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.

High Fracture Rate – Zimmer Biomet Shoulder Replacement Device

Zimmer Biomet Shoulder replacement device was found to have a higher risk of fracturing than it was earlier believed, consumers at risk.

Labeling of the Zimmer Biomet Shoulder replacement failed to adequately disclose fracture risks. Those who received the shoulder replacement may experience substantial pain and suffering.

The Biomet Comprehensive Reverse Shoulder recall, was issued as Class I. Class I recalls are reserved for some of the most serious recalls issued by FDA.  

Risks include:

  • Death
  • Infection
  • Loss of shoulder movement

In December, Zimmer Biomet sent a recall notice and a Certificate of Acknowledgement to all affected customers.

Those with adverse events or side effects related to the use of these products are urged to report such problems.

If you or a family member have received the Biomet Comprehensive Reverse Shoulder System Humeral Tray Model 115340, you may be entitled to compensation. Connect with an attorney at Medical Claim Legal.

Zimmer Biomet Receives FDA Class I Recall for Shoulder Device

The Zimmer Biomet shoulder device is facing a class 1 recall from the FDA.

Due to a “higher fracture rate than stated” the Food and Drug Administration (FDA) has issued a class one recall of the Zimmer BiometZimmer biomet reverse shoulder device. Such recalls are reserved for products that “will cause serious adverse health consequences or death.”

This medical device recall, the most serious recall category, was issued this February. The recall reportedly included 3,662 devices.

Zimmer Biomet
Notice that risk managers received related to Zimmer Biomet recall.

The company acknwledged that these shoulder trays, all manufactured prior to September 2011, would fracture easily.

Risks included a need for revision surgery. According to experts, such surgeries might lead to permanent loss of shoulder function, infection and even death.”

Patients that may have received the Zimmer Biomet device may be entitled to compensation for their pain and/or suffering. For more information about filing a claim through Medical Claim Legal, complete a claim form at this link.

Intuitive Surgical Inc

Intuitive Surgical Inc must warn hospitals about defects

Washington Supreme Court determined that Intuitive Surgical Inc has to warn hospitals about devices.

The Washington Supreme Court ruled that Intuitive Surgical Inc must warn hospitals about devices. They went up against a ruling by a jury that had previously ruled in favor of the manufacturer. In Taylor v. Intuitive Surgical Inc., the high court said the trial court failed to inform the jury that the company had a duty to warn the hospital that purchased the device at issue.

The new ruling came in response to a ruling in a previous case. Jurors had found that Intuitive Surgical Inc had not been negligent in failing to warn Harrison Medical Center about defects in their devices.

The court ruled that under the state’s  liability laws, manufacturers should warn hospitals, in addition to physicians, about the risks of using their medical devices.

Heartmate Php

Use of HeartMate PHP Stopped After Death, Complications

HeartMate PHP use has been stopped after a malfunction precedes death.

Abbott Laboratories acquired Minnesota medical device maker St. Jude Medical in January. In a 2015 deal, St Jude Medical had acquired HeartMate PHP.

During procedures to unclog blood vessels, the HeartMate PHP catheter is Heartmate PHPinserted in the heart to keep blood flowing. The device is used inside the heart with no need for open-chest surgery.

As recently as September, the device received praised from the medical community.

Now, the Lab is putting an end to the commercially successful blood pumps use in the United States and Europe after several malfunctions and a patient death.

One malfunction of the device led to irregular blood flow requiring an emergency medical intervention to save a patient, while another case resulted in a death related to sepsis following the intervention.

In a statement, Abbott Labs gave the following information related to HeartMate php:

“This step is being taken as a precaution due to reports of a small number of clinical events associated with pump stoppage during support of high-risk percutaneous coronary intervention (PCI) patients in both clinical and commercial uses.”

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.

Oxycontin

OxyContin Manufacturer Sued Following Epidemic

The city of Everett, Washington has filed a “first-of-its-kind lawsuit” against Perdue Pharma, the manufacturer of OxyContin.

Everett, Washington is a place where addiction to heroin and other opioids is officially considered an epidemic. Now, the city  has filed a “first-of-its-kind lawsuit” against the manufacturer of OxyContin. Citing gross negligence, the city claims that when Perdue Pharma marketed OxyContin as a  less-addictive alternative to other pain medication, they did the public a disservice.

The city wants the manufacturer to start paying to repair damages done to the coOxycontinmmunity harmed by the epidemic. Everett Mayor Ray Stephanson said “we are going to go at them, and we are going to go at them hard.”

Officials claim that at the height of the epidemic, OxyContin was a factor in more than half of the crimes committed in Snohomish County.

In an LA Times article it was noted that “those drawn to the pills included young people and professionals who saw the painkiller as more fashionable and less dangerous than street drugs.

Many became addicted and lost their homes, jobs and families. After Purdue reformulated OxyContin in 2010 to make it harder to abuse, addicts moved en masse to heroin, which has a similar effect.”

Experts have mixed opinions about Everett’s chances of recovering money.