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Fairfield Pharmaceutical Products Law Blog

FDA 510(k) program leads to defective medical devices on market

The FDA's controversial fast-track device program is under fire after suggestions were made that product recalls were linked to poor testing practices. The 510(k) program was created to move medical devices that are similar to other devices already available to the market faster than normal. Some would argue that this process has allowed defective medical devices to enter the marketplace, putting consumers in Connecticut and nationwide at risk.

Because of complaints about the 510(k) program, the FDA plans to increase and enforce higher standards. However, the program will remain in place as an available option for manufacturers to reduce product development times. The biggest change that will be seen is the elimination of approving what are called split-predicate devices.

Pharmaceutical liability questioned with surge in drug recalls

According to the FDA, there has been an increase in drug recalls over the past few years. So far in 2014, several serious drug recalls have been issued. It is believed to be the worst year for pharmaceutical recalls in the past decade. With so many product recalls, pharmaceutical liability may be questioned by Connecticut consumers.

Products may need to be removed from the market for a variety of reasons, including package defects, contamination, drug safety issues and failure to properly test a product. The FDA classifies a recall under a certain level, depending on the risks associated with that product. These recalls range from a Class I, which could result in serious health consequences or death, to a Class III, which is not likely to produce negative health consequences.

Some artificial hip joints feared to be defective medical devices

The use of artificial joints is a growing practice in Connecticut and across the United States. What science and medicine can do to improve the lives of those suffering from joint pain and deterioration is incredible. However, if defective medical devices are implanted, there is great potential for harm to the patient.

Hip replacement surgeries are on the rise nationwide. Approximately 400,000 hip replacements are performed yearly. For the most part, this surgery is considered highly effective. Unfortunately, there has been an issue related to metal toxicity being produced by the materials used to make these joints.

Manufacturer of CUBICIN issues a voluntary recall

The Food and Drug Administration recently announced a voluntary recall issued by Cubist Pharmaceuticals. The drug manufacturer has recalled specific lot numbers of CUBICIN, which is a medication often given to treat both skin and blood stream infections. This medication has been shipped nationwide and could affect Connecticut consumers.

According to recent reports, the recall was issued after it was discovered there was potential for glass particulates to be present in vials produced by one of Cubist's contracted manufacturers. The cause of this particulate matter has been traced to a specific manufacturing line, and all production from this line has been stopped. Cubist Pharmaceutical's claims that it has not received any reports of adverse medical events related to the affected drug lots.

Lidocaine recall amid fears of causing harm to patients

Drugs are manufactured daily and in mass quantities. Some have been around for decades, other are new to the market and promise better results than predecessors. No matter how old or new a product is, patients trust that drug makers are maintaining high quality and safety standards. Unfortunately, mistakes are sometimes made, and these mistakes can cause serious harm to patients. Recently, a recall of a injectable Lidocaine solution was announced and may affect products in the direct possession of Connecticut patients.

Hospira is a company that supplies a variety of medical devices and medications for both medical facility and at home use. The company issued a recall of its Lidocaine HCL Injection solution offered in single-dose vials. The lot affected has an expiration date of Jan. 1, 2015 and was distributed for use in medical facilities and at home prescriptions.

Manufacturer issues nationwide recall of CO2 detectors

GE Healthcare, a prominent manufacturer of medical devices, has issued a recall of one of its products. This has been labeled a Class I recall, meaning use of this product could cause permanent damage or result in death. The manufacturer has voluntarily issued this recall, and a list of affected devices has been made available. As GE Healthcare provides equipment to hospital across the country, patients in Connecticut could be affected by this faulty device.

This recall is specifically for the Single-Width Airway Module CO2 detectors, all associated accessories and extensions. These products are utilized by hospitals and other medical facilities in order to evaluate patient’s respirations and CO2 levels. This particular model is used for patients that weigh more than 11 pounds.

Supplement manufacturer shut down and all products recalled

Supplements of all types are widely used by people across the country, including residents of Connecticut. A growing need for better quality of life, and natural remedies to assist in achieving that goal, have fueled a multi-billion dollar a year industry of over-the-counter health supplements. With all the products available on store shelves, it is hard to know what is safe and what isn’t. Recently, one supplement manufacturer has been told to halt productions due to supposed violations of the Federal Food, Drug and Cosmetic Act or FDCA.

An East Coast based supplement manufacturer has been forced to stop productions and recall all products that have been sold since Jan. 1 of this year. While this may come as a huge blow to the company’s bottom line, the effects of poor quality control could do far more harm to individuals using this company’s products. A legal complaint was filed earlier this month against Applied Polymer Systems dba APS Pharmaco or APS and the company's president, claiming that the company manufactured and sold impure supplements.

Drug recalled after manufacturer cited for possible contamination

The FDA has recently sent out a warning to physicians who use compounded drugs produced by Unique Pharmaceuticals. According to an FDA spokeswoman, FDA inspectors discovered issues in the facility of the manufacturer that could lead to the contamination of medications. It is believed that possible unsanitary conditions were found in production areas that yield sterile drugs. These drugs are specially formulated for and shipped to doctors nationwide and could possibly affect patients in Connecticut.

It has been reported that patients who use these possibly contaminated drugs could suffer from adverse medical events, including developing a serious infection. Because of this, a recall was issued for all sterile products that are not expired. One of the drugs believed to be affected is a fluid used to help patients that suffer from respiratory issues.

Knee replacement manufacturer recalls components

Knee replacements are a common procedure that is performed all across the country, including in hospitals and surgical centers in Connecticut. Patients who have been through this procedure understand the expense, pain and recovery involved. Naturally, they expect that the equipment used is of good quality and free of defects. Recently, a recall was issued by Zimmer Holdings, Inc., the manufacturer of the NexGen Complete Knee Solution system, for an issue with the tibial components that could lead to device failure.

The system’s manufacturer claims that a possible problem was found regarding the thread specifications, which could lead to a host of complications. These complications include post-surgical infection, bone loss, dislocation and early revision surgery. While this particular device is supposed to be installed in a less invasive surgery, sparing patients from the pain typically associated with this type of procedure, the assembly process surgeons must use is said to make the problems more apparent.

Solution recalled over mold issue that may cause injury

Recently, Hospira Inc. issued a recall of a solution they produce after receiving reports of a possible particulate issue. The particulate found in some bottles of the solution in question is believed to be a mold that -- if injected -- could cause injury to the patient. This is a nationwide recall that could affect residents of Connecticut.

The recall extends to a several units of Lactated Ringers and 5 percent Dextrose Injection, which is essentially a fluid and electrolyte replacement solution. The lot being recalled was distributed between Dec. 2013 and Feb. 2014 to a number of facilities including hospitals, distributors and clinics, and has an expiration date of Nov. 2015. At this time, no adverse medical events have been reported, but the recall was issued as a safety measure.

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