Archive for January, 2011
FDA Releases Video about Fosamax Dangers
Posted by The Brandi Law Firm Blog in Fosamax Osteoporosis Drug on January 28, 2011
The FDA released a video updating information regarding atypical femur fractures that have been associated with the use of bisphosphonates to treat osteoporosis. (Fosamax, Actonel, Boniva, Atelvia, Reclast, and their generic equivalents.)
Click here to watch the FDA Video
Among the FDA recommendations to medical professionals are:
• be aware of the possibility of atypical femur fractures in patients taking bisphosphonates
• consider periodically re-evaluating whether continued bisphosphonate therapy is needed, especially in patients who have been treated for more than five years. Periodic reevaluation is recommended because the fracture reduction efficacy of these drugs has not been established, and the optimal duration of use is uncertain.
• discuss the benefits and risks of these drugs with patients, and instruct them to seek medical attention if they experience new groin or thigh pain, which may be described as dull or aching. This pain can occur weeks or months before a complete fracture occurs.
Click here for more information about the Brandi Law Firm Fosamax Attorneys.
Muni Derailments and Accidents on the Rise
Posted by The Brandi Law Firm Blog in MUNI and Public Transit on January 24, 2011
The San Francisco MUNI system is a public railway depended on by thousands of people every day. MUNI is an essential part of San Francisco, but lack of funding has caused recent problems:
“In less than a week, five trains derailed at a Muni storage facility, a development operators say is due to a lack of investment, raising concerns about potential injuries and damage.”
Click here to read the San Francisco Examiner article.
In fact, in early 2011, San Francisco Supervisors approved almost $2.5 million in City settlements to those injured on MUNI buses, light railway cars, and cable cars. Click here to read the article from ABC reporter Dan Noyes.
The Brandi Law Firm represented some of these persons wh0 were injured by MUNI.
Click here to read more about The Brandi Law Firm Muni Attorneys.
Avandia Maker Sets Aside $3.4 Billion for Lawsuits
Posted by The Brandi Law Firm Blog in Avandia Diabetes Drug on January 21, 2011
British drug manufacturer GlaxoSmithKline (GSK), which makes the recalled diabetes drug Avandia, has set aside a $3.4 billion “to pay for United States government investigations and product liability cases over its marketing of” Avandia.
Click here to read the entire New York Times article.
This set aside is in addition to the $2.36 billion charge taken last summer to settle about 10,000 of 13,000 Avandia product liability lawsuits it was facing in the United States, as well as investigations over its antidepressant Paxil and manufacturing problems in Puerto Rico.
The article continued: “Avandia has been controversial since a 2007 analysis linked it with a 43 percent increase in the risk of heart attacks.”
The Brandi Law Firm is representing people that have been adversely effected by Avandia. Click here to learn more about The Brandi Law Firm Avandia Attorneys.
The FDA Identifies DePuy Hip Replacement Model Numbers
Posted by The Brandi Law Firm Blog in DePuy Hip Replacement on January 14, 2011
On October 13, 2010, the U.S. Food and Drug Administration released a report detailing the extent of DePuy’s recall of its two metal-on-metal hip replacements, the ASL XL Acetabular System and the ASL Hip Resurfacing System. (To see model numbers click here to go to the FDA Enforcement Report). The report divides the recalled implants into two series: the ASR 100 and the ASR 300. The ASR 100 series accounts for 15 models designed to accommodate various hip cup diameters, from 44mm to 70mm. The ASR 300 series includes the remaining 14 models, also defined by diameters of the same range. At the time of the report, 36,486 units were still in commerce
The FDA characterized the DePuy recall as follows:
REASON
Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. As part of the post-market surveillance activities, the firm recently received and analyzed new data regarding the ASR platform which suggests a higher than expected revision rate for the ASR XL Monoblock Metal-on-Metal (MoM) System linked to usage of monoblock MoM cups with corresponding head sizes below 50mm in diameter. As a result of the findings, DePuy Orthopaedics issued a Field Safety Notice to share the new data with the surgeons and reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorship. Reasons for revision are typical for the class of large diameter MoM monoblock cups and includes component loosening, component malalignment, infection, pain, fracture, dislocation and metal sensitivity.
VOLUME OF PRODUCT IN COMMERCE
36,486 units
DISTRIBUTION
Nationwide
The report was silent as to the contamination from metal known as metalosis that presents a significant risk to thousands of users. For more information on whether your device puts you at risk feel free to contact a DePuy lawyer at The Brandi Law Firm
Pharmaceutical Companies Perform Clinical Drug Trials in Other Countries
Posted by The Brandi Law Firm Blog in Avandia Diabetes Drug, DePuy Hip Replacement, Drug and Medical Device Litigation, Fosamax Osteoporosis Drug, Yaz Birth Control, Zicam Loss of Smell on January 12, 2011
“Prescription drugs kill some 200,000 Americans every year. Will that number go up, now that most clinical trials are conducted overseas…in places where regulation is virtually nonexistent, the F.D.A. doesn’t reach…?”
A fascinating article recently discussed the increasingly common practice of performing clinical drug trials outside of the United States for drugs planned to be sold to U.S. citizens. The article also talks of the minimal role of the Food and Drug Administration (F.D.A.) in regard to how it relies almost 100% on studies and data provided by the pharmaceutical company that hopes for F.D.A. approval. There is no question that there is an inherent and unavoidable bias in how this information is presented to administration, particularly when billions of dollars are at stake. Click here to read the entire Deadly Medicine article.
“In 2008 alone, according to the inspector general’s report, 80 percent of the applications submitted to the F.D.A. for new drugs contained data from foreign clinical trials. Increasingly, companies are doing 100 percent of their testing offshore…
Some medical researchers question whether the results of clinical trials conducted in certain other countries are relevant to Americans in the first place. They point out that people in impoverished parts of the world, for a variety of reasons, may metabolize drugs differently from the way Americans do...
One big factor in the shift of clinical trials to foreign countries is a loophole in F.D.A. regulations: if studies in the United States suggest that a drug has no benefit, trials from abroad can often be used in their stead to secure F.D.A. approval.“
Foreign studies have also been used to test on children, sometimes with devastating outcomes:
“In New Delhi, 49 babies died at the All India Institute of Medical Sciences while taking part in clinical trials over a 30-month period…The editor of an Indian medical journal said it was obvious that the trials were intended to extend patent life in Western countries ‘with no consequence or benefit for India, using Indian children as guinea pigs.’ In all, 4,142 children were enrolled in the studies, two-thirds of them less than one year old.”
The (FDA) does little to regulate drug trials, and relies upon the pharmaceutical companies for almost all data:
“The F.D.A. gets its information on foreign trials almost entirely from the companies themselves. It conducts little or no independent research….
In 2008 the F.D.A. inspected just 1.9 percent of trial sites inside the United States to ensure that they were complying with basic standards. Outside the country, it inspected even fewer trial sites—seven-tenths of 1 percent. In 2008, the F.D.A. visited only 45 of the 6,485 locations where foreign drug trials were being conducted.”
Diabetes drug Avandia was heavily tested outside the United States:
It may be just a coincidence, but as controversy swirls around new drugs, and as the F.D.A. continues to slap medicines with new warning labels—especially the black-box warnings that indicate the most serious potential reactions—most of the problematic drugs have all undergone testing outside the United States. Clinical-trial representatives working for GlaxoSmithKline went to Iaşi, Romania, to test Avandia, a diabetes drug, on the local population. Glaxo representatives also showed up in other cities in Romania—Bucureşti, Cluj-Napoca, Craiova, and Timişoara—as well as multiple cities in Latvia, Ukraine, Slovakia, the Russian Federation, Poland, Hungary, Lithuania, Estonia, the Czech Republic, Bulgaria, Croatia, Greece, Belgium, the Netherlands, Germany, France, and the United Kingdom. That was for the largest of the Avandia clinical trials. But there have been scores of others, all seeking to prove that the drug is safe and effective.”
The F.D.A. has also lagged behind in declaring Avandia unsafe once the dangers were well known:
“In 2009 the Institute for Safe Medication Practices, a Pennsylvania-based nonprofit group that monitors the prescription-drug field, linked the deaths of 1,354 people to Avandia, based on reports filed with the F.D.A. Studies also concluded that people taking the drug had an increased risk of developing heart disease, one of the very conditions that doctors treating diabetics hope to forestall…
As always, the F.D.A. was late to the party. In 2008 the American Diabetes Association and the European Association for the Study of Diabetes had warned against using Avandia. The Saudi Arabian drug-regulatory agency yanked it from the market, and the Indian government asked Glaxo to halt 19 of its Avandia trials in that country. In September 2010 the European Medicines Agency pulled Avandia from the shelves all across Europe. The F.D.A. still could not bring itself to take decisive action
This even though the F.D.A. knew that Glaxo had withheld critical safety information concerning the increased risk of heart attacks, and the F.D.A. itself had estimated that the drug had caused more than 83,000 heart attacks between 1999 and 2007. The agency settled for imposing new restrictions on the availability of the drug in the United States.”
Click here to read more of the Deadly Medicine article from Vanity Fair.
Click here for more information Avandia, Avandia heart risks or about The Brandi Law Firm Avandia Lawyers.
48.5% of Irish DePuy Patients Need to Replace their DePuy Hip
Posted by The Brandi Law Firm Blog in DePuy Hip Replacement on January 10, 2011
In August, DePuy Orthopaedics recalled its ASR XL total hip replacement device. At that time, and up to today, DePuy has claimed that about 12% of people who have had the DePuy hip installed have or will need it to revised (removed and replaced with another product). In fact, on its own website, DePuy continues to claim that after five years 12-13% of DePuy patients (about 1 in 8 people) will need revision.
However, an article in RTE News published figures from studies discussed at a recent conference in Dublin, Ireland, which greatly increased the percentage of DePuy hip recipients that need revision. The article claims that the Irish revision rate is 48.5%, or 1700 of the 3500 recipients of the DePuy product. This revision rate is much higher than has been seen so far in other studies. The reason for the revisions are “not just the mechanical failure of the DePuy ASR hip implant, but metal poisoning” from the chromium and cobalt ions that may be released into the body from the defective DePuy product.
At the Brandi Law Firm, our DePuy Attorneys gather information like this in order to properly pursue DePuy and protect our clients’ rights.
DePuy Paid Doctors over $60 Million in the Last 2 Years
Posted by The Brandi Law Firm Blog in DePuy Hip Replacement, Drug and Medical Device Litigation on January 7, 2011
One of the keys to drug and medical device manufacturers’ sale of their products is articles by leading members in the profession that directly or indirectly extol the benefits of the product. Manufacturers have long supported such “research”. Some doctors will fairly disclose the amounts and the nature of their relationships so that the readers are informed of the financial relationship. Others choose silence.
In November 2000, Dr. David Korn wrote in the Journal of the American Medical Association (JAMA) an article entitled Conflicts of Interest in Biomedical Research stating:
“Simply, the relationship between the public and academic medicine is special, different from any other in academe, and rooted in trust that is nowhere more evident or fragile than in medical research involving the participation of human subjects, where even the perception that faculty investigators or their institutions have financial interests that might compromise their independence and credibility cannot be tolerated. This is especially so when those interests have not been openly disclosed from the onset.”
Click here to read more of the Conflicts of Interest in Biomedical Research article.
In July 2001, JAMA Editors DeAngelis, Fontanarosa and Flanagin published an editorial in JAMA entitled a Reporting Financial Conflicts of Interest and Relationships Between Investigators and Research Sponsors which spoke of these conflicts:
“Unlike many of the other potential conflicts of interest, financial conflicts of interest usually are not apparent unless they are pecifically disclosed. Full disclosure is considered an important method for reporting and managing conflicts of interest and serves to highlight the potential for bias, but cannot and does not eliminate the conflicts. On the other hand, failure to prospectively disclose relevant financial interests violates the public’s trust, and if such information is revealed subsequently, the credibility of the investigators and of the journal that publishes the work may be seriously damaged.”
Click here to read more of the Reporting Financial Conflicts of Interest and Relationships Between Investigators and Research Sponsors article.
In July 2005, these same JAMA editors published another editorial entitled Reporting Conflicts of Interest, Financial Aspects of Research, and Role of Sponsors in Funded Studies, which stated:
“The need for transparency in reporting the financial conflicts of interest of authors and the relationships between investigators and funding sources has never been greater and is essential to help maintain confidence and trust in the scientific integrity of medical research articles.
The editors continued:
“All authors of all manuscripts submitted to JAMA … are required to report potential conflicts of interest, including specific financial interests relevant to the subject of their manuscript. Authors are expected to provide detailed information about any relevant financial interests or financial conflicts within the past 5 years and for the foreseeable future, particularly those present at the time the research was conducted or the paper was written and up to the time of publication… JAMA requires complete disclosure of all relevant financial relationships and potential financial conflicts of interest, regardless of amount or value.”
Click here to read more of the Reporting Conflicts of Interest, Financial Aspects of Research, and Role of Sponsors in Funded Studies article.
So while the leaders of the profession have called for more transparency, the writers associated with the manufacturers have often chosen silence. As a result, when you read an article about the DePuy ASR product by Dr. Thomas Vail ($546,376 in 2009 and 2010, including Vail Consulting LLC) or Thomas P. Schmalzried (between $2,766,062 in 2009 and 2010) you may not know of their financial interest or relationship. Below are the top four doctor recipients of funds:
Douglas A. Dennis, M.D. – $7,251,151
Chitranjan S. Ranawat, M.D. – $7,339,709
Richard D. Scott, M.D. – $11,461,882
Thomas S. Thornhill, M.D. – $11,552,532
Click here to see if your doctor was a paid by DePuy Orthopaedics, or click here to look at the DePuy website for DePuy Payments to Doctors.
This is the kind of information used by the Brandi Law Firm DePuy Hip Attorneys when they investigate claims of defective drugs and medical devices.
New Law Provides Vital Nursing Home Information
Posted by The Brandi Law Firm Blog in Elder Abuse on January 5, 2011
Do you have to make a decision for a parent or spouse regarding a nursing home?
It is very difficult to get information that you can trust. Talking with other families will often help, but interviewing the facility does not often lead to full disclosure regarding prior incidents, claims, or whether the facility has liability insurance.
Starting January 1, 2011 there are other sources available.
Nursing Home Ratings
As of January 1, 2011 all California nursing homes are required to post the ratings they received under the U.S. Centers for Medicare and Medicaid Services’ five-star system at their facilities. (Nursing homes must post ratings under new law, VCStar,) December 30, 2010). In addition, the facilities are required to post information explaining what the ratings mean and how people can get information about a facility’s state licensing record. The system looks at three different criteria to determine home’s rating: (1) health inspections; (2) staffing numbers; and (3) quality measures. A five star rating means “much beyond average” in terms of the overall quality of care it provides, and a one star rating means that the quality of care offered is considered “much below average.”
The aim of the California law is to make sure that patients, prospective residents, and families know what rating a nursing facility has been given.
Of California’s over 1,000 federally-rated nursing homes, 195 got the lowest rating, one star, while 187 got five stars. USA Today analyzed government data and found that 27% of the country’s 10,542 for-profit nursing homes are one-star, compared with 13% of the 4,182 not-for-profit nursing homes. Click here to look up a facility in the USA Today Rating System.
How you Can Protect Yourself and Your Family
In making this decision, do not be afraid to ask the facility representative if they have much staff turnover, had any State actions against them, or if they have liability insurance. The Brandi Firm represented a family for the death of their mother at a facility recommended by a local hospital. The mother received horrible care and ended up passing away as a result. Discovery showed the facility had no insurance, filed bankruptcy after suit was filed, and re-emerged later with the same owners and management under a different name.
Even with the ratings system in place, it remains up to us to ask the right questions and be proactive when it comes to care for the elderly or dependent adults. Also, make sure you go to the facility and see how it looks and smells and try to talk with other families about their experiences.
If you have had an incident at a nursing home or residence facility or want to learn more about elder issues, click here to learn about the Brandi Law Firm Elder Abuse Attorneys
Court Denies Avandia Manufacturer’s Request to Exclude Experts
Posted by The Brandi Law Firm Blog in Avandia Diabetes Drug, Drug and Medical Device Litigation on January 5, 2011
This week, Honorable Cynthia M. Rufe of the U.S. District Court for the Eastern District of Pennsylvania rejected GlaxoSmithKline’s (GSK) request to exclude three plaintiff experts from testifying about the health risks associated with taking the diabetes drug, Avandia.
The national Avandia multidistrict litigation is coordinated in front of Judge Rufe. Multidistrict Litigation (MDL) is established when civil actions involving one or more common questions of fact are pending in different districts. Cases subject to MDL are sent from where they are filed around the country to the coordinating court for all pretrial proceedings and discovery matters.
The three experts that GSK wished to exclude from the proceedings were designated by the Avandia Plaintiff’s MDL Steering Committee to testify and provide their expert opinions. GSK claimed that the three experts used unreliable methods for reaching their conclusions that Avandia may cause myocardial infarction (heart attack) in diabetic patients. In order for an expert to provide his or her opinion testimony in must meet the standard outlined in the U.S. Supreme Court case entitled Daubert v. Merrell Dow Pharms. Inc. (1993) 509 U.S. 579: they must demonstrate that they have good grounds for their causation opinion (i.e. the opinion is based on methods and procedures of science, not subjective belief) and a reasonable degree of scientific certainty regarding their causation opinion.
Here, Judge Rufe denied GSK’s motion to exclude the experts and held:
“Each of Plaintiffs’ three experts have consulted an extensive body of epidemiological research to support their conclusions, and evaluated and weighed the quality and usefulness of the various studies. Although the conclusions differ from the conclusions reached by GSK’s experts, generally speaking the epidemiological studies relied upon by Plaintiffs’ experts are the same studies consulted by GSK and the FDA in their evaluation of the risk profile of Avandia.”
Click here if you want to read the Avandia Experts Order.
In California, Honorable Carolyn B. Kuhl, Judge of the Superior Court for Los Angeles, appointed Thomas J. Brandi to one of the five leadership positions on the Plaintiffs Steering Committee in the California consolidated Avandia litigation. Click here to read more about the Brandi Law Firm Avandia Attorneys.
Drug Manufacturer Whistle-Blower Exposes Facility Failures
Posted by The Brandi Law Firm Blog in Avandia Diabetes Drug on January 4, 2011
A segment on 60 Minutes discussed the story of Cheryl Eckard, who was the global quality assurance manager at GlaxoSmithKline (GSK). Her job was to inspect plants to make sure drugs were manufactured properly and met government standards for purity.
In 2002, Ms. Eckard was assigned to GSK’s important Cidra, Puerto Rico, plant where 900 employees manufactured 20 drugs for U.S. consumption. At the plant, Ms. Eckard observed water tainted with bacteria used to make tablets; failures on production lines that made some drugs too strong, some not strong enough; and the employees were contaminating products, including the anti-bacterial ointment Bactroban, which was made in a sealed tank to prevent contamination.
Why?
“It saved money,” said Eckard.
Among the drug mix up problems at Cidra, Ms. Eckard identified nine, including Avandia diabetes pills mixed in packages with over-the-counter Tagamet antacids and Paxil antidepressants, mixed with the Avandia diabetes drug. Currently, the Brandi Law Firm Avandia Attorneys are investigating defects in the design and formulation of the Avandia drug. But our investigations assume that all Avandia pills are identical. The possibility that different Avandia bottles may contain different drugs points to a whole new level of liability.
Eckard did her job and provided a summary to seven GSK executives that detailed nine high-risk areas at the plant, including the mix-ups, the water contamination, and the problems with sterility. She warned that if the FDA knew what the company knew, the government could seize the factory. Weeks later she was laid off due to “downsizing”.
Eckard then provided all of this information to the FDA and assisted in the prosecution of GSK for problems at the Cidra factory.
Click here to read the 60 Minutes Article or here to view the 60 Minutes Video Segment
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