Keep Us Posted: FDA Updates Rules On Changes To Medical Devices

The U.S. Food and Drug Administration has updated its rules regarding how manufacturers of medical devices disclose manufacturing and design changes to previously approved medical devices. The focus of the FDA’s update is on annual reports for Class III devices which are subject to premarket approval. To read the rest of this blog entry, authored by Jesse D. Rutter of Goldberg Segalla, please visit Risky Business: Avoiding Product Liability, Commercial, and Other Litigation.
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Keep Us Posted: FDA Updates Rules On Changes To Medical Devices

The U.S. Food and Drug Administration has updated its rules regarding how manufacturers of medical devices disclose manufacturing and design changes to previously approved medical devices. The focus of the FDA’s update is on annual reports for Class III devices which are subject to premarket approval. Under the FDA’s updated guidelines, manufacturers are to disclose in their annual report all changes made to either the manufacturing or design of the device and the underlying rationale and scientific basis for the change. For more significant and…
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Indiana Appellate Court Holds Negligence Action Involving Medtronic Defibrillator Not Preempted by Federal Law

An Indiana appellate court decided that oral representations by a medical device manufacturer during a surgery about the function of device are not preempted by federal law.  Could this be a significant exception to the U.S. Supreme Court’s seminal decision in Riegel vs. Medtronic? In 1997, David Malander received an implanted Medtronic defibrillator and right ventricular lead (“Lead”), which remained in place until he began experiencing problems several years later.  The Lead was a Class III medical device subject to premarket approval by the…
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Court Refuses to Scrutinize the Sufficiency of Differential Diagnosis Analysis and Permits Causation Testimony in Absence of Controlled Studies

This past week, an Ohio federal court considered under Daubert the standard by which specific causation experts in drug and device cases are to be scrutinized. While the Court precluded the opinions of certain experts who did not engage in a differential diagnosis analysis before forming specific causation opinions, it stopped short of precluding one expert who engaged in what was essentially an incomplete differential diagnosis analysis, concluding the sufficiency of the analysis goes to the weight of the evidence and not its reliability under…
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Preemption Wars Over Class III Medical Devices Continue

Preemption wars over Class III medical devices continue unabated.  The plaintiff’s bar is vigilant, creative and undeterred in their efforts to limit the effects of the Buckman case.  In some cases, their efforts are rewarded.  An example is a case decided just this week.  The issue was addressed in a device manufacturer’s 12(b)(6) motion to dismiss a lawsuit against a Class III device on federal preemption grounds.  According to the court’s opinion, a previous preemption motion to dismiss was granted with leave to re-plead.  The…
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California Court of Appeals – No Breach of Duty for Medical Device Representative in the Operating Room

The California Court of Appeals upheld a lower court’s finding that the presence of a medical device manufacturer’s sale representative in an operating suite does not alone give rise to a duty of care to the patient.  Smith v. St. Jude Med., Inc., 217 Cal. App. 4th 313 (Cal. Ct. App. 2013).  The court also upheld the finding that the manufacturer’s sales representative was not a proximate cause of the injury. In Smith, a woman died following cardiac pacemaker surgery from a…
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DePuy Wins Second Hip Implant Trial

After a five-week trial, an Illinois jury made up of seven women and five men reached its verdict, just one day after it started deliberations, and it was in favor of the Johnson & Johnson subsidiary DePuy Inc. In Carol Strum v. DePuy Orthopaedics, plaintiff claimed that the ASR XL implant she received in 2008 had a defective designed that caused it to shed large amounts of debris from metal-on-meal ware and made it prone to premature failure. DePuy had argued over the course of…
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Medical Device Tax – What is It?

The medical device tax is a 2.3 percent excise tax on the sales price of taxable medical devices.  The tax applies to almost all FDA registered devices.  Those devices range from hip implants to tongue depressors.  The medical device tax has been compared to excise taxes on tobacco and alcohol products. Who is paying this tax? The manufacturer or importer, with limited exceptions.  Thus, companies are losing 2.3 percent off the top of their margins.  Commentators argue that the tax will thwart invention. Others argue…
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