Intuitive Surgical Inc
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Intuitive Surgical Inc must warn hospitals about defects

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
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Use of HeartMate PHP Stopped After Death, Complications

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 Heartmate PHPinserted 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.”

Monsanto
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Monsanto Popular Weed Killer to Be Labeled a Cancer Risk

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.

Tecfidera
| | 0 Comments | Consumer Protection, Drug Issues, Legal Advice, Legal Issues

MS Drug Tecfidera Label Update Discloses Risk for Liver Injury

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. Tecfidera

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
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Medical Device Software Vulnerabilities a Huge Concern

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. Oxycontin

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.

Oxycontin
| | 0 Comments | Drug Issues, Legal Advice, Legal Issues

OxyContin Manufacturer Sued Following Epidemic

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 coOxycontinmmunity 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.

drug
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Nation’s Largest Drug Distributor to Pay $150M in Settlement

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.drug

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.”

Merlin@Home
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St. Jude Updates Merlin@Home Transmitter After Hacking Concerns

Merlin@home transmitter receives updates.

Earlier this week, the US Food and Drug Administration (FDA) and St. Jude’s Medical issued a patch to the software of its Merlin@home Transmitter.

A new software update served to address some of the cyber security problems in St. Jude’s heart devices.

In an intense investigation, the FDA was able to confirm that hackers could remotely access the Merlin@home transmitter and modify the device and take control of it. Hackers could then use the transmitter to  reprogram the implant. There lies risks to create a faster battery depletion, incorrect pacing, unnecessary shocks, etc.

“As medical devices become increasingly interconnected via the Internet, hospital networks, other medical devices, and smartphones, there is an increased risk of exploitation of cyber security vulnerabilities, some of which could affect how a medical device operates,” the FDA said.

The company and the FDA have indicated that there are no proven cases of this happening.

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.

In order for patients to receive the update, they must make sure that the transmitter is plugged in and powered on, and that it’s connected to a land line or cellular service.

Infuse bone graft
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Infuse Bone Graft Lawsuit Gets New Life

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.

Settlement
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Wright Medical Technology Settlement Resolves 1,300 Hip Replacement Claims

The recent Wright Medical Technology settlement, will help to resolve 1,300 hip replacement claims.

On November 02nd, 2016, Wright Medical announced that on November 1st, 2016, its wholly owned subsidiary Wright Medical Technology, Inc. entered into a Master Settlement Agreement (MSA) with Court-appointed attorneys representing plaintiffs in the previously disclosed metal-on-metal hip multi-district litigation known as In Re: Wright Medical Technology, Inc., CONSERVE® Hip Implant Products Liability Litigation, MDL No. 2329 (MDL).

Here at Medical Claim Legal, we are committed to one thing: the success of our clients. So, when we see victories in the area of medical claims, we want to share them with you!

Medical device companies promoted all-metal implants as stronger than other implants, however studies show that they release toxic metal particles into the body as they experience wear and tear.

Companies like Stryker Orthopaedics, Wright Medical Technology and DePuy Orthopaedics provide the device for hip replacements.

On Nov. 1, Wright Medical Technology Inc. entered into a master settlement agreement with attorneys representing plaintiffs in previously disclosed metal-on-metal hip multidistrict litigation, according to a company press release.

Nearly 1,300 claims have been resolved with the Wright Medical Technologies settlement agreement.

If you or a loved one have been harmed by an ineffective hip replacement from one of these companies, Medical Claim Legal can help you get the compensation that you deserve.