Pharmco Laboratories
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SkinCare Co. Pharmco Laboratories Receives Warning From FDA

Pharmco Laboratories received a warning letter from the FDA citing 4 violations.

Pharmco Laboratories received a warning letter from the Food and Drug Administration. The letter to the Florida-based skincare manufacturer “summarized significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.”

In the letter posted to the agencywebsite, four specific violation were referenced.

Pharmco Laboratories was accused of presenting an allergy risk to consumers. The FDA states that there has been insufficient evidence of the proper cleaning of equipment that came in contact with major allergens. Dietary supplements, for example, containing soybeans used the same dryer as the ingreditents in skincare items.

The FDA warning letter stated that “repeated lapses demonstrate a failure of your executive management to exercise proper oversight and control over the manufacture of drugs.”

drug
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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.”

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.

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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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.