Archive for the ‘ Recalls ’ Category

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2
Feb

Pfizer, Inc. Recalls One Million Birth Control Pill Packets

February 2, 2012

The Drug manufacturing giant, Pfizer, Inc., announced a recall of nearly one million packets of birth control pills Tuesday due to a manufacturing mix-up that could put women at an increased risk of unwanted pregnancy. Reports form WRAL News say that 14 lots of Lo/Ovral-28 tablets and another 14 lots of Norgestrel and Ethinyl Estradiol tablets had placebo tablets placed in the wrong order the tablets are to be taken in.

The mix-up was discovered last year when a customer called after noticing the pills were in the wrong order. The company fixed the problem immediately. Then, in December, Pfizer contacted pharmacies asking them to pull the specific recalled lots from the shelves. The recall was announced publicly on Tuesday only after the Food and Drug Administration (FDA) made a request that Pfizer do so. Women who have been using affected pills are advised to begin use other forms of contraception immediately.

Experts say that the manufacturing mix-up could put the drug-maker at risk of a multi-million dollar lawsuit. An article by FOX News says the lawsuit could stand on the same grounds as several lawsuits in the past that have been won after a man’s vasectomy did not take and his partner became pregnant.

The North Carolina drug injury lawyers with HensonFuerst are here to answer any questions you may have if you have been affected by a mistake or side effect of a medication prescribed to you by a doctor.

Popularity: 1% [?]

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5
Jan

More Americans Die From Drug Overdose Than From Car Crashes

January 5, 2012

Right now in the United States, more people die from drug overdoses than from car accidents, according to new research released last month. According to WECT 6 News, the study concluded that the cause of the surge in fatal overdoses could be linked to the increased use of drugs that have potential for abuse.

The study was conducted by the Centers for Disease Control and Prevention (CDC) over a 30-year time period. Over the span of three decades, researchers saw an increase of six times as many drug poisoning deaths. In 1980, there were roughly 6,000 deaths associated with drug poisonings. By 2008, that number had capped out at 36,500. That same year, nine out of ten poisoning deaths were drug related, with 77 percent of them being unintentional.

These findings correlate with earlier research that showed the number one type of drug abused in the United States today are legal pharmaceuticals.

A CDC health scientist involved with the study, Dr. Chris Jones, stated that the number of prescriptions that doctors are willing to write to patients today is a major contributing factor to the problem. “Between 1999 and 2010, the sales of these drugs increased fourfold.” he added.

The Raleigh drug injury lawyers with HensonFuerst are an experienced team of attorneys dedicated to helping victims who have been injured at no fault of their own by a prescription drug. If you or someone you know has experienced a similar scenario, call us today to discuss your case.

Popularity: 2% [?]

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29
Dec

Studies Show Avastin® Has Weak Results Against Ovarian Cancer

December 29, 2011

New studies are showing that a drug once used to treat numerous types of cancer may not work. According to WRAL News, recent data presented to the Food and Drug Administration (FDA) not only led to the organization pulling approval for the use of the drug Avastin® in the treatment of breast cancer, but now also in the treatment of ovarian cancer.

The drug was approved last week for use in advanced ovarian cancer patients despite the findings, but the drug’s manufacturer, Genentech, has stayed mum on whether the company will seek approval for the same in the United States.

Two studies in today’s newest issue of the New England Journal of Medicine found that the drug only slowed the cancers progression for several months and did not improve mortality rates. On top of this, patients have suffered from numerous drug side effects, including:

  • Blood Clots
  • Slow Wound Healing
  • Severe Bleeding
  • Perforations Of The Gastrointestinal Tract

If you or someone you love has suffered ill effects from drugs like Avastin®, contact the experienced team of North Carolina drug injury lawyers with HensonFuerst. They are here to help their clients in every step of the process of filing a claim to get the compensation they deserve.

Popularity: 2% [?]

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14
Nov

Toyota, Lexus, Cadillac Recalls

The National Highway Traffic Safety Administration (NHTSA) reports that two large car manufacturers have recalled vehicles:

Toyota, Lexus

This recall affects more than 420,000 vehicles. Toyota is recalling several different models because the amount of adhesive applied between the outer ring and inner ring in the crankshaft pulley may be inadequate.The outer ring could become misaligned, and may not rotate properly. In some cases, the belt for the power steering pump may become detached from the pulley, which could result in a loss of power steering and a sudden increase in steering effort. Because this would happen without warning, it could increase the risk of a crash.

The NHTSA says that the recall is expected to begin during early January 2012, but if your vehicle is on the list, you may wish to call your dealership sooner to see if your car can be checked out. If there is a problem, the dealer will replace the pulley with a new one at no charge.

The affected vehicles are:

  • 2004-2005 Lexus ES 330
  • 2004-2005 Lexus RX 330
  • 2006 Lexus RX 400H
  • 2004 Toyota Avalon
  • 2004-2005 Toyota Camry
  • 2004-2005 Toyota Camry Solara
  • 2004-2005 Toyota Highlander
  • 2006 Toyota Highlander Hybrid
  • 2004-2005 Toyota Sienna

If you have questions, you may contact Toyota at 1-800-331-4331, or the NHTSA Vehicle Safety Hotline at 1-888-327-4236.

General Motors Cadillac

This small recall (affecting just 674 cars) is for model year 2012 Cadillac CTS vehicles manufactured from October 21, 2011, through October 26, 2011. A nut in the brake system may not be torqued to the proper specification, which could result in a loss of ability to brake, which could lead to a “crash without prior warning.”

How do you know if your 2012 Cadillac CTS is affected? The best way to is call your dealership. Ask them to inspect the power vacuum brake boost pushrod retention nut. If necessary, they will adjust the torque. If you have questions, contact GM at 1-800-458-8006, or the NHTSA’s Vehicle Safety Hotline at 1-888-327-4236.


Popularity: 3% [?]

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3
Nov

GlaxoSmithKline Agrees To Pay Federal Government $3 Billion

November 3, 2011

In an agreement reached yesterday, Drug maker GlaxoSmithKline (GSK) will pay the United States Government $3 billion to settle investigations into the company’s sales and marketing tactics regarding it’s drug, Avandia. According to WRAL News, the deal stems from 2004 allegations that the company had price irregularities with the drug and did not fully disclose the dangers of the medication posed in marketing materials.

Documents show that the settlement will cover both civil and criminal liabilities for the company. As part of the agreement though, the company had to change policy and procedure for compensation of it’s sales force. The company says that bonuses paid to representatives of the company will no longer be based on hitting individual sales targets, but will rather focus on the quality of service that customers receive.

The company is hoping that these strategic moves will put to rest much of the controversy the company has faced regarding its business practices. The company says the payment will be made in the next fiscal year and will come from its cash assets. In all, GSK says it has paid out more $6 billion in settlements surrounding the drug Avandia.

The North Carolina Drug Injury Lawyers with HensonFuerst often deal with cases involving drug injuries. If you or someone you know has been the victim of a drug injury, contact HensonFuerst for a free intial consultation today.

Popularity: 2% [?]

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4
Oct

Hip Replacements Fail, Sometimes Without Symptoms

Last year, DePuy Orthopaedics, a division of Johnson & Johnson, recalled two of their hip replacement systems due to a higher-than-usual failure rate, causing patients to have to have second surgeries to replace the replacement.

Then, in May 2011, the U.S. Food and Drug Administration (FDA) ordered all producers of “metal-on-metal” hip replacements to study the implants to make sure patients remain as safe as possible. That means that DePuy may not be the only potentially dangerous brand of hip replacement. Other brands included in the FDA’s order are Zimmer, Stryker, Biomet, and Wright Medical.

Now, according to a new article in The New York Times, the problems reported to date may be just the tip of the injury iceberg. And many people who have hip replacements may not even be aware that their bodies are in the midst of developing serious, potentially permanent damage.

BACKGROUND

Hips are made of two parts: A round, concave socket on the lower part of the pelvis; and a ball-shaped protrusion of bone at the end of the femur (thigh bone) that fits perfectly into the socket. This ball-and-socket joint allows the leg to extend forward, backward, sideways, and around in a circle in fluid motion.

A hip replacement, therefore, also has two parts:  Ball and socket. The most common implants are made of metal and plastic, but some—such as those involved in the recall—are known as metal-on-metal, in which a metal ball rotates in a metal socket. According to The New York Times:

More than a decade ago, some researchers had warned that the hips shed tiny pieces of metallic debris that posed potential health threats to patients. But those warnings were not heeded, and now doctors and patients face a growing public health problem as one of the country’s biggest medical device failures unfolds.

The metallic debris triggers the body to release scavenger cells to try to get rid of the particles, but they end up only making the problem worse: A chemical reaction converts the metal particles into biologically active metallic ions. In some patients, this causes a cascade of problems in the body that can end up causing permanent muscle and tissue damage.

A COMPLEX PHENOMENON

Metal-on-metal hip replacement devices don’t always cause health problems, and when they do, the path to diagnosis isn’t clear or straightforward. Some patients have severe symptoms that cause them to seek medical care, but sometimes people with severe damage don’t experience pain at all. Sometimes the metallic ions can be picked up in blood work, but sometimes standard test for the ions are negative even though they exist.

For example, Cyndi Lafuente, a senior adviser at the Internal Revenue Service, learned last year that the model of artificial hip she got in 2007 was being recalled by its manufacturer, the DePuy division of Johnson & Johnson, because of its high early failure rate. Ms. Lafuente said she contacted her surgeon, who ordered a blood test and diagnostic scans, which came back with normal results. Still concerned, she contacted a British researcher, Dr. David Langton, who had helped sound the alarm about the recalled model.

In January, she met again with her orthopedist, armed with information from that talk and other research. The physician suggested that they run an added test. It showed very high metal levels, she said.

Patients are being put in the position of having to take an active role in seeking answers about their metal-on-metal hip replacements. Those who don’t could be risking permanent damage.

WHAT TO DO

If you already know that you received one of the recalled DePuy hip replacement systems or any metal-on-metal hip replacement, we recommend two things:

1. Schedule a follow-up appointment with your surgeon, even if you’re not currently having symptoms. It is possible that you could have early signs of failure before you recognize the pain. Your doctor will be able to evaluate how your hip is functioning and whether the recalled implant is in need of replacement.

In that visit, your orthopaedic surgeon may also want do a blood test that looks at the level of microscopic metal particles around your hip. Metal particles are a sign that recalled implant has failed. If the blood test indicates a high level of these particles, your surgeon may want to do a second blood test three months later. These levels may be high even if you are not experiencing any symptoms, so this blood testing is very important.

2. Call HensonFuerst Attorneys for important information about your rights. If you or someone you care about received one of these defective joint replacement components, we would like to speak with you right away.  You may have a legal case and be eligible to collect compensation for the injury caused by this faulty medical device.

What’s most important: DO NOT contact DePuy or other manufacturer, or SIGN ANY RELEASES OF YOUR MEDICAL RECORDS TO DePuy or JOHNSON & JOHNSON or any other manufacturer before you talk with a lawyer. On DePuy’s website, they ask patients to register with them and receive a claim number. DO NOT DO THIS YOURSELF. Let a lawyer handle everything. Big corporations look out for their own financial interests, not the interests of people who may have been harmed. If Johnson & Johnson was interested in helping patients, they would not have allowed the device to continue to be sold even after they knew it was causing serious problems.

At HensonFuerst, your health is our top priority. We dedicate ourselves to protecting individuals from the greed and callousness of large corporations. Let us work for you. Someone is available to take your call 24 hours/day, every day of the year at 1-800-4-LAWMED (1-800-452-9633). Or, visit our website at www.lawmed.com for more information. You can also fill out a free online consultation form for an immediate evaluation of your case.

Life doesn’t wait, and neither should you. If you have questions, HensonFuerst has answers.

RESOURCES

To read the full article in The New York Times, click here:  Remedy Is Elusive as Metallic Hips Fail at a Fast Rate

To read our previous blogs about metal-on-metal hip replacement devices, click here:

Hip Replacements to Be Evaluated for Safety

—or here:

Hip Implant Complaints Surge

To watch our video about the DePuy hip replacement device recall, click here:  HensonFuerst video about DePuy recall

Popularity: 5% [?]

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23
Aug

Hip Implant Complaints Surge

On August 24, 2010, DePuy Orthopaedics, a division of Johnson & Johnson, sent a letter to doctors announcing a recall of two of their hip replacement systems, the ASR XL Acetabular System, and the ASR Hip Resurfacing System. Why? Because they have a higher-than-usual failure rates, causing people to have to have second surgeries to replace the replacement.

About 1 in 8 percent of the DePuy replacements will fail within 5 years. What’s worse, the faulty hip replacement causes serious pain and difficulty walking, and recovery from the second hip replacement is often more difficult than after the first. There is also the possibility of metallic particles being shed by the devices. These potentially toxic cobalt-chromium particles may, in high levels, cause heart and/or nervous system problems.

According to a recent article in The New York Times, since January 2011, the U.S. Food and Drug Administration (FDA) has received more than 5,000 reports of problems with metal-on-metal hip replacements… more than they received in the previous four years combined. About 75 percent of the complaints were about the recalled Johnson & Johnson products.

The mounting complaints confirm what many experts have feared — that all-metal replacement hips are on a trajectory to become the biggest and most costly medical implant problem since Medtronic recalled a widely used heart device component in 2007. About 7,700 complaints have been filed in connection with that recall.

Many of the metal-on-metal hip replacement products were sold without testing them in patients (a move that, strangely is  within FDA guidelines). But in May 2011, the FDA ordered producers to examine the failure rate, the complication rate, and the threat to patients. In addition, researchers are trying to understand exactly how the metal particles cause tissue damage, and why some people experience debilitating pain, while others don’t. According to the article in The New York Times:

As problems and questions grow, most surgeons are abandoning the all-metal hips, saying they are unwilling to expose new patients to potential dangers when safer alternatives — mainly replacements that combine metal and plastic components — are available. Some researchers also fear that many all-metal hips suffer from a generic flaw. Current use of all metal devices has plummeted to about 5 percent of the market, though a few of the models are performing relatively well in select patients.

“It is like playing Russian roulette,” said Dr. Geoffrey H. Westrich, an orthopedic surgeon at the Hospital for Special Surgery in New York, who has stopped using all-metal implants.

But for patients who already have tissue damage from faulty hip replacements, the idea that the FDA will now begin studying the devices amounts to little more than a cruel joke. According to one patient, physical therapist Ann Morrison, who was interviewed by reporters for The New York Times:

“We will be the little crash test dummies here until they figure out the health ramifications for us down the road,” said Ms. Morrison, who has sued the DePuy division of Johnson & Johnson, which made her implants.

What To Do Now

If you already know that you received one of the recalled DePuy hip replacement systems, or any metal-on-metal hip replacement, we recommend two things:

1. Schedule a follow-up appointment with your surgeon, even if you’re not currently having symptoms. It is possible that you could have early signs of failure before you recognize the pain. Your doctor will be able to evaluate how your hip is functioning and whether the recalled implant is in need of replacement.

In that visit, your orthopaedic surgeon may also want do a blood test that looks at the level of microscopic metal particles around your hip. Metal particles are a sign that recalled implant has failed. If the blood test indicates a high level of these particles, your surgeon may want to do a second blood test three months later. These levels may be high even if you are not experiencing any symptoms, so this blood testing is very important.

2. Call HensonFuerst Attorneys for important information about your rights. If you or someone you care about received one of these defective joint replacement components, we would like to speak with you right away.  You may have a legal case and be able to collect compensation for the injury caused by this faulty medical device.

What’s most important: DO NOT contact DePuy, or SIGN ANY RELEASES OF YOUR MEDICAL RECORDS TO DePuy or JOHNSON & JOHNSON or any other manufacturer before you talk with a lawyer. On DePuy’s website, they ask patients to register with them and receive a claim number. DO NOT DO THIS YOURSELF. Let a lawyer handle everything. Big corporations look out for their own financial interests, not the interests of people who may have been harmed. If Johnson & Johnson was interested in helping patients, they would not have allowed the device to continue to be sold even after they knew it was causing serious problems.

At HensonFuerst, your health is our top priority. We dedicate ourselves to protecting individuals from the greed and callousness of large corporations. Let us work for you. Our attorneys are available 24 hours/day, every day of the year at 1-800-4-LAW-MED (1-800-452-9633). Or, visit our website at www.lawmed.com for more information. You can also fill out a free online consultation form for an immediate evaluation of your case.

Life Doesn’t Wait, and neither should you. If you have questions, HensonFuerst has answers!

This law firm is not affiliated with, sponsored by, or associated with the Associated Press, DePuy Orthopaedics, Inc., or Johnson & Johnson

To see the HensonFuerst YouTube video about the DePuy hip recall, click here:  HensonFuerst YouTube video

To read the full article in The New York Times, click here:  Hip Implant Complaints Surge, Even as the Dangers Are Studied

Popularity: 3% [?]

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2
Aug

Ford Recalls 1.1 Million Pickup Trucks

“]

[from MSNBC.com

Some Ford pickup trucks are being recalled due to a problem with the way the fuel tanks are attached. Straps that hold the fuel tanks in place can corrode and break, which can cause the fuel lines to separate from the tank, ore for the tank to actually fall to the ground. The most common cause of the corrosion seems to be road de-icing chemicals.

According to an article on MSNBC.com, Ford reports three vehicle fires and one injury related to the fuel tank strap problem.

The recalled vehicles are:

  • Ford F-150 full-size pickups, model years 1997-2004
  • Ford F-250 pickups of less than 8,500 pounds, model years 1997-1999
  • Lincoln Blackwood trucks, model years 2002-2003

Ford will notify owners in mid-September and recommend that the fuel tank straps be replaced with versions that have a greater resistance to corrosion. In addition, dealers may install a cable support under the strap an an interim repair, or a steel reinforcement over the existing straps as a permanent repair.

For more specific information, visit the recall page from the National Highway Traffic Safety Administration (NHTSA) here:  Ford truck recall information

Popularity: 2% [?]

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13
Jul

Tainted Wipes Linked To Brain Damage, Deaths

Before every injections…before every catheter insertion…before anytime the skin needs to be punctured, the first step is to wipe the skin with an alcohol prep pad. Those are the little packets of rubbing alcohol-soaked gauze that are ever-present in hospitals and doctors’ offices. The alcohol pads sterilize the skin so that an injection is as safe as can be—last thing anyone wants is for dirt, bacteria, or other organisms to enter the body through the injection site.

So imagine what would happen if the pads were full of bacteria, if instead of sterilizing the skin, the pads themselves were a source of infection.

Unfortunately, we don’t have to imagine it. The worst did, indeed, happen.

In January, the U.S. Food and Drug Administration (FDA) announced the recall of Triad alcohol prep pads, alcohol swabs, and alcohol swab sticks due to potential microbial contamination. (Later, the recall was extended to include sterile lubricating jelly, used during vaginal examinations.)

The specific infecting bacteria were Bacillus cereus, which is rare, but most typically found in food poisoning, not hospital infections.

In April, the FDA took further action and seized more than $6 million in products distributed by Triad Group, including cough and cold products, nasal sprays, suppositories, medicated wipes, antifungal creams, and hemorrhoidal wipes. This action was taken after an FDA inspection found multiple violations of manufacturing safety practices.

NOT SOON ENOUGH

JoNel Aleccia, a reporter with MSNBC, has been tracking this story from the beginning, and is conducting her own investigation into the problems caused by the tainted wipes. (To read all related articles, click here: MSNBC’s investigation.) It’s a lot of information, so we’ll summarize the major points.

  • The FDA claims that the severity of the contamination wasn’t known until a Colorado hospital reported a life-threatening infection in November 2010. [MSNBC-1]
  • Then, on December 1, 2010, a lively 2-year-old boy in Houston died of acute bacterial meningitis caused by Bacillus cereus. [MSNBC-2]
  • By July 1, 2011, the FDA had received reports of a total of 8 deaths, 11 infections, and about 250 other health problems all linked to Triad Group products. Bacillus cereus was specifically cited as the cause of death of a 66-year-old man who was being treated for skin cancer and diabetes. [MSNBC-3]
  • Just this week, there was another heartbreaking story of a child whose life was permanently altered by an infection, possibly caused by a Triad wipe. Twin boys were born on September 1, 2007. One twin has developed normally, while his brother cannot walk or speak and must be fed through a stomach tube. He suffers from cerebral palsy and mental delays. And all his problems have been linked to a bacterial infection with Bacillus cereus, which damaged portions of his brain shortly after birth.

It is possible that Triad wipes were to blame. According to an MSNBC article:

An msnbc.com review of the documents shows that FDA inspectors in 2006 found that an H&P Industries Inc. plant in Mukwonago, Wis., “failed to adequately address potential contamination in raw material” used for drug products. In 2002, the firm was cited for failing to “verify the effectiveness of the sanitation process.” An investgation in 2000 found similar problems, inspectors reported.

According to the article, a top DFA official admitted to members of Congress that the agency should have issued a formal warning letter to the firm in August 2010, instead of allowing voluntary compliance.

It’s almost enough to make a person lose faith in the ability of the FDA to properly protect the public.

AFFECTED PRODUCTS

The contaminated products were made by Triad, but could be marketed under a variety of different names and different packaging kits, including:

  • Triad
  • Cardinal Health
  • PSS Select
  • Boca/Ultilet
  • Moore Medical
  • Walgreens
  • CVS
  • Conzellin
  • Smith & Nephew
  • Arixtra Starter Kit
  • Relistor
  • Betaseron pack
  • Boniva pack
  • Fuzeon pack
  • Nutropin A.Q. Pen pack
  • Pegasys Pak
  • TNKase pack
  • Extavia pack
  • Trelstar pack
  • Forteo starter kit
  • Churchill Medical Systems’ Skin-Prep Wipes

To read the initial FDA recall notice, and to learn how to report adverse effects, click here:  FDA recall notice

If you believe that you or someone you love has been injured as the result of infection caused by one of these products, the lawyers of HensonFuerst Attorneys can help you investigation your legal options. Someone is available 24/7 at 1-800-4-LAWMED. If you have questions, HensonFuerst has answers.

Popularity: 4% [?]

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19
May

Avandia Drug Pulled from Shelves

May 18, 2011

The Food and Drug Administration (FDA) has placed restrictions on medications containing the diabetes drug Rosiglitazone, trade name Avandia. GlaxoSmithKline (GSK), the drugs manufacturer, will be required to create a restricted access program that will limit the patients who can take the drug. Only patients who are currently benefiting from treatment of the drug and choose to continue use, or patients whose glucose levels cannot be controlled with any other drug will be eligible for a prescription.

The report states that after November 18, 2011, patients will no longer be able to receive Rosiglitazone medications from retail pharmacies. Eligible patients will be enrolled in the Avandia-Rosiglitazone Medicines Access Program in order to receive the medications by mail through a limited number of certified pharmacies.

Read More.

A study in the Journal of the American Medical Association, found an increased risk of cardiovascular events between patients taking Avandia and a similar drug, Actos. The study found a 25% increased risk of heart failure, a 27% increased risk of stroke, and a 14% increased risk of death.

From January of 2010 to October of 2010, over 460,000 prescriptions were filled for these medications. Although, use dropped by half within that time period from 235,500 patients in January to 119,000 patients in October.

If you or someone you know has been taking a Rosiglitazone-based product such as Avandia, you should contact a North Carolina Medical Malpractice Lawyer. Henson Fuerst Attorneys may be able to assist you with your case.

Popularity: 12% [?]