Yaz, Bayer, and the Whole Truth
Posted by The Brandi Law Firm Blog in Drug and Medical Device Litigation, Yaz Birth Control on December 6, 2011
According to documents unsealed in litigation involving the YAZ birth control product made by Bayer, former FDA head David Kessler stated Bayer didn’t include an analysis “that demonstrated an increase in the U.S. reporting rate” for venous thromboembolism, or clots, in a 2004 review of Yasmin’s safety provided to the agency.
According to Kessler “Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin.” Kessler also indicated that the company also promoted the oral contraceptive for unapproved uses, particularly for treatment of premenstrual syndrome. Kessler’s 196-page report was one of several such expert opinions that were released by a federal court in Illinois, where some thousands of lawsuits are pending over alleged injuries and deaths relating to Yaz and Yasmin, as well as generics. Kessler’s report was submitted on behalf of women suing the manufacturer, and he was compensated for his time.
Read the entire article here: Former FDA Commish: Bayer Hid Yasmin Data
Dr. Kessler wrote: “In my opinion, had I, or a medical review officer, known these facts prior to approval, further investigation would be warranted before a decision on Yasmin’s NDA could be made. These facts would impact the Agency’s risk-benefit equation about the drug and whether it could be approved”.
Women who used YAZ for birth control and who later suffered clots from YAZ obviously were not advised of the increased risk thereby enabling the company to maintain its competitive edge in the market. If the truth were told, sales would have decreased, doctors would have made fewer recommendations for YAZ, and more and more women would not have been exposed to costly life changing risks.
But the whole truth was not told and women and their families suffered needlessly while profits continued to roll in.
Attorneys at The Brandi Law Firm have long been involved in drug and device litigation, from the Dalkon Shield, Fen-Phen, Vioxx, Avandia, YAZ, to POP (pelvic organ prolapse) surgeries from Transvaginal mesh, bladder cancer from Actos, femur fractures from Fosamax, to toxic poisoning and revisions from De Puy ASR metal on metal hip implants. For more information contact Thomas Brandi or the Brandi Law Firm Pharmaceutical Attorneys.
Read This Before You Take Your Vitamins!
Posted by The Brandi Law Firm Blog in Drug and Medical Device Litigation on November 28, 2011
Many people do not realize that the vitamins or other supplement they take on a daily basis are not subject to FDA control, approval, or oversight. “Dietary supplements”, defined by Congress as a product taken by mouth that contains an ingredient intended to supplement the diet, are considered to be “foods” not “drugs” are not subject to pre-market testing requirements or other oversight provided by the FDA for drugs. Instead, manufacturers and/or distributors are responsible for determining that their product is safe and that any representations made about them are supported by adequate evidence to show that they are not false or misleading.
Put simply, the FDA does not need to approve any dietary supplement prior to or after the time it is sold. In fact, a manufacturer or distributor of these products is not even required to provide the FDA with the evidence it relies on to substantiate its safety or effectiveness claims either before or after bringing the supplement to market. The supplement manufacturer is also responsible for determining the appropriate serving size or the amount of a nutrient in any form of dietary supplements without FDA review or approval. The FDA does not analyze dietary supplement ingredients before they are sold to consumers, but rather relies on the manufacturers themselves to ensure that the label and ingredient list are accurate. In order for a dietary supplement to be removed from the market, the FDA and not the manufacturer must show that a supplement is unsafe before it can take action to restrict the product’s use.
What can a consumer do to get information about a specific dietary supplement? To obtain more information than is provided by the label, you may contact the manufacturer directly for information. If you believe that you have a problem or illness caused by the use of a supplement, see your healthcare provider and report this problem to the FDA. The Federal Trade Commission (FTC) can also be contacted to complain about false advertising. The most important protection the consumer has is their common sense: if a product makes claims that seem too good to be true, they probably are.
Click here for more information about the Brandi Law Firm Pharmaceutical Attorneys.
Another Blockbuster Fine, Consumers Shut Out Again
Posted by The Brandi Law Firm Blog in Drug and Medical Device Litigation, Fosamax Osteoporosis Drug on November 22, 2011
Merck, makers of VIOXX and FOSAMAX among other drugs, agreed to pay $950 million to settle criminal and civil claims that it illegally promoted the drug VIOXX. Merck will plead guilty to a misdemeanor offense and pay $321,636, 000 criminal fines. According to the Justice Department, Merck also entered into a civil settlement and will pay $628 million to resolve additional allegations regarding off label marketing of VIOXX and false statements about the drug’s cardiovascular safety. Click here to read the Department of Justice release: U.S. Pharmaceutical Company Merck Sharp & Dohme to Pay Nearly One Billion Dollars Over Promotion of Vioxx
$424,389,000 goes to the US government and $201,975,000 to participating MEDICAID States. According to the Justice Department, “The settlement resolves allegations that Merck representatives made inaccurate, unsupported, or misleading statements about Vioxx’s cardiovascular safety in order to increase sales of the drug, resulting in payments by the federal government. It also resolves allegations that Merck made false statements to state Medicaid agencies about the cardiovascular safety of Vioxx, and that those agencies relied on Merck’s false claims in making payment decisions about the drug.”
In its own statement Merck stated “The civil settlement does not constitute any admission by Merck of any liability or wrongdoing.”
Who loses?
Consumers. Those who were injured by VIOXX, who were led to believe it was safe, and were killed or seriously injured.
Who else?
The medical profession who was taken advantage of in a system that relies on drug companies telling the truth. And our entire society, where a drug company can do this, and simply pay a fine to walk away.
Who Wins? Merck’s management and employees who engaged in improper conduct and face no criminal penalties and keep their jobs. And don’t forget Merck itself. In spite of the amount of the fine, look at what Merck earned versus what they paid.
Our office represented a number of VIOXX users and tried a VIOXX case in California in Los Angeles Superior Court (Arrigale vs. Merck). What a shame that so many people were not told the truth and suffered life changing heart attacks and strokes. Where would they be today if the truth was simply told to consumers, doctors, and the public. Merck also makes FOSAMAX, a drug associated with atypical femur fractures.
The Brandi Law Firm represents a number of women and men who suffered femur fractures while taking FOSAMAX. Only time will tell if Merck told the truth about FOSAMAX. For information about FOSAMAX, or other drug or device cases, contact the attorneys at the Brandi Law Firm www.brandilaw.com Attorneys at The Brandi Law Firm have long been involved in drug and device litigation, from the Dalkon Shield, Phen fen, VIOXX, AVANDIA, YAZ, to POP ( pelvic organ prolapse) surgeries from Transvaginal mesh, bladder cancer from Actos, femur fractures from Fosamax, to toxic poisoning and revisions from De Puy ASR metal on metal hip implants. For more information contact Drug Litigation Attorneys a the Brandi Law Firm.
Recent Studies Highlight Increased Yaz Risks
Posted by The Brandi Law Firm Blog in Yaz Birth Control on November 21, 2011
In an October 2011 British Medical Journal article entitled “Risk of venous thromboembolism from use of oral contraceptives containing different progestogens and oestrogen doses: Danish cohort study, 2001-2009.”, the authors found that birth control pills like YAZ, YASMIN or OCELLA which contain drospirenone or oral contraceptives containing a third generation progestins put women at two times the risk of developing venous thromboembolism when compared to women using birth control pills containing levonorgstrel, a second generation progestin. The study drew upon data from four registries in Denmark and studied non pregnant women ages 15-49 from January 2001 to December 2009 containing 8,010,290 women years of observation.
In a November 7, 2011 Canadian Medical Association Journal, (www.cmaj.ca) Dr. Naomi Gronich reported the findings of her study of drospirenone containing second and third generation oral contraceptives and its relationship to risks of deep vein thrombosis and pulmonary embolism, concluding: “Use of drospirenone containing oral contraceptives was associated with an increased risk of deep vein thrombosis (DVT) and pulmonary embolism but not transient ischemic attack or cerebrovascular attack.” This study examined women in Israel from ages 12 to 50 for whom combined oral contraceptives had been dispensed between January 1, 2002 and December 31, 2008.
If you are a YAZ, YASMIN or OCELLA user containing drospirenone you may wish to talk with your doctor. If you or a loved one has suffered a pulmonary embolism or deep vein thrombosis (DVT) you may wish to consult one of the YAZ lawyers at the Brandi Law Firm.
Off Label Drug Promotions: Who Wins and Who Loses
Posted by The Brandi Law Firm Blog in Drug and Medical Device Litigation on November 15, 2011
In drug litigation, one of the common claims is that drug or device manufacturers failed to adequately warn of risks of the drug or device, and that the manufacturer simply failed to tell the whole truth. By simply turning on your television you are subjected to a seemingly nonstop onslaught of advertizing for drugs and devices that will end your pain, restore your energy, enable you to do activities you have not done in years, and give you a fantastic sex life. If the ads work, the consumers are “asking your doctor about” whatever new drug is the subject of the current slick campaign.
When the drug or device use results in injuries, one of the standard defenses relied on by the drug and device manufacturers is the Learned Intermediary Doctrine, which in simplest terms says, we warned the doctor who possesses superior knowledge and we don’t have to warn the consumer.
But a typically overworked doctor with a limited time to see patients, visit the hospital, attend conferences, fight with insurers over payments, and keep abreast of literature, etc., MUST rely on the drug and device manufactures with their vastly superior knowledge and resources to simply truthfully tell them the risks as well as the benefits.
One of the dirty little secrets is off label use, where someone uses the drug for a potential condition that is not stated on the label. Drug companies seek to expand their market through these procedures which are clearly improper. It is profitable to do this as market share expands, by doctors being urged to expand prescriptions to currently non-labeled uses but for which marketers ensure doctors are supported by research and experience.
But what happens to the manufacturers when they are caught? Here are some recent examples;
On October 19, 2011 Abbott Laboratories ($ABT) has set aside $1.5 billion for a potential off-label marketing settlement with the U.S. Justice Department. According to reports Abbott pushed Depakote (approved for treatment of seizures) for autism, sexual compulsions, agitated and aggressive patients amongst other conditions.
Read more: Abbott Earmarks $1.5B for Off-Label Depakote Settlement
Other recent settlements include Johnson and Johnson paying $81 million for claims regarding Risperadal (J&J, feds reach deal on one Risperdal charge) and, Pfizer’s $2.3 billion settlement of claims of improper promotion of Bextra and other drugs for unapproved uses.
Who loses?
Consumers, who used the drugs, were injured, and receive nothing of these settlements. Instead they are going through the court processes to hold companies liable for their conduct, and where the company likely will claim if any fault exists, it was that of the doctor, who has superior knowledge, and to whom warnings were given, or it is the fault of the consumer who has some pre existing or unique anatomical condition that caused their injury.
Amazingly, the manufacturers contend, based on the Learned Intermediary Doctrine, they have no obligation to tell the consumers the whole truth.
Attorneys at The Brandi Law Firm have long been involved in drug and device litigation, from the Dalkon Shield, Phen fen, Vioxx, Avandia, Yaz, to POP ( pelvic organ prolapse) surgeries from Transvaginal mesh, bladder cancer from Actos, femur fractures from Fosamax, to toxic poisoning and revisions from De Puy ASR metal on metal hip implants. For more information contact Thomas Brandi at The Brandi Law Firm Website.
TOYOTA RECALL: Have We had this Dream Before??
Posted by The Brandi Law Firm Blog in Automobile Defects on November 9, 2011
From sudden acceleration to Intelligent Power Modules resulting in loss of power to defects in power steering system resulting in loss of control, Toyota has set new lows in the automobile league this year in safety recalls. What in the world is happening with their cars?
No need to discuss the issues about sudden acceleration. They are well publicized.
On June 29, 2011 Toyota recalled 45,500 Highlanders and 36,700 Lexus Rx400h vehicles sold in the United States because “The Intelligent Power Module (IPM) located inside the Hybrid System Inverter contains a control board with transistors. Certain transistors on the control boards in some of the subject vehicles were inadequately soldered and could be damaged from heat caused by a large current flow during high-load driving.”
What would be the result?
A blown fuse resulting in loss of power leaving drivers in a coasting mode searching for a safe place.
On November 9, 2011 Toyota announced the recall of 420,000 cars in the United States because of a problem with the power steering system. Involved are some 2004 Toyota Avalons as well as 2004 and 2005 Camrys, Highlander SUVs, Sienna Minivans, Solara convertibles, Lexus ES330 sedans and RX330 SUVs. The 2006 Lexus RX400h hybrid SUV is also included in the recall. All the vehicles affected by the recall are powered by V6 engines.
Apparently a belt in the cars power steering pump can be separated from a pulley causing the power steering system to fail. According to the recall, Toyota has asked its drivers to listen for any unusual noise from their car’s engine compartment and if they hear it, contact Toyota. Not exactly reassuring. By the way, can you describe with confidence an “unusual noise”
Read the Toyota Press Release here: Toyota Announces Voluntary Safety Recall of Certain 2006 and 2007 Model Year Highlander Hybrid and RX 400h Vehicles
Read the CNN Article: Toyota Recalls 420,000 Cars in the U.S.
Americans rely on their car manufactures to provide a safe well designed vehicle. Sadly that is not often the case. The Brandi Law Firm has successfully represented many people injured from defective Toyotas, Fords, GM products and numerous other manufacturers and suppliers. Often time’s people involved in accidents don’t examine the issues of defective vehicle design nor whether the car was truly crashworthy- does it contain the appropriate crash protection. If you or a loved one has been injured in an auto crash, our attorneys are available to consult with you. www.brandilaw.com
Is Your Child’s Helmet Safe?
Posted by The Brandi Law Firm Blog in General Interest on November 8, 2011
As we go deeper into fall, our high schools and colleges are in the final push for league championships, rankings, and bowl bids. Unfortunately some of the equipment they are using is not protecting them in the violent world of football contact.
On November 3, 2011 Under Armour and the CPSC announced a recall of 541,000 chin straps sold from January 2008 through September 2011 for about $20 and used in high school and youth football helmets because the “The metal snap that connects the chin strap to the helmet has sharp edges, posing a laceration hazard when the user’s metal snap comes into contact with another player”.
In this most American game of football the players used chinstraps manufactured in China and marketed as the UA Defender Chin Straps. According to the CPSC “They were sold in the following colors: white and black, red, midnight, navy and royal and have a hard nylon shell, a padded chin area and a plastic strap with “Under Armour” printed on it. The chin straps have metal clasps that tighten the straps and attach them to the helmet.”
According to the recall announcement; “Consumers should immediately stop using the recalled chin straps and contact Under Armour for a free replacement chin strap.”
You may wish to take a look at helmet your youngster is using and take appropriate action.
Attorneys at the Brandi Law Firm have represented helmet wearing athletes (football, lacrosse) and cyclists injured by defective equipment. For more information, contact us at www.brandilaw.com
Under Armour Recalls Chin Straps for Football Helmets Due to Laceration Hazard
GSK Settles Avandia Governmental Probes for $3B, But Nothing For Consumers
Posted by The Brandi Law Firm Blog in Avandia Diabetes Drug on November 4, 2011
Faced with multiple criminal investigations into illegal practices, on November 3, 2011, the British drug company GlaxoSmithKline said that it had agreed to pay $3 billion to settle United States government civil and criminal investigations into its sales practices for numerous drugs, including Avandia. Company whisteblowers alleged that GSK improperly paid Doctors and manipulated medical research to promote sales of the drug.
The $3 billion settlement covers not only the Avandia practices, but also a Justice Department investigation of Medicaid pricing practices and a nationwide Untied States attorneys investigation into sales and marketing of nine of GSK’s drugs.
Left out of the deal are the people who were injured as none of this money is going to the victims of these illegal actions. Avandia victims who suffered heart attacks and strokes will remain in the civil litigation system where they must prove Avandia caused their injuries.
In a move that speaks volumes about our society, GSK stock ROSE 2.96percent to $44.55, near its 52 week high.
The Brandi Law Firm is representing numerous Avandia users who suffered injuries from this product. For more information, click here to read about the Brandi Law Firm Avandia Attorneys.
Glaxo Settles With U.S. for $3 Billion (Wall Street Journal)
Feds Re-Indict Ex-Glaxo In House Lauren Stevens for Corporate Duty
Don’t Overlook Bikes When it Comes to Safety!
Posted by The Brandi Law Firm Blog in General Interest on October 29, 2011
Throughout California, both in the cities and outlying areas, bicycles have become increasingly popular for both recreational and commuter use. In San Francisco, bikes flood special bike lanes on Market street, in the Mission district, South of Market area, the “wiggle”, Golden Gate Park, and along the waterfront in specially marked bike lanes with traffic devices called “Sharrows”, placed there by the City of San Francisco and the State to increase signage and awareness of bike use. Motorists and bicyclists are learning, sometimes slowly, that each have the right to use the road.
In the wine country, mountains, and coastal areas bikes are a common sight on shoulders of two lane roads. There are even locations on California freeways where bikes are allowed, although putting bikes in unprotected shoulders that vehicles need for a refuge often creates a trap for car and bike alike.
We frequently hear of recalls in cars but most people overlook the fact that bikes can have safety issues too.
One of the more popular brands is TREX, who on October 28, 2011 was the subject of a CPSC recall of some 27,000 FX and District bicycles because “the bolts that secure the seat saddle clamp to the seat can break causing you to fall”. The bikes were sold at specialty bike shops from May to September 2011.
In May 2009 Trex recalled the Trex model 7300, 7300 WSD, and 7500 because “a small number of bikes were made with a fork that was assembled incorectly”, which could allow the front wheel to turn unexpectedly .
In 2008 there was a recall of Trex MT 220 Girls bicycles made in 2005, 2006, 2007 that were made with “a front frame that was welded incorrectly”.
When you go riding, make sure you have the proper protective equipment, including helmets. But be aware there as well. On May 4, 2006 Trex and the Consumer Product Safety Commission announced a recall of Trek Anthemn C Elite and Anthemn C Elite WSD bicycle helmets because Consumer Union tests showed the helmets “did not meet the CPSC guidelines.”
If you are in the market for bicycles or related equipment this Christmas season, be an informed consumer and check for recall and safety issues with your dealer and on line. (See www.cpsc.gov)
Our office has represented a number of bicyclists in actions involving defective bikes and unsafe practices by public entities in improper markings, failing to have bike lanes, as well routing bikes into areas where they had no protection whatsoever. We have obtained recoveries for injured bicyclists from manufacturers and public entities. For more information, contact The Brandi Law Firm www.brandilaw.com
Kids Have Safety Rights, Too.
Posted by The Brandi Law Firm Blog in General Interest on October 25, 2011
As we approach Halloween, children of all ages will be getting costumes and going door to door for treats while adults are also costuming and going to parties and celebrations. But as we too often read after a Halloween tragedy, there are safety concerns that do not appear at first sight. For example, many kids will be wearing costumes that come with masks. Too often we assume they are safe when that is simply not the case.
On October 21, 2011 the Consumer Product Safety commission announced the recall of children’s frog masks imported by Target Corp of Minnesota and sold nationwide because “The plush frog masks lack proper ventilation. When secured in place across a child’s face, it presents a suffocation hazard to the child.”
Below is a picture of the mask from the CPSC website:
Another potential issue is flammability of costumes.
The federal Flammable Fabrics Act (FFA) requires costumes sold at retail to be flame-resistant. To prevent costume-related burns, CPSC enforces this requirement and recalls costumes and other products that violate the FFA. Unfortunately, some kids end up wearing costumes that don’t meet these requirements.
The Consumer Product Safety Commission has detailed information on numerous products, recalls, choking hazards, fire related issues that advertisers never hint at. www.cpsc.gov/. This is a valuable website for parents or anyone interested in product history and safety. So look at the labels and if you have any questions, check the CPSC website.
