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.

Coca-cola

Consumer Group Suing Coca-Cola Due to Sugary Soda Risks

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. Coca-Cola

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.”

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.

Johnson & Johnson Faces More Legal Trouble Over Hip Products

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.

If you have suffered pain or suffering due a faulty Johnson & Johnson hip replacement product, you could be entitled to compensation.

Flour Recall Sweeps Nation

flourGeneral Mills, one of the nation’s most popular food companies, has been targeted in a recent flour recall. According to International Business Times, over 40 people have gotten sick spanning across 21 states prompting the recall of roughly 45 million pounds of raw flour. The cause of the widespread sickness was linked to bacteria commonly found in animal feces that had contaminated the flour products.

According to Fox News, FDA testing determined that raw dough eaten or handled by people who became ill was made using flour was produced between November 2015 and February 2016 at the General Mills facility in Kansas City, Missouri.

This is the first time that E-coli has been linked to raw flour, although it has previously been linked to prepackaged cookie dough in 2009.

FDA officials tell consumers to dispose of any flour products included in the recall, as well as make sure to wash hands, work surfaces, and any utensils that have been in contact with raw dough products containing flour.

In an article by the NY Post, New York Senator Charles Schumer, said it takes too long for dangerous food to be taken off shelves, and demanded that the FDA rework its recall guidelines.

Schumer was very upset at the fact that the 21-state ­E. coli outbreak linked to tainted flour began in December — but the recall wasn’t issued until May.

GM Lawsuits On The Way

GM-ignition-switch-lawsuitGeneral Motors (GM) is facing a large amount of pending lawsuits due to a recent federal court ruling. According to USA Today, The U.S. Second Circuit Court of Appeals overturned a bankruptcy judge’s ruling this week that had protected GM from those lawsuits because of the company’s 2009 bankruptcy restructuring.

The ruling gives new life to hundreds of lawsuits from potential victims, including some who refused to accept settlements and instead took their chances in court. It also revives lawsuits from potential victims whom GM refused to offer deals and to class-action lawsuits by consumers who claim their vehicle values fell because of the scandal.

This ruling will undoubtedly bring heavy financial losses to the company as they will now have to go through thousands of cases. According to ABC News, About 1,000 death and injury lawsuits were put on hold waiting for the appeals court to rule, said Robert Hilliard, another attorney in the case. General Motors’ filings with securities regulators say there are another 101 U.S. lawsuits pending that allege that GM’s actions caused vehicle values to decline, with the expected losses for GM to range between $7-$10 billion.

After their bankruptcy in 2009, the Detroit-based automotive manufacturer has made a considerable rebound, as have other car companies since then. It will be interesting to see how this impacts the company moving forward. What makes this case so interesting is the fact that the pre-bankruptcty GM is now affecting the “New GM”.

Jeep Transmission Kills Hollywood Star

Jeep27 year old actor Anton Yelchin, known for his role as Chekov in the new series of Star Trek movies, was killed when his 2015 Jeep Grand Cherokee rolled down his driveway pinning him against the brick wall and fence in front of his Los Angeles home.

The car featured an “e-shift” transmission, which has been an increasingly popular trend in the automotive industry, especially in luxury models. The reason for these new shifting methods are that they take up less space, allowing room for bigger cup holders and more buttons. These new e-shift transmissions can be confusing for many drivers because it lacks the typical grooves and sensation of moving the car into park, drive or reverse. This unfamiliarity among drivers has resulted in many injuries, and in Yelchin’s case, death.

According to a CBS News report, The National Highway Traffic Safety Administration is investigating more than 850,000 vehicles, mostly 2014 and 2015 Grand Cherokees equipped with e-shift. Government investigators found it “…is not intuitive and provides poor tactile and visual feedback to the driver, increasing the potential for unintended gear selection.” That investigation claims reports of 121 crashes, resulting in several people being hospitalized.

Also included in the recall were the 2012 to 2014 Dodge Charger and the 2012 to 2014 Chrysler 300, both of which are equipped with the same shifting technology.chrysler

According to a NBC News report, Gary Titus of Canton, Massachusetts, owner of a 2014 Jeep Grand Cherokee, said he has experienced this “mis-shifting” on “multiple occasions” — including one incident that sounds eerily similar to Yelchin’s. “The worst one,” said the 59-year-old, “was when I got pinned between the car and the garage.”

This shifting malfunction is a problem that the Fiat Chrysler automotive group is working hard to address, as they have even gone as far as taking the technology out of their newer models to avoid further accidents.

If you or anyone you know has been affected by poor handling of a Chrysler/Jeep/Dodge recall, visit our recall page.

 

Kia Faces Minivan Recall

KiaAutomobile 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.

Airbag Recall Looms Over Takata

Takata

The automotive industry has been buzzing lately surrounding the massive airbag crisis caused by Takata, the worlds largest airbag and seat belt supplier. The airbags installed in cars from 2002-2015 have been reported to deploy explosively, injuring hundreds and causing 10 casualties in the U.S.

According to a Consumer Reports article, Fiat Chrysler, Mitsubishi, Toyota, and Volkswagen confirm in a report from Florida Senator Bill Nelson that they are selling some new vehicles with airbags that contain Takata’s ammonium nitrate-based propellant in driver and passenger frontal airbag inflators without a chemical drying agent, also known as a desiccant. These vehicles will have to be recalled by 2018.

The estimated number of recalls needed by 2019 is over 75 million vehicles ranging from 14 different automotive manufacturers. These enormous number of recalls is not only harmful to consumers, it also hurts the entire automotive industry. However, with increased scrutiny being focused on the quality and safety of the airbags, they should become safer in the future so these recalls do not continue to occur.

On April 7, 2016 a 17 year old girl in Texas was killed when shrapnel from an exploding Takata airbag impaled her neck. The fatality marked the 10th life lost due to the malfunctioning airbags. To date, over 8 million airbags have been replaced, but there are still millions more that need to be addressed. The process of replacing all of the airbags that need recalls could take many years, and new cases of faulty airbags continue to be reported frequently. This crisis could open the market for new manufacturers to dethrone Takata as the top dog in the airbag field moving forward. It will be very interesting to see how Takata handles this scenario, their stock prices have plummeted since the reports came out. This story is one that will continue to be in the news as more information comes out.  Infographic-Air bags