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Fairfield Pharmaceutical Products Law Blog

Manufacturer open to liability claim for selling recalled product

Many consumers in Connecticut may not be aware that over-the-counter supplements are not subject to FDA approval before they are released for consumption. Should a problem be discovered with these supplements, it is then that the FDA will step in and recall the product if necessary. Unfortunately, a recent study has found that many of these tainted supplements are staying on store shelves or are available for online purchase long after a recall is issued, which can open a manufacturer up to liability claims.

It has been found than many popular supplements contain prescription level drugs which have not been approved for use in over-the-counter medications. As these drugs can have serious side effects, recalls were issued for the supplements in question. However, it has been found that many of these recalled products are still available for purchase.

Medical products that cause injury subject to recall

Recalled medical products, devices and/or medications, are reported in the news quite frequently. These products are removed from the market after reports of injury are received either by the product manufacturer or the Food and Drug Administration. When a recall is issued, a certain classification is given to inform the public just how dangerous the product is. Unfortunately, people across the country, including those here in Connecticut, may not fully understand what the different classification levels actual mean.

A recall can be initiated voluntarily by the manufacturer, by FDA request or by FDA authority. Depending on the issue with the product in question, a certain classification level is given to specify that amount of harm posed by using said product. The different recall classifications include:

Dosing for children not part of some manufacturer clinical trials

When it comes to medications for children, proper dosing guidelines are often not provided by prescription drug makers. In fact, it is not uncommon for a  pharmaceutical manufacturer to not include clinical trials for children when producing medications. This puts a serious burden on medical providers who have to try and determine the best dosage for children on their own. This also puts children across the nation and here in Connecticut at risk for injury if a dose is miscalculated.

According to Scientific American, only about 46 percent of medications prescribed for children have actually been given FDA approval. While certain laws have been enacted to provide incentives for manufacturers to perform clinical testing in children, not all companies are on board yet. As physicians have the right to use prescription level medications for off-label uses for both children and adults, many manufacturers feel the cost of further clinical trials is not worth it.

Researchers warn of possible harm from certain diet supplements

The number of diet and weight loss supplements on the market today certainly isn't lacking. This is a multi-billion dollar a year industry, and anyone with a product that can fit in this category wants a piece of the pie. As over-the-counter supplements are not regulated by the FDA, getting these products into the hands of consumers here in Connecticut and all across the country is fairly simple. However, just because a product makes it onto store shelves doesn't mean it is safe for consumption. A recent study published in the journal Drug Testing and Analysis questions the safety of certain stimulants in weight loss supplements and warns that using these products may harm consumers.

In total, 14 different weight loss supplements were reviewed by researchers, and 12 of those contained a stimulant called AMP Citrate or DMBA. This particular stimulant is reportedly very similar to amphetamines which are known to cause adverse medical events. It is also closely related to the stimulant DMAA, which was banned by the FDA in 2012 after 86 individuals reportedly suffered a number of negative medical events including stroke, heart attack and even death.

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.

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