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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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.

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VW Faces Massive Payout

VWAutomobile manufacturer Volkswagen has been buried in a huge story of the company cheating on their emissions testing of their diesel cars. VW has agreed to pay U.S. owners and regulators, over $15 billion as a settlement in the case.

According to Reuters, Under Volkswagen’s proposed settlement of U.S. civil claims published on Tuesday, the German group has pledged to compensate 475,000 owners of VW diesel-powered cars there, giving them the option to sell their vehicles back to VW or have them fixed. Most U.S. owners will get $5,100 to $10,000, based on the pre-scandal value of their vehicles, but spending on buybacks could be much less if owners opt for repairs instead.

The process for the automotive giant to recover from this scandal will be lengthy and extremely costly.To go along with the $15 billion going to consumers, there is also a pending $45 billion penalty to be handed down by the Environmental Protection Agency. It has also been proposed that VW pay out settlements to their European customers as well, which according to Bloomberg could be an additional $43 billion.

It will be interesting to see how long this issue drags on for. There are a lot of moving parts, and people involved. Another thing to keep an eye on is how Volkswagen can move on from something like this, as well as how their sales numbers look moving forward.

 

 

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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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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

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Purdue Pharma Under Pressure

PurduePurdue Pharma, makers of OxyContin, are facing some increased scrutiny from the FDA over their marketing of the popular painkiller. Since the release of OxyContin, the packaging has always said “12-hour relief” however in some patients the effects of the drug begin to wear off after about eight hours. This leads to many patients having to take more pills each day than what they were originally prescribed. Opioid addiction is increasing across the country and Purdue is being blamed as one of the leading causes.

In a large-scale investigation of the pharmaceutical company by the LA Times, it was revealed that they knew the effects of OxyContin did not always last 12 hours. The main reasoning for the company’s false advertising was because the 12-hour relief claim gave the drug a large competitive advantage over other, less expensive drugs. In the late 1990’s, doctors began prescribing OxyContin at shorter intervals so Purdue sent a team of sales executives all across the country to convince doctors to stick with the 12-hour doses. According to the LA Times report, More than half of long-term OxyContin users are on doses that public health officials consider dangerously high, according to an analysis of nationwide prescription data conducted for The Times.

In a statement released by Purdue the company had this to say, “Nearly a decade ago, the FDA cited a lack of clinical evidence when it formally rejected the ‘fundamental premise’ that patients receiving OxyContin at intervals more frequent than twice-daily are at increased risk of ‘side effects and serious adverse reactions.’ In doing so, the agency reinforced the twice-daily labeling for OxyContin. The LAT omitted the findings of this report from its story.”

This story will be one that continues to develop and as news comes out, lawsuits may follow. The entire medical world will be following these developments as it could change the market for painkillers in the United States and other countries as well.

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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.

 

 

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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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Airbag Recall Impacts Millions

Airbags are safety devices found in just about every vehicle on the road in the United States. Their intention is pure, they are intended to keep vehicle occupants safe in the event of a collision. Although they usually do, like anything else airbags can fail to operate as intended. At times, due to defective designs, automotive companies may issue an airbag recall. This happens when they fail to keep vehicle occupants safe. When passengers suffer an injury or death due to an airbag malfunction, they may be entitled to compensation.

Takata Recall

airbag recall
Airbags in general are not a dangerous. The Department of Transportation reports that, in the last 30 years, frontal airbags have saved more than 37,000 lives.                         (Photo Credit: Melissa Clark)

Airbag recalls are common. Recently, Honda, the Japanese automobile manufacturer, came clean. They revealed that they had knowledge of defective airbags produced by Takata, years before informing federal regulators and triggering a massive airbag recall.

The airbags in question have exploded during impacts and caused serious injuries and deaths. Takata is an automotive parts company that provides products such as airbags for major car manufacturers. Although Honda is believed to have been most impacted, the defective airbags plague more vehicles than Takata originally suggested in 2013.

In 2015, The National Highway Traffic Safety Administration issued a list to the public of 14 other automakers impacted by the Takata airbag recall. That equals 28 million vehicles with unsafe airbags. Globally, 10 deaths (most in the United States) and more than 100 serious injuries have been linked to these faulty airbags. From burns to air bag chest injuries or death, trauma from airbags are a serious matter.

Recall History

Airbag recalls are nothing new. In 2014 Nissan recalled close to 1 million vehicles due to faulty airbags. Now, over one year later, federal regulators suggest that that they have not made the necessary changes. Many other airbag producers and automakers face legal liability when injuries and death are caused by airbags. In reference to the Takata recall, only about $7.5 million airbags have been repaired, the probability of future injuries remains high.

Airbag Recall Compensation

Replacing these airbags are estimated to cost up to $24 billion dollars. That does not include the coming legal obligations that Takata and automakers might face for medical liabilities. Airbags in general are not a dangerous. The Department of Transportation reports that, in the last 30 years, frontal airbags have saved more than 37,000 lives.  That does not undermine the thousands of individuals have sustained injuries in the last 10 years, some of which are ignored or misdiagnosed.Whether an injury was caused by the Takata airbag or any other legal action may be necessary. If you or a loved one have experience serious bodily injury or death, due to an airbag malfunction, you may be entitled to financial compensation.