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.
Twitter: JjrkCh

Thursday, October 30, 2014

Bum Tornier Elbow, Abandoned Patient, Inversion and a $3.3 BILLION Merger/Sale/Deal. Protect those shareholders! Follow the Money!

FiDA highlight
Just a reminder:  Doug Kohrs, the former CEO of AMS, American Medical Systems/Endo Pharmaceuticals now from Dublin, Ireland (producer of FAILED pelvic surgical mesh) and CEO of Tornier-a Minnesota company-now from the Netherlands-that made the elbow that failed in my brother after just 4 months-left abruptly and gave himself $2.6M when the company was failing to bring in a profit.



Oct 28, 2014, 1:17pm CDT
Staff reporter-
Minneapolis / St. Paul Business Journal


Orthopedic-device maker Tornier has been sold to Wright Medical Group Inc. in an all-stock deal worth $3.3 billion, the companies announced Monday.
Memphis-based Wright Medical Group, which makes surgical devices and bone-growth products, will own 52 percent of the combined company's stock when the deal closes.
The combined company will operate as Wright Medical and be led by Robert Palmisano, Wright's president and CEO. Tornier CEO David Mowry will serve as president and chief operating officer.
Tornier is based in the Netherlands, but its U.S. headquarters and top executives are based in Bloomington. The business ranks as Minnesota's 10th-largest medical-technology company, according to Business Journal research.
Tornier's Bloomington office will serve as the U.S. headquarters for the combined company's upper extremity business unit, Tornier said in a regulatory filing. Wright's U.S. headquarters and executive team will be based in Memphis. Its global headquarters will be based in the Netherlands.

Tornier makes devices for the treating orthopedic problems in shoulders, hand, elbows and other extremities. The company generated $311 million in revenue last year. Wright's sales totaled $242 million in 2013.
___________________________________________________



October 27, 2014 | By Varun Saxena
Wright Medical Group ($WMGI) plans to merge with peer Tornier ($TRNX) in an all-stock transaction designed to create a pure-play orthopedics extremities and biologics company valued at $3.3 billion. The resulting entity is expected to be a midsized growth company that's in what it says are the three fastest growing areas of orthopedics--upper extremities, lower extremities and biologics.
The newly combined company will be incorporated in the Netherlands, where Tornier is currently headquartered. The inversion deal is one of the first since release of the Treasury Department's rules to deter the tax-saving practice. One of them was a med tech deal between hospital products and services companies Steris and U.K.-based Synergy Health.
During the conference call describing the deal, company officials said the short-term tax advantages will be minimal, according to the Wall Street Journal.
The deal values Tornier at a premium of 28% over its Oct. 24 closing price. Wright shares climbed 6% to $33.50 in after-hours trading on the news, while Tornier gained 31% to $31.44. Each share of Wright common stock will be exchanged for 1.0309 ordinary shares of Tornier.
"Together, we will have one of the most comprehensive upper and lower extremity product portfolios in the market, extending our leadership position and further accelerating our growth opportunities and path to profitability, all of which we believe will generate long-term value for our shareholders. In addition, this will provide our employees with opportunities for career growth and development as part of a much larger, dynamic organization," Robert Palmisano, CEO of Wright Medical, said in a statement.
He will become CEO of the newly combined company, to be known as Wright Medical Group N.V. The U.S. headquarters for the Lower Extremity and Biologics businesses will be in Memphis, TN, where Wright is currently headquartered. The U.S. headquarters for the Upper Extremity business will be based in Bloomington, MN, at an existing Tornier facility. Wright shareholders will own 52% of the new company and Tornier shareholders, 48%.
"Both companies have built a deep and loyal customer base and have highly complementary product portfolios, positioning the combined entity to deliver meaningful value to our shareholders. We believe that partnered together, Wright and Tornier will become the fastest-growing company in the Extremities-Biologics industry," said Tornier CEO David Mowry, who will become COO of Wright Medical Group N.V.
The news comes on the same day as Wright's announcement that it received PMA approval from the FDA for its Augment Bone Graft as an alternative to autograft for ankle and/or hindfoot fusion indications.
Both companies make implants to fix or replace the wrist and ankle as well as biologics to encourage healing and tissue regeneration. Tornier's U.S. portfolio also includes implants for the shoulder and elbow, as well as surgical tools enabling sports medicine.
The new company is expected to have revenues growing in the mid-teens with adjusted EBITDA margins approaching 20% in three to four years. Cost synergies are expected to be in the range of $40 million to $45 million within the first three years after the transaction completes; synergies will be due to overlapping public company expenses, support function and system costs as well as process and vendor consolidation. Wright expects the transaction will be accretive to the new company's adjusted EBITDA in the second full year after the transaction completes.
Separately, Tornier reported Q3 revenues were up 14.9% year over year to $76.7 million. Meanwhile, Wright's quarterly net sales of $71.3 million were up 24%. The transaction is expected to close during the first half of 2015.
- read the release
- here's the Wall Street Journal article (sub. req.)
Editor's Note: This article has been updated to indicate that the transaction involves tax inversion.
___________________________________________________________________



New Company Will Be Based in Tornier’s Current Home of the Netherlands
By LAUREN POLLOCK  Wall Street Journal
Updated Oct. 27, 2014 6:20 p.m. ET

Medical-device companies Wright Medical Group Inc. and Tornier NV agreed to combine in an all-stock deal that would move Wright’s headquarters to the Netherlands.
The companies, which both make orthopaedic devices, said their combined equity value is about $3.3 billion. Wright shareholders will own about 52% of the combined company, while Tornier investors will have 48%.
This deal follows other acquisitions prompted in part by potential tax advantages, known as inversion deals. In recent weeks, the Obama administration has moved to stem that wave of corporate inversions by unveiling new tax rules.
On a conference call, the companies downplayed the tax implications of the deal, saying the near-term advantages are minimal.
The combined company will be called Wright Medical Group NV and will be led by Wright’s current CEO, Robert Palmisano, but it will be based in the Netherlands, with a U.S. home at Wright’s current Memphis base.
Tornier CEO David Mowry will be chief operating officer of the combined company. The board will be made up of five representatives from each company’s existing board.
Wright makes extremity and surgical tools, while Tornier makes tools for surgeons who treat musculoskeletal injuries and disorders of the shoulder, elbow, wrist, hand, ankle and foot.
Write to Lauren Pollock at lauren.pollock@wsj.com
_______________________________________________


SHAREHOLDER ALERT: Law Firm of Levi & Korsinsky, LLP Launches Investigation Against the Board of Directors of Wright Medical Group, Inc. Regarding the Fairness of the Sale of the Company to Tornier NV
Published: October 29, 2014
NEW YORK--(BUSINESS WIRE)--Oct. 29, 2014-- Levi & Korsinsky is investigating the Board of Directors of Wright Medical Group, Inc. (“Wright Medical” or “the Company”) (NasdaqGS: WMGI) for possible breaches of fiduciary duty and other violations of state law in connection with the sale of the Company to Tornier NV.
Click here to learn more about the investigation: http://zlk.9nl.com/wright-medical-wmgi.
Under the terms of the transaction, Wright Medical shareholders will receive 1.0309 Tornier common shares for each share of Wright Medical stock they own, representing an approximate value of $24.79 per share, based on Tornier’s recent closing price. The investigation concerns whether the Board of Wright Medical breached their fiduciary duties to stockholders by failing to adequately shop the Company before agreeing to enter into this transaction, and whether Tornier NV is underpaying for Wright Medical shares. In particular, at least one analyst has set a price target for Wright stock at $40 per share.
If you own Wright Medical common stock and wish to obtain additional information, please contact Joseph E. Levi, Esq. either via email at jlevi@zlk.com or by telephone at (212) 363-7500, toll-free: (877) 363-5972, or visit http://zlk.9nl.com/wright-medical-wmgi.
Levi & Korsinsky is a national firm with offices in New York, New Jersey, Connecticut and Washington D.C. The firm’s attorneys have extensive expertise in prosecuting securities litigation involving financial fraud, representing investors throughout the nation in securities and shareholder lawsuits. For more information, please feel free to contact any of the attorneys listed below. Attorney advertising. Prior results do not guarantee similar outcomes.
Source: Levi & Korsinsky
Levi & Korsinsky, LLP
Joseph Levi, Esq., 212-363-7500
or
Eduard Korsinsky, Esq., 212-363-7500
30 Broad Street - 24th Floor
New York, NY 10004
Toll Free: (877) 363-5972
Fax: (866) 367-6510
www.zlk.com

Friday, October 10, 2014

"PROVE IT !!!" M-o-M hips, pelvic surgical mesh, Essure birth control . . .


Posted: October 8, 2014 - 3:15 pm ET

“Prove it.” That was the resounding message to medical-device manufacturers during the annual Advanced Medical Technology Association conference in Chicago this week. Innovation is needed to advance medicine and better patients' quality of life, but gone are the days of sticking higher price tags on products that only provide incremental improvements, the leaders of health insurance companies, health systems, quality improvement and consumer organizations told the industry.

“We don't want to squelch innovation,” said Dr. Scott Josephs, national medical officer for the health insurance provider Cigna Corp. “But tell me what I'm getting for my healthcare costs. Show me that these new technologies are superior,” he told the audience during a session Wednesday morning.


Related Content


Josephs was joined on the panel by Susan DeVore, president and CEO of the health improvement organization and group purchasing organization Premier; and Mark Neaman, CEO of the Chicago area's NorthShore University HealthSystem. An essential element in the aim for higher efficiency will be the need to more critically assess the value of new innovations, the panelists said.

“If it's clinically appropriate but equally efficacious to existing technology, then frankly it's just adding costs to the system,” Josephs said. “That's not something we would prefer.”

Fee for service is dead and the current landscape “is a bit chaotic,” noted DeVore, who said health providers are in the process of integrating what has been a fragmented industry. In light of that, the old ways of doing things are not going to suffice, Neaman said. “The stakes are very high for us as providers,” he told the audience.

New payment models aimed at improving efficiency and getting a handle on costs have proliferated quickly in recent years, nurtured by provisions of the Patient Protection and Affordable Care Act. Many providers are joining accountable care organizations, which are risk-sharing mechanisms available through government payers like Medicare as well as private payers, in which members agree to strive for cost and quality targets and share savings or losses.

Monday, AdvaMed promoted an industry-funded white paper based on the responses of officials from nine unnamed health insurance companies who were interviewed about their movement toward pay-for-performance and risk-based contracts. Officials from five insurers said they had become more selective about approving coverage for new technologies in the past three years. Four said they plan to demand more evidence before covering products. All said costs were driving their organizations to explore new reimbursement models.

The trade group representing medical-device manufacturers worried these rapidly burgeoning pay-for-performance and risk-based reimbursement models will result in what AdvaMed CEO Stephen Ubl called “unintended consequences.”

Too many of the arrangements emphasize cost targets over quality benchmarks, said Joe Almeida, the trade group's chairman as well as CEO of the medical-device manufacturer Covidien. “They run the risk of really tipping too far, so physicians have incentive not to adopt things that really benefit patients,” said David Nexon, an AdvaMed senior vice president.

Health economists countered that the white paper may have overstated those concerns and that it's hard to make the extrapolation. Insurers agreed, saying truly superior innovations would not be overlooked, even if they come at higher costs. And most health officials interviewed by Modern Healthcare said the key factor is the proof.

“The thing that's been missing from the model until now is the evidence,” said Diana Zuckerman, a researcher who has been critical of the Food and Drug Administration's procedures for approving and monitoring medical devices.

The federal agency's recent plans for an accelerated approval pathway for some medical devices has been met with criticism by consumer advocates who say such efforts put patients in danger.

During a conference session on Tuesday afternoon, FDA Commissioner Dr. Margaret Hamburg said that as science and technology advance at extraordinary rates, the agency wants to stay up to speed as a partner with the medical technology community. A more efficient system overall will allow for the delivery of new science and technology for patients in more reliable and cost-effective ways, but the emphasis on speed doesn't mean a step away from scientific rigor, she said.

As new products make their way to the forefront, no matter how rapidly, the onus is increasing for manufacturers to ensure that providers are convinced the innovations are worth the financial investment.

It's not about the lowest price point, that's just one part of the overall value equation, Cigna's Josephs said. It's about having more data and conceiving of partnership arrangements to help get there, according to Premier's DeVore. “Bring your evidence and data, and bring a willingness to collaborate and take risks,” she said.

Follow Sabriya Rice on Twitter: @MHsrice



Monday, October 6, 2014

Criminal?: Scottish Surgical Mesh Scandal

Revealed: Two doctors on mesh safetyreview team linked to makers of controversial devices

         Oct 05, 2014 13:53
         By Marion Scott  Daily Record (UK)  FiDA highlight

HEALTH Secretary Alex Neil under fire after victims claim the government probe into mesh implants is being rigged to give operations the all-clear.


Health Secretary Alex Neil
TWO doctors on the government team reviewing the safety of mesh implants have links to the makers of devices used in the controversial surgery.
The appointments have fuelled concern of campaigners that the review has been weighted to support the continued use of the procedures, which have left women around the world crippled and led to multi-million-pound compensation payments.
Ash Monga and Karen Guerrero have been paid by Ethicon, the makers of a mesh product called Gynecare.
Dr Monga described himself as a “consultant for Gynecare” in a 2009 medical research paper.
Dr Guerrero, a surgeon at Glasgow’s Victoria Infirmary, received “educational sponsorships” – including payments and travel costs – from Ethicon and another major mesh manufacturer called Bard.




Dr Karen Guerrero


He won plaudits in June after apparently suspending mesh procedures when Hear Our Voice campaigners, supported by the Sunday Mail, gave evidence to reveal how they have been left in crippling agony by mesh, used to treat prolapse and bladder problems.
At the time, Neil said: “I’m proud Scotland has taken this stance and I believe we are leading the way on what is a significant global problem.”
But we revealed the anger of campaigners last week after discovering government medical advisers wrote to hospitals within weeks of Neil’s announcement to say the suspension was voluntary and encouraged them to use mesh on patients as part of clinical trials.
Yesterday, politicians and campaigners raised new concerns about the appointments to the review body to establish if there are any conflicts of interest.
Scottish Labour’s shadow health secretary Neil Findlay said: “It is outrageous that, after taking over a year to reach a decision on mesh implants, the Health Secretary has appointed doctors to the review who might appear to have a vested interest.
“Those affected have been through far too much in the past few years and this latest development is simply inexcusable.”



Mesh product


Olive McIlroy, of Scottish Mesh Survivors, said: “We are dismayed that people appointed to carry out this vital review have such links to the manufacturers who profit from the use of these devices.
“Alex Neil promised victims would be at the very heart of the independent review but it feels very much like we are lone voices pitted against the country’s most powerful mesh supporters.”
Ethicon, a subsidiary of Johnson & Johnson, have twice had their TVT-O device declared as “defective” by a US court.
It has also emerged that Gibraltar-born Guerrero was among 23 signatories backing an objection to Neil’s suspension of mesh use in the NHS in June.
Dr Guerrero backed the call made by Aberdeen-based urology consultant Mohamed Abdel-Fattah asking for mesh trials to be exempted.
Abdel-Fattah, who has also received “travel sponsorship” from Ethicon, was supported by two other members of the review group, Professor Charis Glazener and consultant urologist Voula Granitsiotis.
Ethicon’s Lucinda Macari said: “Ethicon, in conjunction with the Association of British Healthcare Industries, are supporting efforts by the Scottish Independent Review to gather full and accurate information about pelvic mesh products.”
The Scottish Government said: “This must be an entirely independent review and will be completed as such.”
          
         Sep 14, 2014 14:11
         By Marion Scott  Daily Record (UK)
MARTHA Salazar's case in Dallas, Texas – the second major victory for mesh victims in America within days – prompts new calls for criminal inquiry in Scotland.


Campaigner Elaine Holmes in the Scottish Parliament.
AN American mesh patient has been awarded £60million compensation by a US court.
Martha Salazar won the huge payout after the court in Dallas, Texas, heard that the Obtryx implant made by Boston Scientific was defective.
They jury was also told that the manufacturers had failed to properly test the device on humans.
It was the second major victory for mesh victims in the States within days.
Earlier this month, Jo Huskey was awarded damages totalling £3million by a West Virginia court for pain and suffering caused by a TVT-O mesh 
implant made by Johnson & Johnson firm Ethicon.
Both these mesh devices were given to Scottish women on the NHS before the procedures were suspended pending safety reviews after an outcry by mesh victims.
The US payouts have led to politicians and victims calling for the Scottish Government to sue manufacturers and launch a criminal probe.
Labour’s shadow health secretary Neil Findlay said: “These cases are proof, if any further evidence is needed given the hundreds of women injured here, that the mesh scandal is shaping up to be a very big issue for Scotland’s NHS.
“It’s high time the Scottish Government challenged the manufacturers over the catastrophic health problems these devices have inflicted on so many women.
“If there’s evidence of clinic data and trial evidence being deliberately withheld, criminal action should be considered.”
Elaine Holmes, of Scottish Mesh Survivors, added: “A car manufacturer who did this would face a criminal investigation and lengthy jail sentences. It should be the same for mesh manufacturers.”
Lawyer Cameron Fyfe, who is acting for over 400 women involved in the biggest-ever medical legal action in Scotland, said: “Potential damages in 
Scotland would be a fraction of those in the US but we expect to have similar success.”

Gareth Easton

Scottish Health Secretary Alex Neil





Health Secretary Alex Neil suspended mesh operations in March pending an independent safety review.

It followed a Sunday Mail campaign which exposed the hidden agony of hundreds of women given mesh implants to treat incontinence and bladder problems.

Friday, October 3, 2014

Buy! Buy! Medical Device Indu$try Consolidate$/Invert$: Follow the Money



FiDA highlight



By John N. Frank   
Posted: October 2, 2014 - 1:45 pm ET
Device maker payments to providers
Aug. 1, 2013-Dec. 31, 2013
Device maker
Payment
Zimmer*
$17,428,680.83
Medtronic*
$13,024,707.80
Boston Scientific Corp.*
$8,882,851.72
Stryker Corp.
$8,742,778.75
Intuitive Surgical
$8,638,153.40

Created with Datawrapper

Five prominent medical-device makers gave a total of $56.7 million to doctors and teaching hospitals from Aug. 1-Dec. 31, 2013, for research and general purposes, according to a Modern Healthcare analysis of data posted on the new Open Payments website.

Leading the list of devicemakers is Warsaw, Ind.-based Zimmer, which gave $17.4 million, followed by Minneapolis-based Medtronic, which gave $13 million. Medtronic competitor Boston Scientific gave $8.8 million.

Competition among devicemakers has been intense, and the companies have been pursuing mergers and acquisitions and new contract models with providers, which view high-cost supplies as an area to cut costs. Zimmer, which makes orthopedic reconstructive, spinal and trauma devices, dental implants and related surgical products, is pursuing a $13.35 billion acquisition of competing orthopedic manufacturer Biomet. Medtronic announced plans to buy surgical supplier Covidien for $42.9 billion as the sector continues to consolidate.

The data were published on the Open Payments website, which was required by the Physician Payments Sunshine Act, a provision of the Patient Protection and Affordable Care.

*Zimmer recently purchased Biomet:  the only manufacturer that provided patients a warranty on product. 
*Medtronics will  avoid paying U.S. taxes, as it employed ‘inversion’ to acquire a foreign company and claim that as its corporate headquarters. 
*see FiDA post on Salazar v Boston Scientific Obtryx surgical mesh 73M verdict:  the company executives were aware of the irreversible, permanent, catastrophic harm and the MSDS stating that pp mesh product should not be implanted in humans and did not inform the implanting surgeons and patients.
_______________________________________________________________________


September 30, 2014  LA Times

Opening the book on long-hidden industry relationships, the federal government revealed nearly $3.5 billion worth of payments and other ties that U.S. doctors and teaching hospitals have with drug and medical-device companies.
These financial details, published Tuesday under a requirement in the federal health law, have been sought for years by patient advocates and lawmakers from both political parties concerned about conflicts of interest in the medical profession.
Initially, the new federal website includes 4.4 million payments made during the last five months of 2013. More data will be published next summer.
Database
Officials said the data cover financial transactions involving about 546,000 physicians and 1,360 teaching hospitals across the country.
Consumer advocates hope the increased disclosure will ultimately help curb unethical practices by some doctors who prescribe medications and devices after receiving large sums from manufacturers, possibly putting patient care at risk.
Physicians and academic medical centers defend industry collaboration as essential to advance research into life-saving treatments. They have also questioned the accuracy of the government data.

The Physician Payments Sunshine Act was included in the Affordable Care Act that President Obama signed in 2010 amid growing demands for more openness in the U.S. healthcare system, which historically has shielded doctors, hospitals and other medical providers from much public scrutiny.
“The Sunshine Act is a watershed moment,” said Susan Chimonas, associate director of research at Columbia University's Center on Medicine as a Profession. “It’s a tantalizing first look at what kind of industry ties doctors have.”
In the last several years, the Obama administration has published data on how much hospitals charge for medical procedures and how much the massive federal Medicare program pays individual physicians.
At the same time, hospitals, nursing homes and others are being required to report an increasing number of quality measures to the federal government, which posts the data on a public website.



These industry payments have long been a target for patient advocates concerned about the huge sums companies expend to woo physicians with speaking fees, luxury trips and meals.
“It’s a widespread practice that does influence the kind of care patients get,” said Lisa McGiffert, manager of Consumers Union’s Safe Patient Project in San Francisco. “This exposure will require everybody to talk about something that’s been underground.”
In one national survey, nearly 30% of doctors said they received money for consulting, giving lectures or enrolling patients in clinical trials.

Medical groups have cautioned that the data on payments risk jeopardizing crucial collaborations that have helped foster medical breakthroughs that benefit patients.
“If the information made available to the public involves dollar amounts without full context, it can lead to gotcha-style news stories and healthcare providers facing the presumption of ethical wrongdoing even when they have done nothing wrong and their work is benefiting patients,” said Mary Grealy, president of the Healthcare Leadership Council, an association of medical industry leaders.
Major medical societies, including the American Medical Assn., have expressed concerns about the increased disclosures about physicians, often complaining that the data are not always correct.
In advance of the release of the new payment data, medical groups renewed their complaints that physicians had not been given adequate opportunity to review the information before it was published.
Dr. Shantanu Agrawal, a deputy administrator at the Centers for Medicare & Medicaid Services, said the new database "does not identify which financial relationships are beneficial and which could cause conflicts of interest. It simply makes the data available to the public."
The government website details a wide range of payments and financial information, from consulting fees, meals and travel expenses to physician ownership stakes in medical companies.
But the Obama administration said about 40% of the records published Tuesday don't include physician names because officials are still working to confirm the accuracy of the payouts. An additional 199,000 records are being withheld for now because they are either exempt from the reporting requirement or under dispute, federal officials said.
The law requires medical companies to report payments and gifts to physicians that exceed $10.
U.S. Sen. Charles E. Grassley (R-Iowa) authored the Sunshine Act after numerous investigations into conflicts of interest among physicians. He said the rollout may be rocky but the data will eventually become a valuable resource for consumers, insurers and taxpayers.
"It should empower consumers to learn whether their doctors take payments and if so, why and whether that matters to them," Grassley said.