Angiodynamics Inc. said it has settled with the parent company of C.R. Bard Inc., over a series of conflicts over patents held by Bard that will cost Angiodynamics nearly $10 million just in 2024, potentially significantly more.
Artivion Inc. (formerly Cryolife Inc.) received U.S. FDA premarket application (PMA) approval of its Perclot absorbable hemostatic system and promptly sold the product line to Baxter International Inc., in keeping with the terms of an agreement announced in July 2021. Artivion will begin shipping Perclot product to Baxter following receipt of a milestone payment of $18.75 million in cash, of which $4.5 million will go to Artivion’s former partner Starch Medical Inc.
Alivecor Inc. has nudged the U.S. International Trade Commission (ITC) into issuing a limited exclusion order for products by Apple Inc. that are said to violate patents held by Alivecor, but there is one more stage gate to go for Alivecor. The ITC order notes that the exclusion won’t go into force until resolution of an inter partes review (IPR) involving the two firms, a process that could devour as much as a year and a half before a resolution is available.
Medical device product liability litigation can take a number of seemingly unique twists and turns, but the case of Nelson v. Bard took a path that might have been predicted based on FDA-mandated labeling content. The U.S. Court of Appeals for the Fifth Circuit affirmed a lower court’s ruling that the instructions for use for a Bard inferior vena cava filter indemnified the company because the IFU listed the very events seen by the patient, undercutting the patient’s claim that Bard had failed to warn of these events.
Jury trials for product liability litigation are not always the last stop for these lawsuits, but courts are more frequently banning device makers from presenting evidence related to premarket filings in these proceedings. One example of this was the pelvic mesh trial of McGinnis v. Bard, in which the trial judge allowed the plaintiff to make nearly two dozen references to the FDA without allowing rebuttal from counsel for the defense, thus biasing a jury that awarded the plaintiff $68 million without hearing the entirety of the evidence.
The U.S. FDA said the results of a Section 522 postmarket surveillance study of transvaginal mesh devices by Boston Scientific Corp. suggested similar effectiveness and safety outcomes at 36 months compared to native tissue repair. However, the agency said patients with mesh repair for pelvic organ prolapse (POP) are exposed to additional risks, such as mesh exposure and erosion, and thus the agency is disinclined to allow these devices back onto the market.
The FDA’s premarket review mechanisms for class II medical devices may strike some as little more than so much regulatory esoterica, and several courts have ruled that information about the 510(k) process is inadmissible during jury trials due to the possibility of sowing confusion among jurors. An appellate court in New Jersey has ruled that such an exclusion of evidence is prejudicial in a case involving surgical mesh manufactured by two device companies, however, opening a larger debate about the propriety of such exclusions in product liability litigation for medical devices.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA warning letter to company promoting test kits.