Class III Medical Device Product Liability Claim Based On A Violation Of Federal Law Is Not Preempted

BAUSCH v. STRYKER CORP. (December 23, 2010)

Several days after the FDA advised the Stryker Corp. that its Trident hip replacement system’s manufacturing process was deficient, Margaret Bausch received a new hip -- a Trident. Bausch's Trident failed, she required additional surgery, and she experienced a number of medical problems. Bausch brought a negligence and strict liability suit under state law, alleging that the device violated federal law. Judge Der-Yeghiayan (N.D. Ill) granted the defendants' motion to dismiss on the grounds that the claims were preempted by federal law. The court also entered final judgment without allowing Bausch an opportunity to amend. Bausch appeals.

In their opinion, Seventh Circuit Chief Judge Easterbrook and Judges Manion and Hamilton reversed and remanded. The Court first considered express preemption. Class III medical devices such as the Trident system are granted an express, but limited, preemption defense from product liability claims by the Medical Device Amendments of 1976. Citing the Supreme Court's decisions in Lohr and Riegel, the Court stated that the preemption protection applies to devices that comply with federal law and does not preclude claims based on a violation of federal law. Although expressly not deciding whether Bausch would be able to prove the allegations of her complaint that the device violates federal law, the Court concluded that the express preemption defense should not preclude her from trying. The Court also rejected the defendants' implied preemption defense under Buckman. Buckman involved an allegation of fraud on the FDA -- the Supreme Court expressly distinguished that type of claim from a traditional state court claim. Having concluded that the claims alleged were not preempted, the Court next addressed whether they were adequately stated under Iqbal and Twombly. The Court concluded that both the original complaint and the proffered amended complaint met that standard. With respect to the original complaint, although it did not specify the specific federal violation, it did provide enough information to put defendants on notice of the nature of the claim. This is particularly true in the situation here, because the victim of a defective product frequently does not know the exact nature of the defect and much information regarding Class III medical devices is kept confidential by law. The Court also concluded that the proffered amended complaint was sufficient and should not have been rejected. It provided additional factual detail as well as a clarification that Bausch was proceeding under a federal violation theory. The Court found no merit in any of the district court's rationales for denying leave to amend and cautioned district courts to allow a party an opportunity to amend after dismissal for failure to state a claim, even if the court is skeptical of the party's ability to successfully do so. 

Evidence Was Insufficient To Support Inference Of Causation Or Breach Of Duty

CLIFFORD v. CROP PRODUCTION SERVICES (November 29, 2010)

John Clifford, III, had a contract with Monsanto to farm seed corn. One of the strains he planted in 2007 was a sensitive to two herbicides. When he noticed weeds in his corn and sought advice from Monsanto, however, he was told that there were no herbicide restrictions. Clifford went to Crop Production Services (“CPS”) for the proper treatment. CPS recommended a blend of the very two herbicides to which this particular strain was sensitive. CPS mixed a custom blend on several occasions and dispensed it into a tank that it had loaned Clifford for the season. Clifford applied the herbicide himself. Within a week, Clifford noticed corn damage. He eventually destroyed all the corn in one field and some of the corn in another. Pat Geneser, a Monsanto employee, inspected the fields and suspected that the damage was caused by glyphosphate, an ingredient in a different Monsanto herbicide. Laboratory tests confirmed trace amounts of glyphosphate in the corn. Clifford brought suit against CPS for negligence. CPS defended on four grounds: a) that the glyphosphate did not cause the harm, b) that if the glyphosphate did cause the harm, it did not come from CPS, c) that if CPS was the source of the glyphosphate and it did cause the harm, CPS did not breach a duty of care, and d) the claim was barred by the economic loss doctrine. Clifford did not disclose Geneser (or anyone else) as an expert witness within the time limitations, CPS moved for summary judgment on all four of its defenses, specifically relying on the absence of expert testimony for the first three. Magistrate Judge Bernthal (C.D. Ill.) concluded that Geneser's testimony was expert testimony and that it was inadmissible because of Clifford's failure to disclose. He granted summary judgment to CPS on the grounds that Clifford could not establish causation or breach of duty. Clifford appeals.

In their opinion, Seventh Circuit Judges Posner and Wood and District Judge Adelman affirmed. The Court first concluded that Clifford waived his arguments that Geneser was a lay witness and that, even if he was an expert, his failure to disclose him was harmless. Clifford never even responded to CPS's waiver argument in its briefs. Alternatively, the Court concluded that it would affirm the summary judgment ruling even if it considered Geneser’s testimony. To defeat summary judgment, Clifford had to present sufficient testimony in three areas: that glyphosphate caused the harm, that CPS was the source of the glyphosphate, and that the harm would have been prevented had CPS exercised reasonable care. Even if admitted, Geneser's testimony would not permit a reasonable trier of fact to infer that CPS was the source of the glyphosphate or that it breached a duty of care. In fact, Clifford offered no evidence on a standard of care or its breach. To the extent that Clifford was invoking the doctrine of res ipsa loquitor, the Court stated that it was not a proper case for that doctrine. 

Plaintiffs Foreseeable Conduct Does Not Stand As An Accident's Sole Cause

MALEN v. MTD PRODUCTS (November 19, 2010)

Donald Malen bought a reconditioned riding lawnmower in 2001 from Home Depot. The mower was manufactured in 1998 by MTD Products. It was designed with two particular safety features that turned off the engine if the operator rose from his seat or shifted into reverse, respectively, without completely disengaging the mower blade. It also came with warning labels instructing the operator to disengage the blade before leaving his seat. Malen operated the mower for several years without a problem. In late 2004, the mower got hung up on a curb while Malen was mulching leaves. He tried "rocking" between forward and reverse but without success. He lifted his foot from the pedal that engages the blade and stepped off the mower. He did not turn off the engine. He slipped as he stepped to the ground and the blade struck and severely injured his foot as it went under the mower. He brought suit against Home Depot and MTD Products under strict products liability and negligence theories. The negligence theories were that: a) the mower was negligently manufactured because the safety devices were not operable and b) the mower was negligently designed because it did not have a fail-safe system that would have stopped the blade even without the safety device. Discovery established that: a) Malen thought he disengaged the blade when he lifted his foot off the pedal, b) the safety devices were present but not connected, c) when connected, the devices worked and stopped the blade within 2.6 seconds of the operator rising from his seat, and d) a fail-safe version of the safety feature was available at the time Malen purchased the reconditioned mower. Judge Norgle (N.D. Ill) granted summary judgment to the defendants, concluding that Malen understood and ignored the warning labels and was, therefore, the sole cause of his accident. Malen appeals.

In their opinion, Seventh Circuit Chief Judge Easterbrook and Judges Evans and Williams reversed and remanded. Under both the strict liability and negligence theories of liability, causation is a necessary element. The Court concluded that a reasonable jury could find that the mower was defective and the proximate cause of Malen's injury. The Court first addressed the issues of unreasonably dangerous and negligent design, even though the district court found no need to. It concluded that a jury could find, on the record before it, that the mower was originally put into the stream of commerce without the safety switch. Such a finding would lead to the conclusion that the mower was unreasonably dangerous and that its manufacturer was negligent. Although Malen did not purchase the mower new, the Court concluded that a reconditioned product sold with a full warranty should be treated like a new one. The Court found no controlling Illinois decision on that point, but found support for its conclusion in other jurisdictions and from the Restatement. The Court found sufficient evidence to go to a jury on the negligent design theory as well. The evidence established that MTD incorporated the improved, fail-safe design in its products before Malen purchased his mower. Finally, the Court addressed proximate cause and identified several reasons why summary judgment based on proximate cause was improper. First, the Court concluded that Malen’s failure to heed the warnings was not relevant if the mower was defective for lack of a safety system. Second, if it was relevant, it would be a factor only in determining whether Malen’s conduct was foreseeable. The evidence in the record is that the safety device was developed because that kind of conduct was actually not only foreseeable but routine. Third, the Court concluded that Illinois would extend crashworthiness doctrine to mowers. That doctrine requires a manufacturer to reasonably design a product to minimize the effects of an accident. Malen's conduct here was foreseeable under the crashworthiness doctrine and does not establish proximate cause. Finally, under Illinois law, Malen is barred from recovery only if his negligence contributed more than 50% to the proximate cause of the injury. For all those reasons, the Court found summary judgment erroneous.

Bartender's Failure To Protect Patron From Foreseeable Attack States A Claim

REYNOLDS v. CB SPORTS BAR (October 22, 2010)

Loretta Reynolds (according to her complaint) had car trouble while leaving Jerzey’s Sports Bar in O’Fallon, Illinois. The bartender told her no cabs were available and suggested she get a ride from another patron. Two other patrons agreed to give her a ride but first bought her several drinks (and possibly drugged her). Reynolds realized while in their car that they were not driving her to her hotel but were intent on sexually assaulting her. She managed to escape but, in the process, was hit by a car and severely injured. She brought suit against the two other patrons and CB Sports, the establishment’s owner. She alleged alternatively that the bartender “knew or should have known” that the patrons were getting her drunk in order to sexually assault her or that the bar and bartender intentionally aided the patrons in doing so. Judge Gilbert (S.D. Ill.) dismissed the complaint against CB Sports, finding no duty under the circumstances. Reynolds appealed. While her appeal was pending, the court entered a default judgment against one of the individual defendants and held a hearing on damages. At the hearing, Reynolds presented additional facts with respect to the night in question – including that two different bartenders refused her request for a phone book, told her that no taxis were available, and vouched for the character of the two other patrons.

In their opinion, Judges Posner, Ripple (dissenting), and Kanne reversed and remanded. The Court first considered the significance of the testimony at the damages hearing. Prior to Iqbal and Twombly, a plaintiff was free to offer an unsubstantiated version of the events on appeal in support of its position as long as it was consistent with the complaint. The Court concluded that Iqbal and Twombly raised the bar with respect to the content of the complaint but did not limit a plaintiff’s ability to argue facts outside the complaint to show that a complaint should not have been dismissed. Next, to the extent the complaint alleged an intentional tort, the Court noted that CB Sports could not be liable. It turned to the negligence claim and, specifically, the existence of a duty. Under Illinois law, the general rule is that a business owner is liable for foreseeable criminal attacks while an invitee is on the premises. Generally, liability does not attach for an attack off the premises. The Court noted, however, that Illinois courts have recognized some exceptions to the off-premises rule. Illinois courts have extended liability to off-premises attacks In Shortall, Osborne, and Haupt – but in each case the attack took place just off the premises. Here, the attack was over a mile away. Nevertheless, it was the foreseeability of the attack that the courts considered in Shortall, Osborne, and Haupt. And here, taking the facts alleged as true, the attack was foreseeable. Foreseeability is not enough, however. The Court also considered the likelihood of the injury, the burden on the establishment owner, and the consequences of that burden. Here, the likelihood is high given the intentional scheme at play. The burden and consequences of imposing that duty are not high. The Court emphasized that this was not a burden to investigate – only a burden to protect when it was aware of an intent to injure. The Court was satisfied that Reynold’s allegations sufficiently pled a duty. Finally, the Court declined to find an absence of proximate cause as a matter of law and emphasized that it was not accepting Reynold’s “voluntary undertaking” theory of liability.

Judge Ripple dissented. Although he recognized the Illinois courts’ expansion of off-premises business invitee liability, he disagreed with the Court’s further extension of the principle. On the one hand, Reynold’s complaint alleges an intentional act. Judge Ripple would not extend negligence principles to the situation where the employee is a participant in the execution of the planned attack. As for the alternate allegation that the bartender “should have known,” Judge Ripple believed the burden imposed by the panel opinion on the establishment is too great. He saw no facts alleged in the complaint upon which to base a “should have known” conclusion. Either way, Judge Ripple thought the panel opinion extended Illinois law beyond where the Illinois Supreme Court would go.

Substantive Law Of The Place Of Original Injury Governs In Products Liability Case

ROBINSON v. MCNEIL CONSUMER HEALTHCARE (August 11, 2010)

In early 2005, Karen Robinson purchased Children's Motrin for her child. Motrin is manufactured by McNeil Consumer Healthcare. The label, which she read before purchase, warned of a possible severe allergic reaction. Several months later, she took a dose of the Motrin for a headache. She neither reread nor recalled the warnings. The next day, Robinson developed a rash and a fever – so she took more Motrin. A doctor’s visit resulted in treatment for an allergic reaction. The doctor did not comment on her disclosure that she had taken Motrin. Her rash and fever worsened and she took a third dose of the Motrin. She was hospitalized the next day and diagnosed with toxic epidermal necrolysis (TEN). She recovered but lost much of her skin, is blind in one eye and expected to lose sight in the other, and has had multiple operations to treat organ damage. She brought a products liability suit against McNeil. The jury awarded damages of $3.5 million but also found Robinson contributorily negligent. Applying Virginia law, where contributory negligence is a complete defense to a negligence claim, Judge Holderman (N.D. Ill.) entered judgment for McNeil. Robinson appeals.

In their opinion, Chief Judge Easterbrook and Judges Posner and Kanne affirmed. The Court first addressed the district court's application of Virginia law. Illinois' conflict rule is the "most significant relationship" test. In the case of a tort, that test points to the location of the injury. Here, the place of the initial injury was Virginia, although the Robinsons have since moved to Illinois where her condition worsens and her injury continues. The Court rejected a "continuation of the injury" location test. That approach would allow potential plaintiffs to relocate to favorable jurisdictions after an initial injury. Since the law was correctly applied and there was evidence of contributory negligence, the court ruled correctly. The Court then embarked on a lengthy and interesting, albeit unnecessary, analysis applying Illinois law to show that the result would be the same. In Illinois, a plaintiff's contributory negligence is only a complete defense if it exceeds the negligence of the defendant. The Court adopted a test under which the party who could have avoided the accident at a "lower cost" was the least negligent. After a discussion of the benefits of Motrin, the evidence of any causal connection between Motrin and TEN, the effect of requiring a prescription for Motrin, the role of the FDA, the warnings, and the effect of additional warnings, the Court concluded that Robinson had the lower cost of avoidance. The outcome would have therefore been the same. Finally, the Court concluded that a) the defendant's statement in closing argument that it was "not blaming" Robinson for her injuries was not so deliberate and unambiguous so as to amount to a judicial admission that she was not contributorily negligent, and b) the district court did not abuse its discretion in denying Robinson's request to reinstate her breach of warranty claim right before trial.

Real Property Vendor Is Not Liable For Personal Injury Damages Caused By A Defect Known To The Purchaser

TINDLE v. PULTE HOME CORP. (June 9, 2010)

Terry and Diane Tindle moved into their new home in West Dundee, Illinois in late 2003. Their home was part of a subdivision developed by Pulte Home Corp. Soon after moving in, the Tindles noticed holes developing in both their front and rear yards. They complained about the holes in the front yard. Although Pulte considered them normal, they did repair the holes. For months, the Tindles used their rear yard without incident. In the summer of 2004, however, Terry Tindle stepped into a concealed hole in the rear yard. He suffered serious injuries to his leg. Tindle brought suit against Pulte. Judge Manning (N.D. Ill.) granted summary judgment to Pulte. Tindle appeals.

In their opinion, Judges Flaum, Kanne, and Evans affirmed. The Court noted that Illinois law generally excuses a vendor of real property from liability for personal injury after transfer of possession. Section 353 of the Restatement (Second) of Torts, also the law in Illinois, creates a five-pronged exception to the general rule. A vendor can be liable if a) it knew of a hazardous condition that created an unreasonable risk, b) it concealed or failed to disclose the condition, c) it had reason to believe the purchaser would not discover the condition, d) physical harm resulted from the condition before the purchaser knew of the condition and risk, and e) the purchaser did not have an opportunity to protect against the risk. The Court concurred with the district court that Tindle could not meet his § 353 obligations both because of the state of his knowledge and that of Pulte. First, Tindle was well aware of the dangerous condition created by the holes in his yard. That knowledge defeats any recovery under § 353. Second, Tindle presented no evidence that Pulte was aware of the dangerous condition at the time of the sale. That lack of knowledge independently defeats recovery under § 353.

Suicide Breaks A Chain Of Causation

JOHNSON v. WAL-MART STORES (December 1, 2009)

Candace Johnson visited her local Wal-Mart store in January 2008. Although she did not possess a Firearm Owners Identification Card, a salesclerk nevertheless sold her some bullets. Tragically, Candace Johnson then shot and killed herself. Her husband and the administrator of her estate, Mark Johnson, sued Wal-Mart for negligence and wrongful death. The district court dismissed the claims on the ground that suicide is an independent intervening event, negating proximate cause. Johnson appeals.

In their opinion, Judges Cudahy, Flaum and Evans affirmed. The Court recited the traditional elements of a negligence claim: a duty, a breach, and proximate cause. Historically, Illinois courts have found that suicide is unforeseeable and its presence breaks the chain of causation that is necessary for probable cause. The Court agreed that the sale of the bullets violated federal law and amounted to prima facie evidence of negligence, since the federal law is a public safety statute. The Court concluded, however, that Illinois courts continue to find that suicide breaks the chain of causation.

A Plaintiff's Failure To Present Evidence That Her Fall On A Patch Of Ice Outside Defendant's Restaurant Resulted From An Unnatural Accumulation Of Ice Precludes Recovery

CICIORA v. CCAA, INC. (September 4, 2009)

Lela Ciciora went to Burrito Jalisco one winter day in Chicago to pick up her lunch. She parked in the lot and used the sidewalk to get to the store. It had snowed earlier but the snow had been removed from the sidewalk. A store employee had also salted the sidewalk that morning. Nevertheless, Ciciora slipped on a small patch of ice and fractured her ankle. She brought a personal injury lawsuit against the owner of the premises and CCAA, who ran the restaurant. The district court granted summary judgment to the defendants. Ciciora appeals.

In their opinion, Judges Kanne, Rovner and Evans affirmed. The Court started with the general rule that a property owner has no duty to remove natural accumulations of snow and ice. A duty may exist, however, if one is contractually obligated to do so or if one voluntarily does so. Here, the restaurant owner voluntarily cleared and salted the sidewalk regularly. The Court noted that a volunteer could be liable if her actions resulted in an unnatural accumulation or increased an existing hazard in some other manner. There was simply no evidence presented, however, of an unnatural accumulation or of an aggravation of existing hazard. Ciciora relied on mere speculation. The district court properly granted summary judgment. Similarly, the court concluded that Ciciora failed to present any evidence that the owner of the premises failed to exercise reasonable care in its obligation to maintain the sidewalks.

District Court's Exclusion Of Expert Testimony Was Not An Abuse Of Discretion When Proponents Did Not Contest A Substantive Challenge

LEWIS v. CITGO PETROLEUM CORP. (April 6, 2009)

Michael Lewis and Tammy Livingston, employees of Philip Services Corporation, were performing maintenance work at a CITGO refinery when they were allegedly exposed to a hazardous gas. Emergency personnel responded, they went to the hospital, they received a full medical examination, they were released, and they returned to work the next day. Several years later, Lewis and Livingston asserted common-law negligence claims against CITGO. Livingston also asserted a negligent infliction of emotional distress claim. Their claims were supported by two physicians -- -- Dr. Jordan Fink, a doctor of internal medicine, and Dr. Norman Kohn, a psychiatrist and neurologist. The court granted summary judgment to CITGO, holding that the plaintiffs had failed to satisfy their burden of demonstrating the reliability of the expert testimony. Lewis and Livingston appeal.

In their opinion, Judges Ripple, Kanne and Tinder affirmed. The Court first addressed the question of whether Livingston was a "bystander" or a "direct victim" for purposes of the emotional distress claim under Illinois law. Concluding that she was a "direct victim," the Court noted that the plaintiffs' burden on both the common-law negligence and negligent infliction claims were to demonstrate a duty on the part of defendant and a breach that proximately caused the injury. The Court turned to causation and the lower court’s exclusion of the expert testimony. The Court approved the lower court’s application of Rule 702 and Daubert. It is the burden of the proponent, said the Court, to establish both the qualifications and the methodology of its experts. CITGO challenged Dr. Fink on both qualifications and methodology -- it challenged Dr. Kohn only on methodology. Although the Court recited some of the problems relating to the experts, it ultimately relied on the fact that plaintiffs failed to advance any substantive arguments in support of their experts’ qualifications. The Court concluded that the lower court was well within its discretion to exclude the evidence. Without this testimony, neither Lewis nor Livingston could provide evidence of causation with respect to the common law negligence claims. With respect to Livingston's claim for negligent infliction of emotional distress, however, one of CITGO's own experts did testify that Livingston experienced "relatively mild" anxiety as a result of the exposure. The Court agreed with the lower court’s conclusion that the injury did not reach the threshold of severity to be compensable and was properly dismissed.

Arranger of Transportation Services Is Not a "Motor Carrier" Under the Federal Motor Carrier Safety Regulations

CAMP v. TNT LOGISTICS CORPORATION (January 14, 2009)

Lola Camp was a truck driver in the employ of Transport Leasing Company (“TLC”). TLC in turn provided her services to DeKeyser Express (“DeKeyser”), a transport company. One of DeKeyser’s customers was TNT Logistics Corporation (“TNT”). TNT provided transportation logistics services to shippers. In January 2003, TNT directed DeKeyser to pick up a shipment of automobile parts from Trelleborg YSH, Inc. (“Trelleborg”) for delivery to a Mitsubishi automobile plant. DeKeyser assigned the job to Camp. When Camp arrived and surveyed the shipment, consisting of three pallets of parts, she concluded that the only way to fit them onto the truck was to stack one of the pallets on top of one of the others. She was concerned that such a load might not be safe. She advised Trelleborg, DeKeyser and TNT of her concern. TNT personnel advised DeKeyser and Camp that it understood the risk. TNT advised Camp to go ahead with the shipment. TNT released Trelleborg and Camp of any liability for cargo damage. When Camp arrived at her destination, she opened the truck door. The pallet started to fall – she injured herself while trying to prevent the fall. Camp brought an action against TNT and Trelleborg for negligence. The court granted summary judgment to TNT and Trelleborg. Camp appeals.

In their opinion, Judges Ripple, Manion and Sykes affirmed. The Court started with the elements of a negligence claim in Illinois – duty, breach of the duty, and an injury proximately caused by the breach. The Court found it necessary to discuss only the duty requirement. It understood Camp’s claim to be one for common-law negligence based on two alternate theories of duty – statutory and common-law. Camp alleged that the statutory duty claim arose from TNT’s and Trelleborg’s violation of the Federal Motor Carrier Safety Regulations (“FMCSR”). The Court disagreed. It noted that the regulations applied only to “motor carriers.” It held that TNT was not a motor carrier (Camp conceded that Trelleborg was not.) The Court distinguished between a “motor carrier,” defined as a “person engaged in the transportation of goods,” and a “broker,” defined as one who “provid[es] . . . or arrang[es]” for transportation by motor carriers. Even though “transportation” includes “services related to” the movement of property, the Court determined that TNT’s activities were that of a broker and did not rise to the level of providing services relating to the transportation. Also with respect to the statutory duty claim, the Court held that Camp could not recover from TNT or Trelleborg for aiding and abetting the violation of FMCSR. Camp herself violated the FMCSR. Illinois law does not allow a plaintiff to recover from a defendant for adding or abetting the plaintiff’s own tortious conduct.

With respect to the common-law duty claim, the Court identified the factors under Illinois law that courts consider to determine the existence of a duty: a) reasonable foreseeability of an injury, b) likelihood of an injury, c) magnitude of the burden of protecting against the injury and d) the consequences of placing this burden on the defendant. The Court concluded that neither TNT nor Trelleborg owed a duty of care to Camp -- Camp was aware of the risk, a reasonable person would have avoided the danger, TNT and Trelleborg knew of no particular reason why Camp would be compelled to act otherwise, Camp was in a better position to avoid the injury, it would be a burden to impose the obligation to avoid the injury on TNT or Trelleborg, and placing the burden on TNT and Trelleborg would result in significant resources devoted to preventing the injury. Having found no duty, Camp cannot establish negligence.