Lupron

Lupron, a Drug Used to Delay Puberty, Causes Problems in Women

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

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.

Software

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.

Asbestos

The Risks of Asbestos Exposure and Your Legal Rights

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

Infuse bone graft

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.

Powdered medical gloves

Powdered Medical Gloves Banned By the FDA

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.Powdered medical gloves

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.

Pelvic Mesh Lawsuit

Pelvic mesh lawsuit
Johnson & Johnson faces a massive pelvic mesh lawsuit

Johnson & Johnson is back in the news, although it is not they type of news they would like to hear. The company is entrenched in a pelvic mesh lawsuit that has already seen over 100 cases settled in the past year, and faces over 30,000 more cases that have yet to be heard. While the exact settlement numbers have not been released by Johnson & Johnson, it is speculated that the company could lose millions.

What is the Reason for the Lawsuits?

The pelvic mesh lawsuits are flooding in from patients all over the country who have experienced severe side effects from the mesh. The claims are being made that Johnson & Johnson did not properly market the products, failing to cite the side effects that were caused by the product.

In a report by the Associated Press, Attorneys General Bob Ferguson of Washington and Kamala Harris of California accused the New Jersey-based health care giant of neglecting to tell patients and doctors about the risks and occurrences of dire, sometimes irreversible complications. Those include urinary dysfunction, loss of sexual function, constipation and severe pain. These side effects can make everyday activities such as walking up and down stairs, laying down, or exercising extremely painful.

In a Reuters article, it is stated that Johnson & Johnson sold more than 787,000 pelvic mesh devices in the United States from 2008 until 2014, including more than 42,000 in California. Also in that article, the Food and Drug Administration said it was reclassifying mesh used to treat pelvic organ prolapse trans-vaginally from class II, or moderate risk, to class III, for high-risk devices, which will require manufacturers to submit extensive data to establish the devices’ safety. Hopefully this increased scrutiny by the FDA will prevent something like this from happening again in the future.