MD and orthopedic surgeon Scott Ball gives us his opinion on the recent issues concerning metal on metal hip replacements.
Thursday, May 24, 2012
Saturday, May 19, 2012
US Drug Watchdog Urges All Depuy ASR Patients to Contact Attorneys
US Drug Watchdog, a group that identifies itself as the premier consumer advocate for victims of recalled drugs or defective medical devices in the United States to come forward and contact attorneys. To date, only 3500 of the potentially 40,000 claimants have filed claims.
This is extremely important for a number of reasons. First, there is quite a bit of misinformation being distributed. Secondly, it is important to identify individuals who received implants in 2010 AFTER they were pulled from the market in other countries.
The following are things that I hear every day.
MY DOCTOR TELLS ME MY BLOOD LEVELS ARE NORMAL:
This is perhaps the most common response I get from people who contact me at this time and it is often wrong. Just this week, I was contacted by two individuals who said that they were concerned because their hip pain was continuing to get worse. Both had Depuy ASR hips. One had a cobalt level of 5.2, up from 3.2 and the other with a cobalt level of 6.1, up from 3.8. Despite what physicians are saying, these are dangerous levels. Further, it is clear evidence of implant failure. From my experience (I represent over 150 claimants), these levels are going to continue to climb, resulting in many more medical problems.
According to Dr. Stephen Tower, levels of cobalt above 1 are considered excessive, causing subclinical myocardial and memory impairment and at level 5 you are toxic. Other reports indicate that a level of 2 or more indicates implant failure.
I HAVE NOT HAD MY DEPUY ASR HIP REPLACED YET:
Just because you have not been revised yet does not mean that you do not have damages or that you will not have damages in the future. It is important to have your claim filed and receive monitoring. So far, over 50% of my clients have had to have revision surgery. That number has increased dramatically since 2010 when the recall was announced. Most of us believe that it is not a matter of if, but when!
BROADSPIRE IS HANDLING MY CLAIM:
Broadspire is a third party administrator for Depuy. They are providing your information to Depuy and Depuy's attorneys. They represent Depuy's interests, not yours.
If you have a Depuy ASR hip implant, the worst thing you can do is nothing. Don't let your time to file a claim run out. You should contact an attorney immediately and continue to have your blood levels checked at regular intervals.
I will be happy to provide any medical literature or other information I have at my disposal. Feel free to contact me at Chrish@PittmanDutton.com or call me at toll free at 866-515-8880
This is extremely important for a number of reasons. First, there is quite a bit of misinformation being distributed. Secondly, it is important to identify individuals who received implants in 2010 AFTER they were pulled from the market in other countries.
The following are things that I hear every day.
MY DOCTOR TELLS ME MY BLOOD LEVELS ARE NORMAL:
This is perhaps the most common response I get from people who contact me at this time and it is often wrong. Just this week, I was contacted by two individuals who said that they were concerned because their hip pain was continuing to get worse. Both had Depuy ASR hips. One had a cobalt level of 5.2, up from 3.2 and the other with a cobalt level of 6.1, up from 3.8. Despite what physicians are saying, these are dangerous levels. Further, it is clear evidence of implant failure. From my experience (I represent over 150 claimants), these levels are going to continue to climb, resulting in many more medical problems.
According to Dr. Stephen Tower, levels of cobalt above 1 are considered excessive, causing subclinical myocardial and memory impairment and at level 5 you are toxic. Other reports indicate that a level of 2 or more indicates implant failure.
I HAVE NOT HAD MY DEPUY ASR HIP REPLACED YET:
Just because you have not been revised yet does not mean that you do not have damages or that you will not have damages in the future. It is important to have your claim filed and receive monitoring. So far, over 50% of my clients have had to have revision surgery. That number has increased dramatically since 2010 when the recall was announced. Most of us believe that it is not a matter of if, but when!
BROADSPIRE IS HANDLING MY CLAIM:
Broadspire is a third party administrator for Depuy. They are providing your information to Depuy and Depuy's attorneys. They represent Depuy's interests, not yours.
If you have a Depuy ASR hip implant, the worst thing you can do is nothing. Don't let your time to file a claim run out. You should contact an attorney immediately and continue to have your blood levels checked at regular intervals.
I will be happy to provide any medical literature or other information I have at my disposal. Feel free to contact me at Chrish@PittmanDutton.com or call me at toll free at 866-515-8880
Friday, March 30, 2012
FDA to Convene Meetings in June to Review and Discuss Metal on Metal Hips
Logo of the . (Photo credit: Wikipedia)The AP is reporting that The Food and Drug Administration will hold a meetings in June to discuss growing safety concerns about metal-on-metal hip replacements.
Metal hip joints have been under scrutiny due to reports of high failure rates. 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.
Tuesday, March 27, 2012
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.
"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," the Washington Times. "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."
Friday, March 23, 2012
Consumer Reports: Americans want more oversight of Implanted Medical Products
U.S. House Committee on Energy and Commerce official Seal. (Photo credit: Wikipedia)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."
Tuesday, March 6, 2012
Drugmakers have paid a whopping $8 BILLION in fraud fines since 2002
Image via WikipediaAccording to the USA Today, the nations largest drug companies have paid at least $8 Billion in fraud fines since 2002. Pfizer alone has paid almost $3 Billion since 2002.These fines include such conduct as illegal kickbacks, improper marketing of drugs, and refusing to pay rebates to the government.
Government investigators say their hands are tied. They can't deny treatment to people who need it, which leaves them with leveling fines and extracting promises not to defraud the government in the future, a promise that is often ignored.
A Bipartisan bill has been introduced that would make it easier for the government to exclude individuals from working with the government even after they have left a company where fraud occurred
Drug companies spent more than $200 million lobbying Congress in 2011.
Thursday, March 1, 2012
British Medical Journal--One Million and Counting at risk for Metal on Metal Implants
Image via WikipediaFebruary 28, 2012The 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
Wednesday, February 22, 2012
What did Johnson & Johnson know about their hips and when did they know it?
Image via WikipediaAccording 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.
Thursday, June 2, 2011
DePuy Pinnacle MDL Update
Our firm has four of the first Pinnacle cases filed in the DePuy Pinnacle MDL and anticipates filing more in the coming months. We are seeing rapid failures of the device due to high cobalt levels in blood tests. Excessive levels of cobalt in the blood stream is a sign of metallosis, which can cause rashes, soft-tissue damage, peripheral neuropathy and pseudo-tumors.
The DePuy Pinnacle cases have been consolidated in the U.S. District Court for the Northern District of Texas under Judge James E. Kinkeade. Judge Kinkeade is currently presiding over at least one of the cases, and the Panel determined his current caseload will accommodate the litigation. There are approximately 57 DePuy Pinnacle hip lawsuits currently pending in federal courts nationwide and that number is expected to rise over the next few months.
DePuy is a subsidiary of Johnson & Johnson, one of the largest corporations in the world. DePuy recalled the ASR XL Acetabular hip system last August, after researchers found 13 percent of patients needed a repeat operation to fix problems with the implant. The company took a $280 million charge in the fourth quarter to pay for the recall. The company faces more than 500 lawsuits by patients who had the hip implants, most of which are consolidated in a separate MDL dealing only with ASR hips. There has been no recall of the DePuy Pinnacle hip.
Johnson & Johnson’s DePuy Orthopaedics division, a maker of artificial prosthetics such as hips and knees, has struggled with product recalls and lawsuits over faulty implants lately. It was announced earlier this year that the worldwide president would leave the company in March. The executive, David Floyd, has been president of the unit since 2007. He is leaving to pursue interests outside the company, a spokesman on behalf of the company, Lorie Gawreluk, said, declining to be more specific.
Our firm is currently investigating claims for those people who have been implanted with the DePuy hip replacement devices, both ASR and Pinnacles. If you would like a free case evaluation, please contact Chris Hellums at toll free 1-866-515-8880 or at chrish@pittmandutton.com.
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