August 28, 2018

GREEN BAY, Wisc., Aug. 23, 2018 /PRNewswire/ — The Dallas-based intellectual property and business litigation law firm Caldwell Cassady & Curry has won an $8.2 million patent infringement verdict for Acantha LLC against medical device manufacturer DePuy Synthes, a subsidiary of health care giant Johnson & Johnson (NYSE : JNJ ).

A jury of five women and three men issued the unanimous verdict on Aug. 21, 2018, following seven days of trial before the Hon. Chief Judge William C. Griesbach in the U.S. District Court for the Eastern District of Wisconsin in Green Bay. Jurors reached their verdict following five hours of deliberations.

DePuy Synthes was sued in 2015 based on claims that it had infringed an Acantha patent, U.S. Patent No. RE43,008 (‘008 patent), which covers an orthopedic implant assembly used to join bone segments. Acantha’s ‘008 patent was originally issued in 2001 before being reissued in 2011 by the U.S. Patent and Trademark Office.

The Caldwell Cassady & Curry trial team representing Acantha at trial included Brad Caldwell, Austin Curry, Chris Stewart, John Summers and Seth Reich.

Jurors heard evidence that David Talaber, one of the two co-inventors of the ‘008 patent, informed DePuy Synthes’s predecessors about the patent in writing and by phone the year after it was issued.

Mr. Talaber’s co-inventor, Dr. James Lloyd, later traveled to DePuy’s Massachusetts headquarters in 2006 to explain how Acantha’s patent could help with problems DePuy experienced with its implant devices. The DePuy companies never licensed the patent.

Acantha asserted that DePuy Synthes subsequently infringed the ‘008 patent in a series of spine implant devices, including the Zero-P VA System and the Vectra, Vectra-T, and Vectra-One products.

The Green Bay jury found that the DePuy companies willfully infringed Acantha’s patent, awarding $8.2 million in actual damages. The case is Acantha LLC v. DePuy Synthes Sales Inc., et al., No. 1:15-CV-01257.

Caldwell Cassady & Curry represents companies and individuals in high-stakes civil litigation, including patent infringement cases, trade secrets claims, fiduciary duty cases, class actions, and disputes involving company founders. The firm has tried and won some of the nation’s top verdicts against the largest companies in the world. For more information, visit www.caldwellcc.com.

For more information, contact Bruce Vincent at 214-763-6226 or bruce.vincent@musecommunicationsllc.com.

SOURCE Caldwell Cassady & Curry

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17 August 2018 | By Ana Mulero 

In a comment submitted on the US Food and Drug Administration’s (FDA) recent action plan to promote medical device safety, the Advanced Medical Technology Association (AdvaMed) raised several concerns with the merit and logistics of the proposal.

The five-pronged action plan—revealed in April—consists of establishing a medical device safety net, exploring regulatory options for postmarket mitigations, spurring innovation towards safer devices and further strengthening cybersecurity.

It also involves plans for a major structural reorganization at FDA’s Center for Devices and Radiological Health (CDRH), which is expected to have an impact on the regulatory reviews, approvals and clearances of devices, to better support the total product life cycle.

The trade association expressed concerns with implying that devices cleared via the expanded abbreviated 510(k) program are safer compared to the traditional 510(k) pathway, whereas Johnson & Johnson expressed support for expanding the alternative to more moderate-risk devices.

The company also further stressed the trade association’s concerns around FDA’s statement that “the marketplace…does not provide strong incentives to make an established device safer in the absence of a new or greater-than-previously-understood safety concern.

“FDA should identify and overcome whatever internal obstacles prevent efficient practice,” said AdvaMed associate VP for technology and regulatory affairs Zachary Rothstein. “We note that at the time of this submission, our members’ experience indicates that FDA’s current use of emerging signals is subjective and, at times, lacks appropriate input from the manufacturer.”

But CDRH’s reorganization plans and advancing the use of RWE in support of regulatory decision-making were both endorsed by AdvaMed. The center’s RWE efforts, as well as those around advancing cybersecurity, are centered on developing the National Evaluation System for Health Technology, which is run by the nonprofit Medical Device Innovation Consortium (MDIC).

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August 16, 2018

MON, JUL 30, 2018 08:30 CET

Episurf Medical (NASDAQ: EPIS B) today announces that the company has received initial feedback from the US Food and Drug Administration (FDA) on the Investigational Device Exemption (IDE) application for the Episealer® knee implant that was submitted in June.  The company filed the IDE application to get approval to initiate a clinical study in the US.

Episurf Medical has now received communication on the IDE application within 30 days according to FDA’s communicated timetable and now has some details to address prior to a finalised IDE study design will be set.

“We are now entering into the next phase for the IDE application. Episurf considers the FDA feedback as manageable and we are looking forward to continued work with our advisors to get the IDE study up and running according to our initial schedule” comments Pål Ryfors, CEO, Episurf Medical.

For more  information, please contact:

Pål Ryfors, CEO, Episurf Medical

Tel:+46 (0) 709 62 36 69

Email: pal.ryfors@episurf.com

About Episurf Medical

Episurf Medical is endeavoring to bring people with painful joint injuries a more active, healthier life through the availability of minimally invasive and personalised treatment alternatives. Episurf Medical’s Episealer® personalised implants and Epiguide® surgical drill guides are developed for treating localized cartilage injury in joints. Episurf Medical’s μiFidelity® system enables implants to be cost-efficiently tailored to each individual’s unique injury for the optimal fit and minimal intervention. Episurf Medical’s head office is in Stockholm, Sweden. Its share (EPIS B) is listed on Nasdaq Stockholm. For more information, go to the company’s website: www.episurf.com.

This information is information that Episurf Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.30 CEST on 30 July 2018.

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Kevin Krause, Federal Courts Reporter   / Photo: (Jae S. Lee/Staff Photographer)

While federal prosecutors in Dallas prepare for upcoming health care fraud trials, the FBI and other investigators are continuing to raid more medical businesses, looking for evidence of illegal kickbacks.

Last week, the FBI searched the Dallas offices of Next Health, which owned a network of testing labs and pharmacies. Next Health is already facing fraud allegations from insurance giant United Healthcare, which claims the company gave people gift cards to urinate in cups in Whataburger bathrooms.

The FBI also searched the offices of Critical Health Care Management, which agents say took over Next Health’s operations.

Andrew Hillman and Semyon Narosov, who allegedly control both businesses, are charged with health care fraud in an unrelated federal case in Dallas involving the defunct Forest Park Medical Center.

Next Health is one of several Dallas-area health care businesses that are currently the subject of federal indictments and investigations. The recent raids indicate the government is not done cracking down on testing labs and compounding pharmacies, which have been a focus of kickback investigations nationwide for the past few years.

Michael McCaslin, a Dallas FBI agent, said during a July 24 court hearing that the bureau is looking at whether Next Health paid kickbacks to doctors for referring patients to the company’s pharmacies.

The agent also said Next Health is suspected of using animal drugs in its pharmacies and manipulating ingredients to overcharge insurance companies.

McCaslin said doctors invested in Next Health’s pharmacies and were paid kickbacks in the form of dividends that in some cases were tied to the volume of their referrals.

“You had to be prescribing or else you’d be asked to leave,” the agent said.

McCaslin’s testimony was given during a detention hearing for Hillman and Narosov, who were recently arrested on drug distribution charges related to a marijuana dispensary they allegedly owned in Los Angeles.

An attorney for Next Health did not respond to requests for comment about the raids and FBI investigation.

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