Baby powder
| | 0 Comments | Consumer Protection

American Pediatric Association Recommends Against Using Baby Powder

Pediatricians recommend against using baby powder, amid talcum risks.

American Pediatric Association is now recommending against the use of baby powder. There have been recent notable concerns over talc being harmful to babies. Research suggested that the mineral could be inhaled and harm babies’ lungs.

Baby powder is a talcum powder blend that absorbs moisture and reduces chafing. Traditionally, it has been an important part of diaper-changing.

Some safer options on the market are using cornstarch  to replace the talc in their powders.  Additionally, some pediatrician recommend leaving babies bare altogether. Others suggest petroleum-based products for rashes.

David Soma, a Pediatrician with the Mayo Clinic Children’s Hospital, notes that the biggest issue is powders in general, not specially talcum-based powders. Soma states that whether it’s cornstarch-based or talcum-based “try to keep it well localized to the diaper and away from any area that can be inhaled.”

Merlin@Home
| | 0 Comments | Legal Issues

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.

Coca-cola
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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
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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.

Powdered medical gloves
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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.

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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.

 

Settlement
| | 0 Comments | Legal Issues

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.

Adverse event
| | 0 Comments | Drug Issues, Legal Advice, Legal Issues, medical lawsuit | , , , , , , , ,

FDA Complaints Just Got Transparent: Adverse Event Now Public

Data from the Center for Safety and Applied Nutrition’s Adverse Event Reporting System can be useful in litigation and beyond.

Thanks to a new service, consumers might be little bit safer. The Food and Drug Administration (FDA) recently announced that the Center for Safety and Applied Nutrition’s Adverse Event Reporting System (CAERS) database will be made public. The CAERS is a database that includes reports about harm and product complaints submitted to the FDA.

The new database can be accessed by consumers, researchers, industry pros and attorneys. The boon helps individuals learn more about products and their potential or previous harm to individuals.

Perhaps more importantly, industry professionals now have access to data with transparency.  The co-founder of Center for Science in the Public Interest in Washington, a group that monitors concerns about food safety, Michael Jacobson sees this as a victory.

“If somebody, like a poison-control center, has concerns, they can go and see if there happen to be some reports,” Jacobson said told Bloomberg.

Lawyers and companies, will find this information particularly useful. Some of the information can help with litigation. The information will certainly be mined by parties who could use reports to file lawsuits against manufacturers or retailers.

The CAERS  data will help the FDA and other experts monitor and study trends in “adverse event reports” that could signal a genuine safety issue with a product.

FDA provides raw data extracted from the CAERS database. The files include data from January 2004 through March 2016, including:

  • demographic and administrative information and the CAERS report ID number;
  • product information from the case reports;
  • symptom information from the reports;
  • patient outcome information from the reports.

For  those who may have experienced any type of adverse effects from food, drugs, or cosmetics, further evidence to support your claim might be available for you through the CAERS data.

See if the Medical Claim Legal team can help you along the way.

| | 0 Comments | medical lawsuit | ,

Actos Lawsuit Continues To Lumber On…

Much has been written and analyzed about the issues surround Actos (Pioglitazone), the drug released in 1999 by Takeda Pharmaceuticals, which was supposed to help control blood sugar levels in Type 2 diabetes cases.  As we have discussed previously, many people using Actos developed bladder cancer among other health complications.   Since first being announced, plaintiffs have filed Actos lawsuit claims alleging a link between Actos and bladder cancer. Plaintiffs claim they were impacted by the medication and weren’t alerted to the risks.

Actos Lawsuit Claims Continue
Actos Lawsuit Claims Continue

As noted consistently, studies have yielded conflicting results regarding the risk of bladder cancer linked to the use of Actos. The Journal of the American Medical Association found there was no significantly increased risk of cancer in patients who took Actos, but researchers said they could not exclude a small increased risk. The British Medical Journal earlier this year had Actos linked to a 63 percent increased risk of bladder cancer.

Obviously the pharmaceutical giant Takeda has taken action and settled actos lawsuit claims filed by plaintiffs. Additionally, some lawsuits went to court, with juries awarding millions of dollars in damages.

If you or a loved one has taken Actos, you could be at risk for health complications including dangerous and sometimes deadly bladder cancer.  You could be entitled to compensation and should consider joining the Actos lawsuit.

Why Medical Claim Legal is Right for Your Case

Medical Claim Legal can give you the access to a vast network of lawyers who are trained and versed in Actos lawsuits.  Their knowledge and history in the court room will increase the likelihood that you will  get the settlement you are entitled to.  Using our free referral process,  you will take the first step towards your claim.  No payment needed, just the courage to take the first step.

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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.