Case Name: KROHN v. HOME-OWNERS INSURANCE COMPANY
Court: Michigan Supreme Court
Jurisdiction: Michigan
Decision Date: 2011-07-29
Citations: 490 Mich. 145
Docket Number: Docket No. 140945
Parties: KROHN v HOME-OWNERS INSURANCE COMPANY
Judges: Young, C.J., and Markman and Mary Beth Kelly, JJ., concurred with ZAHRA, J.
Reporter: Michigan Reports
Volume: 490
Pages: 145–197

Head Matter:
KROHN v HOME-OWNERS INSURANCE COMPANY
Docket No. 140945.
Argued April 5, 2011
(Calendar No. 5).
Decided July 29, 2011.
Kevin Krohn brought an action in the Lenawee Circuit Court under the no-fault act, MCL 500.3101 et seq., seeking personal protection insurance benefits from his no-fault insurer, Home-Owners Insurance Company, for the costs of an experimental surgical procedure he underwent in Portugal after a motorcycle accident left him paraplegic. The procedure involved removing tissue containing stem cells from his sinus cavities and transplanting it into the injured area of his spine. Defendant moved for a directed verdict on the ground that the procedure was not reasonably necessary for plaintiffs care, recovery, or rehabilitation under MCL 500.3107(l)(a). The court, Timothy P Pickard, J., denied the motion, ruling that whether the procedure was reasonably necessary was a question of fact. A jury rendered a verdict in favor of plaintiff, and defendant appealed. The Court of Appeals, Cavanagh and K. F. Kelly, JJ. (Fort Hood, PJ., dissenting), reversed in an unpublished opinion per curiam issued January 26, 2010 (Docket No. 283862), holding that plaintiffs failure to present expert testimony demonstrating that the procedure had gained general acceptance in the medical community required a directed verdict for defendant. The Supreme Court granted plaintiffs application for leave to appeal. 488 Mich 876 (2010).
In an opinion by Justice Zahra, joined by Chief Justice Young and Justices Markman and Mary Beth Kelly, the Supreme Court held:
A plaintiff seeking reimbursement from a no-fault insurance carrier for a medical treatment that is experimental and not generally accepted within the medical community must present objective and verifiable medical evidence that the treatment is efficacious in his or her care, recovery, or rehabilitation.
1. MCL 500.3107(l)(a) provides that personal protection insurance benefits are payable for all reasonable charges incurred for reasonably necessary products, services, and accommodations for an injured person’s care, recovery, or rehabilitation. The statute does not define the term “reasonably”; however, dictionary definí tions of the word “reasonable” reflect the absence of personal sentiment, prejudice, and bias that are associated with a subjective point of view, which is one based on an individual’s perceptions, feelings, or intentions rather than the externally verifiable phenomena associated with an objective viewpoint. Accordingly, what is reasonably necessary for purposes of MCL 500.3107(l)(a) must be determined under an objective perspective. The fact that the voters by referendum rejected 1993 PA 143, one provision of which excluded experimental treatment from no-fault coverage, was irrelevant to interpreting the existing statute.
2. An insured who is seeking reimbursement for an experimental surgical procedure must present evidence that the surgery is efficacious, that is, that it may result in care, recovery or rehabilitation. Because this determination involves the exercise of medical judgment, efficacy must be based on objective and verifiable medical evidence that is established through expert testimony. However, MCL 500.3107 does not require an insured to prove that an experimental surgical procedure has gained general acceptance in the medical community before a trier of fact may consider whether it was reasonably necessary. If there is objective and verifiable evidence that an experimental surgical procedure is efficacious, the fact-finder can determine whether the procedure was reasonably necessary by considering relevant factors, such as the severity and chronicity of the condition, the outcome of any previous treatment, the likelihood that alternative treatments would be efficacious, a personal physician’s recommendation in conjunction with the patient’s preference, and the short-term and long-term risks and benefits. Under MRE 702, the trial court must ensure that any expert testimony or scientific evidence is reliable. Specifically, the trial court must ensure that expert testimony is based on sufficient facts or data, is the product of reliable principles and methods, and that the witness applied the principles and methods reliably to the facts of the case.
3. Plaintiff failed to present evidence to establish that the experimental surgical procedure at issue presented him with an objectively verifiable chance that it would be efficacious in his care, recovery, or rehabilitation. In particular, one of plaintiff’s expert witnesses did not endorse, recommend, or prescribe the procedure for plaintiff, testified that it was not regarded as necessary, and admitted that the outcome was uncertain because the procedure was new and experimental. The other expert failed to present medical evidence to support his theory of the procedure’s benefit to plaintiff. Therefore, the procedure was not an allowable expense under MCL 500.3107(l)(a), and defendant was entitled to judgment as a matter of law.
Affirmed.
Justice Hathaway, joined by Justice Cavanagh (except for footnote 20) and by Justice Marilyn Kelly, dissenting, would have upheld the jury’s finding that the procedure performed on plaintiff was reasonably necessary and would have held that plaintiff is entitled to reimbursement of the costs associated with the procedure. She stated that by requiring objective and verifiable medical evidence of efficacy, the majority’s holding added language to the no-fault act that the voters rejected by referendum and that the majority’s holding erroneously removed the determination of which expenses are reasonably necessary from the jury and created a more stringent standard for proving that a treatment is reasonably necessary than MCL 500.3107(l)(a) requires.
Insurance — No-Fault — Personal Protection Insurance Benefits — Experimental Treatments — Evidence.
A plaintiff seeking reimbursement from a no-fault insurance carrier for a medical treatment that is experimental and not generally accepted within the medical community must present objective and verifiable medical evidence through expert testimony that the treatment is efficacious in his or her care, recovery, or rehabilitation; if the plaintiff has provided this evidence and the trial court has ensured that it is reliable, the finder of fact may determine whether the treatment was reasonably necessary by considering such factors as the severity and chronicity of the condition, the outcome of any previous treatment, the likelihood that alternative treatments would be efficacious, a personal physician’s recommendation in conjunction with the patient’s preference, and the short-term and long-term risks and benefits of the treatment (MCL 500.3107[1]; MRE 702).
Logeman, Iafrate & Pollard, P.C. (by Craig J. Pollard), for plaintiff.
Conlin, McKenney & Philbrick, P.C. (by Allen J. Philbrick), for defendant.
Amici Curiae:
Dykema Gossett PLLC (by Jill M. Wheaton and Joseph Erhardt) for the Michigan Catastrophic Claims Association.
Speaker Law Firm, PLLC (by Liisa R. Speaker), and Sinas Dramis Brake Boughton & McIntyre PC (by George T. Sinas) for the Coalition Protecting Auto No-Fault.
Clark Hill PLC (by James E. Brenner) for the Michigan Defense Trial Counsel.

Opinion:
ZAHRA, J.
Plaintiff, Kevin Krohn, who suffered an extremely severe spinal fracture that left him paraplegic, brought this suit under the no-fault act, MCL 500.3101 et seq. Plaintiff sought personal protection insurance benefits from defendant, Home-Owners Insurance Company, to cover costs incurred for a surgical procedure performed in Portugal. It is undisputed that this surgical procedure was experimental and not a generally accepted treatment for plaintiffs injury. The dispositive question presented in this case is whether this experimental procedure was a reasonably necessary service for plaintiffs care, recovery, or rehabilitation under MCL 500.3107(1)(a). We conclude that if a medical treatment is experimental and not generally accepted within the medical community, an insured seeking reimbursement for this treatment must, at a minimum, present objective and verifiable medical evidence establishing that the treatment is efficacious. A treatment or procedure that has not been shown to be efficacious cannot be reasonable or necessary under the no-fault act. An insured's subjective belief that medical treatment is efficacious, reasonable, and necessary is not enough to create a question of fact. Viewed in the light most favorable to plaintiff, the objective and verifiable medical evidence presented at trial failed to establish that the experimental surgical procedure at issue was in any way efficacious in plaintiffs care, recovery, or rehabilitation. Plaintiffs expert witnesses merely opined that plaintiffs decision to undertake the experimental surgical procedure was an "understandable" personal decision that offered plaintiff only a medically unproven "possibility," or hope, for an efficacious result. Therefore, the procedure was not an allowable expense under MCL 500.3107(1)(a). We affirm the judgment of the Court of Appeals.
I. FACTS AND PROCEEDINGS
On December 11, 2001, plaintiff was struck head-on by a large van while riding his motorcycle. Plaintiff suffered a severe spinal fracture that left him paraplegic, without sensation or function below the mid-chest area ("injury site"). Consequently, plaintiff was unable to touch his feet, move any part of his lower body, or determine when to reheve himself. Plaintiff underwent intensive physical therapy but did not regain any sensation below the injury site and was released from the program.
While investigating treatment options, plaintiff discovered a procedure known as olfactory ensheathing glial cell transplantation, an experimental surgery performed in Portugal. The procedure involves transplanting tissue from behind the patient's sinus cavities, which contains stem cells, to the injury site. The theory behind the procedure is that, once applied to the injury site, the transplanted stem cells could develop into spinal cord nerves. The procedure is not approved by the United States Food and Drug Administration (FDA) and therefore cannot be legally performed in the United States. In addition, there is insufficient existing research to allow for clinical trials, including controlled studies, peer review, and publication for FDA evaluation. Thus far, no one has applied for FDA approval of the procedure for any purpose.
In March 2005, plaintiff visited the Rehabilitation Institute of Michigan (RIM) and discussed the procedure with Dr. Steven Hinderer. Dr. Hinderer specializes in physical medicine and rehabilitation and is the medical director of the Center for Spinal Cord Injury Recovery Program (CSCIRP). Dr. Hinderer explained to plaintiff that he could not endorse or in any way recommend the procedure because it was highly experimental, had not yet been approved by the FDA, could not be legally performed anywhere in the United States, and lacked medical evidence to establish its efficacy. Neither party disputes that no one had yet applied for FDA approval of the procedure for any purpose, and the existing research was insufficient to allow clinical trials to begin. Dr. Hinderer also informed plaintiff that the procedure was not part of standard clinical care and was not likely to be covered by insurance. After consulting with Dr. Hinderer, plaintiff met with a patient who had undergone the procedure. Plaintiff claimed that this individual was able to stand on a device similar to a treadmill and walk with braces after the procedure.
After seeking advice from family members, plaintiff decided to undergo the procedure in Portugal. Plaintiffs primary health insurer denied coverage. Plaintiff then sought coverage from defendant, a no-fault auto insurance provider. Defendant's claims specialist told plaintiff that defendant would pay for testing to determine whether plaintiff medically qualified for the procedure, but would not pay for the procedure itself because it was experimental, non-FDA approved, and illegal to perform in the United States.
Plaintiff traveled to Portugal and underwent the procedure on November 10, 2005. Ten days later, plaintiff returned to the United States and began what he described as a grueling physical therapy program at the RIM, entailing four-hour therapy sessions three times a week. Defendant paid for all the postsurgical physical therapy treatment plaintiff received. Plaintiff filed suit against defendant to recover.the expenses he incurred traveling to and from Portugal and undergoing the surgery. At trial, plaintiff testified that he noticed improvements immediately after the procedure. Specifically, plaintiff testified that he could sometimes move his legs, crawl forward and backward, and control bowel and bladder movements, resulting in fewer urinary tract infections.
Dr. Hinderer testified that plaintiff had experienced "some small amount of voluntary motor function" after the procedure. Dr. Hinderer also testified that it was not possible to conclude that these minor improvements were the result of the procedure. Dr. Hinderer acknowledged that the intense physical therapy program in which plaintiff engaged postprocedure could alone have accounted for plaintiffs improvements. Dr. Hinderer testified about the highly experimental nature of the procedure. He described plaintiffs decision to undergo the procedure as a "personal choice" and acknowledged that this procedure was not considered necessary to the treatment and care of spinal cord injuries.
Dr. Carl Lima, a neurologist and neuropathologist at a public hospital in Portugal who is not licensed in the United States, was a member of plaintiffs surgical team, but did not perform the procedure. According to Dr. Lima, experimental data showed that transplanting nasal tissue, which contains stem cells, to the injury site provides functional recovery of neurons. He testified that this research had begun 18 years earlier on guinea pigs. There was no evidence presented at trial that the procedure has been efficacious in guinea pigs. The testimony established only that the procedure could be performed on guinea pigs without the guinea pigs' developing infections or forming tumors.
Dr. Lima testified that he started conducting human trials of the procedure in the government-operated hospital where he works, which sanctions the procedure for research purposes. No testimony was offered to suggest that the hospital had sanctioned the procedure because of its efficaciousness. Dr. Lima testified that, since 2001, 110 patients have undergone the procedure; however, Dr. Lima did not offer testimony regarding individual patients, the severity or location of their injuries, the outcomes following their procedures, or their prognoses. Dr. Lima published a paper in 2006 that summarized the outcome for seven patients who had undergone the procedure. All seven patients engaged in physical therapy following the procedure, but only two of the seven showed improvements in bladder and bowel control. Although there had been no controlled clinical studies regarding this procedure, Dr. Lima testified, "I would say the majority of the patients have some kind of improvement."
Dr. Lima found plaintiffs spinal cord injury to be one of the most severe injuries that he had ever treated. Dr. Lima testified that he was very surprised by the "quite unexpected" results of plaintiffs procedure. Dr. Lima acknowledged that plaintiff would never fully recover from such a severe injury. Nonetheless, Dr. Lima testified that the procedure was necessary to allow plaintiff a chance at some recovery. He added that any degree of recovery requires physical therapy. Although Dr. Lima conceded that the procedure was experimental, he opined that it was reasonably necessary because a person with a chronic spinal cord injury has no other available option. The lack of FDA approval did not change Dr. Lima's opinion.
Defendant moved for a directed verdict, arguing that as a matter of law, experimental surgery is not "reasonably necessary" under the no-fault act. The trial court denied defendant's motion, ruling that whether the procedure was "reasonably necessary" was a question of fact. The jury rendered a verdict in favor of plaintiff, concluding that the procedure was reasonably necessary. Judgment was entered, awarding plaintiff $51,412.85 in allowable expenses, plus interest, case-evaluation sanctions, and taxable costs.
The Court of Appeals reversed. The Court of Appeals observed that because the dispositive issue required a review of medical judgment, plaintiff was required to present expert testimony. Citing SPECT Imaging, Inc v Allstate Ins Co, the Court of Appeals concluded that plaintiff was required to demonstrate that the procedure had gained general acceptance in the medical community. Because plaintiff lacked such proof, the Court of Appeals concluded that a directed verdict in favor of defendant was required. The dissent criticized the majority for sua sponte raising the issue of admissibility of scientific evidence because the issue was not preserved for appellate review. The dissent also concluded that the question whether the procedure was "reasonably necessary" was properly submitted to the jury.
Plaintiff applied for leave to appeal in this Court. We granted the application to consider, among other issues, whether the experimental surgical procedure plaintiff underwent in Portugal was an allowable expense under MCL 500.3107(1)(a) of the no-fault act.
II. STANDARD of review
We review de novo a trial court's decision to direct a verdict. In doing so, we "review the evidence and all legitimate inferences in the light most favorable to the nonmoving party." Only if the evidence, when viewed in this light, fails to establish a claim as a matter of law should a motion for a directed verdict be granted.
Issues of statutory interpretation are questions of law that this Court reviews de novo.
III. ANALYSIS
A. BACKGROUND
The Michigan no-fault act requires that owners and registrants of automobiles carry personal protection insurance to cover an insured's medical care arising from injuries sustained in an automobile accident.
This case requires us to determine whether the experimental surgical procedure undergone by plaintiff constituted a compensable expense under the personal protection insurance requirements of MCL 500.3107(1)(a). MCL 500.3107(1) provides in pertinent part:
[P]ersonal 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. [Emphasis added.]
B. PRINCIPLES OF STATUTORY INTERPRETATION
The primary goal of statutory interpretation is to "ascertain the legislative intent that may reasonably be inferred from the statutory language." "The first step in that determination is to review the language of the statute itself." Unless statutorily defined, every word or phrase of a statute should be accorded its plain and ordinary meaning, taking into account the context in which the words are used. We may consult dictionary definitions to give words their common and ordinary meaning. When given their common and ordinary meaning, "[t]he words of a statute provide 'the most reliable evidence of its intent.. .' "
C. PRECEDENT
This is not the first time this Court has been called upon to interpret MCL 500.3107(1)(a). In Nasser v Auto Club Ins Ass'n, this Court held that under MCL 500.3107(1)(a), "an insurer is not liable for any medical expense . if the product or service itself is not reasonably necessary." This Court further observed that "[t]he plain and unambiguous language of [MCL 500.3107] makes both reasonableness and necessity explicit and necessary elements of a claimant's recovery, and thus renders their absence a defense to the insurer's liability." This Court rejected the notion that public-policy concerns would require the payment of expenses for medical care not shown to be reasonable and necessary to the care of an insured. Justice BOYLE, writing for the majority, observed that "[w]hile policy considerations may indeed cause some reluctance on the part of courts to allow insureds to be 'stuck' with unnecessary expenses" that they incurred, "that determination was made by the Legislature when it drafted [MCL 500.3107] and restricted [personal protection insurance] benefits under a rule of reasonableness." Finally, this Court recognized that while the question of reasonable necessity under this provision is generally one for a jury, "it may in some cases be possible for the court to decide the question of the reasonableness or necessity of particular expenses as a matter of law . . . ,"
While Nasser made clear that the language of MCL 500.3107 only permits an insured to recover expenses that are reasonable and necessary to the care, recovery, or rehabilitation of the insured, Nasser provided little guidance on how properly to determine what is a reasonably necessary expense or when such a determination may be made as a matter of law. To provide guidance along these lines, we observe that the no-fault act does not require coverage for all treatments. Obviously, treatments such as apricot pit therapy, coning (ear candling), homeopathy, magnet therapy and psychic surgery are patently unreasonable. Even if administered by licensed health-care providers, these so-called treatments not only lack a scientific basis to conclude that they are generally accepted by the medical community, but there is simply no basis to conclude that they are at all efficacious. On the other hand, we presume, subject to rebuttal, that services generally accepted by the medical community for treatment or care of a specific and diagnosed injury are reasonably necessary under MCL 500.3107(1)(a). Less clear is the case presented here, in which an insured has undergone a surgical procedure that is not generally accepted by the medical community. Defendant maintains that experimental procedures, by their nature, cannot, as a matter of law, be reasonably necessary under the no-fault act. We reject defendant's position and conclude that experimental treatments are not necessarily barred from being compensable under the no-fault act. The ultimate question whether the surgical procedure at issue here is a covered expense under the no-fault act does not turn on its status as experimental. Rather, like all claims for allowable expenses, the question turns on whether the procedure was reasonably necessary for plaintiffs care, recovery, or rehabilitation.
D. MCL 500.3107(1)(a) MUST BE ASSESSED USING AN OBJECTIVE STANDARD
In order to give meaning to this statutory provision, we start by examining the perspective from which reasonable necessity is determined. Stated more precisely, when the Legislature provided that allowable expenses consist of "all reasonable charges incurred for reasonably necessary products, services and accommodations for an injured person's care, recovery, or rehabilitation," did it intend for reasonable necessity to be determined under a subjective or objective standard?
The term "reasonable" commonly refers to that which is "agreeable to or in accord with reason; logical," or "not exceeding the limit prescribed by reason; not excessive[.]" The term "reasonable" has also been defined to mean "fair, proper, or moderate under the circumstances" and "[f]it and appropriate to the end in view." These definitions evidence an absence of the personal sentiment, prejudice, and bias associated with a subjective point of view, which is "based on an individual's perceptions, feelings, or intentions," rather than the "externally verifiable phenomena" associated with an objective viewpoint. Accordingly, we conclude that reasonableness is not based merely on the subjec tive perception that a service is necessary for an injured person's care, recovery, or rehabilitation. Rather, the term "reasonably" must be determined under an objective perspective.
This conclusion is entirely consistent with this Court's precedent interpreting MCL 500.3107. In Nasser, the plaintiff was involved in a minor accident. Complaining of pain in his "head, neck, chest, shoulder, and both upper and lower back, as well as blurred vision and nausea, he initially sought medical treatment from an internist, who then admitted him to a hospital. Over the following three months, he spent 50 days in the hospital and underwent a battery of medical tests.
The plaintiffs no-fault insurer refused to pay for the plaintiffs hospitalization, and the plaintiff sued to recover allowable expenses under the no-fault act. The trial court granted the plaintiff summary disposition on the issue of liability. The Court of Appeals affirmed, citing policy considerations to justify allowing the plaintiff to rely on his subjective beliefs that his hospital expenses were "reasonably necessary" when he accepted treatment. In doing so, the Court of Appeals also agreed with the plaintiff that "[t]he reasonableness of medical expenses cannot be used as a defense to liability in a no-fault accident case." This Court rejected both the plaintiff s claims, clearly stating that the defendant insurer could challenge the reasonableness of the plaintiffs expenses and impliedly rejecting the plaintiffs reliance on his subjective belief of reasonableness.
This Court has also held when interpreting insurance contracts that the use of the term "reasonably" requires the application an objective standard unless it is used in reference to a particular person's point of view or expectation under certain circumstances. In the companion cases of Allstate Ins Co v Freeman and Metro Prop & Liability Ins Co v DiCicco, this Court distinguished between language identifying objective and subjective standards in exclusionary insurance clauses. In Freeman, this Court unanimously held that the phrase "reasonably be expected" unambiguously directed the use of an objective standard of expectation. In DiCicco, a majority of this Court applied a subjective standard to an insurance policy that excluded "bodily injury or property damage which is either expected or intended from the standpoint of the insured."
More recently, in Allstate Ins Co v McCarn (After Remand), we addressed an insurance policy that excluded coverage for damage that "may reasonably be expected to result" from an insured's intentional or criminal acts. Because the contract used the phrase "reasonably expected," six members of this Court agreed that the contract required the application of an objective standard.
The statutory provision at issue in this case uses the term "reasonably," and there is no statutory language suggesting that "reasonably" should be determined on a subjective basis. Most indicative that an objective standard applies is the absence of language providing for any particular point of view, such as "from the standpoint of the insured" or "by an insured person." Thus, although "reasonably necessary" is a broadly worded phrase, we conclude that this phrase must be assessed by using an objective standard.
E. AN EXPERIMENTAL SURGICAL PROCEDURE CANNOT BE REASONABLY NECESSARY IF IT IS NOT EFFICACIOUS
Having determined that the term "reasonably necessary" must be assessed from an objective perspective, we next consider what it is that must be reasonably necessary under MCL 500.3107(1)(a): "products, services and accommodations" that are provided "for an injured person's care, recovery, or rehabilitation." Thus, a service, product, or accommodation must be (1) objectively reasonable and (2) necessary for an insured's care, recovery, or rehabilitation. If, as in this case, the service under consideration is an experimental surgical procedure, the insured must present evidence that the surgery may result in care, recovery, or rehabilitation. In other words, there must be evidence that the surgery is efficacious. Further, because a surgery involves the exercise of medical judgment, the efficacy determination must be based on objective and verifiable medical evidence. Experimental surgical procedures lacking objective and verifiable medical evidence of their efficacy cannot be "reasonably necessary" simply because it cannot be shown to effect the insured's care, recovery, or rehabilitation. To interpret MCL 500.3107(1)(a) as allowing reimbursement for nonefficacious experimental treatments "for an injured person's care, recovery, or rehabilitation" would be to read the phrase "reasonably necessary" out of this provision.
Requiring the minimum threshold of efficacy in the context of experimental surgical procedures is consistent with our precedent regarding nonmedical allowable expenses. In Griffith, for example, we rejected the proposition that insurers were "obligated to pay for any expenses that an injured person would otherwise be provided in an institutional setting as long as they are remotely related to the person's general care." Rather, we concluded that coverage "requires that allowable expenses be causally connected to a person's injury." We also emphasized that "the statute specifically limits compensation to charges for products or services that are reasonably necessary 'for an injured person's care, recovery, or rehabilitation[,]'. . . suggesting] that 'care' must be related to the insured's injuries." Just as Griffith required that expenses for food actually be related to a person's injury, so also do we require here that expenses for experimental medical treatment actually be for an injured person's care, recovery, or rehabilitation. This requires, at a minimum, that services be efficacious in an injured person's care, recovery, or rehabilitation.
If a surgical procedure is experimental, an insured cannot establish its reasonable necessity under MCL 500.3107 unless expert testimony indicates that the surgery presents a reasonable chance that it will be efficacious in the injured person's care, recovery, or rehabilitation. Contrary to the Court of Appeals' holding in this case, an insured is not required to prove that an experimental surgical procedure gained general acceptance in the medical community before its reasonable necessity becomes a question for consideration by the trier of fact. MCL 500.3107(1)(a) does not require that medical treatment be shown to have gained general acceptance within the medical community. Rather, an insured must present objective and verifiable medical evidence that medical treatment is efficacious in an injured person's care, recovery, or rehabilitation. If there is objective and verifiable evidence that an experimental surgical procedure is efficacious, the finder of fact can begin to make an informed decision in regard to whether the treatment was reasonably necessary by considering whatever factors were relevant in that case, which may include but are not limited to the severity and chronicity of the condition, the outcomes of any previous treatments, the likelihood that alternative treatments would be efficacious, a personal physician's recommendation in conjunction with the patient's preference, and both the short-term and long-term risks and benefits. Absent objective evidence to establish that the experimental surgical procedure is at least efficacious, there would not exist a material question of fact about whether the medical treatment was reasonably necessary to the care recovery or rehabilitation of an insured.
We also observe that MRE 702 imposes an obligation on the trial court to ensure that any expert testimony or scientific evidence admitted at all stages of a proceeding is reliable. "While the exercise of this gatekeeper role is within a court's discretion, a trial judge may neither 'abandon' this obligation nor 'perform the function inadequately.' " The trial court must specifically ensure that expert testimony is based on sufficient facts or data, the product of reliable principles and methods, and that the witness has applied the principles and methods reliably to the facts of the case.
F. THE PROCEDURE WAS NOT REASONABLY NECESSARY FOR THE CARE, RECOVERY, OR REHABILITATION OF PLAINTIFF
In this case, plaintiff failed to present evidence to establish that the experimental surgical procedure at issue presented him with an objectively verifiable chance that it would be efficacious in his care, recovery, or rehabilitation. Therefore, defendant was entitled to judgment as a matter of law because plaintiff did not meet the minimum threshold for recovery.
Plaintiff relied on the testimony of two expert witnesses, Dr. Hinderer of the RIM and Dr. Lima, to establish that the procedure was "reasonably necessary." Dr. Hinderer's testimony cast doubt on whether the procedure was efficacious in plaintiffs care, recovery, or rehabilitation. In particular, Dr. Hinderer did not endorse, recommend, or prescribe the procedure to plaintiff. Dr. Hinderer testified that the procedure is not regarded as necessary in his field of medicine and that "[fit's certainly not standard of practice given its experimental nature." More importantly, when asked whether the surgical procedure increased the chances of an injured person's potential for recovery, Dr. Hinderer agreed with defense counsel's statement that "we don't know the outcomes yet because this is such a new procedure."
Further, Dr. Hinderer's testimony actually confirmed that the decision to undergo the procedure was purely subjective. He candidly testified that
there are individuals who would not even remotely consider this procedure; there are others who don't even want to hear anything negative about it because they want to pursue it, and everything in between, so it — you know, relative to someone, you know, placing oneself in a situation like this, you know, it's a personal choice, but certainly understandable....
Taken in the light most favorable to plaintiff, Dr. Hinderer's testimony does not provide any evidence that the experimental procedure presented plaintiff a medically verifiable chance that it would be efficacious in his care, recovery, or rehabilitation. Accordingly, Dr. Hinderer's testimony did not provide an objective basis from which a jury could conclude that the experimental surgical procedure was reasonably necessary.
Dr. Lima's testimony does not save plaintiffs claim. Plaintiff maintains that the procedure afforded him the possibility or opportunity to recover as much function as possible below his injury site. Dr. Lima did indeed claim that the procedure was reasonably necessary if plaintiff wanted the opportunity to recover some function below the injury site. And plaintiff has clearly relied on Dr. Lima's affirmative answer to counsel's question whether, "as a result of the procedure, the possibility exists that [plaintiff] may regain some level of function below the injury site[.]"
This possibility, however, cannot be measured without objective evidence establishing efficacy in the first place. Further, as with the legal standard for establishing causation, the mere possibility of efficacy is not enough, and "when the matter remains one of pure speculation or conjecture,... it becomes the duty of the court to direct a verdict for the defendant." While Dr. Lima articulated his theory, he failed to present medical evidence to support it. Whatever research he may have conducted, it was unsupported by any controlled studies, it had not been subjected to peer review, and the medical evidence had not been debated in scholarly publications. Dr. Lima did not base his testimony on any verifiable evidence that undergoing the procedure would be efficacious. The record reflects that his testimony, at best, reflects his personal belief, or hope, that many of the patients who undergo the procedure improve. This is clearly established by the fact that Dr. Lima was very "surprised" by the "quite unexpected" results of plaintiffs procedure. In sum, Dr. Lima's testimony also fails to provide an objective basis by which a jury could conclude that the experimental surgical procedure was reasonably necessary for plaintiffs care, recovery, or rehabilitation.
G. RESPONSE TO THE DISSENT
The dissent's declaration that "[t]oday's decision rewrites [MCL 500.3107] to require that a procedure be 'medically necessary' or 'medically appropriate' in order for an insured to be reimbursed by his or her insurer" is patently false. Nowhere in this opinion, except in response to the dissent, will you find the phrases "medically necessary" or "medically appropriate." After falsely ascribing these standards to us, the dissent uses them to set up the straw-man argument that we are thwarting the will of the people by enacting standards that were rejected when 1993 PA 143 was rejected by referendum. This is also patently false.
1. WE ARE INTERPRETING MCL 500.3107
The dissent claims that our opinion adds language to MCL 500.3107. We obviously disagree with this characterization. We believe that the dissent fails to give meaning to the portion of the provision that states "for an injured person's care, recovery, or rehabilitation" by concluding that evidence of a treatment's efficaciousness is not required to prove that it is reasonably necessary. A treatment or procedure that has not been shown to be efficacious can be neither "reasonable" nor "necessary" under the no-fault act.
Our interpretation of MCL 500.3107 gives meaning to the phrase "reasonably necessary . . . for an injured person's care recovery or rehabilitation," and, in doing so, we define the minimum amount of evidence that must be presented on the question before the matter becomes a genuine and material question of fact sufficient to be submitted to a jury for its determination. We merely conclude that the reasonably necessary standard cannot be met when there is no evidence that medical treatment will have any beneficial effect on the "injured person's care, recovery, or rehabilitation."
It is a bedrock legal principle that "[i]t is, emphatically, the province and duty of the judicial department, to say what the law is. Those who apply the rule to particular cases, must of necessity expound and interpret that rule." This Court stated that "it is necessary . . . that the law shall be known and certain, and shall not depend on each jury that tries a cause." It is axiomatic that courts decide questions of law and juries apply the law given them to the facts as they have found them. This principle is reflected in our model civil jury instructions, and the trial court instructed the jury consistently with those instructions. We do not add language to MCL 500.3107(1)(a), but expound upon the phrase "reasonably necessary. . . for an injured person's care recovery or rehabilitation" to provide essential legal guidance.
We find overwrought the dissent's protestations regarding the so-called "stringent" standard that the dissent claims this opinion articulates. Again, we merely hold that an insured must establish that medical treatment is efficacious in his or her care, recovery, or rehabilitation. We conclude that this standard is entirely consistent with the common meaning of the phrase "reasonably necessary... for an injured person's care, recovery, or rehabilitation." On the other hand, the dissent's position that a reasonably necessary treatment is any treatment that a person hopes could possibly work falls far short of any commonly accepted meaning of "reasonably necessary. . . for an injured person's care, recovery, or rehabilitation." The dissent's standard would allow a nonefficacious treatment— which is worthless — to be considered "reasonably necessary" for the sole reason that an expert witness offered an opinion that the medical treatment is rea sonably necessary. For the same reasons that we caution trial courts not to "admit opinion evidence which is connected to existing data only by the ipse dixit of the expert," we believe that what constitutes a reasonably necessary medical treatment cannot solely be based on the ipse dixit of a physician. And while we recognize that our standard, which requires evidence of efficacy, is more imposing than the dissent's standard of let the jury figure it out, it bears repeating that medical treatments, like any other personal protection insurance benefit, must be efficacious to be reasonably necessary. Ignoring this basic principle sanctions the dissent's anything-goes approach, whereby every insured's demand for payment would inexplicably become a question of fact and no-fault benefits would be paid for treatments not even shown to be reliable or effective, let alone reasonable or necessary.
2. 1993 PA 143
The dissent maintains that our interpretation of MCL 500.3107(1)(a) thwarts the will of the voters as expressed in the 1994 general election, in which the voters rejected 1993 PA 143. But, as explained earlier, in order to advance this argument, the dissent must ascribe to us legal standards not adopted in this opinion. Further, we are unfamiliar with a method of statutory interpretation that commences interpretation of an existing statute not by reviewing the words of that statute, but instead by examining the language of one rejected by referendum. Employing this method of interpretation, the dissent maintains that an experimental surgical procedure may never be deemed unreasonable as a matter of law and that a jury must always determine what is reasonable and necessary, regardless of the evidence presented at trial.
1993 PA 143 would indeed have amended MCL 500.3107 to state in subsection (4)(c) that "[e]xpenses within personal protection insurance coverage shall not include experimental treatment or participation in research projects." But it defies logic to presume that because a total bar on experimental treatments was rejected by the voters, the reasonableness and necessity of all experimental treatments must be resolved by a jury. Following the dissent's reasoning, if a medical doctor opined that treatments such as apricot pit theory, ear candling, homeopathy, magnet therapy, and psychic surgery could possibly give an insured a chance to recover, a jury would have to resolve whether those treatments were reasonable and necessary to the care, recovery, or rehabilitation of the insured. This could not possibly be the effect of the rejection of 1993 PA 143.
Further, [a]t least one Michigan court has declined to adopt the method of statutory construction adopted here by the dissent. In Michigan Chiropractic Council v Office of Fin & Ins Servs Comm'r the Court of Appeals was asked to assume that the rejection by ballot referendum of 1993 PA 143 amounted to a rejection by the voters of every single aspect of the act. The Court of Appeals did not accept this argument. The Court of Appeals observed that "1993 PA 143 made comprehensive changes to Michigan's no-fault insur anee scheme. Because the referendum rejected the act in its entirety, it has little bearing on the [specific issue presented in] this case." We agree with the Chiropractic Council panel that 1993 PA 143 was a comprehensive insurance reform bill, and one can only speculate whether the rejection of 1993 PA 143 signified that voters expected every type of experimental treatment to be covered under the no-fault act. Indeed, the language on the ballot proposal did not even mention experimental treatment. The dissent engages in guesswork and, on this basis, believes that Michigan voters intended its courts to rubber-stamp all determinations under the no-fault act, regardless of the paucity of evidence supporting a jury's finding and regardless of how unreasonable and unnecessary the expense may be. We base our opinion on the current law. We do not base it on what the law once was or could have been.
This case does not turn on any aspect of 1993 PA 143. As already stated, we reject defendant's claim that plaintiff cannot prevail merely because the procedure was experimental. We also reject the Court of Appeals' holding that an insured is required to prove that an experimental surgical procedure has gained general acceptance in the medical community before consideration by the trier of fact. The question whether an experimental treatment is reasonably necessary for an insured's care, recovery, or rehabilitation must be resolved by a fact-finder if the insured can present objective and verifiable medical evidence to support the conclusion that the treatment is efficacious. The dissent maintains that this is an illusory standard because, if objective and verifiable medical evidence of efficacy exists, "it is unclear how the procedure would still be termed 'experimental' or in the 'research' phase." But the practices of the FDA establish that an efficacious treatment may nonetheless be experimental. The FDA has three phases of testing before a medical procedure or product receives full FDA approval. Phases II and III of the FDA process, in which the treatment is still experimental or in the research phase, focus on efficacy. This is but one example. And contrary to the dissent's representation, we do not hold that the objective and verifiable medical evidence must include "controlled studies subject to peer review or scholarly publications" supporting the science behind the surgery. Likewise, we are in no way suggesting that data from the FDA are required. Rather, these are additional examples of objective and verifiable evidence that can establish efficacy. Presentation by an expert witness of any of this objective and verifiable evidence, even if opposed by several witnesses claiming the proposed medical treatment is not efficacious, is sufficient to sustain plaintiffs burden. Since we are not medical experts, we are not going to artificially limit the types of objective and verifiable evidence that a party may present to support its claim; instead, we simply note that there must be some evidence from the medical community that a particular procedure would have some beneficial effect on a person's "care, recovery, or rehabilitation" in accordance with MCL 500.3107(1)(a).
IV CONCLUSION
We conclude that the question whether a product, service or accommodation is reasonably necessary for an injured person's care, recovery, or rehabilitation must be determined under an objective standard. We further conclude that when medical treatment is experimental, an insured seeking reimbursement for this treatment must present objective and verifiable medical evidence establishing that the treatment is efficacious. A treatment or procedure that has not been shown to be efficacious cannot be reasonable or necessary under the no-fault act. An insured's subjective belief that medical treatment is efficacious, reasonable, and necessary is not sufficient to create a question of fact. Viewed in the light most favorable to plaintiff, the objective and verifiable medical evidence presented at trial failed to establish that the experimental surgical procedure at issue in this case was any way efficacious in the care, recovery, or rehabili tation of plaintiff's injury. Accordingly, we affirm the judgment of the Court of Appeals.
Young, C.J., and Markman and Mary Beth Kelly, JJ., concurred with ZAHRA, J.
Although we affirm the judgment of the Court of Appeals, we do so for reasons different from those stated by the Court of Appeals.
The dissent claims we erroneously conclude that Dr. Hinderer's testimony cast doubt on the efficacy of the procedure. Dr. Hinderer's testimony, however, merely suggested that the procedure required scientific research. The literature from the CSCIRP clearly outlined the highly experimental nature of this procedure. According to defendant's brief in this Court, the literature stated that "[t]here has been very little scientific data collection of the efficacy and long-term outcome of these procedures." The literature also encouraged those "who choose to pursue these alternative surgical procedures" to enroll in the RIM's clinical research study to "begin scientific knowledge" and "evaluate the effectiveness of these procedures." This literature was provided to plaintiff before he decided to undergo the procedure, and Dr. Hinderer's trial testimony was consistent with the CSCIRP literature.
The medical history of this individual was not developed at trial and there was no medical evidence in the record establishing that the procedure caused any improvement this individual may have experienced.
Dr. Hinderer was asked whether he had seen patients make similar improvements after very aggressive physical therapy without this sur gery. He responded that he sees "improvements in virtually all participants [who undergo intensive physical therapy], surgery or no surgery."
The dissent cites Dr. Lima's testimony as providing that "of the 110 patients who had undergone the treatment in his program, a majority of the patients showed improvement." Post at 180-181. However, the lower court record only reflects that Dr. Lima testified as follows:
Q. Overall, would you describe — how would you describe the degree of success of the surgeries on patients?
A. Well, maybe I'm not right person to say that, and that's why we want to publish the whole results of the patient, but I would say the majority of patients have some kind of improvement.
This testimony hardly demonstrates that a_ "majority of patients showed improvement." The testimony better reflects that Dr. Lima could only guess that the experimental surgical procedure was efficacious in some patients. More significantly, this testimony reflects Dr. Lima's assumption that any improvement that may have been noted was the result of the experimental surgical procedure and not physical therapy alone. As both Dr. Hinderer and Dr. Lima stated, and as plaintiff concedes, there is no evidence regarding the extent to which any improvement after this procedure can be attributed to the procedure alone, physical therapy alone, or a combination thereof. To this extent, the quoted testimony reflects an absence of the objectivity required to support a legal conclusion that the procedure is efficacious.
Krohn v Home-Owners Ins Co, unpublished opinion of the Court of Appeals, issued January 26, 2010 (Docket No. 283862), p 3.
SPECT Imaging, Inc v Allstate Ins Co, 246 Mich App 568, 578; 633 NW2d 461 (2001).
Id. at 3-4.
Id. at 5-6.
Id. at 5 (Fort Hood, EJ., dissenting).
Id. at 8.
Krohn v Home-Owners Ins Co, 488 Mich 876 (2010).
Sniecinski v Blue Cross & Blue Shield of Mich, 469 Mich 124, 131; 666 NW 2d 186 (2003).
Id. (quotation marks and citations omitted).
Id.
Griffith v State Farm Mut Auto Ins Co, 472 Mich 521, 525-526; 697 NW2d 895 (2005).
MCL 500.3101(1); MCL 500.3105(1). We note that while the no-fault act mandates the minimum insurance coverage to be obtained by an owner or registrant of an automobile, it does not bar an insured from obtaining insurance coverage in excess of that amount. As a preliminary matter, we note that all owners and registrants of automobiles in Michigan are free to purchase insurance contracts that provide greater coverage than the minimum required under the no-fault act.
Griffith, 472 Mich at 526, citing Sotelo v Grant Twp, 470 Mich 95, 100; 680 NW2d 381 (2004).
In re MCI Telecom. Complaint, 460 Mich 396, 411; 596 NW2d 164 (1999), citing House Speaker v State Admin Bd, 441 Mich 547, 567; 495 NW2d 539 (1993).
MCL 8.3a; Robertson v DaimlerChrysler Corp, 465 Mich 732, 748; 641 NW2d 567 (2002).
2000 Baum Family Trust v Babel, 488 Mich 136,175; 793 NW2d 633 (2010).
Halloran v Bhan, 470 Mich 572, 578; 683 NW2d 129 (2004).
Veenstra v Washtenaw Country Club, 466 Mich 155, 160; 645 NW2d 643 (2002), citing MCL 8.3a.
Klooster v City of Charlevoix, 488 Mich 289, 296; 795 NW2d 578 (2011), quoting United States v Turkette, 452 US 576, 593; 101 S Ct 2524; 69 L Ed 2d 246 (1981).
Nasser v Auto Club Ins Ass'n, 435 Mich 33; 457 NW2d 637 (1990).
Id. at 49 (emphasis in original).
Id.
Id. at 55.
Id.
Random, House Webster's College Dictionary (2000).
Black's Law Dictionary (7th ed).
Black's Law Dictionary (6th ed).
Black's Law Dictionary (7th ed) (defining "subjective").
Nasser, 435 Mich at 38.
Id.
Id. at 38-39.
Id. at 40-41.
Nasser v Auto Club Ins Ass'n, 169 Mich App 182, 186; 425 NW2d 762 (1988).
Id.
Nasser, 435 Mich at 48-50.
Inasmuch as the no-fault act is statutorily mandated insurance coverage, we find it appropriate to seek guidance from insurance contract caselaw in regard to the meaning of the word "reasonably."
Allstate Ins Co v Freeman, 432 Mich 656, 672; 443 NW2d 734 (1989).
Id. at 688 (opinion by Riley, C. J.); id. at 709 (opinion by Boyle, J.); id. at 721 (opinion by Archer, J.).
Id. at 672 (opinion by Riley, C. J.); id. at 710 (opinion by Boyle, J.); id.. at 721 (opinion by Archer, J.). In Fire Ins Exch v Diehl, 450 Mich 678, 684; 545 NW2d 602 (1996), this Court addressed an insurance policy provision excluding " '[a] sudden event, including continuous or repeated exposure to the same conditions, resulting in bodily injury or property damage neither expected nor intended by the insured.' " The Court noted the provisions in both Freeman and DiCicco, then stated that,
[in] [e]xplaining the distinction, Justice Boyle noted that the [Freeman] policy required an objective standard because, of the two exclusionary phrases in the policy, the first exclusionary phrase applied to injury "reasonably" expected, and the policy counterpoised the first exclusionary phrase to the second phrase that applied if the injury was "in fact intended." Therefore, the first phrase must require application of an objective standard or the word "reasonably" loses its meaning and the second exclusionary phrase is redundant. On the other hand, the policy exclusion from the [DiCicco] policy did not contain the word "reasonably," but instead employed the phrase "from the standpoint of the insured." This language required application of a subjective standard. [Id. at 685 (citations omitted).]
The Diehl Court stated that the policy in question was "somewhere between the two policies at issue in Freeman and DiCicco," noting that, "[although the policy does not employ the term 'reasonably,' the phrase 'from the standpoint of the insured' is also absent." Id. The Diehl Court nonetheless held that "[t]he manner in which the policy employs the phrase 'by the insured' suggests that the emphasis of the policy is on whether the insured expected or intended the injury" and thus applied a subjective analysis. Id. In further support, the Diehl Court noted that a subjective approach to determining reasonableness is appropriate if the policy expressly directed consideration of the insured's subjective expectations. Id. at 685-686, quoting Auto-Owners Ins Co v Churchman, 440 Mich 560, 567-568; 489 NW2d 431 (1992) (holding that a policy exclusion for injury "expected or intended by an insured person" is unambiguous and requires a subjective standard) (quotation marks omitted).
Allstate Ins Co v McCarn (After Remand), 471 Mich 283, 289; 683 NW2d 656 (2004).
Id. at 290, 297 (WEAVER, J. dissenting); id. at 302 (Young, J., dissenting). Justice CAVANAGH concurred in the result only. We note a Court of Appeals decision, Allstate Ins Co v Keillor (On Remand), 203 Mich App 36, 39-40, 511 NW2d 702 (1993), in which an objective standard was applied to a contractual exclusion for harm that " 'may reasonably be expected to result from the intentional.. . acts of an insured person or which is in fact intended by an insured person.' "
We note with approval the Court of Appeals' conclusion that evidence of the effects of a medical treatment on a plaintiffs condition, whether positive or negative in a particular case, is the type of post hoc evidence that is inconsistent with making an objective determination of whether medical treatment was "reasonably necessary." Krohn, unpub op at 4 n 2.
MCL 500.3107.
Nasser, 435 Mich at 50.
See Bryant v Oakpointe Villa Nursing Ctr, Inc, 471 Mich 411; 423-424; 684 NW2d 864 (2004).
Indeed, plaintiffs counsel conceded this point at oral argument when acknowledging that treatment with a placebo could not be considered "reasonably necessary" under the no-fault act. A placebo is "a pharmacologically inactive substance or a sham procedure administered as a control in testing the efficacy of a drug or course of action." Random House Webster's College Dictionary (2000). While a placebo may cause a subjective effect of "lessening of symptoms," see id. (defining "placebo effect"), the administration of a placebo is decidedly without objective efficacy. Like a placebo, treatments such as the procedure here that lack efficacy can provide no basis for concluding that they were "reasonably necessary" for an injured person's care, recovery, or rehabilitation.
Griffith, 472 Mich at 539.
Id. at 530-531.
Id. at 534.
See Krohn, unpub op at 4. The Court of Appeals' reliance on SPECT Imaging was misplaced. In that case, the Court addressed whether a particular form of brain imaging was a reasonably necessary service under MCL 500.3107. SPECT Imaging, 246 Mich App at 574. The Court remanded for the trial court to conduct an evidentiary hearing to determine whether expert testimony and evidence relating to brain imaging were admissible under MRE 702. Id. at 578. The Court of Appeals did not require that brain imaging equipment be shown to have gained acceptance in the medical community. Rather, only the expert testimony or evidence offered in support of the brain imaging and the inferences therefrom had to have gained acceptance in the medical community before brain SPECT imaging would be considered reasonably necessary under MCL 500.3107. Id. at 578-579. SPECT Imaging expressly stated that
[i]f the court determines that the expert testimony and evidence relating to [brain] SPECT imaging satisfy the standards of MRE 702 and [the general-acceptance requirement], and are therefore admissible at trial, the ensuing determination, whether brain SPECT imaging was a reasonably necessary expense in the treatment of defendants' insureds pursuant to MCL 500.3107(1)(a), is a question reserved for the trier of fact. [Id. at 579.]
We reject the proposition that a proposed product, service, or accommodation must have gained general medical acceptance to be compensable.
We emphasize that evidence of efficacy is not, by itself, sufficient in every case to establish reasonable necessity or no-fault liability; instead, our opinion makes clear that efficacy is a minimum threshold standard that, if demonstrated by a plaintiff, precludes judgment as a matter of law on this particular issue. As with threshold standards generally, efficacy as demonstrated through objective and verifiable medical evidence is merely the first step to proving liability when considering the unique facts and circumstances of each case.
Notably, the parties' attorneys at trial elicited evidence in regard to several of these factors. Accordingly, we believe that attorneys of record are in the best position to propose factors that are most relevant to establishing whether a minimally efficacious treatment is "reasonably necessary."
This opinion does not in any way prevent no-fault insureds from themselves paying for procedures that are not "reasonably necessary" or entering into insurance contracts that provide broader coverage.
Edry v Adelman, 486 Mich 634, 639-642; 786 NW2d 567 (2010). We have consistently held that medical issues raised in medical malpractice actions are not within the common experience and understanding of jurors, and they thus require the assistance of expert testimony. See, e.g., Wilson v Stilwill, 411 Mich 587, 611; 309 NW2d 898 (1981); see generally Bryant, 471 Mich 411; Dorris v Detroit Osteopathic Hosp Corp, 460 Mich 26; 594 NW2d 455 (1999).
Gilbert v DaimlerChrysler Corp, 470 Mich 749, 780; 685 NW2d 391 (2004) (citation omitted). In this case, however, defendant waived this issue by failing to object. Craig v Oakwood Hosp, 471 Mich 67, 82; 684 NW2d 296 (2004) (holding that "a party may waive any claim of error by failing to call this gatekeeping obligation to the court's attention").
Dr. Lima is a neurologist, not a surgeon, and he did not participate in plaintiffs surgery. Dr. Lima, however, described himself as a member of plaintiffs surgical team.
During oral argument, plaintiffs counsel conceded that, at best, Dr. Hinderer took a neutral stance with regard to the procedure. In light of this admission, Dr. Hinderer's testimony can hardly be found to support the conclusion that the procedure was reasonably necessary for plaintiffs care, recovery, or rehabilitation.
Dr. Hinderer did testify that the procedure was approved by the "Geneva Protocol," which plaintiff claims is similar to FDA approval. We note that this was likely intended to be a reference to the Declaration of Geneva, which, together with the Declaration of Helsinki, governs the ethics of human medical research under principles set forth by the World Medical Association. See World Medical Association, WMA Declaration of Helsinki —Ethical Principles for Medical Research Involving Human Subjects, <http://www.wma.net/en/30pubhcations/10pohcies/b3/index.html> (accessed July 20,2011). In any event, Dr. Hinderer's testimony only addressed the "Geneva Protocol" in regard to whether it was safe and ethical for humans to undergo the procedure for purposes of research. In comparing the FDA's approval process to the "Geneva Protocol," Dr. Hinderer testified that the "FDA really is concerned about safety first and then efficacy, and the FDA does it in a staged set of approaches or phases, Phase [I] being a safety trial, Phase [II] being continued safety monitoring and early investigation of efficacy, Phase [III] being primarily focused on efficacy . ." Dr. Hinderer did not suggest that the "Geneva Protocol" had something comparable to Phase II FDA review for investigation of efficacy, or that the procedure had been reviewed for efficacy in any manner. In fact, Dr. Hinderer admitted that he had not actually tried to compare the relative criteria of the "Geneva Protocol" and the phases of review preceding FDA approval.
The dissent relies on Dr. Lima's testimony regarding the procedure's conformity with the European Commission's guidelines regarding clinical procedures. There was no evidence that these guidelines verify the efficacy of any given procedure. At most, these guidelines suggest that the procedure may be performed safely.
Weymers v Khera, 454 Mich 639, 563 NW2d 647 (1997).
Contrary to the dissent's assertion, we are not holding that plaintiffs subjective decision to undergo the procedure was unreasonable. Instead, we are simply holding that because plaintiff presented no objective evidence that the procedure would have any beneficial effect on his "care, recovery, or rehabilitation," he failed to satisfy the requirement of MCL 500.3107(1)(a) that the procedure be "reasonably necessary [for his] care, recovery, or rehabilitation." Under Nasser, 435 Mich at 55, and this Court's more recent statement in Wilcox v State Farm Mut Auto Ins Co, 488 Mich 1011 (2010), we agree with the dissent that in "most cases" a jury is the proper vehicle to determine whether a procedure is reasonably necessary. However, as we hold here, medical treatment that lacks objective and verifiable evidence of efficacy cannot ever be considered "reasonably necessary," and thus the issue should be decided as a matter of law.
Post at 188.
The dissent cites Owens v Auto Club Ins Ass'n, 444 Mich 314, 326; 506 NW2d 850 (1993), for the proposition that "an issue of fact still existed for the jury to resolve" "even if doubt was cast by one of the two assessing physicians . . ." Post at 185. Unlike the situation in Owens, plaintiffs expert witnesses here either independently or cumulatively failed to testify that objective and verifiable evidence existed to establish that the experimental surgical procedure was efficacious, and therefore reasonably necessary to plaintiffs care, recovery, or rehabilitation. Because no evidence was presented by any expert to create a genuine issue of fact, the principles of Owens are not implicated by this case.
Marbury v Madison, 5 US (1 Cranch) 137, 177; 2 L Ed 60 (1803).
Hamilton v People, 29 Mich 173, 191 (1874).
See M Civ JI 2.01 ("You must take the law as I give it to you," and "Your responsibility as jurors is to decide what the facts of the case are.").
As previously stated, outside the litigation context, the dissent's position provides absolutely no guidance for how to determine the issue of reasonable necessity. By providing meaning to MCL 500.3107, this opinion provides guidance to all members of the relevant community— insureds, insurance claims adjusters trying to determine whether a medical procedure is covered, lawyers, medical experts, and so forth — to know that, as with other personal protection insurance benefits, there must be objective and verifiable evidence of efficacy before coverage is contemplated under the no-fault act. We believe that all interested parties are better off knowing their responsibilities and liabilities before the necessity of litigation arises. The dissent's position provides no guidance whatsoever — not to the community generally, and not even to juries who must decide questions of "reasonable necessity."
Gilbert, 470 Mich at 783, quoting General Electric v Joiner, 522 US 136, 146; 118 S Ct 512; 139 L Ed 2d 508 (1997).
Surely the dissent'would not require an insurer to reimburse the cost of placebo pills. Yet, the dissent would hold that there remains a question of fact whether the experimental surgical procedure here is reasonably necessary, even though plaintiff presented no objective evidence that it has any more demonstrated efficacy than a placebo.
Michigan Chiropractic Council v Office of Fin & Ins Servs Comm'r, 262 Mich App 228; 685 NW2d 428 (2004), vacated 475 Mich 363; 716 NW2d 561 (2006).
Chiropractic Council, 262 Mich App at 246 n 12.
The official ballot language stated:
PROPOSAL C
A REFERENDUM ON PUBLIC ACT 143 OF 1993 — AN AMENDMENT TO MICHIGAN'S AUTO INSURANCE LAWS
Public Act 143 of 1993 would:
1. ) Reduce auto insurance rates by 16% (average) for six months for policyholders reducing personal injury (medical) insurance to $1 million. Extra coverage made available at added cost.
2. ) Permit Insurance Commissioner to waive company's obligation to reduce rates if statutory formula would be in excess of 1989-1992 state average.
3. ) Place limits on personal injury (medical) benefits.
4. ) Limit fees paid to health care providers.
5. ) Limit right to sue by setting higher standards for the recovery of damages for "pain and suffering" and prevent uninsured drivers and drivers over 50% at fault from collecting damages.
6. ) Allow rate reductions for accident-free driving with the same insurer.
Post at 190.
Post at 189.
Because we hold that plaintiff cannot demonstrate that the procedure was "reasonably necessary" to his care, recovery, or rehabilitation, we need not address defendant's alternative argument that the procedure was not "lawfully rendered" and therefore not compensable under the no-fault act.