This opinion will be unpublished and

may not be cited excxept as provided by

Minn. Stat. § 480A.08, subd. 3 (2000).






Lynn Donovan, et al.,


Bioject, Inc., d/b/a Bioject Medical Technology, Inc., et al.,

Metropolitan Visiting Nurse Association, et al.,

Filed March 13, 2001


Peterson, Judge

Dakota County District Court

File No. C0998265


Michael A. Bryant, Bradshaw & Bryant Law Offices, 1505 Division Street, Waite Park, MN  56387 (for appellants)


Martha K. Sieber, Candlin & Wright, 3800 West 80th Street, Suite 1500, Bloomington, MN  55431-4429 (for respondent Bioject)


Gregory P. Bulinski, Bassford, Lockhart, Truesdell & Briggs, P.A., 3550 Multifoods Tower, 33 South Sixth Street, Minneapolis, MN  55402-3787 (for respondents Metropolitan Visiting Nurse Association et al.)


            Considered and decided by Stoneburner, Presiding Judge, Lansing, Judge, and Peterson, Judge.

U N P U B L I S H E D   O P I N I O N


            Appellant Lynn Donovan suffered an injury to her arm after receiving a flu shot that was administered using a Biojector.  She and her husband, appellant Terrance Donovan, brought this action against (1) the Biojector’s manufacturer and distributor, respondent Bioject, Inc., alleging claims for products liability and failure to warn, and (2) the nurse who administered the injection and her employer, respondents Jane Doe and Metropolitan Visiting Nurse Association (MVNA), alleging negligence and negligent nondisclosure claims.[1]  On appeal from a summary judgment, appellants argue that the district court erred in (1) concluding that the evidence was insufficient to prove causation;  (2) finding their expert affidavit did not meet the requirements of Minn. Stat. § 145.682 (2000); and (3) denying their motion for reconsideration.  We affirm.


            A nurse employed by MVNA administered a flu shot in Lynn Donovan’s left arm using a Biojector 2000.  The Biojector is a needle-free injection system that uses compressed carbon dioxide gas and sterile, disposable medication syringes to deliver medication into body tissue.  Immediately after receiving the injection, Lynn Donovan felt a burning and stabbing pain in her left arm.  The following morning, her left arm began swelling, and a painful, golf-ball-sized lump developed on it.  Lynn Donovan testified that she still has a lump about the size of a quarter in her left arm, and appellants presented evidence that she continues to experience a burning sensation with some movements, reduced sensation, and significant pain when she raises her left arm more than 90 degrees.  Appellants allege that the injury to Lynn Donovan’s arm resulted from the flu injection going too deep into a nerve.

            Appellants submitted an affidavit by Joanne Gladden, an associate nursing professor at the University of Mary in Bismark, North Dakota, opining that the nurse who administered the flu shot to Lynn Donovan violated the standard of care for performing inoculations by failing to give Lynn Donovan sufficient information about the Biojector 2000.  Specifically, Gladden stated that when using a new inoculation method, a nurse should give a patient the choice between the new method and the time-tested needle injection method and should obtain the patient’s informed consent before using the new inoculation method.  Gladden also stated that Lynn Donovan should have been provided with follow-up information, including a direct telephone number to those in charge of giving the inoculation so that immediate problems could be addressed.


            On appeal from summary judgment, this court must review the record to determine whether any genuine issues of material fact exist and whether the district court erred in applying the law.  Offerdahl v. University of Minn. Hosps. & Clinics, 426 N.W.2d 425, 427 (Minn. 1988).  This court must view the evidence in the light most favorable to the nonmoving party.  Id.  But

summary judgment on a claim is mandatory against a party who fails to establish an essential element of that claim, if that party has the burden of proof, because this failure renders all other facts immaterial.


Lloyd v. In Home Health, Inc., 523 N.W.2d 2, 3 (Minn. App. 1994) (citation omitted).

            1.  To establish a product liability claim based on strict liability,

an injured party must show (1) the product was in a defective condition, unreasonably dangerous to the user, (2) the defect existed when the product left the manufacturer’s control, and (3) causation.


Westbrock v. Marshalltown Mfg. Co., 473 N.W.2d 352, 356 (Minn. App. 1991), review denied (Minn. Sept. 13, 1991).

            Appellants have not identified any design defect in the Biojector 2000.  Nor have they presented any evidence that the Biojector used to inoculate Lynn Donovan was defective.  Appellants did produce a report regarding complaints about the Biojector 2000, but the report does not indicate that any defects were identified in any Biojectors or that any injuries were caused by a Biojector.[2]

Appellants also failed to present evidence that would establish causation.  A plaintiff’s burden of proving causation in a strict liability action is the same as that in a negligence action.  Worden v. Gangelhoff, 308 Minn. 252, 254, 241 N.W.2d 650, 651 (1976).

            In negligence cases, * * * proof of causal connection must be something more than consistent with the plaintiffs’ theory of how the claimed injury was caused.


Hoffman v. Naslund, 274 Minn. 521, 530, 144 N.W.2d 580, 589 (1966).

When the injury might, with equal probability, have resulted from the acts of others as well as from the acts of defendant, proof of facts, other than that of injury, from which defendant’s negligence can be inferred, must be made before the question can be submitted to the jury.  Otherwise, the verdict would be founded on mere speculation.  An inference of negligence based on an inferred fact of which there is neither evidence nor predominating probability cannot be safely made.


Collings v. Northwestern Hosp., 202 Minn. 139, 144, 277 N.W. 910, 912-13 (1938) (citations omitted). 

To prove causation, appellants needed to present evidence identifying a characteristic of the Biojector and relating that characteristic to the injury suffered by Lynn Donovan.  The fact that Lynn Donovan’s arm was injured after she received a shot with a Biojector is insufficient to prove that a defect in the Biojector caused the injury.  The district court properly granted summary judgment in favor of respondents on appellants’ product liability claim.  See Hoffman, 274 Minn. at 530, 144 N.W.2d at 589 (affirming directed verdict in favor of doctor in malpractice action when plaintiff presented no expert testimony on the standards ordinarily followed in using medical equipment in performing colon study and no expert testimony as to the causal relation of such a use and the injury to the patient’s colon); Western Surety & Casualty Co. v. General Elec. Co., 433 N.W.2d 444, 447 (Minn. App. 1988) (when expert testified that headlight that exploded had anomalies but did not testify that headlight was legally defective, i.e. unreasonably dangerous, and did not testify that anomalies caused headlight to explode, evidence was insufficient to submit products liability claim to jury), review denied (Minn. Feb. 22, 1989); see also Lee v. Crookston Coca-Cola Bottling Co., 290 Minn. 321, 331-32, 188 N.W.2d 426, 433-34 (1971) (when expert testified that there were three fundamental causes of pop bottle explosions and that the two causes other than product defect were not plausible explanations for explosion in that case, evidence was sufficient to submit strict liability claim to jury).

            2.  To prevail on a failure to warn claim, a plaintiff must establish that:  (1) the defendant had a duty to warn; (2) any warnings provided were inadequate; and (3) the lack of an adequate warning caused the plaintiff’s injuries.  See Erickson v. American Honda Motor Co., Inc., 455 N.W.2d 74, 77-78 (Minn. App. 1990) (discussing jury instructions), review denied (Minn. July 13, 1990); Balder v. Haley, 399 N.W.2d 77, 81 (Minn. 1987) (discussing issues to be decided by court and submitted to jury).

            Whether a manufacturer or distributor has a legal duty to warn users of dangers related to the use of its product is a question of law for the court to decide.  Germann v. F.L. Smithe Mach. Co., 395 N.W.2d 922, 924 (Minn. 1986).  To determine whether a manufacturer has a duty to warn, the court

goes to the event causing the damage and looks back to the alleged negligent act.  If the connection is too remote to impose liability as a matter of public policy, the courts then hold there is no duty, and consequently no liability.  On the other hand, if the consequence is direct and is the type of occurrence that was or should have been reasonably foreseeable, the courts then hold as a matter of law a duty exists.


Drager by Gutzman v. Aluminum Indus. Corp., 495 N.W.2d 879, 884 (Minn. App. 1993), review denied (Minn. Feb. 23, 1993).  “Only if there is a specific factual dispute concerning a manufacturer’s awareness of a risk should the issue be submitted to the jury for its resolution.”  Huber v. Niagara Mach. & Tool Works, 430 N.W.2d 465, 467 (Minn. 1988).  A manufacturer has a duty not only to warn of danger but also to provide adequate instructions for the safe use of the product.  Harmon Contract Glazing, Inc. v. Libby-Owens-Ford Co., 493 N.W.2d 146, 151 (Minn. App. 1992), review denied (Minn. Feb. 12, 1993).

            Appellants argue that Bioject had received complaints about the Biojector 2000 and, therefore, had a duty to warn of dangers associated with its use.  But appellants failed to present admissible evidence showing that other individuals suffered injuries similar to Lynn Donovan’s injury as a result of receiving a shot with a Biojector or any other evidence that the type of injury suffered by Lynn Donovan was a foreseeable risk of receiving a shot with a Biojector.  Appellants also failed to identify the risk about which Lynn Donovan should have been warned.  Absent any such evidence, the district court properly granted summary judgment in favor of Bioject on the failure-to-warn claim.

            3.  Appellants argue that the district court erred in granting summary judgment in favor of Doe and MVNA under Minn. Stat. § 145.682 (2000) on appellants’ malpractice claims.  This court will not reverse a dismissal for failure to comply with the requirements of Minn. Stat. § 145.682 absent a showing that the district court abused its discretion.  Tousignant v. St. Louis County, 615 N.W.2d 53, 58 (Minn. 2000).  However, interpretation of the requirements of Minn. Stat. § 145.682 requires statutory interpretation, a question of law subject to de novo review.  Id.

            Appellants alleged two malpractice claims against Doe and MVNA, negligence in administering the flu shot and negligent nondisclosure. See id. at 59 (elements of negligence); K.A.C. v. Benson, 527 N.W.2d 553, 561 (Minn. 1995) (elements of negligent nondisclosure).

            Under Minn. Stat. § 145.682, an expert affidavit must set forth

specific details concerning their experts’ expected testimony, including the applicable standard of care, the acts or omissions that plaintiffs allege violated the standard of care and an outline of the chain of causation that allegedly resulted in damage to them.


Sorenson v. St. Paul Ramsey Medical Ctr., 457 N.W.2d 188, 193 (Minn. 1990).  An expert affidavit must show how the conclusions therein follow from the facts of the case.  Id.  It is insufficient to merely state how defendant violated the standard of care.  Id. at 192-93.

            Appellants argue that Gladden’s affidavit meets the requirements of Minn. Stat. § 145.682.  Regarding the negligent nondisclosure claim, Gladden’s affidavit states that the nurse who administered the flu shot to Lynn Donovan violated the standard of care by failing to provide sufficient information about the Biojector 2000 before administering the flu shot and by failing to provide sufficient information regarding follow-up care.  Gladden’s affidavit, however, does not identify what information the standard of care required the nurse to provide.  Also, Gladden’s affidavit contains only a conclusory statement that the violation of the standard of care resulted in the injury to Lynn Donovan’s arm, no explanation of how additional information would have prevented the injury.

            Regarding the negligence claim, Gladden’s affidavit contains statements explaining what needs to be done when administering an injection to comply with the standard of care.  Gladden’s affidavit, however, does not indicate that the nurse’s technique deviated from the standard of care or that any deviation caused the injury to Lynn Donovan’s arm.  The district court did not err in dismissing appellant’s claims against Doe and MVNA under Minn. Stat. § 145.682.  See Anderson v. Rengachary, 608 N.W.2d 843, 846-48 (Minn. 2000) (discussing information required under Minn. Stat. § 145.682).

            4.  “Motions to reconsider are prohibited except by express permission of the court, which will be granted only upon a showing of compelling circumstances.”  Minn. R. Gen. Pract. 115.11.  Appellants argue that the district court erred in denying their motion for reconsideration in light of Dr. James Allen’s affidavit, which provides:

            October 24, 1996, incident with a pressure-type flu vaccination.  There does not appear to have been any allergic reaction.  There is some question as to whether there was bruising right away * * *.  There apparently was a 4 X 5 inch bruise/hematoma noted at the Mayo Clinic when she was seen there a few days later.  It was just their impression that this represented an axillary nerve injury involving the sensory branches of the axillary nerve.  I would agree that this is the most likely diagnosis. * * *


            * * * *


            As to permanent impairment from this injury, she does apparently continue to be symptomatic from it, more than three years after the incident.  This would suggest that it is of a permanent nature, although with the newer treatments for neuralgia, we have found excellent relief and, if that were to be the case with Ms. Donovan, then it may be that this would not be a permanent condition.


            Allen’s affidavit establishes that Lynn Donovan suffered an injury to her arm after receiving a flu shot and that the injury may be permanent.  Allen’s affidavit does not add any evidence regarding the standard of care or causation to that already in the record.  The district court did not err in denying appellants’ motion for reconsideration.


[1]Appellants alleged additional claims against against Bioject, Inc., Jane Doe, and MVNA but do not address these claims on appeal.  Issues not briefed on appeal are waived.  Melina v. Chaplin, 327 N.W.2d 19, 20 (Minn. 1982).

[2] Lynn Donovan testified that a pharmacist employed where the flu shot was administered told her that another woman had been bruised on her arm after receiving a shot with the Biojector.  But the district court must disregard inadmissible hearsay evidence on a summary judgment motion.  Bersch v. Rgnonti & Assocs., Inc., 584 N.W.2d 783, 788 (Minn. App. 1998), review denied (Minn. Dec. 15, 1998).