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From Health Law Daily, September 26, 2014

Broken and defective medical device allegations continue in pieces

By Bryant Storm, JD

A district court granted part of a manufacturer’s motion to dismiss but allowed an injured patient’s state law product liability claims to proceed on the grounds that the patient sufficiently alleged that her injury arose from a reasonably anticipated use of a defective device. The court also denied the manufacturer’s arguments that the claims were prescribed, because they were filed after the one year deadline, by applying the doctrine of contra non valentem and holding that the claims were tolled because the patient experienced a delay in determining who manufactured the allegedly defective device (Hargrove v Boston Scientific Corporation, September 24, 2014, Brown, N).

ERCP. Donna Hargrove underwent an endoscopic retrograde cholangiopancreatography procedure (ERCP) on October 20, 2011. As part of the procedure, a Pathfinder Exchange Guidewire (guidewire), manufactured by Boston Scientific Corporation (Boston Scientific), was placed in Hargrove’s body. Subsequently the guidewire broke off within Hargrove’s pancreatic duct, which led to additional ERCPs and the development of chronic pancreatitis. Following the failure of the device, Hargrove and her husband, John Burns, (the Hargroves) subsequently began requesting information about the Hargrove’s medical records, the procedure, and the device from the hospital. Despite repeated attempts to discover information, the Hargroves did not learn until November 12, 2012, the identity of Boston Scientific. Following the discovery of the manufacturer’s identity, the Hargroves filed a lawsuit in federal court against Boston Scientific alleging violations of the Louisiana Products Liability Act (LPLA), and the warranty of redhibition. After voluntarily dismissing their first lawsuit, the Hargroves refiled on May 21, 2013.

Prescription. Boston Scientific argued that the Hargroves’ claims were barred because claims under the LPLA must be brought within a year of the accrual of a cause of action. Contending that October 20, 2012, the date of the original ERCP was the date that the cause of action accrued; the manufacturer argued that the Hargroves filed their case outside of the time limit. The Hargroves disagreed as to the relevant date of accrual and asserted that the claims did not arise until they knew the name of the manufacturer. Accordingly, the Hargroves argued that the Louisiana doctrine of contra non valentem suspends the running of prescription in specific circumstances, for example, when a plaintiff does not know or could not reasonably know about a cause of action.

The court agreed with the Hargroves that the doctrine of contra non valentem could apply and potentially toll the one year prescription or statute of limitations of their claim because they were not aware of the identity of Boston Scientific until November 12, 2012. Accordingly, the court denied Boston Scientifics’s attempt to dismiss the case on prescription grounds.

LPLA. Regarding the products liability claims, the court initially held that the Hargroves succeeded in alleging that the broken guidewire was the proximate cause of the injury and that the injury arose from a reasonably anticipated use of the guidewire. The court also held that because the Hargroves alleged that, by breaking, the guidewire deviated from the manufacturer’s specifications and intended use, the Hargroves alleged sufficient facts to support the first element of a design defect claim. However, the court determined that the Hargroves did not successfully allege the second element of a design defect because they did not point to an alternative, safer design that Boston Scientific could have but chose not to use. The court also decided that the Hargroves did not sufficiently plead a claim for inadequate warnings under the LPLA because they did nothing more than conclude that Boston Scientific failed to warn end users about risks associated with the guidewire without supplying any facts to substantiate that claim.

Construction and compositions. The court found that the only theory under the LPLA the Hargroves had successfully pled was a “construction and composition” theory. The court held that the Hargroves construction and composition claim could survive because the Hargroves presented facts which demonstrated: (1) the guidewire was defective; (2) because of the defect, the guidewire broke off inside of Hargrove; and (3) the break occurred subsequent to a procedure where the guidewire was being utilized as the manufacturer had intended it to be used.

Redhibition. The Hargroves also asserted under the LPLA that they were entitled to redhibition or the return of the purchase price of the device and all of the other economic costs associated with the injury and the lawsuit. Although Boston Scientific argued that the Hargroves request for redhibition damages exceeded the scope of damages authorized by the LPLA, the court determined that in so far as the redhibiton claims sought damages directly related to economic loss, the claims could continue.

Other claims. The Hargroves also brought negligence, deceptive practice, breach of implied warranty claims, and a claim that the guidewire was “inherently dangerous.” The court held that none of the additional claims fell under the LPLA or any other law and, therefore, did not state tort claims that could result in relief for the Hargroves.

Leave to amend. Arguing in the alternative, the Hargroves sought to have the court grant them leave to amend their complaint. Despite the argument from Boston Scientific that the court did not have good cause to give the Hargroves another opportunity to cure their defective compliant, the court granted the Hargroves 30 days to address the deficiencies.

The case number is No. 13-3539.

Attorneys: Douglas Robert Plymale (Dugan Law Firm) for Donna Hargrove. Brent A. Talbot (Chaffe McCall LLP) for Boston Scientific Corp.

Companies: Boston Scientific Corp.

MainStory: TopStory CaseDecisions PLDeviceNews MDeviceNews SafetyNews LouisianaNews

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