Adverse event
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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.

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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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Takata Settles Airbag Lawsuit

airbag recall

Airbag manufacturer Takata has been in the news over the course of the past few months as scrutiny of their malfunctioning airbags has increased. The company recently settled one of their lawsuits with a family who had a member paralyzed and later die to to injuries caused by the airbag. The settlement was made just moments before a hearing was supposed to take place where the judge could have made Takata executives testify in court. Many people were surprised at the settlement, including the lawyer representing the family of the victim, Patricia Mincey.

Mincey was paralyzed from the neck down after the Takata airbag in her 2001 Honda Civic forcefully inflated after a collision on June 15, 2014. The airbag was among those recalled by Honda less than a week later.

Takata’s airbags have caused several deaths and numerous injuries to drivers and passengers, causing automakers to recall nearly 60 million vehicles in the US alone.

While the exact numbers on the settlement have not been released, Takata has handled all of their previous lawsuits with swift action. The company is currently trying to repair their image and restore consumers confidence in their products. With airbags being a vital safety component in any car, it may take the company a very long time to be trusted by car drivers and manufacturers alike.

According to a New York Times Article, the mass recalls of Takata airbags gained new urgency last month, when federal safety regulators warned that airbags in more than 300,000 older Honda and Acura vehicles were at an unacceptably high risk of exploding and needed to be replaced immediately.

 Takata also faces a class-action lawsuit brought by owners of affected cars and is the subject of a criminal investigation by the Justice Department.
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Panera Facing Peanut Butter Lawsuit

paneraPanera, a chain bakery/restaurant popular across the United States, has been cast in some negative light through the media lately. The company faces a lawsuit due to an allergy mishap at a store in Massachusetts.

Elissa and John Russo ordered their 6 year-old daughter a grilled cheese online, and explicitly stated the child’s severe allergy to peanut butter. When the little girl became extremely ill after eating the sandwich, the parents knew something had gone wrong. Supposedly, a language barrier caused the workers at the store to put 2 tablespoons of peanut butter on the sandwich, causing the allergic reaction that hospitalized the girl for several days.

In an article from The Daily Meal, the Russo’s stated they have chosen to sue the Panera New England franchise for negligence, saying the sandwich chain, “engaged in unfair and deceptive business practices by adding peanut butter to the plaintiff’s grilled cheese sandwich knowing that [she] has a life-threatening peanut allergy.”

With an increase in awareness of allergies it is surprising to see such an event occur, especially one where the instructions were explicitly defined. The details of the lawsuit have not been released, but it will be interesting to see how the company handles this incident. If people with allergies to certain foods do not feel safe eating at Panera, their company will lose a large amount of money.

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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.

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Invokana Lawsuit

Invokana Lawsuit
Invokana, a diabetes treatment drug that has led to cases of Ketoacidosis.

Invokana is a drug used for treatment of type-2 diabetes that has recently become the topic of many lawsuits in North America. The purpose of the drug is to maintain blood sugar levels in the patient by forcing the kidneys to release excess sugar through urination. This causes more stress on the kidneys than what is typically put on them without the drug. The Invokana lawsuit is growing everyday as more patients have been affected by the drug.

What is the reason for the lawsuits?

According to the FDA there have been 19 filed claims of people who developed blood and kidney infections as a result of Invokana. According to Digital Journal, all of the patients filing the Invokana lawsuit alleged to have required hospitalization and kidney failure treatment with dialysis.  The first side effect that can cause serious health issues is an increase in the amount of acid in the blood, as well as Urinary Tract Infections (UTI). These harmful side effects have led to the hospitalization of many Invokana users. Another serious side effect of the drug is Ketoacidosis. In another post by Digital Journal,  many patients have filed lawsuits against manufacturers claiming that the drug causes severe side effects and that the companies were negligent in communicating the risks associated with the drugs.

What is Ketoacidosis?

Ketoacidosis is defined by the FDA as “a serious condition in which the body produces high levels of blood acids called ketones.  Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness, and trouble breathing.  Patients should also be alert for signs and symptoms of a urinary tract infection, such as a feeling of burning when urinating or the need to urinate often or right away; pain in the lower part of the stomach area or pelvis; fever; or blood in the urine.” If you have experienced symptoms of Ketoacidosis, you should contact a doctor immediately.

 

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Johnson & Johnson Baby Powder Lawsuit

A common household item, talcum powder (baby powder) has recently made headlines involving a 72 million dollar lawsuit against Johnson & Johnson. The baby powder lawsuit was filed by the family of a deceased woman who’s ovarian cancer was linked to the use of the product for feminine hygiene.

Common Uses of Baby Powder

  • Pet Cleaner
  • Deodorant
  • Baby/Feminine Care
Baby Powder Lawsuit
The Johnson & Johnson baby powder lawsuits have reached upwards of 1,200 still-pending cases.

Jackie Fox of Birmingham, Alabama was diagnosed with ovarian cancer roughly two years before her death. At the time of her passing in the fall of 2015, she was involved in a 60-person lawsuit against Johnson & Johnson, where her son took over as the plaintiff. The lawsuit resulted in the company owing Fox $10 million in actual damages, and $62 million in punitive damages. According to an AP article, the verdict “doesn’t bode well for Johnson & Johnson” as there are over 1,200 still-pending lawsuits and thousands more are expected.

The ingredient talc, in baby powder, had once contained asbestos which was extremely dangerous and there is speculation of some contamination in the product, but modern baby powder is reportedly asbestos-free. Although the modern powder is “safer” there were dozens of women who sued Johnson & Johnson according to USA Today. The cause and effect relationship between the baby powder and ovarian cancer is somewhat inconclusive according to an ABC News article about the subject, but there are thousands of lawsuits against Johnson & Johnson regarding this matter.

 

Why Medical Claim Legal is Right for Your Case

A consultation with our lawyers at Medical Claim Legal is free.  We will assure a lawyer with specific training in the consumer protection litigation field is assigned to your case.  If you or a loved one have been diagnosed with ovarian cancer that may be linked to the use of baby powder, you deserve compensation.  Let us help you start the process towards that claim today.

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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.