g., Jacobs v. Dista Products Co., 693 F. Supp. 1029, 1030 (D. Wyo. 1988).

  

6Smiths 
Medical also argued in the district court that mechanical damage to the catheter 
was another reasonable secondary cause of the Port-A-Cath's fracture.  It asserted the Port-A-Cath may have 
broken because medical personnel damaged it by either puncturing or applying too 
much pressure to the catheter.  
Because compression was clearly one reasonable secondary cause of the 
device's fracture, we do not need to determine whether mechanical damage is 
another reasonable cause.

  

7Interestingly, 
Mr. Rohde did not oppose summary judgment in favor of Dr. Poore, the "learned 
intermediary" whose responsibility it was to pass on Smiths Medical's warning to 
the patient.