New playoff system means additional money for college football

The newly approved playoff format for college football teams will bring in huge dollar amounts, including over a half-billion dollars per year in television rights alone. The question still remains as to whether or not to compensate college football players. The current Bowl Championship Series in contract with ESPN, and the Rose Bowl’s separate contractual agreement with ABC, together pay the major college football schools around $155 million per year. This money is distributed unevenly with the bigger conferences getting more money for their members; conferences like Big Ten and the Big 12 for example.

Some college football coaches including Texas coach Mack Brown, question whether some of the extra money produced by the new playoff system should be given to the players. After the new semifinal format was approved, Brown tweeted his opinion that “with the amount of money the playoff will generate, I hope we can revisit the student-athlete stipend.” Brown believes that the players are the ones who make the event possible.

Furthermore, the fight over raising student compensation already has begun. While NCAA President Mark Emmert strongly urges against paying football players as if they were professionals, on the other hand, South Carolina’s coach Steve Spurrier has been attempting to do just that for the past two years.

Last year, legislation was approved that would have permitted schools to offer a $2,000 stipend, in addition to a players scholarship. This stipend would have gone towards what the NCAA calls the full cost-of-attendance. However, this idea was put off to the side when over 100 schools asked for an override vote. The schools criticizing the new stipend were concerned with two major issues. First, they were concerned with whether all schools would be able to afford the new stipend, especially in the poor economic conditions. And second, concern was raised as to whether the schools which could afford to pay the extra $2,000 as a stipend would gain an advantage in recruiting.

Despite these concerns, Emmert continues to support the legislation and wants it passed. Additionally, Emmert is in favor of the approval of a new postseason format to take place of the current BCS. “I commend the BCS Presidential Oversight Committee on its leadership to move to a playoff model,” he said. “I remain confident that as the details of the new format are determined in the coming weeks, presidents will continue to keep student-athlete well-being, both in the classroom and on the field, front of mind.”

Concerned with whether schools will be permitted to continue to offer the set number of scholarships to incoming football players, Arizona coach Rich Rodriquez believes that it would be crazy to cut back on scholarships at this point. Teams are being asked to play as many as many as 15 games in a season currently and the therefore Rodriquez thinks that there is no way that universities can be asked to reduce the 85-schloarship limit currently in place. “Any talk about that going forward has to cease,” he said. “You’re going to need more players to get through a season healthy.”

One coach that sees the extra funds in a positive light is Washington State’s coach Mike Leach. Leach has no problem awarding players with larger scholarships and believes that the additional money could go towards doing so. As a result, Leach believes that this would in turn allow for additional opportunities for boys to attend a college university. “Give everybody five more scholarships, five more opportunities for guys to go to school,” he said.

On the other hand, Texas Tech athletic director Kirby Hocutt believes it is too soon to be concern with what to do with the extra money.“I think there’s still a lot of work to be vetting out, and how the revenue is going to be distributed is the first step in that,” he said. “We haven’t gotten that far along in the process but I expect over the course of the next academic year we will do that in meetings.”

Safety and health are two of the most popular reasons that people believe the extra money that will be generated from the new system should be spent on the players. Some former and current athletes have even been attempting to have some of the new funds to be spent on player safety and health.

Safety is the priority of the National College Players Association. This group is an advocacy group comprised of over 17,000 current and former Division I student-athletes. They do not believe that actually compensating the players by paying them with the extra funds is as important as spending the money on keeping the players safe. Former UCLA football player Ramogi Huma and president of the National College Players Association believes that the universities should not be permitted to add extra games to a team’s season without adding extra safety protections to decrease head trauma risks that go along with contact sports.

http://sportsillustrated.cnn.com/2012/football/ncaa/06/27/college-football-playoff-paying-players.ap/index.html

NCAA: From Hypocrisy To Revulsion To Outrage

In the last couple of weeks, we have seen a number of things that should take any college sports fan from hypocrisy to revulsion to outrage.

We learned from USA Today that Mark Emmert is making 40% more than his predecessor, Miles Brand.  Good for Mark. We all love America, apple pie, the flag, and of course, our beloved college sports teams.  We also learned that the NCAA national championship game will be auctioned off to the highest bidding city, which, of course, will generate an estimated additional $155 million in revenue. Finally, we have seen the new EA Sports commercials that allow you to place former Heisman trophy winners on any team in the new game.  Even more money for the NCAA.  You think EA is paying those Heisman trophy winners?  You think they would pay current players or set the money in trust for those players if the NCAA would let them?  You bet they would!

It is a given that the NCAA is synonymous with the term hypocrisy.  It is repulsive that Emmert gets to play king and live large on the backs of college athletes that can't get royalties from the use of their images sold off to the highest bidders by Emmert and his buddies behind the farce called "student athlete", a term of art manufactured by the NCAA.  I wonder if Mr. Bigshot Emmert would have the same opinion if he traded places with Tyrone Prothro for a day, but that is a discussion that has taken place for years.

No, today it is about OUTRAGE, NCAA style.

Ok, here is how it goes.  There is a guy at Penn State.  Got two last names--Graham Spanier.  He likes being a big shot.  He likes to play the Penn State card.  You know the one---we are different.  We do things the right way.  We are not like the SEC.  Same stuff we have been hearing for 150 years.

He is the ultimate NCAA  hall monitor.  He chaired the Board of Directors of the NCAA, chaired the BCS oversight committee and was on the high-level NCAA management council.  He is that nameless, faceless  bureaucrat that we despise and who writes the rules while flying on a private jet somewhere unaware of what is happening on the ground below. As Dan Wetzel of Yahoo Sports describes him, he is the model of self-interest, distorted ethics and misplaced authority.

He railed against reforms that were designed to assist athletes.  His most recent push was for stricter admissions standards that coaching and advocacy groups say will hurt kids from poor performing high schools.

He hammered Curtis Ennis, running back for Penn State.  He declared him ineligible, banned him from Penn State and was publicly shamed by Mr. Two Last Names.  For what?  A new suit he got from an agent.   "He fooled around with the integrity of the university" and "I won't stand for that" Spanier was quoted at the time.  Want us to apply that same standard to you after what has come to light, Mr. Two Last Names?

Don't get me wrong, I am not condoning what Ennis did, but lets compare it to Mr. Two Last Names, who was running a Ted Haggard illusion!

In December of 1997, Spanier learned that Sandusky had been accused of molesting a young boy while showering with him in the Penn State locker room.  Spanier didn't report it because that would not be the "humane" thing to do!  He covered it up.  He wanted to protect his name, the Penn State name, and his Marie Antoinette lifestyle.  We know how it ended for her.  I bet there are some mothers in Happy Valley who think it would end that way for you, Mr. Two Last Names!

Stryker Offers $33 Million to U.S. Department of Justice for Fraudulent Marketing of Knee Systems and Pain Pump Devices

Stryker Corp, headquartered in Kalamazoo, MI, offered the United States Department of Justice $33 million in May 2012 to resolve 2010 allegations regarding a knee device. The company recognizes that this offer is preliminary and it is indefinite as to whether a "resolution will be reached".

A filing signed by interim CEO Chris Hartman stated, "We recently entered into discussion with the DOJ regarding the potential settlement of this matter, and on May 31, 2012, we offered $33 million to the DOJ." The company claimed that the $33 million represented "our best estimate of the minimum of the range of probable loss to resolve this matter."

In 2010 Stryker received  two subpoenas from the U.S. Department of Justice regarding the marketing of its OtisKnee and PainPump devices. These subpoenas, filed with the Securities and Exchange Commission, regarded regulatory matters related to the sales and marketing of the devices that had not been cleared by the U.S. Food and Drug Administration.

OtisMed, a software technology firm, was acquired by Stryker Corp in 2009 for $103 million. As a subsidiary of Stryker Corp, OtisMed focuses on customizable instrumentation that has the potential to complement the many benefits that surgeons and patients realize from Stryker's Triathlon Knee System, as well as other Stryker implants. Simply, the OtisKnee provided surgeons with software that facilitated a 'custom cut' on a patients knee which sought to produce higher success rates of a Total Knee Arthroplasty. This custom cut allowed surgeons to custom fit Stryker total knee devices onto patients knees.  

Smith and Nephew Withdraws Metal Hip Liner

Business Week reports that London based medical device company Smith & Nephew PLC is withdrawing a metal liner used in its R3 Acetabular Metal-on-Metal hip replacement system. The company stated that it pulled the device because it was "not satisfied with the clinical results" of the liner, and some patients needed an additional surgery to have the liner removed. The company reports that this device is an optional metal liner for its R3 Acetabular System hip device and current patients needing surgery will use a different plastic liner. Smith & Nephew claims that the pulling of this device is a precautionary move. These metal liners were developed with the hope of producing longer lasting results than the traditional plastic liner, but unfortunately, did not live up to expected standards.

The primary reason for recall is that the device produced a higher than desired level of patient problems or a higher than expected failure rate. Patients using this Smith & Nephew metal liner experience problems including infections, fractures and dislocations. There have been no reported instances of this particular device causing  "metallosis" or the build up of other metallic debris in the body, as reported in problems with other Metal-on-Metal hip implants. This liner was introduced in 2009 and 7,700 of the devices have been implanted in patients.

This is not the first time metal-on-metal hip implants have been subject to scrutiny. Metal-on-Metal hip implants generally have been linked to high rates of revision surgery and systemic complications, apparently because of component erosion and leaching of metal ions both locally and into blood circulation. In 2010, DePuy Companies issued a recall of its ASR metal-on-metal hip due to early failure rates. Problems surrounding the ASR device include increased blood levels of chromium and cobalt ions and possible necrosis, intense hip, thigh, and groin pain, a loss in overall mobility, and component misalignment and loosening.

Related articles

• Failure Rates High in All-Metal Hip Implants, Not Just DePuy (earlsview.com)
• Smith & Nephew pulls metal-on-metal hip component - Reuters (drugstoresource.wordpress.com)

Depuy ASR: How many injured people are still out there?

  It is estimated that 30,000-40,000 people had Depuy ASR hip cups installed in the United States between 2003-2010.  To date, there have been roughly 3500-4000 claims filed.  As the two year anniversary of the recall quickly approaches, the court managing the litigation is preparing for a waive of filings.  However, even if the filings double in the next couple of months, many individuals could be unaware that their statute of limitations may be set to expire?

Just because you have a claim number with Broadspire does not mean that you claim has been preserved.  If you claim is not filed within the requisite statute of limitations, you could be precluded from filing a claim.

http://www.prweb.com/releases/2012/5/prweb9547537.htm
http://www.prweb.com/releases/2012/5/prweb9548533.htm
http://www.prweb.com/releases/2012/5/prweb9547683.htm

Consumers Union: Patients at Risk with Dangerous Medical Device Loophole

Consumer Reports (Photo credit: Wikipedia)

As the Senate prepares to vote on a bill this week reauthorizing the statute governing medical device oversight, Consumers Union has placed a full-page print ad in Politico today to help make patients aware of problems arising in the dangerous medical device loophole which may put them at risk. The new law would back the present system and ratify an agreement between the FDA and the medical device industry which would get devices on the market at an even quicker rate.

Consumers Union is urging lawmakers to provide the FDA with the authority it believes to be necessary to protect patients. In its ad, Consumers Union calls attention to the fact that under the current law, the FDA does not have the authority to require device makers to demonstrate they have corrected any design flaws when they desire to sell a new device based on a device that has already been recalled by manufacturers for safety issues. Consumers Union along with the FDA and the public, according to a recent poll, advocate that makers of medical devices should be required prove that the safety flaws which were the central basis of previous devices being recalled, have been corrected in the new device.

Lisa McGiffert, director of Consumers Union's Safe Patient Project refers to requiring this of manufactures of medical devices as "common sense reform." McGiffert believes that it is the "politically powerful medical device lobby has blocked this common sense reform," and that it is time to "close this absurd loophole" by authorizing the FDA with the power necessary to protect patients. She asserts that the makers of such medical devices "should have no objection to proving they have fixed safety flaws in order to sell products based on ones that are dangerous to patients."

McGiffert stresses that "medical device makers have misled Congress that this reform isn't necessary, but the evidence is clear that the FDA doesn't have the power it needs to protect patients. It's time to use some common sense and close this indefensible loophole in the law."

Although the medical device industry argues to Congress that the FDA has the necessary authority to address this issue, Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, disputes this argument. While he does admit that "the program has served American patients well," and that "it's a challenge to eliminate a program without having a better alternative," he has expressed in media that the agency does not in fact possess the necessary power to fix this problem and properly safeguard patients. Likewise, he has stated that this loophole allows device makers to repeat safety flaws in new devices being cleared based on their similarity to previous devices recalled by manufacturers.

According to McGiffert, the investigation of the Safe Patient Project has illustrated that several implanted medical devices are never clinically tested on humans before being put on the market. However, tens of millions of Americans have undergone surgery and now live with medical device implants. Do these patients assume that such devices have been tested for safety and effectiveness on someone, somewhere? Consumer Reports believes that it is a safe bet to assume so.

Consumers Union's Safe Patient Project has determined that the FDA clears medical devices through its fast track 510(k) process. This process is based on whether devices are "substantially equivalent" to devices previously placed on the market. Therefore, over 90% of these medical devices do not require clinical testing before the FDA clears them for sale.

For most medical device implants, manufacturers only have to file paperwork and submit a user fee of around $4,000 paid to the FDA in order to begin marketing a product. As a result, the safety "testing" that occurs is generally in the bodies of unsuspecting patients

Furthermore, the current law requires the FDA to clear a medical device for sale, despite the new device being centered around a similar device previously recalled due to safety issues, even if the agency is aware that it repeats the same design flaws.As a result, it has been express by many that patients could potentially suffer severe consequences from these later cleared medical devices.

One currently well known example of a risk facing patients due to this loophole involves vaginal mesh implants. These implants are used to treat urinary incontinence along with weak pelvic organs in women in order to keep women's internal organs in place after tissue has been weakened by childbirth or age. Two years after the first vaginal mesh implant was introduced by Boston Scientific, after getting clearance by the FDA in 1997, its ProteGen bladder sling recalled. The company issued the recall after several hundred women implanted with the device had claimed serious complications as a result of the surgery.

However, even after the recall, the FDA has been forced to approve several other vaginal mesh products due to their "substantial equivalence" to the recalled ProteGen bladder sling. Subsequently, the FDA has received thousands of complaints from injured women because, as predicted, the problems they have been expeirencing with vaginal mesh implants were not exclusive to the recalled ProteGen sling.

Despite its clearance of vaginal mesh slings after ProteGen was recalled, in 2011 the FDA warned doctors and their patients that in addition to the serious injuries associated with these implants, that such consequences were not uncommon. It provided specific dangers accompanying vaginal mesh implants including mesh erosion through the vagina, bleeding, infections, urinary problems, and organ perforation. As a result of such injuries, many require numerous surgeries to fix the injuries. Additionally, the FDA warned that the complications associated with the implants along with the follow up surgeries to attempt to repair such damages may even leave some patients permanently disabled.

Furthermore, Consumers Union called attention to another issue regarding the risk involved with this loophole. It made it clear that this loophole would permit makers of medical devices to market other versions of hip implants after clearance by the FDA due to the similarities in former models of hip implants which have been recently recalled for issues regarding the safety of the product. Just as it is with the vaginal mesh implants and other medical devices, currently law does not permit the FDA to require manufacturers to establish that their new device has addressed and corrected any safety flaws associated with the previously recalled device.

Not only does Consumers Union generally disagree with the current law, its director of  its Safe Patient Project, Lisa McGiffert, and the director of the FDA's Center for Devices and Radiological Health, Dr. Jeffery Shuren, a recent poll conducted by Consumer Reports illustrates the overwhelming opposition of the public to the practice under the current law. The poll showed 71% of Americans being of the opinion that a newly manufactured device, based on its similarities to a previous device recalled for safety issues, should not be permitted to be cleared by the FDA and therefore marketed.

Consumers Union recommends to the FDA the following to fix this issue:

1. Require that implants and other "life sustaining" devices be tested as least as rigorously as drugs.

2. End the practice of "grandfathering" high-risk new implants and life-sustaining devices.

3. Create a "unique identifier system," or IDs for implants, so that patients can be quickly notified    about recalls and safety prblems.

4. Create national registries so that problems can be spotted quickly and patients notified.

5. Increase the user fees paid by manufacturers for regulatory review so that the FDA has enough money to do its job.

Note: Consumers Union is the policy and advocacy arm of Consumer Reports.

http://www.ocregister.com/news/devices-354854-fda-device.html

http://www.infozine.com/news/stories/op/storiesView/sid/51908/

http://news.consumerreports.org/health/2012/05/loophole-in-medical-device-governing-statute-puts-patients-at-risk.html

http://www.consumerreports.org/cro/magazine/2012/04/cr-investigates-dangerous-medical-devices/index.htm

Older Americans Going Broke as Medical Costs Rise

According to the WSJ, citing analysis by the EBRI, older Americans are running of of money and the poverty rate is rising.

The main reason: Older adults are using up their nest eggs as medical expenses rise, says Sudipto Banerjee, the report’s author.

Almost 15% of Americans who were older than 85 were living in poverty in 2009, and 6% of those in the age group were newly impoverished, the analysis found.

One in 10 Americans who were at least 65 were also living in poverty.

For single women, almost 21% over the age of 65 are living in poverty as of 2009.

The Health and Retirement Study, sponsored by the National Institute of Aging, is considered the most comprehensive national survey of older Americans.

Employer Based Health Insurance Declining Due to High Cost

More bad news for workers.  According to a report by The Employee Benefit Research Institute, between December 2007 and April 2011, the number of individuals with health insurance from 60.3% to 55.8%.  Most uninsured workers reported that the reason they lacked coverage was cost.

Employer-based health insurance are the most common form of heath insurance for working Americans.  Since the 1980s, the percentage of individuals without heath insurance has increased, in large measure due to high premium costs on employers.  The general trend of in the percentage of uninsured workers reporting cost as a reason for not having coverage has increased steadily since 2008.

Between 2003-2007, the percentage of workers who were offered dependent coverage also dropped to 16 percent.

Drug Maker Fined AGAIN for Illegal Marketing Practices

            

            Abbott Laboratories reached a settlement with the Justice Department and several states over illegal marketing practices for its anti-seizure drug Depakote, in which Abbott will pay $1.6 billion in criminal and civil fines. The announcement generated heavy media coverage, including a brief mention on ABC World News.

            ABC World News reported, "Tonight one of the largest drug companies, Abbott Laboratories, has agreed to a staggering settlement. Today $1.6 billion in criminal and civil fines for improperly marketing the anti-seizure drug Depakote in nursing homes. The company convinced the nursing homes to use the drug to treat aggression in dementia patients, despite the lack of credible evidence that the drug was effective for that use."

            The New York Times reports, "The settlement comes as the Justice Department and the states have increased scrutiny of the sales and marketing practices of pharmaceutical companies, particularly in cases in which they market drugs for uses that are not approved by the Food and Drug Administration."

            The Wall Street Journal reports that in addition to the fines, Abbott would plead guilty to a misdemeanor charge of violating a federal drug law.

            The Washington Post notes the settlement "is the second-largest in a string of multimillion-dollar payouts in recent years resulting from stepped-up enforcement by the Justice Department and state investigators against drug makers that 'misbrand' their products. The company will to plead guilty to one misdemeanor violation of the Food, Drug and Cosmetic Act for misbranding. Abbott also agreed to a five-year probationary period in which it must report any probable violations of the law to the probation office."

            The Chicago Tribune reports, "As part of the settlement agreement, North Chicago-based Abbott said it would pay $800 million to resolve civil cases brought by federal and state governments, $700 million in criminal penalties and $100 million to states to resolve consumer protection matters. The company will plead guilty to one misdemeanor violation of the Food, Drug and Cosmetic Act for misbranding. Abbott also agreed to a five-year probationary period in which it must report any probable violations of the law to the probation office."

            The Chicago Sun-Times reports, "The company admitted that it trained a specialized sales force to promote Depakote in treating dementia because the drug was not subject to federal regulations designed to prevent the use of unnecessary medications in nursing homes."

FDA to Convene Meetings in June to Review and Discuss Metal on Metal Hips

Fda (Photo credit: Wikipedia)

The Food and Drug Administration will hold a two-day meeting in June to discuss growing safety concerns about metal-on-metal hip replacements, which recent studies suggest are more likely to fail than traditional plastic hips.

Metal hip joints have been under scrutiny due to reports of pain and swelling that have sometimes required removal. In 2010, Johnson & Johnson recalled roughly 93,000 implants. The FDA already asked device companies to conduct additional follow-up studies to monitor problems with the implants.

The agency says it will hold a two-day meeting beginning June 27 to consider whether more rigorous testing standards are needed.

Earlier this month, British experts said doctors should stop using metal hip joints because data show they have to fixed or replaced more often than older implants.

Orthopedic Surgeon Becomes Victim of Depuy Hip

Logo of CBS News (Photo credit: Wikipedia)

CBS News has been investigating medical products and what they found it something known to may lawyers, but not to consumers and some physicians, that being that many medical products are not as safe or monitored as people may think. According to Consumer Reports, most medical devices are approved only by filing paperwork with the FDA.

Dr. Stephen Tower, an orthopedic surgeon, became a victim of a the Depuy ASR hip which has been recalled and my claim was defectively designed, tested, manufactured, and represented to consumers. The FDA had cleared the device without testing based on "substantial equivalence" to earlier similar devices. Use of metal parts over plastic was supposed to give the patient more mobility so they could participate in all kinds of physical activity.

After a year, he had high levels of chromium and cobalt in his blood and his hip was constantly painful. He started having other problems like disturbed sleep, mood swings, anxiety, hearing loss, and tinnitus, constant ringing in the ears. The symptoms got so bad he couldn't go to work.  Even though he kept calling the DePuy engineers, they claimed they never had any problems with the device. Then a British Medical Journal and BBC Newsnight investigation revealed that millions of people with similar implanted devices also had high levels of toxins seeping into their bloodstream.

 HealthPop reported that the investigation showed that the chromium and cobalt ions leak into surrounding tissue and destroy muscle and bone, eventually spreading to lymph nodes, the spleen, liver and kidneys and potentially causing damage. The ions also had the ability to change a person's chromosomes, meaning genetic changes.

Biomet Busted for Bribery

Biomet (Photo credit: Wikipedia)

The Wall Street Journal reports Biomet Inc has agreed to pay the government more than $22 million to settle allegations made by the Justice Department and Securities and Exchange Commission that it violated the Foreign Corrupt Practices Act.

According to the Washington Times, "The Justice Department's Criminal Division announced Monday that the Indiana-based company, which manufactures and sells medical devices worldwide, made various improper payments or paid bribes from 2000 to 2008 to health care providers in Argentina, Brazil and China to secure lucrative business with hospitals." "During this time, according to information filed in US District Court in Washington, more than $1.5 million in direct and indirect payments were made. Modern Physician reports, "These payments were then falsely recorded as commissions, royalties, consulting fees or scientific incentives, according to the release."

http://www.washingtontimes.com/news/2012/mar/26/medical-device-maker-biomet-agrees-22m-penalty/

http://finance.fortune.cnn.com/2012/03/26/biomet-busted-for-bribery/

Bloomberg: J & J Marketed Vaginal Mesh Without Approval

According to Bloomberg News writers David Voreacos and Alex Nussbaum, Johnson & Johnson sold a vaginal mesh implant for three years before U.S. regulators approved the device.

J&J’s Ethicon unit introduced the Gynecare Prolift device in March 2005, touting it in an annual report as an “innovative and effective surgical option” for weakened pelvic muscles.

Here is the problem. The U.S.Food and Drug Administration said it learned of the Prolift in 2007, when J&J sought approval for a related product. The FDA cleared both devices in May 2008.

Johnson & Johnson’s unauthorized sales might cost it more to resolve lawsuits over the product.

J&J’s unauthorized sales might cost it more to resolve lawsuits over the product. J&J already has endured recalls of artificial hip implants and over-the-counter drugs. Three J&J units have pleaded guilty in the past two years to bribery or illegal marketing of drugs. A fourth agreed to plead guilty in a marketing case.

This type of conduct again raises questions about the FDA’s approval process, which lets companies introduce products without human testing if the agency decides they’re similar to devices already for sale, or so-called predicates.

An FDA report in July found a fivefold jump in deaths, injuries or malfunctions tied to vaginal mesh for prolapsed organs. In September, an advisory panel urged the FDA to reclassify such mesh as “high-risk” devices needing human testing.

In Atlantic City, patients’ lawyers are seeking to interview more than 70 company witnesses, including Gary Pruden and Sheri S. McCoy, the leader of J&J’s pharmaceutical and consumer products unit. Both Pruden and McCoy previously served as company group chairman and worldwide franchise chairman of Ethicon.

Consumer Reports: Americans want more oversight of Implanted Medical Products

Less than 1% of of implanted medical products are subjected to the strenuous PMA (pre-market approval) process of the FDA. And the draft legislation put together by the House Energy and Commerce Health Subcommittee would actually allow the approval process to go even faster. The Senate Health, Education, Labor and Pensions Committee's draft bill does provide some additional protections for patients once devices are on the market, but does nothing new to prevent potentially unsafe medical devices from being sold in the first place.

But according to a new poll by our publishing pals Consumer Reports, 82% of Americans believe that preventing safety problems is more important than limiting safety testing in order to prevent delays and encourage innovation.

91% of poll respondents said each implant should be safety tested before being sold even when similar implants were in use.

71% said that a new device should not be allowed to be sold based on its similarity to an existing implant that has a safety problem or has been recalled.

94% indicated that medical device makers should be required to do long-term monitoring of implants if there are safety concerns or problems with a particular device. Existing law gives the FDA only limited authority to require such long-term safety monitoring.

95% said that effective consumer protections for medical implants should include a nationwide system for tracking medical implants so patients can be notified about safety problems or recalls. No such system currently exists in the U.S. even though it was required by Congress' previous reauthorization of the law.

66% indicated a high level of concern about safety decisions or recommendations made by expert committees that included doctors who had current financial relationships with medical device makers.

Industry lobbyists have been pushing lawmakers to weaken current rules designed to prevent such conflicts of interest. The Senate and House discussion drafts remove current caps on the percentage of expert committee members that can be granted waivers if they have a conflict of interest, a provision championed by consumer advocates five years ago.

"Recent problems with metal hip implants and surgical mesh have shown how our current system fails to ensure medical devices are safe and effective," said Lisa Swirsky, senior policy analyst for Consumers Union. "Unfortunately, the House bill weakens current standards to speed up device approvals rather than improving safety oversight. The Senate bill offers some improvements but it should be strengthened to require stricter safety testing of new implants and life sustaining devices. Congress should recognize that the public is far more concerned about making sure devices are safe and work than how quickly they are made available."

The Depuy hip problems came to light, in part, due to tracking systems in place in other countries, which indicated higher than normal failure rates. In this country, the information received by doctors is often limited to data provided by the manufacturer and their sales representatives, which is often times false and misleading.

As one of my clients told me this morning, "I don't need a doctor to tell me that my hip has failed and needs to be removed, I live it every day."

British Medical Journal---Safety of Metal on Metal Hip Implants Questioned

New hip (Photo credit: okadots)

February 28, 2012

The British Medical Journal reported today that a million or more Americans have had metal on metal orthopedic implants installed since 2003.  That number continues to climb as as manufacturers continue to promote metal on metal devices.  This, despite the recall of devices (Depuy ASR), growing evidence of exposure to toxic and potentially carcinogenic metal ions, and the unprecedented requirement by the FDA that manufacturers conduct post-marketing studies.

Startling Highlights Contained in the Report Include the Following:

*Failure rates for all metal on metal hip implants is currently 13.6% as opposed to 3.3% for implants made of other materials.

*Multiple studies and research organizations have warned about the carcinogenic potential of metal-on-metal hip implants.

*Internal Depuy memos from July 2005 identify potential immune function changes and carcinogenic concern.

*Because of concerns, Depuy sales representatives were given paper entitled "Setting the record straight on metal hypersensitivity" written by Dr. Thomas Schmalzried (Depuy's hired consultant, stooge, or whatever you want to call him).

*In 2006, based on concerns, the MHRA (Medicines and Healthcare Products Regulatory Agency) committtee concluded that "there is evidence to suggest that some metal-on-metal hip replacements may be associated with increased DNA changes.

*Data showed raised metal ion levels in the Depuy Pinnacle were available since 2008, yet the device was promoted as the alternative for the subsequently recalled Depuy ASR.

*Speaking of the lax regulatory environment, one Depuy product manager responded to an email stating that "you could literally implant a tent rod if you wanted!"

Unfortunately for those with MOM implants, I fear that the news is only going to get worse.  The revision rate on our Depuy ASR clients is currently 46% and climbing.

If you have a MOM hip implant, it is imperative that you have regular blood tests for cobalt and chromium.

For additional information, feel free to contact me at Chrish@PittmanDutton.com

Related articles

• Serious concerns over Metal on Metal Hips - British Medical Journal (earlsview.com)
• Metal scare over hip replacement joints (guardian.co.uk)
• Jeremy Laurance: The regulator needs to recover its grip, fast (independent.co.uk)
• Hip implant fiasco highlights regulatory failings in Europe (guardian.co.uk)
• Thouands with metal-on-metal hip implants will need annual checks - WalesOnline (walesonline.co.uk)
• Metal Hip Implant Concerns - Potentially Bigger Scandal Than Breast Implants (medicalnewstoday.com)

What did Johnson & Johnson know about their hips and when did they know it?

According to the New York Times, a year before Johnson & Johnson's Depuy division recalled their ASR hip systems, Pamela Plouhar, vice president of Depuy Orthopedics, reported privately to top executives that the FDA was going to refuse to approve the device after data showed it failed prematurely in "significant" numbers.  The device was on the market overseas starting in 2003 and was marketed in the United States in 2005 under a loophole in the law.

This, of course, is in direct conflict with public statements by Johnson & Johnson which insisted that its internal studies refuted complaints by surgeons and regulators in other companies. Johnson & Johnson maintained that the failures were the result of improper placement of the implants by physicians--a position I continue to hear parroted by uninformed doctors or physicians still on Johnson & Johnson's gravy train.

There is only one problem with this defense----the data came from clinical studies performed by surgeons hand picked by Depuy and who received royalties and consulting fees associated with it.  In other words, Depuy's hand picked surgeons were seeing failures at the same rate as other Depuy surgeons who were using the product.

In addition to this email, documents filed with a Senate committee indicate knowledge of a serious problem in 2008, nearly 2 years before the hips were recalled.

Of course, lost in this discussion were the hundreds, if not thousands of people who are now suffering crippling injuries as Depuy continued to mislead both surgeons and consumers about the condition of its product.

Related articles

• Johnson & Johnson CEO resigns after series of missteps (money.cnn.com)
• Flawed DePuy Hip Implant Had Early F.D.A. Notice (nytimes.com)
• Hip Implant the FDA Rejected Was Marketed Abroad - New York Times (nytimes.com)
• Regulator dithering put hundreds of hip patients at risk (smh.com.au)
• J&J DePuy - Hip Implant that U.S. Rejected Was Sold Overseas (earlsview.com)