Many drug-makers filing incomplete side effect reports to FDA, analysis concludes

STAT (2/23, Silverman) reports that a new analysis published in Pharmacoepidemiology and Drug Safety concludes that drug-makers “generally fail to include key data that the FDA might use to assess future warnings” in their reports to the agency’s Adverse Event Reporting System. According to the analysis, 40% of expedited reports and 51% of periodic reports filed by drug-makers to the FDA were incomplete, with 38% lacking the patient’s age and sex. Another 47% of reports did not include the date of the adverse event. According to STAT, “reports involving patient deaths offered the least amount of complete information for all of the key data points.” A spokesperson for the FDA said the agency is “aware that the quality of adverse event reports may vary.”

We believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a lawsuit on your behalf if necessary. If you or a loved one has been affected by prescription drugs due to a recall or another mistake, and you believe it caused harm, contact Chhabra & Gibbs today by going to www.cglawms.com or by calling this number: 601-948-8005.

How does the process work to apply for Social Security Disability?

The first step to make is to apply for disability.  We can assist you in doing that by meeting with you and walking through the online application with you.

The social security administration will then make a decision on your application.  Unfortunately, for the vast majority of people that means a denial.

Once you are denied, you will need to timely appeal the decision. This step in the appeal process is called reconsideration.   If you have not already hired an attorney, this is the time that you need to do so.  Please also make sure that you do so immediately, so that the appeal can be timely filed in order to avoid having to start the whole process over again.

The social security administration will then review then case.  Unless there has been a significant change in your condition between the initial application and the reconsideration, the likely result will be another denial from social security.

At this point, you or your attorney will file a request for a hearing before an administrative law judge.  This is the step where you are able to go before a judge who independently reviews your case and hears your testimony.  This is the step at which most people are approved for disability.

Social Security disability is a long process and usually takes 12-18 months (sometimes longer) before a final decision is made by the administrative law judge.  You should not get frustrated with the process and give up on disability if you are unable to work.

Teresa E. Harvey

If you are interested in learning more about social security disability or in getting assistance to apply, please contact Chhabra & Gibbs, P.A., at 601-948-8005 or by going to our website at http://www.cglawms.com .

Recalls Of Select Single Lumen Catheters

Cook Medical is recalling 360 lots of its single lumen central venous catheters, pressure monitoring sets and trays due to issues with catheter tip fracture and separation.

A total of 17,872 devices are subject to the recall, according to Cook Medical, who said it began notifying customers and distributors of the issue in January and that it has contacted the FDA and other regulatory bodies over the issue.

The problem was discovered during an internal inspection, in which a catheter “exhibited the potential for catheter tip fracture and/or separation,” according to an FDA press release. Cook Medical said they investigated further and found the technique used by the assembler to attach the tip was likely at fault.

Cook Medical said there have been no reports of injury or illness associated with the issue, though potential adverse events could occur due to tip fracture or separation that would require medical interventions to retrieve the fractured or separated tips.

Such an event could result in occluded blood flow to end organs, with complications including stroke, kidney injury or damage to the intestines or limbs, the company said.

The devices were distributed internationally between April 2013 and October 2015.

The recall affects multiple part, product and lot numbers. Included in the recall are Cook’s femoral artery pressure monitoring catheter tray, femoral artery pressure monitoring catheter set, radial artery pressure monitoring catheter tray, radial artery pressure monitoring catheter set, single lumen central venous catheter set, single lumen central venous catheter tray and single lumen pressure monitoring kit.

Cook Medical said customers and distributors should quarantine and discontinue use of all affected units, and return them to the company for credit.

If you’ve been injured or hurt due to any of the catheters, trays, or sets that is on this recall list, please contact the attorneys at Chhabra & Gibbs, P.A., at 601-948-8005 or by going to our website at http://www.cglawms.com . We might be able to help you receive compensation allowed by law for damages or injuries. It doesn’t cost you anything to call and talk to an attorney to see what options you have.

If it legal for the insurance company to do surveillance on me after a work injury?

Yes it is legal as long as done peacefully without harassment.  After an injury, you should always consider the possibility you may be under surveillance.  Be careful not to violate your doctor restrictions, unless you want to see yourself on camera doing something that you and your doctor said you couldn’t do.  After you have been injured on the job, your doctor should tell you what activities are safe to do and what activities will aggravate or worsen your injury.  If your doctor has not told you what your restrictions or limitations are, or your current work status, talk to your doctor today and let your attorney know.  

Do not violate doctor’s orders.  If you do not follow your doctor’s orders and instructions, your injury could get worse, and the insurance company could gather evidence to make it look like you aren’t as hurt as you and your doctor say you are.  We all want our injuries to get better, not worse.  And here at Chhabra & Gibbs, we want you to heal and get better as soon as possible.  So follow your doctor’s instructions, even when you are tempted to perform the activities you could perform before your injury.  If you do not follow your doctor’s instruction and you are violating your restrictions, the Judge may not require your employer to pay for future medical treatment caused by the aggravation of your injury, and your lack of credibility may cost you your rightful disability payments.

Amanda G. Hill

Should you have questions regarding a legal matter and would like to set up a free consultation, please contact me by going to our website http://www.cglawms.com or by calling 601-948-8005 today.

Can I file a discrimination case in Mississippi?

Although Mississippi is an at-will state (meaning an employer can fire you for almost any reason), it is unlawful for your employer to discriminate against you based on your religion, sex, race, national origin or disability.  In addition, your employer cannot retaliate against you for engaging in a protected activity or reporting illegal conduct to the proper authorities.

If you have experienced any of the above, you should immediately contact the Equal Employment Opportunity Commission (EEOC) and file a charge of discrimination against your employer. You only have 180 days from the act of discrimination in order to file the charge of discrimination and you cannot file a lawsuit against your employer until the charge of discrimination is filed and you receive a right to sue letter from the EEOC.

Once you file the charge of discrimination, your employer will be notified of the charge and the EEOC will conduct its investigation. If you have not already hired an attorney, this is the stage where you should contact an attorney for representation. Do not wait until you receive the right to sue letter. You will only have 90 days from the date of the right to sue letter in order to file suit against your employer so the sooner you find an attorney the better, as it can sometimes take a while to find the right attorney to help you and you do not want to risk waiting too long and your deadline to file suit passing.

Teresa E. Harvey

If you have experienced discrimination or retaliation in your employment and you wish to discuss a possible lawsuit, please contact us by going to our website http://www.cglawms.com or by calling 601-948-8005 today.