Summary: Defendants moved for summary judgment on all of the claims asserted by the plaintiff. Following oral arguments, the court granted defendants' motion. Plaintiff asserted that his dependence on the drug ULTRAM was the result of the defendants' failure to warn of the dependency potential and "overpromotion" of the drug. Although whether or not a warning is adequate is a question of fact, the court held that plaintiff's inability to establish through the presentation of competent evidence that the allegedly deficient warning was the proximate cause of his injuries was fatal to his claims. Plaintiff's warranty claims were also dismissed due to the plaintiff's failure to respond to defendant's motion for summary judgment as to these remaining counts.

Case Name: Harris v. McNeil
Case Number: A3-98-105
Docket Number: 48
Date Filed: 9/5/00
Nature of Suit: 365

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NORTH DAKOTA
SOUTHEASTERN DIVISION

MEMORANDUM AND ORDER

Defendants McNeil Pharmaceutical, Ortho Pharmaceutical Corporation, Ortho-McNeil Pharmaceutical and Ortho-McNeil Pharmaceutical, Inc. (hereinafter "McNeil) have moved for summary judgment (Doc. #18) on all of plaintiff Scott Harris M.D.'s ("Harris") claims asserted in his complaint filed on September 24, 1998. The court held oral argument on defendant's motion for summary judgment on June 12, 2000. At the time of the oral argument plaintiff acknowledged that negligent misrepresentation has not been recognized in North Dakota. Thus, defendant's motion for summary judgment as to count six is GRANTED. The following is the order of the court as to the remaining claims.

Factual Background

The following factual recitation was derived from the statement of material facts submitted by the defendant, taking into account the plaintiff's response thereto. Where there are discrepancies, the facts were viewed by the court in a light most favorable to the plaintiff for purposes of this summary judgment order.

Plaintiff Harris was a physician employed by MeritCare Hospital at the time this action arose. The claims stem from his addiction to ULTRAM, a prescription drug manufactured and sold by McNeil. Harris admits to having a previous opioid drug dependency for which he received treatment at the DePaul Rehabilitation Hospital in March 1984. From 1984 to 1990 Harris refrained from the use of alcohol and prescription medications. In 1990 he resumed social consumption of alcohol but was able to refrain from the abuse of prescription and illegal drugs until 1995. In 1995 Harris was provided with some sample boxes of ULTRAM by a McNeil sales representative. The sample boxes contained an FDA approved package insert. Relevant portions of the insert are repeated here.

Under PRECAUTIONS the labeling stated:

Patients Physically Dependent on Opioids

ULTRAM is not recommended for patients who are dependent on opioids. Patients who have recently taken substantial amounts of opioids may experience withdrawal symptoms. Because of the difficulty in assessing dependence in patients who have previously received substantial amounts of opioid medication, caution should be used in the administration of ULTRAM to such patients.

The labeling also addressed drug dependency:

DRUG ABUSE AND DEPENDENCE

Although tramadol (ULTRAM) can produce drug dependence of the mu-opioid type (like codeine or dextropropoxphene) and may be abused, there has been little evidence of abuse in foreign clinical experience. In clinical trials, tramadol produced effects similar to an opioid, and at supra therapeutic doses was recognized as an opioid in subjective/behavioral studies. Tolerance development has been reported to be relatively mild, and withdrawal, when present, is not considered as severe as that produced by other opioids. Part of tramadol's activity is believed derived from its active metabolite, which is responsible for some delay in onset of activity and some extension of the duration of the mu-opioid activity. Delayed mu-opioid activity is believed to reduce a drug's abuse liability.

Harris admits he never read the portion of the labeling recited herein but rather "scanned" the package inserts to "see about how much [he] could take, how much [he] could tell someone to take, refresh [his] memory." Deposition of Dr. Scott Harris, p. 76. He also testified to the following:

Q. Do you recall, as you scanned the package insert, reviewing any information about the drug having a potential for abuse or dependence?

A. No.

Deposition of Dr. Scott Harris, pp. 76-79.

Harris asserts the McNeil sales representative told him that ULTRAM was "a new, highly effective pain reliever which was non-narcotic, nonaddictive" that "it was non-scheduled" and that it had virtually unlimited prescribing potential. Deposition of Dr. Scott Harris, p. 73. Harris contends that the sales representative also "went so far as to say it wouldn't surprise him to see that ULTRAM would go the way of ibuprofen." Deposition of Dr. Scott Harris, pp. 73-74. Plaintiff recalls being provided some literature which contained information concerning foreign studies which he asserts substantiate the representative's statements that ULTRAM was nonaddictive. ⁽¹⁾ Harris testified that he read these articles "to [his] own satisfaction" and was "satisfied that the drug was extremely safe." Deposition of Dr. Scott Harris, p. 75. Based on these representations, Harris began self-prescribing ULTRAM as a means to relieve minor aches and pains, particularly in his neck.

During his use of ULTRAM for symptomatic pain, Harris noticed he experienced a sedative effect. He increased his use of ULTRAM to obtain this effect, particularly in the evening, to the point that he was taking it on a regular basis. He also noticed a pattern of tolerance showing up, requiring increased amounts of the drug to obtain the desired effect. By the fall of 1995 Harris acknowledges he was in "full blown addiction," and when he would try to stop he experienced some withdrawal symptoms, including ringing in his ears, sleeplessness and nervousness. When he realized he was addicted, Harris testified, he did "read something, somewhere" to the effect that ULTRAM "can produce dependence of mu-opioid type like codeine or dextropropoxyphene." Deposition of Dr. Scott Harris, p. 88. He also testified that he read statements "along the lines" that Tramadol may be abused. Deposition of Dr. Scott Harris, p. 89.

Harris testified that he obtained his supply of ULTRAM from a number of sources, including samples and diverting the drug from the clinic and later by self-prescribing. In January 1996, at the insistence of family and friends, Harris was admitted to Hazelden Foundation for treatment of his addiction relapse, where he successfully completed treatment for drug addiction.

Summary Judgment Standard

Summary judgment is appropriate if there is not a genuine issue of material fact and the moving party is entitled to judgment as a matter of law. Fed. R. Civ. Pro. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986). Rule 56 of the Federal Rules of Civil Procedure "mandates the entry of summary judgment . . . against a party failing to make a showing sufficient to establish the existence of an element essential to that party's case." Celotex, 477 U.S. at 322. If the moving party has supported its motion for summary judgment, the nonmoving party has an affirmative burden placed on it to go beyond the pleadings and show a genuine triable issue of fact. Commercial Union Ins. Co. v. Schmidt, 967 F.2d 270, 271 (8th Cir. 1992). However, the court considering a motion for summary judgment must view the evidence in the light most favorable to the nonmoving party who enjoys "the benefit of all reasonable inferences to be drawn from the facts." Vacca v. Viacom Broadcasting of Missouri, Inc. Et al., 875 F.2d 1337, 1339 (8th Cir. 1989)(citation omitted).

Summary judgment is improper if the court finds a genuine issue of material fact; however, "the mere existence of some alleged factual dispute between the parties will not defeat an otherwise properly supported motion for summary judgment . . .." Commercial Union Insurance Co. v. Schmidt, 967 F.2d 270, 271-72 (8th Cir. 1992)(citation omitted). The issue is whether "the evidence is sufficient to allow a reasonable jury to return a verdict for the nonmoving party." Landon v. Northwest Airlines, Inc., 72 F.3d 620, 624 (8th Cir. 1995). Law and Discussion

Harris' first cause of action in his complaint sounds in strict liability for allegedly "manufacturing, labeling, selling, distributing or placing in the stream of commerce an analgesic medication that was defective and unreasonably dangerous." The second cause of action asserts that defendants acted negligently in failing to provide an adequate warning for ULTRAM and failing to design and test the product properly. Plaintiff asserts that material facts preclude the granting of summary judgment as to these counts, specifically asserting that whether the defendants failed to provide an adequate warning to the medical community regarding the abuse potential of ULTRAM and whether ULTRAM was appropriate for use in patients who had a history of abuse or dependence upon opioid drugs is a question for the jury.

Recovery sought under a negligent failure to warn theory and recovery sought under a strict liability theory that the product is unreasonably dangerous because it was not accompanied by an adequate warning are two separate and district theories of recovery. Mauch v. Manufacturers Sales & Service, Inc., 345 N.W.2d 338, 345 (N.D. 1984). Under a negligence theory, the question is whether or not the conduct of the manufacturer in providing a certain warning with its product falls above or below the standard of reasonable care. Id. Under a products-liability theory, the question is whether or not the warnings, if any, which accompany the product are adequate to render the product not unreasonably dangerous. Id. at 346.

As the plaintiff points out, whether or not a warning is adequate is a question of fact. See id. at 511 ("Whether a product is unreasonably dangerous to the user because of a lack of proper warnings is generally a question of fact."); Formella v. Ciba-Giegy Corporation, 300 N.W.2d 356, 358, 100 Mich. App. 649, 653 (1981) ("The adequacy of the warning is a question of fact, properly left to the jury."). Ordinarily such a fact question would preclude the entry of summary judgment. ⁽²⁾ However, this court finds that the better argument asserted by the defendants in favor of summary judgment is the plaintiff's inability to establish through the presentation of competent evidence that the allegedly deficient warning was the proximate cause of his injuries. Thus, although proximate causation in negligence and strict liability actions may be a question of fact, see Butz v. Werner, 438 N.W.2d 509 (N.D. 1989), plaintiff has the burden of establishing that his injuries were proximately caused by the alleged inadequacy of the warning. Holley v. Burroughs Wellsome Co., 348 S.E.2d 772, 773 (N.C. 1986) ("[I]n order to establish a prima facie case of negligence in a products liability action, a party must show. '(1) evidence of care owed by the reasonably prudent person in similar circumstances; (2) breach of that standard of care; (3) injury caused directly or proximately by the breach, and (4) loss because of the injury.'") (citations omitted). This he admittedly cannot do. ⁽³⁾

Case law supports the proposition that a physician's failure to read the warnings, including package inserts and the Physician Desk Reference, essentially "negates any possible liability on the part of [the manufacturer]." Formella, 100 Mich. App. at 653, 300 N.W.2d at 358. For example, in Formella, plaintiffs brought an action for injuries sustained as a result of taking the drug Tandearil. The complaint alleged malpractice on the part of the physician in prescribing the drug and negligence on the part of the manufacturer for failing to warn the physician of the dangers of the drug and promoting its use. Id. The court concluded that the negligence on the part of the physician in failing to read the package insert and PDR was the intervening, independent and sole proximate cause of the plaintiff's injuries. Id. In Douglas v. R.A. Bussabarger, 73 Wash.2d 476, 477, 438 P.2d 829, 831 (1968), the plaintiff raised the question whether the pharmaceutical company should have labeled the drug's container so as to warn of the possible dangers of the drug. The court, assuming such labeling should have taken place, found that such negligence could not be the proximate cause of the plaintiff's injuries because the physician testified that he relied on his own knowledge and "did not read the labeling which was on the container." Id. Accordingly, the defendant manufacturer was dismissed. ⁽⁴⁾ The facts in the case of Oppenheimer v. Sterling Drug, Inc., 7 Ohio App.2d103, 219 N.E.2d 54 (1964), further support the proposition that the physician's failure to recall reading the precautions would defeat the plaintiff's failure to warn claims. Because the physician did not recall reading the warnings and called on his own experience in prescribing the drug, the doctor's failure to rely on the warnings negated the manufacturer's liability. Id. See also Wehling v. Sandboz Pharmaceuticals Corporation, 162 F.3d 1158, 1998 WL 546097 (4^th Cir. 1998) (To create a jury question, the evidence must be of sufficient weight to establish, by the preponderance of the evidence, at least some reasonable likelihood that an adequate warning would have prevented the plaintiff from receiving the drug." (citing Thomas v. Hoffman-La Roche, Inc., 949 F.2d 806, 812 (5^th Cir. 1992)).

Harris testified that he does not recall reading the package insert, other than to scan its contents for dosage information. He does not recall reading anything about the mechanism of action of ULTRAM or a discussion of the drug having a potential for abuse or dependence, until after he recognized he was addicted. Nor does Harris recall reading the package insert portion which provides that "ULTRAM is not recommended for patients who are dependent on opioids," or that portion which provides that "because of the difficulty in assessing dependence in patients who have previously received substantial amounts of opioid medication, caution should be used in the administration of ULTRAM to patients who have previously received substantial amounts of opioid medication." Harris further testified he relied on what the sales representative told him and what he read at the time and did not conduct "an extensive search after that." Deposition of Dr. Scott Harris, p 76-79. ⁽⁵⁾

Rule 56 of the Federal Rules of Civil Procedure "mandates the entry of summary judgment . . . against a party failing to make a showing sufficient to establish the existence of an element essential to that party's case." Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986). Proximate cause is such an element. It is this court's opinion that Harris's failure to review the contents of the package insert pertaining to precautions and dependency potential accompanying the samples of ULTRAM provided to him is fatal to his claims under all theories of liability. Defendants Motion for Summary Judgment (Doc. # 18) is GRANTED on counts one and two.

Plaintiff's third, fourth and fifth causes of action sound in breach of warranty. Defendants assert that Harris's breach of warranty claims overlap the negligence and strict liability claims "and are defective for the same reasons." Defendants assert that no express warranties were made to the plaintiff and there is no breach of implied warranty claim because they adequately warned the medical community concerning the use of ULTRAM. Plaintiff has not responded to the motion to dismiss these counts, asserting only that "[a] jury should decide whether the warnings issued by Ortho-McNeil regarding ULTRAM were adequate in light of the representations by the Defendants' sales representatives in promoting the drug." Based on the plaintiff's failure to respond to the motion for summary judgment as to the warranty claims, the above discussion of lack of causation, and the fact that plaintiff has made no allegation that the drugs he consumed were contaminated, impure or defective, see Douglas, 73 Wash.2d at 477, 438 P.2d at 831 (The court found there was no substantial basis for appeal of a jury verdict in favor of the drug company because there was no question raised as to the correctness or purity of the substance delivered to the hospital), defendants' Motion for Summary Judgment (Doc. #18) is GRANTED as to counts three, four and five.

Based on the foregoing grant of summary judgment as to all counts of the complaint, IT IS ORDERED that Plaintiff's Complaint and causes of action be DISMISSED, with prejudice, and judgment be entered accordingly.

Defendants' Motion in Limine to Exclude Any Evidence Regarding Alleged Statements by Drug Representatives to Non-Treating Physicians or Fact Witnesses (Doc. # 38) and Motion in Limine to Exclude Any Testimony of Plaintiffs in Other ULTRAM Cases Offered as Fact Witnesses Who Allegedly Became Addicted to ULTRAM (Doc. #42) are DENIED as MOOT.

Dated this _____ day of September, 2000.

Karen K. Klein
United States Magistrate Judge

2. Defendant asserts that the adequacy of the warning may be determined as a question of law when the warning is accurate, clear and unambiguous. Upjohn Co. v. MacMurdo, 562 So.2d 680 (Fla. 1990). This court is reluctant to make such a finding and grants summary judgment on an alternative basis. However, it is this court's opinion that the warnings issued by defendants adequately advised of the state of knowledge of the addiction propensity of ULTRAM known to the defendants at the time. See Doe v. Miles Laboratories, Inc., 927 F.2d 187, 193 (4^th Cir. 1991) ("A pharmaceutical manufacturer must warn physicians or other medical personnel authorized to prescribe drugs by state law of risks known or reasonably foreseeable at the time the product is administered."). All of the literature submitted to this court and made available to the plaintiff suggests a low addiction potential, not that there was no possibility of addiction.

3. The presumption that had an adequate warning been given it would have been read and heeded, see Butz v. Werner, 438 N.W.2d 509, 516 (N.D. 1989), is rebutted by plaintiff's testimony that he did not read the warning.

4. ULTRAM, because it is only available by prescription, is an ethical drug. It is well recognized that the duty an ethical drug manufacturer owes to the consumer is to warn only physicians or others permitted to dispense prescription drugs of any risks or contraindications associated with that drug. See Stanbeck v. Parke, Davis and Company, 657 F.2d 642, 643 (4^th Cir. 1981) (citations omitted)(discussion of the learned intermediary theory). The circumstances of this case are unusual in that the physician and the consumer are the same. McNeil does not deny its obligation to provide an adequate warning to the physician but contends it has no obligation to warn of the abuse potential to third parties. Given the fact that Harris self-prescribed, if the warning was adequate to him as a physician, McNeil has satisfied its warning obligation. Additionally, Harris's failure to read the warnings insulates the manufacturer from liability to third persons. Frankly, Harris should consider himself lucky that he did not prescribe the medication to a third person with the same disastrous results. Case law suggests liability against the physician in similar circumstances.

5. Plaintiff argues that the warning provided by the defendants was so "watered down" by the over-promotion of ULTRAM that any warning was inadequate. The court disagrees. First, Harris only had one contact with the sales representative and that was brief at best. Deposition of Dr. Scott Harris, p. 81 (Q. Other than that one conversation with Mr. Franzen at the display stand did you have any other conversations with him about ULTRAM? A. No. Q. Did you have any other conversations with any drug representative of Ortho McNeil Pharmaceuticals about ULTRAM? A. No.) This one contact hardly evidences over-saturation of the market with promotional information lacking in adequate warning. See Stevens v. Parke, Davis and Company, 520 F.2d 1359 (4^th Cir. 1975) (An adequate warning to the profession may be eroded or even nullified by the over-promotion of the drug through a vigorous sales program which may have the effect of persuading the prescribing doctor to disregard the warnings given.). Thus, the court finds as a matter of law that the warnings given were not nullified by over-promotion of the product. Furthermore, Harris did not read the warnings that were provided and therefore there was nothing to nullify. Any nullification could not have been the proximate cause of his injuries.