Blog Home

FDA Inspection Reveals Adulterated Synchromed? II Insulin Pumps
Posted by: Micah Adkins
July 01, 2009
Topic: DANGEROUS DRUGS

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.

Permalink

HOW DO I OBTAIN A FREE CREDIT REPORT?
Posted by: Micah Adkins
June 24, 2009
Topic: ID THEFT, DATA BREACHES AND CREDIT REPORT DISPUTES

The Fair Credit Reporting Act ("FCRA") provides consumers with the right to request a credit report from any of the three nationwide credit reporting agencies ("CRAs")(e.g., Equifax, Experian and Trans Union) for free one time in a twelve (12) month period. 15 U.S.C. 1681j(a)(2). The CRA must provide the consumer with a the credit report within fifteen days of receiving the consumer's request. 15 U.S.C. 1681j(a)(2). Further, even when consumer demands for their credit reports increase, CRAs, by law, must have the requisite ability to meet the reasonable anticipated consumer requests. 16 C.F.R. 610.2(e) and 3(c).

The CRA may request additional identifying information from the consumer prior to sending the report, but the CRA may only do so to process the consumer's request, process a simultaneous transaction as requested by the consumer, update the consumer's personal identifier, or comply with any of the other requirements of the FCRA.

A consumer may request all three credit reports online at http://www.annualcreditreport.com/, by telephone at 1-877-322-8228, or via mail at:

Annual Credit Report Request Service
P.O. Box 105281
Atlanta, GA 30348-5281

Our firm helps consumers get their credit reports and resolve consumers' disputes with CRAs for inaccurate or incomplete information contained in their credit files.  For a free consultation, contact attorney Micah Adkins.

Permalink

Alabama Auto Fatality Statistics
Posted by: Micah Adkins
June 01, 2009
Topic: CAR ACCIDENTS

In 2000, according to the Bureau of Transportation Statistics (BTS), 995 traffic fatalities were reported in Alabama. Click here for 2000 Report.  In 2006, the number of fatalities increased 1,208. Click here for 2006 Report.  Of the 1,208 traffic fatalities in 2006, 1,117 of those fatalities involved "large trucks." See Table.  The National Highway Traffic Safety Administration defines a "large truck" as a commercial vehicle weighing over 10,000 lbs.

The above statistics demonstrate how dangerous the roads can be in Alabama, especially when commercial trucks are involved in wrecks with cars or other vehicles. Attorneys for trucking companies vigorously defend personal injury claims and often begin preparing their clients' defense within minutes of the accident. Victims of commercial truck accidents need aggressive and professional representation. If you or a loved one has been involved in an accident with a commercial truck or other vehicle, contact attorney Micah Adkins for a free consultation.

Permalink

HYDROXYCUT RECALL
Posted by: Micah Adkins
May 21, 2009
Topic: DANGEROUS DRUGS

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:
hydroxycut_samples.jpeg

Permalink

SWIFT TRUCKING & SWIFT DRIVING ACADEMY DRIVING INVESTIGATION
Posted by: Micah Adkins
April 29, 2009
Topic: CONSUMER PROTECTION

The Tennessee Department of Safety is notifying various state departments of public safety and transportation, including Alabama, Georgia and Arkansas, that truck drivers that received a commercial drivers license (CDL) from the Swift Driving Academy (located in Middleton, TN) between May 2005 and January 2008, is not valid because the administrator of the skills and driving portion of the examination did not have the proper credentials. As a result of the letter, commercial truck drivers all over the country are being grounded until they can re-apply and re-take their CDL examination.

Click here for Tennessee Department of Safety Media Advisory regarding FBI investigation of Swift.

If you attended the Swift Driving Academy in Middleton, TN between May 2005 and January 2008 and if you would be willing to discuss your experience with us, please contact attorney Micah Adkins.

Permalink

Visicol & OsmoPrep Linked to Kidney Damage
Posted by: Micah Adkins
April 24, 2009
Topic: DANGEROUS DRUGS

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.

Permalink

SCHOOL EMPLOYEES VICTIM OF IDENTITY THEFT
Posted by: Micah Adkins
April 14, 2009
Topic: ID THEFT, DATA BREACHES AND CREDIT REPORT DISPUTES

According to Katherine Leal Unmuth of the Dallas Morning News, at least 3,400 teachers and school employees of the Irving Independent School District (suburb of Dallas, Texas) are victims of low-tech identity theft. The personal data (including Social Security numbers) is believed to have been taken from a trash dumpster and was not shredded.

"Dumpster diving" is a low-tech method for identity thieves to collect personal information. Many states do not have laws prohibiting people from taking trash from dumpsters; however, employers have a duty to safeguard its employees personal information and should always shred personal information prior to disposal. As a result of the security breach that seemingly could have been easily avoided, Irving School District employees are complaining of fraudulent credit card charges, out-of-pocket expenses to change driver's license numbers and sleepless nights.  Two people have been arrested in connection with the identity theft.

FULL STORY

If you or a family member has been a victim of identity theft as a result of a security breach at your place of employment, contact attorney Micah Adkins for a free consultation.

Permalink

SOCIAL SECURITY DISABILITY AND FRAUD
Posted by: Micah Adkins
April 09, 2009
Topic: SOCIAL SECURITY BENEFITS

The Social Security Administration's Office of Inspector General (OIG) is charged with the investigation of potentially fraudulent Social Security Disability (SSD) applications. Since 1998, the OIG has performed Cooperative Disability Investigations (CDIs) with the assistance of state law enforcement officers and employees of the Social Security Administration (SSA). The goal of the of the investigation is to identify and prosecute fraudulent SSD applications. The investigations may include surveillance of the claimant on his way or leaving "consultative" examinations. These examinations may be set up by the OIG for investigative purposes only.

The local SSA office is to notify the claim or the claimant's attorney of CDI information contained in the claimant's file for consideration by the Administrative Law Judge (ALJ).  The claimant or the claimant's attorney should be afforded the opportunity to view the surveillance tape(s) prior to the benefits hearing. Often, in anticipation of criminal charges, the claimant's attorney may then refer or associate a criminal defense attorney to handle the potential criminal charges.

The CDI information will be divulged to the claimant only if the information is sent to the ALJ or the local SSA office. In other words, if the OIG does not send the results of its its CDI report to the ALJ, then the claimant will not have access to the surveillance tapes.  The OIG typically provides ALJs with information that makes the claimants look bad. As a result, information obtained by the OIG that supports the claimant's application will not be provided to the ALJ or local SSA.

If you, or a loved one, have applied for Social Security benefits and have been turned down, then you need an attorney. Contact attorney Micah Adkins for a free and confidential consultation.

Permalink

I'VE BEEN HURT AT WORK, DO I HAVE TO PUT MY EMPLOYER ON NOTICE OF MY INJURY?
Posted by: Micah Adkins
March 30, 2009
Topic: HURT AT WORK

I've been hurt on the job, do I have to put my employer on notice of my injury? In short, yes. Under the Alabama Workers' Compensation Act, an employee must give notice to the employer of the injury within five (5) days of the accident. Ala. Code (1975) Section 25-5-78. The notice requirement enables the employer to provide the employee quick access to medical care and treatment. In theory, the sooner the employee has access to medical care, the sooner the employee will be able to return to work.

Alternatively, the notice requirement is met if an employer has actual or constructive notice of the injury. In Russell, the Alabama Court of Civil Appeals defined actual knowledge as such information that would put a reasonable man on inquiry. Russell Coal Co. v. Williams, 550 So.2d 1007 (Ala. Civ. App. 1989). Constructive notice occurs when the employer observes an injury and has knowledge of surrounding facts connecting the injury to work. Virginia-Carolina Chem. Co. v. Cherry, 173 So. 86 (Ala. 1937). Also, oral notice may satisfy the notice requirement when the employer is notified that the injury occurred while in the line and scope of the employee's employment. Nabisco Biscuit Co. v. Slimp, 660 So.2d 991 (Ala Civ. App. 1993).  Because notice is so important, it is a better idea, if possible, to giver your employer notice, in writing, as soon after the accident as you can. 

If your employer is not given proper notice of the on the job injury, the Alabama Workers' Compensation Act can be unforgiving. For example, generally speaking, an employer is not required to pay for an employee's medical treatment. See Ex parte Gulf States Steel, Inc., 772 So.2d 1122 (Ala. 2000). However, the employee may be entitled to benefits if he can show "good reason" for not providing actual notice of the injury within ninety (90) days after the accident. See Ex parte Murray, 490 So.2d 1241 (Ala. 1986).

If you or a loved one has been hurt at work and your are not sure that the employer has notice of the on the job injury, contact attorney Micah Adkins for a confidential consultation.

Permalink

Can I Recover Under Multiple Under/Uninsured Policies?
Posted by: Micah Adkins
March 20, 2009
Topic: CAR ACCIDENTS

An insured may recover under multiple uninsured/underinsured policies where the loss exceeds the limits of one policy. Safeco Ins. Co. of America v. Jones, 243 So.2d 736 (Ala. 1970). Thus, an insured may "stack" multiple uninsured/underinsured policies, but the amount of recovery may not exceed the insured's actual loss. Id., at 738. In other words, if you have two policies that provide you with uninsured/underinsured motorist coverage for $25,000.00 each, then you may add (stack) the polices together for a total uninsured/underinsured motorist coverage of $50,000.00.

A named insured may stack as many as three coverages (i.e., three vehicles covered under one policy) within one policy and there is no limit as to the number of policies the insured may stack. State Farm Mut. Auto Ins. Co. v. Fox, 541 So.2d 921 (Ala. 1989). The passenger in a vehicle that has been involved in a car wreck may stack up to three coverages on the named insured's policy covering the vehicle. Allstate Ins. Co. v. Alfa Mut. Ins. Co., 565 So.2d 1070 (Ala.1990). The passenger may also stack any coverages he has on his own vehicle.

The insured's ability to stack uninsured/underinsured polices is very important because multiple policies can provide a larger recovery for the injured driver/passenger. If you have been in a car wreck and are not sure what insurance benefits you are entitled to under Alabama law, then contact attorney Micah Adkins at Massey, Stotser & Nichols, P.C. for a free consultation.

Permalink