Health Law Daily Claim for deviation from design must first show that design was suitable
Thursday, May 16, 2019

Claim for deviation from design must first show that design was suitable

By Jeffrey H. Brochin, J.D.

Where no suitable design was identified in the complaint, a patient could not reasonably argue that the subsequent manufacturing of the device deviated from its design.

A federal district court in California has granted a medical device manufacturer’s motion to dismiss a strict product liability-manufacturing defect claim because the patient provided absolutely no information regarding the design specifications. Although it can be difficult to allege details regarding the manner in which a particular device has deviated from its design, the patient did not come close to alleging that the IVC Filter was suitably designed or how the unit implanted in her deviated from such design. The court did however deny the manufacturer’s motion to dismiss regarding the strict product liability-inadequate warning claim (Broge v. ALN International, Inc. May 13, 2019, Freeman, B.).

Perforated vena cava wall. A California patient was implanted in June, 2014 with an Inferior Vena Cava (IVC) filter designed, manufactured, and marketed by ALN International, Inc. to treat deep vein thrombosis and pulmonary embolism by trapping and filtering blood clots. The manufacturer marketed the IVC filter as safe and easy to remove after implantation. However, when her physician attempted to remove the IVC filter on November 9, 2015, removal was impossible because the IVC filter had perforated, and become embedded in the vena cava wall. She underwent a second surgery on March 6, 2016, at which time the IVC filter was successfully removed.

She alleged that as a result of these events, she suffered permanent and life-threatening injuries and incurred significant medical expenses. She filed suit asserting several claims which the court subsequently whittled down to four: (1) strict products liability—inadequate warning; (2) strict products liability—manufacturing defect; (3) negligence; and (4) unjust enrichment. The manufacturer moved to dismiss Claims 1 and 2, arguing that the patient failed to cure defects in those claims. For the reasons stated below, the court denied the motion as to the inadequate warning claim, but granted it as to the manufacturing defect claim.

Strict Products Liability—Inadequate Warning. The patient alleged strict products liability based on inadequate warning pursuant to California law which places a duty on manufacturers to warn of a particular risk if it is known or knowable based on prevailing best scientific and medical knowledge available at the time of manufacture and distribution. Under that standard, a manufacturer is held to the knowledge and skill of an expert in the field and is obliged to keep abreast of any scientific discoveries. However, a manufacturer is not under a duty to warn of every report of a possible risk, no matter how speculative, conjectural, or tentative, because inundating the public indiscriminately with notice of every hint of danger would inevitably dilute the force of any specific warning given.

Identifying the correct time-frame. The court previously dismissed the inadequate warning claim because the patient had focused on the manufacturer’s knowledge at the time she was implanted with the IVC Filter rather than the time period when the IVC Filter was manufactured or distributed. However, because the patient amended to add facts deemed sufficient to state a claim for relief, the court concluded that the complaint now focused on the correct time frame—being when the IVC Filter was manufactured—and therefore denied the motion to dismiss the inadequate warning claim.

Strict Products Liability—Manufacturing Defect. Under a strict products liability claim based on manufacturing defect, the patient was required to allege that although there was suitable design in place, the manufacturing process in some way deviated from that design resulting in a defective product. A bare allegation that the device had a manufacturing defect was merely an insufficient legal conclusion. The court found that the patient did not allege facts indicating that the IVC Filter was suitably designed; rather, to the contrary, she alleged facts giving rise to a reasonable inference that the IVC Filter was notsuitably designed and that the medical issues she suffered were due to the design rather than her particular unit’s deviation from the design. She went into much detail describing how the IVC Filter was designed with barbs that made the device more susceptible to post-implantation perforation, penetration, or intertwining with other veins and/or tissue and that the device actually lead to the formation of thromboembolism and pulmonary emboli—the exact condition that the device was meant to prevent.

Although the court recognized that it can be difficult to allege details regarding the manner in which a particular device deviated from its design, the instant patient did not come close to alleging that the IVC Filter was suitably designed or how the particular unit implanted in her deviated from such design. To the contrary, all of her allegations suggested that her medical issues derived from the overall product design itself. Accordingly, the court granted the manufacturer’s motion to dismiss the strict product liability—manufacturing defect claim.

The case is No. Case 5:17-cv-07131-BLF.

Attorneys: Dale Bernardo Ratner (Marc J. Bern and Partners, LLP) for Sandra Broge. Matthew Mihaly (Lewis Brisbois Bisgaard Smith LLP) for ALN International.

Companies: ALN International

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