Georgia Court Rules Physician Has No Duty to Inform
Patients about Chelation Therapy "Alternative"

Stephen Barrett, M.D.


In 1991. a federal judge in Georgia dismissed a claim asserted by a woman who suffered a stroke following surgery in 1989 for partial blockage of her left carotid artery. The woman had charged that her neurosurgeon had committed malpractice by failing to inform her that a chelation therapy was a possible alternative to the surgery. Georgia’s informed consent law requires physicians, before performing surgery, to inform their patients of the risks and of “practical alternatives . . . which are generally recognized and accepted by reasonably prudent physicians.” The judge ruled that the plaintiff had failed to prove that this standard had been violated.

Chelation therapy is not a legitimate alternative to vascular surgery. In explaining his reasoning, the judge noted that chelation therapy was not taught in medical schools, was not FDA-approved for treating blocked arteries, and had been criticized as unproven by the American Medical Association, American Heart Association, American College of Cardiology, and American College of Physicians. Even the doctors who testified as expert witnesses on the woman’s behalf had admitted that chelation therapy is unpopular and not recognized as effective against cardiovascular disease by the great majority of physicians.


UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF GEORGIA
BRUNSWICK DIVISION

JUDITH MOORE,
Plaintiff,

v.

ROY BAKER, M.D., and
NEUROLOGICAL INSTITUTE OF SAVANNAH, P.C.,
Defendants.

CV 491-93

ORDER

Before the Court is the Defendants' motion for summary judgment on the issue of informed consent. As explained below, the Court GRANTS this motion. This decision, however, does not dispose of the case in its. entirety. The Court has recently allowed the Plaintiff to amend her complaint to add a claim that the Defendants committed medical malpractice during and after the surgery. This claim remains extant.

BACKGROUND

The facts in this order are derived from the Plaintiff'’s complaint and response to this motion. In March 1989, the Plaintiff, Judith Moore, was suffering from a partial blockage of her left common carotid artery, which impeded the flow of oxygen to her brain and caused her to feel dizzy and tired. She consulted the defendant, Dr. Roy Baker, an employee of the Neurological Institute of Savannah, P.C. ("Neurological"), about her symptoms. Dr. Baker tested Moore and diagnosed a blockage of her left carotid artery due to arteriosclerotic plaque. He recommended that she check into the hospital to undergo a neurosurgical procedure known as carotid endarterectomy to correct her medical problem.

Baker discussed the proposed procedure with Moore, and advised her of the risks of undergoing the surgery. He did not advise her, however, of an alternative treatment known as Ethylene Diamine Tetra Acetic Acid Chelation ("EDTA Chelation"). According to the Plaintiff's complaint, this alternative procedure is as effective as a carotid endarterectomy but does not entail those risks that accompany any invasive surgery. As explained in more detail below, the mainstream medical community does not recognize or accept EDTA Chelation as an alternative to carotid endarterectomy. A minority of doctors, particularly those who practice holistic medicine, do advocate EDTA Chelation for this use.

Moore signed a written consent allowing Dr. Baker to perform the carotid endarterectomy on April 7, 1989. Initially she appeared to recover well, but soon the hospital staff discovered that Moore was weak on one side. Baker had to reopen the operative wound and remove a blood clot. Although the clot was promptly removed and the area repaired, the clot caused permanent damage to Moore's brain. As a result, Moore is permanently and severely disabled.

ANALYSIS

I. Summary Judgment

"[T]he purpose of Rule 56 is to enable a party who believes there is no genuine dispute as to a specific fact essential to the other side's case to demand at least one sworn averment of that fact before the lengthy process of litigation continues." Lujan v. National wildlife Fed'n, 110 S. Ct. 3177, 3188-89 (1990). The Court "must determine whether there is any genuine issue of material fact and whether the moving party is entitled to judgment as a matter of law." Warren v. Crawford, 927 F.2d 559, 561 (11th Cir. 1991); Regan v. United States Small Business Admin., 926 F.2d 1078, 1080 (11th Cir. 1991) (both citing Celotex Corp. v. Catrett, 477 U.s. 317, 322 (1986)). Thus, summary judgment is appropriate where the  nonmovant fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial." Celotex, 477 U.S. at 322.

The "party seeking summary judgment always bears the initial responsibility of informing the district court of the basis for its motion, and identifying those portions of the pleadings, depositions, answers to interrogatories, and admissions on file, if any, which it believes demonstrate the absence of a genuine issue of material fact." Celotex, 477 U.S. at 323; see Brown v. Crawford, 906 F.2d 667, 670 (11th Cir. 1990), cert. denied, 111 S. Ct. 2056 (1991). The movant typically must discharge this burden by producing evidence that negates an essential element of the nonmovant's claim. E.g., Adickes v. S.H. Kress & Co., 398 U.S. 144, 157 (1970); Clark v. Coats & Clark, Inc., 929 F.2d 604, 608 (11th Cir. 1991).

Only after the movant successfully discharges this initial burden, does the burden shift to the nonmovant to establish, by going beyond the pleadings, that there is a genuine issue as to facts material to the nonmovant's case. Thompson v. Metropolitan Multi-List, Inc., 934 F.2d 1566, 1583 n.16 (11t~ Cir. 1991); Earlev v. Champion Int'l Corp., 907 F.2d 1077, 1080 (11th Cir. 1990); Rollins v. TechSouth, Inc., 833 F.2d 1525, 1528 (11th Cir. 1987). "Factual disputes that are irrelevant or unnecessary will not be counted." United States v. Gilbert, 920 F.2d 878, 883 (11th Cir. 1991) (citation omitted). The nonmovant must present affirmative evidence in order to defeat a properly supported motion for summary judgment." Anderson v. Liberty Lobby, Inc., 477 U. S. 242, 257 (1986); Gilbert, 920 F.2d at 882. This means that the nonmovant "must set forth specific facts showing that there is a genuine need for trial." Johns v. Jarrard, 927 F.2d 551, 555 (11th Cir. 1991) (citation omitted).

In assessing whether the movant is entitled to summary judgment in its favor, the district court must review the evidence and all reasonable factual inferences arising from it in the light most favorable to the nonmoving party. E.g., Regan, 926 F.2d at 1080; Gilbert, 920 F.2d at 882. A mere "scintilla" of evidence supporting the opposing party's position, however, will not suffice. E,g., Walker v. Darby, 911 F.2d 1573, 1577 (11th Cir. 1990). "Where the record, taken as a whole could not lead a rational trier of fact to find for the nonmoving party, then there is no genuine issue for trial.” Matsushita Elec. Indus. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986); see Liberty Lobby, 477 u.s. at 252; Johns, 927 F.2d at 556. The evidence need not be in a form that would be admissible at trial. Celotex, 477 U.S. at 324; Cottle v. Storer Communication, Inc., 849 F.2d 570, 575 (11th Cir. 1988). The Court, however, must avoid weighing conflicting evidence, Liberty Lobby, 477 U.S. at 255; Brown v. Hughes, 894 F.2d 1533,1536 (11th Cir.), cert. denied, 110 S. Ct. 2624 (1990); Tippens v. Celotex Corp., 805 F.2d 949, 953 (11th Cir. 1986), or making credibility determinations. Liberty Lobby, 477 U.S. at 255; McKenzie v. Davenport-Harris Funeral Home, 834 F.2d 930, 934 (11th Cir. 1987). At bottom, "where the facts specifically averred by [the nonmovant] contradict facts specifically averred by the movant, the motion must be denied." Lujan, 110 S. Ct. at 3188.

II. Informed Consent

Moore brought this action against the Defendants, alleging that Dr. Baker violated Georgia's informed consent law, O.C.G.A. 31-9-6.1 (Supp. 1991). Moore claims specifically that Dr. Baker failed to tell her about EDTA Chelation as an alternative treatment. The informed consent law requires physicians, before performing surgery, to inform their patients of the risks of surgery and of "practical alternatives to such proposed surgical or diagnostic procedure which are generally recognized and accepted by reasonably prudent physicians." O.C.G.A. S 31-9-6.1 (a) (5) (Supp. 1991). Failure to comply with this statute "may give rise to an action for medical malpractice as defined in Code Section 9-3-70 . . . and any such action shall be brought against the responsible physician. . .." O.C.G.A. S 31-9-6.1 (d) (Supp. 1991).

A. Evidence Negating an Element of the Plaintiff's Claim

The Defendants contend that Dr. Baker had no duty to inform Moore about EDTA Chelation therapy because that treatment is not "generally recognized and accepted by reasonably prudent physicians" as an alternative treatment for Moore's condition. The Defendants have submitted evidence, including Dr. Baker's own affidavit, that demonstrates that reasonably prudent physicians oppose the use of EDTA Chelation to treat conditions such as Moore's. In his affidavit, Dr. Baker states that he was never taught, in medical school or during his graduate training, that chelation therapy is a practical alternative to carotid endarterectomy. [Footnote 1: Baker Aff. at ¶ 7] Dr. Baker went to medical school at the University of Alabama, and received graduate training at Washington University in St. Louis, Missouri; Carraway Methodist Medical Center in Birmingham, Alabama; and Barnes Hospital, Washington University in St. Louis. [Footnote 2: Id.] In fact, Dr. Baker does not know of any medical school or residency program where EDTA Chelation is even suggested. [Footnote 3: Id.] To confirm his suspicions, Dr. Baker contacted Dr. Fenwick T. Nichols, III, a cerebral vascular neurologist in the Department of Neurology at the Medical College of Georgia. Dr. Nichols confirmed Dr. Baker's belief that no one at the Medical College of Georgia either teaches chelation therapy or considers it a practical alternative to a carotid endarterectomy. [Footnote 4. Id. at ¶ 8.]

A number of professional associations have voiced their opposition to EDTA Chelation treatment in this context. As the Plaintiff concedes, the American Medical Association (the "AMA") published a document in 1983 that concluded "there is general agreement that chelation therapy has not been established as an acceptable treatment for coronary or other arterial atherosclerosis. [Footnote 5: Brief in Support of Defendants' Motion for Summary Judgment at 3.] The American Heart Association does not recommend EDTA Chelation for. treatment of heart disease because "the benefits claimed for [the treatment] aren't scientifically proven.” [Footnote 6: Id. at 4.] This year, the American Academy of Family Physicians agreed that EDTA Chelation" is not an established treatment for atherosclerotic vascular disease. [Footnote 7: Id at 5.] Both the American College of Cardiology and the American College of Physicians, noting the lack of objective evidence suggesting therapeutic benefit from EDTA therapy for arteriosclerosis disease, have opposed the therapy except on an experimental basis. [Footnote 8: Id. at 4-5.]

Opposition to this treatment is based not only upon the lack of objective evidence that the treatment is effective, but also upon evidence that the treatment may be dangerous. In 1982, The Medical Letter, a medical publication, reviewed chelation therapy and concluded "there is no acceptable evidence that chelation therapy with EDTA is effective in the treatment of atherosclerosis and the adverse effects of the drugs can be lethal." [Footnote 9: Id. At 3-4.] The Food and Drug Administration (the "FDA") has approved chelation therapy for the treatment of lead poisoning, but it has not approved the therapy for treating conditions such as Moore's blocked carotid artery.

In October 1989, the FDA published an article entitled Top 10 Health Frauds. 23 FDA Consumer 28 (Oct. 1989). This list of frauds includes instant weight-loss schemes, fraudulent sexual aids, and quack baldness remedies. The eighth fraud listed is chelation therapy:

Promoters of this therapy claim that an injection or tablet of the amino acid EDTA, taken with vitamins and minerals, cleans out arteries by breaking down arterial plaque (deposits of cholesterol and other lipid materials). Such treatment is supposed to prevent circulatory disease, angina (chest pains), heart attacks, and strokes and is advertised as an "alternative" to heart bypass surgery. Both FDA and the American Heart Association say there is no scientific evidence that chelation therapy works. Nevertheless, patients spend as much as $3,000 to $5,000 for chelation treatments. Not only are they paying for an ineffective treatment, they are also buying a dangerous drug. EDTA can cause kidney failure, bone marrow depression, and convulsions.

Id. at 31 (emphasis added).

As noted above, the Georgia informed consent statute required Dr. Baker to disclose only those alternatives to surgery that are "generally recognized and accepted by reasonably prudent physicians." O.C.G.A. § 31-9-6.1 (a)(5). The Defendants have produced ample evidence that EDTA Chelation is not a generally recognized and accepted alternative treatment for conditions such as Moore's. With this evidence, the Defendants have negated an essential clement of the Plaintiff's claim. See e.g., Adickes, 398 U.S. at 157; Coats & Clark, 929 .i.2d at 608. Thus, the Defendants have shifted the burden to the Plaintiffs to establish, by going beyond the pleadings, that there is a genuine issue as to facts material to the nonmovant's case. Thompson, 934 F.2d at 1583 n.16.

B. The Plaintiff's Attempt to Survive Summary Judgment

In response to the Defendants' motion, the Plaintiff has produced two affidavits: the affidavit of David A. Steenblock, an osteopathic physician, and the affidavit of Murray R. Susser, M.D. The parties also have presented the Court with portions of the deposition testimony of Dr. Steenblock. Both of these doctors support the use of EDTA Chelation therapy to treat conditions such as Moore's.

Dr. Steenblock supports the use of EDTA Chelation therapy as part of an overall approach to vascular disease. Along with EDTA Chelation, Dr. Steenblock advocates changing the patient's diet to lower cholesterol intake, requiring the patient to stop smoking, advising the patient to take vitamins, minerals, amino acids, treating the patient's allergies, and reducing the patient's stress. He notes that this alternative therapy is much cheaper than surgery. He opines that surgeons, hospitals, and trade associations whose members are surgeons and hospitals, oppose EDTA Chelation because this alternative therapy would reduce profits of the therapy's opponents. According to Dr. Steenblock, "[w]hen one can earn the price of a brand new European sports car for a half days [sic] work, one's enthusiasm for that work tends to climb and remain rather high, as would ones [sic] disdain for a new procedure which threatened to make such highly profitable work largely obsolete. [Footnote 10: Steenblock Aff. at 6-7.]

Steenblock also asserts that, “EDTA has been used successfully for many years by holistic physicians for the treatment of occlusive arterial disease. Footnote 11: Id. at 8.] He estimates that approximately one thousand physicians routinely treat occlusive arterial disease with EDTA, although he concedes that medical insurance companies who pay for cardiovascular surgery routinely refuse to pay for this chelation therapy.

Moreover, Steenblock avers that several physician organizations sponsor educational courses on the use of EDTA chelation. The American College for Advancement in Medicine publishes a protocol for correct methods of using EDTA. The American Board of Chelation Therapy sponsors educational program’s for physicians. The American Holistic Medical Association offers workshops on the use of EDTA. Steenblock does not specify whether these organizations advocate the use of EDTA Chelation specifically for treating arteriosclerosis disease like Moore's, or whether they advocate the use of this treatment for other diseases.

Several pages of Steenblock's affidavit attempt to show that treatments once dismissed as quackery are now accepted by the mainstream medical profession. For example, Dr. Semmelweis, who urged doctors to wash their hands before delivering babies, was persecuted by. his colleagues in the medical profession. These doctors refused to believe that they could transmit disease from one patient to another through their unwashed hands. [Footnote 12: Steenblock at 17.] With this analogy, Steenblock suggests that the medical profession's current opposition to EDTA Chelation is misguided. The implication of this analogy is that the medical community may one day accept EDTA Chelation as completely as the profession has embraced the notion that diseases can be transmitted on a physician's dirty hands.

Because the Court does not have a crystal ball, it cannot determine whether Steenblock's prediction will come true. Unfortunately for the Plaintiff, the Court need not make this determination. Georgia's informed consent law does not require physicians to inform patients of all alternatives to surgery, or even of all alternatives that the medical profession should accept. The law requires disclosure only of those alternatives that are "generally recognized and accepted by reasonably prudent physicians." O.C.G.A. § 31-9-6.1 (a) (5). Dr. Steenblock's testimony, in essence, concedes that Dr. Baker met this standard. At Dr. Steenblock's deposition, the following exchange occurred:

Q: Chelation therapy is not a conservative, standard or recognized treatment recognized by physicians who perform endarterectomies; is that a fair statement?

A [by Dr. Steenblock]: That's true.

Q: Would that be true as well with cardiologists, neurosurgeons and physicians who perform vascular surgery, and cardiologists [sic]?

A: As of this point in time, since the F.D.A. hasn't approved its use for vascular disease, the great majority of physicians, including those you mentioned, would not advocate the use of chelation therapy for treatment of vascular disease.

Q: And they wouldn't advise clients of chelation therapy as an. alternative to surgery or conservative treatment with aspirin and other medications?

A: I am sorry. Would you repeat that question?

Q: . . . and that same group of physicians that we have just talked about would not include chelation therapy in the alternatives that they tell their patients about when discussing surgery? Isn't that correct?

A: That's correct. [Footnote 13: Steenblock Dep. At 120-21.]

The Plaintiff has a second expert witness, Murray R. Susser, M.D. Dr. Susser, like Dr. Steenblock, avers that Dr. Baker's failure to advise the Plaintiff about EDTA Chelation violated O.C.G.A. 31-9-6.1. Like Dr. Steenblock, Dr. Susser concedes that EDTA Chelation therapy is unpopular with surgeons and other members of the medical profession. [Footnote 14: Susser Aff. at 6.] The rest of Dr. Susser's affidavit is duplicative of Dr. Steenblock's affidavit and testimony.

The Plaintiff has produced evidence that suggests that some physicians approve of EDTA Chelation therapy as an alternative to surgery. Drs. Susser and Steenblock believe that the medical profession should embrace this therapy as a viable alternative to surgery. Whether the medical profession should change its opposition to this treatment, however, is not the issue before the Court. The Court must determine the narrow issue of whether Dr. Baker violated the Georgia informed consent law when he failed to inform the Plaintiff that EDTA Chelation was an alternative treatment. Because the Plaintiff has not shown that reasonably prudent physicians generally recognize and accept this alternative treatment, the Court concludes that Dr. Baker did not violate the statute. The Defendants' motion for summary judgment is GRANTED.

CONCLUSION

Georgia's informed consent law does not require physicians to inform patients who are about to undergo surgery about every new experimental treatment that might be efficacious. It certainly does not require physicians to inform patients about treatments that the mainstream medical profession rejects as quackery or condemns as dangerous. Instead, the statute limits the physician's duty to informing the patient of generally accepted alternatives. The Defendants have established that EDTA Chelation is not a generally accepted alternative to the surgery Dr. Baker performed on Moore. Moore has been unable to refute the Defendants' evidence on this point. Because there are no material facts in dispute and the Defendants are entitled to judgment as a matter of law on this issue, the Court GRANTS the Defendants' motion for summary judgment.

As noted above, this conclusion does not dispose of the case. Still remaining is the Plaintiff's contention that Dr. Baker acted negligently during and after the surgery.

SO ORDERED this 5th day of September 1991.

________________________________

B. AVANT EDENFIELD, CHIEF JUDGE
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF GEORGIA

This page was posted on August 11, 2004.

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