Products Liability Law Daily Travel to Japan during duodenoscope development satisfied causation for jurisdictional purposes
Thursday, June 6, 2019

Travel to Japan during duodenoscope development satisfied causation for jurisdictional purposes

By Jeffrey H. Brochin, J.D.

The proximate cause test is a demanding one, and travels to and from Japan were insufficient to meet that test. However, the but-for test is significantly less demanding, and the travels constituted part of the causal chain leading to the claimed injuries.

The various trips to Japan by a Colorado evaluator of the medical device at issue in a patient’s action based on her developing a bacterial infection stemming from the device did not satisfy the proximate cause test for personal jurisdiction, a federal magistrate judge in Colorado found. However, the court determined that the trips instead were events in the causal chain leading to the alleged injury pursuant to the but-for causation test. Accordingly, the court denied the Federal Rule of Civil Procedure 12(b)(2) motion to dismiss filed by Olympus Medical Systems Corp. (Olympus Medical), a Japanese corporation, after determining that the patient’s first amended complaint sufficiently remedied previous deficiencies to establish that the foreign corporation fell under the personal jurisdiction of the court (Lynch v. Olympus America, Inc., June 5, 2019, Wang, N.).

Drug-resistant bacteria infection. A Colorado patient who underwent an endoscopy at a Colorado hospital in January, 2016, alleged that she contracted a drug-resistant bacterial infection because her doctor used a duodenoscope device that retained biological contaminates from prior use due to the defective design and cleaning protocol provided with the scope. She filed suit against two American Olympus entities as well as against the Japanese manufacturer. After identifying six substantive deficiencies in her first complaint, the court granted motions to dismiss pursuant to Rules 12(b)(6) and 12(b)(2). However, after reviewing her First Amended Complaint, the magistrate judge denied the renewed motions to dismiss for the reasons stated below.

Contacts with Colorado. Olympus Medical maintained contact and business relations with a UCH Hospital physician who was an evaluator of Olympus Medical’s prototype devices. Specifically, he evaluated a prototype scope for Olympus Medical in 2009, before the introduction of the scope to the U.S. market in 2010, and again later in 2013, one year after UCH Hospital purchased the scope at issue, and approximately three years before the patient’s endoscopy procedure. In addition, her treating physician who performed her endoscopy on January 20, 2016, also maintained ties with Olympus Medical—in 2009, he travelled to Japan on Olympus Medical’s invitation several months prior to the release of the device to the U.S. market to give feedback to Olympus Medical about the device. The company also sent representatives to Colorado to build relationships with the treating physician and the hospital.

Contacts insufficient for proximate cause test. In reviewing the records of the foregoing contacts, the court concluded that the patient fell short of establishing specific personal jurisdiction over Olympus Medical when applying the proximate cause test. The treating physician’s travels to Japan were insufficient because out-of-state contacts cannot, in the usual course, constitute activity directed at the forum. The "minimum contacts" analysis looks to the manufacturer’s contacts with the forum state itself, not its contacts with persons who reside there. Furthermore, two company representatives’ visits to Colorado and to the evaluating doctor there in 2009 and 2013 for in-state evaluation of the prototypes were also too attenuated pursuant to precedent. Accordingly, the patient failed to provide enough evidence to tie the flawed design and reprocessing protocol at issue with Olympic Medical’s contacts with Colorado. There was no indication that the 2009 prototype evaluation even included the same design challenged in the instant case, or that any reprocessing protocols were even evaluated by the evaluating physician.

"But-for" causation test satisfied. Notwithstanding the foregoing application of the proximate cause test to the contacts with Olympus Medical, the court took a very different view of applying those facts to the "but-for" causation test. The court noted that the but-for test is significantly less demanding, and under that test, any event in the causal chain leading to the injury is sufficiently related to the claim to support the exercise of specific jurisdiction. The test is satisfied when the manufacturer’s contacts with the forum are a necessary event in the causal chain leading to the injury. The less restrictive but-for standard permitted the court to focus not on the issue of whether Olympus Medical’s Colorado contacts were proximately related to the challenged design of the scope, but rather on the issue of whether Olympus Medical’s actions directed at Colorado were for the purposes of developing and promoting the use of the scope by physicians and patients in Colorado.

For the foregoing reasons, the court found that it has personal jurisdiction over Olympus Medical, the Japanese corporation, and the court denied its Rule 12(b) 2 motion to dismiss.

Design defect claim. After concluding that the court could exercise personal jurisdiction over Olympus Medical, it considered whether the patient's first amended complaint set forth a cognizable design defect claim. The court found that the complaint asserted sufficient facts to support the conclusion that the scope was defectively designed. It established that the scope was designed with a fixed distal-end cap that sealed the elevator wire channel from the outside, supposedly preventing the ingress of fluids from a patient during use. The patient alleged that the cap did not fully seal the elevator wire channel but did effectively prevent reprocessing under the provided reprocessing protocols. The patient also posited that two alternatives were feasible and would have prevented the harm—either remove any end cap, permitting easy cleaning or have a removable cap, which would both reduce the inflow of fluids and allow for easy reprocessing. In fact, these systems were used on other Olympus scopes. The court first determined that the complaint set forth a plausible causal chain of events, finding that the essence of her claim was that due to the particular design of the scope, it was more likely to retain contaminates from prior use and in fact did so during her procedure. As a result of this exposure, she allegedly contracted a multi-drug resistant bacterial infection, similar to the ones that had been previously identified as related to the scope in the United States and Europe. Further, she identified the unsafe characteristic of the device and pointed to a feasible alternative. This, along with a more detailed theory of causation set forth in her complaint, was sufficient to give the manufacturers adequate notice of a cognizable claim.

Failure to warn claim. Similarly, the court found the patient’s complaint set forth a cognizable failure to warn claim under Colorado law. The patient’s theory of the case set out in her first amended complaint was that the device was hard to clean in general, and impossible to clean reliably with the provided instructions which made the device more dangerous, more likely to carry contaminates, and the patient’s doctor should have received a warning as to this propensity. At this point in the litigation, this was sufficient for a plausible claim for relief for a failure to warn.

The case is No. 1:18-cv-00512-NYW.

Attorneys: Gregory M. Sonstein (Panish Shea & Boyle LLP) for Kathleen Lynch. Richard Charles Beaulieu (McGuireWoods) for Olympus America, Inc.

Companies: Olympus America, Inc.; Olympus Corporation of the Americas; Olympus Medical Systems Corp.

MainStory: TopStory CausationNews DesignManufacturingNews WarningsNews JurisdictionNews MedicalDevicesNews ColoradoNews

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