FDA Warns Consumers Metal Hip Implants are Causing Injury

To many elderly people, a slip and fall could cause serious injury.  In many cases, these elderly people break bones in their fall, including breaking their hip.  This is a traumatic injury which not only limits people's mobility, but can cause additional injuries.  To prevent additional injury and to preserve freedom and autonomy, many opt to receive a hip implant.

There are various kinds of hip implants, but recently, the most common hip implant has been metal hip implants.  These metal hip implants commonly act like a ball and a cup, aiding movement.  Approximately 1 in 3 joint replacement surgeries in the United States have utilized metal hip implants.  To date, that accounts for over 500,000 patients with metal hip implants. 

However, the U.S. Food and Drug Administration (FDA) has released a safety communication warning consumers of the danger for injury with metal hip implants.  Under their new expanded authority from Congress, the FDA is seeking to protect consumers from injury and close former loopholes that existed in the law. 

The Danger of Metal Hip Implants

According to the FDA, metal hip implants have been failing at alarming rates.  Thousands of consumers have experienced additional injury because their metal hip implants have been failing almost immediately after implantation.  These metal hip implant failures have injured patients, causing a need for more expensive surgery to take out and replace the item.  Unfortunately, many elderly patients are too fragile for major surgery like this.  

Doctors have reported these metal hip implants have not only failed in the joint, but they have additionally injured consumers when its metal debris is released as the joint moves.  These injuries have included: 

• bone damage
• severe tissue damage
• disability

How the FDA Seeks to Protect Consumers from Injury

The FDA is now pursuing regulations that would force metal hip manufacturers to produce data to support their claims of safety and effectiveness.  To date, these products have largely exploited a 1976 law which allowed manufacturers to introduce products for approval which are substantially similar to another product on the market.  Under this law, the FDA alleges manufacturers did a disservice to consumers by failing to do extended testing on device safety over the years.  

The FDA is seeking to make serious regulatory changes this year, and one of their first targets is the metal hip implants that are failing.  Until these devices are either recalled or modified safely, many consumers are still experiencing high rates of injury.  If you have been injured  by your metal hip implant, please call a skilled product liability attorney for help.  You may be eligible for compensation. Get the help that you need and deserve to protect your health. 

15,000 Infant Recliners Recalled Due to Infant Deaths

When you're a parent, you want the best for your child.  Your baby's care is in your hands. Often, this leads parents to buy products that claim to increase comfort and care for a child.  One such product is the Nap Nanny, which is a device parents place their children in while they nap. Essentially, it is a recliner with a safety harness to prevent the child from moving around too much and hurting themselves.

However, the U.S. Consumer Product Safety Commission is recalling the item, stating they received 92 reports of infants hanging over the side of the device and 5 deaths.  The shocking truth is this product was originally recalled in 2010 after reports of one death. But the product's manufacturer, Baby Matters, is "unable or unwilling to participate in the recall."

Retailers Amazon, Buy Buy Baby and Toys R Us are recalling the devices, which amount to an estimated 15,000 devices.  In response, the company released a statement expressing their disapproval of the recall and boasting the continued benefits of the device to thousands of infants.

What's the Danger?

Reports to the Consumer Product Safety Commission paint a picture of infants nearly wiggling fully out of the harness, falling over the side and even becoming trapped between the recliner and crib bumpers. According to the Consumer Product Safety Commission, multiple reports to their agency have included:

• entrapment claims
• suffocation hazard claims
• fall hazard claims
• claims of deaths

The Consumer Product Safety Commission is encouraging parents to call them today to report similar hazards.  Additionally, you may want to consult a skilled personal injury and product liability attorney to preserve your rights.  Parents may be able to obtain compensation for their child's injuries.  To determine whether or not you are eligible, please call a skilled personal injury and product liability attorney today. 

ACTOS SUITS INCREASE IN CALIFORNIA

This morning, another 14 diabetes patients in California filed suit in the Los Angeles Superior Court, bringing the count of Californiavictims filing suit to over 115. Nationwide, there have been over 1,000 lawsuits to date.

These complaints allege the manufacturer, Takeda Pharmaceuticals, and their distributor, Eli Lily, “concealed and failed to completely disclose their knowledge that Actos was associated with or could cause bladder cancer or their knowledge that they had failed to fully study and test regarding that risk and, further, made conscious decisions to ignore the association between the use of Actos and pioglitazone hydrochloride and the risk of developing bladder cancer.” 

Many of these lawsuits, such as 5 new lawsuits filed in Los Angeles Superior Court today, are wrongful death claims initiated by surviving family members. Common claims are that a loved one took Actos for over a year in order to control their type 2 or “lifestyle” diabetes and died of bladder cancer while on the drug.

 

WHAT IS ACTOS' EFFECT?

Studies show that there is as much as a 40% increase in getting bladder cancer after taking Actos for a year or longer.  Due to these often repeated results, the U.S. Food and Drug Administration (FDA) has issued a public health warning that using this drug could increase your chances of getting bladder cancer.  Thousands of patients claim to have been injured by Actos. 

Over 20% of the diabetes medication prescribed today is Actos.  Since 2007, it is the most commonly prescribed drug in the world for treating type-2 diabetes.  In America alone, it is the 10^th most prescribed drug. That’s a lot of diabetics at risk for developing bladder cancer.

Injured patients have been filing suit across the United States seeking relief for their injuries.  If you’ve developed bladder cancer after taking Actos, you may be entitled to compensation.  Consult a trusted attorney today to discuss your rights.

CDC AND FDA REPORT FUNGAL MENINGITIS OUTBREAK

This morning the internet is abuzz about fungal meningitis.  Last week, complaints to the FDA and the CDC began to pour in from medical facilities across the nation.  This rare but life threatening outbreak has already claimed 91 victims and 7 deaths in 9 states.  As federal investigators continue their investigation, these numbers are likely to rise again.

Federal investigators tracked the outbreak to the New England Compounding Center (NECC), which distributed tainted steroidinjections.  These steroids, named Methylprednisolone Acetate, were tainted with a fungus which caused many patients to develop this rare and potentially deadly disorder. Approximately 76 centers in 23 states received these tainted medications and are now on high alert for patients who may have developed fungal meningitis. 

A facility investigation has revealed foreign substances in unopened vials.  When tested, the CDC claims these substances were fungus.  In response, the NECC has issued a voluntary recall of its products and has voluntarily surrendered its license to operate.  As investigations continue and the death count rises, the nation is on high alert.

If you or a loved one has received steroid injections between July 1 and September, you should immediately get checked by your doctor.  Fungal meningitis has a 1 to 4 week incubation period, after which you may experience mild symptoms which will rapidly deteriorate.

These symptoms include:

·         Headache

·         Confusion or altered state

·         Vomiting

·         Sensitivity to light and sound

·         Low blood pressure

These symptoms could rapidly deteriorate into the following:

·         Lack of blood flow to the organs

·         Gangrene

·         Excessive blood clotting

·         Death

Fungal meningitis is a serious health emergency and needs to be treated as such.  If you have any of these symptoms and have recently received medication from the NECC or have recently received steroid injections, you should get tested immediately.  Your life could literally be on the line.  

If you or a loved one has in fact been injured by receivingtainted steroids, you could be entitled to compensation.  You should consult an experienced and trusted attorney. 

DOCTORS LACK FAITH IN DRUG COMPANY STUDIES

DOCTORS LACK FAITH IN DRUG COMPANY STUDIES

Somewhere out there, my mother is rolling her eyes.  To the surprise of no one, even doctors lack full faith in drug company sponsored studies.  Does anyone trust research paid for by the manufacturer? If you truly want to know the details of a product, conventional wisdom says its generally the independent studies that offer the most insight. 

According to a recent report in the New England Journal of Medicine, researchers from Harvard Medical School showed that doctors are rethinking the efficacy of drugs based upon the source of studies’ funding.  The report concludes that doctors are only half as willing to prescribe drugs in industry- sponsored drug trials compared to independent National Institute of Health funded trials.  To drug makers, this is the sound of their bottom line taking a nose dive.

WHY THE LACK OF FAITH

It turns out that doctors are a skeptical bunch.  Concerned with splashy headline driven drugscandals, many doctors are recoiling from new drugs whose only studies are sponsored by the drug companies themselves.  Perhaps this amount of caution is warranted.  Recently, we’ve seen a lot of press about drugs which were released amid glowing pharmaceutical company studies and later turned into nightmares for the general public. 

There are multiple reasons for this skepticism including:

·         Pharmaceutical companies’ reputation for not including certain unsightly complications and side effects in studies

·         Pharmaceutical companies’ profits over people image

·         Splashy headlines in major newspapers warning of the latest FDA recall or dangerous drug

With so many good reasons for skepticism, are there legitimate reasons for trusting these studies that doctors are closing themselves off to?

PERHAPS CAUTION IS THE BEST APPROACH

Perhaps rather than jumping to immediate conclusions, a cautioned approach would be best.  Doctors already have enough on their plates, but a little investigation into the study and potential outside opinions, studies, and research might be a good idea.  Nobody wants to miss out on prescribing a drug that might extend patients’ lives and improve their health drastically.  But until the next new miracle drug presents itself, a measured and cautioned approach is probably the best. 

As a patient, does it make you feel better that your doctor is cautiously weighing the options prior to subscribing potentially risky drugs? It would help me sleep better at night to know that my doctor is thinking it through. But if you find you’ve suffered just the opposite, and your doctor has gone all in and prescribed you a risky and dangerous drug, you do have options.  If you’ve been injured, you might want to talk to an attorney.  Call us and we’ll listen to your case.

SUNLAND INC. AND TRADER JOE’S RECALL OVER 76 PEANUT AND ALMOND BUTTERS

On the heels of the September 22 salmonella outbreak at Trader Joes, 76 additional peanut and almond butters have been recalled by manufacturer Sunland Inc.  The New Mexico based company is recalling the product after 29 cases of salmonella in 18 states have caused concern for the public health.

Trader Joe’s voluntarily recalled its Creamy Salted Valencia Peanut Butter after 4 customers were hospitalized after eating the product. But the 76 additional peanut and almond butters were all manufactured with the same equipment. Manufacturer Sunland Inc. isn’t taking any chances and is investigating the origins of the salmonella outbreak.

WHAT IS SALMONELLA

Salmonella is the most widely reported of all food borne illnesses. The salmonella bacteria causes over 1.4million illnesses and 400 deaths a year in the United States alone.  It is a microscopic organism that lives in the infected intestinal tract of both humans and animals and passes to others through feces.  If present on food, this bacteria does not alter the taste, smell, or appearance of food. 

When infected with the salmonella bacteria, people exhibit the following symptoms:

• Vomiting
• Diarrhea
• Severe abdominal pain
• Fever, chills
• Headaches
• Nausea

Symptoms of salmonella usually show in 4 to 72 hours after ingesting the contaminated food and can last 4 to 7 days.  Most cases are unpleasant but pass quickly.  Severe cases may lead to hospitalization or death.

HOW DO YOU PROTECT YOURSELF FROM SALMONELLA BACTERIA

There are a number of ways you can protect yourself from salmonella infection.  These include:

• Refrigerating perishable items quickly
• Cooking foods to their proper temperature
• Washing surfaces, utensils, and foods thoroughly
• Avoid cross- contamination of items

The effects of salmonella can be particularly hazardous to the elderly, children, and in people with compromised immune systems.  In these people, salmonella could potentially be fatal.  If you lose a loved one to the effects of salmonella infection, you may want to consult a personal injury attorney to discuss your legal options.