Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Twitter: @JjrkCh
Showing posts with label elbow replacement. Show all posts
Showing posts with label elbow replacement. Show all posts

Wednesday, April 12, 2017

J&J Lawsuits on Recalled Elbow Replacement: Deja vu all over again . . .


JANUARY 13, 2017 BY BRAD PERRIELLO 

Johnson & Johnson (NYSE:JNJ) is recalling its DePuy Synthes radial head prosthesis because of the risk of loosening in the component that anchors the implant in the arm’s radius bone.
The entire prosthesis is designed for primary and revision replacement of the radial head, but only the radial stem surgeons insert into the radius is involved in the loosening issue, according to a letter the J&J unit sent to physicians Dec. 30, 2016.
“Based on the currently available data, we believe the cause to be multifactorial (including possible product characteristics, operative and patient factors), but we have not been able to fully characterize these factors. Consequently, we have not been able at this time to issue further instructions to surgeons that might lead to a reduction in issue rate and have decided to remove the DePuy Synthes Radial Head Prosthesis Stem from the global market,” the company wrote.
If the radial stem loosens, the risks include osteolysis, poor joint mechanics, pain, post-operative fracture and soft tissue damage, J&J said.
Patients already implanted with the device should be followed as normal and the device will still be available on request for revision surgeries “in which only the head would be replaced using the evaluation or loaner set programs only,” according to the letter.




DePuy Elbow Implant Lawsuit Evaluations Offered By Bernstein Liebhard LLP Following Class II Recall for Synthes Radial Head Prosthesis System

NEW YORK, April 11, 2017 /PRNewswire/ -- The nationwide law firm of Bernstein Liebhard LLP is now investigating potential product liability lawsuits involving the recall of more than 50,000 DePuy Synthes Radial Head Prosthesis Systems The DePuy elbow implant components were removed from the global market in December out of concern that the radial stem could loosen at the stem-bone interface following implantation. The U.S. Food & Drug Administration (FDA) has declared this action a Class II medical device recall, which indicates that recipients of the DePuy Synthes Radial Head Prosthesis System may be at risk for temporary or medically reversible health consequences.
"Individuals who allegedly suffered complications related to this DePuy elbow implant recall could be entitled to compensation for medical bills, lost wages and other injury-related damages. However, it is important that those affected act quickly to ensure that their legal rights are protected," says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is now offering free, no-obligation case reviews to individuals who may be eligible to file a DePuy elbow implant lawsuit.

 DePuy Synthes Radial Head Prosthesis System
The DePuy Synthes Radial Head Prosthesis System was cleared via the FDA's 510(K) protocols in June 2011, which do not require human clinical trials when a device is shown to be "substantially equivalent" to a product that was previously approved by the agency. The DePuy elbow implant system is indicated for primary and revision replacement of the radial head.
DePuy Synthes announced that it was removing the Radial Head Prosthesis System from the worldwide market in December 2016, due to the potential for the radial stem to loosen at the stem-bone interface. Complications associated with radial-stem loosening include:
  • Osteolysis
  • Poor joint mechanics
  • Pain
  • Post-operative fracture
  • Soft tissue damage
DePuy Synthes noted that multifactorial issues (including possible product characteristics, as well as operative and patient factors) could be to blame for radial-stem loosening. Because it was unable to determine the exact cause, the company could not issue further instructions to surgeons that might mitigate the problem.
The FDA granted the DePuy elbow implant recall a Class II designation in February 2017.
 Patients who experienced complications related to radial-stem loosening of the DePuy Synthes Radial Head Prosthesis System may be entitled to compensation. To learn more about filing a DePuy elbow implant lawsuit, please visit Bernstein Liebhard LLP's website, or call 800-511-5092 to arrange for a free, no obligation case review.
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993. As a national law firm, Bernstein Liebhard LLP possesses all of the legal and financial resources required to successfully challenge billion dollar pharmaceutical and medical device companies. As a result, our attorneys and legal staff have been able to recover more than $3.5 billion on behalf of our clients. Bernstein Liebhard LLP is honored to once again be named to The National Law Journal's "Plaintiffs' Hot List," recognizing the top plaintiffs firms in the country. This year's nomination marks the thirteenth year the firm has been named to this prestigious annual list.
Bernstein Liebhard LLP 
10 East 40th Street 
New York, New York 10016 
800-511-5092
ATTORNEY ADVERTISING. © 2017 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, 800-511-5092. Prior results do not guarantee or predict a similar outcome with respect to any future matter.
Contact Information: 
Sandy A. Liebhard, Esq. 
Bernstein Liebhard LLP 
info (at)consumerinjurylawyers(dot)com

Friday, November 16, 2012

Outrageous!




Medical Device CEO Douglas W. Kohrs retires at age 54. 
His salary $2.6M while company (Tornier) did not profit for 3 years.  
Tornier Appoints David H. Mowry as Interim President and Chief Executive Officer
Posted 4:34PM 11/12/12
Posted under: Investing
-
Tornier Appoints David H. Mowry as Interim President and Chief Executive Officer
Medical Device Industry Veteran Kevin C. O'Boyle Named Interim Vice Chairman
AMSTERDAM--(BUSINESS WIRE)-- Tornier N.V. (NAS: TRNX) , a global medical device company focused on providing surgical solutions to orthopaedic extremity specialists, today announced the appointment of David H. Mowry as Interim President and Chief Executive Officer, effective immediately. Mr. Mowry succeeds Douglas W. Kohrs, who has retired as President, Chief Executive Officer and Executive Director. Also effective immediately, Non-Executive Director, Kevin C. O'Boyle was named Interim Vice Chairman to serve as a liaison between Mr. Mowry and the Board.

Mr. Mowry, 50, will work with Mr. O'Boyle and Mr. Kohrs to ensure a smooth and orderly transition as the Board of Directors conducts a search for a permanent CEO.
Sean D. Carney, Chairman of Tornier, commented, "On behalf of the company and the Board of Directors, I would like to express our appreciation to Doug, for his leadership and contribution in building the Tornier business over the past six years. Doug was instrumental in bringing Tornier public, leading the recent acquisition of the OrthoHelix business and expanding our international footprint, core capabilities and the innovation pipeline."
Douglas W. Kohrs commented, "I have greatly enjoyed my tenure with Tornier, and am proud to have had the opportunity to work with a fantastic team in growing the company to be one of the most prominent providers of orthopaedic solutions. I have great confidence in the skills and talent of Dave and rest of the management team and their ability to continue to execute on the strategy we have laid out together."
David H. Mowry, Interim President and Chief Executive Officer of Tornier, commented, "I appreciate the opportunity to accept this expanded role with the company. I look forward to working with the Board and the talented management team in continuing to build the strong brand and reputation we have established at Tornier over the past 70 years."
"As we look ahead to the next phase of Tornier's growth, we are pleased Dave has agreed to take on additional responsibility to lead the company with the rest of the management team," continued Mr. Carney. "Dave's experience in the industry and specifically with Tornier provides confidence that he will continue to drive forward the strategic growth plans we have been executing."
Mr. Mowry joined Tornier N.V. in July 2011 as Chief Operating Officer. He brings to Tornier 23 years of medical device industry experience in various engineering and management assignments. Prior to Tornier, Mr. Mowry served as Senior Vice President and President of the Neurovascular Division of Covidien plc, and in the same position with ev3 Inc., prior to its acquisition by Covidien. Mr. Mowry is a graduate of the United States Military Academy in West Point, New York with a degree in Engineering.
As Interim Vice Chairman, Mr. O'Boyle will serve as a liaison between the Interim President and Chief Executive Officer and the Board. Mr. O'Boyle has served as a director of Tornier since June 2010. Since December 2010, Mr. O'Boyle has served as Senior Vice President and Chief Financial Officer of Advanced BioHealing Inc., a medical device company which was acquired by Shire PLC in May 2011, and since June 2011 has served as Senior Vice President of Business Operations. From January 2003 until December 2009, Mr. O'Boyle served as the Chief Financial Officer of NuVasive, Inc. He currently serves on the Board of GenMark Diagnostics, Inc., a molecular diagnostics company. Mr. O'Boyle is a Certified Public Accountant and received a Bachelor of Science degree in Accounting from the Rochester Institute of Technology and completed the Executive Management Program at the University of California Los Angeles, John E. Anderson Graduate Business School.
Tornier is reiterating its previously issued financial guidance for the remainder of 2012, which is contained in Tornier's earnings release issued on November 5, 2012.
Forward-Looking Statements
Statements contained in this release that relate to future, not past, events are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on current expectations of future events and often can be identified by words such as "expect," "should," "project," "anticipate," "intend," "will," "may," "believe," "could," "would," "continue," "outlook," "guidance," "future," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause Tornier's actual results to be materially different than those expressed in or implied by Tornier's forward-looking statements. For Tornier, such uncertainties and risks include, among others, Tornier's future operating results and financial performance, fluctuations in foreign currency exchange rates, the effect of global economic conditions, the European sovereign debt crisis, and austerity measures, risks associated with Tornier's international operations and expansion, risks associated with Tornier's recent acquisition of OrthoHelix and the new credit facility agreement, the timing of regulatory approvals and introduction of new products, physician acceptance, endorsement, and use of new products; the effect of regulatory actions, changes in and adoption of reimbursement rates, potential product recalls, competitor activities, the effect of changes in Tornier's distribution channels and the costs and effects of litigation, risks associated with Tornier's recent management changes; and changes in tax and other legislation. More detailed information on these and other factors that could affect Tornier's actual results are described in Tornier's filings with the U.S. Securities and Exchange Commission, including its most recent quarterly report on Form 10-Q. Tornier undertakes no obligation to update its forward-looking statements.
About Tornier
Tornier is a global medical device company focused on serving extremities specialists who treat orthopaedic conditions of the shoulder, elbow, wrist, hand, ankle and foot. The Company's broad offering of over 100 product lines includes joint replacement, trauma, sports medicine, and ortho-biologic products through Tornier and OrthoHelix brands to treat the extremities, as well as joint replacement products for the hip and knee in certain international markets. Since its founding approximately 70 years ago, Tornier's "Specialists Serving Specialists" philosophy has fostered a tradition of innovation, intense focus on surgeon education, and commitment to advancement of orthopaedic technology stemming from its close collaboration with orthopaedic surgeons and thought leaders throughout the world. For more information regarding Tornier, visit www.tornier.com, or OrthoHelix, visit www.orthohelix.com.
Tornier N.V.
Shawn McCormick
Chief Financial Officer
(952) 426-7646
shawn.mccormick@tornier.com

http://www.fool.com/investing/general/2012/11/13/why-tornier-shares-tumbled.aspx


November 13, 2012 |
Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares of medical-device maker Tornier (Nasdaq: TRNX  ) were getting tripped up today, falling as much as 15% after a downgrade from Northland Securities.
So what: The downgrade, from "market perform" to "underperform," came on the heels of yesterday's surprise announcement that 54-year-old CEO Doug Kohrs was leaving the company.
"The sudden nature of the announcement combined with the recent deceleration in sales growth could raise questions 2013 outlook for the company," Northland said.
Tornier has missed EPS estimates in its last two quarters with a $0.29 loss in its most recent quarter.
Now what: Countering Northland's opinion was investment house Piper Jaffray, which reaffirmed its overweight rating on Tornier today. Speculating about Kohrs' departure is unlikely to lead to any sure answers, but investors may want to be reminded that Tornier has yet to turn a profit in its three-year history, and with growth slowing this could be a problem. Analysts are eyeing small losses for the next two quarters as well. I'd wait for new CEO David Mowry to prove himself by getting the company into positive territory before getting on board.

http://www.bizjournals.com/twincities/news/2012/05/18/pay-tornier-kohrs.html

Minneapolis / St. Paul Business Journal by Ed Stych, Web Producer
Date: Friday, May 18, 2012, 2:59pm CDT

Web Producer- Minneapolis / St. Paul Business Journal
Now making more than $2.6 million
Tracking the pay of Minnesota’s business leaders
Douglas Kohrs
CEO
Tornier Inc. (Nasdaq: TRNX)
                         Headquarters: Dutch company with U.S. headquarters in Edina
                         Business: Makes orthopedics devices
Total pay
         2011: $2.61 million, up 59 percent
         2010: $1.64 million
         2009: $1.25 million
Base salary
         2011: $503,000
         2010: $490,000
Bonus

         2011: None
         2010: None
Incentive pay
         2011: $209,000
         2010: $237,000
Stock awards
         2011: $830,000
         2010: None
Option awards
         2011: $1.07 million
         2010: $913,000
Other compensation
         2011: None
         2010: None
Total compensation for other highly-compensated executives:
            Carmen Diersen, chief financial officer: $1.02 million, down 52 percent
         David Mowry, chief operating officer: $1.20 million (first year with company)
            Stéphan Epinette, vice president of International Commercial Operations: $932,000, up 12 percent
            Kevin Klemz, chief legal officer: $739,000, down 27 percent
Notes
Data comes from documents filed with the U.S. Securities and Exchange Commission.
Ed Stych reports on Twin Cities breaking business news for mspbj.com, manages online features and writes the Workshop and Fast 50 Diary features for the print edition


http://ryortho.com/companyNews.php?news=2321_Tornier-CEO-Retires-Abruptly
Tornier CEO Retires Abruptly
Orthopedics This Week / Walter Eisner • Wed, Nov 14th, 2012


It was a surprise retirement.
Tornier N.V. announced on November 12 that the company's President and CEO, Doug Kohrs was retiring. David Mowry, the company's chief operating officer was immediately named interim president and CEO.
Kohrs was clearly the captain of this ship. Sean Carney, the company's board chair noted Kohrs', "leadership and contribution in building the Tornier business over the past six years. Doug was instrumental in bringing Tornier public, leading the recent acquisition of the OrthoHelix business and expanding our international footprint, core capabilities and the innovation pipeline."
Why?
In the world of publicly traded companies, retirements are usually well-orchestrated and telegraphed well ahead of time to keep investors calm. So why didn't this happen with Kohrs and Tornier?
BMO Capital Markets analyst Joanne Wuensch wrote that she was not a fan of this announcement, "particularly on the heels of the departure of CFO Carmen L. Diersen in July 2012. We could speculate that the departure is simply a personal decision (and take it at face value), or take the view that after several missteps since its February 2011 IPO, it was time for new senior leadership. What we do not read into this announcement is anything nefarious (the consulting agreement appears to imply that they are departing on reasonably good terms)."
Bank of America analyst Bob Hopkins said that his conversations with the company suggested that Kohrs did want to retire over the course of the next 12-18 months. However he believes Kohrs departure was probably hastened "due to [Tornier's] recent well-documented issues and the lack of value creation since the IPO. Importantly, we do not believe any new issues have arisen since last week's Q3 call, and Mr. Kohrs has signed a six month consulting agreement with [Tornier] to help with the transition, and remains one of the largest shareholders."
Kohrs, according to a company SEC filing, will receive $2,500 per month for up to eight hours of consulting services per month and will be compensated at a rate of $300 per hour for any additional hours.
Mowry and O’Boyle Assume Leadership
Mowry joined Tornier in July 2011 as chief operating officer. He has 23 years of medical device industry experience in various engineering and management assignments. Prior to Tornier, Mowry served as senior vice president and president of the Neurovascular Division of Covidien plc, and in the same position with ev3 Inc., prior to its acquisition by Covidien. He is a graduate of the United States Military Academy in West Point, New York with a degree in engineering.
Kevin O'Boyle, the former chief financial officer of NuVasive, Inc. and one of Tornier's non-executive board members was named interim vice chairman to serve as a liaison between Mowry and the board.
Wuensch said that while the company clearly has work to do, her thesis is that, with the distribution changes well under way, and the OrthoHelix acquisition filling an important hole in the company's extremity bag, the current strategy should accelerate the top-line growth rate over the coming quarters.
While this "unnecessarily awkward transition" creates as much risk as opportunity for the company, Hopkins said he continues to see real long-term value in the franchise. He notes that Kohrs, "leaves behind a strong bench; the Tornier brand remains strong; their markets are healthy; Warburg [owner of 47% of Tornier] has a best in class track record with management changes in their portfolio companies and Tornier remains comfortable with 2012 guidance and with 2013 guidance that calls for a return to double-digit top-line growth by midyear."
Kohrs' Record
Kohrs was CEO of American Medical Systems Holdings, Inc.from 1995 to 2005 before turning that firm into a publicly-traded company. Prior to that he co-founded Spine-Tech, Inc. which was later acquired by Sulzer Medica A.G.
According to a July 2012 TwinCities Business article, Kohrs left American Medical in 2006 to become entrepreneur-in-residence at Split Rock Partners. That's when he convinced a group of investors to buy the French family-owned Tornier. Tornier's sales have grown from $100 million in revenues in 2006 to $261 million last year. When he took over, Tornier sold 23 products in 15 European countries; today it sells 100 products in 45 countries worldwide, including Japan, China, Australia, and Argentina. Headcount worldwide has jumped from 350 to 800.
Whether Kohrs stays retired or continues his serial entrepreneurial track record is unknown.