Pharmco Laboratories received a warning letter from the FDA citing 4 violations.
Pharmco Laboratories received a warning letter from the Food and Drug Administration. The letter to the Florida-based skincare manufacturer “summarized significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.”
In the letter posted to the agencywebsite, four specific violation were referenced.
Pharmco Laboratories was accused of presenting an allergy risk to consumers. The FDA states that there has been insufficient evidence of the proper cleaning of equipment that came in contact with major allergens. Dietary supplements, for example, containing soybeans used the same dryer as the ingreditents in skincare items.
The FDA warning letter stated that “repeated lapses demonstrate a failure of your executive management to exercise proper oversight and control over the manufacture of drugs.”
Monsanto, a major agricultural corporation, can now be required to label its popular weed-killer, as a possible cancer threat.
California can require Monsanto to label Roundup, its top-selling herbicide, as a possible cancer threat, a judge tentatively ruled Friday.
Monsanto has insisted that its product poses no risk to people.
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.
Unfortunately, new information suggested that the public is not completely in the clear.
“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, the FDA had prosed the 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 gloves easier 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.
Johnson and Johnson is facing more legal trouble related to their hip products.
There are currently more than 8,000 suits for the DePuy Orthopaedics products manufactured by Johnson & Johnson.
In the past, the company has lost one trial involving the device and won another where the courts ruled in the manufacturer’s favor.
In the new case, the victim claims to have “suffered substantial injuries and damages” from the Johnson & Johnson subsidiary manufactured hip implant.
This comes less than a month after a federal jury in Dallas ordered Johnson & Johnson and its DePuy Orthopaedics unit to pay more than $1 billion to plaintiffs who claimed they were injured by Pinnacle hip implants.
The Indiana man filed the lawsuit in Middlesex County Superior Court on Dec. 9, the new suit alleges that the metal-on-metal version of the product is defective. As a result of defects, metal particles move into a recipient’s bloodstream and tissue after wear and tear.
Automobile manufacturer Kia, is recalling nearly 100,000 of the company’s Sedona minivans with model years spanning from 2006 to 2012. The recall is in place due to some suspension parts that are susceptible to rust damage when they come into contact with salt used on icy roads in the winter.
The recall will effect drivers in the following cold-weather states: Alaska, Connecticut, Delaware, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Dakota, Ohio, Pennsylvania, Rhode Island, South Dakota, Utah, Vermont, West Virginia, Wisconsin and Washington, D.C.
According to a Chron article, the same recall problem was addressed in 2013. 2006 and 2007 model year vehicles will have their suspension parts replaced by the company, while the remaining vehicles will receive an anti-rust coating on the parts to protect them from any further damage.
Kia will reportedly inform consumers of their recall on July 25th.