Articles Posted in Dangerous Drugs & Medical Devices

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Medical device maker Ethicon is one of the two chief manufacturers of surgical staplers in the U.S.  Surgical staplers are widely marketed and used as an alternative to manual sutures made by surgeons to close internal wounds, their greatest benefit being reducing a patient’s time in surgery. However, Ethicon and other stapler makers have long been dogged by reports that their products frequently malfunctioned, causing serious injury and even death to patients.

Now Ethicon has initiated a recall of more than 8,000 of its Echelon Flex Endopath staplers, announced by the U.S. Food and Drug Administration in October. The FDA has identified this as a Class I recall, which indicates the devices could cause life-threatening injuries or death. As of October 3, seven serious injuries and one death had been reported to Ethicon for the affected products.

The Echelon Flex Endopath staplers are designed for use on only one patient, in major or minimally invasive surgical procedures including gynecologic, urologic, thoracic, pediatric, and general surgeries. They were manufactured between July 18 and August 3, 2019, and distributed to healthcare providers between August 1 and September 26.

ndma-examined-scientist-lab-microscopeIn late 2019, the U.S. Food and Drug Administration announced recalls of multiple drugs believed to be contaminated with a carcinogenic substance called NDMA. Those recalls affected both prescription and over-the-counter versions of the heartburn and ulcer medication ranitidine, known by the name brand Zantac but also sold as a prescription and over-the-counter generic. The FDA had earlier recalled several types of blood pressure medications—losartan, valsartan, and irbesartan—because of contamination with NDMA. It believes there has been NDMA contamination in those drugs for up to four years.

What Is NDMA?

NDMA is short for N-Nitrosodimethylamine, an organic chemical. It’s present in low levels in certain foods, particularly smoked or cured foods, but most often found as a manufacturing and water treatment by-product. It’s also used in biological science as a way to create cancer in laboratory rats, and according to the World Health Organization, the International Agency for Research on Cancer believes it probably causes cancer in humans. The U.S. Environmental Protection Agency says NDMA comes from a family of known and powerful carcinogens.

Litigation Dealing With Round UpMonsanto’s Roundup litigation has begun to present a near-existential issue for its corporate parent Bayer. When the German company purchased the American chemical manufacturer, it inherited all of its past, present and future liabilities. One of these liabilities concerns the pesticide Roundup, which is alleged to cause non-Hodgkin’s lymphoma after extended exposure.

Monsanto has lost several high-profile lawsuits recently, and the jury awards have been eye-popping. One married couple was awarded $2 billion by a jury for their cases of cancer. Even after a judge reduced the verdict, the company was still assessed a damages award of nearly $90 million. There have been several other verdicts that, even after appeals, have remained in the tens of millions of dollars. Much of the damage amount consist of punitive damages assessed by the juries.

Monsanto now faces over 18,000 lawsuits relating to this product. The company’s predicament has only been worsening as there have been over 5,000 lawsuits alone that have been filed between July and the first half of August. Roundup lawsuits continue to make headlines and the publicity has encouraged more plaintiffs to lawsuits for compensation.

Valsatran and Cancer Causing CarcinogensPatients who were taking drugs containing the substance Valsartan to treat high blood pressure were surprised to find out that there was a voluntary recall of some medications due to the presence of a carcinogen. As time has gone on, the problem has only gotten worse as more medications have been found to contain the substance. There are a number of lawsuits against the makers of these drugs, both brought on behalf of all purchasers as well as on behalf of patients who have suffered their own injury from taking the drugs. Rosenfeld Injury Lawyers can help anyone who has taken Valsartan and suffered a cancer-related injury file a complaint that could help them receive compensation.

Valsartan is not a drug unto itself, but rather is an ingredient that is found in a class of drugs. This class of drugs is meant to treat high blood pressure and heart failure. Valsartan is an Angiotensin II receptor blocker. The total size of the market is valued at roughly $1.5 billion. There are many different types of drug that contain the ingredient Valsartan, and these medications are manufactured in different places.

In November 2018, the FDA announced a voluntary recall of several medications that contain Valsartan. The specific problem was that impurities were detected in the manufacturing process that resulted in the introduction of possible carcinogens into the medications.

Gout Drug Increases Risk of Heart Problems In February 2019, the FDA included a box warning for the gout medicine Uloric. This warning addressed the fact that those taking the drug may be at a greater risk for heart-related and other types of deaths. Recently, attorneys have begun to file suits on behalf of those who have been injured by Uloric and their families. Currently, there are more cases that are in the investigatory phase and will likely be filed soon. Anyone who has suffered harm from Uloric or have had a loved one die while taking the medication should contact Rosenfeld Injury Lawyers to discuss their legal options.

Uloric was approved by the FDA for use to treat gout in 2009. Gout is caused by high uric acid levels in the blood, and Uloric is intended to lower those levels. Gout develops in part because the body is taking substances called purines that are found in food and drink and turns them into uric acid. Uloric is supposed to stop that process. Uloric is manufactured by Takeda Pharmaceuticals. The global market for the drug is estimated at just under $1 billion and continues to grow at an 11 percent annual rate.

When the FDA initially approved Uloric, it included a Warning and Precaution addressing the possibility of a cardiovascular event associated with use of the drug. However, at the time that the FDA approves a drug, there sometimes is only limited testing performed with some testing still to be done as the FDA requires. Here, the FDA directed Takeda to perform further studies about the possibility of cardiovascular deaths and events. The test results did indicate that there was a possibility of non-fatal and fatal heart attacks and stroke associated with the drug. Still, the FDA took no further action at the time.

military-personnel-battlefield-3m-earplug-hearing-loss-defectEvery serviceman and servicewoman working for the U.S. military expects that they will be provided the best standard issued equipment when fighting for the nation in combat. Our soldiers likely assume that every piece of equipment from helmets to boots will fit properly and provide ultimate protection against all situations in the field from bombs and firearms to harsh conditions in the environment. Unfortunately, our military force may have had their hearing and safety compromised from defective earplugs.

For twelve years between 2003 and 2015, the 3M Company and Aearo Technologies, Inc. manufactured and sold the dual-ended Combat Arms Earplugs – model CAEv2 to the United States military as standard issued equipment for service members deployed to combat zones around the world, including in the Middle East.

In 2018, as a result of an intensive lawsuit, the manufacturer agreed to a $9.1 million settlement filed by a manufacturing competitor and whistleblower Moldex-Metric, Inc. in a suit that was later joined by the US Department of Justice.

Cancer Lawsuits Caused by Valsartan ConsolidatedBeginning on February 14th, 2019, survivors seeking compensation through class action and product liability lawsuits involving Valsartan will now consolidate into a multi-district litigation, known as an MDL. The MDL will take place in the District of New Jersey before the Honorable Robert B. Kugler.

The MDL order will have significant implications on the lawsuits already filed by victims of the harmful Valsartan contaminant, impacting new cases as well as those currently in process. If you are suffering injuries from Valsartan-contaminated medication, here is what you need to know about the new Valsartan litigation.

What Is Valsartan?

10 Most Dangerous Prescription Drugs Research from Johns Hopkins suggests that medical errors constitute the third most common cause of death in the United States. Prescription errors account for far too many of these deaths, with a few drugs, in particular, responsible for a shocking level of suffering. Several of the most dangerous prescription drugs are highlighted below:

1. Fentanyl

If used properly, opioids can play an important role in pain management. Unfortunately, these drugs carry significant risks, including, most notably, the potential for abuse. Fentanyl, in particular, has seen skyrocketing abuse in recent years. In 2017, the Centers for Disease Control estimated that 29,406 Americans died due to overdoses involving the category of synthetic opioids dominated by fentanyl. While many of these deaths were related to illicitly obtained substances, many others involved prescribed medications.

How to Dispose of Expired DrugsIf you’re like many Americans, your medicine cabinet is full of pill bottles you no longer use — stamped with expiration dates that passed ages ago. Those expiration dates are intended to represent the last date on which manufacturers can guarantee that drugs are both potent and safe.

Interestingly, a groundbreaking Food and Drug Administration study found that some drugs are safe and effective over a decade after their expiration date. That doesn’t mean, however, that it’s prudent to let expired drugs sit around. If accidentally ingested, unwanted pills could prove dangerous or even deadly. This is particularly true for medications that contain controlled substances. Sometimes, a single pill is all it takes to cause damage. Accidental ingestion is far more likely with forgotten medications that are improperly labeled or left in easily accessible locations.

If you have children at home or otherwise suspect that expired pills could be accidentally ingested, it’s best to take action now. Below, we offer instructions for safely disposing of prescription pills.

monsanto safety documents to be discolsedMonsanto is catching a lot of heat now that a court has unsealed documents that cast the company in a negative light and suggest that it was responsible for providing false assertions to the government and public regarding the safety of Roundup. As the most popular herbicide in the world, Roundup and similar products produced by Monsanto are used across the globe for the elimination of pests from lawns, crops, gardens and nurseries. It has provided research that opposes the belief Roundup’s main active ingredient can cause cancer, but the documents unsealed by the court show that these accounts were misleading and, in some cases, false.

Ghostwritten Research

The research that was presented to defend the safety of its products was in fact, ghostwritten and attributed to academics. It also claimed that a senior EPA official attempted to dismiss a report from the United States Department of Health and Human Services that the product could in fact be linked to the deaths of numerous people who suffered from non-Hodgkin’s lymphoma. The evidence tells a story of arguments within the Environmental Protection Agency and conflicting beliefs over whether Roundup and similar products were safe to use.