What’s BIA-ALCL? Rare Cancer Deaths Tied to Breast Implants

The FDA has linked BIA-ALCL deaths to a breast implants.

In 1997, The World Health Organization first made the link between the rare cancer and breast implants, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) occurs in a capsule of tissue that develops around the implant. The cancer typically surfaces around ten-year following the breast implantation. BIA-ALCL

The FDA was quoted this week saying that “…the available information suggests women with breast implants have a very low, but increased risk of ALCL compared to women who do not have breast implants.”

Women that have both silicone and saline-filled breast implants have been affected by ALCL.

The FDA says, it has received 359 reports of the lymphoma.

One recent study determined that 3.3 out of every 100,000 women with textured breast implants will develop BIA-ALCL. The textured breast implant variety seem to have the highest occurence of the cancer diagnosis according to FDA and the Australian government.

If you or a loved one has been diagnosed with BIA-ALCL, you may be entitled to compensation due to your pain and suffering. Let the Medical Claim Legal team help you through the process.

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.

Lupron

Lupron, a Drug Used to Delay Puberty, Causes Problems in Women

Lupron was injected in thousands of women in an effort to inhibit puberty or increase height.

More than 10,000 adverse event reports have been filed with the FDA based on the experiences of women who’ve taken Lupron. The reports describe a variety of symptoms experienced by those who took the drug to grow taller or delay puberty. Lupron

Lupron, currently manufactured by AbbVie, is an injection designed to reduce testosterone in men or estrogen in women. The drug is also approved for use by men with prostate cancer.

The experiences of the women that used the drugs are varied but complex. Many women reported experiencing symptoms and conditions linked to older, even elderly people. According to the FDA reports:

A 20-year-old was diagnosed with osteopenia, a thinning of the bones. A 26-year-old in Massachusetts needed a total hip replacement. One 25-year-old woman from Pennsylvania has osteoporosis and a cracked spine. In Wisconsin, another woman in her 20’s  has chronic pain and degenerative disc disease.

Other women described depression and anxiety.

Additionally, the FDA is reviewing deadly seizures caused by the use of Lupron and similar drugs.

The drug has had success in the marketplace. In 2015, the drug-maker reportedly brought in $826 million in sales.

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.”

Monsanto

Monsanto Popular Weed Killer to Be Labeled a Cancer Risk

Monsanto, a major agricultural corporation, can now be required to label its popular weed-killer, as a possible cancer threat.

California can require Monsanto to label Roundup, its top-selling herbicide, as a possible cancer threat, a judge tentatively ruled Friday.

Monsanto has insisted that its product poses no risk to people. 

On Friday, a federal judge denied the corporation’s bid to overturn a 2015 state ruling to label it as a cancer risk.

The main criticism is Roundup’s main ingredient. The popular weed-killer includes Glyphosate, a chemical which was originally touted as a way to kill weeds while leaving crops and plants intact.

The U.S. Environmental Protection Agency, says it has ‘low toxicity.’ The agency considers Glyphosate safe when used correctly.
However, under California Proposition 65 label requirements in California, businesses are required to notify Californians about significant amounts of chemicals in the products that they purchase.

Chemicals that require labeling include ingredients or additives in pesticides, common household products, food, drugs, dyes, or solvents.

California regulators are waiting for the lawsuit to be resolved before deciding whether to require warnings, said Sam Delson, a spokesman for the state Office of Environmental Health Hazard Assessment.

Tecfidera

MS Drug Tecfidera Label Update Discloses Risk for Liver Injury

The Tecfidera label now reflects a possible side effect of liver injury.

Tecfidera, Biogen Inc’s multiple sclerosis (MS) drug,  has received label updates to  disclose a potential liver injury that could require hospitalization. Tecfidera

The world’s best selling oral MS drug experienced sales of $1.03 billion in the third quarter and accounts for about a third of the pharmaceutical company’s revenue.

Biogen reports that only 14 instances of liver injury have occurred around the 230,000 patients who have taken Tecfidera.

This isn’t the first time Tecfidera has had the spotlight. Just last week,  Biogen Inc. announced a settlement of a patient infringement lawsuit for $1.25 billion concerning the multiple sclerosis drug.

The label updates mention that abnormalities are resolved after use of  Tecfidera ends. A few cases required that the user be hospitalized. None of the cases have led to serious conditions including liver failure, liver transplant, or death.

Software

Medical Device Software Vulnerabilities a Huge Concern

Software vulnerabilities of medical devices may be difficult for health sector officials and manufacturers to manage.

As we reported last week, St. Jude implemented software updates that could protect pacemakers and other medical devices from being compromised by hackers. Oxycontin

Unfortunately, new information suggested that the public is not completely in the clear.

“Software is never perfect and all systems still will have these flaws,” says Joshua Corman, director of the Cyber Statecraft Initiative at the Atlantic Council and an expert on medical device security. “The question is how gracefully and collaboratively and quickly and safely can we respond to these flaws.”

In late 2016, there were reports that the Merlin@home transmitter used in monitoring certain St. Jude Medical implant devices could be hacked. These hacks could lead to deadly consequences for  the patient.

MedSec, a cybersecurity firm,  initially found the problems in the St. Jude devices. After which they “tipped off”- the activist investment firm Muddy Waters, which publicized the flaws and advised clients to bet against the health care firm’s stock.

Ever since the US government and St. Jude confirmed the one flaw, the VA has been “taking steps to be sure all our patients and providers are aware of this issue and take appropriate actions to be sure that all our patients get the update for their monitor,” said Merritt Raitt, acting director of the VA National Cardiac Device Surveillance Program.

drug

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.”

Baby powder

American Pediatric Association Recommends Against Using Baby Powder

Pediatricians recommend against using baby powder, amid talcum risks.

American Pediatric Association is now recommending against the use of baby powder. There have been recent notable concerns over talc being harmful to babies. Research suggested that the mineral could be inhaled and harm babies’ lungs.

Baby powder is a talcum powder blend that absorbs moisture and reduces chafing. Traditionally, it has been an important part of diaper-changing.

Some safer options on the market are using cornstarch  to replace the talc in their powders.  Additionally, some pediatrician recommend leaving babies bare altogether. Others suggest petroleum-based products for rashes.

David Soma, a Pediatrician with the Mayo Clinic Children’s Hospital, notes that the biggest issue is powders in general, not specially talcum-based powders. Soma states that whether it’s cornstarch-based or talcum-based “try to keep it well localized to the diaper and away from any area that can be inhaled.”

Coca-cola

Consumer Group Suing Coca-Cola Due to Sugary Soda Risks

Lawsuit claims Coca-Cola misled consumers on sugary soda health risks.

The consumer-advocacy group, Center for Science in the Public Interest (CSPI) asserts that Coca-Cola has misled consumers about the health risks of sugary drinks such as soda. Coca-Cola

In 2015, it was revealed that the corporate giant had heavily funded and been involved in the operation of the research group Global Energy Balance Network. Coca-Cola aimed to help establish the group as a “reputable scientific source to counter “public health extremists.” The company has starkly tried to avoid claims that their products are unhealthy.

It is based on these findings that the lawsuit claims that, “for years, [the] defendants have engaged in a pattern of deception to mislead and confuse the public (and governmental entities that bear responsibility for the public health) about the scientific consensus that consumption of sugar-sweetened beverages is linked to obesity, type 2 diabetes, and cardiovascular disease.”

The industry group, American Beverage Association (ABA) is the co-defendant in the lawsuit. The ABA continues to argue that obesity is a “complex condition.” Further asserting that as obesity and diabetes rates continue to rise, that soda consumption is dropping.

CSPI wants the ABA and Coca-Cola to make some changes. They want marketing to disclose the health risks of sugary drinks, while stopping ads directed at children. They also want the groups to disclose file “indicating the potential health implications.” Plus, the CSPI would like for Coca-Cola and the ABA to fund a public health campaign.

The ABA said in a statement that “America’s beverage companies know we have an important role to play in addressing our nation’s health challenges. That’s why we’re engaging with health groups and community organizations to drive a reduction in the sugar and calories Americans get from beverages.”

Coca-Cola has called the suit “legally and factually meritless.”