KEVIN KROHN V HOME-OWNERS INS CO
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STATE OF MICHIGAN
COURT OF APPEALS
KEVIN KROHN,
UNPUBLISHED
January 26, 2010
Plaintiff-Appellee,
v
HOME-OWNERS INSURANCE COMPANY,
No. 283862
Lenawee Circuit Court
LC No. 06-002176-NF
Defendant-Appellant.
Before: Fort Hood, P.J., and Cavanagh and K.F. Kelly, JJ.
FORT HOOD, J. (dissenting).
I would affirm the jury verdict, and therefore, I respectfully dissent.
On December 11, 2001, plaintiff was involved in a car accident during his drive to work.
His car was coming up on a hill when a one-ton van hauling medical supplies hit plaintiff’s
vehicle head on. Plaintiff suffered serious injuries. His right arm was nearly severed, his ribs
were punctured, a lung collapsed, and his spine was fractured at T-10 and T-11. This spinal
fracture was just below plaintiff’s midchest area. After the accident, plaintiff did not have any
kind of sensation or function below the injury site. He could not touch his feet or move any part
of his body below the injury. Plaintiff could not even determine when he needed to go to the
bathroom. Eventually, plaintiff was moved to an inpatient rehabilitation program at the
University of Michigan (U of M) to learn how to do transfers and other things necessary to
accommodate his injuries. During his physical therapy program at the U of M, plaintiff did not
obtain any improvement in his condition. Consequently, plaintiff was released to perform the
rehabilitation and physical therapy on his own.
After the accident, plaintiff began investigating whether there was any reasonable option
that would improve his situation for himself and his family. Through the rehabilitation program
at U of M, plaintiff learned of procedures performed in different parts of the world. Plaintiff
learned of a procedure in Lisbon, Portugal through a patient who had benefited from the
procedure. The patient referred him to the Rehabilitation Institute of Michigan (the institute), a
facility that offers intensive physical therapy and other medical rehabilitation to individuals with
spinal cord injuries. Although there were other stem cell procedures, plaintiff had an ethical
problem with the embryonic type of procedure. Therefore, he decided to pursue the stem cell
procedure in Portugal to determine if it would give him a benefit.
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In order to be considered as a candidate for the stem cell procedure, plaintiff had to
submit an application in order to obtain an interview at the institute. After his application, Dr.
Steven Hinderer interviewed plaintiff. At the institute, plaintiff was able to see the patient who
had the surgery in Portugal. She was able to stand on a device similar to a treadmill and walk
with braces. This experience at the institute caused plaintiff to pursue the surgery. Dr. Hinderer
advised plaintiff that the procedure was experimental. However, in plaintiff’s opinion, the doctor
explained both the pros and cons of the procedure in a positive way. Legally, Dr. Hinderer was
unable to recommend the surgery. Additionally, to comply with legal standards, the decision to
have the surgery remained with plaintiff. Although the Food and Drug Administration (FDA)1 in
the United States did not approve the procedure, plaintiff was not concerned about having a
procedure performed that was not yet accepted in the U.S. Plaintiff had relatives who worked in
the medical field that advised him of other procedures that were not yet performed in the U.S.
that were positive and beneficial to people.
With regard to insurance, plaintiff testified that he had health care insurance through Blue
Cross and Blue Shield (Blue Cross). As his primary health insurance, Blue Cross paid for his
medical bills first, and defendant provided secondary insurance. Benefits not covered by
plaintiff’s health insurance were submitted to defendant. Plaintiff contacted Raymond Mickus,
defendant’s representative, and explained the procedure that he wanted to have performed. After
conducting an investigation, Mickus advised that defendant would pay for the testing to
determine if plaintiff was a candidate for the surgery, but would not pay for the surgery itself.
Despite this knowledge, plaintiff decided to proceed to Portugal and have the surgery.
Immediately after the surgery, plaintiff noticed a difference in his body below the injury
site. He was able to push stool out on his own during a bowel movement. Previously, plaintiff
would have to use a glove to physically remove the stool. Also, plaintiff could now determine
when he needed to empty his bladder, something he was unable to do before the surgery.
Plaintiff’s inability to determine when he had to use the bathroom impacted his health. This
inability created problems such as leaking and also caused plaintiff to suffer from frequent
urinary tract infections. As a result of the surgery, leaking was limited, and plaintiff suffered
from fewer infections.
Plaintiff’s commitment to the surgery required him to engage in an intensive physical
therapy program at the institute in Detroit. He traveled to the institute three days a week for a
“grueling” physical therapy session that would last over four hours. This therapy involved
repetitive motion, floor contact, and crawling. Before the surgery, plaintiff was unable to crawl.
Now, he was able to crawl both forward and backwards. Before the surgery, plaintiff was unable
to move any of the lower extremities. Now, there were times when plaintiff was able to
voluntarily move his lower extremities. Plaintiff testified that the benefits of the surgery
included control over his bladder and bowel movements, increased hip function and control over
his hips that aided his transfers, and increased circulation and blood flow to the lower extremities
1
An expert or representative from the FDA did not testify that this agency did or would in fact
monitor and approve of this surgery.
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and his heart that also helped him maintain his weight. Plaintiff testified that the surgery was
worth it, and he owed it to himself and his family to do what was reasonable to improve his
situation. He rejected the suggestion that he was desperate and willing to do anything to improve
his situation. Rather, he testified that he performed the research and would not have any
procedure that posed a danger in any way. The lack of FDA approval did not concern him. In
light of his research and discussions with other patients, plaintiff knew that the surgery was not a
scam. Furthermore, the surgery had met European guidelines. Therefore, plaintiff requested that
defendant reimburse him for the amount of money that he paid out of pocket to have the surgery
performed and the travel expenses.
Dr. Carlos Lima, a neurologist and neuropathologist at a public hospital in Lisbon,
Portugal, was part of the team that performed the procedure on plaintiff.2 He testified that the
tissue located in the area between the upper nose and the outside of the brain was unusual
because it was one of the few parts of the body that continued to grow in a mature individual.
This tissue formed new neurons. Consequently, when transplanted into the part of the central
nervous system where connection was lost because of a lesion, the tissue would perform as it did
in the nasal area by forming new neurons and new connections.
Initially, Dr. Lima studied every pathology, but he began to focus on paralyzing injuries.
When he started his research and the clinical trials, there existed experimental data that the nasal
tissue, when transplanted to the spinal cord injury, will provide functional recovery of neurons.
The tissue located in the olfactory stem consisted of several cells, not just stem cells but other
ensheathing cells. The first studies began eighteen years earlier on guinea pigs. Stem cells had
great potential because they could be used, not just in the central nervous system, but in other
locations of the body and take on characteristics of the environment in which they were placed.
Because of the use of an adult’s own stem cells, ethical or technical issues were avoided.
In order to provide this treatment to people with spinal cord injuries, Dr. Lima had to
obtain the approval of the public hospital where he worked. The government operated the
hospital. Consequently, he had to apply to the hospital administration, which included the
clinical director and the ethical committee. Although Portugal did not have “the FDA”, there
was an equivalent FDA institute in Europe with rules regarding cells and cell application on
humans. He acknowledged that the European FDA was not in existence at the time he started the
study in 2001. However, at the beginning of the study, he followed the principles for clinical
trials on humans as set forth in the Helsinki Declaration, worldwide universally accepted
guidelines. Dr. Lima obtained approval from the hospital and the government to perform the
surgical procedures. He started treatment on humans in 2001, and the procedure continued to
this day.
To be a candidate for the surgery, a patient had to fall within a particular set of criteria.
The patient had to have a chronic spinal cord injury. That is, the person had to have been injured
at least six months earlier and stabilized, and there was no anticipation that with rehabilitation
2
Dr. Lima was deposed at the institute in Michigan. He was at the institute because he worked
with patients and colleagues there to study spinal cord injuries.
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that the patient would experience new signs of recovery. Secondly, the patient had to be less
than 40 years of age. This age restriction was imposed because, as humans age, they lose stem
cells from the nose. Lastly, the patient had to be completely immobile; there was no movement
below the site of the injury. Both the U.S. and Portugal adopted the “ASIA” Scale for
determining the severity of a spinal cord injury. To qualify for the surgery, the patient had to
suffer from a severe injury, a level A or B on the ASIA Scale. Before traveling, the patient had
to have medical tests on the spinal cord and nose. Between 2001 and the time of deposition, the
surgery had been performed on 110 patients from all over the world.
After the surgery, the patient had to commit to physical therapy as part of the
rehabilitation process. Physical therapy was important because the nervous system was
permanently damaged, and the brain no longer recognized the damaged area of the body. For the
surgery to be successful, the spinal cord connection to the brain had to be rewired so the body
would learn to reuse what was damaged. Rehabilitation was essential to reverse the
nonrecognition between the brain and the spinal cord as a result of the injury. Therefore, a
rehabilitation known as “gait training” was utilized. Patients who had the surgery reported
improvements in sensation below the injury site and were able to obtain greater improvements in
bladder and bowel control. Patients who were continuing rehabilitation three to five years after
the surgery continued to see improvements. However, patients who had undergone the surgery
had not regained the ability to walk without the use of a walker. At that time, the results of the
clinical study had not been published.
Plaintiff had the surgery on November 10, 2005. It was one of the most severe injuries
that Dr. Lima had ever treated. Because of the degree of injury, the team not only had to remove
the scar tissue in the spinal cord area, but also had to rebuild the normal anatomical structure of
the area. After the surgery, Dr. Lima was advised of plaintiff’s improvements and learned that
he had improved from an ASIA level of A to a C. Dr. Lima was very happy with these results in
light of the degree of the injury and the short period of time in which the improvements had
occurred. The doctor acknowledged that, at this point, there was no complete recovery from
such a severe lesion. That is, no patient had ever returned to pre-injury functioning levels.
However, at this point in time, the surgery was necessary for plaintiff to have any chance of
recovery. Additionally, rehabilitation was crucial to the recovery. If plaintiff underwent
rehabilitation or physical therapy without the surgical procedure, there would be no recovery.
Dr. Lima was currently working on pilot studies in other countries.
Dr. Lima acknowledged that the surgery was experimental, but he nonetheless opined
that it was reasonably necessary because there was no other option available for a person with a
chronic spinal cord injury. The lack of approval from the FDA did not change Dr. Lima’s
opinion. An autograft, or transfer of a person’s own cells to another part of the body, was
analogous to a burn patient who had skin transferred from a thigh to replace burned skin on the
arm. The olfactory tissue was an extension of the brain and could be considered tissue of the
nervous system.
On cross-examination, Dr. Lima acknowledged that he was not licensed to practice
medicine in the U.S. He also acknowledged that he did not perform the surgery himself, but was
part of the team that coordinated the project. The government of Portugal paid for the program
for its citizens. Dr. Lima acknowledged that, to obtain FDA approval, the project had to present
controlled studies of the effectiveness and risks of the surgery with peer review. At this point,
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U.S. doctors had not applied for such approval. He also acknowledged that there was no
controlled study distinguishing between the effectiveness of the surgery as opposed to intensive
physical therapy. He noted that patients would obtain benefits from intensive physical therapy,
and that the surgery would not return a patient to fully functioning or pre-injury condition. The
doctor disputed defense counsel’s characterization regarding government approval. Dr. Lima
testified that the hospital was a government institute and the administration of the hospital had to
approve the surgery. Therefore, governmental approval was obtained.
The jury concluded that the surgery was reasonable and necessary. Defendant appeals
this determination.
I. Evidentiary Issue
As an initial matter, I note the majority sua sponte raises the issue of the admissibility of
Dr. Lima’s testimony and concludes that it was improperly admitted pursuant to MRE 702.
Review of the lower court record reveals that this issue is not preserved for appellate review
because it was not raised, addressed, and decided in the trial court. Miller v Inglis, 223 Mich
App 159, 168; 567 NW2d 253 (1997). Counsel for defendant did not file a motion in the trial
court challenging the qualifications and scientific data underlying Dr. Lima’s factual conclusions
and testimony. This Court, as an error correcting court, should not address unpreserved issues,
Burns v Detroit (On Remand), 253 Mich App 608, 615; 660 NW2d 85 (2002), and defendant did
not brief the issue of the admissibility of Dr. Lima’s testimony or the scientific reliability.
Consequently, the trial court was never asked to act as the gatekeeper with regard to admission
and did not conduct an evidentiary hearing to determine the scientific reliability underlying this
testimony. See Gilbert v DaimlerChrylser Corp, 470 Mich 749, 780; 685 NW2d 391 (2004).
Thus, plaintiff was never given the opportunity at a Daubert hearing3 to demonstrate that the
testimony met the reliability standards of Michigan evidentiary law. When reviewing an
evidentiary issue, the proper role of the trial court is:
to filter out expert evidence that is unreliable, not to admit only evidence that is
unassailable. The inquiry is not into whether an expert’s opinion is necessarily
correct or universally accepted. The inquiry is into whether the opinion is
rationally derived from a sound foundation. [People v Unger, 278 Mich App 210,
217; 749 NW2d 272 (2008), quoting Chapin v A & L Parts, Inc, 274 Mich App
122, 139; 732 NW2d 578 (2007) (opinion by Davis, J.).]
Scientific testimony need not be based on certainties. Nelson v American Sterilizer Co (On
Remand), 223 Mich App 485, 491-492; 566 NW2d 671 (1997). Rather, “[a]s long as the basic
methodology and principles employed by an expert to reach a conclusion are sound and create a
trustworthy foundation for the conclusion reached, the expert testimony is admissible no matter
how novel.” Id. at 492. Inferences or assertions in proposed testimony is acceptable provided
the source rests in the application of scientific methods. Id. at 491.
3
Daubert v Merrell Dow Pharmaceuticals, Inc, 509 US 579; 113 S Ct 2786; 125 L Ed 2d 469
(1993).
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Although Dr. Lima had treated 110 patients, he did not testify in detail regarding each
patient, the location of the lesion, the ASIA level of severity, the outcome following the
procedure, and the prognosis. The doctor was never asked to provide a summation of the
underlying applicable science, which had a foundation in treatment in animals, and was never
asked to provide a summation of the scientific data regarding the 110 patients. If defense
counsel had challenged the admission of Dr. Lima’s opinion, the trial court would have had the
opportunity to conduct a Daubert hearing to review the science. Despite the fact that an
evidentiary hearing was not held, this Court conducts its own analysis based on the limited
record. A reversal on the basis of an unpreserved issue when a request for an evidentiary hearing
was not made to the trial court is inappropriate. Burns, supra. I would not sua sponte reverse a
jury verdict premised on an unpreserved issue that was not briefed or raised as an error by the
appellant.
II. Preserved Issues on Appeal
Defendant contends that the trial court erred in denying its motion for summary
disposition because the experimental surgery was not reasonably necessary and it was not
lawfully rendered. A trial court’s ruling regarding a motion for a directed verdict is reviewed de
novo. Elezovic v Ford Motor Co, 472 Mich 408, 418; 697 NW2d 851 (2005). When reviewing
the trial court’s decision, the evidence and all legitimate inferences are examined in the light
most favorable to the nonmoving party. Id. The appellate court reviews the evidence presented
up to the time of the motion and resolves any conflict in the evidence in favor of the nonmoving
party to determine if a question of fact is presented. Thomas v McGinnis, 239 Mich App 636,
643-644; 609 NW2d 222 (2000). “A directed verdict is appropriately granted only when no
factual questions exist on which reasonable jurors could differ.” Cacevic v Simplimatic
Engineering Co (On Remand), 248 Mich App 670, 679-680; 645 NW2d 287 (2001).
Application of disputed facts to the law present proper questions for the jury or trier of fact.
White v Taylor Distributing Co, 482 Mich 136, 143; 753 NW2d 591 (2008).
Questions involving statutory interpretation present questions of law subject to de novo
review. Hunter v Hunter, 484 Mich 247, 257; 771 NW2d 694 (2009). The language of the
statute expresses the legislative intent. Dep’t of Transportation v Tomkins, 481 Mich 184, 191;
749 NW2d 716 (2008). The rules of statutory construction provide that a clear and unambiguous
statute is not subject to judicial construction or interpretation. Id. When a statute plainly and
unambiguously expresses the legislative intent, the role of the court is limited to applying the
terms of the statute to the circumstances in a particular case. Id. The fair and natural import of
the terms employed in light of the subject matter of the law governs. In re Wirsing, 456 Mich
467, 474; 573 NW2d 51 (1998). The no-fault act is “remedial in nature and must be liberally
construed in favor of the persons intended to benefit from it.” Turner v Auto Club Ins Ass’n, 448
Mich 22, 28; 528 NW2d 681 (1995).
MCL 500.3107(1)(a) addresses personal protection insurance benefits and allowable
expenses and provides:
(1) Except as provided in subsection (2), personal protection insurance benefits
are payable for the following: (a) Allowable expenses consisting of all reasonable
charges incurred for reasonably necessary products, services and accommodations
for an injured person’s care, recovery, or rehabilitation. Allowable expenses
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within personal protection insurance coverage shall not include charges for a
hospital room in excess of a reasonable and customary charge for semiprivate
accommodations except if the injured person requires special or intensive care, or
for funeral and burial expenses in the amount set forth in the policy which shall
not be less than $1.750.00 or more than $5,000.00.
MCL 500.3157 addresses treatment and rehabilitative training and provides:
A physician, hospital, clinic or other person or institution lawfully rendering
treatment to an injured person for an accidental bodily injury covered by personal
protection insurance, and a person or institution providing rehabilitative
occupational training following the injury, may charge a reasonable amount for
the products, services and accommodations rendered. The charge shall not
exceed the amount the person or institution customarily charges for like products,
services and accommodations in cases not involving insurance.
First, defendant contends that the experimental surgery was not reasonably necessary.
However, “entitlement to no-fault benefits is dependent on the facts and circumstances of each
case.” Begin v Mich Bell Telephone Co, 284 Mich App 581, 590; 773 NW2d 271 (2009). The
plain and unambiguous language of MCL 500.3107 makes “both reasonableness and necessity
explicit and necessary elements of a claimant’s recovery[.]” Nasser v Auto Club Ins Ass’n, 435
Mich 33, 49; 457 NW2d 637 (1990). The claimant bears the burden of proof of demonstrating
both reasonableness and necessity. Id. “Where a plaintiff is unable to show that a particular,
reasonable expense has been incurred for a reasonably necessary product and service, there can
be no finding of a breach of the insurer’s duty to pay that expense, and thus no finding of liability
with regard to that expense.” Id. at 50.
The issue of whether personal injury protection expenses are reasonable and necessary
generally presents a question of fact for the jury. Begin, supra at 597; Rose v State Farm Mut
Auto Ins Co, 274 Mich App 291, 296; 732 NW2d 160 (2007). Although the issue of reasonable
and necessary generally presents a question of fact, it is possible for the court to decide the issue
as a matter of law. Nasser, supra at 55. “Thus, if it could be ‘said with certainty’ that an
expense was both reasonable and necessary, the court could make the decision as a matter of
law.” Id. However, when the trial court makes the threshold determination as a matter of law,
the evidence must be viewed in the light most favorable to the nonmoving party. Id.
In Griffith v State Farm Mut Auto Ins Co, 472 Mich 521, 534-535; 697 NW2d 895
(2005), the Supreme Court addressed the statutory use of the terms “care,” “recovery,” and
“rehabilitation” to determine that food costs were not an appropriate expense for purposes of
MCL 500.3107. With regard to defining the terms “recovery” and “rehabilitation,” the Court
stated:
As an initial matter, it is important to note that the statute does not require
compensation for any item that is reasonably necessary to a person’s care in
general. Instead, the statute specifically limits compensation to charges for
products or services that are reasonably necessary “for an injured person’s care,
recovery, or rehabilitation.” (Emphasis added.) This context suggests that “care”
must be related to the insured’s injuries.
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This conclusion is supported by the fact that the statute lists “care”
together with “recovery” and “rehabilitation.” “Recovery” is defined as
“restoration or return to any former and better condition, esp. to health from
sickness, injury, addiction, etc.” Random House Webster’s College Dictionary
(2001). “Rehabilitate” is defined as “to restore or bring to a condition of good
health, ability to work, or productive activity.” Id. Both terms refer to restoring
an injured person to the condition he was in before sustaining his injuries.
Consequently, expenses for “recovery” or “rehabilitation” are costs expended in
order to bring an insured to a condition of health or ability sufficient to resume his
preinjury life. [Griffith, supra at 534-535.]
Review of the record reveals that plaintiff presented sufficient facts and circumstances to
present the issue of reasonableness and necessity to the jury. Begin, supra; Nasser, supra.
Because the issue could be not decided as a matter of law “with certainty,” the jury verdict must
be affirmed.
Plaintiff testified that a serious car accident left him paralyzed from his midchest. He had
no sensation or feeling below the location of the injury site. Consequently, plaintiff researched
his options to improve his standard of living. He learned of a fellow patient at the institute that
had the transfer of olfactory cells procedure at issue and saw that the patient could walk on a
treadmill type device, albeit with braces. In his physical state as a result of the accident, plaintiff
was limited in his mobility and could not even meet basic bathroom needs, causing him to
experience leakage and bladder infections. The no-fault act provides for allowable expenses for
reasonable charges incurred “for reasonably necessary products, services and accommodations
for an injured person’s care, recovery, or rehabilitation.” MCL 500.3107(1)(a). As set forth in
Griffith, supra, “recovery” is defined as “return to any former and better condition.” The
surgical procedure in Portugal provided plaintiff, as a paralyzed individual, with the only option
to “return to any former and better condition.” The accident in 2001 left plaintiff in a chronic
state with continued physical therapy as his only progressive option. However, plaintiff did not
experience any additional benefit from physical therapy and was merely continuing therapy at
home on his own. Dr. Lima testified that because of the severe state of plaintiff’s injury, plaintiff
had no other option for recovery.4 Indeed, plaintiff was in his late 30s at the time of the
procedure and waiting for a consensus regarding approval5 would eliminate this surgical
4
The contention that there was no evidence regarding reasonableness and necessary is without
merit. Dr. Lima was questioned about this issue and testified, “I mean, there’s no – there’s no
possibility for [plaintiff] to have any recovery with such a lesion … which is not just functionally
complete, but it was anatomically very destructive and complete also.” Additionally, Dr. Lima
testified that, without the surgery, plaintiff had no chance of recovery, stating, “No, [plaintiff] is
a patient with almost four years with lesion before, and he was completely stabilized and without
no further improvements.” Dr. Lima further opined that the nature of the surgery, as
experimental, did not alter his opinion regarding reasonable and necessary “because there’s
almost nothing in the world to help a patient with a spinal cord injury chronic before. There’s
nothing.”
5
As will be set forth later in this opinion, there was no evidence admitted by an individual with
(continued…)
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procedure as a treatment option because the change of the status of the nasal cells in adults over
the age of 40. In light of the above, the trial court properly submitted this issue to the jury for
resolution.
Defendant next alleges that the surgery is not a covered benefit because it was not
lawfully rendered. As previously stated, MCL 500.3157 provides in relevant part:
A physician, hospital, clinic or other person or institution lawfully rendering
treatment to an injured person for an accidental bodily injury covered by personal
protection insurance, and a person or institution providing rehabilitative
occupational training following the injury, may charge a reasonable amount for
the products, services and accommodations rendered. [Emphasis added.]
Defendant submits that the surgical procedure was not lawfully rendered because it was not
performed in the U.S., and it did not have FDA approval. However, the plain language of the
statute places no qualification regarding the location of treatment or that FDA approval is
required. Rather, the plain language of the statute provides that the treating physician or hospital
must lawfully render treatment. The surgery occurred in a public hospital owned by the
government in Lisbon, Portugal, by a team of medical professionals. The government of
Portugal funded the hospital program for “Portuguese patients.” Dr. Lima did not have any other
type of funding or grant money from other entities or other foreign governments; rather, the
Portuguese government funded his program for its citizens.6 Dr. Lima’s employment at a public
hospital operated by the government meant that he had to obtain approval to take the procedure
tested on animals and apply it to humans. Consequently, he had to apply to hospital
administration that included the clinical direction committee and the ethical committee. With
regard to standards and practices, Dr. Lima testified that, at the start of the project, there was no
FDA equivalent in Europe. Consequently, his program initially followed the Helsinki
Declaration on clinical trials for humans and later followed the European equivalent of the FDA
that was created.
Based on the testimony of Dr. Lima, there was sufficient evidence to conclude that the
surgical procedure at issue was lawfully rendered. Dr. Lima’s program was funded by the
government and was subject to oversight by the clinical direction and ethical committees. The
program followed the Helsinki Declaration for clinical trials on humans and later followed the
European equivalent that created rules regarding cells and cell application on humans during this
ongoing program. As previously stated, there is no statutory limitation regarding the location of
the service or the type of approval that is required.
Defendant urges this Court to adopt a standard that requires FDA approval.7 However, to
impose such a standard would require the inclusion of additional language not contained in the
(…continued)
personal knowledge that FDA approval is the standard.
6
Visitors to the country were responsible for the costs of the procedure.
7
Defendant questioned Dr. Hinderer extensively regarding FDA approval and the submission of
documentation and peer review. However, the value of FDA approval is questionable. In late
June 2009, the FDA held a joint meeting between three of its advisory committees to address
(continued…)
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statute as written. That is, the statute would have to be rewritten to provide for coverage for
treatment “lawfully rendered in the U.S. and approved by the FDA.”8 It is also important to note
that the propriety of “FDA approval” was raised in questioning of Dr. Lima and Dr. Hinderer.
However, Dr. Hinderer is the medical director at the Center for Spinal Cord Injury Recovery. He
did not perform plaintiff’s surgery. Additionally, although he described a four-stage process for
obtaining FDA approval, it is unclear if he had the requisite expertise or underlying foundational
knowledge to render such an opinion. Defendant urges this Court to adopt an FDA approval
standard, but did not offer testimony from a representative of the FDA to attest that the agency
monitors stem cell procedures or approves surgical procedures that do not involve the
implantation of a medical device.9 However, review of the function of the FDA reveals that it is
(…continued)
acetaminophen, a commonly used over the counter drug marketed under the brand name Tylenol
and contained in other products. In the late 1990s, research began to demonstrate that acute liver
failure was occurring as a result of accidental overdose of acetaminophen. Consequently, in
1998, the FDA finalized a regulation regarding acetaminophen products to contain a warning
regarding product use and consumption of alcoholic beverages. In 2002, the FDA convened an
advisory committee that recommended a specific liver toxicity warning and distinctive labeling
on over the counter packages. In 2004, the FDA launched a public education campaign to help
consumers use acetaminophen more safely. In 2004, the FDA sent communication to every state
board of pharmacy asking them to “consider” labeling on prescription acetaminophen products.
However, as of February 2008, no state had implemented the requested regulation. In 2006, the
FDA proposed regulations for over the counter labeling of acetaminophen to include new safety
information. The final version was still under review as of June 2009. Finally, in 2007, the
FDA’s Center for Drug Evaluation and Research (CDER) convened a multidisciplinary working
group to continue to evaluate acetaminophen related liver injuries. The report of the working
group
was
to
be
addressed
at
the
June
2009
meetings.
See
www.fda/gov/AdvisoryCommittees/Calendar/ucm143083.htm (accessed December 16, 2009).
Curiously, this report contains no statement regarding the number of accidental liver overdoses
or liver injuries in the eleven-year period since this problem was first recognized and does not
propose a definitive resolution for the problem. Therefore, I would not elevate FDA approval as
the measure of whether a procedure is “lawfully rendered” in the absence of an express statutory
requirement.
8
Defendant also argues the role of policy and costs. However, I conclude that the issues raised
in this case are appropriately resolved by examining the plain language of the statute. Moreover,
defendant’s argument regarding policy is one-sided. Although it is argued that FDA studies and
peer review is necessary, defendant fails to recognize that research regarding stem cells has been
limited by regulations and political viewpoints. Patients in need of need of new technology and
therapies relying on stem cell research have been hampered by limitations that have been placed
on scientists. Recently, human stem cell policy in the U.S. was altered. See Exec. Order No.
13505, 74 Fed. Reg. 46 (March 9, 2009) (“Removing Barriers to Responsible Scientific Research
Involving Human Stem Cells”). However, the change in policy is of little benefit to individuals
such as plaintiff who had a limited time period in which an autograft stem cell procedure is
available because of the age of the stem cells. Perhaps that is why the statute at issue only
requires that the treatment be “lawfully rendered” and contains no regulation regarding the
location of the procedure or the type of approval necessary to have the procedure.
9
The National Institutes of Health (NIH) is a division of the United States Department of Health
and Human Services. Its mission is to uncover new knowledge to improve health. The NIH
plans to achieve its mission by “conducting research in its own laboratories; supporting the
(continued…)
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the federal agency “responsible for ensuring that foods are safe, wholesome and sanitary; human
and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics
are safe; and electronic products that emit radiation are safe.”10 The surgery at issue as described
by Dr. Lima did not involve the implantation of a medical device, but rather, involved the
surgery movement of plaintiff’s stem cells from one location of his body to another. Whether
FDA approval is the standard for this type of procedure was presumed in the record, and
defendant did not present any representative of the FDA to testify regarding the agency’s
supervision of “experimental” surgeries. Consequently, irrespective of the language of the
statute, I would not impose an FDA approval requirement when defendant failed to present
evidence by individuals with personal knowledge of the FDA standards and the federal agency
(…continued)
research of non-Federal scientists in universities, medical schools, hospitals, and research
institutions throughout the country and abroad; helping in the training of research investigators;
and
fostering
communication
of
biomedical
information.
See
http://directory.psc.gov/nih/12.html (accessed December 22, 2009) (emphasis added). A portion
of the NIH is devoted to registering clinical trials in the U.S. and around the world including the
trial’s purpose, participants, and location. See http://clinicaltrials.gov/ (accessed January 6,
2010). Therefore, because the parties did not submit evidence from the FDA, I would not
conclude that FDA approval is the standard for acceptance of this or any other surgical procedure
unless it involves the implantation of a medical device. In this case, Dr. Lima testified regarding
the surgery and never testified that a medical device was implanted in plaintiff. Dr. Hinderer, as
the director of rehabilitation, was not questioned regarding his interaction with the FDA, his
personal knowledge of the surgery at issue and whether it involved implantation of a medical
device, and whether he had ever applied to the FDA for approval of a surgical procedure.
Without an examination of the foundation of an expert’s opinion, the trier of facts’ evaluation of
the value of the opinion is necessarily circumscribed and the reliability of the ultimate
determination correspondingly compromised. People v Dobben, 440 Mich 679, 697; 488 NW2d
726 (1992). Therefore, I would not sua sponte impose an FDA standard where the appropriate
foundation for such a conclusion was not provided in the lower court record. The majority sua
sponte questions the foundations underlying the opinion of Dr. Lima, but does not question the
foundation provided by Dr. Hinderer and his knowledge of FDA approval.
10
See http://www.fda.gov/AboutFDA/WhatWeDo/WhatFDARegulates/default.htm (accessed
December 22, 2009).
-11-
charged with categorizing surgeries as experimental or standard.
presented to the trial court, I would affirm the jury verdict.11
Therefore, on the record
/s/ Karen M. Fort Hood
11
I note that defendant asserts that an approval of insurance coverage for experimental surgeries
will be cost prohibitive and lead to a flood of claims. The record does not support such a broad
conclusion. The standard for determining the propriety of a claim for coverage is based on what
is reasonable and necessary under the facts and circumstances of each individual case. Any
affirmation of the jury verdict in this case does not lead to the conclusion that experimental
surgeries are subject to payment upon request. Under the facts and circumstances of this case,
there was sufficient evidence to submit the issue to the jury. That is the conclusion reached in
this dissent. Furthermore, under a cost benefit analysis, defendant did not present proofs
regarding the cost savings it will attain when a paralyzed individual suffering from mobility
related issues obtains the ability to monitor their own hygiene levels. Also with regard to the
assertion of costs, plaintiff’s surgery performed by a team of doctors, his weeklong hospital stay,
and his transportation for three individuals was approximately $51,000. There was no record
evidence of the cost of the equivalent procedure if approved and performed in the U.S. In the
absence of record evidence, it cannot be concluded the affirmation of this verdict will lead to
defendant’s fear of a flood of burdensome claims. Finally, the contention that success of the
procedure is not an issue in this case is correct. Rather, this case hinges on the construction of
the reasonableness and necessity of the procedure in relationship to the specific facts and
circumstances of this case. White, supra.
-12-
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