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Fairfield Pharmaceutical Products Law Blog

Fear of injury prompts pediatric breathing circuits recall

Another medical device is being pulled from the market amid fears that a specific part of the product may break, which could cause patients using this device to suffer adverse medical events. In an effort to avoid patient injury, the FDA has issued a Class I recall on the Hudson RCI Pediatric Anesthesia Breathing Circuits. These devices are used in both professional and home settings nationwide, and patients in Connecticut may be affected.

Teleflex Medical, the makers of this particular device, sent out letters to customers about possible issues with the product in early September. According to the company, the ends on the device may break either during or before use. If this happens, the patient may experience difficulties breathing, and even death, if the part is not immediately replaced.

What does an implantable defibrillator do and is it safe?

Connecticut residents with heart health issues may be familiar with defibrillator devices. A defibrillator is used to send an electrical pulse to the heart in order to shock the heart back into normal sinus rhythm. These devices are often used in hospital settings, and portable machines can be found in a variety of places. For patients who are known to have irregular heart beats or arrhythmias on a frequent basis, an implantable defibrillator device may be used.

An implantable cardioverter defibrillator is placed under the skin, either in the chest or abdomen of the patient. Electrodes are then inserted into the right ventricle of the heart through a vein. Much like a pacemaker, this device will monitor heart rhythms and send an electrical pulse if needed to maintain a normal sinus rhythm. Depending on the issue detected, these pulses can be low or high-energy shocks, which can be painful.

Patient injury linked to medications from compounding pharmacy

A multitude of patients, both here in Connecticut and all across the country, require specialty formulated medications for the illnesses they struggle with. In order to get these medications hospitals, patients and other medical facilities are often required to use a compounding pharmacy. These pharmaceutical companies specialize in mixing medications and, like drug manufacturers, are held to high standards to ensure product safety. Unfortunately, in the past few years, questions have been raised regarding the safety of these drugs, as patient injury has been linked to the medications produced by these compounding companies.

Numerous recalls for compounded drugs have been reported in the last two years for both sanitary and safety issues. While some of these recalls were issued simply as a safety precaution and no patients suffered any harm, others are the direct result of patient injuries and/or deaths. In another jurisdiction, the company Specialty Compounding is facing several legal complaints for medications it reportedly supplied to a local hospital that supposedly resulted in 15 patients suffering from a bacterial infection, two of whom ultimately died.

Injured by an improperly designed medical product -- now what?

At some point in their lifetime, a majority of Connecticut residents will require the use of some sort of medical product; whether that is a medication, supplement or other medical device. While there are wonderful products on the market that greatly improve health and well-being, there are also those that may be improperly designed and/or dangerous to use. Those who have been injured or who have lost a loved one due to using one of these products may be entitled to legal recourse.

When products are purchased, consumers are placing their trust not only in the manufacturers of those products but in those who choose to distribute them. Consumers want to believe that they are spending their money on products that not only work, but are safe as well. Unfortunately, some medications and devices may be released for use without adequate safety testing.

Are there time limits on product related wrongful death claims?

It is a sad reality that a pretty significant number of patients die every year due to the use of medical devices and medications. While every individual situation has its own set of circumstances, if the death can be related to any negligence on behalf of drug or device manufacturers or others in the chain of commerce, wrongful death claims may be filed. However, Connecticut residents who have been negatively affected by this type of event should be aware that time limits are generally in place for filing any legal claims.

Time limits put on filing legal claims are known as statutes of limitations. When this time period is up, any legal rights to file a lawsuit pretty much goes out the window. Every state has a different time limit put on wrongful death claims. In Connecticut, wrongful death claims can be filed up to two years from the date of death or five years from the date of the act that resulted in the death. However, in cases where product liability is claimed, the time limits may be somewhat different.

FDA warns of fake drugs on the market that could cause harm

In our last post, we discussed the dangers of prescription medications from some foreign manufacturers. Along with the desire of the Food and Drug Administration to crack down on the quality of foreign drug-maker's products, the agency is also worried about fake drugs being distributed unknowingly, which could ultimately harm patients if consumed. According to a recent statement released by the FDA, there appears to be an increase in supposed prescription medication wholesalers pushing fake or unapproved merchandise on their unsuspecting clients. This is apparently a nationwide issue and may affect individuals here in Connecticut.

The FDA is warning all healthcare providers and administrators of this issue. To help with this, the agency has recently started a new program designed specifically to educate medical providers about safe drug purchasing. The name of the program is Know Your Source, and it provides information about buying medications from licensed distributors.

Improperly designed medications from foreign makers cause concern

It has been a tough year for some foreign pharmaceutical companies. The United States has banned certain improperly designed products from entering the country and recalled several others. With these issues, there has been a demand for higher standards to be utilized by these drug manufacturers and for these companies to accept responsibility in product liability measures. Patients in Connecticut, and all across the nation, may have unknowingly been exposed to low-quality medications produced by these companies and certainly have the right to question what legal actions they have at their disposal.

Several foreign pharmaceutical firms have been accused of selling inferior medications. These drugs are used for a variety of medical issues, and if formulations are not correct, patients are put at serious risk of injury or even death. Unfortunately, a recent study showed that about 10 percent of certain medications lacked adequate levels of the active ingredients necessary to make the drugs effective.

False drug rep claims can be a pharmaceutical liability issue

A few years back, the U.S. Second Court of Appeals made a decision that would help pharmaceutical sales representatives in Connecticut and other states in the courts purview. According to the court, in the effort to move products, these drug reps are allowed to promote any off-label uses for the medications they sell. This does not, however, mean they are permitted to make false or misleading claims about the medications. Doing so could create a pharmaceutical liability issue for the manufacturer.

The FDA is responsible for approving prescription medications for specific uses before it is released for mass consumption. Drug manufacturers are required to show, through extensive testing, what the product is for, how it works and if it is safe before it is granted this FDA approval. From development to approval, this process can take years before a medication is out on the market.

Fear of injury prompts nationwide Heparin recall

Anytime a medication is suspected of possibly causing harm to consumers, a recall is generally announced. These recalls can be issued for a variety of reasons, including for quality control concerns or due to dangerous side effects. Patients across the country, including some living in Connecticut, may be affected by these recalls and could be entitled to legal recourse should they experience injury from these medications.

Recently, Hospira Inc. issued a recall on one particular lot of Heparin. This pertains to injectable Heparin Sodium 500mL units that were distributed nationwide this summer and have an expiration date of Nov. 1, 2015. According to Hospira, human hair was found in a bottle of the medication prompting concerns over the medication's safety.

Manufacturer Customed, Inc. recalls multiple products

The FDA announced that they recently reported the biggest single-day recall since its conception. This recall was voluntarily offered by the medical device manufacturer Customed, Inc, and is not in reference to any one product. All devices manufactured by this company are believed to be involved, and patients across the country, including some here is Connecticut, may be affected by this.

The FDA reportedly recalls anywhere from 13 to 75 devices on any given day. The majority of these recalls are issued at Class II or Class III levels. In total, 233 recalls at a Class I level were posted to the FDA's website on a single day in August. It is believed that a significant number of product units are likely to be affected by this, several hundred thousand in fact.

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