Health Law Daily PMA preemption applied where doctor ordered off-label device
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Tuesday, April 13, 2021

PMA preemption applied where doctor ordered off-label device

By Jeffrey H. Brochin, J.D.

Patient’s medical device claims were federally preempted as to injuries occurring after her doctor put hydromorphone into the device that was only approved for three other medications.

A federal district court in Kentucky has granted the motion to dismiss filed by Medtronic, Inc. as to those claims of the patient arising after her doctor used her drug infusion device for a drug other than that for which it was approved. By making an unapproved use of an FDA-approved device, the patient was asking the manufacturer to do something "different from, or in addition to" federal law, thereby defeating her allegations that the alleged violation of state law paralleled federal law. However, as to injuries alleged during the period of approved use, the manufacturer’s motion to dismiss was denied (Engle v. Medtronic, Inc., April 8, 2021, Jennings, R.).

Change of medication regimen. Because of suffering from chronic lower back pain, the patient’s doctor had her implanted with Medtronic’s SynchroMed II medication infusion pump device in October 2018. He initially prescribed morphine as the pain-relief drug to be infused, however, in the months following device implant, the patient suffered from weakness and fatigue, followed by a return of significant back pain. Because of that pain, in January, 2019, her doctor altered the medication to hydromorphone.

However, over the next months, she continued to suffer periods of extreme weakness, fatigue, and lethargy, coupled with periods of significant pain, and during a routine pump refill procedure in July 2019, it was discovered that her pump contained one-sixth of the medicine it should have contained. At a follow-up procedure later that month, her pump again contained less medicine that it should have, leading her doctor to conclude that the pump and catheter were not working properly, and that the device had been over-infusing significant amounts of medicine into her body, causing a rollercoaster of overdose symptoms followed by under-infusion and withdrawal symptoms that necessitated the removal of her Device. She filed suit against Medtronic, who moved to dismiss, which the court granted in part and denied in part.

Narrow exception to federal preemption. Medtronic argued that the patient’s claims were expressly preempted under the preemption provisions of the 1976 Medical Device Amendments (MDA), as an FDA-approved Class III medical device that was approved under the PMA process. The MDA preemption provision provides that no state may establish requirements related to devices that are different from those established by the FDA.

However, the patient cited Supreme Court rulings that state requirements are pre-empted under the MDA only to the extent that they are "different from, or in addition to" the requirements imposed by federal law, so that the preemption provision does not prevent a state from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case ‘parallel,’ rather than add to, federal requirements.

Off-label use of device. Medtronic argued that the patient admitted that her pump was used to deliver hydromorphone--an unapproved medication--and that the device was only FDA-approved for use solely with morphine, zinconotide, and baclofen. The patient responded that the defects in her pump were present on December 12, 2019, when she began to suffer weakness and fatigue, followed by a return of significant back pain, and that that was while she was initially using her pump to administer morphine—a drug for which the SynchroMed II device was indicated; therefore, her pump failure began to occur while her device was used for an approved purpose.

Injury from unapproved use. The court noted that off-label usage of medical devices (use of a device for some other purpose than that for which it has been approved by the FDA) is an accepted and necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the practice of medicine. However, when a patient is injured because her doctor used an FDA-approved device for an unapproved use, the patient is asking the manufacturer to do something different from federal law; this is because the doctor’s off-label use is not a result of the manufacturer’s conduct, and in fact, the manufacturer in this situation is adhering to federal law. Once her doctor altered her medication to hydromorphone starting January 14, 2019, her use of the device was no longer an FDA-approved use.

Accordingly, the court ruled that to the extent the patient’s claims arose out of device issues occurring after her doctor put hydromorphone into the device, they were preempted.

Based on the foregoing, the court granted Medtronic’s motion to dismiss only as to claims arising after January 14, 2019.

The case is Civil Action No. 3:19-cv-909-RGJ.

Attorneys: Ben C. Martin (Martin Baughman, PLLC) for Dawn M. Engle. Brandon Dwayne Cox (Greenberg Traurig, LLP) for Medtronic, Inc., Medtronic Logistics, LLC., Medtronic Puerto Rico Operations Co. and Medtronic USA, Inc.

Companies: Medtronic, Inc.; Medtronic Logistics, LLC; Medtronic Puerto Rico Operations Co.; Medtronic USA, Inc.

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