Health Law Daily Claims against spinal stimulation device maker survive dismissal, again
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Wednesday, October 16, 2019

Claims against spinal stimulation device maker survive dismissal, again

By Deirdre Kennedy, J.D.

A patient alleging injury by a spinal stimulator can move forward with her claims of failure to warn and negligent manufacturing against the device’s maker.

A woman who was injured allegedly as a result of the implantation of a defective spinal cord stimulator could pursue failure to warn and negligent manufacturing claims against the maker of the device, Delaware’s federal district court ruled. The amendments to her complaint addressed previous deficiencies, and St. Jude Medical, Inc failed to clearly brief an argument opposing the failure to warn claims (Freed v. St. Jude Medical, Inc., October 11, 2019, Burke, C.).

Inury. A patient suffering from chronic lower back pain underwent implantation surgery of a Protege 16-channel Spinal Cord Stimulator (SCS) manufactured by St. Jude Medical. The patient underwent further exploratory and fusion surgery of her lumbar spine, and began using a prescribed bone growth stimulator. While using the stimulator, the patient began experiencing discomfort in her left buttocks, where the SCS device had been implanted. The SCS began emitting painful electric shocks, causing a severe burning sensation. The patient subsequently underwent surgery to have the SCS device removed after experiencing, and expecting to continue to experience, severe pain and emotional distress as a result of the SCS implant. She filed suit against St. Jude, alleging breach of warranty, failure to warn, and negligent manufacturing. St. Jude filed a motion to dismiss, arguing that the patient failed to state a plausible claim for relief and that her claims were preempted by federal law.

Prior proceedings. In a previous decision, this court held that the patient could pursue a negligent manufacturing claim against the maker of the device. The court also found that although the patient did not adequately plead a causal nexus between the manufacturer’s alleged failure to report adverse events to the FDA and the patient’s injuries in her failure-to-warn claim, the court granted leave to amend the claim in that regard (see Negligent manufacturing claim against spinal stimulation device maker moves forward, February 5, 2019).

Failure to warn. In her second amended complaint, the patient added new allegations relevant to causation. She argued that if St. Jude had notified the FDA of its device’s risks, the patient would have learned of them and avoided use of the device. St. Jude argued that even these new allegations failed to adequately plead sufficient facts relating to the causation element for the failure to warn claim. It claimed that because the adverse effects that the patient referenced were related to previous products, and not the one used by the patient, they were insufficient.

The court, however, noted that St. Jude did not clearly and explicitly raise this argument in its briefing on the motion, and therefore waived this argument for purposes of the motion. The court further found that it was plausible that St. Jude’s alleged failure to warn the FDA (and, therefore, the patient) about alleged hazards, risks and defects relating to the device at issue could have caused the patient’s injuries.

Negligent manufacturing. In the motion at issue here, St. Jude also asserted that the patient’s negligent manufacturing claim should be dismissed with prejudice. The claim was raised, however, in the original complaint and St. Jude did not raise these arguments in its original motion to dismiss, and therefore could not raise them now.

The case is No: 17-1128-CJB.

Attorneys: David G. Culley (Tybout, Redfearn & Pell) for Kathleen M. Freed and Richman Freed. Brian M. Rostocki (Reed Smith LLP) for St. Jude Medical, Inc., St. Jude Medical S.C., Inc., Abbott Laboratories, Inc. and Advanced Neuromodulation Systems, Inc. d/b/a St. Jude Medical Neuromodulation Division.

Companies: St. Jude Medical, Inc.; St. Jude Medical S.C., Inc.; Abbott Laboratories, Inc.; Advanced Neuromodulation Systems, Inc. d/b/a St. Jude Medical Neuromodulation Division

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