Wednesday, 24 October 2012 20:53

Drug & Medical Device Claims

Written by Law Offices Of Gary Green

Law Offices of Gary Green has offices located in Little Rock, Arkansas, and Memphis, Tennessee. Our lawyers are familiar with the individual laws of each state, and practice in the following types of nursing home neglect and abuse law:

Thursday, 28 June 2012 12:49

Yaz/Yasmin

Written by Law Offices Of Gary Green

Yasmin and its newer version, Yaz, are birth control pills manufactured by Bayer Healthcare. Their generic counterpart, Ocella, is produced by Barr Laboratories.

These once-a-day oral contraceptives contain drospirenone and ethinyl estradiol and were heavily marketed without adequate warnings about the serious and potentially life-threatening side effects. Users with pre-existing kidney or liver disease could be particularly susceptible to these safety concerns, yet the manufacturers of these drugs failed to provide adequate information and warnings to consumers and healthcare providers.

Although Yaz and Yasmin contain components used in birth control pills for years, the component drospirenone is exclusive to these drugs. Drospirenone has been linked to dehydration which can then lead to an increase in potassium. This potassium increase is known as hyperkalemia. Because of the direct connection between potassium levels and heart rhythm, any disturbance in potassium levels can be serious and dangerous.

Some side effects associated with the use of Yasmin, Yaz and Ocella include:

  • Blood clots and blood clot-related injuries
  • Strokes
  • Deep vein thrombosis
  • Pulmonary embolism
  • Heart attacks
  • Gallbladder injuries; gallbladder removal
  • Kidney stones
  • Kidney failure
  • Pancreatic cancer
  • Death

If you or someone you know suffered from blood clots, stroke, heart attack, deep vein thrombosis, gallbladder disease or death while using Yasmin, Yaz or Ocella, contact Law Offices of Gary Green toll free at 1-888-4GARYGREEN or send us an e-mail at ggreen@gGreen.com to discuss your legal options without obligation.

Wednesday, 6 June 2012 12:54

Pradaxa

Written by Law Offices Of Gary Green

Pradaxa (chemical name dabigatran), is manufactured by the privately held German company Boehringer Ingelheim and was approved for use in the United States in October, 2010. Pradaxa is used in patients with atrial fibrillation (dangerous irregular heartbeat) as an anticoagulant medicine that reduces the risk of blood clots forming in the body and causing a stroke. Atrial fibrillation mostly affects the elderly. Pradaxa is a direct thrombin inhibitor meant to replace warfarin. One of the main problems with Pradaxa is in the event of traumatic hemorrhage, there are currently no effective reversal agents. The Journal of Neurosurgery cites the case of an 83 year old man that was hospitalized following a routine fall. Initial CT scans revealed small, superficial area of hemorrhage in his brain. A repeat CT scan two hours later showed a massive brain hemorrhage that resulted in the patient’s death.

If you or someone you know has suffered as a result of Pradaxa, contact Law Offices of Gary Green toll free at 1-888-4GARYGREEN or send us an e-mail at ggreen@gGreen.com

Wednesday, 6 June 2012 12:53

Transvaginal Mesh

Written by Law Offices Of Gary Green

Transvaginal mesh is used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI).

POP occurs when a pelvic organ drops from its normal position and pushes against the wall of the vagina. POP often occurs after childbirth or surgery when the muscles that hold the pelvic organs become weak or stretched. Thirty to fifty percent of women may experience POP. Two percent of women develop symptoms.

Between 2005 and 2010 almost 4000 cases involving complication were reported to the Food and Drug Administration (FDA).

Transvaginal mesh is manufactured by several different companies, including, but not limited to: Bard, Gynecare, American Medical Systems (AMS), Boston Scientific, Tyco, Covidian, Mentor, Johnson & Johnson and Ethicon. Complications associated with transvaginal mesh are not linked to a single brand. Complications include:

  • Erosion of the mesh through the vagina
  • Infection
  • Pain
  • Painful intercourse
  • Urinary problems
  • Recurrence of prolapse
  • Incontinence
  • Injury to surrounding organs

The most common complications occur within 10% of women within one year of surgery.

If you or someone you know has suffered as a result of transvaginal mesh, contact Law Offices of Gary Green toll free at 1-888-4GARYGREEN or send us an e-mail at ggreen@gGreen.com

Thursday, 17 November 2011 12:56

Actos

Written by Law Offices Of Gary Green

Actos (pioglitazone) is manufactured by Takeda Pharmaceuticals and is a drug normally prescribed for the treatment of Type II diabetes. On June 16, 2011, the FDA issued a new warning citing increased risk of bladder cancer in patients taking Actos for more than a year. In September, 2011 the FDA began a safety review of Actos after initial data from the manufacturer’s ongoing study indicated that the drug may increase the risk of bladder cancer. Two European countries have already banned the use of the drug. However, the FDA has not banned these medicines from being issued in the United States.

If you or someone you know suffered from bladder cancer while using Actos, contact Law Offices of Gary Green toll free at 1-888-4GARYGREEN or send us an e-mail at ggreen@gGreen.com

Friday, 21 May 2010 22:41

Drug and Medical Device Claims

Written by Law Offices Of Gary Green

Please click on one of the following links for more information.

 

Friday, 21 May 2010 22:41

Gadolinium

Written by Law Offices Of Gary Green

Gadolinium is an FDA approved contrast agent for MRI and MRA. Gadolinium provides greater contrast between normal tissue and abnormal tissue in the brain and body. It looks clear like water and is non-radioactive. After it is injected into a vein, Gadolinium accumulates in the abnormal tissue that may be affecting the body or head. Gadolinium causes these abnormal areas to become very bright (enhanced) on the MRI. This makes it very easy to see. Gadolinium is then rapidly cleared from the body by the kidneys.

On May 23, 2007—The FDA announced that it is asking manufacturers of gadolinium-based contrast agents to include a black box warning alerting patients to the risk of a potentially fatal disease NSF (Nephrogenic Systemic Fibrosis) or NFD (Nephrogenic Fibrosing Dermopathy).

It is a condition which involves hardening of the skin, resulting in varying degrees of immobility, can damage internal organs, and is sometimes fatal. It appears to affect only those persons with impaired renal function caused by kidney disease. NSF / NFD is resistant to treatment and can be very painful and debilitating. Most importantly, NSF / NFD is entirely preventable.

The following gadolinium-based agents are implicated by the warning:

  • Magnevist (gadopentetate dimeglumine)
  • Omniscan (gadodiamide)
  • OptiMARK (gadoversetamide)
  • MultiHance (gadobenate dimeglumine)
  • ProHance (gadoteridol)

The FDA has been aware of problems with gadolinium since at least June 2006, when the agency warned healthcare professionals about the risk of nephrogenic systemic fibrosis. A subsequent warning was issued in December 2006.

If you experience any of the symptoms of NSF / NFD after MRI (Magnetic Resonance Imaging) or MRA (Magnetic Resonance Angiogram), you should seek immediate medical attention and get tested for the disease. Symptoms include:

  • Tightening and swelling of the skin, typically starting with the legs, moving to the arms, and sometimes the trunk
  • Thickening of the skin around the joints, restricting movement
  • Skin which feels “woody” and has a texture similar to that of an orange peel
  • Red or dark patches of skin
  • Burning, itching, and/or sharp pains in affected areas
  • Fluctuating hypertension preceding the appearance of skin lesions
  • Symmetrical skin lesions, commonly on the ankles and thighs and between the wrists and upper arms
  • Muscle weakness
  • Deep bone pain in the hips and ribs
  • Calcification of soft tissues
  • Yellow plaques near the eyes

If you have kidney disease or impaired renal function you should always question having a MRI / MRA with contrast to make sure the contrast being used is not one of the ones listed above.  When asked if you are allergic to any medications you should say “Yes, Gadolinium!”

Currently, there are federal lawsuits pending in the United States against the drug manufacturers: Bayer Healthcare, Bracco, GE Healthcare and Mallinckrodt due to the possibility that they have not properly informed patients and doctors regarding the dangerous side effects of these drugs.

Over 250 federal lawsuits have been consolidated in a Multidistrict Litigation (MDL) in the Northern District of Ohio, and at least another 104 cases have been filed in various state courts. The purpose of the MDL is to prevent inconsistent pretrial rulings, avoid duplicity and serve the convenience of the parties, witnesses and the Court. Under the MDL rules, if the cases do not settle or resolve during pretrial, they will be returned to the court in which they were filed.

Attorneys representing persons suffering from NSF have been pushing for aggressive scheduling deadlines to move the cases quickly to trial or settlement, as most of the people are very sick and many may not survive a lengthy trial.

If you have been diagnosed with NSF or NFD you should contact  Law Offices of Gary Green toll free at 1-888-442-7947 or send us an e-mail at ggreen@gGreen.com to discuss your legal options without obligation.

Friday, 21 May 2010 22:41

Reglan (Metoclopramide)

Written by Law Offices Of Gary Green

Reglan is a drug used to treat heartburn caused by gastroesophageal reflux in individuals who have used other medications with no relief of symptoms. The generic form of Reglan is Metoclopramide Hydrochloride. Reglan/Metoclopramide is also used to treat slow gastric emptying in people with diabetes (diabetic gastroparesis) which can cause nausea, vomiting, heartburn, loss of appetite and a feeling of fullness after meals.

In some cases, Reglan/Metoclopramide is used to treat pregnant women suffering from morning sickness. Reglan/Metoclopramide is a short-term use drug only and should not be used for more than three months. Use for more than 90 days is not safe!

Prolonged use of Reglan/Metoclopramide can result in a serious movement disorder called tardive dyskinesia. The term tardive dyskinesia was introduced in 1964. Dyskinesia refers to an involuntary movement. The effect of these drugs can be tardive, meaning the dyskinesia sometimes continues or appears even after the drugs are no longer taken.

Tardive dyskinesia is characterized by repetitive, involuntary, purposeless movements. Features of the disorder may include grimacing, tongue protrusion, lip smacking, puckering and pursing of the lips, and rapid eye blinking. Rapid movements of the extremities may also occur. Impaired movements of the fingers may also appear. Tardive dyskinesia is a drug induced anxiety (tardive means it does not go away). Tardive dyskinesia is a common side effect of Reglan use. Tardive dyskinesia is a signature side effect – almost nothing else causes tardive dyskinesia.

On February 26, 2009, the Food and Drug Administration issued an alert warning requiring that the manufacturers of Reglan/Metoclopramide add a boxed warning to their drug labels regarding the risk of long-term or high-dose use. Manufacturers will also be required to implement a risk evaluation and mitigation strategy (REMS) to ensure patients are provided with a medication guide that discusses this risk. Reglan was never authorized for pediatric use.

If you have been diagnosed with tardive dyskinesia, contact ggreen@gGreen.com or call toll-free, 1-888-442-7947.

Friday, 21 May 2010 18:39

Fosamax

Written by Law Offices Of Gary Green

Fosamax has been widely used to prevent or treat osteoporosis. It is also used for the treatment of Paget’s Disease. Fosamax has been associated with the development of bone loss in the jaw, also called osteonecrosis of the jaw (ONJ) or “jawbone death.” Criteria for Fosamax cause of action include:

  • Diagnosed with osteoporosis or Paget’s Disease
  • No kidney disease.
  • Development of osteonecrosis of the jaw (ONJ)
  • Long-term use of Fosamax
  • Atrial Fibrillation
  • Esophageal Tumors and/or cancer
  • Unusual Bone Fractures
  • Severe Bone, Joint and Muscle Pain

If you or someone you know suffered bone loss in the jaw after taking Fosamax, contact Law Offices of Gary Green toll free at 1-888-4GARYGREEN or send us an e-mail at ggreen@gGreen.com to discuss your legal options without obligation.

Friday, 21 May 2010 18:37

Digitek Recall

Written by Law Offices Of Gary Green

Actavis Totowa LLC notified healthcare professionals of a Class I nationwide recall of all strengths of Digitek (Digoxin) on April 28, 2008, a drug used to treat heart failure and abnormal heart rhythms. The products are distributed by Mylan Pharmaceuticals Inc., under a Bertek label and by UDL Laboratories, Inc. under a UDL label. The product is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient.

The existence of double strength tablets poses a risk of digitalis toxicity in patents with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Several reports of illnesses and injuries have been reported. If you have suffered kidney failure, heart problems, or other permanent complications after as a result of Digitek, please contact us at ggreen@gGreen.com.