By Rebecca Mayo, J.D.
A patient can not necessarily be expected to discover that a medical device is the cause of her injury where the doctor intentionally misrepresents that the device is safe and not subject to recall.
A district court denied a motion to dismiss claims against a knee replacement device manufacturer after finding that it was up to the jury to decide whether the patient should have discovered the device was the cause of her injury after it had to be replaced or when a doctor giving a second opinion later indicated it was the cause. The court found that the patient made a sufficient claim that she had no reasonable way to know, so long as the surgeon was a paid representative of the device manufacturer and misrepresented that the device was safe, and allowed the claim to move forward (Chmil v. Arthrex, Inc., February 27, 2019, Caputo, A.).
The claim. A patient had a total knee replacement, during which an Arthrex iBalance® knee system was used. A year later the patient returned to her doctor complaining of severe pain, swelling, and discomfort. The doctor indicated that there was a recall of the iBalance devices, but none of the parts used for the patient’s knee surgery were subject to the recall. The doctor removed the knee system and replaced it with another iBalance device, which again resulted in excessive post-surgical discomfort. A year later, the patient went to another doctor who removed the device after the device failed due to loosening of the tibial tray. The patient brought suit against the manufacturer for failure to exercise due care in designing, manufacturing, marketing, testsig, promoting and fixing iBalance, and for failure to warn doctors of the faults and continuing to promote iBalance despite knowing it was a defective product. The manufacturer moved to have the claims dismissed.
Statute of limitations. The manufacturer argued that the statute of limitation began running when the patient had her first corrective surgery because she should have realized she was injured by the iBalance device. The patient argued that even exercising reasonable diligence, she could not have discovered that the iBalance was the culprit until a physician told her it was. The original doctor denied that iBalance was the cause of the injuries and therefore the patient had no reason to suspect iBalance until the second doctor identified it as the cause. The court held that because reasonable minds could differ as to whether the patient should have discovered the cause of the injuries sooner, the motion to dismiss must be denied.
Negligence. The manufacturer argued that the negligence claims were federally preempted because the device was regulated by the FDA. It further argued that the learned intermediary doctrine relieves the manufacturer of duty. However, the court held that the negligence claims go beyond failure to warn and include negligent manufacture, therefore are not preempted. It also held that the learned intermediary doctrine does not shield the manufacturer from a negligent failure to warn claim where the warning provided to the intermediary is inadequate and the patient has alleged just that. Therefore, the motion to dismiss was denied.
Intentional misrepresentation. The patient alleged that the original doctor was the lead surgeon consultant-designer for the iBalance knee system and he was paid royalties and other payments for his consulting and promoting efforts. The doctor told the patient that the device was safe, effective, and not subject to the recall, even though he knew that was all false, with the intent that the patient rely on his lie, which she did to her own detriment. The manufacturer also disseminated information that misrepresented the efficacy and longevity of iBalance with the intention that health care professionals and consumers would rely on that information. The patient did not indicate when the patient or the original doctor saw the untruthful publications or single out which employee authored the publications. However, the court held that it was enough to allege the dates on which the patient had the devices implanted because it would have been around the time that she or the doctor relied on the manufacturer’s publications. The patient therefore stated her claim with particularity and the motion to dismiss was denied.
The case is No. 3:18-CV-01616.
Attorneys: Christopher L. Coffin (Pendley, Baudin & Coffin, LLP) for Lisa Chmil and Terrance Chmil. Megan E. Grossman (Lewis Brisbois Bisgaard & Smith LLP) for Arthrex, Inc.
Companies: Arthrex, Inc.
MainStory: TopStory FDCActNews MDeviceNews PLDeviceNews SafetyNews PennsylvaniaNews
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