pAXIL

FDA Refused Update to Suicide Risk on Paxil Label

Paxil suicide risk was disclosed, according to GlaxoSmithKline.

According to the GlaxoSmithKline court filing, the FDA refused four requests to change labels on the antidepressant Paxil to update a warning label to reflect that “there was a statistically significant increase in the frequency of suicidal behavior in patients treated with paroxetine.” pAXIL

As far back as 2006 the antidepressant and its controlled-release version, Paxil CR, added a warning about suicide risk in young adults. Facts such as this are of increasing importance as GlaxoSmithKline fights a complicated lawsuit.

The suit was brought on by the widow of Stewart Dolin, a Paxil user who at the time of his suicide was taking a generic version of the drug. The $12 million suit alleges that GlaxoSmithKline was negligent in not updating the warning label to demonstrate the risk for suicide while using.

The claim insists that the labeling did not provide enough information about the risk of suicide, which as a result led to the Chicago lawyer jumping in front of a train just 6 days into using a generic form of Paxil.

Dolin’s widow’s complaint notes that certain dangerous side-effects were listed on the label, but the labeling did not properly represent the risk posed. In fact, labeling only highlighted an increase in suicidal thoughts for users under the age of 24.

She further claims that doctors were not informed about the suicide risks in adults associated with the drugs, and had that information been clear, Mr. Dolin would have been prescribed the drug.

As the trial drags on in Illinois, GlaxoSmithKline a federal jury Wednesday that the U.S. Food and Drug Administration claims that the FDA rejected a label change to Paxil four times. The updated label would have addressed the increased risk of suicide on adult patients.

If you or someone that you love has been effected by the use of Paxil, connect with an attorney at Medical Claim Legal. You could be entitled to financial compensation, find out now.

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.

drug

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.”

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.”

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.

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.

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

Addicts Suing Doctors

Addiction to painkillers, and other opioid drugs, is a serious problem in the state of West Virginia. According to a CBS News report, West Virginia has the highest rate of overdose deaths in the nation. Each year doctors write the equivalent of one painkiller prescription for every man, woman and child in this state of 1.8 million people. The painkiller problem has become so severe that state legislature has stepped in to make changes, and has led to the addicts suing doctors.

More than 30 addicts have sued their doctors for enabling their addiction. Many of these patients suffered from work related injuries and had to rely on painkillers in order to continue working.

Addicts suing doctorsPatients are not the only ones filing lawsuits regarding this subject. West Virginia Attorney General Patrick Morrisey has filed a lawsuit against McKesson Corporation, a prescription drug distributor, for allegedly failing to identify, detect, report and help stop the flood of suspicious drug orders into the state.

According to a CBS San Francisco article, The DEA, along with six states, sued McKesson (a San Francisco based company) in 2008 for supplying hundreds of suspicious hydrocodone orders to rogue pharmacies. McKesson settled, paying more than $13 million in fines and agreeing to closely monitor their pill supply.

In research of McKesson’s involvement in West Virginia, it shows that more than 100 million doses of opioids to a state where the population is 1.8 million. This egregious amount of drugs being sent to a state that has the most overdose related deaths in the country is what has put the company in hot water. McKesson could face tens of millions in legal fees, but for a company that makes over a billion dollars that is simply pocket change.

Hopefully the changes made by the legislation in West Virginia can help the addicts recover and find the treatment they need.

 

 

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.

Invokana, Lawsuits and Johnson & Johnson

Two new recent lawsuits were filed in New Jersey federal court against giant Johnson & Johnson, who face allegations that users of its diabetes drug, Invokana, developed kidney damage and heart disease. These revelations include claims by defendants who say they suffered kidney damage after being prescribed Invokana for diabetes. One patient actually suffered a stroke.

According to New Jersey Law Journal, the suit includes claims for “failure to warn, defective manufacturing, breach of express warranty, breach of warranty of fitness for everyday use, negligence, breach of implied warranty, fraudulent misrepresentation, negligent misrepresentation, fraudulent concealment and fraud.”

Background on Invokana Lawsuits

Lawsuits Against Johnson & Johnson's Diabetes 2 Medication, Invokana, Continue
Lawsuits Continue Against Johnson & Johnson’s Diabetes 2 Medication, Invokana

The U.S. Food and Drug Administration (FDA) approved the drug in 2013 for treatment of Type 2 diabetes. Two years later, the FDA issued a warning about Invokana and Invokamet stating that they may lead to diabetic ketoacidosis – a serious condition in which the body produces high levels of blood acids known as ketones. An analysis of incidents reported to the FDA shows patients taking Invokana for diabetes are several times more likely to report kidney disease than those taking other types of diabetes treatment, the complaints allege.

Johnson & Johnson Invokana History

According to court papers, Invokana made Johnson & Johnson $278 million in the first quarter of 2015, so clearly they have much at stake. A statement from Johnson & Johnson spokeswoman Kaitlin Meiser said: “Invokana is an important medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. With real world experience that includes more than five million prescriptions to date, we are confident in the overall safety profile of Invokana. The company remains committed to aggressively defending against allegations made in these lawsuits.”

Medical Claim Legal and Lawsuits Against Johnson & Johnson

Our team of lawyers has worked on medical claim lawsuits against firms like Johnson & Johnson and will work to get you the attention and claims you deserve. Again, MedicalClaimLegal does not get compensated, unless you do.