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FILE NO. 95 CVS 05585

JANE COPE, individually and as Administratrix )
of the Estate of Jimmy Ray Cope, deceased )
Plaintiff, )
vs. )
        Defendants.                              )
                        IN OPPOSITION TO
                  SUMMARY JUDGMENT


          This cause is before the Court on defendants' Motion for Summary Judgment pursuant to Rule 56 of the North Carolina Rules of Civil Procedure. Plaintiff's husband was the third of three patients who died during 1994 of a massive overdose of a cancer chemotherapy drug known as Navelbine (defendant's name for the drug "vinorelbine"), a dangerous, toxic agent that was manufactured by Burroughs Wellcome (Bigley dep. p. 85). In each of these deaths the nurse administering the drug read the label on the container as stating 10 mg of Navelbine  rather than 50 mg (Bigley dep. Exhibit 26). In fact the label involved in each of these deaths stated "10 mg vinorelbine per mL," although the vial actually contained 50 mg of the drug (Bigley dep. Exhibit 15, p. 2). After the three overdose deaths defendant changed the label to read A50 mg/5 mL." (Defendant's Amended Response to Plaintiff's First Set of Interrogatories, No. 2 and No. 23).

          In summary, Mr. Cope died because the Navelbine product was dangerously defective due to the fact that the label on the container was not adequate. Although the container had 50 mg of drug in it the numeral 10 mg appeared prominently on the label, the nurse saw that and thought that was the quantity of the drug in the container (Williams dep. p 47; Exhibit 3). The label in this case was contrary to standard industry practice and standards which was to show the total quantity of drug on the label (Wogalter affidavit). 

          This same type of overdosing error caused by the fact that the label stated 10 mg rather than the total quantity of 50 mg had occurred twice before Mr. Cope's overdose during 1994. In addition, FDA safety regulations required the defendant to notify all physicians using Navelbine in their practices, including Mr. Cope's doctor, that these overdoses had occurred and why they occurred. The defendant failed to comply with these safety regulations and did not notify Mr. Cope's doctor of the prior overdose deaths in a timely and adequate manner. Defendant's violation of the federal safety regulations is negligence per se

          Further, plaintiff has provided an affidavit from Dr. Michael S. Wogalter, a nationally known expert in human factors/ergonomics/pharmaceutical matters who has stated his opinion that the label in this case was defective and not adequate. The facts of this case also show that further confusion aggravating the defective and inadequate label was caused by defendant's shipping of two types of containers to the doctor's office for treatment of Mr. Cope, all labeled 10 mg but with some containing 10 mg and some containing 50 mg. 

          There are also admissions of defendant in this record that the Navelbine label involved in the overdose deaths was not adequate, that defendant failed to send safety information to physicians about the facts and circumstances of the first overdose that occurred in April of 1994 and defendant again violated federal safety regulations by failing to immediately notify physicians of the second overdose death that occurred in July of 1994 prior to Mr. Cope's overdose which occurred on August 3, 1994.

          Plaintiff's Complaint seeks damages against the defendant drug manufacturer for the wrongful death of her husband and for her severe emotional distress caused by the defendants in failing to provide reasonable and adequate packaging, instructions, warnings, prescribing information and labeling text in connection with Navelbine; failing to warn of known dangers which could be encountered during foreseeable use of the drug; failing to exercise its continuing duty to provide warnings of deficiencies it learned existed in the packaging, the packaging materials and labels contained on the drug containers, which warnings were required by federal safety regulations; and failing to provide reasonable and timely warnings and notice to health care providers administering the drug concerning deficiencies. As a proximate result of defendants' failures, negligence, breach of the standard of care and unlawful conduct the plaintiff's husband died of an overdose of Navelbine, and the plaintiff suffered severe emotional distress.

          This action was filed on December 29, 1995, prior to the effective date of recent changes in North Carolina's punitive damages and product liability laws. Defendant responded to the Complaint by filing a Motion to Dismiss pursuant to Rule 12(b)(6) of the North Carolina Rules of Civil Procedure. That matter was briefed and argued by the parties, and, on July 3, 1996, this Court denied defendants' Motion to Dismiss. At the present time discovery is continuing in this action. Ten depositions have been taken and defendant has produced voluminous documents pursuant to Plaintiff's Request for Production of Documents and a Consent Protective Order. Also, on February 7, 1997, during the deposition of defendants' former employee Dr. Judith Kramer, counsel for defendant advised plaintiff's counsel that there are a substantial number of additional documents relevant to plaintiff's discovery requests that had not been produced. On Friday, March 7, 1997, plaintiff began analyzing copies of those discovery documents, which are contained within eight boxes located at the office of defense counsel. More depositions are being scheduled during April and the case is set for trial on May 19, 1997.


          Defendant's answers to interrogatories, documents it has produced during discovery, its responses to Requests for Admission and depositions show that at best for defendant, there are genuine issues of material facts that must be resolved by a jury. During 1994 plaintiff's decedent, Jimmy Ray Cope, was 49 years old and lived in Durham with his wife of 29 years, the plaintiff Jane Cope. Mr. Cope had lung cancer and was under the care of Dr. Walter E. Davis, a physician practicing at the Durham Clinic. Although Mr. Cope was being treated for lung cancer he continued to work every day, was ambulatory and functioning. Mr. Cope was scheduled to undergo treatment with an experimental chemotherapy drug known as Navelbine that was manufactured by defendant Burroughs Wellcome (which was subsequently merged into Glaxo Wellcome, Inc. during 1995). Navelbine was a dangerous, toxic drug because it attacks healthy organs and tissues in the same manner it attacks cancer, and during 1994 Navelbine had not yet been approved for marketing by the United States Food and Drug Administration (FDA)(Bigley dep. p 85). The use of Navelbine in the treatment of human patients during this time was strictly controlled and regulated by FDA regulations while the safety and efficacy of the drug were being studied.

          The proper dose for Mr. Cope was 50 mg of Navelbine for each treatment. Unfortunately, Burroughs Wellcome shipped the Navelbine to Durham Clinic for administration to Mr. Cope in two different sizes of containers. One container, referred to as an ampule, contained 10 mg of Navelbine within one milliliter of fluid. The second size of container, referred to as a vial, contained 50 mg of Navelbine within five milliliters of fluid. The concentration of Navelbine in both the ampule and vial containers was 10 mg/mL, and the label on each size of container confusingly stated, "10 mg vinorelbine per mL" (Bigley dep. Exhibit 15, p. 3). Burroughs Wellcome provided both ampules and vials of Navelbine to Durham Clinic for Mr. Cope, even though each vial contained exactly the proper quantity of Navelbine for Mr. Cope's dose (DeAngelis dep. pp. 46-50; Williams dep. p 59). 

          Mr. Cope's first course of Navelbine treatment took place on July 20, 1994 at Durham Clinic. During this treatment Mr. Cope received the proper dose of 50 mg of Navelbine administered to him intravenously, which was prepared in a solution that used five ampules of Navelbine, each containing ten milligrams of Navelbine

          On July 27, 1994 Mr. Cope underwent his second course of treatment with Navelbine at Durham Clinic. During this second course of treatment Mr. Cope again received the proper dose of 50 mg of Navelbine administered to him intravenously in a solution that was prepared using five ampules of Navelbine, each containing ten milligrams of Navelbine. During these first two courses of treatment, the same nurse administered the Navelbine to Mr. Cope. These initial two treatments used all of the ampules (10 mg/mL) of Navelbine that Burroughs Wellcome had provided to Durham Clinic for Mr. Cope, leaving only vials of Navelbine (50 mg/5mL) available for subsequent treatments of Mr. Cope (Williams dep. p 60).

          Mr. Cope underwent his third and fatal course of treatment with Navelbine at Durham Clinic on August 3, 1994. During this third course of treatment a nurse who had not administered Navelbine to Mr. Cope previously, administered the Navelbine to him intravenously by preparing a solution for him made up of the contents of five vials of Navelbine. Consequently, on this third occasion Mr. Cope was administered a lethal dose of 250 mg of Navelbine, which was five times greater than the amount of Navelbine he should have received on this occasion. The nurse who administered the Navelbine to Mr. Cope on August 3, 1994, reasonably thought that each vial contained 10 mg rather than 50 mg. She testified that when she read the label she saw "10 mg." (Williams dep. p. 47). Indeed, nowhere on the label did the numeral "50" appear (Kramer dep. Exhibit 3). Ms. Cope was physically present with her husband during all three of his Navelbine treatments (Cope affidavit). 

          On August 5, 1994 Mr. Cope was admitted to Durham Regional Hospital for treatment of his overdose, which manifested itself by the appearance of severe symptoms. At the time of Mr. Cope's admission to the hospital his treating physician was unaware that Mr. Cope had been administered an overdose on August 3. The fact of the overdose was not discovered until August 9, 1994. On this date personnel at Durham Clinic read a letter from Burroughs Wellcome dated and allegedly mailed on August 3, 1994 (the date Mr. Cope was overdosed) that informed physicians treating patients with Navelbine that there had been two cases of Navelbine overdoses in which patients had been administered approximately five times the amount of the drug that had been prescribed because the administering nurses in both cases read the label on the vial of Navelbine as containing 10 mg rather than 50 mg. Upon reading this letter personnel at Durham Clinic ascertained that Mr. Cope had been administered an overdose of five times the amount of his prescription because the nurse administering the drug to him read the label on the container as containing "10 mg" rather than 50 mg (Williams dep. p 54).

          During Mr. Cope's hospitalization he was confused, toxic and delirious, he suffered from hallucinations, he had severe headaches, neck aches, irritated discharge from his left eye, burning, blistering and breaking down of the skin, kidney and liver failure, and other ailments, and he died a horrible death over a twelve day period which culminated on August 17, 1994. The cause of his death was the Navelbine overdose (Davis dep. p 96). Ms. Cope remained with her husband in his hospital room continuously from the day of his admission on August 5, 1994 until his death on August 17, 1994 (Cope affidavit).


     In the case of prescription drugs "...the adequacy of the warning by the manufacturer shall be determined by the prescribing information made available by the manufacturer to the health care practitioner..." G.S. ' 99B-4(1). In North Carolina issues of the adequacy of labels and warnings are usually considered jury issues. In Reid v. Eckerds Drugs, Inc., 40 N.C. App. 476, 253 S.E.2d 344 (1979), the plaintiff suffered burns after applying deodorant from an aerosol can and attempting to light a cigarette. The plaintiff had put the can down, walked across the room and struck a match to light a cigarette when the burns occurred. Although the deodorant conformed to federal standards for flammability the Court found that the labeling of the deodorant, viewed in the light most favorable to the plaintiff, was not sufficient as a matter of law to entitle defendant to summary judgment. AA question of fact as to the sufficiency of the packaging and labeling clearly exists and is one for the jury." Id., 253 S.E.2d at 350. In Salmon v. Parke, Davis and Company, 520 F.2d 359 (4th Cir. 1975), the Fourth Circuit, applying North Carolina law, reversed the trial court's entry of summary judgment in an action brought by the guardian ad litem of a child against a drug manufacturer based on its failure to warn physicians effectively of a drug's hazards. The Court noted that a jury could reasonably find that the company failed to warn physicians with an emphasis that was commensurate with the risk, that a jury could further conclude that the fault of misuse of the drug should be shared by both the manufacturer and the physician, and that the action could not properly be decided by the Court as a matter of law:

Our catalog of permissible inferences is intended neither to define nor to decide the issues in this case. It serves simply to illustrate our reasons for concluding that summary judgment is inappropriate and that, as in negligence actions generally, it is for the jury to say whether the defendant breached its duty to exercise reasonable care.

Id. at 1363.

Likewise, in a case against Burroughs Wellcome involving an anesthetic called Fluothan and a muscle relaxant called Anacetine, our Supreme Court held that the adequacy of a warning was a jury question. Holley v. Burroughs Wellcome Co., 318 N.C. 352, 348 S.E.2d 772 (1986). And, as our Court of Appeals pointed out in Ziglar v. E. I. Dupont De Nemours and Co., 53 N.C. App. 147, 280 S.E.2d 510, 513 (1981), disc. review denied, 304 N.C. 393, 285 S.E.2d 838 (1981):

It is elemental that it is usually the jury's prerogative to apply the standard of reasonable care in a negligence action, and summary judgment is, therefore, appropriate only in exceptional cases where the movant shows that one or more of the essential elements of the claim do not appear in the pleadings or proof at the discovery stage of the proceedings. Ragland v. Moore, 299 N.C. 360, 261 S.E.2d 666 (1980). See, e.g., Moore v. Fieldcrest Mills, Inc., 296 N.C. 467, 251 S.E.2d 419 (1979); Strickland v. Dri-Spray Division Development, 51 N.C. App. 57, 275 S.E.2d 503 (1981).

This case is not such an exceptional case because there is overwhelming evidence in this record that defendant's Navelbine label was clearly inadequate.

1. Evidence of the First Two Overdoses Creates a Prima Facie Case of Defect, Notice to Defendant and Causation

          It is undisputed that prior to Mr. Cope's overdose and in close proximity thereto, two other patients died of Navelbine overdoses under identical circumstances to the facts of Mr. Cope's overdose because administering nurses read the label on the vial as containing 10 mg rather than 50 mg. Under longstanding North Carolina law this evidence establishes a prima facie case of defect of the product and notice to the defendant of the defect with the corresponding duty to provide reasonable and adequate warnings to physicians treating patients with Navelbine. Evidence of prior similar accidents involving a product is admissible to prove fault and notice to the manufacturer. In Perry v. Kelford Coca-Cola Bottling Co., 196 N.C. 690, 691, 146 S.E. 805 (1929), our Supreme Court reasoned as follows:

evidence of the occurrence of similar events is probative on an issue...[of] whether a like occurrence happened at another time...for under such circumstances the observed uniformity of nature raises an inference that like causes will produce like results even though there may be some dissimilarity of conditions...

In Maybank v. Kresge Co., 46 N.C. App. 687, 690, 266 S.E.2d 409, 411 (1980), modified and aff'd, 302 N.C. 129, 273 S.E.2d 681 (1981), the Court stated that A[p]laintiff could have established a jury question on the issue of negligence by showing similar occurrences." See Byrd, Proof of Negligence in North Carolina: Part II - Similar Occurrences and Violations of Statute, 48 N.C.L.Rev. 731, 736, 739 (1970) (AThe Court has adopted a liberal view of what constitutes 'substantially similar circumstances' in the vast majority of cases...The evidence of similar occurrences may establish a prima facie case of negligence...") Accord, J. Stansbury, STANSBURY'S NORTH CAROLINA EVIDENCE, ' 89 (2nd rev. ed. 1982), where the following appears:

Evidence of similar occurrences or conditions may, in negligence actions, be admitted as relevant to the issue of negligence for example, to show a defective or dangerous machine, place or condition, or to the issues of defendants' knowledge, or to the issue of causation...

2. Defendant has admitted the Navelbine label was not adequate

          Facts have been established during discovery that constitute an admission on the part of the defendant that the Navelbine label was "not adequate." These facts show that during 1994, before Mr. Cope's overdose, but after the first two overdoses, Dr. Judith E. Kramer, an officer of defendant and head of U.S. Clinical Research (Bigley dep. p. 70), told Joseph Bigley, who was section head of Experimental Oncology of defendant, that the Navelbine label was "not adequate" (Kramer dep. p. 74). In addition, Dr. Kramer testified that she suspected she may have said, "Well, gee, why didn't we have the total dose on that

          1 See deposition of Joseph Bigley, pp. 67-94 and Exhibit 2 thereto; deposition of Dr. Judith E. Kramer, pp. 57-77 and Exhibit 1 thereto.

label?"(Kramer dep. p. 74). During the telephone conversation between these two key employees of defendant, Mr. Bigley took detailed handwritten notes of statements made to him by his superior, Dr. Kramer, who was responsible for the Oncology Department which was conducting the Navelbine trials. (Bigley dep. Exhibit 2; Kramer dep. Exhibit 1). Other telling admissions made by Dr. Kramer during the conversation which were explicitly spelled out in Mr. Bigley's notes, are to the effect that defendant violated federal safety regulations by not sending safety information to physicians treating patients with Navelbine after the first overdose, and by not notifying the physicians "immediately" (Bigley dep. pp. 78-79) after the second overdose. These admissions are discussed in more detail hereinbelow.

3. There is Evidence that Defendant was Negligent in Manufacturing an 
Inherently Dangerous, Toxic Substance Without Taking Reasonable 
Precautions to Decrease the Risk of Confusing 50 mg with 10 mg.

          After Mr. Cope's tragic overdose, defendant sent fluorescent stickers that stated "50 mg/5mL" to the offices of physicians treating patients with Navelbine to be placed on all Navelbine vial containers, and defendant also changed the label on the Navelbine vial to read "50 mg/5mL" rather than A10 mg vinorelbine per mL." (Bigley dep. pp. 45-47; Defendant's Amended Response to Plaintiff's First Set of Interrogatories, No. 2 and No. 23). These facts create a factual issue for a jury as to whether defendant was negligent in providing an inherently dangerous, toxic substance to physicians for their use in treating patients without taking reasonable precautions to decrease the risk of the lethal confusion of 50 mg with 10 mg. In this regard, the Court of Appeals held the following in Ziglar, supra, 280 S.E.2d at 516:

The law requires a manufacturer to eliminate the dangerous character of goods to the extent that the exercise of reasonable care, considering all of the circumstances, enables him to do so. See Cashwell v. Bottling Works, 174 N.C. 324, 93 S.E. 901 (1917). It is not without significance, therefore, that DuPont began bottling Vydate L in gray, opaque containers, on 24 May 1974, shortly after this tragic accident occurred, as requested by the State of North Carolina, and that it added amber coloration to the colorless poison in January 1975. Thus, on this record, a critical factual issue, and one not susceptible to disposition by summary judgment, was whether DuPont was negligent in manufacturing an inherently dangerous, toxic substance without taking reasonable precautions to decrease the risk of its lethal confusion with ordinary, harmless drinking water. (emphasis supplied)

          Similarly, defendant suspended its use of ampules for the packaging of Navelbine in the Treatment IND after Mr. Cope's death, which under the rationale explained above in Ziglar, creates a fact issue regarding plaintiff's claim that defendant was negligent by packaging Navelbine in both ampules and vials and without clearly stating the quantity of drug contained within each size of container. (Martini dep. Exhibit 1; Bigley dep. Exhibit 18).

4. The Affidavit of Plaintiff's Expert Creates a Fact Issue of Adequacy of the Label

          Plaintiff has presented the Affidavit of Michael S. Wolgalter, Ph.D., a highly qualified expert in human factors/ergonomics, who is an Associate Professor of Psychology at North Carolina State University, to the effect that the Navelbine label implicated in the three overdose deaths during 1994 was not adequate



1. Defendant Violated Federal Safety Regulations Which Required it to Provide Physicians Treating Patients with Navelbine with an IND Safety Report Containing Information about the April 1994 Overdose Death AAs Soon as Possible and in No Event Later than 10 Working Days after the Sponsor's Initial Receipt of the Information."

          Defendant learned of the first Navelbine overdose on April 22, 1994. As noted hereinabove, during 1994 Navelbinewas a cancer chemotherapy drug that was the subject of clinical trials and Navelbine had not yet been approved by the FDA for marketing. Navelbine's use in the treatment of human patients was restricted and controlled by federal regulations. These regulations required defendant to notify FDA and all participating investigators (Mr. Cope's physician at Durham Clinic was a participating investigator) in a written IND (investigational drug) Safety Report of any fatal or life-threatening overdose associated with the use of Navelbine. 21 C.F.R. Sec. 312.32(c) required that such notification "shall be made as soon as possible and in no event later than 10 working days after the sponsor's (Burroughs Wellcome Co.) initial receipt of the information."(emphasis supplied) In addition, 21 C.F.R. Sec. 312.55(a) required defendant to give each participating clinical investigator an Investigator's Brochure containing Aa summary of information relating to safety and effectiveness in humans obtained from prior clinical studies." Furthermore, 21 C.F.R. Sec. 312.55(b) required the following with respect to safety reports:

The sponsor [Burroughs Wellcome, Co.] shall, as the overall investigation proceeds, keep each participating investigator informed of new

2 Defendant's Response to Plaintiff's Second Set of Interrogatories, No. 25.

observations discovered by or reported to the sponsor on the drug particularly with respect to adverse effects and safe use. Such information may be distributed to investigators by means of periodically revised Investigator's Brochures, reprints or published studies, reports or letters to clinical investigators, or other appropriate means. Important safety information is required to be relayed to investigators in accordance with Sec. 312.32.

          In addition to receipt of notice on April 22, 1994, that a patient had died of a Navelbine overdose, on April 25, 1994 defendant received by facsimile transmission from the site of the investigation where this patient had died, the following information:

(a) the patient's death was caused by a Navelbine overdose; 
(b) that the dose that was actually administered to the patient on the day in question was 197.5 mg of Navelbine whereas the dose ordered by the physician was 39.5 mg and was reconfirmed by phone with the administering nurse prior to the fatal drug administration; 
(c) that the registered nurse who prepared and administered the medication had been in the employment of the investigator-physician's practice for seventeen months and administered approximately four to fifty chemotherapy treatments per week; 
(d) that the nurse had been trained to give chemotherapy during a twelve month period of direct supervision by the practices's senior chemotherapy nurse who also had six years of experience in the administration of investigational and conventional chemotherapy; 
(e) that when questioned about this error, the nurse related that she read the label as containing 10 mg and not 10 mg/mL; 
(f) that, indeed, on no vial of medication [Navelbine] is there any indication of the total dose contained in the vial; 
(g) that while the error was a nursing calculation error such a problem may possibly have been obviated by an indication of total dose on the label; 
(h) that this type of labeling [showing total dose] is seen on all other similar drugs; and

(i) that the physician's practice was unaware of any other mixing or dosing errors performed by this nurse in her seventeen months of employment or prior to her employment.

(Adamkiewicz dep. Exhibit 3)

          Pursuant to the applicable federal safety regulations cited herein, Burroughs Wellcome Co. was required to A...keep each participating investigator [including Dr. Walter E. Davis of Durham Clinic] informed of new observations discovered by or reported to the sponsor on the drug, particularly with respect to adverse effects and safe use." 21 C.F.R. Sec. 312.55(b) (emphasis supplied). In addition, the Investigator's Brochure that was provided to Dr. Davis and the Durham Clinic prior to the beginning of Mr. Cope's treatment with Navelbine during the summer of 1994, should have contained the information that Burroughs Wellcome Co. had received from the physician whose patient suffered a fatal Navelbine overdose during April of 1994. Information was not provided to physicians about the April 1994 overdose until the

          3  See GL00421,(Davis dep. Exhibit 2) a letter dated July 6, 1994, from defendant's Barbara Orban to Dr. Walter E. Davis, specifying the IND Safety Reports included within his Investigator's Brochure. Unfortunately, neither Dr. Davis nor the other physicians treating patients with Navelbine were provided information required by federal regulations about the April 1994 overdose until two more patients had died, including Mr. Cope.

mailing of a letter dated August 3, 1994, the day Mr. Cope received his overdose. (Bigley dep. Exhibit 3).

          Discovery documentation and deposition testimony taken in this case show that defendant violated the applicable Code of Federal Regulations identified hereinabove (1) by failing to notify all participating investigators in a written IND Safety Report of the first fatal Navelbine overdose that occurred during April of 1994 Aas soon as possible and in no event later than 10 working days" after the company's initial receipt of the information; (2) by failing to provide information concerning the circumstances of the April 1994 Navelbine overdose to investigators treating patients with Navelbine, including Dr. Walter E. Davis of the Durham Clinic, prior to the time Dr. Davis and the Durham Clinic began treating Mr. Cope with Navelbine; and (3) by failing to provide a summary of the information concerning the April, 1994 overdose as a part of the Investigator's Brochure prior to the time that Mr. Cope began receiving Navelbine treatment.

2. Defendant's Violation of Safety Regulations is Negligence per se.

          The violation of a safety regulation promulgated by the executive branch of government which imposes a duty upon the defendant in order to promote the safety of others, including the plaintiff, is negligence per se. Baldwin v. GTE South, Inc., 335 N.C. 544, 439 S.E.2d 108 (1994) (violation of a Department of Transportation safety regulation is negligence per se). Such negligence of the defendant actionable if it is the proximate cause of injury." Ratliff v. Duke Power Co., 268 N.C. 605, 610, 151 S.E.2d 641, 645 (1966). The regulatory standard is conclusive on the issue of reasonable care and the defendant is negligent as a matter of law as the Supreme Court of North Carolina stated in the case of Carr v. Murrows Transfer, Inc., 262 N.C. 550, 554, 138 S.E.2d 228, 231 (1964):

It is the generally accepted view that the violation of a statute enacted for the safety and protection of the public constitutes negligence per se, i.e., negligence as a matter of law. The statute prescribes the standard and the standard fixed by the statute is absolute. The common law rule of ordinary care does not apply - proof of the breach of the statute is proof of negligence. The violator is liable if injury or damage results, irrespective of how careful or prudent he has been in other respects. No person is at liberty to adopt other methods and precautions which in his opinion are equally or more efficacious to avoid injury...In short, where a statute or municipal ordinance imposes upon any person a specific duty for the protection or benefit of others, if he neglects to perform that duty, he is liable to those for whose protection or benefit it was imposed for any injuries or damage of the character which the statute or ordinance was designed to prevent, and which was proximately produced by such neglect, provided the injured party is free from contributory negligence.

          In Baldwin, supra, the plaintiff suffered injuries when a vehicle struck the telephone booth she was using. The booth was located within the public right-of-way in violation of regulations of the North Carolina Department of Transportation. Although the Court of Appeals found that the regulation had been enacted for safety reasons, the Court was of the view that because the plaintiff was a pedestrian rather than a motorist, she was not in the class of protected persons. Therefore the defendant's violation did not constitute negligence per se. The Supreme Court reversed, finding that although the regulation was silent as to its purpose, the implied purpose was to protect pedestrians who travel within the public rights-of-way as well as motorists:

One implied purpose is to protect the safety of motorists by eliminating an obstruction a motorist otherwise might strike...Here, the telephone booth, which naturally attracts pedestrians, was twenty-five feet from the edge of the road yet within the right-of-way. Logic dictates that the purpose of this regulation was to protect the safety of the motorist who might leave the road and strike the booth while simultaneously protecting the pedestrian who might be using the booth.

Baldwin, supra, 335 N.C. at 547-548, 439 S.E.2d at 110.

          The purpose of the FDA safety regulations obviously is to protect the safety of patients being treated with investigational drugs that have not been approved by the FDA for marketing (Bigley dep. pp. 66-67). In his deposition, Joseph Bigley, who was defendant's Section Head in Clinical Oncology, Clinical Research Division during 1994, testified that he and the other employees of defendant who were involved in clinical trials of investigational drugs were thoroughly trained in the provisions of the federal regulations and that a safety report should have been sent to the physicians during the Spring of 1994 but one was not sent because defendant felt the April, 1994 overdose was a random act that had occurred for the first time (Bigley dep. p. 73). However, Mr. Bigley admitted that defendant was not allowed to violate the safety regulations by not sending the required safety information merely because this was the first overdose that had occurred (Bigley dep. p.74). An additional admission of defendant's violation of 21 C.F.R Sec. 312.32(c) is found in Mr. Bigley's handwritten notes concerning a telephone conversation he had with Dr. Judith Kramer, who was defendant's Vice President of U.S. Clinical Research Division during 1994, concerning the first two overdoses. With respect to the first overdose, Mr. Bigley, who was taking notes while Dr. Kramer spoke to him on the phone, wrote A1ST OD in April...resulting in death - we should have sent letter then."(Bigley dep. Exhibit 2; Kramer dep. Exhibit 1)

3. Defendant Again Violated Federal Safety Regulations by Failing to Provide an IND Safety Report to Physicians Treating Patients with Navelbine A...As Soon as Possible... after Being Notified on July 25, 1994, That a Second Patient Had Been Overdosed with Navelbine.

          Defendant was notified of a second patient's Navelbine overdose on July 25, 1994. Defendant was notified that this patient had died of her overdose on July 28, 1994. Defendant knew that this overdose was caused by the fact that the nurse who administered the drug read the label on the vial of Navelbine as containing 10 mg rather than 50 mg, which is the identical circumstance that caused the initial patient overdose during April of 1994 (Bigley dep. Exhibits 3 - 5). Although the federal safety regulations required defendant to provide this important safety information to physicians treating patients with Navelbine, including Mr. Cope's physician, defendant failed to provide this information " soon as possible..." 21 C.F.R. Sec. 312.32(c). Defendant claims that it mailed the required safety information about the first two overdoses to the participating investigators on August 3, 1994, the very date Mr. Cope was administered the overdose in Durham. Other information uncovered during discovery indicates that although defendant"s letter concerning the first two overdoses was dated August 3, 1994, it may not have been mailed until August 5, 19945. Regardless of the actual date the letter was mailed, there is again overwhelming evidence that defendant failed to reasonably and timely provide an adequate warning and notice of the circumstances of the first two overdoses. Mr. Bigley"s handwritten notes of the statements made to him by Dr. Kramer during their telephone conversation following the second overdose states, "why take so long

          4 Defendant's Response to Plaintiff's Second Set of Interrogatories, No. 26 
          5 Martini dep. Exhibit 1; Bigley dep. Exhibit 18

between 7/28 [the date of the second patient's death] + 8/3 Inv. [investigators] letter + 8/8 FDA letter." When questioned at his deposition about these notes Mr. Bigley acknowledged that someone [Dr. Kramer] must have felt the information about the second overdose should have been provided to the physicians "immediately."6  "Immediately" is the same as the requirement of the federal regulation that such notice be provided " soon as possible." 

          Regarding the reasonableness of the timing of defendant's notice dated August 3, 1994, and the means of transmission of the notice or warning, it should be noted that during the summer of 1994 defendant's employee Diane DeAngelis was in regular communication with Durham Clinic concerning Mr. Cope's enrollment in the Navelbine treatment program by telephone and fax from her office at Research Triangle Park, North Carolina. Ms. DeAngelis testified that she was aware of the first two overdoses because they were big news in her work area at Burroughs Wellcome at the times they occurred (DeAngelis dep. p. 36). She initially testified that safety information concerning the overdoses was provided by defendant to Mr. Cope's physician in "plenty of time" before he was overdosed, but when questioned about the dates of the Mr. Cope's overdose and defendant"s letter to the investigators Ms. DeAngelis changed her testimony, saying she Amisspoke."(DeAngelis dep. pp. 26, 27).

4. Information Contained in the Investigator's Brochure, Open-label Protocol, and Correspondence Concerning Use of Ampules and Vials Is

          6 Bigley dep. pp. 78-79

Not Adequate as a Matter of Law to Warn Health Care Personnel That There Were 50 Mg of Navelbine in the Vial.

          During depositions defendant has questioned witnesses about the contents of the lengthy Navelbine Investigator's Brochure, the Open-Label Protocol, shipping documents and correspondence sent from defendant to Durham Clinic prior to Mr. Cope's overdose. Although there is information buried in these documents indicating that Navelbine is supplied in 10 mg ampules and 50 mg vials [i.e. see page 18 of open-label protocol attached as Exhibit 3 to Dr. 1' deposition] these facts merely provide further evidence of negligence on the part of the defendant. Defendant should have clearly and adequately shown the amount or quantity of Navelbine on the vial's label rather than emphasize its concentration. It is simply unreasonable to package a dangerous, highly toxic substance into two sizes of containers with each emphasizing the concentration of 10 mg and with the label on the vial not clearly showing that it contained 50 mg7. It is unreasonable to package a dangerous drug in two sizes of containers when the numeral shown on both sizes states "10 mg." See article about the 1994 Navelbine overdoses entitled Accidental Overdoses of Investigational Drug Because of a Misunderstood Label from Hospital Pharmacy, Volume 30, at page 70, stating that, "The label confusingly states ' 10 mg/mL' on both sizes, and in each case practitioners confused the contents of the 5 mL vial as 10 mg total."(Bigley dep. Exhibit 1; Cohen affidavit Exhibit B) Numerals distinguishing between the 10 mg ampules and 50 mg vials should have been

          7 See Exhibit 4 to Bigley deposition, a memo in which Dr. John Lennox, defendant's director of Quality Assurance, pointed out to Mr. Bigley that the Aroot cause of the problem" created by the label is the fact that" all product is 10 mg/mL" and that the overdoses had occurred because of the Apresumption that the 5 mL vial contained only 10 mg of vinorelbine, rather than the 50 mg of drug actually present in the vial."

clearly and adequately set forth on the labels of the containers themselves rather than buried in lengthy brochures, protocols and correspondence. See Wogalter Affidavit, paragraph 20. As the Court of Appeals held in Ziglar, supra, 280 S.E.2d at 518:

We believe that such facts raised a substantial question as to whether DuPont was negligent in not instructing more plainly, on the product's label itself, that, in cases of accidental ingestion, vomiting should be immediately induced by whatever means available. (Emphasis supplied)

          North Carolina law requires a manufacturer to provide warnings of any dangers associated with the product's use. These warnings must be "sufficiently intelligible and prominent to reach and protect all those who may be reasonably expected to come into contact with the product." Id., 280 S.E.2d 510, 516. 

          A manufacturer is also required to give adequate directions for use of a product, when reasonable care calls for them. Corprew v. Chemical Corp., 271 N.C. 485, 491, 157 S.E.2d 98, 103 (1967). In addition, a manufacturer does not completely discharge its duty to warn simply by providing some warnings of some dangerous propensity of its product at the time of sale. A continuing duty exists to provide post-sale warnings of any deficiencies it learns exist in the product to users. Smith v. Selco Products, Inc., 96 N.C. App. 151, 385 S.E.2d 173 (1989), disc. rev. denied, 326 N.C. 598, 393 S.E.2d 883 (1990) (citing Davis v. Silloo Inc., 47 N.C.App. 237, 244, 267 S.E.2d 354, 359, disc. rev. denied, 301 N.C. 234, 283 S.E.2d 131 (1980)).

          The duty of care of a manufacturer in the production of a dangerous instrumentality or substance is the "highest" or "utmost" caution, commensurate with the risks of serious harm involved. See Ziglar, supra, 280 S.E.2d at 515 and cases cited therein. Defendant had knowledge and notice prior to Mr. Cope's overdose that at least two patients had died because competent nurses read the label on the Navelbine vial to contain 10 mg rather than 50 mg, despite any information that appeared in the Investigator's Brochure, Open-Label Protocol, shipping documents and correspondence. These facts, along with the circumstances of Mr. Cope's overdose, create jury issues and cannot be resolved as a matter of law.


1. North Carolina Law Does Not Insulate a Drug Manufacturer's Negligence in Labeling and Warning Cases with Conduct of Health Care Providers.

          Despite defendant's admissions of negligence both to the adequacy of its Navelbine label and its violation of applicable safety regulations, defendant is attempting to shift all of the blame for this needless tragedy to the Durham Clinic and its employees by arguing that it is protected against liability by the learned intermediary doctrine, the intervening negligence doctrine and alteration or modification of Navelbine after it left the defendant. See defendants' Answer. First of all, the law of North Carolina does not exonerate defendant from its own negligence pursuant to a learned intermediary theory. In the case of prescription drugs "...the adequacy of the warning by the manufacturer shall be determined by the prescribing information made available by the manufacturer to the health care practioner.." G.S.' 99B-4(1). In Salmon, supra, the Fourth Circuit applying North Carolina law, ruled that simply because a drug manufacturer provides certain warnings to the treating physician, the drug manufacturer is not absolved from liability for negligence causing personal injury to the patient:

...A jury could reasonably find that...the company failed to warn physicians, particularly in its advertising, with emphasis that was commensurate with the risk. A jury could also conclude that the fault of misuse should be shared by both the physician and the manufacturer.

Salmon, Id. at 1362

          In addition, in a case involving the same defendant in this action, the Supreme Court of North

Carolina affirmed the Court of Appeals' reversal of a summary judgment for the defendant drug manufacturer that had been entered by the trial court. The summary judgment had been based on the deposition testimony of the patient's treating physician that he did not rely on any of the information made available by defendants through advertisements, representations by sales people, the Physician's Desk Reference, or package inserts regarding the use and possible dangers of the products. The physician further denied that the plaintiff's injuries had been caused by malignant hyperthermia as plaintiff alleged in the Complaint. Holley v. Burroughs Wellcome Co., 318 N.C. 352, 348 S.E.2d 772 (1986). The Supreme Court of North Carolina ruled that the forecast of evidence presented in the case was sufficient to raise a permissible inference that the physician had relied, directly or indirectly, on information from defendants' package inserts and promotional literature thereby establishing a genuine issue of material fact as to the element of proximate cause. In rejecting the defendant's argument that a jury should not be able to decide the question of whether an adequate warning would have changed or altered the conduct or treatment of a health care provider the Supreme Court cited with approval an Ohio case:

Plaintiffs cite an Ohio Supreme Court case providing an excellent rationale for allowing the jury to decide if an adequate warning would have altered the doctor's conduct. Sealey v. G D. Searle Company, 67 Ohio St.2d 192, 423 N.E.2d 831 (1981). In that case plaintiff suffered a stroke and numbness in her left side as a result of defendant's failing to warn of the side effects of the contraceptive Ovulen. The prescribing doctor testified that Ahe had acquired full knowledge from other sources of the increased risk of hypertension and stroke in women with a history of toxemia." Id. at 839. The Court rejected the contention that the doctor's independent knowledge broke the causal link. Instead the Court stated :
A warning may serve purposes other than merely filling gaps in the intended recipient's knowledge - one many benefit from being warned or reminded of what he already knows. Similarly, only speculation can support the assumption that an adequate warning, properly communicated, would not have influenced the course of conduct adopted by a physician, even where the physician had previously received the information contained therein" Id. (emphasis supplied)

          Furthermore, not only is there a presumption that the nurse who administered the overdose to Mr. Cope would have followed, heeded and complied with an adequate label and safety warning that there were 50 mg of Navelbine in the vial, but, in addition, the nurse who administered the overdose to Mr. Cope testified at her deposition that if the label had shown 50 mg rather than 10 mg she would have used the contents of one vial to prepare Mr. Cope's dose because she knew his dose was 50 mg, and also that she would have complied with any warning to the effect that there were 50 mg of Navelbine in the vial (Williams dep. pp 47, 57). The evidence shows without dispute that the nurse who administered the overdose to Mr. Cope was extremely qualified, Asweated the details" (Cox dep. p 28), was certified in giving chemotherapy, (Williams dep. p. 13) had more than ample training and experience, was hand-picked for her position at Durham Clinic by Dr. Davis and Dr. Cox (Cox dep. pp.27-28), that she was an excellent employee who followed instructions, that she never suffered any adverse employment actions at any of her jobs, that she continued to give chemotherapy to patients at Durham Clinic after the date of Mr. Cope's overdose and without any negative incident whatsoever, that she was a highly dedicated, caring, committed nurse who went into this line of work in order to help people based on her personal experiences with friends who suffered from cancer. In addition, she has given thousands of chemotherapy treatments and her administration of Navelbine to Mr. Cope on August 3, 1994 is the only dosing error she has ever made (Williams dep. pp. 31, 51). Similarly, the nurse who administered the overdose in April of 1994 was highly qualified and had never committed a dosing error (Adamkiewicz dep. Exhibit 3). At the present time, plaintiff has not seen any documents concerning the qualifications of the nurse involved in the second overdose, but discovery is continuing and the applicable protocol and informed consent generally restrict treatment of patients with Navelbine by competent personnel.

          In Whitley v. Cubberly, 24 N.C. App. 204, 210 S.E.2D 289(1974) the Court of Appeals reversed a summary judgment order in favor of a drug manufacturer in a case that included claims of failing to label the drug adequately and failure to make adequate warnings about the dangerous properties of the drug to the medical profession. In this action the doctor testified that he was familiar with the manufacturer's warnings but not "completely aware" that there should be periodic blood studies during treatment with the drug and that he was not aware of the manufacturer's warning that it was desirable to hospitalize patients to perform studies and observations during therapy. The Court found that the record did not entitle the defendant to summary judgment:

All that is significant for present purposes is that the record does not so clearly establish that no genuine issue of fact exists in this regard that Parke, Davis is entitled to summary judgment as a matter of law. Only in exceptional negligence cases is summary judgment appropriate. AThis is so because the rule of the prudent man (or other applicable standard of care) must be applied, and ordinarily the jury should apply it under appropriate instructions from the Court." Page v. Sloan, supra, at 706, 190 S.E.2d at 194.

2. The Nurse's Administration of the Overdose to Mr. Cope Is Not an Intervening Act That Insulates Defendant's Negligence

          In order to prevail on its motion for summary judgment on the question of whether conduct of employees of Durham Clinic insulates defendant's negligence, defendant has the heavy burden of showing that the acts of Durham Clinic constitute a new proximate cause which is completely independent from and has no connection with the original cause (the inadequate label and failure to warn) and is itself solely responsible for Mr. Cope's death. As our Supreme Court, quoting from Harton v. Telephone Co., 141 N.C. 455, 462-63, 54 S.E. 299, 301-02 (1966), stated in the case of Hairston v. Alexander Tank & Equipment Co., 310 N.C. 227, 236-37, 311 S.E.2d 559, 566-67 (1984):

An efficient intervening cause is a new proximate cause which breaks the connection with the original cause and becomes itself solely responsible for the result in question. It must be an independent force, entirely superseding the original action and rendering its effect in the causation remote. It is immaterial how many new elements or forces have been introduced, if the original cause remains active, the liability for its result is not shifted. (emphasis supplied)

          Foreseeability of the intervening act is the critical question in this analysis. As the Court stated in Rattley v. Powell, 223 N.C. 134, 136, 25 S.E.2d 448, 450 (1943), "The test is not to be found in the degree of negligence of the intervening agency, but in its character - whether it is of such an extraordinary nature as to be unforeseeable." It was certainly foreseeable to defendant prior to Mr. Cope's overdose that because of its negligence in providing a dangerous, experimental chemotherapy drug with an inadequate label that did not show the amount or quantity of the drug contained within the vial, that nurses administering the drug would read the label as containing 10 mg of Navelbine rather than 50 mg. Any question of whether it was foreseeable to defendant that a nurse administering Navelbine to a patient could read the label as containing 10 mg rather than 50 mg was laid to rest when the first overdose occurred in April of 1994. At this time defendant was expressly informed that a highly qualified, trained and competent chemotherapy nurse had read the label on the vial of Navelbine as containing 10 mg rather than 50 mg, that the labels on all other similar drugs show the total quantity of the drug, that the mishap might have been avoided had the label shown the total quantity of drug, and that the nurse's employer was unaware of any other dosing error that had ever been committed by the nurse in question. Based on these facts it would not be unreasonable to expect defendant to anticipate the happening of additional dosing errors. In fact, within four months of the date of the initial Navelbine overdose, defendant was notified of a second Navelbine overdose that occurred because the administering nurse read the label on the vial as containing 10 mg rather than 50 mg. Defendant was notified of the second overdose at least eight days before Mr. Cope's overdose occurred under circumstances identical to those involved in the first two overdoses. It is clear that defendant cannot show that Durham Clinic's administration of the overdose to Mr. Cope is an act that operates to insulate and supersede any negligence on the part of the defendant. "The North Carolina courts apply the terms 'insulating' and 'superseding' when the later-occurring act is unforeseeable and excuses the defendant from liability for her negligence." See Logan & Logan, North Carolina Torts (1966), ' 7.30[2] p 167 (emphasis supplied).

          In Nance v. Parks, 266 N.C. 206, 146 S.E.2d 24 (1966), the defendant took his car to a garage for service. He parked the car, applied the emergency brake and then left the engine running with the transmission in drive. One of the garage's employees leaned on the accelerator causing the car to move forward, which caused the plaintiff's injuries. The defendant car owner claimed that the employee's negligence was active and intervening negligence but the Supreme Court ruled that the defendant was not excused. The Court observed that leaving the car in drive with the engine running created the risk that the car would move forward and the fact that the employee was negligent did not protect the defendant. AAn automobile left in gear with the motor running is 'like a gun loaded and cocked, ready to go off'." Id. at 208, 146 S.E.2d at 26, citation omitted. Similarly, in Petty v. Charlotte, 85 N.C.App. 391, 398, 355 S.E.2d 210, 214 (1987), disc. rev. denied 319 N.C. 674, 356 S.E.2d 792 (1987), the Court ruled that neither the intervening negligence of the city in maintaining a road nor the negligence of an oncoming driver who caused the operator of the vehicle in which the plaintiff was a passenger to swerve, thereby causing the plaintiff's injuries, excused the defendant housing authority from liability for negligent maintenance of a chain link fence, upon which the plaintiff became impaled, because the defendant is on "notice of the exigencies of traffic and the prevalence of that 'occasional negligence which is one of the incidents of human life.'" (citation omitted)

          Our Supreme Court has also held that even felonious conduct of a third party that intervenes between defendant's negligence and the plaintiff's injury does not necessarily break the chain of causation and insulate the defendant's negligence. In Murrow v. Daniels, 321 N.C. 494, 364 S.E.2d 392 (1988) the Court held that evidence of past criminal activity at the defendant's motel could show foreseeability on the part of defendant that its patrons could be assaulted and robbed and therefore defendant's negligence was not insulated by criminal activity.

3. Administration of a Navelbine Overdose to Mr. Cope at Durham Clinic Does Not Constitute an Alteration or a Modification of the Product Pursuant to G.S. ' 99B-3

          In order to avoid liability because of alteration or modification of a product by a party other than the manufacturer, defendant is required to prove, as a matter of law, the following: (1) that a proximate cause of Mr. Cope's death was either an alteration or a modification of the product by a party other than the manufacturer, which alteration or modification occurred after the product left the control of the manufacturer; (2) that any alteration or modification was not in accordance with instructions or specifications of the manufacturer; and (3) that any alteration or modification was not made with the express consent of the manufacturer. G.S. ' 99B-3(a). Further, G.S. ' 99B-3(b) provides that, " For the purposes of this section, alteration or modification includes changes in the design, formula, function or use of the product from that originally designed, tested, or intended by the manufacturer. It includes failure to observe routine care and maintenance, but does not include ordinary wear and tear."

          It is obvious from a reading of this section that it does not apply to the facts of this case where a drug overdose occurred because of the manufacturer's admitted inadequate label and admitted violation of safety regulations. Mr. Cope was not overdosed because of any alteration or modification of the Navelbine that was administered to him. Rather his death was caused by the fact that the nurse administering the drug to him read the label as containing 10 mg rather than 50 mg, just as two other nurses administered overdoses to other patients because they read the label in exactly the same way. It is the manufacturer's specifications on the label that created the problem, and not the conduct of the nurses. Assuming, arguendo, that the nurses were negligent as well as the manufacturer, there is joint and concurring negligence, not intervening negligence and alteration and modification of Navelbine. Durham Clinic did not change the design of Navelbine, its formula, its function or its use. Too great a quantity of Navelbine was administered to Mr. Cope because of the Ainstructions or specifications" of the defendant. See G.S. ' 99B-3(a)(1).

          It cannot be said that the nature or properties of Navelbine itself were changed or made different in any respect or that the Navelbine itself was changed in form or character. Furthermore, the Navelbine open-label protocol pursuant to which Mr. Cope was treated with the Navelbine anticipated and instructed that the dose of Navelbine was to be prepared by combining its contents in a solution to be administered to the patient intravenously. Therefore, the actual process of combining the contents of the Navelbine containers with other solution for administration to the patient was specifically anticipated and indeed instructed. Deaths

          8 See definitions of "alter" and "modify" in the American Heritage Dictionary of the English Language, 3rd

occurring from Navelbine overdoses were caused simply by personnel reading the label as containing 10 mg rather than 50 mg and, in this respect, it was the express numeral specification "10 mg" appearing on the Navelbine label that caused these accidents and not any unforeseen "alteration" or "modification" of the Navelbine by nursing personnel.

          Defendant's attempted reliance upon the alteration or modification defense is misplaced. This is a case based on inadequate packaging, labeling and warnings. As the Court of Appeals pointed out in the case of Reid, supra, 253 S.E.2d 344 at 350: "No argument having been made that the labeling or warnings on the can were altered in any way after the time of sale, plaintiff has made a prima facie showing..."


edition, Houghton Miflin Company, 1992

          This action was filed prior to the effective date of changes in our state's punitive damages laws. Therefore, this action is controlled by the punitive damages provision under the Wrongful Death Act, G.S. ' 28A-18-2, which allows punitive damages based on "...maliciousness, wilful or wanton injury, or gross negligence." (emphasis supplied). It is not required that the plaintiff prove wilful or wanton conduct in order to recover punitive damages in this action. It is sufficient if the plaintiff proves gross negligence. See Beck v. Carolina Power & Light Co., 57 N.C.App. 373, 291 S.E.2d 897, aff'd, 307 N.C. 267, 297 S.E.2d 397 (1982), Cole v. Duke Power Co., 81 N.C.App. 213, 344 S.E.2d 130, cert. denied, 318 N.C. 281, 347 S.E.2d 462 (1986). As the Court stated in the case of Rogers v. T.J.X. Companies, Inc., 329 N.C. 226, 230, 404 S.E.2d 664, 666 (1991), "...exemplary damages have been frequently awarded when the...[tort]...was accompanied by circumstances of...recklessness...or a wrongful act without a reasonable excuse...or in known violation of law."(emphasis supplied). The character of defendant's conduct in this action is aggravated, outrageous, oppressive, in reckless disregard for the rights and safety of the plaintiff's decedent and other patients, involves repetitive conduct and is conduct in known violation of applicable safety regulations. The evidence shows that defendant knowingly violated safety regulations by failing to notify physicians of information concerning the first Navelbine overdose death that occurred during April of 1994 (Bigley dep. pp. 73, 74). Afterwards, defendant failed to notify physicians "as soon as possible"9 after the defendant was notified of the second overdose on July 25, 1994.

          9 See 21 C.F.R. Sec. 312.23(c). It should be noted that defendant's employees who have been deposed have admitted that defendant's personnel responsible for compliance with federal safety regulations during the Navelbine clinical trials had been trained in the regulations prior to the date of these cumulative violations. i.e., Bigley dep. pp 15, 16, 52, 53; Kramer dep. p 29; Atwood dep. pp 15-17; DeAngelis dep. pp 10-11

There is evidence that one of defendant's high ranking officers admitted during 1994 after the second overdose and prior to Mr. Cope's death that the label was not adequate to begin with, that a safety letter should have been sent to the physicians after the April overdose and that the physicians should have been notified immediately after the second overdose.(Bigley dep. Exhibit 2, Kramer dep. Exhibit 1). All of this conduct occurred prior to the date of Mr. Cope]s overdose. This conduct is cumulative, repetitive, in knowing violation of safety regulations, aggravated, outrageous, and in reckless disregard for the rights and safety of plaintiff and her husband.


          Plaintiff easily satisfies the elements required for a claim of negligent infliction of emotional distress (NIED). Johnson v. Ruark Obstetrics and Gynecology Assoc., 327 N.C. 283, 395 S.E.2d 85 (1990). Plaintiff has established a prima facie case that defendant negligently engaged in conduct. In addition, it was reasonably foreseeable that such conduct would cause the plaintiff severe emotional distress and the conduct has in fact caused the plaintiff severe emotional distress. Although it is not required that the plaintiff prove any physical impact, physical injury or physical manifestation of emotional distress in order to recover on a claim for NIED, the plaintiff's severe emotional distress in this case did include physical injuries. This is established by the affidavit of her psychiatrist, Dr. Jean G. Spaulding, in which Dr. Spaulding notes that because of the psychological trauma surrounding her husband's Navelbine overdose death, Ms. Cope lost 27 pounds, and suffered extreme insomnia and anorexia. In addition, Dr. Spaulding has found that Ms. Cope suffered severe emotional distress because of her husband's overdose and she has been diagnosed with chronic depression and post-traumatic stress syndrome. Further, the evidence shows that Ms. Cope was with her husband at the time the overdose was administered to him and she was with him continuously at the hospital from the date of his admission on August 5, 1994 until his death on August 17, 1994 (Cope affidavit). During this time and following Mr. Cope's death, Ms. Cope suffered extreme night terrors and dreams where her husband would be calling to her but she was unable to reach him.

          Plaintiff's evidence also shows that it was reasonably foreseeable to defendant that its conduct would cause the plaintiff severe emotional distress. As the Court stated in Ruark, Id., 395 S.E.2d at 98:

Factors to be considered on the question of foreseeability in cases such as this include the plaintiff's proximity to the negligent act, the relationship between the plaintiff and the other person for whose welfare the plaintiff is concerned, and whether the plaintiff personally observed the negligent act. Questions of foreseeability and proximate cause must be determined under all the facts presented, and should be resolved on a case-by-case basis by the trial court and, where appropriate, by a jury.


          In this regard, the evidence shows that Ms. Cope was present when the overdose occurred, she had been married to Mr. Cope for 29 years and she observed the severe effects of and her husband's death caused by the defendant's negligence. In addition, there is evidence that the defendant had actual knowledge that Ms. Cope was married to Mr. Cope and that she was anxious about his condition and treatment with Navelbine10 In Wrenn v.

          10 See GL00286 and GL00420; DeAngelis dep. Exhibits 1 and 2

Byrd, 120 N.C.App. 761, 464 S.E.2d 89 (1995), disc. rev. denied, 342 N.C. 666, 467 S.E.2d 738 (1996), the Court held that a jury question was created when the plaintiff was present with her husband when the misdiagnosis occurred and medical personnel knew of the marital relationship. Also in Wrenn, Id., the Court rejected the defendant's argument that proof was required of defendant's personal knowledge of the plaintiff's emotional condition. However, under the facts of this case, plaintiff can surmount all obstacles confronted by a plaintiff attempting to prove a claim for NIED.


          Based on the foregoing reasoning and authorities, the plaintiff respectfully requests the Court to deny the defendant's Motion for Summary Judgment.

This _____ day of March, 1997. BENTLEY & ASSOCIATES, P.A.


Charles A. Bentley, Jr. 
Post Office Box 52089 
Durham, North Carolina 27717-2089 
Telephone: (919) 489-1330 
Attorney for Plaintiff


          I do hereby certify that on this _____ day of ________, 1997, I served a copy of the foregoing PLAINTIFF=S MEMORANDUM IN OPPOSITION TO DEFENDANTS= MOTION FOR SUMMARY JUDGMENT on counsel for defendants by personal delivery of same in the Durham County Judicial Building, Durham, North Carolina



Charles A. Bentley, Jr.


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