Archive for February, 2011
Federal Court Holds that Hershey RSRs are Entitled to Overtime
Posted by The Brandi Law Firm Blog in Hershey Overtime Lawsuit on February 23, 2011
On February 23, 2011, the Honorable Magistrate Bernard Zimmerman, United States District Court for the Northern District of California, issued an order holding that the Hershey Retail Sales Representative (“RSR”) plaintiffs and those RSRs who have joined the case of Campanelli, et al. v. The Hershey Company, Case No. 3:08-cv-01862-BZ, are entitled to overtime compensation. The Court held that the RSRs are not exempt under the “outside sales” or “administrative exemptions” as a matter of law. Click here to read a copy of the Hershey Order Granting Plaintiffs Motion for Partial Summary.
Click here to learn more about the Hershey Overtime Lawsuit.
Bisphosphonates (Fosamax) Increases Risk of Femoral Fractures
Posted by The Brandi Law Firm Blog in Fosamax Osteoporosis Drug on February 23, 2011
A recent article in the Journal of the American Medical Association (JAMA) has again linked use of bisphosphonates for osteoporosis to increased risk of subtrochanteric and femur fractures. The drugs in the bisphosphonate family include Fosamax, Boniva, Actonel, Aredia, Zometa, and Reclast.
The JAMA article, entitled “Bisphosphonate Use and the Risk of Subtrochanteric and Femoral Shaft Fractures in Older Women” followed women aged 68 and older in Ontario, Canada, who had bisphosphonate therapy starting between 2002 2008.
While the overall risk of such fractures is low, the authors found that 64% of those with these fractures were women who had taken bisphosphonates for 5 years or more. Other data suggested that 10% of these fractures may have been prevented if no patient received more than 5 years of bisphosphonate exposure.
Click here to read the entire article: Bisphosphonate Use and the Risk of Subtrochanteric and Femoral Shaft Fractures in Older Women
If you or a loved one have taken Fosamax or another bisphosphonate drug and have suffered these fractures, please click here to speak to a Brandi Law Firm Fosamax Attorney.
Louisiana Sues GSK for Avandia Fraud
Posted by The Brandi Law Firm Blog in Avandia Diabetes Drug on February 18, 2011
Louisiana Attorney General Buddy Caldwell has filed suit in a Baton Rouge state court against GlaxoSmithKline claiming that it defrauded Louisiana’s Medicaid program out of $36 million in reimbursement payments related to Avandia. AG Caldwell contends that GSK “wrongfully and illegally marketed, priced, sold and promoted the diabetes medication”. Avandia use has been linked to an increased risk of hypertension, obesity, stroke, heart attack and heart disease.
The Louisiana Department of Health and Hospitals secretary has stated: “It is terribly disturbing that a company this size would take advantage of people by offering misleading information and take funds away from those who need it most’’.
Click here to read the full State Sues Drug Maker article.
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.
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.
FDA to Outsource Inspections of Non-U.S. Pharmaceutical Factories
Posted by The Brandi Law Firm Blog in Avandia Diabetes Drug, Drug and Medical Device Litigation, Fosamax Osteoporosis Drug, Yaz Birth Control on February 11, 2011
With the advent of globalization and the move of manufacturing plants off shore, many drug manufacturers have taken advantage of lower costs and shipped American jobs overseas. Unfortunately the FDA’s U.S. based inspectors did not follow overseas to ensure the quality of the products manufacture for consumption in the U.S.
In the U.S., FDA inspections generally occur every 30 months according to the Government Accountability Office. But how often do the seam inspections occur in the off shored locations? About once every nine years.
In an article in Bloomberg news, the FDA’s acting principal deputy commissioner, John Taylor (a former executive at Abbot Labs and Biotechnology Industry Trade Organization in Washington) said the agency is looking to outsource the inspections to private concerns. Click here to read the article about the FDA Outsourcing Overseas Factory Inspections.
Drugmakers have farmed out everything from research and manufacturing to IT and sales. In January 2010 Eli Lilly said it would outsource more of its R&D, and in December 2009 AstraZeneca announced more outsourced manufacturing. Click here to read more about Pharmaceutical Company Outsourcing.
To read a previous Brandi Law Firm Blog entry regarding what could go wrong at foreign pharmaceutical factories, click here: Drug Manufacturer Whistle-Blower Exposes Facility Failures
With the combined outsourcing of production AND regulation of that production, it seems that the only person that loses is the consumer.
Click her to read more about the Brandi Law Firm lawsuits concerning Avandia, Fosamax, and Yaz.
San Francisco’s Most Dangerous Streets for Bicyclists
Posted by The Brandi Law Firm Blog in General Interest on February 8, 2011
San Francisco is certainly a bike-friendly city, but with more bicyclists on the road comes more accidents with motor vehicles.
The Bay Citizen has just released its comprehensive bicycle accident study which used information from police reports to determine location and fault of bicycle-related accidents in San Francisco since 2009. Click here to view the Bay Citizen article.
In our cases that concern bicycle incidents, there are two issues that we often face with police reports. First, a significant number of bicycle accidents are never reported to the police, even if they cause injuries. This results in a well known overall under-reporting of bicycle accidents. Second, even if there is a police report, often the police officer assigns fault based upon incomplete or one-sided information.
Even though the police reports may not be perfectly accurate, the Bay Citizen has digested a mountain of information and created a very useful Bike Accident Tracker.
There are a number of other resources available to learn more about safe bicycling in San Francisco.
The 2010 San Francisco Bicycle Count report that discusses the most common routes used by San Francisco bicyclists. This can be helpful to plan bicycle routes within San Francisco.
The San Francisco 2008 Traffic Collision Report discusses the prevalence and severity of automobile, bicycle, and pedestrian accidents in the City. The 2008 injury collision total was the highest in the previous ten years.
This report includes the 10 most dangerous San Francisco intersections and on page 31 there is a table of the Highest Motor Vehicle / Bicycle Injury Collision Intersections. This is the type of information that San Francisco bicyclists should use in an effort to avoid conflict with motor vehicles.
If you or a loved one has been involved in a bicycle accident, click here to learn more about the Brandi Law Firm Bicycle 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.
Johnson and Johnson Earnings Down Amid DePuy Charge
Posted by The Brandi Law Firm Blog in DePuy Hip Replacement on February 1, 2011
In recent financial reports Johnson & Johnson, owner of DePuy Orthopaedics, has set aside almost $1 billion to prepare for litigation and settlements related to injured plaintiffs who have used the DePuy hip replacement apparatus. The litigation nationally is just commencing with the formation of an MDL (multi-district litigation). It is has been active in California for some time and a motion is pending in San Francisco Superior Court to join the cases for pre trial proceedings there.
Over 93,000 DePuy hip replacement devices were recalled in August of 2010 largely due to a failure rate much higher than previously anticipated by Johnson & Johnson.
Click here to read more about Johnson and Johnson’s 2010 income performance: Product recalls weigh on JJ earnings – MarketWatch
Click here for more information about the Brandi Law Firm DePuy Attorneys.
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