New FDA Off-Label Marketing Rule Delayed by One Year

The FDA has delayed new rule for off-label uses of pharmaceuticals.

After interferences from Pharma, the Food and Drug Administration (FDA)   has delayed implementing a new rule that regulates off-label marketing. Off-label

The new rule regulates the way in which pharmaceutical manufacturers can discuss the unapproved uses of their products with health-care providers.

was delayed in an effort to recieve public comments. Device and pharma industry groups have accused the agency of ignoring proper rulemaking procedures.

The new rule would mean that drug makers must update a product label if there’s an indication that a company intends to use its medicine for an off-label or unapproved use.

Doctors sometimes prescribe drugs as a treatment for conditions outside of medications original purpose.

Companies can face criminal charges and liability if they tout their products to doctors and the public for off-label uses the FDA hasn’t specifically approved.

The FDA is pushing back the rule’s effective date to March 19, 2018.  Nearly one year after it’s original date.

Pharmco Laboratories

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.”

Asbestos

The Risks of Asbestos Exposure and Your Legal Rights

The more a person breathes in tiny asbestos particles, the more likely that individual will develop a large variety of lung and breathing complications.

Asbestos was introduced to the construction industry over 100 years ago.  It was widely considered the standard for strengthening building materials in the construction of buildings.

The dangers of inhaling asbestos fibers began to surface around 1980.  It does not take extreme exposure to asbestos for it to be dangerous.  Most victims of asbestos exposure and asbestosis have worked or lived in an environment where there is asbestos in the building or home.

These effects range from wheezing and shortness of breath to mesothelioma and lung cancer.  Regardless of your condition, Medical Claim Legal can help you obtain compensation.

There are a large number of lawsuits involving asbestos exposure and asbestosis.  Do not let your case get passed over.  Medical Claim Legal will connect you with a lawyer who is experienced and successful in the asbestos lawsuit field.  To get the compensation that may be owed to you, contact Medical Claim Legal today.

MedicalClaimLegal, simplifying the process for Asbestos Exposure and Asbestosis compensation

Infuse bone graft

Infuse Bone Graft Lawsuit Gets New Life

A lawsuit accusing Medtronics of covering up negative side effects of its Infuse bone graft has been revived by an appeals court.

A lawsuit accusing Medtronic of misleading shareholders by concealing the adverse effects of its Infuse bone graft, has been revived by the The 8th U.S. Circuit Court of Appeals in St. Paul, Minnesota.

The Infuse bone graft has been used in more than 1 million surgeries. In 2002, the FDA approved the Infuse bone graft for use in specific types of spinal fusion surgeries. The Infuse bone grafts variety are “synthetic, concentrated proteins…mixed with collagen from cows and injected into the spine to alleviate pain.”

The Spine Journal found, in 2011, that the risks of the product had been understated by medical professionals.

In 2012, the U.S. Senate Finance Committee stated that Medtronic, Inc., the manufacturer of the Infuse bone graft, had paid doctors hundreds of millions of dollars to write favorable articles and manipulate studies on the popular product.

In 2013, Medtronic shareholders sued the company claiming that the company’s stock had been inflated due to these unethical activities. As the truth about the product emerged, they have alleged hundreds of millions of dollars in losses.

In 2014, Medtronic agreed to settle its Infuse bone graft lawsuit for $22 million that involves 950 people. Around 2,300 surgeons had used Medtronic products in the US prior to any serious side effects being reported.

An earlier decision in the case judged that shareholders had waited too long before seeking legal action. As 2016 came to a close an appeals court found that the case could still be brought forward.

The case will now be returned to the lower court for further proceedings.

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.

Zofran Lawsuit Continues to Gain Plaintiffs

The story is a pretty well-known one by now: Zofran was created in 1991 by medical manufacturing giant GlaxoSmithKline and grew to become one of the most popular drugs ever. The actual medication works by limiting the amount of serotonin that gets to the part of the human brain that triggers nausea and vomiting. Obviously this is the kind of thing that a pregnant mother would love. Unfortunately the FDA only permitted the use of Zofran to surgery and cancer patients—not pregnant women.  Additionally, reports now allege that GlaxoSmithKline knew the product could be potentially hazardous to pregnant mothers and could cause birth defects.  The reality is pregnant women did take the medication and sadly many birth defects occurred, including musculoskeletal abnormalities, club foot, cleft lip, cleft palate, jaundice and heart deficiencies. This has caused a number of Zofran lawsuit claims to be filed.

The Zofran Lawsuit continues to gain plaintiffs
The Zofran Lawsuit continues to gain plaintiffs

Similar charges were brought by the Department of Justice, in one of the largest alleged health care fraud in history, a case GlaxoSmithKline settled for $3 billion. What is more stunning is additional plaintiffs have come forward now claiming the company has hid evidence of Zofran’s alleged link to major birth defects for more than two decades.

If you are interested in the December 2014 study that showed the impact of the drug on young mothers from Dr. Gideon Korenin in the American Journal of Obstetrics and Gynecology you can find that here.

The U.S. Food and Drug Administration [FDA] issued their formal warnings and instructions on Zofran here.

When lawsuits are brought against a pharmaceutical manufacturer such as GlaxoSmithKline, they either end in a financial settlement for the plaintiff or the lawsuits go to trial.  Generally, zofran lawsuit claims are settled prior to a trial. Medical Claim Legal and its experts have assisted Zofran lawsuit plaintiffs in similar claims.