DANGEROUS DRUGS
MERCK
Posted by: Micah Adkins
September 04, 2009
According to the NY Times, Natasha Singer, Merck's first Fosamax case involving jawbone tissue breakdown is now before a federal jury. Approximately nine-hundred (900) other cases have been filed by users of Fosamax and allegations include jawbone issues. Merck is on the defensive and has argued that the users' jawbone issues were caused by other health issues. FULL STORY
Click HERE for Merck's position.
If you or a loved one has used Fosamax and have been diagnosed with osteonecrosis of the jaw, you may be entitled to money damages. For a free and confidential consultation, contact attorney Micah Adkins.
FDA Inspection Reveals Adulterated Synchromed? II Insulin Pumps
Posted by: Micah Adkins
July 01, 2009
Under section 201(h) of the Federal Food, Drug and Cosmetic Act (the "Act"), 21 USC Section 321(h), the federal government has the authority to regulate devices that are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body. The Food and Drug Administration (FDA) conducts inspections of manufacturing facilities that manufacture such devices. Recently, during an inspection of a Medtronic Inc. manufacturing facility in Puerto Rico, FDA inspectors discovered adulterated Synchromed® II Insulin Pumps. In other words, the pumps were not manufactured in conformity with with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System regulation. See 21 C.F.R. Part 820. According to the FDA, the manufacturer's failure to follow CGMP has resulted in infections by users of Synchromed® II Pump serial numbers NGP319205H and NGV416698H. Click HERE for the FDA warning letter sent to Medtronic.
The FDA's warning letter cites additional adverse events associated with the MiniMed Paradigm® Insulin Pump. Specifically, the FDA's stated in pertinent part: Our inspection also revealed that your MiniMed Paradigm® Insulin Pumps are misbranded under section 502(t)(2) of the Act [21 U.S.C. 352(t)(2)], in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 C.F.R. Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
5) Failure to report to FDA no later than 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that a device that you market: (1) may have caused or contributed to a death or serious injury; or (2) has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a).
Incidents of diabetic ketoacidosis resulting from use of the MiniMed Paradigm® Insulin Pump have been reported by Medtronic through MedWatch. Diabetic ketoacidosis can be life threatening, require hospitalization and can cause serious injury.
If you or a loved one has used a Synchromed® II Insulin Pump or MiniMed Paradigm® Insulin Pump and have suffered a serious injury and required hospitalization, your legal rights may have been violated. For a free consultation contact attorney Micah Adkins.
HYDROXYCUT RECALL
Posted by: Micah Adkins
May 21, 2009
The Food and Drug Administration (FDA) recently warned consumers using Iovate Health Sciences' diet supplement Hydroxycut to stop using the dietary supplement immediately. The Hydroxycut products marketed for energy and weight loss under the Iovate and MuscleTech trade names. An association between Hydroxycut products and serious renal issues, including liver and kidney injuries, has been demonstrated by several users of the dietary supplements.
One death case due to liver failure has been reported to the FDA and at least 23 adverse event reports (e.g., jaundice, elevated liver enzymes and liver damage requiring a liver transplant). Other symptoms of health problems reported to the FDA include seizures, cardiovascular disorders and rhabdomyolysis.
The FDA has not identified the ingredients, dosages, or other factors that are contributing to the above described risks related to the Hydroxycut. The FDA continues its investigation of the potential relationship between Hydroxycut dietary supplements and liver injury or other serious health problems.
Click here for the FDA's May 8, 2009 Press Release regarding the Hydroxycut recall.
If you, or a loved one, have purchased and consumed Hydroxycut and have suffered any of the above illnesses, then you may be entitled to money damages. Contact attorney Micah Adkins for a free and confidential consultation.
Attachments:
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Visicol & OsmoPrep Linked to Kidney Damage
Posted by: Micah Adkins
April 24, 2009
In December 2008, the U.S. Food and Drug Administration (FDA) ordered the makers of Visicol and OsmoPrep to include black box warnings on the drugs' labels regarding acute kidney risks associated with prescription sodium phosphate medications (OSPs). Click HERE for FDA info sheet. The medications can be taken for bowel prep before a colonoscopy. A March 2009 article in Public Citizen's "Worst Pills, Best Pills" newsletter highlighted patient reports of acute phosphate nephropathy, a type of serious, acute kidney damage, associated with the use of OSPs.
The FDA has acknowledged similar kidney problems in people who used over-the-counter (OTC) sodium phosphate products as bowel preps, and the FDA has not endorsed the usage of such products for bowel prep. Further, the FDA plans to amend OTC OSP labels to encourage users not to use this product for bowel cleansing. One manufacture of the drug, C.B. Fleet Co., has already announced a voluntary recall of OTC Fleet Phospho-soda products.
Earlier, in 2006, the FDA outlined the risks associated with the use of OSPs for bowel cleansing to healthcare professionals. After the FDA's report, it has received at least 20 reports of kidney damage associated with the use of OsmoPrep. Of the 20 reported cases, 3 included cases of acute phosphate nephropathy. According to the FDA, the onset of kidney damage varied from several hours up to 21 days after initial usage. In addition, the FDA is not recommending OSPs to be used by children or persons under 18 years old. Further, OSPs should not be used in combination with laxatives that contain sodium phosphate. Caution is also given to persons: over 55; history of dehydration, kidney disease, acute colitis, or delayed bowel emptying; and people taking medications that affect kidney function, i.e., diuretics or NSAIDS. According to an article published in the the Journal of the American Society of Nephrology, acute phosphate nephropathy is a serious condition in which calcium phosphate deposits build up in the kidney (renal tubules) and can result in permanent kidney function impairment. In fact, persons diagnosed with acute phosphate nephropathy may suffer from permanent impairment of kidney functions. Prescription alternatives to OSPs include oral solutions such as Colyte and TryLyte, neither of which contains sodium phosphate.
If you, a loved one or a friend have used a bowel cleansing prep containing sodium phosphate, such as Visicol or OsmoPrep and have suffered kidney damage, you may be entitled to money damages. Contact attorney Micah Adkins for a free and confidential consultation.
JOHNSON & JOHNSON $16.6 MILLION VERDICT - PAIN PATCH DEATH
Posted by: Micah Adkins
November 19, 2008
Bloomberg reported a $ 16.6 million verdict aginst two units of Johnson & Johnson. The lawsuit was filed by the family of a Chicago woman that died after using a Duragesic pain patch.
ETHEX RECALLS OVERSIZED TABLETS - POSSIBILITY OF LIFE THREATENING OVERDOSE
Posted by: Micah Adkins
November 12, 2008
According to the FDA, Ethex Corporation issued a recall for five generic/non-branded products. The recall includes the following drugs: Propafenone HCI; Isosorbide Mononitrate; Morphine Sulfate; and Dextroamphetamine Sulfate. Ethex warns of the possibility of serious and potentially life threatening side effects, including irregular heartbeat and low blood pressure.
The following lot numbers (shipped before May 22, 2008) include:
Propafenone HCl Tablets, 150 mg: Lots: 73761, 78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, and 90526 with expiration dates ranging from 3/2009 to 3/2011
Propafenone HCl Tablets, 225 mg: Lots: 71720, 74831, 76014-15, 81243-45, 89731, 90527-29, and 90657 with expiration dates ranging from 3/2009 to 2/2011
Propafenone HCl Tablets, 300 mg: Lots: 72834, 76016-18, 81246, 89092, 89732, 90530, 90532, and 91641-42 with expiration dates ranging from 6/2009 to 3/2011
Isosorbide Mononitrate Extended Release Tablets, 30 mg: Lots: 62355, 66423, and 68102 with expiration dates ranging from 11/2008 to 8/2009
Isosorbide Mononitrate Extended Release Tablets, 60 mg: Lots: 63466, 66034, 67351, and 67354 with expiration dates ranging from 12/2008 to 11/2009
Morphine Sulfate Extended Release Tablets, 15 mg: Lots: 81175, 82514-16, 89660, 89664, 89667, 90249-51, and 91687 with expiration dates ranging from 12/2008 to 2/2010
Morphine Sulfate Immediate Release Tablets, 15 mg: Lots: 77852-54, 81746, 82519-20, 84113, and 90276-78 with expiration dates ranging from 9/2009 to 1/2011
Morphine Sulfate Immediate Release Tablets, 30 mg: Lots: 75093, 77855-57, 82297, 82521-22, 87239, 88925, and 90288-98 with expiration dates ranging from 8/2009 to 3/2011
Dextroamphetamine Sulfate Tablets, 10 mg: Lots: 73934, 75892, 77945, 81137, 86320 with expiration dates ranging from 6/2009 to 5/2011
If you or a loved one have purchased one of the above medications and experienced an adverse reaction, please contact Micah Adkins for a free case evaluation.
JURY AWARDS FAMILY $13 MILLION FOR FENTANYL PAIN PATCH DEATH
Posted by: Micah Adkins
November 04, 2008
Bloomberg reports a Sanford, Florida jury awarded the family of a 34-year-old mother of five $13 million after the woman died from an overdose of painkillers. Johnson & Johnson has lost three of three cases brought to trial over the pain patches.
If you or a loved one has suffered a catastrophic injury, which you believe is the result of fentanyl or other pain patch, contact Micah Adkins for a free case evaluation.
GADOLINIUM AND DANGER OF NEPHROGENIC SYSTEMIC FIBROSIS (NSF) AND NEPHROGENIC FIBROSING DERMOPATHY (NSD)
Posted by: Micah Adkins
October 12, 2008
Assocication between MRI/MRA Contrast Agent and Nephrogenic Systemic Fibrosis (NSF)/Nephrogenic Fibrosing Dermopathy (NFD)
Our firm is investigating cases involving gadolinium-containing contrast agents used in patients with kidney failure and a disease known as Nephrogenic Systemic Fibrosis (NSF), also called Nephrogenic Fibrosing Dermopathy (NFD).
FDA Requests Boxed Warning for Contrast Agents Used to Improve MRI Images
The U.S. Food and Drug Administration (FDA) has asked manufacturers to include a new boxed warning on the product labeling of all gadolinium-based contrast agents which are used to enhance the quality of magnetic resonance imaging (MRI).
The new warning would better inform patients of the risks associated with gadolinium and the potential for severe kidney insufficiency when receiving gadolinium-based agents. The drug can lead to a debilitating, and a potentially fatal disease, nephrogenic systemic fibrosis (NSF). Additionally, the warning would state that patients just before or just after liver transplantation, or those with chronic liver disease, are also at risk for developing NSF if they are experiencing kidney insufficiency of any severity.
According to the director of the FDA's Center for Drug Evaluation and Research, Steven Galson, M.D., the "FDA has been carefully monitoring potential safety signals related to these contrast agents after receiving reports about the risk of this potentially life-threatening disease."
Symptoms of NSF and NSD often experience the following symptoms, thickening of the skin and connective tissues that inhibits their ability to move and may result in broken bones. Other organs are at risk of thickening as well. The cause of NSF is not known and there is no consistently effective treatment of this condition.
The following Gadolinium-based contrast agents been approved for use in the UnitedStates:
- Magnevist (gadopentetate dimeglumine)
- Ominiscan (gadodiamide)
- OptiMARK (gadoversetamide)
- MultiHance (gadobenate dimeglumine)
- Prohance (gadoteridol)
Omniscan has been the most common reported agent associated with NSF/NSD, followed by Magnevist and OptiMARK. No reports of NFS/NSD among patients with normal kidney function or those with mild-to-moderate kidney insufficiency.
If you or a loved one had an MRI/MRA using a contrast agent to enhance the image, and you developed NFS/NFD, contact Micah Adkins for a free case evaluation.
EMAIL SUGGESTS PFIZER MANIPULATED NEURONTIN DRUG STUDY
Posted by: Micah Adkins
October 12, 2008
E-mails and other internal Pfizer corporate documents suggest that executives at Pfizer covered up a negative European study of the epilepsy drug Neurontin in order to bolster marketing efforts. The evidence was revealed from discovery in a pending Boston lawsuit. The documents also suggest that Pfizer based a large-scale marketing campaign on the results of a seemingly positive study. FULL STORY
Avandia
Posted by: Micah Adkins
September 02, 2008
Avandia (aka Rosiglitazone) is a drug prescribed to patients for type 2 diabetes and manufactured by GlaxoSmithKline. Avandia was approved by the FDA in 1999 and increases insulin sensitivity for non-insulin dependent diabetics.
The New England Medical Journal has released findings of adverse events associated with the use of Avandia. Specifically, 42 clinical trials compared almost 28,000 patients, of which about 15,000 were taking Avandia. The results of the research indicated a 43% increase in the likelihood of a heart attack. Also, the study found Avandia users have an increased lielihood of death by a cardiac arrest. See Abstract.
In 2007, the FDA acknowledged the the increased risk of heart attacks by users of Avandia. As a result, the FDA ordered GlaxoSmithKline to include a "black box" warning on its packaging that says the drug may cause chest pain or heart attacks. FDA Report
However, the product remains on the market. Why? Here are 3.3 billion reasons - $ 3.3 BILLION dollars in revenue for GlaxoSmithKline in 2007! Avandia is the drug makers second biggest seller! The warning label language may reduce sales by as much as 1 billion dollars in 2008.
Massey, Stotser & Nichols is investigating potential lawsuits for users of Avandia (for at least 12 weeks) that died or suffered serious injury after a cardio event. Contact an attorney at our firm for a free consultation.
WARNING To All "Total Body Formula" & "Total Body Mega Formula" Users
Posted by: Micah Adkins
August 05, 2008
Recently, the FDA issued a warning to consumers after the distributor for Total Body Formula recalled the products. However, the warning came too late for many consumers. According to the FDA, the Florida Department of Health has already received reports of consumers that have experienced severe adverse reactions after using the product.
The products of concern are: Total Body Formula (Tropical Orange & Peach Nectar) and Total Body Mega Formula (Orange/Tangerine flavors). The products are distributed by Total Body Essential Nutrition of Atlanta. Total Body Formula and Total Body Mega Formula have been distributed across the southeastern US, including: Alabama, California, Florida, Georgia, Kentucky, Louisiana, North Carolina, Tennessee, Texas and Virginia.
The dietary supplement may cause hair loss, muscle cramps, diarrhea, joint pain and fatigue. The sysmptoms may be a result of excessive amounts of selenium in the products.
Our firm is investigating potential consumer claims against Total Body Essential Nutrition. For a free consultation, contact one of our attorneys.
Abbott Labs Sued for Inflating HIV Drug Prices
Posted by: Micah Adkins
August 05, 2008
In 2003, Abbott Labs inflated the price of Norvir by 400% in 2003. Now, several lawsuits have been filed against the drug maker in an Oakland, California federal court. The suits allege Abbott Labs inflated the drug price to eliminate its competitors and increase the sales of another drug, Kaletra.
Johnson & Johson Served With Subpoena
Posted by: Micah Adkins
August 05, 2008
On Monday, according to the New York Times, Johnson & Johnson received a subpoena from the Justice Department for information regarding one of the company's medical devices, bile duct stents. The Justice Department has been investigating Johnson & Johnson, Abbott Laboratories and Boston Scientific for marketing the devices for unapproved uses, such as the repair of weakened blood vessels.
Pharmaceutical manufacturer's are creative when it comes to marketing their products and increasing profits. The bile duct stent device has been approved by the FDA to treat obstructions in tubes that carry bile to the intestines. However, the FDA has received reports the medical device is being used to prop open blood vessels in patients' legs.
Vioxx Settlement Payments Coming Soon From Merck
Posted by: Micah Adkins
July 22, 2008
According to the Associated Press, writer Linda A. Johnson reports Merck & Co. will begin issuing settlement checks next month to resolve about 50,000 lawsuits alleging cardiovascular side effects from the drug Vioxx. The drug was introduced to the US market around 1999. After $11 billion in sales, Merck ultimately pulled off the market in 2004.
WYETH SETTLES PREMPRO AND PREMARIN SUITS
Posted by: Micah Adkins
July 17, 2008
Wyeth agreed to settle claims made by two women in Nevada before trial this week. The women, Vesta Woodhouse and Annie Woods, filed suit against the manufacturer of the hormone replacement drug Prempro and Premarin because Wyeth failed to warn them of the risks of cancer with use of the drugs.
Both Woodhouse and Woods were diagnosed with breast cancer after the use of the menopause drugs. A 2002 study found women using the hormone replacement therapy (HRT) drugs had a 24% higher risk of breast cancer! Full Story
For a free case evaulation, contact an attorney at Massey, Stotser & Nichols, PC
DIGITEK RECALLED
Posted by: Micah Adkins
July 16, 2008
Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalls all lots of Bertek and UDL Laboratories Digitek®. According to the FDA, the drug is used to treat heart failure and abnormal heart rythyms. The recalled Digitek tablets pose a risk to patients with renal failure. Symptoms can include nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. FDA Press Release
For a free consultation, please contact Micah Adkins
Davol/Bard Composix Kugel Mesh Hernia Patch Recall
Posted by: Micah Adkins
July 15, 2008
Davol/Bard Composix Kugel Mesh Hernia Patch Recall
Every year over 600,000 hernia operations are performed in the United States. Recently, healthcare providers have begun to use a medical device called a "mesh patch" that is inserted through a small incision and placed inside the body. Typically, the device is used to treat ventral hernia (aka incisional hernias). Through the aid of a "memory spring" the physician places a folded patch behind the hernia defect. After placement, the mesh hernia patch is supposed to spring open, lay flat and seal the hernia.
However, the Kugel Mesh Hernia Patch made by Davol (parent company Bard, Inc), may pose a serious danger to recipients of the device. Many patients have complained of complications after using the device. Specifically, the company has found broken rings at the ring weld. Symptoms of patients implanted with the defective device may include: bowel perforation, chronic intestinal fistulae and/or abdominal cramping.
Please click on the pdf attachment below for more information about the recalled hernia mesh patches.
Attachments:
Bard-DavolHerniaMeshMDL-ScopeofProductscovered.pdf
Johnson & Johnson and Novartis Recall Pain Patches - Possible Fatal Overdose
Posted by: Micah Adkins
May 21, 2008
Pharmaceutical giants Johnson & Johnson and Novartis have recalled Fentanyl Duragesic Pain Patches with expiration dates on or before December, 2009, after discovering manufacturing defects. These defects may result in leaking of the drug Fentanyl which can result in a fatal overdose or other serious injury. Fentanyl is a potent pain reliever which can cause fatal respiratory and/or cardiac arrest if not administered correctly.
The adhesive "pain patch" is intended to be applied to the skin and is designed to deliver a steady dosage of Fentanyl (an extremely powerful opiate) over an extended period of time. The drug is often prescribed to cancer patients or others suffering from chronic and/or debilitating pain.
The Fentanyl pain patches affected by the recall (patches with an expiration date on or before December 2009) may have a physical cut in the patch, allowing direct and unregulated exposure to the Fentanyl gel by the users, caretakers, healthcare workers or others whose skin comes into direct contact with the patch.
This is the fifth recall of the Fentanyl Pain Patch in the last 14 years. In 2005 the drug was recalled after 120 deaths by Fentanyl pain patch users.
The Federal Drug Administration (FDA) has issued a "black box warning" label due to the dangerous nature of the drug explaining the risk of accidental fatal overdose and respiratory depression or hypoventilation.
Be On the Lookout for these Symptoms and Side Effects of Duragesic Fentanyl Patch
Healthcare professionals are concerned with accidental fatal overdose by Duragesic pain patch patients. An overdose can occur if the patch is damaged, cut, or defective (as those involved in the recent recall).
The drug can stay in patients' systems for as long as 72 hours. Symptoms of a Fentanyl overdose include: slow breathing; seizures; dizziness; weakness; loss of consciousness or coma; confusion; tiredness; cold and clammy skin; and small pupils. The long term side effects of the drug are yet to be determined. Patients can become addicted or dependent on the drug after continued exposure to uncontrolled amounts of Fentanyl.
Attachments:
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