Caldera Medical May Pay Restitution To Pelvic Mesh Injured

August 1, 2016
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Mesh Medical Device News Desk, August 1, 2016 ~ The following is an article written by “Samantha” who is one of the 4,000  plaintiffs in the Caldera Medical pelvic mesh litigation. She does not want to be identified because she still may seek representation.

On her own she has forged inroads to stop the "no opt-out" settlement proposal by Caldera which would have allowed Caldera Medical to avoid pelvic mesh litigation by offering what was left in its settlement pot - $11.75 million.

Last week the proposed settlement was denied by U.S. District Judge Judge Stephen V. Wilson.

Samantha fought the proposed Caldera Medical settlement which would have offered approximately $3,000 per claim to women who said they were injured by its mesh products - T-Sling, Desara, Ascend, Hydrix, POPmesh and Vertessa.

Desara mesh by Caldera Medical
Desara mesh by Caldera Medical

As you may recall, last February, California-based mesh device maker, Caldera Medical, said it was insolvent. A lawsuit with its insurance carrier Federal Insurance Company, (Chubb Insurance) had drained a $25 million insurance fund by roughly half.

Samantha was one of the 50 or so women who objected. She didn’t believe the company claims of insolvency and felt the company was deliberately undercapitalized and was hiding conflict of interest relationships with doctors who used its medical devices.

All of the women objected to Caldera's refusal to allow women to opt-out to file their own product liability lawsuits as a violation of the Seventh Amendment to a remedy through the courts, a right under our U.S. Constitution.

So she filed motions with U.S. District Judge Stephen Wilson of the Central District of California (Los Angeles) that the company was leaving settlement monies on the table by not tapping into the patent holders of the implantation method.

One week ago, Judge Stephen Wilson denied Caldera’s settlement proposal.

Filing Motions

Now Samantha wants to take her inquiry to the next level. She will file three motions to uncover the company’s privately held secrets, secrets such as:

*Pierce the Corporate Veil of Caldera Inc. – Who are the board members and what is their conflict of interest with Caldera, this could include doctors who have ownership arrangements with the privately held company.

*Produce stockholders of Caldera Medical – Since the company is not a public one, the public cannot know the identity of stockholders who also may have beneficial financial arrangements with Caldera Medical.

*Return at least $13 million from unsuccessful litigation with its insurance provider, Federal Insurance Co in Case No. 2:15-cv-00393-SVW-PJW District Court Central District of California.

Executives can no longer hide behind the corporate veil. They need to be accountable for what their companies do, because entities are responsible for socially irresponsible behavior.
~Simon Mainwaring
"I am very grateful for the ruling by the Judge Wilson few days ago. I am still unsure if my claims will be removed or remanded back to my State Court. So, in an attempt to move forward I will be filing a Motion To Pierce The Corporate Veil as it may help others. I will also be filing a Motion for the Production of the Stockholders list as I believe they too are part of the parties who should be held responsible. Additionally, a Motion to Cease  and Desist the Caldera Medical and IVUmed partnership to eradicate the incapacitation and suffering of women with Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP) and to do no harm or spend anymore capital for this venture until harmed Americans have been paid restitution.
"Caldera Medical, a medical device company, develops differentiated surgical implants for the treatment of SUI and POP. “Millions of women in poverty-stricken countries are incapacitated by incontinence and/or prolapse and are not receiving the care they need,” stated Bryon L. Merade, Chairman and CEO, Caldera Medical, adding, “teaming up with IVUmed to eliminate the suffering of women with SUI and POP will enable us to fulfill our mission of improving the quality of life for women.”
"I think they will harm these women.
"I think it is important to add all pathways to find assets for those injured. The Court DENIED the motion for final settlement approval and class action certification. The Court DENIED the motion for attorneys’ fees as moot. The Court acknowledged Caldera Medical, Inc. remains a solvent, operational business without evidence of it’s potential liquidated value.
"So, I think it is reasonable to also include the assets of the Board of Directors and the stockholders as two of them were coinventors of devices for Caldera Medical, Inc. I pray the Honorable Court will grant the  Piercing the Corporate Veil of Caldera Medical, Inc. to include Board of Directors and Stockholders.
"In my previous objections I attempted to provide the Honorable Court with the knowledge that my implanting surgeon owns the patent for the implantable sling procedure used on me as a human experiment, April 20, 2004 with two of Caldera Medical, Inc.’s Board of Directors. Because my implanting physician had a financial interest in the T Sling and procedure he has violated Starks Laws and False Claims Act. Maybe the Honorable Court will consider the life altering harm I and others have endured and lift the corporate veil.  As it is an equitable doctrine which imposes upon certain companies (e.g. pharmaceutical, medical device and other.) the most equitable route to compensate for life altering injuries and harm.
"California courts have developed a number of factors they will consider when determining whether the Motion To Pierce the Corporate Veil, including 17 reasons I have found so far but number 9 is one we can all be sure of:
  1. Failure to adequately capitalize a corporation, the total absence of corporate assets, and undercapitalization;
"I think it is clear to the all parties that there was a failure to have capitalized and insure the medical devices brought to market by Caldera Medical, Inc. The overwhelming knowledge for the Honorable Court to consider is the POWERHOUSE BOARD of DIRECTORS that has existed since 2002. These parties knew they were failing to adequately capitalize Caldera Medical, Inc. If proper capitalization had occurred then more reasonable insurance policies would have been purchased.
"As the Honorable Court reviews these Bios I pray the court applies the “IF IT WALKS LIKE A DUCK IT IS A DUCK Doctrine”  These directors are not medical urological or gynecological professionals, they are INVESTORS, Bankers, Venture Capitalist. They knew exactly how to capitalize this corporation and chose not to. Whereas, there are many facts within the BIOs that confirm the reasons that under capitalization was avoidable here is one:
"Mr. Cappello has led several public and private companies including Cappello Capital Corp. (member NASD-SIPC), a global merchant bank, whose principals have conducted over $140 billion in transactions in over 50 countries. Mr. Cappello has more than 35 years of global experience in corporate management, corporate finance, investment banking and merchant banking. Surely his skills alone could have prevented the issues at hand.
At this time these are the parties that I believe along with the stockholders may be affected if the Motions are approved.
"They chose not to and the harmed me and others and should be required to make personal restitution. In reviewing the current Board any reasonable person would conclude they knew they unfunded and under insured their medical devices. I hope they and their stockholders will be held responsible for our injuries."

BOARD OF DIRECTORS Caldera Medical 2010 To Present

Brian Merade Chair & CEO Caldera Medical

Brian Merade
Chair & CEO
Caldera Medical

Bryon L. Merade

Chairman and Chief Executive Officer

Mr. Merade has spent the past 21 years in Women‘s Health and Urology with the past 18 years leading organizations in this sector. Mr. Merade founded Caldera Medical in April 2002, and focuses on corporate strategy, portfolio development and intellectual property. In 1997, Mr. Merade founded Surgical Solutions, Inc. which he built into a successful medical device distribution organization focused on Gynecology and Urology technologies. Prior to founding Surgical Solutions, he served as Director of U.S. Sales for BEI Medical Systems, a publicly traded manufacturer of devices for the Gynecology market acquired by Boston Scientific. While at BEI, Mr. Merade had complete responsibility for the company‘s U.S. sales operations, which represented 88% of BEI‘s revenue. He led a team of 70 sales representatives, 15 distributors and 20 inside sales professionals. Mr. Merade began his career with Integra Precision Corporation as a Regional Sales Manager, where he had sales management responsibilities in numerous states and developed his region into the company‘s largest revenue producing and most profitable area.

Mr. Merade received his M.B.A. from the University of Southern California, his B.S. in Business Administration from Regis University, and an A.S. in Criminal Justice from Moorpark College.

alexander cappello

Alexander L. Cappello

Outside Director

Mr. Cappello has led several public and private companies including Cappello Capital Corp. (member NASD-SIPC), a global merchant bank, whose principals have conducted over $140 billion in transactions in over 50 countries. Mr. Cappello has more than 35 years of global experience in corporate management, corporate finance, investment banking and merchant banking. He currently serves as a Trustee of the University Southern California (USC), and the Board of the Pacific Council on International Policy (PCIP). In addition, he serves as a Trustee of the City of Hope, a Director of RAND Corporation‘s Center for Middle East Policy (CMEPP) and the RAND Russia Forum, Director of California Republic Bank (largest capitalized bank in California history) and Lead Director of The Cheesecake Factory, Inc. (NASDAQ).

Formerly he was Chairman of Inter-Tel (NASDAQ), a global leader in high speed routers and telecom solutions; Chairman of Intelligent Energy, PLC (London), a global technology leader in hydrogen fuel cells; Chairman Geothermal Resources Intl. (AMEX); as well as a Director of Cytrx (NASDAQ), Genius Products (NASDAQ) Koo Koo Roo, Inc (NASDAQ) and Chairman Advanced Biotherapeutics (OTC). Mr. Cappello also served as Chairman of the International Board of the Young Presidents Organization (YPO).

Mr. Cappello received a Bachelor of Science degree from the Marshall School of Business at USC in 1977 with honors, including recognition as an “Order of the Palm” scholar. He received an Honorary Doctorate of Humanities from Goodwin College in Stamford, CT and has been inducted in the Order of Honorary Fellows at Marymount College in Palos Verdes, CA.

fred haney

Dr. Fred Haney

Outside Director

Dr. Haney has been a venture capital fund manager and private investor for twenty six years. He is a co-founder and Chairman of NovaDigm Therapeutics, Inc. He is also a co-founder of Dynamic Reconfigurable Computing, Inc., a provider of super-computer co-processors.

Dr. Haney was the founder and manager of 3i Ventures, California, a venture capital fund that invested $80 Million in 60 companies and produced top-quartile returns. He has been a principal in numerous investment transactions, and he has served on the board of directors of 25 private companies and 4 public companies. He founded the Monday Club, an active 150-member startup business mentoring group, in 1983. He was a co-founder, in 1997, of Tech Coast Angels, the largest angel investment group in the U.S. Dr. Haney has held senior management positions with Scientific Data Systems, Xerox, Computer Sciences Corporation, and TRW. The Orange County Forum for Corporate Directors named him “Director of the Year for Early Stage Companies” in 2002. In 1999, he was selected “Mentor/Angel of the Year” by the American Electronics Association in Orange County.

He holds a Ph.D. in Computer Sciences from Carnegie-Mellon University, an M.S. in Mathematics from Colorado State University, and a B.A. from Ohio Wesleyan University.

yuri Pickover

Yuri Pikover

Outside Director

Mr. Pikover held various executive, founder, and CEO-level positions at a number of private and public technology companies and has guided numerous private companies through financing, public offerings, and acquisitions. Mr. Pikover is currently a private investor and board member of 6 companies.

Previously Mr. Pikover was Chairman of 5square as well as Chairman and CEO of Access360. In 1993, he was co-founder and EVP of Xylan Corporation (XYLN), which was one of the fastest-growing technology companies in history and was responsible for the sale of Xylan to Alcatel in 1999 for $2 billion. Mr. Pikover has served as a board member of 20 companies.

Mr. Pikover was named Entrepreneur of the Year by the San Fernando Business Journal in 2005, and is a co-author of Security Provisioning: Managing Access in Extended Enterprises.

michael ziering

Michael Ziering

Outside Director

Mr. Ziering served as Chief Executive Officer of Diagnostics Products Corporation, a medical manufacturer that employed over 650 people in Los Angeles and 1,800 worldwide, from 1999 until Siemens acquired the company for $1.86 Billion in 2006.

Mr. Ziering joined Diagnostics Products Corporation in 1986 as legal counsel, and served as Vice President-Administration from 1988 to 1994, Chief Operating Officer from 1994 to 1999, and as President from 1994 to 2004.

Mr. Ziering earned his Juris Doctorate from Loyola Law School, and is an alumnus of University of California Santa Barbara with his Bachelor of Science degree in Political Science.


Dov Tamler

Dov Tamler

Chief Operating Officer

Mr. Tamler joined Caldera in 2002, and has held a series of roles across the organization. He currently oversees the company’s finance, administration, and operational functions. Prior to Caldera, Mr. Tamler was Category Marketing Director for Keen, a consumer internet company, where he was responsible for the company’s largest market and oversaw revenue growth in excess of 300%. Prior to Keen, Mr. Tamler held a series of business development and marketing roles at Intel Corporation, where he partnered with consumer software companies in support of Intel’s next generation processors, including the 1999 launch of the Pentium® III Processor. Mr. Tamler received his M.B.A. from Columbia Business School, and holds a B.A. in Communication Studies with honors from the University of California at Los Angeles.

Sandra Muhlfield

Sandra Muhlfeld

Vice President, Research and Development

Ms. Muhlfeld joined Caldera in 2006, and is responsible for all product development, product management, and corporate marketing activities. Previously, Ms. Muhlfeld was Global Product Manager for St. Jude Medical, where she focused on implantable left ventricle leads and delivery systems for cardiac resynchronization therapy. Ms. Muhlfeld has also held several marketing positions with Guidant, including serving as Senior Product Manager for global drug eluting stent marketing. Ms. Muhlfeld received her M.B.A. from Kellogg School of Management at Northwestern University, and her B.S. in Physical Therapy from the University of Connecticut.

Pat K

Pat Kothari

Director of Finance

Mr. Kothari joined Caldera in 2010 and oversees the Finance and Accounting functions of the company. Prior to Caldera, Mr. Kothari was Corporate Controller at JSM, a privately held real estate development company, where he headed the Finance, Accounting and Management Information Systems. At JSM, Mr. Kothari managed the Accounting & Reporting for as many as 15 LLCs in addition to budgeting, treasury management, tax planning and annual audits. Previous to JSM, Mr. Kothari was Assistant Controller at Citysearch, an online City Guide and a wholly-owned subsidiary of InterActive Corp. At Citysearch, Mr. Kothari was instrumental in building the Accounting department from the ground up, establishing internal controls and policies. Mr. Kothari was the point person to the CFO during the CitySearch IPO process and oversaw SEC reporting post IPO. Mr. Kothari holds a B.S. in Accounting from California State University, Dominguez Hills.

eric geismer

Eric Geismar

Vice President, Corporate Development and General Counsel

Eric P. Geismar is Caldera Medical’s Executive Vice President of Corporate Development and General Counsel. From 2001 through 2016, Eric was the Vice President and Chief Counsel of Medtronic Diabetes. From 2001-2008, Eric was also responsible for Business Development at Medtronic Diabetes and served on the Business Development Leadership Committee throughout his career at Medtronic. From August 1999 through 2001, Eric served as Vice President, Legal Affairs and Assistant General Counsel at MiniMed Inc., prior to its acquisition by Medtronic. Eric’s responsibilities included oversight of the day to day legal affairs of the company, as well as responsibilities for securities and regulatory compliance and the formation and management of strategic relationships. Eric joined MiniMed in May 1997 as Director, Legal Services & Assistant General Counsel. Prior to joining MiniMed, Eric was an Associate with the Los Angeles office of Dewey Ballantine. Eric’s practice at Dewey Ballantine included securities regulation, mergers and acquisitions, corporate governance and general transactional work. Eric earned a B.A. degree from Cornell University, an M.B.A. from the Anderson Graduate School of Management at University of California, Los Angeles and a J.D. degree from the University of Southern California Gould School of Law.

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