Archive for category DePuy Hip Replacement
FDA Edges Closer Towards Action on Metal Hip Implants
Posted by The Brandi Law Firm Blog in DePuy Hip Replacement, Drug and Medical Device Litigation on April 6, 2012
Previously we have chronicled some of the problems surrounding the De Puy ASR metal on metal hips that have required revisions by countless people in the USA and elsewhere.
In April 2010, the United Kingdom’s (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) issued a medical device alert that included specific follow-up recommendations for patients implanted with metal on metal hip replacements. The recommendations included blood tests and imaging for patients with painful metal on metal (MoM) hip implants. In 2009, citing “declining sales, Johnson and & Johnson stopped marketing the De Puy ASR. On August 26, 2010 the De Puy ASR was effectively recalled.” (DePuy Orthopaedics, Inc. is a Johnson & Johnson company.)
DePuy Orthopaedics Voluntarily Recalls ASR™ Hip System
In May 2011 the FDA ordered manufacturers of metal on metal implants to collect more safety data on the devices. Covered by the order are DePuy ASR, and devices by Zimmer and Stryker.
In February 2012 the New York Times reported that Johnson & Johnson continued to market an artificial hip in Europe and elsewhere after the 2009 rejection by the FDA of its sale in the USA.
Britain Extends Monitoring for People with Metal Hips
Hip Implant U.S. Rejected Was Sold Overseas
In February 2012, MHRA published a medical device alert with updated advice on the management and monitoring of patients implanted with MoM hip systems recommending that people with metal on metal hip implants undergo annual examinations to make sure they are not suffering tissue damage or other problems.
On March 29, 2012, The FDA announced an Advisory panel hearing set for June 27-28 to gather information that will help decide if new requirements are needed before a device can be sold in the USA.
About 270,000 hip replacements are performed each year in the United States, accounting for nearly 40 percent of all joint replacements, according to the British Medical Journal. Failure rates on the nearly 500,000 people in the USA who have received metal on metal implants is unclear, but data from orthopedic registries in Australia and England has shown that all-metal hips are failing prematurely at two to three times the rate of those made from metal and plastic. Studies have indicated that the use of the larger ball component increases the amount of torque and motion at the points where that ball and cup or the ball and stem are joined, generating debris.
This office is currently representing numerous people injured by De Puy ASR and other metal on metal hip implants. If you would like more information contact the Brandi Law Firm at (800) 481-1615 or click here to learn more about the Brandi Law Firm DePuy Attorneys.
The FDA Medical Device Fasttrack Approval Process Draws New Fire
Posted by The Brandi Law Firm Blog in DePuy Hip Replacement, Drug and Medical Device Litigation on August 19, 2011
35 years ago, Congress passed the Medical Device Amendments of 1976 which established the framework of the current FDA regulatory system. This set of laws included one commonly known today as the 510(k) process. This 510(k) process allows medical devices, from tongue depressors to pacemakers to artificial hips, to be cleared for sale in the United States if the manufacturer shows that it is substantially similar to any device already on the market.
Recently, it has become clear that many medical devices cleared through the 510(k) process are essentially untested before being sold and then later are found to be defective and unsafe. The Brandi Law Blog has has discussed this matter before:
Government Accountability Office Criticizes FDA Fastrack Process
78% of Recalled Medical Devices were Approved by the FDA’s Fasttrack Process
A Loophole Allowed the DePuy Hip to be FDA Approved Without Testing
In July 2011, the Institute of Medicine of the National Academies (IOM) published a report discussing the 510(k) process and whether or not is should be revised. The IOM is an independent nonprofit organization established in 1970 with the mission to serve as adviser to the nation to improve health. In its report, the IOM came to some concerning conclusions:
- The 510(k) clearance is not a determination that the device is safe or effective.
- The 510(k) clearance process is not reliable to screen devices for their safety and effectiveness.
- The 510(k) process is flawed based on its legislative foundation and unfixable.
- Rather than trying to fix the 510(k) process, the FDA should develop a new program that would provide a reasonable assurance of safety and effectiveness of medical devices.
Click here to read the entire IOM report – Medical Devices and the Public’s Health: the FDA 510(k) Clearance Process at 35 Years
On August 10, 2011, the New England Journal of Medicine published an article discussing this topic as well, linking the 510(k) process to the current issues with the DePuy ASR XL artificial hip. In that article, the Journal applauds the IOM’s findings and supports its recommendation that the 510(k) process be replaced with one that evaluates the safety and effectiveness of medical devices before they hit the market. Unfortunately, it appears that the FDA does not intend to implement the suggestions of the IOM to fix this process.
Click here to read the entire New England Journal of Medicine Article: Medical Devices – Balancing Regulation and Innovation
If you or a loved one has a DePuy hip, please click here to learn more about the Brandi Law Firm DePuy Attorneys.
FDA Orders Artificial Hip Makers to Perform Study
Posted by The Brandi Law Firm Blog in DePuy Hip Replacement on May 13, 2011
According to the May 11. 2011 article in the New York times, The FDA has ordered the manufacturers of the De Puy artificial hip and all producers of metal on metal artificial hips to undertake studies of the implants, which have been linked to high early failure rates and severe health effects in some patients.
Click here to read the entire New York Times article: Hip Makers Told to Study More Data
Metal-on-metal hips, in which the ball-and-socket components are made from metals like cobalt and chromium, accounted until relatively recently for about one-third of the estimated 250,000 hip replacement procedures performed annually in the United States. In March 2011, the British Orthopaedic Association, a professional medical group, reported that the De Puy ASR was projected to fail in one-half of the patients who received it within six years after implant.
Dr. William H. Maisel, the deputy director for science at the F.D.A.’s Center for Devices and Radiological Health, said the order marks the broadest use of the agency’s authority to conduct studies of devices after approval for sale. Dr. Maisel said companies would be expected to collect information from patients who received the devices, including taking blood samples to determine the levels of metallic ion in their systems. Invoking FDA procedures calling for post market testing and studies, Dr. Maisel said that the F.D.A. wanted information about the entire category of implants, not just the De Puy. Manufacturers will have 30 days to file a proposed plan with the F.D.A. Hopefully this will provide De Puy ASR and Pinnacle users as well as people with other implants important data as to what De Puy and others knew and enable physicians to make informed choices as to future care needs.
This office is currently representing numerous consumers with significant problems from the De Puy ASR and Pinnacle devices. Click here to learn more about the Brandi Law Firm Hip Attorneys
British Study Finds 49% of DePuy ASR Hips Fail At 6 Years
Posted by The Brandi Law Firm Blog in DePuy Hip Replacement on May 13, 2011
The more attention that is paid to the DePuy metal on metal replacement hips, the more it seems that the problem is bigger than anyone thinks. Initially, the projected rates of failure of the DePuy ASR was in the realm of about 12-13%. (DePuy Hip Recall Lawsuit). In fact, DePuy still claims on its website that this number is accurate.
But independent physician group studies paint a different picture. In January 2011, a study in Ireland determined that almost half of those that received replacement hips are anticipated to need their hip replaced earlier than expected. 48% of Irish DePuy Patients Need to Replace Their DePuy Hip.
In March 2011, a study published by the British Orthopaedic Association published a study that essentially had the same conclusion:
“The presented results show a higher than anticipated early failure rate. These range from 21% revision rate at 4 years (potentially rising to 35% if all currently known painful implants progress to revision) to 49% at 6 years for the ASR XL device.”
Click here to read the entire British Orthopaedic Association Study.
These studies leave us wondering what DePuy knew, when did they know, and why did it take so long to have this product recalled from the market.
Click here to learn more about the Brandi Law Firm DePuy Attorneys.
Government Accountability Office Criticizes FDA Fastrack Process
Posted by The Brandi Law Firm Blog in DePuy Hip Replacement, Drug and Medical Device Litigation on April 22, 2011
“The FDA is falling short in how it handles recalls of risky medical devices, a new report from the Government Accountability Office concluded, adding to the ever-mounting criticisms of the agency’s fast-track, 510(k) approval process.”
The Government Accountability Office (GAO) is known as “the investigative arm of Congress” and “the congressional watchdog.” GAO supports the Congress in meeting its constitutional responsibilities and helps improve the performance and accountability of the federal government for the benefit of the American people.
In a recent article, the GAO complained that the FDA failed to keep track of the reasons devices such as hip implants are recalled, and it doesn’t always follow up to make sure the recall was complete.
Click here to read the article: GOA Still Leary of Fast-Track Device Approvals
The GAO is only the most recent group to criticize the FDA for the 510(k) fast-track approval process for medical devices.
Click here to read a previous post about the high recall rate for fast-tracked medical devices.
International Bribery, Oil, Drugs…and Artificial Hips??
Posted by The Brandi Law Firm Blog in DePuy Hip Replacement, Drug and Medical Device Litigation on April 18, 2011
Johnson and Johnson has admitted that it bribed European doctors and paid kickbacks in Iraq to win contracts to sell drugs and artificial joints.
The late Warren Zevon sang “Send lawyers, guns, and money, the sh*t has hit the fan”. Is that what they are thinking these days at Johnson & Johnson?
J & J is the parent of DePuy, Inc., the manufacturer of the ASR, a metal on metal replacement hip system that doctors around the world believe is defective and was recalled in 2010. According to the SEC, Johnson & Johnson carried out a program since 1998 of using slush funds, sham contracts, and offshore companies to bribe hospitals and doctors in Europe and Iraq to sell drugs and install their artificial joints. The SEC also claims that Johnson & Johnson made illegal payments to Iraqi officials to win contracts under the United Nations Oil for Food Program.
Read the full story here: Johnson & Johnson Will Pay $70 Million Over Bribery Claims
Read the SEC’s filed complaint here: SEC Complaint against J & J
The SEC action follows up a United Kingdom action against British businessman Robert Dougall, then director of marketing at DePuy International (DPI), another subsidiary of Johnson & Johnson. He pleaded guilty in the regarding his involvement in £4.5m of payments to Greek surgeons to encourage them to use DPI products. From 1998 to 2006, J&J earned more than $24 million in profits by bribing Greek doctors to buy surgical implants including artificial knees and hips, the SEC said.
Read the full story here: SFO Whistleblower Robert Dougall is Spared Prison
What was the response from embattled Johnson & Johnson?
Johnson & Johnson is paying $70 million to resolve the bribery claims. J & J agreed to pay $48.6 million in disgorgement of profits and interest to settle the SEC’s claims, a $21.4 million fine to settle criminal charges filed by the Justice Department, and admitted the allegations of the charges filed by the Justice Department. J & J has recalled more than 50 products since the start of 2010 including the DePuy ASR replacement hip, which was affected thousands of people worldwide.
Click here to find out more about the Brandi Law Firm DePuy Hip Attorneys.
Is Your Doctor Also Working for a Drug Company?
Posted by The Brandi Law Firm Blog in DePuy Hip Replacement, Drug and Medical Device Litigation on April 7, 2011
How independent is your doctor when making a prescription choice for you?
On March 31, 2011 Merck revealed it paid $20.4 million to over 2088 physicians ($10,600 on average) in 2010 for speaking on its behalf. These figures do not include what Schering Plough, acquired by Merck in 2009, paid to doctors. This is the same Merck who spent millions on doctors who prescribed the withdrawn Vioxx and the embattled Fosamax that is the subject of numerous suits around the Country and studies showing its causal relationship to femur fractures in women.
Following up Merck’s doctor-payment disclosures, Pfizer and GlaxoSmithKline announced their payments:
The world’s largest drugmaker, Pfizer spent $177 million to doctors in support for clinical trials and speaking fees. 4,600 physicians collected a total of $34.4 million, or $7,400 on average. Broken down, that figure is comprised of $18 million in free meals for doctors, $8.9 million in advisory fees (paid to 1,400 doctors), $5.8 million for travel, and $1.7 million for education.
GSK’s (maker of the embattled Avandia) payments were only total of $85 million for trials and speaking.
Merck and Glaxo posted their numbers voluntarily, while Pfizer is required to disclose payments under its off-label marketing settlement with the U.S. Justice Department.
This office represents clients injured by Avandia (GSK) and Fosamax (Merck) and formerly represented numerous people injured by Vioxx (Merck).
Do you the patient have the right to know if your prescribing Doctor is working for the maker of the drug you are getting?
- read the Reuters article: Pfizer, GSK Paid $262 Million to U.S. Doctors in 2010
- or the article in the Wall Street Journal: Pfizer, Glaxo Disclose Fees to U.S. Doctors
- or in the Telegraph: GlaxoSmithKline Reveals Fees Paid to US Doctors
- or the Philadelphia Telegraph’s take: Big Pharma Reveals How Much it Paid Doctors
Other Related Articles:
Merck pays 2,000-plus docs $20.4M for speaking
Study: Fewer doctors report industry ties
Live From BIO: Biotech, Pharma are living in a fishbowl
Are pharma-doc links necessary or questionable?
78% of Recalled Medical Devices were Approved by the FDA’s Fasttrack Process
Posted by The Brandi Law Firm Blog in DePuy Hip Replacement on February 16, 2011
An article has been published in the Archives of Internal Medicine attacking the FDA’s fast track approval processes that include the 510(k) application for medical devices.
“Most medical devices recalled for life-threatening or very serious hazards were originally cleared for market using the less stringent 510(k) process or were considered so low risk that they were exempt from review (78%).”
The 510(k) process is available for use when a company claims that its product is substantially similar to another device that was previously approved. The medical device company However, a much higher percentage of 510(k) products have been found to be defective and end up getting recalled:
“Medical devices cleared through the less rigorous 510(k) pathway comprise more than two-thirds of the products that are recalled by the FDA because they could seriously harm patients or result in death. When devices that were intentionally exempt from any FDA review were added to the 510(k) devices, they comprise more than 3 out of 4 of the high-risk recalls during the last 5 years. Thus, the standards used to determine whether a medical device is a high-risk or life-sustaining product prior to approval are clearly very different from the standards used to recall a medical device as life threatening. Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy.”
Click here to read the Medical Device Recalls and the FDA Approval Process article.
To read a previous Brandi Law Firm Blog entry explaining the 510(k) process and linking to a New York Times Articla and DePuy’s actual application for the recalled ASR XL hip, click here: A Loophole Allowed the DePuy Hip to be FDA Approved without Testing
If you or a loved one has a DePuy hip, please click here to learn more about the Brandi Law Firm DePuy Attorneys.
Celebrities and Athletes : PR Ambassadors
Posted by The Brandi Law Firm Blog in DePuy Hip Replacement, Drug and Medical Device Litigation on February 3, 2011
American companies with public relations issues have historically turned to celebrities and athletes for advertising help to improve their image or promote their product. We all remember celebrity endorsements to oppose negative press for asbestos manufacturer Johns Manville and American Express.
More recently, pharmaceutical manufacturer Merck turned to Dorothy Hamill and Bruce Jenner to advertise Vioxx, an anti inflammatory prescription medication that has since been pulled from the market after it was shown to increase cardiac issues and chance of death.
View the Dorothy Hamill television ad for Vioxx, or another for Merck by clicking here.
Now, DePuy (owned by Johnson & Johnson) is turning to college basketball hall of famer and 2008 Olympic coach Mike Krzyzewksi (Coach K).
Click here to view the DePuy website, or see below:
A Loophole Allowed the DePuy Hip to be FDA Approved Without Testing
Posted by The Brandi Law Firm Blog in DePuy Hip Replacement on February 2, 2011
A enlightening article in the New York Times discusses this “Implant Loophole” and how DePuy (owned by Johnson & Johnson) skirted the clinical testing requirement in order to get this product on the market as soon as possible.
There is a significant controversy about the recalled DePuy ASR XL replacement hip. Studies of people that have received this product show that it needs to be removed and replaced at a significantly higher rate than other devices and that the shedding of metallic particles into the body can result in permanent damage. In fact, the director of Australia’s orthopedic database which tracks success of replacement joints said that he believed that DePuy had been less than forthright about the A.S.R. data in that country:
“When it is clear to the orthopedic community that a company has not been honest, that is a problem,” said Australia’s registry’s director, Dr. Stephen Graves. “I think that J. & J. has a major issue with DePuy.”
The recent inquiry centers on the following question: “Why was this product approved by the FDA in the first place?”
The short answer: A FDA approval loophole exists for medical implants to be approved without clinical testing as long as the manufacturer claims the product similar to implants already approved.
The DePuy ASR may have been similar, but it was different in its rate of failure and in the dangers posed by the claimed defects. Click here to view the DePuy FDA Application (and the FDA’s response) for yourself.
As a result of the relaxed standards the “testing” occurs on the general public after approval:
“You are basically testing these devices in an uncontrolled way on a large number of people,” said Dr. Sidney M. Wolfe, the director of the Public Citizen’s Health Research Group and a longtime FDA critic.
The article continues and discusses the FDA’s requirements, symptoms of the defective DePuy hip, the increasing worldwide concern, and DePuy’s response to that concern. Click here to read more of The New York Times: The Implants Loophole.
If you or a loved one has a DePuy hip, please click here to learn more about the Brandi Law Firm DePuy Attorneys.
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