Title: Stephen A. and Suzan M. Cox v. William Paul, D.D.S.
Citation: N/A
Docket Number: 71S03-0409-CV-417
State: Indiana
Issuer: Indiana Supreme Court
Date: June 14, 2005

ATTORNEYS FOR APPELLANTS 
 
 
 
 
ATTORNEYS FOR APPELLEE 
Edmond W. Foley 
 
 
 
 
 
Elizabeth H. Knotts 
Douglas D. Small 
 
 
 
 
 
 
Rori L. Goldman 
South Bend, Indiana 
 
 
 
 
 
Indianapolis, Indiana 
________________________________________________________________________ 
 
In the 
Indiana Supreme Court  
_________________________________ 
 
No. 71S03-0409-CV-417 
 
 STEPHEN A. AND SUZAN M. COX, 
 
 
 
 
 
 
 
 
Appellants (Plaintiffs below), 
 
v. 
 
WILLIAM E. PAUL, D.D.S., 
 
 
 
 
 
 
 
 
Appellee (Defendant below). 
_________________________________ 
 
Appeal from the St. Joseph Circuit Court, No. 71C01-9801-CP-000135  
The Honorable Terry A. Crone, Judge 
_________________________________ 
 
On Petition To Transfer from the Indiana Court of Appeals, No. 71A03-0303-CV-92  
_________________________________ 
 
June 14, 2005 
Boehm, Justice. 
 
We hold that a health care provider who receives notice of possible dangerous side 
effects of a treatment is not strictly liable for failure to warn a patient who received the treatment 
from the provider, but may be held liable for failure to make reasonable efforts to warn the 
patient.  If there is credible evidence that the patient did not receive notice, it is the burden of the 
provider to establish that reasonable steps were taken.  In this case, the provider did not carry 
that burden. 
 
 
Factual and Procedural Background 
 
In 1983, Suzan Cox consulted Dr. William Paul, an oral and maxillofacial surgeon, for 
problems in her temporomandibular joints which connect the jaw to the skull.  On March 20, 
1984, Paul performed a surgical replacement of Suzan’s right and left temporomandibular joints 
using Vitek dental implants.  After the surgery, Suzan underwent a course of physical therapy 
and enjoyed an uneventful recovery.  Suzan’s last appointment with Paul was on June 18, 1984.  
In late 1989, Suzan began to experience vertigo, neck pain, headaches, fatigue, and insomnia.  
The severity of these symptoms “escalated” with each year, but her family doctor could not 
identify their source.   
 
In September 1991, the Food and Drug Administration announced a recall of Vitek 
implants.  As is customary in recalls, Paul received a “Dear Doctor” letter advising that Vitek 
implants were potentially defective.  The FDA requested that doctors discuss the risk of implant 
failure with their patients who had received the implants, conduct a clinical follow-up with those 
patients, and encourage the patients to enroll in the Medic Alert Foundation International Implant 
Registry.  The FDA also requested that doctors respond within thirty days, informing the FDA 
through Medic Alert, of the actions that they had taken, and complete a form with information 
for each of the Vitek implant patients the doctor had or may have had.     
In early 1992 Paul instructed his staff to search his patient charts, identify patients who 
had received the implants, and inform them of the dangers.  The record contains no indication 
that Paul responded to the FDA as requested.  Paul’s staff performed a second search in 1994.  
Paul explains that he conducted this second search “simply to try and be thorough and continue 
to try to notify patients.”  Suzan’s record was not identified in either the 1992 or the 1994 search.   
In 1996, Suzan was identified by Paul’s office as a Vitek patient under circumstances not 
revealed by the record.  She was then notified of Vitek issues.  Paul testified that he does not 
know why Suzan was not identified until 1996.  He hypothesizes that her file might not have 
been in his office at the time of the two “sweeps” of his records.  Paul explains that he had been 
in a partnership with Dr. David Harris, but the two separated and Paul started an individual 
practice near the end of 1989, before he received the “Dear Doctor” letter.  Paul points out that 
when the separation occurred, charts were divided between the two doctors, so it is possible that 
 
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Suzan’s chart had been moved to Harris’s office.  Paul states that he does not know whether 
Suzan’s chart was ever actually moved to Harris’s office or how her chart came to his attention 
in 1996.  After Paul’s staff notified Suzan, she met with Paul who recommended that she have an 
MRI.  The MRI revealed that Suzan’s Vitek implants were extensively damaged and had 
disintegrated.  In November 1996, she underwent surgery to remove the implant remnants.   
 
Suzan and her husband filed a complaint against Paul in January 1998, alleging that 
Suzan was injured as a result of Paul’s breach of his duty to warn her of the dangers associated 
with Vitek.  The Coxes also submitted the proposed complaint to the Indiana Department of 
Insurance as required by the Medical Malpractice Act.  As the MMA provides, a medical review 
panel was convened, and the panel found that the evidence did not support the conclusion that 
Paul failed to meet the applicable standard of care.  The Coxes then moved in the trial court for 
partial summary judgment on the issue of liability, arguing that “Paul totally failed to ever notify, 
or even identify, Suzan Cox for nearly five years after his duty to do so first existed.  Such 
failure is a breach of his duty as a matter of law.”  Paul responded that this breach of duty to 
Suzan turned on a genuine issue of material fact, specifically, “whether the steps taken by Dr. 
Paul in conducting the two searches was reasonable.”  The trial court denied the Coxes’ motion 
and certified its ruling for interlocutory appeal.  The Court of Appeals reversed, Cox v. Paul, 805 
N.E.2d 901 (Ind. Ct. App. 2004), and this Court granted transfer.  Cox v. Paul, 822 N.E.2d 976 
(Ind. 2004). 
 
The standard of review of a grant or denial of a motion for summary judgment is the 
same as that used in the trial court:  summary judgment is appropriate only where the designated 
evidence shows there is no genuine issue of material fact and the moving party is entitled to a 
judgment as a matter of law.  All facts and reasonable inferences drawn from those facts are 
construed in favor of the nonmoving party.  Corr v. Am. Family Ins., 767 N.E.2d 535, 537-38 
(Ind. 2002) (citing Bemenderfer v. Williams, 745 N.E.2d 212, 215 (Ind. 2001)).  
 
 
 
 
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Liability for Failure to Notify Patient of Newly Discovered Risks 
In Harris v. Raymond, 715 N.E.2d 388 (Ind. 1998), this Court faced an almost identical 
set of facts.  In 1986 Dr. David Harris1 surgically replaced Mary Raymond’s temporomandibular 
joints with Vitek implants.  Id. at 390.  In 1991, Harris received the Vitek “Dear Doctor” letter 
from the FDA.  Id. at 391.  Harris’s staff attempted to compile a list of patients with Vitek 
implants, but Raymond was not contacted even though Harris’s staff had access to Raymond’s 
current address, received phone calls from her, and responded to her request for copies of her 
medical records, all after 1991.  In 1993, Raymond sought medical care when she developed a 
severe earache and began bleeding from the ear.  A CT scan revealed that her Vitek implants had 
shattered.  Id.  Raymond subsequently sued Harris, alleging that he failed to warn her that the 
implants were defective and that she suffered damages including a perforated eardrum and 
muffled hearing as a result.   
Harris moved for summary judgment contending that Raymond’s claims were barred by 
the statute of limitations provided in the Medical Malpractice Act.  Id.  Raymond responded that 
the two-year statute of limitations was unconstitutional.  The trial court denied Harris’s motion 
and the Court of Appeals affirmed.  Id.  On transfer, before addressing the statute of limitations 
question, this Court noted “two preliminary issues” that were not raised by the parties on appeal.  
Id. at 392.  One of those was the validity of Raymond’s claim that Harris had breached his duty 
to warn her of the safety issues related to Vitek.  This Court stated that “it is essential that the 
health care provider disclose material facts to the patient at appropriate times during the course 
of the patient’s treatment.”  Id. at 394.  This Court pointed out that the physician was best 
positioned to maintain patient records so that patients may be contacted if “significant new 
information” becomes available bearing on the safety of a treatment.  Id.  This Court concluded 
that, “as a matter of law, defendant had a duty to warn both current and former patients, 
including plaintiff, of safety issues highlighted by the manufacturer and/or the FDA, and that, 
based on the undisputed facts, defendant has breached that duty here.”  Id. at 395.  This Court 
went on to state that “at the very least” a safety alert “triggers the need to make reasonable 
efforts” to notify patients.  Id.  
                                             
 
1 The record does not reveal whether this is the same Dr. David Harris who at one time practiced with Dr. 
Paul. 
 
4
In this case, the parties, following Harris, agree that the plaintiffs’ claim requires duty, 
breach, injury, and proximate cause.  At this stage of the litigation the issue is solely whether 
breach is established by the agreed fact that Paul failed to communicate the dangers of Vitek 
implants until some five years after he was informed of the product’s recall.  Whether a 
defendant has a duty to conform conduct to a certain standard for the benefit of the plaintiff is 
generally a question of law.  Id. at 393.  The question of the breach of a duty is usually one for 
the trier of fact.  Id.  However, if any reasonable jury would conclude that a specific standard of 
care was or was not breached, the question of breach becomes a question of law for the court.  Id. 
at 394.  The Coxes argue that under Harris Paul had a duty to warn Suzan of the recall and 
breached that duty as a matter of law.  Paul agrees that he had a duty to make “reasonable 
efforts” to identify those patients who had received the Vitek implants, but contends that whether 
he made reasonable efforts is a fact for resolution by a jury. 
The Coxes argue that under Harris, breach is established as a matter of law by a showing 
that Paul did not notify Suzan.  In effect, this calls for strict liability for failure to notify Suzan.  
We agree that Paul had a duty to warn Suzan of the risks associated with her dental implants, but 
we do not think that the duty is absolute.  In Harris we stated that on that record Harris breached 
his duty to Raymond as a matter of law.  Id.  We also explained, “at the very least, a safety alert 
issued by the manufacturer or the FDA triggers the need to make reasonable efforts to contact all 
current and former patients with the implants.”  Id. at 395.  We adopt the latter formulation as the 
general rule, and expressly hold that the applicable standard is a requirement to exercise 
reasonable care to communicate to the patient but not necessarily to ensure that the patient 
received notification.   
Although Paul is not subject to strict liability for failure to notify, as Harris observed, the 
doctor is in the best position to know who received what treatment.  Id. at 395.  The doctor is 
also in the best position to establish the efforts to notify patients.  We think that in this case, an 
analysis similar to res ipsa loquitor should apply.  The plaintiff in a negligence action ordinarily 
bears the burden of proving the failure of the defendant to conform to a specified standard of 
conduct.  Restatement Torts (Second) § 328A (1965).  However, in some situations the plaintiff 
is able to raise an inference that the defendant was negligent from the facts known to the 
plaintiff, but proof of the specific negligent act or omission may be difficult or impossible.  “The 
 
5
general rule of res ipsa loquitor merely permits the trier of fact to infer negligence as the cause 
of harm without proof of specific acts of negligence when the facts fairly analyzed show that, 
more likely than not, (a) the plaintiff’s harm was caused by negligence, even though the specific 
act of negligence is not identified, and (b) the defendant was the author of the negligence.”  Dan 
B. Dobbs, The Law of Torts § 154, at 371 (2001).   
Here, the Coxes have raised an inference that Paul was negligent by showing that he did 
not notify Suzan until several years after he received the FDA notice.  Res ipsa loquitor, in some 
circumstances, merely permits the trier of fact to infer negligence.  In others, it may function “as 
a rule of policy which goes beyond the probative effect of circumstantial evidence, and requires 
the defendant to explain the event of circumstantial evidence or be liable.”  Restatement Torts 
(Second) § 328D, cmt. b.  If so, res ipsa loquitor may be “given a greater procedural effect” by 
shifting the burden of proof to the defendant or creating a presumption of negligence.  Id.
We think this reasoning is appropriate here.  A showing that no communication was 
received is sufficient to shift the burden to Paul to explain what steps he took to notify Suzan or 
why no steps were taken.  The Restatement points out that cases in which the defendant is 
required to explain an event frequently involve special responsibility of the defendant to the 
plaintiff.  Id.  This is the case here.  Paul undertook a special responsibility toward Suzan when 
she became his patient and he performed her surgery.  “The relationship between a health care 
provider, such as a physician or oral surgeon, and a patient is special and particularly important 
in that the patient relies heavily on the expertise of that health care provider in making decisions 
that may greatly impact the patient’s health and well-being.”  Harris, 715 N.E.2d at 394; see also 
Dobbs, supra at § 242, at 631 (“the duty of care owed by medical and other professionals is 
usually expressed and applied in a special way”).  Equally important, Paul, either directly or 
through one of his employees, was in exclusive control of the patient records.  He, therefore, is 
fairly charged with responsibility for explaining the steps he took to give notice and why they 
were reasonable under the circumstances.  If he shows reasonable steps, the trier of fact may find 
him not liable despite the failure of those steps to accomplish the goal of completing the 
communication to the patient. 
 
6
 
There are a number of explanations that might be found by the trier of fact to be 
sufficient to explain lack of notice.  For example, there may be no liability if it can be shown that 
some catastrophe has befallen the doctor’s office through no fault of the doctor, and the relevant 
files had been destroyed, rendering identification of all patients impossible.  Moreover, failure of 
receipt does not establish lack of reasonable steps to send notice.  But only the sender can 
maintain a record of the patients identified and the means of notification.  It is therefore 
appropriate to place the burden on the sender to show what was done to give notice if the claim 
is that reasonable steps were taken, even if notice was not received.   
The Coxes claim that Suzan was not given notice of the FDA warning until nearly five 
years after Paul received it.  Paul does not dispute that, but argues that he made reasonable 
efforts to contact her because he directed his staff to make two sweeps of his office and because 
he contacted her as soon as he discovered her file.  Of course, if the sweeps were negligently 
performed by Paul’s staff, his civil tort liability is the same as for his personal negligence.  See, 
e.g., Stropes v. Heritage House Childrens Center, Inc., 547 N.E.2d 244, 247 (Ind. 1989).  
Although he explains that Suzan’s file might have been moved or misplaced when Paul left his 
partnership with Harris and started his own office, he does not know whether this occurred, and 
if it did, he does not explain how it was not a result of negligence.2  There is no evidence of any 
attempt to notify Suzan in this record and no claim of an office fire or other intervening event 
that might have frustrated reasonable efforts to give notice.  Only speculation, not evidence, is 
offered to support any explanation for lack of notice, and that explanation even if it were 
supported by evidence is not free of the inference of negligence.  In short, the facts the Coxes 
have established leave room for no explanation other than negligence attributable to Paul or one 
of this employees or a non-negligent explanation as to which Paul has the burden of proof but 
failed to carry that burden.  This is enough for the Coxes to make their res ipsa loquitor case.  
The Coxes are therefore entitled to partial summary judgment as a matter of law. 
                                             
 
2 The Chief Justice addresses only the reasonable care in the design of the overall search of Dr. Paul’s 
records.  Reasonable care is also required in the recording of each individual patient’s records and in 
identifying those to whom notice is required.  In a products liability case, one can establish liability either 
by showing negligent design or negligent manufacture.  See Hoffman v. E.W. Bliss Co., 448 N.E.2d 277, 
281 (Ind. 1983).  Similarly, Paul or those in his employ may have designed a reasonable process to 
identify the affected patients.  But if that is the case there is no apparent explanation for failure of notice 
other than negligent execution of that design or failure to keep records of what the process was and how it 
was implemented. 
 
7
Conclusion 
 
The order of the trial court on the parties’ cross motions for partial summary judgment is 
vacated.  This case is remanded with instructions to grant the plaintiffs’ motion for partial 
summary judgment. 
Dickson, Sullivan, and Rucker, JJ., concur. 
Shepard, C.J., concurs and dissents with separate opinion. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8
 
 
SHEPARD, C.J., concurring and dissenting. 
 
 
I agree with the Court’s description of the physician’s duty to make reasonable efforts to 
notify patients of safety issues identified by manufacturers and the FDA. 
 
 
I think the Court’s disposition of the motion for summary judgment, however, places the 
law declared by this case much closer to strict liability than to reasonable efforts, 
notwithstanding the majority opinion’s disclaimer to the contrary. 
 
 
The evidence before us on summary judgment is that Dr. Paul initiated an examination of 
all his patient files after receiving the FDA notice.  This campaign involved the reading of every 
chart to identify which of his patients received Vitek implants.  The records were a veritable 
mountain, some 13,000 files in all.  It took several months to examine them all in search of the 
.8% that ultimately turned out to be Vitek patients who needed notification. 
 
 
The doctor directed his staff to do this search not once but twice, and they conducted 
another examination of files in 1994.  Indeed, it is apparent that they were still on the lookout 
even after that, as Mrs. Cox’s implant was ultimately identified in 1996. 
 
 
The majority opinion says nothing about the extent of the doctor’s efforts to identify and 
notify these patients.  This omission is appropriate, taken in light of the straightforward 
observation that any such effort that does not succeed in identifying every patient and generating 
a notice for every patient is likely the product of negligence that would constitute breach of duty 
as a matter of law.  (Slip op. at 7.)  Only a fire or other catastrophe is said to be a defense.  (Id.) 
 
 
By the time the Court travels to this point, claiming that the doctor has not offered “any 
explanation for lack of notice,” (id.), it has wandered off the legal standard we set seven years 
ago for such matters:  “a safety alert ‘triggers the need to make reasonable efforts.’”  (Slip op. at 
4, quoting Harris v. Raymond, 715 N.E.2d 388, 305 (Ind. 1998). 
 
 
9
 
If, under Harris v. Raymond, the legal question is whether the doctor made “reasonable 
efforts,” I would say that this record makes summary judgment for either party inappropriate.  I 
would direct the denial of both motions and have the case submitted to a jury. 
 
 
 
 
 
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