Washington Supreme Court determined that Intuitive Surgical Inc has to warn hospitals about devices.
The Washington Supreme Court ruled that Intuitive Surgical Inc must warn hospitals about devices. They went up against a ruling by a jury that had previously ruled in favor of the manufacturer. In Taylor v. Intuitive Surgical Inc., the high court said the trial court failed to inform the jury that the company had a duty to warn the hospital that purchased the device at issue.
The new ruling came in response to a ruling in a previous case. Jurors had found that Intuitive Surgical Inc had not been negligent in failing to warn Harrison Medical Center about defects in their devices.
The court ruled that under the state’s liability laws, manufacturers should warn hospitals, in addition to physicians, about the risks of using their medical devices.
HeartMate PHP use has been stopped after a malfunction precedes death.
Abbott Laboratories acquired Minnesota medical device maker St. Jude Medical in January. In a 2015 deal, St Jude Medical had acquired HeartMate PHP.
During procedures to unclog blood vessels, the HeartMate PHP catheter is inserted in the heart to keep blood flowing. The device is used inside the heart with no need for open-chest surgery.
As recently as September, the device received praised from the medical community.
Now, the Lab is putting an end to the commercially successful blood pumps use in the United States and Europe after several malfunctions and a patient death.
One malfunction of the device led to irregular blood flow requiring an emergency medical intervention to save a patient, while another case resulted in a death related to sepsis following the intervention.
In a statement, Abbott Labs gave the following information related to HeartMate php:
“This step is being taken as a precaution due to reports of a small number of clinical events associated with pump stoppage during support of high-risk percutaneous coronary intervention (PCI) patients in both clinical and commercial uses.”
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.
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.
The Tecfidera label now reflects a possible side effect of liver injury.
Tecfidera, Biogen Inc’s multiple sclerosis (MS) drug, has received label updates
to disclose a potential liver injury that could require hospitalization.
The world’s best selling oral MS drug experienced sales of $1.03 billion in the third quarter and accounts for about a third of the pharmaceutical company’s revenue.
Biogen reports that only 14 instances of liver injury have occurred around the 230,000 patients who have taken Tecfidera.
This isn’t the first time Tecfidera has had the spotlight. Just last week, Biogen Inc. announced a settlement of a patient infringement lawsuit for $1.25 billion concerning the multiple sclerosis drug.
The label updates mention that abnormalities are resolved after use of Tecfidera ends. A few cases required that the user be hospitalized. None of the cases have led to serious conditions including liver failure, liver transplant, or death.
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 city of Everett, Washington has filed a “first-of-its-kind lawsuit” against Perdue Pharma, the manufacturer of OxyContin.
Everett, Washington is a place where addiction to heroin and other opioids is officially considered an epidemic. Now, the city has filed a “first-of-its-kind lawsuit” against the manufacturer of OxyContin. Citing gross negligence, the city claims that when Perdue Pharma marketed OxyContin as a less-addictive alternative to other pain medication, they did the public a disservice.
The city wants the manufacturer to start paying to repair damages done to the community harmed by the epidemic. Everett Mayor Ray Stephanson said “we are going to go at them, and we are going to go at them hard.”
Officials claim that at the height of the epidemic, OxyContin was a factor in more than half of the crimes committed in Snohomish County.
In an LA Times article it was noted that “those drawn to the pills included young people and professionals who saw the painkiller as more fashionable and less dangerous than street drugs.
Many became addicted and lost their homes, jobs and families. After Purdue reformulated OxyContin in 2010 to make it harder to abuse, addicts moved en masse to heroin, which has a similar effect.”
Experts have mixed opinions about Everett’s chances of recovering money.
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.”