Fourth Circuit & Virginia Case Law Update

Compiled by Candace Blydenburgh and Kerry R. Wortzel

Fourth Circuit Affirms Award of Summary Judgment to Fetal Monitor Manufacturer

Moyers v. Corometrics Medical Systems, Inc., 2000 WL345399 (4th Cir. April 4, 2000)*

Hope Moyers suffered serious neurological injuries at birth allegedly caused by the failure of the Corometrics Spectra 400 fetal monitor system to sound an audio alert when she allegedly went into distress soon before birth. The district court granted summary judgment to Corometrics on the grounds that Moyers had failed to prove that any defect in the Spectra 400 had caused her injuries. The Fourth Circuit affirmed on the grounds that Moyers had failed to show that any act or omission by Corometrics caused her injuries. Both the nurse attending Mrs. Moyers and the obstetrician who delivered Moyers testified that they did not rely on the Spectra 400 to alert for the particular type of fetal heart pattern that occurred in Moyers’ case and that they did not change alter their practices based on the Spectra 400’s audio alert function.

In addition, the obstetrician testified that he could not state, without speculating, whether he would have ordered a cesarean section any earlier even if he had been present in the room when Moyers alleged the audio alert should have sounded. Since Moyers failed to present evidence to remove the issue of whether the obstetrician would have performed the cesarean section earlier from the realm of conjecture into the realm of legitimate inference, the Court held, summary judgment for Corometrics was appropriate.

* Troutman Sanders LLP represented Corometrics in Moyers v. Corometrics.

Fourth Circuit Affirms Exclusion of Expert Testimony from Mechanical Engineer

Under Kumho Tire

Oglesby v. General Motors Corporation, 190 F.3d 244 (4th Cir. 1999)

Oglesby sued General Motors, the manufacturer of his 1988 Chevrolet Silverado pickup truck to recover for burns he suffered on his torso and waist as he leaned into the engine compartment while adjusting a transmission cable. Oglesby claimed that the truck’s radiator hose detached due to a defect in the radiator hose connector. Oglesby’s expert, Douglas Bradbury, claimed that the connector was out of round and concluded that the out of roundness was a manufacturing defect. Bradbury, however, did not know the connector’s composition, how it was manufactured nor did he know its strength or the stresses to which it was subjected.

The district court found that Daubert did not apply to Bradbury’s testimony since he was not offering scientific testimony but nonetheless refused to consider Bradbury’s opinion on the grounds that it was speculative. Oglesby appealed and argued that Bradbury’s prior working experience with industrial products qualified him to give an opinion as to whether the connector was defective.

The Fourth Circuit held that the district court did not abuse its discretion in excluding Bradbury’s opinion testimony and affirmed the judgment in favor of General Motors. Applying Daubert and Kumho Tire, the Court agreed that Bradbury’s testimony was unreliable and did not properly draw on specialized knowledge. Specifically, Bradbury assumed that the manufacturer’s mold for the connector was round and that the connector became out of round only after it left the mold but before it was fully set. These assumptions, the Court held, had no factual basis. Further, Bradbury’s opinion that a particular stress caused the plastic part to reshape and break was speculative because he did not have any data regarding the amount of stress or the stress resistance of the part.

Fourth Circuit Affirms Exclusion of Expert Testimony Regarding Air Bags

Norris v. Ford, 182 F.3d 909 (table opinion), 1999 WL 410119 (4th Cir. 1999)

Norris sued Ford for injuries she sustained when her driver’s side air bag failed to deploy. In support of her theory, Norris offered the testimony of an expert who opined that a manufacturing defect caused the air bag not to open. The expert, however, did not examine the car or its airbag system. Instead, he based his opinion on a Technical Service Bulletin (TSB) issued by Ford for 1992 Ford Tempos. The TSB only applied to cars built before December 1, 1991 and Norris’ car was made in April 1992. The district court excluded the expert’s testimony as speculative and granted summary judgement since Norris presented no other evidence of negligence.

The Fourth Circuit affirmed, holding that the district court did not abuse its discretion in excluding the expert’s testimony. Under Federal Rule of Evidence 702, the Court held, an the expert’s opinion must be based on assumptions supported by record. Applying these principles, the Court held that the expert had assumed without factual basis that the problem identified in the TSB had not been corrected when Norris’s car was built the following year.

Fourth Circuit Declines to Adopt Cross-Jurisdictional Equitable Tolling Rule

Wade v. Danek Medical Inc., 182 F.3d 281 (4th Cir. 1999)

Wade filed suit in October, 1995, against Danek and several other defendants for damages she sustained from the implantation of a pedicle screw spinal fixation device preformed in October 1992. Wade was also a putative class member in two federal class actions suits filed against pedicle screw manufacturers filed in 1993. However, these classes had been denied certification in February, 1995.

Danek and other defendants moved for summary judgment based on Virginia’s two-year statute of limitations. In response, Wade argued that the limitations period was equitably tolled during which the pendency of the federal class actions. The district court rejected this argument and entered summary judgment for Danek.

The Fourth Circuit affirmed. The Court found that under Virginia law an injury is deemed to occur and the statute of limitations begins to run whenever the injury, however minimal, is caused by a negligent act. Further, the limitations period begin to run at the time of injury, not discovery or diagnosis.

The Fourth Circuit also agreed that equitable tolling did not apply. The Court found that the Virginia Supreme Court would not adopt a cross-jurisdictional equitable tolling rule since Virginia had no interest in furthering the efficiency and economy of class action procedures in another jurisdiction. Moreover, the Court held, adoption of a cross-jurisdictional tolling rule would result in an increase in filings of class actions that had been dismissed from other jurisdictions and render Virginia’s limitations period dependent on the resolution of claims in other jurisdictions.

*Mays & Valentine represented Danek Medical, Inc. in Wade v. Danek

Fourth Circuit Reverses Exclusion of Expert Testimony on Causation

Anderson v. Quality Stores, Inc., 181 F.3d 86 (table opinion), 1999 WL 387827 (4th Cir. 1999)

Hannelore Anderson sued Quality Stores Inc. alleging that her husband’s death was caused by the inhalation of toluene in spray paint sold by Quality Stores. The district court excluded the testimony of two of plaintiff’s causation experts on the basis that the experts were unable to quantify Anderson’s exposure. The district court also held that without the expert testimony, Anderson failed to present evidence sufficient to raise a genuine issue of fact and granted summary judgment in favor of Quality Stores.

The Fourth Circuit reversed, holding that the district court abused its discretion in excluding the experts’ opinions. The Court held that the opinions were based on a reliable differential diagnosis and a strong temporal relationship between a substantial exposure to paint fumes and the onset of Wesley Anderson’s symptoms. The Court also noted that the Material Safety Data Sheet and medical literature supported a conclusion that the presence of significant amounts of chemicals from the spray paint could result in pulmonary problems.

Fourth Circuit Holds that Violation of FDCA Does Not Constitute Negligence Per Se and that Learned Intermediary Doctrine Bars Liability for Failure to Warn

Talley v. Danek Medical, 179 F.3d 154 (4th Cir. 1999)*

Talley sued Danek for injuries allegedly sustained from the use of Danek’s spinal fixation device, called the Dyna-Lok Device, in her spinal fusion surgery. The district court granted summary judgment in favor of Danek and the Fourth Circuit affirmed.

On appeal, Talley argued that Danek committed negligence per se by marketing the Dyna-Lok Device for use in the pedicles of the spine when the FDA had not yet approved the device for that use. The Court rejected this argument, holding that the regulations regarding approval of medical devices were administrative requirements that did not amount to an articulation of a standard of care and so could not support a negligence per se claim. Moreover, Talley failed to present evidence that the breach of an FDA regulation proximately caused her injuries.

The Fourth Circuit also affirmed summary judgment for lack of proof of product defect. In support of this claim, Talley offered testimony from two expert witnesses, Dr. O’Rourke and Dr. Alexander. Dr. O’Rourke testified that the Dyna-Lok device was negligently designed because the screws were too short, but O’Rourke did not know the actual length of the screws and his opinion that the screws were too short had no support in the record. Dr. Alexander testified that a dispute within the industry existed as to whether the use of spinal fixation device was more likely to be successful than fusion without such a device, but he identified no design flaw in the device.

Finally, Talley claimed that the learned intermediary doctrine did not apply because the surgeon who performed her surgery was a consultant to Danek and so was not "independent." The Fourth Circuit, however, held that Talley had failed to show that her surgeon’s consulting relationship with Danek interfered with his independent medical judgment. The surgeon was not committed to using Danek’s spinal fixation device, and, in fact, he first attempted fusion without a fixation device. Moreover, the surgeon’s consulting relationship with Danek involved devices unrelated to spinal fixation.

*Mays & Valentine represented Danek Medical, Inc. in Talley v. Danek

Fourth Circuit Affirms Admission of a Treating Physician’s Opinion of Causation

Based on Differential Diagnosis.

Westberry v. Gislaved Gummi AB, 178 F.3d 257 (4th Cir. 1999)

Westberry filed suit against Gislaved Gummi AB (GGAB) for sinus injuries allegedly caused by his exposure to high concentrations of airborne talc at his workplace. Westberry relied on the testimony of his treating physician, Dr. Isenhower, that the talc aggravated his preexisting sinus condition. After a jury verdict in favor of Westberry, GGAB appealed, contending that the district court failed to evaluate the reliability of Dr. Isenhower’s testimony.

The Fourth Circuit agreed that the district court had an obligation to determine if Dr. Isenhower’s testimony was reliable. Nonetheless, the Fourth Circuit affirmed the admission of the testimony. The Court held that Dr. Isenhower based his opinion on a reliable differential diagnosis as well as a temporal relationship between Westberry’s exposure and his symptoms. Differential diagnosis, the Court held, had widespread acceptance in the medical community and did not frequently lead to incorrect results. In addition, the temporal relationship between Westberry’s exposure and the worsening of his condition supported the conclusion that talc was the source of the problem. Further, defendant’s expert admitted that the inhalation of high levels of talc could irritate the mucous membranes, and Westberry testified that he experienced a substantial exposure to airborne talc. Finally, Dr. Isenhower opined that he had considered and excluded other potential causes for Westberry’s sinus disease.

 

Federal District Court Cases

Federal Court Upholds Limitation of Consequential Damages, Including Personal Injuries, in Sales Contract for Hay Baler

Blevins v. New Holland North America, Inc., No. 1:99CV00101 (W.D. Va. March 1, 2000)

Blevins’ employer, Vannoy Farms, purchased a hay baler manufactured by New Holland. When the hay baler was delivered, it was accompanied by a form document entitled "Warranty and Limitation of Liability." Among other things, the form stated, in capital letters, that New Holland shall not be "liable for loss of use of the product, loss of time, inconvenience, commercial loss or consequential damages." Vannoy Farms’ name was filled in on the form, and Blevins himself signed the form on behalf of his employer. A few days later, Blevins was injured when an operating belt pulled his arm into a "nip" point, and he sued New Holland for negligence and breach of warranty.

New Holland moved for summary judgment on the claim of breach of warranty. Section 2-719 of the U.C.C. allows a seller to exclude liability for consequential damages, including personal injuries, unless the exclusion is unconscionable. A limitation of consequential damages for personal injuries in the case of consumer goods is prima facie unconscionable but a limitation of damages where the loss is commercial is not. Since Vannoy Farms bought the hay baler for use in a commercial enterprise, the Court held, it was not consumer goods, and so the exclusion was not prima facie unconscionable.

The Court also held that Blevins bore the burden of proving unconscionability and that unconscionability is determined from the point of view of the purchaser (Vannoy Farms), not from the perspective of the injured party. The Court noted that the essence of unconscionability is (1) the absence of meaningful choice together with (2) contract terms that are unreasonably favorable to the other party. There was evidence that Blevins’ employer had the opportunity to purchase a hay baler from other suppliers and no evidence that such an exclusion was uncommon or unexpected in farm equipment sales. Thus, the Court found, Vannoy Farms was not compelled to accept the limitation of remedies by lack of meaningful choice. Even though the nature of the loss was personal injury and not commercial loss, the court refused to find the limitation unconscionable and entered judgment in favor of New Holland on the breach of warranty claim.

Federal Court Grants Summary Judgment to Maker of Spinal Fixation Device Based on Lack of Causation

Hartwell v. Danek Medical, Inc., 47 F. Supp.2d 703 (W.D. Va. 1999)*

Hartwell alleged injuries from the use of Danek’s spinal fixation device (the "TSRH device"). Hartwell’s spine fused as her surgeon intended, and her TSRH device was subsequently removed. However, she continued to experience back pain.

Hartwell sued Danek claiming that the TSRH device was defective and unreasonably dangerous. In deposition, Hartwell’s expert witness testified that the surgeon chose the wrong procedure in the first place and admitted that he had failed to rule out other possible causes for Hartwell’s painful conditions.

The Court granted summary judgment to Danek on the grounds that Hartwell failed to meet her burden of proof on the issue of causation. Under Virginia law, a plaintiff must demonstrate that a defective product caused the injury. If the injury is caused by a doctor’s malpractice, then the product is not the cause. In addition, where there is more than one possible cause of an injury, a plaintiff must show with "reasonable certainty" that the defendant caused the injury.

The court also held that the testimony of Hartwell’s expert was unreliable because the expert did not examine her, talk to her, read her deposition, or review her x-rays.

*Mays & Valentine represented Danek Medical, Inc. in Hartwell v. Danek

Federal Court Grants Summary Judgment to Maker of Spinal Fixation Device Based on the Statute of Limitations

Smith v. Danek Medical, Inc., 47 F. Supp.2d 698 (W.D. Va. 1998)*

Smith underwent spinal fusion surgery which included the use of Danek’s spinal fixation device (the "TSRH device") attached to the pedicles of his spine with bone screws. At the time of the surgery, the FDA had cleared Danek’s TSRH device for labeling and marketing for a variety of spinal indications, but had not cleared it for fixation to the pedicles of the spine. Smith claimed that the TSRH device became broken or loosened, allegedly causing injury.

Danek moved for summary judgment, arguing that Virginia’s two-year statute of limitation had expired before Smith filed his lawsuit. The court agreed, holding that Smith’s cause of action accrued and the statute of limitations began to run at the time of surgery, because that was when the initial injury took place. The fact that more substantial injuries may have occurred later was irrelevant.

*Mays and Valentine represented Danek Medical, Inc. in Smith v. Danek

Federal Court Excludes Introduction of a New Theory of Causation Two Years into Litigation

Lamonds v. General Motors Corp., 34 F.Supp.2d 391 (W.D. Va. 1999)

In a one-car accident, Lamonds suffered severe injuries when she was ejected through the rear-view window of her 1988 Chevy Spectrum. She sued G.M., claiming that the seat belt design allowed it to become wrapped around the seat back release lever, causing the seat to recline during an accident and allowing her to slide out from under the seat belt. Two years into litigation, she attempted to introduce a new theory of causation through an expert witness who opined that the structural weakness of the seat caused her ejection from the vehicle.

The Court held that the seat belt theory and the new "weak seat" theory were factually inconsistent. Further, Lamond had previously represented to the Court that the seat belt theory was her only theory of causation. Because of these representations, the court excluded the new "weak seat" theory under the doctrines of judicial estoppel and judicial admission. Judicial estoppel precludes a party from asserting a position that is factually inconsistent with a position taken in prior proceedings if (1) the prior position was accepted by the tribunal and (2) the party to be estopped took the position intentionally for the purpose of gaining unfair advantage. Under the doctrine of judicial admission, admissions made by counsel can have a binding effect on the parties, and preclude conduct that is inconsistent with prior statements.

 

Virginia Supreme Court Requires Plaintiff to Offer Affirmative Evidence that Defect Existed When a Product Left Defendants’ Possession

Garrett v. I.R. Witzer Co., 258 Va. 264, 518 S.E.2d 635 (1999).

Garrett alleged that he was injured when a pin on a truck trailer manufactured by I. R. Witzer failed and caused the trailer to fall on Garrett’s foot. Garrett sued Witzer alleging that the pin was too small. In response, Witzer presented evidence that the pin that was in the trailer at the time of the accident was not the same pin delivered with the trailer.

The trial court granted judgment to Witzer as a matter of law, and the Supreme Court affirmed, holding that Garrett failed to prove that a defect existed in trailer when it left defendants’ possession. Specifically, Garrett failed to present any evidence about the condition of the pin when Witzer delivered the trailer.

Supreme Court Holds that Sales Material do not Create Express Warranties

Bayliner Marine Corp. v. Crow, 257 Va. 121, 509 S.E.2d 499 (1999).

Crow sued for breach of express and implied warranty when a boat he purchased from Bayliner would not reach the speed that he expected. Prior to purchase, Crow received "prop matrixes" from a Bayliner distributor that listed the maximum speed of his model boat as 30 miles per hour. Despite numerous repairs and adjustments by the distributor, the boat never went faster than 17 miles per hour. Crow argued that the "prop matrixes" he received created an express warranty that the boat was capable of a maximum speed of 30 miles per hour and that a statement in Bayliner’s sales brochure that the boat "delivers the kind of performance you need to get to the prime offshore fishing grounds" created an express warranty of the boat’s maximum speed.

The Supreme Court held that the "prop matrixes" did not create an express warranty because they did not relate to the particular boat Crow purchased, or to one with "substantially similar" characteristics. Instead, the matrixes referred to a boat with different sized propellers and equipment weighing substantially less than the equipment on Crow’s boat. The Court also held that the sales brochure was merely an opinion of the boat’s performance, rather than an express warranty.

The Court also affirmed the holding that Crow failed to present evidence that the boat was not fit for its ordinary purpose as an offshore sport fishing boat and that the boat "would not pass without objection in the trade" and so there was no evidence that Bayliner breached an implied warranty of merchantability.

Supreme Court Holds that Notice of a Breach of Warranty is Required Only If the Injured Person is the Buyer of the Product.

Yates v. Pitman Manufacturing, Inc., 257 Va. 601, 514 S.E.2d 605 (1999).

Yates asserted claims for breach of express and implied warranties for injuries he sustained when an outrigger on a crane manufactured by Pitman dropped onto his foot. Koch, the owner of the unit, was using it to deliver equipment to Yates’ employer when the injury occurred.

The trial court held that Yates was required to provide notice of breach of warranty to Pitman in order to recover under a warranty claim. The Supreme Court reversed, holding that the notice requirement of the U.C.C. applies only to buyers of goods, and Yates was not a "buyer" of the crane.

The Court also held that Pitman’s certification to the crane distributor that the crane met "applicable design and construction standards as prescribed by ANSI B30.5-1968" was an affirmation of fact that became part of Pitman’s express warranty and that the express warranty ran to Yates even though he was not the purchaser of the crane.