FDA Issues a Number of Recalls This Month

Stay updated with FDA safety here as we report clinically important information provided by MedWatch, the official FDA newsletter.

 

 

FDA recalls dye used in retinal surgery due to eye infections 

The Food and Drug Administration (FDA) has recalled Brilliant Blue G, a dye used in retinal surgery, supplied by Franck’s Pharmacy after numerous reports of patients developing eye infections. The eye infections were reported in several states and the FDA had advised all healthcare professionals to avoid using the dye completely.

Brilliant Blue G has not been approved in the U.S. and has been linked specifically to fungal endopthalmitis, a fungal infection widely regarded as one of the more serious complications that arise from eye surgery. Endopthalmitis may result in loss of vision or even the eye entirely. Some symptoms of the infection include loss of vision, severe pain and redness or swelling in the eye. This infection can spread throughout the eye as well as to tissue surrounding the eye.

Endopthalmitis requires urgent care by an expert and usually requires either injection of potent antibiotics, removal of affected tissues or enucleation of the entire eye. These medical procedures are expensive and can result in even further complications. Franck’s pharmacy is currently undergoing medical and legal investigation because of this recall, as the consequences of these infections are far-reaching and dangerous to everyday optometry patients.

Ultrasound transmission gel recalled because of bacterial contamination 

The FDA has recalled Other-Sonic Generic Gel, an ultrasound transmission gel, due to bacterial contamination. Certain batches of the gel produced from June through December 2011 contain deadly bacteria such as Pseudomonas aeruginosa and Klebsiella oxytoca, according to an update by the administration’s Medwatch report.

The FDA’s investigation found numerous batches produced by Pharmaceutical Innovations Inc. and has expressed the importance of urgently discontinuing the use of the product altogether. Medwatch describes both bacteria and the fatal symptoms they have been known to cause. Pseudomonas aeruginosa, usually found in water and soil, can harm human skin causing inflammatory dermatitis. Klebsiella oxytoca is usually found in digestive tracts but it’s application to other tissue can cause complications such as pneumonia, wound infections and bloodstream infections.

The FDA has also stated that ultra sound transmission gel is used in ultrasound procedures to improve the transmission of the ultrasound signal to the body, which creates direct contact between the contaminated gels and skin and other tissue. Essentially, the Medwatch report brings to light the danger of contact with these contaminated gels, which can cause very serious complications or ultimately lead to death.

Pre-filled drug cartridges overfilled to potentially dangerous doses 

In a recent Medwatch report, the FDA notified healthcare professionals of a series of Carpuject pre-filled drug cartidges produced by Hospira Inc. may be overfilled. These cartridges may contain at least twice the amount of the drug inside, according to the report. Some of these cartridges contain drugs that are dangerous and fatal in high amounts such as morphine and hydromorphone.

The FDA has stated that many healthcare professionals have complained after visually inspecting these cartridges and confirming that they are indeed overfilled. The Medwatch report also states that although these cartridges can be identified visually before administering, precautions should be taken so as to avoid accidental overdoses.

The problem in the manufacturing of the Carpuject cartridges that causes the overfilling is expected to have been present in over 280 lots of over 15 different Carpuject products. Due to the number of the faulty cartidges, a recall would result in an immediate shortage, so the FDA recommends that healtcare professionals and facilities should continue to inspect the cartridges as well as be wary as to the presence of these overfilled cartridges.

A Review of Complex Business Litigation (CBL)

Complex Business Litigation generally involves two or more businesses with considerable resources in a dispute over money or other property. The Law Office of Roberto Villasante specializes in Complex Business (or Commercial) Litigation, representing public and private companies in connection with contract disputes, business torts, and disputes involving the Uniform Commercial Code, business dissolutions, and other commercial and financial relationships.

 

Complex business litigation (CBL) cases typically involve a controversy that exceeds the amount of $150,000, exclusive of interest, cost and attorney’s fees. Cases where a breach of contract occurs between businesses, a partnership, shareholder, joint venture or other business arrangement are classified as CBL cases.

 

Other cases that are subject to CBL procedures involve an intentional act resulting a claim for intentional interference with a contractual business relationship, fraud, misrepresentation, and unfair competition; actions based on a statutory or common law violation where the breach arose out of a business dealing; actions asserting a claim arising under the UCC; actions involving the purchase or sale of the stock, assets or liabilities of a business; actions relating to a surety bond; actions arising from a franchisee/franchiser relationship and associated liabilities; actions under the Florida Deceptive and Unfair Trade Practices Act; actions under a state or other antitrust law.

 

In addition, cases involving a construction defect that is not based upon a claim of personal injury can be considered CBL, just as a shareholder derivative action or other action relating to director and officer liability or a corporate governance issue. An action relating to trade secrets or non-compete agreements, an action involving the dissolution of a business entity or an assignments for the benefit of creditors, and any actions involving securities or asserting a claim under a state or other securities law as classified as CBL cases in Florida.

 

While all these cases are subject to CBL procedures, there are some cases that are NOT categorized under this area of law. For example, matters involving occupational health or safety, environmental claims which does not involve the sale or disposition of a business or insurance coverage dispute; a matter in eminent domain; employment law cases; administrative agency, tax, zoning or other appeals; a matter required by statute or other law to be heard in some other Court or Court Division; residential foreclosure matters; tobacco litigation; business foreclosures; and Chinese drywall related cases do not fall under the CBL category.