Consumer Lawyers

Archive for the ‘Uncategorized’ Category

Group wants FDA to add warning on testosterone products

In Uncategorized on March 9, 2014 at 12:18 am

A non-profit consumer advocacy group petitioned the U.S Food and Drug Administration (FDA) to add black box warnings on product labels of all testosterone-containing drugs that will explain the increased cardiovascular risks.

Over two decades, 27 studies have been performed and 14 of them show salient increases in cardiovascular risk. The FDA is not convinced that the approved products carry that risk. Dr. Sidney Wolfe, founder and senior adviser of Public citizen’s Health Research Group is outraged by the lack of support from the FDA.

https://www.sycamoreeducation.com/index.php?schoolid=2266

 

 

 

Pfizer recalls antidepressant after report of wrong drug in bottle

In Uncategorized on March 9, 2014 at 12:15 am

Effexor XR antidepressant and another lot of its generic version of the drug after a pharmacist reported finding one capsule of a different medicine in a bottle of Effexor.

“Although Pfizer has not received any other such reports, these three lots are being voluntarily recalled as a precaution because they were packaged on the same line,” the largest U.S. drugmaker said in an announcement of the recall.

 

http://finance.yahoo.com/news/pfizer-recalls-antidepressant-report-wrong-230838090.html

BP and the fight to Disparage Lawyers

In Uncategorized on July 6, 2013 at 12:20 am

From Take Justice Back:

BP has orchestrated a campaign to avoid accountability and delay justice for Gulf Coast small business owners for years.  In its latest move, BP has dumped hundreds of thousands of dollars in a PR campaign purchasing full-page color ads in The New York Times, Wall Street Journal and the Washington Post that accuses some small businesses of taking money “they don’t deserve.”  

BP also sent letters warning lawyers for many Gulf Coast businesses that it may seek to recover some of the settlement if its appeal before the Fifth Circuit is successful – to this date BP has lost every similar appeal.

 

As American Association for Justice President Mary Alice McLarty has said, “BP needs to stop the backpedaling and live up to the settlement its corporate lawyers negotiated and agreed to.  BP is not a victim of small businesses, judges or even trial lawyers; they are still just a corporate felon who pled guilty to killing 11 rig workers, polluted the Gulf and ruined the livelihoods of thousands of Americans.”

Here are the facts:

  • BP pled guilty to 11 counts of manslaughter and lying to the Federal Government, stemming from the Deepwater Horizon tragedy.
  • BP is a convicted felon. 
  • BP was on probation for three prior disasters at the time of the blowout.
  • BP has been suspended from doing business with the US government for a lack of corporate integrity.
  • For nearly two years BP’s team of corporate lawyers negotiated, co-authored, agreed to, and sought Court approval of every word in the Settlement Agreement. 

 

 

Alabama 5/25/13: Main Street Pharmacy Tainted Injections in 1 clinic

In Uncategorized on May 26, 2013 at 12:49 am

The Alabama Department of Public Health is working with other health agencies to investigate an injectable anti-inflammatory drug prepared by a compounding manufacturer in Tennessee.
    
Main Street Family Pharmacy of Newbern, Tenn. shipped the tainted medicine to clinics in 13 states, including to one clinic in Alabama.
    
The investigation began after the U.S. Food and Drug Administration was notified of seven people who developed infections or adverse reactions after receiving injections of methylprednisolone acetate (MPA). It’s the same drug that was linked to last year’s deadly outbreak of fungal meningitis.
    
The investigation is in an early stage and is rapidly evolving, according to Dr. Mary McIntyre of the ADPH.
    
The Alabama clinic will begin notifying patients to ask them to report any signs and symptoms of complications.

http://www.local15tv.com/news/local/story/Drug-Maker-Recalls-Meds-in-13-States/3NOZYYsa7EeeY2mLMvM4og.cspx

 

Main Street Pharmacy Steroid Recall update 5/26/13

In Uncategorized on May 26, 2013 at 12:17 am
Federal authorities have identified five cases in Illinois and two more in North Carolina. The Illinois patients received injections at the Logan Primary Care clinic in the town of Herrin between Jan. 3 and Feb. 21, according to Illinois health officials.
All five patients from Illinois had skin infections in the hips and buttocks while at least one patient in North Carolina appears to have a fungal infection, according to the Centers for Disease Control and Prevention.
 

April 30, 2013 News: Lipitor Linked to Type 2 Diabetes Risk in Women

In Uncategorized on April 30, 2013 at 6:24 pm

News this week about Lipitor:

More than 20 million Americans take cholesterol-lowering drugs known as statins. These drugs, including the brand name Lipitor, have been linked to a high risk of Type 2 diabetes, especially in middle-aged and older women.

A study conducted by the Women’s Health Initiative of 150,000 postmenopausal women found that those taking a statin such as Lipitor were almost twice as likely to get a diabetes diagnosis. Studies published in the Journal of the American College of Cardiology and the Journal of the American Medical Association also reported a higher risk of diabetes for people taking statins.

The FDA has issued a warning about side effects of Lipitor, including the risk of diabetes. Data from large clinical trials reveal the danger of developing Type 2 diabetes from Lipitor is particularly high in women with existing risk factors including:

High blood sugar

Elevated triglycerides (a type of blood fat)

High blood pressure

Omontys Recall News 3/26/13

In Uncategorized on March 26, 2013 at 7:39 pm

March 26 , 2013: Omontys Recall – Background

 
Almost a year ago, Omontys was approved by the FDA.

The U.S. Food and Drug Administration today approved Omontys (peginesatide) to treat anemia, a condition in which the body does not have enough healthy red blood cells, in adult dialysis patients who have chronic kidney disease (CKD).
 
What is anemia? From the NIH:
 
Anemia is a condition in which your blood has a lower than normal number of red blood cells.
 
Anemia also can occur if your red blood cells don’t contain enough hemoglobin (HEE-muh-glow-bin). Hemoglobin is an iron-rich protein that gives blood its red color. This protein helps red blood cells carry oxygen from the lungs to the rest of the body.
If you have anemia, your body doesn’t get enough oxygen-rich blood. As a result, you may feel tired or weak. You also may have other symptoms, such as shortness of breath, dizziness, or headaches.
Severe or long-lasting anemia can damage your heart, brain, and other organs in your body. Very severe anemia may even cause death.

Overview

Blood is made up of many parts, including red blood cells, white blood cells, platelets (PLATE-lets), and plasma (the fluid portion of blood).
 
Red blood cells are disc-shaped and look like doughnuts without holes in the center. They carry oxygen and remove carbon dioxide (a waste product) from your body. These cells are made in the bone marrow—a sponge-like tissue inside the bones.
 
White blood cells and platelets (PLATE-lets) also are made in the bone marrow. White blood cells help fight infection. Platelets stick together to seal small cuts or breaks on the blood vessel walls and stop bleeding. With some types of anemia, you may have low numbers of all three types of blood cells.
Anemia has three main causes: blood loss, lack of red blood cell production, or high rates of red blood cell destruction. These causes might be the result of diseases, conditions, or other factors.

 
Continuing with the 2012 FDA report:
 
Continuing with the 2012 FDA report:
Omontys is a new erythropoiesis-stimulating agent (ESA) that aids in the formation of red blood cells. It works by stimulating the bone marrow to produce more red blood cells, usually measured as hemoglobin levels, to reduce the need for transfusions in patients with CKD. Omontys is administered as a once-a-month injection.
 
“Omontys represents the first new FDA-approved and marketed ESA for this condition since 2001,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “This new drug offers patients and health care providers the convenience of receiving ESA therapy just once per month instead of more frequent injections.”
Two randomized, active-controlled, open-label, multi-center clinical trials demonstrated the safety and efficacy of Omontys in patients with CKD who were on dialysis. The trials randomly selected a total of 1,608 patients with hemoglobin levels initially stabilized by ESA to receive either Omontys once monthly or to continue their current ESA (epoetin) treatment. Results showed Omontys was as safe and effective as epoetin in maintaining hemoglobin levels within the studies’ pre-specified range of 10 to 12 grams per deciliter.
The most common side effects observed in 10 percent or more of dialysis patients treated with Omontys were diarrhea, vomiting, high blood pressure (hypertension) and joint, back, leg or arm pain (arthralgia).
Omontys should not be used in patients with CKD who are not receiving dialysis or in patients with cancer–related anemia, according to the FDA-approved labeling. It also should not be used as a substitute for red blood cell transfusions in patients who require immediate correction of anemia. Omontys has not been shown to improve symptoms of anemia, physical functioning or health-related quality of life in patients with CKD on dialysis.
The FDA approved Omontys with a Risk Evaluation and Mitigation Strategy (REMS), which added safety measures consisting of educational elements for health care professionals and a requirement to assess drug use data.
 
Now fast forward to 2013, with the recall of this product. 
 Affymax, Inc. and Takeda Pharmaceutical Company Limited along with the U.S. Food and Drug Administration (FDA) are informing the public of a voluntary recall of all lots of OMONTYS® (peginesatide) Injection to the user level as a result of new postmarketing reports regarding serious hypersensitivity.
eactions, including anaphylaxis, which can be life-threatening or fatal.
 
To date, fatal reactions have been reported in approximately 0.02% of patients following the first dose of intravenous administration. The reported serious hypersensitivity reactions have occurred within 30 minutes after such administration of Omontys. There have been no reports of such reactions following subsequent dosing, or in patients who have completed their dialysis session. Since launch, more than 25,000 patients have received Omontys in the postmarketing setting.  The rate of overall hypersensitivity reactions reported is approximately 0.2% with approximately a third of these being serious in nature including anaphylaxis requiring prompt medical intervention and in some cases hospitalization.
BACKGROUND: Omontys (peginesatide) Injection is indicated for the treatment of anemia due to chronic kidney disease in adult patients on dialysis and is packaged in 10 mg and 20 mg Multi-dose vials:
  • 10mg Multi-dose Vials – NDC 64764-610-10  Lots C18685, C18881, C19258
  • 20mg Multi-dose vials – NDC 64764-620-20  Lots C18686, C18696
 
What is anaphylaxis? 
 

Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death. It typically causes a number of symptoms including an itchy rash, throat swelling, and lowblood pressure. Common causes include insect bites/stings, foods, and medications.
On a pathophysiologic level, anaphylaxis is caused by the release of mediators from certain types of white blood cells triggered either by immunologic or non-immunologic mechanisms. It is diagnosed based on the presenting symptoms and signs. The primary treatment is injection of epinephrine, with other measures being complementary.
 
File:Signs and symptoms of anaphylaxis.png
 

Voluntary Worldwide Field Corrective Action Issued for the T-piece Circuit used on GE Healthcare’s Giraffe and Panda

In Uncategorized on January 8, 2013 at 3:24 pm

GE Healthcare initiated a voluntary worldwide field correction of the T-piece circuit used with GE Healthcare’s Giraffe and Panda resuscitation units. The T-piece circuits affected by this recall are sold under the following part numbers and contain a red inspection stamp (those containing a blue inspections stamp are NOT affected by this recall):

  • M1091335 Kit, Circuit, T-Piece Disposable, 10 pack
  • M1091316 Kit, Circuit, T-Piece Disposable, W MASK Size 0, 10 pack
  • M1091365 Kit, Circuit, T-Piece Disposable, W MASK Size 1, 10 pack

The T-piece circuit used with GE Healthcare’s Giraffe and Panda resuscitation units may impact patient safety. The issue occurs when the T-piece circuit is not able to achieve maximum PIP (Peak Inspiratory Pressure) of 45 +/- 5 cmH[2]O as measured by the built-in Airway Pressure Manometer during the pre-use checkout procedure. The built-in Airway Pressure Manometer of the resuscitation system is not affected by this issue and will accurately display airway pressure. Clinicians should always use the airway pressure manometer to verify Peak Inspiratory Pressure (PIP). The affected units were manufactured from September 10, 2009 to May 10, 2012.

GE Healthcare initiated the field correction on June 26, 2012, and began notifying customers with affected units through an Urgent Medical Device Correction letter and follow up has been conducted to confirm their receipt of the letter. Through these efforts, approximately 84% of identified customers have confirmed receipt of the safety instructions provided and have also confirmed all affected product has been returned or destroyed. The remaining unconfirmed customers are being contacted directly to resolve and close the issue as soon as possible. Customers have been directed to NOT use the T-piece circuit with the part numbers listed above and to isolate all affected product. To date, no patient injuries have been reported with this issue.

Southwest Ice Cream Specialties Conducts Voluntary Recall of ShurFine® Brand “Creamery Select Premium Ice Cream Dulce de Leche”

In Uncategorized on January 8, 2013 at 3:23 pm

Southwest Ice Cream Specialties is voluntarily recalling ShurFine Brand “Creamery Select (Premium Ice Cream) Dulce de Leche” Ice Cream (1.75 quarts, 1.66L) because it may contain praline pecan ice cream, which contains wheat, soy and pecans. The product is packed with a ShurFine Praline Pecan lid, but bears the Dulce de Leche product labeling on the carton. While no ShurFine product has been linked to any illness related to allergens at this time, Southwest Ice Cream Specialties is taking this precautionary measure because the ice cream inside the carton contains pecans, soy and wheat that are not declared on the packaging.

To date, no complaints or reactions have been reported. People who have an allergy or severe sensitivity to pecans, soy and/or wheat run the risk of serious or life-threatening allergic reaction if they consume this product.

This product is produced by the Southwest Ice Cream Specialties processing facility in McKinney, Texas, and is sold at various retail outlets under the ShurFine brand name.

Size Name Flavor UPC # Date Plant Code
1.75 quarts (1.66L) “scround” container ShurFine “Creamery Select” Premium Ice Cream Dulce de Leche carton with incorrect product and “ShurFine Praline Pecan” lid 015400224840 Best By NOV 8, 2014 48-3202-F

 

The affected product has a “Best By” date of November 8, 2014, and was sold by retailers in Arizona, Arkansas, Colorado, Kansas, Oklahoma, New Mexico and Texas. The carton carries the above referenced Universal Product Code (UPC) and plant code 48-3202-F.

11/29/12: Steroid Meningitis Recall News: Litigation Update

In Uncategorized on November 29, 2012 at 10:05 pm

Evidence of a deadly fungus that has sickened thousands and killed hundreds of patients may still exist inside the New England Compounding Center and should  be collected now, say  attorneys who represents a man who has filed a lawsuit against the Center.

“We should to be allowed inside the NECC business office to gather valuable evidence and information by mid-December,” says Mark Zamora, the lawyer for the Plaintiff in the case pending in United States District Court in Boston.

Attorney Mark Zamora,  along with Janet, Jenner & Suggs, represent C. Green who claims he received one or more steroid injections formulated by NECC and now suffers from serious side effects.  Green’s 22-page complaint filed  in  Superior Court of Middlesex County, MA, describes “greenish black foreign matter” and “white filamentous material” discovered by government inspectors when they examined NECC’s products.

The Centers for Disease Control and Prevention said at least 36 people in 19 states are dead and 474 more have been sickened or are seriously ills after receiving injections possibly contaminated with the fungus that causes fungal meningitis.

On Wednesday, U.S. District Court Judge F. Dennis Saylor IV ordered owners of the NECC a to preserve all physical and electronic evidence related to its operations, including personal phone and email records. The Court ruled on Motions filed by Zamora and co counsel Kim Dougherty.

Judge Saylor has temporarily consolidated 12 local lawsuits against the NECC, including the Green suit so that pre-trial proceedings may move forward.

“The NECC’s blatant disregard for even the most basic sterility obligations, its wanton disregard for the limited scope of its licenses, its conscious disregard for safety standards, its deplorable facility conditions where mold and bacteria festered, and blatant contempt for prior complaints, adverse events, and inspection findings, all lead to a national epidemic of fungal meningitis,” according to Green’s complaint.