Lupron was injected in thousands of women in an effort to inhibit puberty or increase height.
More than 10,000 adverse event reports have been filed with the FDA based on the experiences of women who’ve taken Lupron. The reports describe a variety of symptoms experienced by those who took the drug to grow taller or delay puberty.
Lupron, currently manufactured by AbbVie, is an injection designed to reduce testosterone in men or estrogen in women. The drug is also approved for use by men with prostate cancer.
The experiences of the women that used the drugs are varied but complex. Many women reported experiencing symptoms and conditions linked to older, even elderly people. According to the FDA reports:
A 20-year-old was diagnosed with osteopenia, a thinning of the bones. A 26-year-old in Massachusetts needed a total hip replacement. One 25-year-old woman from Pennsylvania has osteoporosis and a cracked spine. In Wisconsin, another woman in her 20’s has chronic pain and degenerative disc disease.
Other women described depression and anxiety.
Additionally, the FDA is reviewing deadly seizures caused by the use of Lupron and similar drugs.
The drug has had success in the marketplace. In 2015, the drug-maker reportedly brought in $826 million in sales.
On Friday, a federal judge denied the corporation’s bid to overturn a 2015 state ruling to label it as a cancer risk.
The main criticism is Roundup’s main ingredient. The popular weed-killer includes Glyphosate, a chemical which was originally touted as a way to kill weeds while leaving crops and plants intact.
The U.S. Environmental Protection Agency, says it has ‘low toxicity.’ The agency considers Glyphosate safe when used correctly.
However, under California Proposition 65 label requirements in California, businesses are required to notify Californians about significant amounts of chemicals in the products that they purchase.
Chemicals that require labeling include ingredients or additives in pesticides, common household products, food, drugs, dyes, or solvents.
California regulators are waiting for the lawsuit to be resolved before deciding whether to require warnings, said Sam Delson, a spokesman for the state Office of Environmental Health Hazard Assessment.
Software vulnerabilities of medical devices may be difficult for health sector officials and manufacturers to manage.
As we reported last week, St. Jude implemented software updates that could protect pacemakers and other medical devices from being compromised by hackers.
“Software is never perfect and all systems still will have these flaws,” says Joshua Corman, director of the Cyber Statecraft Initiative at the Atlantic Council and an expert on medical device security. “The question is how gracefully and collaboratively and quickly and safely can we respond to these flaws.”
In late 2016, there were reports that the Merlin@home transmitter used in monitoring certain St. Jude Medical implant devices could be hacked. These hacks could lead to deadly consequences for the patient.
MedSec, a cybersecurity firm, initially found the problems in the St. Jude devices. After which they “tipped off”- the activist investment firm Muddy Waters, which publicized the flaws and advised clients to bet against the health care firm’s stock.
Ever since the US government and St. Jude confirmed the one flaw, the VA has been “taking steps to be sure all our patients and providers are aware of this issue and take appropriate actions to be sure that all our patients get the update for their monitor,” said Merritt Raitt, acting director of the VA National Cardiac Device Surveillance Program.
The more a person breathes in tiny asbestos particles, the more likely that individual will develop a large variety of lung and breathing complications.
Asbestos was introduced to the construction industry over 100 years ago. It was widely considered the standard for strengthening building materials in the construction of buildings.
The dangers of inhaling asbestos fibers began to surface around 1980. It does not take extreme exposure to asbestos for it to be dangerous. Most victims of asbestos exposure and asbestosis have worked or lived in an environment where there is asbestos in the building or home.
These effects range from wheezing and shortness of breath to mesothelioma and lung cancer. Regardless of your condition, Medical Claim Legal can help you obtain compensation.
There are a large number of lawsuits involving asbestos exposure and asbestosis. Do not let your case get passed over. Medical Claim Legal will connect you with a lawyer who is experienced and successful in the asbestos lawsuit field. To get the compensation that may be owed to you, contact Medical Claim Legal today.
MedicalClaimLegal, simplifying the process for Asbestos Exposure and Asbestosis compensation
Drug distributor McKesson Corporation will pay a $150 million fine.
Regulators have alleged that McKesson Corporation, a drug distributor, failed to report suspicious orders of painkillers that have been linked to the opioid addiction epidemic.
The company has agreed to pay a $150 million fine after they allegedly failed to detect and report suspicious orders of prescription pain pills, according to federal prosecutors. This has arguably led to the growing heroin crisis.
For example, more than 1.6 million orders for controlled substances were filled by McKesson in Colorado between June 2008 through May 2013. However, just 16 of them from a single customer as suspicious, the Justice Department said.
In a statement from the White House last summer, federal fears related to pain killer and opioid addictions were made clear:
“President [Obama] has made [it] clear that addressing this epidemic is a priority for his Administration. While Federal agencies have been using their authority to take every available action they can, Congress needs to take action on what is most urgently needed now – additional funding to make lifesaving treatment available to everyone who seeks it. The President has called for $1.1 billion in new funding to help Americans who want treatment get it wherever they live.”
Those addicted to opioid painkillers are most likely to form a heroin addiction according to the Centers for Disease and prevention.
McKesson, the nation’s largest drug distributor, was accused of failing to create an effective system to detect suspicious pharmacy orders. This was argued to be a violation of the Controlled Substances Act.
In 2008, McKesson agreed to a $13.25 million civil penalty for actions including failing to report suspicious sales of their drugs on “internet pharmacies.”
In a statement, McKesson said it settled “in the interest of moving beyond disagreements about whether McKesson was complying with the controlled substance regulations … and to instead focus on the company’s partnership with regulators and others to help stem the opioid epidemic in this country.”
Lawsuit claims Coca-Cola misled consumers on sugary soda health risks.
The consumer-advocacy group, Center for Science in the Public Interest (CSPI) asserts that Coca-Cola has misled consumers about the health risks of sugary drinks such as soda.
In 2015, it was revealed that the corporate giant had heavily funded and been involved in the operation of the research group Global Energy Balance Network. Coca-Cola aimed to help establish the group as a “reputable scientific source to counter “public health extremists.” The company has starkly tried to avoid claims that their products are unhealthy.
It is based on these findings that the lawsuit claims that, “for years, [the] defendants have engaged in a pattern of deception to mislead and confuse the public (and governmental entities that bear responsibility for the public health) about the scientific consensus that consumption of sugar-sweetened beverages is linked to obesity, type 2 diabetes, and cardiovascular disease.”
The industry group, American Beverage Association (ABA) is the co-defendant in the lawsuit. The ABA continues to argue that obesity is a “complex condition.” Further asserting that as obesity and diabetes rates continue to rise, that soda consumption is dropping.
CSPI wants the ABA and Coca-Cola to make some changes. They want marketing to disclose the health risks of sugary drinks, while stopping ads directed at children. They also want the groups to disclose file “indicating the potential health implications.” Plus, the CSPI would like for Coca-Cola and the ABA to fund a public health campaign.
The ABA said in a statement that “America’s beverage companies know we have an important role to play in addressing our nation’s health challenges. That’s why we’re engaging with health groups and community organizations to drive a reduction in the sugar and calories Americans get from beverages.”
Coca-Cola has called the suit “legally and factually meritless.”
A lawsuit accusing Medtronics of covering up negative side effects of its Infuse bone graft has been revived by an appeals court.
A lawsuit accusing Medtronic of misleading shareholders by concealing the adverse effects of its Infuse bone graft, has been revived by the The 8th U.S. Circuit Court of Appeals in St. Paul, Minnesota.
The Infuse bone graft has been used in more than 1 million surgeries. In 2002, the FDA approved the Infuse bone graft for use in specific types of spinal fusion surgeries. The Infuse bone grafts variety are“synthetic, concentrated proteins…mixed with collagen from cows and injected into the spine to alleviate pain.”
The Spine Journal found, in 2011, that the risks of the product had been understated by medical professionals.
In 2012, the U.S. Senate Finance Committee stated that Medtronic, Inc., the manufacturer of the Infuse bone graft, had paid doctors hundreds of millions of dollars to write favorable articles and manipulate studies on the popular product.
In 2013, Medtronic shareholders sued the company claiming that the company’s stock had been inflated due to these unethical activities. As the truth about the product emerged, they have alleged hundreds of millions of dollars in losses.
In 2014, Medtronic agreed to settle its Infuse bone graft lawsuit for $22 million that involves 950 people. Around 2,300 surgeons had used Medtronic products in the US prior to any serious side effects being reported.
An earlier decision in the case judged that shareholders had waited too long before seeking legal action. As 2016 came to a close an appeals court found that the case could still be brought forward.
The case will now be returned to the lower court for further proceedings.
The use of most powdered medical gloves has been banned by the FDA.
For only the second time in history the FDA has banned a medical device. Powdered medical gloves seem to pose adverse risks.
The Food and Drug Administration (FDA) has found that powdered medical gloves (powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove) “present an unreasonable and substantial risk of illness or injury.” This has led to a new rule banning these products from use, effective January 18, 2017.
One group has called the ban “18 years too late.” Nearly 20 years ago, in 1998, the advocacy group Public Citizen, filed the first of several citizen’s petition calling on FDA to ban powdered gloves.
After the ban was proposed by the FDA,Public Citizen responded saying that “when a medical product, drug or, in this case device, has unique serious risks but no unique benefit, it should be banned. The FDA’s statement that “we … only take this action when we feel it’s necessary to protect the public health” ignores overwhelming evidence going back almost two decades about the necessity to do so.”
Back in March of 2016, theFDA had prosedthe powdered medical gloves citing evidence that they were a danger to patients, risks included airway and wound inflammation, post-surgical adhesions and allergic reactions.
Powdered gloves aim to make the removal of gloveseasier for medical professionals. So, the FDA had to determine whether the ease of use outweighed the risks.
The rules not that powder is fine when used in the manufacturing process, but should not be a part of the finished product. The rule from the FDA “encourages manufacturers to ensure finished non-powdered gloves have as little powder as possible.”
If you believe that you or a loved one might have suffered from the medical use of powdered gloves, let the Medical Claim Legal Team help.
Data from the Center for Safety and Applied Nutrition’s Adverse Event Reporting System can be useful in litigation and beyond.
Thanks to a new service, consumers might be little bit safer. The Food and Drug Administration (FDA) recently announced that the Center for Safety and Applied Nutrition’s Adverse Event Reporting System (CAERS) database will be made public. The CAERS is a database that includes reports about harm and product complaints submitted to the FDA.
The new database can be accessed by consumers, researchers, industry pros and attorneys. The boon helps individuals learn more about products and their potential or previous harm to individuals.
Perhaps more importantly, industry professionals now have access to data with transparency. The co-founder of Center for Science in the Public Interest in Washington, a group that monitors concerns about food safety, Michael Jacobson sees this as a victory.
“If somebody, like a poison-control center, has concerns, they can go and see if there happen to be some reports,” Jacobson said told Bloomberg.
Lawyers and companies, will find this information particularly useful. Some of the information can help with litigation. The information will certainly be mined by parties who could use reports to file lawsuits against manufacturers or retailers.
The CAERS data will help the FDA and other experts monitor and study trends in “adverse event reports” that could signal a genuine safety issue with a product.
demographic and administrative information and the CAERS report ID number;
product information from the case reports;
symptom information from the reports;
patient outcome information from the reports.
For those who may have experienced any type of adverse effects from food, drugs, or cosmetics, further evidence to support your claim might be available for you through the CAERS data.
Airbags are safety devices found in just about every vehicle on the road in the United States. Their intention is pure, they are intended to keep vehicle occupants safe in the event of a collision. Although they usually do, like anything else airbags can fail to operate as intended. At times, due to defective designs, automotive companies may issue an airbag recall. This happens when they fail to keep vehicle occupants safe. When passengers suffer an injury or death due to an airbag malfunction, they may be entitled to compensation.
Takata Recall
Airbags in general are not a dangerous. The Department of Transportation reports that, in the last 30 years, frontal airbags have saved more than 37,000 lives. (Photo Credit: Melissa Clark)
Airbag recalls are common. Recently, Honda, the Japanese automobile manufacturer, came clean. They revealed that they had knowledge of defective airbags produced by Takata, years before informing federal regulators and triggering a massive airbag recall.
The airbags in question have exploded during impacts and caused serious injuries and deaths. Takata is an automotive parts company that provides products such as airbags for major car manufacturers. Although Honda is believed to have been most impacted, the defective airbags plague more vehicles than Takata originally suggested in 2013.
In 2015, The National Highway Traffic Safety Administration issued a list to the public of 14 other automakers impacted by the Takata airbag recall. That equals 28 million vehicles with unsafe airbags. Globally, 10 deaths (most in the United States) and more than 100 serious injuries have been linked to these faulty airbags. From burns to air bag chest injuries or death, trauma from airbags are a serious matter.
Recall History
Airbag recalls are nothing new. In 2014 Nissan recalled close to 1 million vehicles due to faulty airbags. Now, over one year later, federal regulators suggest that that they have not made the necessary changes. Many other airbag producers and automakers face legal liability when injuries and death are caused by airbags. In reference to the Takata recall, only about $7.5 million airbags have been repaired, the probability of future injuries remains high.
Airbag Recall Compensation
Replacing these airbags are estimated to cost up to $24 billion dollars. That does not include the coming legal obligations that Takata and automakers might face for medical liabilities. Airbags in general are not a dangerous. The Department of Transportation reports that, in the last 30 years, frontal airbags have saved more than 37,000 lives. That does not undermine the thousands of individuals have sustained injuries in the last 10 years, some of which are ignored or misdiagnosed.Whether an injury was caused by the Takata airbag or any other legal action may be necessary. If you or a loved one have experience serious bodily injury or death, due to an airbag malfunction, you may be entitled to financial compensation.
