Appeals court declines full review of $254m Zimmer loss to Stryker

Stryker, Zimmer BiometA federal appeals court declined a full review of its earlier decision to affirm a $248 million win for Stryker (NYSE:SYK) in its surgical tool patent case against Zimmer Biomet (NYSE:ZBH).

The U.S. Court of Appeals for the Federal Circuit last December upheld treble damages in the case, based on a U.S. Supreme Court decision in Halo Electronics v. Pulse Electronics that relaxed the standard for enhanced damage awards in patent infringement cases. Zimmer Biomet appealed that per curiam decision, asking for both a three-judge panel and the full Federal Circuit bench to re-evaluate the case. The court denied both petitions March 19, setting March 26 as the date for issuing the mandate of the court.

The case dates back to December 2010, when Stryker sued Zimmer the U.S. District Court for Western Michigan, alleging infringement of three patents covering wound debridement technology by Zimmer’s Pulsavac Plus device. In February 2013 a jury awarded $70 million to Stryker; Judge Robert Jonker trebled the damages in August of that year.

The Federal Circuit in 2014 rolled back that $228 million ruling, finding that Stryker failed to prove willful infringement. Stryker appealed to the Supreme Court, which vacated the appeals court’s ruling and ordered it to reconsider the case. The Supremes found that the Federal Circuit’s test was too rigid and allowed egregious infringers to evade liability.

The post Appeals court declines full review of $254m Zimmer loss to Stryker appeared first on MassDevice.

10+ orthopedic products from AAOS 2019 you need to know

Attendees line up to register for the American Academy of Orthopaedic Surgeons annual meeting in Las Vegas this week. More than 30,000 people were expected. (Image from AAOS)

The American Academy of Orthopaedic Surgeons (AAOS) annual meeting in Las Vegas is abuzz about robotics, according to industry analysts from SVB Leerink.

While the SVB Leerink analysts termed Stryker’s  (NYSE:SYK) Mako platform “best-in-class,” it’s an expanding category. Other major orthopedics companies are using this week’s AAOS meeting to introduce new offerings or tout updates to existing ones.

Johnson & Johnson (NYSE:JNJ), for example, said it plans to debut its Orthotaxy total knee system in 2020, with spine, hip and eventually shoulder indications likely to follow. J&J bought the French robot-assisted surgery startup in 2018, and didn’t have any photos of the prototype to share. But the analysts said it attaches to the patient table and includes a saw/bone cutting capability, like Mako. Unlike Mako, it will not have haptic capability. Rather, it gets the surgeon locked into a cutting plane and preserves the surgeon’s control of the saw (side to side and front to back) on that plane.

Get the full story on our sister site, Medical Design & Outsourcing.


The post 10+ orthopedic products from AAOS 2019 you need to know appeared first on MassDevice.

Owens & Minor taps former Thermo Fisher CCO Pesicak as prez, CEO | Personnel Moves – February 27, 2019

Owens & Minor CEO Pesicka

Owens & Minor (NYSE:OMI) said this month that it named former Thermo Fisher Scientific chief commercial officer Edward Pesicka as its new prez & CEO, effective March 4.

Pesicka will replace interim prez & CEO Robert Sledd, who will continue to serve as board chair, the Richmond, Va.-based company said.

Prior to his position as chief commercial officer, Pesicka served as CFO for divisions within Thermo Fisher Scientific, the company said. Before joining Thermo Fisher, Pesicka held corporate finance positions, including divisional CFO, at TRW.

“The board is extremely pleased to welcome Ed as the new CEO of Owens & Minor. Ed is a seasoned senior executive with a deep understanding of distribution, manufacturing and service within our industry. He also has a proven ability to lead performance improvement. During his time at Thermo Fisher Scientific, Ed was responsible for leading a portfolio of businesses focused on distribution, manufacturing and services. He demonstrated his sales and financial acumen and developed a reputation for providing outstanding customer service and driving strong financial results. We are pleased that our process resulted in identifying the ideal CEO,” Sledd said in a press release.

“After a thorough search and careful evaluation of candidates, the Board believes we have found the right leader with practical management and people development skills that align with our strategy. Furthermore, as a man of great integrity, Ed fits well with the Owens & Minor culture, making him an excellent fit for the role. We thank Bob for his willingness to step into the Interim CEO role and look forward to continuing to benefit from his wealth of experience as the chairman of our board,” search committee member & lead director Anne Marie Whittemore said in a prepared statement.

“I’m honored to be appointed to lead Owens & Minor, a company with a rich 137-year history of serving the healthcare industry and providing customers with the solutions they need to deliver exceptional patient care. I am committed to uncovering practical and innovative ways of improving the customer experience and driving value for shareholders. I look forward to working alongside our talented teammates and, together, furthering our mission of serving the healthcare industry across the continuum of care with integrity, dedication, innovation and passion,” Pesicka said in a prepared release.

 McGinley Orthopedics appoints ex-Xtant Medical head O’Connell as CEO

McGinley Orthopedics said earlier this month that it appointed former Xtant Medical (NYSE:XTNT) CEO Carl O’Connell as its new chief exec, effective February 4.

Prior to joining Xtant Medical, O’Connell served as extremities global marketing VP for Wright Medical (NSDQ:WMGI). O’Connell has also held positions with Stryker (NYSE:SYK), Carl Zeiss Meditec and Hudson Healthcare Partners, Casper, Wyo.-based McGinley said.

“We are proud to announce Carl O’Connell as our new CEO. With his extensive leadership in the medical device industry and commercialization expertise, we are confident he is the right choice to lead McGinley Orthopedics to new levels of growth and success. Carl has served as an advisor to the company for the last 5 years, and we share his enthusiasm for the outlook of the company,” co-founder Dr. Joseph McGinley said in a prepared statement.

“I am excited to lead what has the potential to be a world-class organization and a considerable competitor and innovator in the market. The company has exciting patented technology that will significantly improve safety and surgical outcomes. I look forward to expanding upon our recent successes and continuing to establish the strategic course to take McGinley Orthopedics to the next level,” O’Connel said in a press release.

Read more

 Cirtronics lifts COO Patterson to prez & CEO

Contract manufacturing firm Cirtronics said last week that it is lifting current COO Dave Patterson to the position of prez & CEO, with founder and former CEO Gerardine Ferlins staying with the company as chief governance officer and board chair.

Patterson joined Cirtronics in 2010 as global sourcing director and become COO in 2012, the Milford, N.H.-based company said.

“Dave has been an integral part of the Cirtronics leadership team for the last eight years. With his steadfast commitment to the culture of Cirtronics and his years of operational experience, he is well equipped to take on his new role,” Ferlins said in a press release.

“I am humbled and very proud to be part of such a great organization. We are an organization led by a purpose – to be an example of how a company can serve society in an ethical and productive way. I look forward to taking the next steps in this journey together with the whole Cirtronics team,” Patterson said in prepared remarks.

Read more

 Surmodics promotes corp dev & strategy VP Arens to CFO

Surmodics (NSDQ:SRDX) said earlier this month that it is promoting corporate development & strategy VP Timothy Arens to the position of CFO, effective immediately.

Arens has been serving as interim CFO since May 2018 following the departure of Andrew LaFrence, the Eden Prairie, Minn.-based company said.

“Tim has been an impressive partner to me and an invaluable contributor to our management team and Surmodics’ success during the past eight years. I am personally delighted that he has been formally appointed to the role. Tim’s excellent financial, operational and strategic skills and strong leadership are ideally suited to his new role as we continue to drive our strategic initiatives and financial goals of consistent and profitable long-term growth,” prez & CEO Gary Maharaj said in a press release.

“I am excited to work with a group of dedicated and talented colleagues to accelerate our strategic transformation while continuing to deliver on our operating commitments. Surmodics is well-positioned to execute on our strategic initiatives including the development of highly innovative products that benefit patients. I am looking forward to being part of that journey,” Arens said in prepared remarks.

Read more

 Magnolia Medical taps Lehr as IP special counsel

Magnolia Medical Technologies said earlier this month that it named Matthew Lehr as its new intellectual property special counsel.

Prior to joining Seattle-based Magnolia, Lehr served as head of the IP litigation department at law firm Davis Polk & Wardwell.

“Intellectual property is a critical asset for any innovative medical device company that invests heavily to develop new technologies that drive important paradigm shifts in medicine. In our case, we have invested well over a decade along with significant resources to create the category known as initial specimen diversion to significantly improve sepsis testing accuracy. We will benefit from Matt’s expertise and active participation as we continue to drive hospital adoption of our Steripath platform to prevent blood culture contamination,” CEO Greg Bullington said in a prepared statement.

“I am pleased to work with Magnolia as they commercialize and protect their groundbreaking technologies, which directly improve the quality of care for patients. The company has built an extensive and broad intellectual property foundation that will allow them to maintain appropriate protection in numerous medical device categories in the years to come,” Lehr said in a prepared release.

Read more

The post Owens & Minor taps former Thermo Fisher CCO Pesicak as prez, CEO | Personnel Moves – February 27, 2019 appeared first on MassDevice.

Zimmer Biomet shares rise on Q4, 2018 earnings beat

Zimmer Biomet logo

Shares in Zimmer Biomet (NYSE:ZBH) rose today after the medical device maker beat expectations on Wall Street with its fourth quarter and full year 2018 earnings results.

The Warsaw, Ind.-based company posted losses of $902.5 million, or $4.42 per share, on sales of approximately $2.07 billion for the three months ended December 31, seeing a swing into the red while sales grew 0.1% compared with the same period during the previous year.

Adjusted to exclude one-time items, earnings per share were $2.18, a single cent ahead of the $2.17 consensus on Wall Street, where analysts expected to see sales of $2.06 billion, which the company also topped.

For the full year, Zimmer Biomet posted profits of $379.2 million, or a loss of $1.86 per share, on sales of approximately $7.93 billion, seeing profits shrink 79.1% while sales grew 1.7% compared with the previous year.

After adjusting to exclude one-time items, earnings per share were $7.64, again a single cent ahead of the consensus on Wall Street where analysts expected to see sales of $7.92 billion, which the company topped.

“We are encouraged with the solid close to 2018, driven by strong fourth quarter performance in the Asia Pacific and Europe, Middle East and Africa regions, and in our spine & CMF category. Overall, our financial results for the full year were in-line with our expectations for the progress of the turnaround of the business, and increase our confidence in achieving our 2019 objectives.  We look forward to delivering on our near-term commitments to transition to offense and drive enhanced shareholder value, including the launch of a number of exciting new products and platform technologies to expand our ecosystem of differentiated solutions,” prez & CEO Bryan Hanson said in a prepared statement.

The company provided guidance for 2019, expecting to see sales growth of between -0.5% and 0.5%. Zimmer Biomet said that it expects to post adjusted diluted EPS of between $7.70 and $7.90 for the year, with an adjusted operating profit margin of between 27% and 28%.

Shares in Zimmer Biomet have risen approximately 6.6% today, at $116.83 as of 9:56 a.m. EST.

The post Zimmer Biomet shares rise on Q4, 2018 earnings beat appeared first on MassDevice.

Zimmer Biomet wins FDA nod for Rosa Knee robotic surgical system

Zimmer Biomet logo

Zimmer Biomet (NYSE:ZBH) said today that it won FDA 510(k) clearance for its Rosa Knee robotically-assisted total knee replacement surgery platform.

The newly cleared Rosa Knee system includes 3D pre-operative planning tools and real-time intraoperative data on soft tissue and bone anatomy to improve bone cut accuracy and range of motion gap analysis, the Warsaw, Ind.-based company said.

“Complementing the skill and expertise of the surgeon with Rosa Knee’s robotically-assisted technologies can improve accuracy, precision and consistency, which can improve patient satisfaction, clinical outcomes and efficiency. Rosa Knee functions as a surgical assistant that gives me the tools and real-time data to perform bone cuts with greater precision and improve patient-specific soft-tissue balancing and implant alignment, without losing my feel for a natural fit and flexion,” Dr. Christopher Cannova of the Washington Joint Institute at OrthoBethesda said in a prepared statement.

Zimmer Biomet said that the Rosa Knee also features its proprietary X-Atlas imaging protocol, which provides X-ray based preoperative imaging to create a 3D model and plan of the patient’s bone anatomy.

“We are excited for the launch of Rosa Knee, which brings together Zimmer Biomet’s robotics technology with our industry-leading Knee implants to help surgeons personalize surgical procedures for their patients. Zimmer Biomet is committed to leading the industry in bringing differentiated and holistic solutions to market that address the needs of our customers and improve patient outcomes,” orthopedics group prez Ivan Tornos said in a press release.

In November, Zimmer Biomet said that it won FDA 510(k) clearance for its Persona revision knee implant.

The post Zimmer Biomet wins FDA nod for Rosa Knee robotic surgical system appeared first on MassDevice.

Analyst downgrades pressure medtech stocks

thumbs downSeveral medical device companies took hits yesterday after analysts on Wall Street downgraded their stocks, on a day when the major market indices each closed up a hair, and even medtech firms that enjoyed upgrades came under pressure.

Globus Medical (NYSE:GMED) suffered the most after Morgan Stanley analyst David Lewis cut his rating on the stock from “overweight” to “equal-weight,” sliding -8.5% to a $39.61-per-share close yesterday, compared with the prior day’s closing price.

In fact, Lewis’s downgrades led the pack in terms of impact, taking Insulet (NSDQ:PODD) and Hologic (NSDQ:HOLX) shares down some -7.4% and -6.5%, respectively. Here’s a look at some of yesterday’s downgrade action:

Company Analyst Old rating New rating Close 1/2/19 %
Globus (GMED) Morgan Stanley Overweight Equal-Weight $39.61 -8.5%
Insulet (PODD) Morgan Stanley Hold Hold* $73.43 -7.4%
Hologic (HOLX) Morgan Stanley Equal-Weight Under-Weight $38.42 -6.5%
Abbott (ABT) Citigroup Neutral Sell $69.50 -3.9%
Medtronic (MDT) Citigroup Buy Neutral $87.92 -3.3%
Henry Schein (HSIC) Robert W. Baird Outperform Neutral $76.39 -2.7%
Smith & Nephew (SNN) JP Morgan Overweight Neutral $36.40 -2.6%
Bayer (BAYN) JP Morgan Overweight Neutral $17.40 -1.0%
*cut price target

The upgrade picture was murkier, with a trio of medical device companies taking hits despite upgrades, but three others gaining (including a bullish move from Lewis on shares of Baxter (NYSE:BAX)):

Company Analyst Old rating New rating Close 1/2/2019 %
Tactile Systems (TCMD) Northland Capital Under Perform Market Perform $44.59 -2.1%
Stryker (SYK) Evercore ISI In-line Outperform $154.50 -1.4%
Zimmer Biomet (ZBH) Citigroup Neutral Buy $102.28 -1.4%
Bausch Health (BHC) Piper Jaffray Neutral Overweight $20.23 0.1%
Baxter (BAX) Morgan Stanley Under-Weight Overweight $65.30 0.8%
Citigroup Neutral Buy
Apollo Endosurgery (APEN) Northland Capital Under Perform Market Perform $3.65 5.8%

By way of comparison, the three major U.S. market indices all closed up a hair yesterday, with the Dow Jones Industrial Average closing up 0.1% at 23,346.24. The S&P 500 also closed up 0.1%, at 2,510.03, and the NASDAQ index ended at 6,665.94, up 0.5%.

The post Analyst downgrades pressure medtech stocks appeared first on MassDevice.

Sanuwave confirms acting CEO Richardson as company head | Personnel Moves – December 12, 2018

Sanuwave CEO Kevin Richardson

Sanuwave said late last month that it lifted acting CEO and board chair Kevin Richardson to a permanent position in the corner office.

Richardson joined the Suwanee, Ga.-based company in 2009 as board chair, and has served as acting CEO since 2014. He also served as managing partner of investment management firm Prides Capital from 2004 to September 2018.

Sanuwave said that Richardson took over as the permanent CEO as of November 30, and that he will continue to serve as board chair alongside his new position heading the company, according to an SEC filing.

 Common Sensing lifts Schmid to CEO, White to board chair

Common Sensing said late last month it lifted COO and board member Kevin Schmid to the role of CEO, and that it appointed co-founder James White as its board chair.

Prior to joining Common Sensing, Schmid held “pivotal roles” at Insulet (NSDQ:PODD), Bose, JDS Uniphase and the Stevanato Group and served as a board member for Sorrel Medical.

“Kevin’s appointment to the chief executive role puts Common Sensing in a very strong position to scale Gocap injector monitoring platforms for insulin and beyond. As we transition from pilot level to commercial level operations over the next year, Kevin’s transformative leadership of the talented and growing Common Sensing team will evolve and drive the execution of our go-to-market strategies for our patented dose sensing technology. Our goal is to provide a smart dose sensing platform for patients, health care providers and payers to embrace injectable medicines for home use,” White said in a prepared statement.

During his time with Insulet, Schmid aided in the development, industrialization and commercialization of wearable, smart drug delivery pumps, Cambridge, Mass.-based Common Sensing said.

Common Sensing said that Schmid will lead top-level strategy, expansion and investor relations, while prez and co-founder Richard Whalley will focus on clinical, quality and regulatory functions.

“We are well underway with the development of our high performance, scalable, and commercial Gen 2 Gocap platform. This, combined with insightful user data from existing studies and patients, lays the foundation for Gocap technology to make a tremendous impact on wireless integrated health care. Gocap is an easy-to-use, cost-effective dose monitoring and reporting solution which will be accessible to millions of self-injecting patients,” Schmid said in a press release.

Read more

 Glympse Bio appoints former Bristol-Myers exec Loew as prez & CEO

Glympse Bio said early this month that it appointed former Bristol-Myers Squibb (NYSE:BMY) exec Dr. Caroline Loew as its new prez & CEO.

Most recently, Loew served as R&D, strategy and planning VP at Bristol-Myers Squibb, the Cambridge, Mass.-based company said. She has also held senior roles with Merck and PhRMA, leading teams in drug development ,regulatory policy, market access and commercial fronts, Glympse Bio said.

“I’m excited to join Glympse and work alongside the exceptional and dedicated team here. Glympse’s powerful, tunable platform technology has the ability to transform how we detect and manage disease, and help both improve and save patients’ lives. I’m looking forward to building the company and fully realizing the potential of this platform for patients,” Loew said in a press release.

In connection with the appointment, Loew will also join Glympse Bio’s board of directors, which the company said it recently expanded. The expansion includes that appointment of co-founder Dr. Sangeeta Bhatia as head of the scientific advisory board and the appointment of Stanley Lapidus as board chair and Robert Langer as a board member.

“Caroline is an outstanding leader who brings a wealth of experience in life sciences, and we are thrilled she is joining Glympse. She is recognized for her acumen and operational execution, her ability to build talented teams and lead organizations, and for strategic development and commercialization of important products that change patients’ lives. We are also fortunate to have Sangeeta’s continuing scientific and clinical leadership on the Scientific Advisory Board,” board member & LS Polaris Innovation Fund partner Amy Schulman said in a prepared release.

Read more

 NovaDip Biosciences taps former Argos CEO Abbey as chief exec

Regenerative medicine company Novadip Bioscences said today that it named former Argos Therapeutics prez & CEO Jeff Abbey as its new CEO, succeeding Jean-François Pollet.

Abbey spent 15 years at immuno-oncology cell therapy company Argos Therapeutics, holding the position of president and CEO during the past eight years, Belgium-based Novadip said. During his time with Argos, Abbey guided the company through a phase 3 trial and helped raise $250 million in equity financings which included an initial public offering.

“With his extensive experience in cell therapy combined with his expertise in equity financing, business development and strategy, Jeff possesses the skills necessary to lead Novadip through the next phases of its development. The board is highly confident that Jeff’s wealth of international experience and proven leadership will help Novadip in its mission to become a leading regenerative medicine company. As the founding CEO, Jean-François Pollet, along with co-founder and CSO, Denis Dufrane, has led Novadip through a number of important milestones and positioned the company in a strong position to succeed. The board would like to express its gratitude to Jean-François Pollet,” board chair Eric Pâques said in a prepared statement.

Novadip is developing an autologous three-dimensional cell therapy that is currently being studied in a phase I/IIa trial in spinal fusion patients, the company said. It added that it recently launched a second clinical program looking to enroll patients with non-healing bone fractures and that it is developing a regenerative skin product based on its cell therapy platform.

“I am excited to have the opportunity to join Novadip The technology platform and portfolio of products the company is developing offer tremendous opportunities to provide unique solutions to patients with catastrophic conditions in the fields of bone disease and skin regeneration. I look forward to working with the founders and the outstanding team of Novadip to bring truly innovative therapies to market and build a preeminent biotechnology company,” Abbey said in a press release.

Read more

 Owens & Minor lifts interim CFO Snead to permanent chief finance officer position

Owens & Minor (NYSE:OMI) said today that it lifted interim CFO Robert Snead into a permanent role as chief financial officer and exec VP, effective December 6.

Snead has served as interim CFO since June, and will continue to report to board chair and interim prez & CEO Robert Sledd, the Richmond, Va.-based company said. He joined Owens & Minor in 2010 as corp dev VP and has held positions including treasurer and global solutions strategic biz unit finance group VP, the company added.

Prior to joining Owens & Minor, Snead served as Barclays Capital M&A group director in New York, the company said.

“We are very pleased Robert is taking on this important, strategic role for Owens & Minor. Robert’s eight years of service to Owens & Minor in a variety of finance and strategy roles have prepared him well for this leadership position. He brings valuable experience in working with the investor community, providing disciplined financial management oversight, and partnering with other leaders to help drive operating efficiency and profitability. Without question, Robert is the right choice for Owens & Minor as we prepare for the future,” board chair and interim prez & CEO Sledd said in a press release.

Read more

The post Sanuwave confirms acting CEO Richardson as company head | Personnel Moves – December 12, 2018 appeared first on MassDevice.

Appeals court OKs $248m Stryker win over Zimmer Biomet

Stryker, Zimmer Biomet

The U.S. Court of Appeals for the Federal Circuit this week affirmed Stryker‘s (NYSE:SYK) enhanced $248 million win in a surgical tool patent case against Zimmer Biomet (NYSE:ZBH).

The Federal Circuit court affirmed the judgement in a per curiam ruling dated on Monday, according to recently released court documents.

The damages in the case were previously enhanced due to a US Supreme Court ruling which made it easier to award enhanced damages. In July, Western District of Michigan Judge Robert Jonker reaffirmed an earlier decision to award enhanced damages “in light of the Supreme Court’s clarification of the governing standard in Halo Electronics, Inc. v. Pulse Electronics, Inc.,” according to court documents.

The court was also asked to reconsider its award of attorney’s fees, due to a Supreme Court ruling in Octane Fitness, LLC, v. Icon Health & Fitness, Inc., which it also reaffirmed.

Judge Jonker reaffirmed both decisions for triple damages for the 2013 jury verdict, which had been vacated on appeal by the Federal Circuit last year. He ruled that in the case, Stryker had “proven by clear and convincing evidence” that Zimmer had willfully infringed on 1 or more claims in all 3 of the patents-in-suit, according to court documents.

Last September, a federal appeals court overturned the enhanced damages and attorney fees awarded in the $70 million patent infringement case Stryker had won over Zimmer Biomet, but upheld its prior ruling that patents were valid and infringed.

The case was sent back to the U.S. Court of Appeals for the Federal Circuit in June, when the Supreme Court held that the standard for enhanced damages awards in patent infringement cases should be relaxed. The case dates back to December 2010, when Stryker sued orthopedics rival Zimmer, alleging infringement of 3 patents covering wound debridement technology by Zimmer’s Pulsavac Plus device.

In February 2013 a jury in the U.S. District Court for Western Michigan awarded $70 million to Stryker in damages plus royalties, ruling that Zimmer infringed all 3 patents claimed in the suit. Judge Robert Jonker trebled the damages in August of that year, ruling that the infringement was willful, ordering a permanent injunction and granting Stryker’s bid for lost profit damages for another nearly $2.4 million. The judge also granted Stryker’s motion for prejudgment interest, awarding nearly $11.2 million, plus reasonable attorney’s fees and additional prejudgment interest on those fees at a rate of 3.83%.

The Federal Circuit court in 2014 rolled back that $228 million ruling, finding that Stryker failed to prove willful infringement. Stryker appealed to the Supreme Court, which vacated the appeals court’s ruling and ordered it to reconsider the case. The Supremes found that the Federal Circuit’s test was too rigid and allowed egregious infringers to evade liability.

The post Appeals court OKs $248m Stryker win over Zimmer Biomet appeared first on MassDevice.

Ex-Zimmer Biomet SVP loses in court

Zimmer Biomet logo

A former Zimmer Biomet executive has temporarily lost her bid for severance pay and cannot claim company stock options after her 2016 resignation.

Robin Barney resigned from her post as a senior vice president claiming a hostile work environment, alleging sex discrimination, breach of contract, and constructive or involuntary discharge.

Barney became Zimmer’s SVP of global operations and logistics after serving as an SVP at Biomet since 2008. (The companies merged in 2015.) Barney alleged that Zimmer told her in August 2016 that her position would be moved from Indiana to Switzerland by the end of 2017, requiring her to relocate. Barney refused.

She also alleged that in October 2016, “Zimmer’s CFO demanded that she concoct a story to mislead Zimmer’s investors about the cause of recent quarterly shortfalls,” court documents said. Barney refused again. She also claimed that the company pressured her about sales and product shipments related to one of its facilities, even though production had already been shut down at that facility due to an FDA audit.

Barney claimed that Zimmer CEO David Dvorak ordered her to terminate employees under a false pretext in October 2016. Again she refused and claimed she was told that Dvorak “was not happy with her refusal, and that they would talk further about it.”

Barney submitted her resignation that same day, later claiming that she had no choice because these incidents constituted intolerable conditions, and “she further wished to extricate herself from the potential securities fraud being committed by other executives,” court documents said.

U.S. District Court Judge Jon DiGuilio dismissed Barney’s claim for severance pay because Barney did not specifically claim in her lawsuit that she told Zimmer within 30 days that she would not relocate to Switzerland. DiGuilio allowed her the ability to make this claim again.

The court also found that she didn’t qualify for vesting of stock options because she hadn’t worked for Zimmer for 10 years. Ruling from U.S. District Court for Northern Indiana, South Bend Division, DiGuilio also said that Barney had “not made sufficient allegations that anyone at Zimmer led her to reasonably believe that she would be terminated for refusing to mislead investors (or for refusing to terminate employees, for that matter)….

“In sum, Barney has failed to adequately allege that Zimmer breached its Employment Agreement with her, or that Zimmer subjected her to a wrongful constructive discharge,” the judge concluded.


The post Ex-Zimmer Biomet SVP loses in court appeared first on MassDevice.

Medtech companies, industry groups shrug off ICIJ’s “Implant Files” report

Medtech companies and industry groups have shrugged off the recently released “Implant Files” report from the International Consortium of Investigative that was highly critical of the industry, seeing shares stay steady or rising only days after the report was posted.

The highly critical “Implant Files” report, which was released early this week, is a collaborative effort overseen by the ICIJ and includes work from 252 journalists from 59 media groups across 36 countries.

On its first day of trading this week after the release of the report, industry giant Medtronic (NYSE:MDT) saw its shares rise 1.6% to close at $92.06. Other major players, including Johnson & Johnson (NYSE:JNJ), Boston Scientific (NYSE:BSX) and Zimmer Biomet (NYSE:ZBH) saw shares drop less than 1% in response to the report.

Responses from medical device industry groups varied greatly, with some expressing sympathy to the issues presented in the report and reiterating their intentions to improve global health and wellness through the use of advanced technology.

“The medical device industry understands that just one adverse event is too many, particularly if it affects you or your loved ones. It is heartbreaking when our healthcare system, which is set up to heal people, results in patients being harmed. Everyone involved in care feels the pain when a patient is hurt, from the nurses and doctors on the front lines of care, to the women and men building medical technology. Our first and primary purpose is to help patients and we do that, every day for millions of people around the globe,” MassMEDIC president & former MassDevice publisher Brian Johnson wrote in a statement in response to the ICIJ report. “Patients can feel confident that the medical devices being used to treat them are safe and have been rigorously vetted by a robust and stringent regulatory system. Independent research has shown that the overall recall rate of medical devices, cleared through the FDA is remarkably low, less than 1%. However, nobody involved in this system believes in resting on their laurels. The medical device industry, the FDA and our healthcare system will continue to seek ways to improve the process of patient safety, while giving patients access to groundbreaking new treatments that will improve their lives.”

“While there is no medical procedure that can be performed without risk, Medical Alley companies always strive to innovate and produce the safest possible technologies that deliver better outcomes for patients. Medical Alley has a history of leadership, as the birthplace of the modern medical technology industry and as the co-creator of the Medical Device Innovation Consortium. Medical Alley looks forward to working with all health stakeholders to improve the products, the regulatory process and the press coverage of the medical technology industry and the patients whose lives depend on these products,” Minnesota’s Medical Alley Association representatives wrote in response to the report.

Other groups were more dismissive of the issues covered in the release and accused investigators of “cherry-picking” dramatic stories and “overlooking the overwhelmingly positive experiences” that the industry supports.

“The ICIJ’s coverage of this dynamic industry is cherry-picking a handful of adverse outcomes at the exclusion of the nearly 200,000 medical devices currently on the market improving patient care. This only serves to frighten the millions of patients who benefit from medical technology innovation every day, while inaccurately portraying the rigorous regulatory pathways that are in place to ensure patient safety,” Medical Device Manufacturer’s Association prez & CEO Mark Leahey said in press release responding to the ICIJ report.

“Every one of us will inevitably face a moment where we will hope for a miracle to make a child, sibling, parent, grandparent or loved one well again. Whether it’s a pacemaker that keeps a heart beating, an implant that allows a child to hear for the first time, or an artificial knee that allows a grandmother to play with her grandkids, medical devices are the foundation of modern medicine, providing physicians and nurses the tools they rely on to improve patient care. Yet, instead of a comprehensive look at both the challenges and the achievements of an industry that touches almost every human life, these stories counterfeit the life-changing and life-saving solutions delivered to billions of people worldwide,” AdvaMed wrote in response to the ICIJ report. “We should never discount any patient’s experience. But by magnifying the stories of only a few individuals, we overlook the overwhelmingly positive experiences of millions of others. We take seriously all reports of patient impact, and though the medical community can never completely eliminate risk, we always strive to improve our technologies and care delivery.”

The report is the second major examination of the medtech industry to release this year, after Netflix released a highly critical documentary, titled “The Bleeding Edge,” earlier this summer.

The post Medtech companies, industry groups shrug off ICIJ’s “Implant Files” report appeared first on MassDevice.