The FDA's prolonged, covert monitoring of the whistleblowers continued even after the HHS Office of Inspector General denied the FDA's request to take any criminal and/or administrative action against the whistleblowers. In their letter of refusal, the OIG explicitly informed the FDA that the whistleblowers' communications to Congress were protected under law.
 
The NWC issued an Action Alert strongly encouraging the public to send email to the President, FDA officials, and members of Congress demanding that the six whistleblowers be protected and targeted surveillance be halted throughout the government.
 
 
Links:  
 
Senator Grassley's Letter to FDA Commissioner
(http://www.whistleblowers.org/storage/whistleblowers/documents/FDAComplaint/grassleyletter.fdaspying.pdf)
 
FDA Whistleblower Complaint
(http://www.whistleblowers.org/storage/whistleblowers/documents/FDAComplaint/fdacomplaint.redacted.pdf)
 
Intercepted Emails from FDA Whistleblowers
(http://www.whistleblowers.org/index.php?option=com_content&task=view&id=1332) 
 
Letter from the HHS OIG
(http://www.whistleblowers.org/storage/whistleblowers/documents/FDAComplaint/oigletter.fdawbdisclosuresprotected.pdf)
   
NWC Action Alert
(http://www.whistleblowers.org/index.php?option=com_content&task=view&id=1333)
 

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New Jersey divorce attorney, Laura D'Orsi, is now offering help for those going through divorce on her new website, www.lauradorsilaw.com. This website combines her experience and knowledge regarding New Jersey divorces and makes it possible for people going through a divorce to have the most accurate information available to them.

The website, www.lauradorsilaw.com, offers a Question and Answer page where people can get basic information about divorce practices in New Jersey. From information on what steps one should take to start the divorce proceedings to more in depth information on mediation and collaborative divorces, the site visitor will leave with great knowledge of what must be done in their own divorce matter.

On the website, visitors will also have access to articles about divorces. For many, how to help their children during a divorce is a difficult thing, but with the information provided on this site, the situation will become much easier.

According to D'Orsi, "Divorce is a traumatic thing for everyone involved. By provided my clients with accurate information, they can lessen the stress they are dealing with. Being that divorce is especially hard on children, it is crucial that people have the means to make things easier on their children."

D'Orsi adds, "I created this website so people would have a place to go to get the information they need on how to get a divorce in New Jersey. Without the information, they may not get a fair share of what they accumulated during their marriage, including the rights to see or have a say in their children?s lives."

For more information on the divorce in New Jersey and the services of Laura D'Orsi, visit www.lauradorsilaw.com.

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In an attempt to give dealers clarity on these recent developments, First Class Educators today announced a very important addition to the 2012 Digital Marketing Strategies Conference (DMSC) agenda in Las Vegas.   Brian Pasch, CEO of PCG Digital Marketing will moderate a panel discussion with special guests Tim Jackson, President/CEO of the Colorado Automobile Dealers Association (CADA) and Bill Walters, partner at Heizer Paul Grueskin LLP in Denver, Colorado.  The subject of the panel discussion is Dealer Compliance Issues and Internet Marketing.

The panel discussion is scheduled for Thursday morning, February 2nd at 9:30 am and will be held at the morning general session with hundreds of automotive professionals in attendance.  

About Tim Jackson
Tim Jackson serves as President/CEO of the Colorado Auto Dealers Association, the trade association for 260 state new car and truck dealers.  As the chief staff officer of CADA, Tim advocates for issues of importance to franchise auto dealers, business and employment issues and fights for entrepreneurial freedom in the legislative process. 
CADA provides training and education, legislative and regulatory advocacy, member services and legal compliance support for Colorado's auto dealer community.   Tim also oversees the operation of the annual Denver Auto Show, Colorado's largest consumer show.  For the prior seven years, Tim served as the Colorado state director for the National Federation of Independent Business (NFIB), small business advocacy organization, with had over 12,000 members in Colorado and 600,000 nationally. 

About Bill Walters
Bill Walters is a partner with the law firm of Heizer Paul Grueskin LLP in Denver, Colorado. Bill specializes in representing businesses and organizations including professional and trade associations.   Since 1981, his practice has included representation of automobile dealers as well as other business entities and a number of nonprofit organizations including the Colorado Automobile Dealers Association.   He has lectured at numerous CADA educational programs for dealers; participated in drafting and revising legislation impacting the automobile industry in Colorado; represented numerous individual dealerships; and contributed to the NADA publication concerning the licensure of salespersons in Colorado.  Bill is also a member of the National Association of Dealer Counsel.

Bill is a graduate of Emory University and the Columbia University School of Law and is a Past- President of the Colorado Bar Association and the Denver Bar Association. 

For the full agenda of the 2012 Digital marketing, please visit
http://www.digitalmarketingstrategies.org/agenda/

About First Class Educators
First Class Educators (FCE) is a new company created by PCG Digital Marketing, a full service automotive digital marketing agency.  FCE offers high impact digital marketing education, private or partnered events and a variety of consulting opportunities for all industries throughout the US and Canada. 
Featured national events include the Digital Marketing Strategies Conference, Automotive Marketing Boot Camp and PCG Pit Stop.

FCE also offers the Automotive Internet Program, an intense online training program that provides certificates in Digital Marketing and Social Media for dealership employees across the US and Canada as well as private partnered events with top vendors and industry leaders.

http://www.firstclasseducators.com/
 

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The complaint recites that instead of making these necessary software updates available to all customers that have purchased its operating system and application software licenses, as does Apple, Hewlett-Packard, Microsoft and many others, Cisco makes these software updates only available to those customers that have purchased its SMARTnet service.

The complaint further alleges that Cisco also engages in a series of illegal exclusionary and anti-competitive acts such as (but not limited to);

• Cisco coercing its 52,000 reseller partners to refuse-to-deal with Multiven and not resell better quality and/or lower cost services from Multiven – an Independent Service Organization ('ISO') – that competes with Cisco SMARTnet,
• Cisco voiding the software licenses of customers that install their valid Cisco software on genuine Cisco equipment procured from Cisco-independent sources.

• Competition in the market for service and maintenance of Cisco networking equipment has been suppressed and virtually eliminated. Additionally, ISOs have been effectively precluded from competing for and earning profits on the servicing of Cisco networking equipment.
• Customers have been deprived choice and forced to purchase Cisco SMARTnet maintenance services over that of substantially better quality and/or lower priced maintenance services from ISOs like Multiven; and
• Consumers have been harmed because supracompetitive prices have been maintained and increased, and the quantity, quality and choice of service offerings in the marketplace has been reduced and constrained.

Multiven is represented by Schellenberg Wittmer - led by Dr. Jürg Borer and Dr. Juhani Kostka.



About Multiven

Headquartered in Zurich, Switzerland, Multiven is the leading provider of affordable maintenance services for all Internet networks. Through its advocacy group, Multiven is leading a global industry-wide effort to open up the multi-Billion dollar per annum Internet network maintenance services marketplace to free and fair competition which will lead to lower operational and capital expenditure for network operators and a reduced Internet voice, video, TV and data costs for consumers. For more information about Multiven, please visit www.multiven.com. 



Multiven is a registered trademark of Multiven, Inc. and Multiven GmbH. All other company and product names may be trademarks of the respective companies with which they are associated.

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Linked here are key documents related to this lawsuit and the FDA's spying program.

The complaint details how the FDA targeted its employees with a covert spying campaign that lasted for two years. The FDA began the program after learning that the employees wrote a letter to President-Elect Obama and his transition team in early 2009 detailing government misconduct in approving unsafe medical devices.  The Agency installed (or activated) spyware on their workplace computers and used other technology that to monitor their password-protected Gmail-to-Gmail communications.

In addition to reading the whistleblowers' emails, the FDA took contemporaneous screen shots of the employees' computer screens. Managers used the collected information to learn the identities of confidential whistleblowers and to obtain the details of the public health and safety concerns the whistleblowers intended to disclose to the Office of Special Counsel, Congress and the Agency's own Inspector General.

The FDA also intercepted email communications to and from staff members of the House Committee on Energy and Commerce and the Ranking Member of the Senate Finance Committee.  These Congressional intercepts are linked here.

The FDA's prolonged covert monitoring of the whistleblowers continued even after the HHS Office of Inspector General denied the FDA's request to take any criminal and/or administrative action against the whistleblowers. In their letter of refusal, the OIG explicitly informed the FDA that the whistleblowers' communications to Congress were protected under law.

The managers who spearheaded the surveillance efforts were the same managers involved with the wrongdoing and corruption that the whistleblowers were seeking to report. Lawyers at the FDA and HHS Offices of General Counsel, who should have understood that the program breached the employees' confidentiality, helped FDA managers with their obstruction and retaliation.

In their lawsuit, six FDA whistleblowers who were fired by the agency (including two highly respected medical doctors, a Branch Chief, a former Health and Safety Officer employed by the Public Health Service and a 23-year FDA career M.D./Ph.D Scientist) are requesting a nationwide injunction prohibiting the federal government from targeting whistleblowers with selected surveillance and monitoring.

The lawsuit alleges that such targeted monitoring of whistleblowers violates their First Amendment rights of freedom of speech and association.

Stephen M. Kohn, NWC Executive Director and attorney for six FDA whistleblowers, issued the following statement:

The FDA declared war on employees who were trying to warn Americans about threats to public health and safety.The federal government cannot---and should not---spy on whistleblowers. The First Amendment prohibits targeting whistleblowers and selectively monitoring them using highly intrusive electronic surveillance without a warrant.

Targeting the employees who raise health and safety concerns---or who try to report waste, fraud and abuse to the proper authorities---will have a massive chilling effect on employees.

The FDA's illegal spying program is not just a problem for the six victims in this case. The day we allow the government to spy on employees based on their lawful whistleblower activities is the day we give up privacy for every honest public servant in America.

If permitted to stand, the FDA's whistleblower surveillance program will be used by government agencies throughout the United States to silence employees who want to report misconduct.  Those who are not silenced will be subjected to years of intrusive covert spying designed to dredge up embarrassing information that the agencies can use to destroy the whistleblowers' reputations and careers.

Today, the NWC issued an Action Alert seeking public support for the FDA whistleblowers and demanding an end to the federal government's targeted and selective surveillance of whistleblowers.
The NWC obtained the intercepted emails as a result of a lawsuit filed under the Freedom of Information Act and from documents produced by the FDA as a result of administrative actions taken against three of the whistleblowers.

Links:  FDA Whistleblower Complaint
Intercepted Emails from FDA Whistleblowers
Letter from the HHS OIG
Support FDA Whistleblowers
PageNWC Action Alert

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RJW Chief Executive Officer Neil Kinsella said the announcement would bring security and growth.

He added: "We will continue to deliver first class legal services, but as a result of today's announcement, we will have the resources and backing to develop and grow. We want to become the largest and most trusted provider of personal legal services in the UK.

"Our commitment to making justice and legal services accessible and affordable to all remains, but our ability to do this increases as a result; this development will bring real benefits to our clients and affiliated organisations."

Slater & Gordon Managing Director Andrew Grech said that, while the UK had a similar legal jurisdiction to Australia, it had spent three years searching for the right opportunity in the UK.  He commented on how RJW shares the same values as Slater & Gordon, which will help them achieve their joint aspiration of being the first choice for personal legal services in the UK.

Kinsella said becoming part of Slater & Gordon will put RJW ahead of the competition and provide a wider pool of talent and knowledge.

He explained: "In Slater & Gordon we have found the perfect partner; a firm with a similar history and ethos to RJW. We are also joining a firm focussed on innovation and one which is ahead of the pack in terms of its corporate and business structure. Slater & Gordon publicly listed five years ago, which gives us a five-year head start on any UK firm considering this option.

The two law firms have jointly identified the opportunities that may come as a result of the changes in the UK market and have already benefited from sharing their knowledge. By joining forces, they can share technology and have greater resources to retain and attract additional talented people.

The RJW principals and senior management are highly committed to the long term strategy of the group and will remain in place for at least three years.  All of the equity owners of RJW have taken a substantial proportion of the consideration as shares in the ASX listed Slater & Gordon demonstrating their confidence in and commitment to the group.

Subject to regulatory approval, the acquisition of Russell Jones & Walker should be completed by April 2012.  

About Russell Jones & Walker:
With over 85 years of experience, Russell Jones and Walker Solicitors are considered one of the UK's leading law firms with over 420 employees in 10 offices nationwide. Its focus has always been to provide accessible, affordable legal services for individuals. Neil Kinsella is one of the country's leading commentators on the changing face of the legal profession and aims to ensure that the firm remains at the forefront of it, irrespective of the likely new competition.

PR Contact:
Andy Hoe
Marketing Director
Russell Jones and Walker
50-52 Chancery Lane
London
WC2A 1HL
020 7657 1681
www.rjw.co.uk

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"The greatest bike show on earth" will feature the hottest new bikes of 2012, and promises massive savings on all sorts of bike kit and accessories.

But one of the hottest tickets in town will be the dinky SMIDSY cards which the Sorrymate.com people will be handing out, explaining how bikers can take advantage of free legal expenses cover in the event of them having to make an insurance claim for an accident which wasn't their fault.

All keen bikers themselves, the people from Sorrymate.com make up a team of specialist solicitors who every year advise many motorcyclists who have been involved in a non-fault accident.

Paul Dutton from Sorrymate.com explained that the firm has a stand at all the major bike shows across the UK, and over the past year has handed out thousands of SMIDSY – an acronym for "Sorry mate, I didn't see you" – cards detailing the services he and his colleagues offer.

This includes understanding and professional handling of all motorbike accident compensation claims, when a rider has been involved in an accident which isn't their fault.

"We love the excitement of the big shows such as Motorcycle News Live, but we also realise that, away from all the high-revving action, when bikers are out on the road, they encounter risks on the road, day in, day out," said Paul.

"We want them to know that, if they ever need to make a motorcycle accident claim, we offer them free advice to make the process as smooth and hassle-free as possible.

"As bikers ourselves, we get just as much excitement from being at these shows as they do," he added. "But on their way home, or just while they're riding around, they could be the victim of an accident which isn't their fault.

"Besides the physical injuries they might have to deal with, we want to show them that they don't have to worry about getting advice and recompense for the damage to their bikes and any loss of income that might result.

"All they need to do is enlist our help, and we'll make sure they know what help they're entitled to – including the right to appoint a solicitor of their choice to handle their case."
Sorrymate.com's 'smidsy' card holders know that, if they need to make a claim, their case won't be sold on to just any other company, but will be handled by experts.
So grab a bit of this little peace of mind by visiting the Sorrymate.com team on stand N320 at the Motorcycle Live show, taking place from 10am to 5pm on Thursday and Friday, February 2 and 3, and between 9am and 6pm on Saturday and Sunday, February 4 and 5.
 
About sorrymate.com:
Sorrymate.com deals with all manner of motorcycle accident claims, road traffic accident claims and smidsy claims. If a motorbike accident wasn't your fault, the company will try to ensure you receive 100 per cent compensation without paying a penny. The people behind the company are bikers too, so they understand such situations.
 
 
For further information contact Paul Dutton:
Email: marketing@sorrymate.com            Website: http://www.sorrymate.com/
Phone: 0800 6 300 301

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Davos-Klosters, Switzerland – Despite the uncertainty sweeping across the European Union, British Prime Minister David Cameron was bullish about the prospects for resolving the current Eurozone crisis. 'Europe could recover its dynamism. I still believe we can. But only if we are bold. Only if we fight for our prosperity ... [and if we] get to grips with the debt,' he said.

The Prime Minister called for bold decisions on deregulation, on opening up the Single Market, on innovation and trade, and to address the 'fundamental issues' at the heart of the Eurozone crisis. 'All of these decisions lie in our own hands. They are the test of Europe's leaders in the months ahead. ... The problems we face are man-made and with bold action and real political will we can fix them,' the Prime Minister urged.

Short-term issues must be dealt with. 'Greece, banks and the firewall. If you do all those three things together quickly, you would ease the sense of the crisis. For 2012, that would make a clear difference,' he advised. Cameron's remarks came on the heels of pressure from the International Monetary Fund on Monday 23 January to 'bolster the firewall' around Italy and Spain as talks between Greece and its creditors have been mired in deadlock for a third week.

Cameron outlined the features common to all successful currency unions:

- A central bank that can comprehensively stand behind the currency and the financial system
- The deepest possible economic integration with the flexibility to deal with economic shocks
- A system of fiscal transfers and collective debt issuance that can deal with the tensions and imbalances between different countries and regions within the union.

'Currently it's not that the Eurozone doesn't have all of these…it's that it doesn't really have any of these,' he declared.

The Eurozone crisis calls for 'tough fiscal discipline', but the Prime Minister pointed out that this is a problem of trade deficits, not just budget deficits. 'It means countries with those deficits making painful decisions to raise productivity and drive down costs year after year to regain their competitiveness,' he said. 'That does not happen overnight and it can have painful economic and even political consequences. Nor is it sufficient. You need the support of single currency partners and ... a system of fiscal integration and risk sharing, perhaps through the creation of Euro area bonds to make that support work.'

Despite Britain's refusal last December to sign an EU treaty that would change the way the single market is regulated, Cameron said Britain is not walking away from Europe. 'Britain is part of the European Union. Not by default, but by choice. It fundamentally reflects our national interest to be part of the single market on our doorstep and we have no intention of walking away from it. We want Europe to be a success. … When that political will is there, we can make a decisive difference.'

The Co-Chairs of the World Economic Forum Annual Meeting 2012 are: Yasuchika Hasegawa, President and Chief Executive Officer, Takeda Pharmaceutical, Japan; Vikram Pandit, Chief Executive Officer, Citi, USA; Paul Polman, Chief Executive Officer, Unilever, United Kingdom; Alejandro Ramirez, Chief Executive Officer, Cinepolis, Mexico; Sheryl Sandberg, Chief Operating Officer, Facebook, USA; and Peter Voser, Chief Executive Officer, Royal Dutch Shell, Netherlands.

Notes to Editors

Find more information about the Annual Meeting 2012 at http://wef.ch/Davos
View the best photographs from the Annual Meeting on Flickr at http://wef.ch/pix
Watch live webcasts of the sessions on Livestream at http://wef.ch/live
Watch the sessions on YouTube at http://wef.ch/youtube or Youku at http://wef.ch/youku
Ask a World Leader on YouTube: http://wef.ch/askaleader
Become a fan of the Forum on Facebook at http://wef.ch/facebook
Follow the Forum on Twitter at http://wef.ch/twitter and http://wef.ch/livetweet
Listen to the Forum Podcast at http://wef.ch/podcast
Read the Forum Blog at http://wef.ch/blog
Read Forum reports on Scribd at http://wef.ch/scribd
Follow the Meeting on the iPhone at http://wef.ch/app
Upcoming Forum events at http://wef.ch/events
Subscribe to Forum News Releases at http://wef.ch/news
Connect with the Forum at http://wef.ch/connect

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Most business owners don't realize how important the LLC Operating Agreement is when forming an LLC.  Lee is an attorney and counselor to the US Supreme Court who has 'seen it all' and knows how quickly the corporate veil can be pierced if an LLC is not structured properly and guidelines not met.  He says that most LLCs are set up through legal professionals which is good, however, in most cases, no time is spent with the business owners in teaching them how to customize the LLC Operating Agreement for their business.

Without a customized operating agreement, the LLC is worthless and the business has no protection.  'It's sad that more business owners don't realize this until it's too late,' Lee says.   'That's why I've decided to do something about it.'  The best way to protect yourself and your business is to understand the rules and the guidelines you have to follow to maintain the LLC.  It all starts with the LLC Operating Agreement. 

Lee Phillips has spent his career educating individuals and business owners about the proper way to protect one's assets.  He has written a book called Guaranteed Millionaire which focuses on and teaches how to use the law to protect one's assets.  To learn more about the guidelines to forming an LLC or to get your own LLC operating agreement template to either use for your LLC or compare against the one you have visit http://www.llcwizard.com.

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According to the latest data from AutoInsuranceMonitor.com, the Green Mountain State has an average car insurance premium of $995, while the national average according to the insurance website was $1,561. Vermont's small population and long winters combine to result in less driving on its road leading to lower costs.

In contrast, the state of Michigan ranked last on the list with an average premium of $2,541 with the large disparity attributed to its poor roads and a non-existent car inspection law, coupled with another Michigan law mandating personal injury protection payments for several years and coverage for lost wages.

The site compiled the latest ranking of the United States, including Washington D.C., by collecting average rates per policy from six best auto insurance companies on over 2,400 cars and spread throughout 10 zip codes for each state. The large population states that made the list keep rates low by encouraging a competitive marketplace such as in Ohio and South Carolina, while North Carolina keeps rates low by capping premiums.

But drivers across the United States can keep rates low with these tips:

• Credit Scores – Maintaining good credit scores help keep auto insurance premiums low.
• Ask For Discounts - Drivers should ask their auto insurance companies if they qualify for discounts when they join a community organization, enrolled in college, over even if they recently retired. They won't know if they don't ask.
• Combine Policies – Drivers save money when they combine home and auto insurance policies with one insurance company instead of spread around several companies.
• Sedate Beats Sporty – When car shopping, drivers should look for cars with safety features such as side impact airbags or automatic seat belts. Also, insurance on sedate sedans is less than sports cars always.
• Drive Slower – Speeding tickets add to the cost of premiums so drivers should slow down to save money.
• Drop Collision – Drivers with an old car should drop collision coverage which will only cover them for the Blue Book value of their vehicle in the event their car needs to replaced after an accident.

1. Vermont    $995
2. S. Carolina    $1,095
3. Maine    $1,126
4. Wisconsin    $1,128
5. Tennessee    $1,146
6. Ohio    $1,152
7. N. Carolina    $1,154
8. Iowa    $1,179
9. Virginia    $1,237
10. Utah    $1,271

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The NWC has called upon its grassroots network to oppose the bill, calling it an act of war on whistleblowers. The NWC objects to the following measures of the bill, which systematically dismantle the current, effective whistleblower process from beginning to end:

• Gag orders legalized -- The bill permits companies to enforce, "any established employment agreements, workplace policies, or codes of conduct," regardless of the impact on the right of an employee to report corporate crimes. This means that companies can force employees to sign agreements forfeiting their whistleblower rights.
• Retaliation legalized -- "Any adverse action taken against a whistleblower for any violation of such agreements, policies, or codes shall not constitute retaliation" (emphasis added).
• Law enforcement crippled -- The Grimm Act requires the SEC to, "promptly notify any entity that is to be subject to [an investigation]" before beginning an investigation. Tipping off companies suspected of violating the law allows the corporations to intimidate witnesses and tamper with evidence before the investigation begins.
• Anonymity destroyed -- The Grimm Act allows, and in most cases requires, the SEC to, "disclose to the employer's audit committee such information provided by the whistleblower." This means that the SEC would not only be unable to guarantee confidentiality, but it would be required to turn whistleblowers over to the very corporations accused of wrongdoing.
• Accountability minimized -- The Dodd-Frank Act provides incentives for companies to self-report violations, including reduced fines and penalties. The Grimm Act creates a gaping loophole, allowing companies to claim they self-reported even when a whistleblower makes a report to the SEC. This applies even if the company initially covered up problems and retaliated against the whistleblower.
• Whistleblowers disqualified -- The Dodd-Frank Act reasonably excludes persons found guilty of fraud from obtaining the benefits of the new SEC whistleblower program. However, the Grimm Act disqualifies employees who in any way "participated in" the violation. This means that low- and mid-level employees¬, such as a secretary who took a phone call or a clerk who made a photocopy, are excluded from the whistleblower program. This subtle-but-deliberate language would cut out the vast majority of whistleblowers from protection, as almost every whistleblower "participates" in the violations they uncover.
• Awards program broken -- The Grimm Act makes whistleblower awards discretionary, returning the SEC whistleblower program to its pre-Dodd Frank Act status. The old program was completely discredited by a 2010 report by the SEC Inspector General. This document reported that the SEC helped only five people and awarded only $159,537 during 20 years of operating a discretionary program. The report lamented that the discretionary program was, "not fundamentally well-designed to be successful," and made recommendations that were implemented by the Dodd-Frank Act. The Grimm Act turns back the clock.

Stephen M. Kohn, Executive Director of the National Whistleblowers Center, issued the following statement about the Grimm Act:
The Grimm Act is a license to steal. It undermines every major whistleblower protection achieved for corporate employees in the past 20 years. Employees witness fraud every single day, and they are going to stay silent if this bill is passed. It stacks the deck in favor of those who are accused of waste, fraud, and abuse, and it removes the only incentive David has to fight Goliath. This is a green light for corporate fraud. It must be stopped.
Today on Honesty Without Fear, Stephen Kohn will discuss the Grimm Act with Eugene Ross, a financial analyst who exposed millions of dollars in corporate fraud committed by Bear Stearns under the SEC's pre-Dodd Frank whistleblower program. Tune in today at 1pm ET or download the episode at whistleblowersradio.org.

Links:

Grimm Act (H.R. 2483)
2010 SEC Inspector General Report
Honesty Without Fear
Dodd-Frank Rulemaking webpage

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For the past year, proponents of the European Union's medical device approval process - which allows complex devices to reach consumers in European markets an average of two years sooner than in the U.S. - have been calling for the FDA to adopt a similar process, according to the article. Medical device industry supporters argue that the EU is luring device manufacturers away from the U.S., and contributing to high unemployment rates.

The breast implant debacle in Europe, which involves the removal of thousands of potentially faulty implants manufactured by the now-defunct French company Poly Implants Protheses SA, has brought negative attention to the EU's medical device approval process, however. The European breast implant problem therefore should make U.S. regulators realize that it would be unwise to adopt a medical device approval process similar to the one in Europe, according to Carl Heneghan, an Oxford University teacher who has studied device recalls and is quoted in the Bloomberg article.

'All industry guys in the U.S. say, 'we should have access to these products much sooner, like in Europe,'' the Bloomberg article quotes Heneghan as saying. 'The flip side is, the European people are being used as guinea pigs.'

The importance of subjecting medical devices to comprehensive FDA reviews before they are approved for sale has been highlighted in recent months by the thousands of women in the U.S. who have suffered injuries as a result of vaginal mesh implants. The implants were granted FDA approval based on their similarity to devices already on the market, without the benefit of human testing. The implants have so far spawned more than 650 lawsuits filed by patients alleging that they have been significantly injured as a result of having surgical mesh products implanted transvaginally.

Anyone seeking more information about vaginal mesh can visit the Rottenstein Law Group's Vaginal Mesh Lawsuit Information Center. The site has vital information about the dangers of this medical device, along with easy-to-use social media features that allow for easy sharing on sites like Facebook and Twitter. Visitors are also encouraged to link to their own Web sites and blogs in order to spread the word about defective medical products and dangerous drugs.

About the Rottenstein Law Group
The Rottenstein Law Group is a New York-based law firm that represents clients in mass tort actions. The firm was founded by Rochelle Rottenstein, a lawyer with over two decades of experience in compassionate representation of clients in consumer product injury, mass tort, and class action law suits. For more information, please visit their Web site, or call (888) 9-ROT-LAW.

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