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Fairfield Pharmaceutical Products Law Blog

Child safety concerns regarding defective medical devices

It is safe to say that every parent only wants the best for his or her children. Among the many things parents wish to provide, safety and security rank near the top of the list. The fear of children being injured, by any means, is common, and parents will do all they can to prevent injuries from occurring. Unfortunately, injury and illness happen, and parents in Connecticut may find their children in need of medical devices to aid in their recovery. Sadly, children, just like adults, may suffer further injury due to defective medical devices.

Medical devices can range in complexity from simple band aids or other over-the-counter products, to sophisticated machines utilized in the home or in medical facilities. Medical devices are supposed to be tested for safety before they are released to the market for use; however, unfortunately, defective products do tend to end up on store shelves, in hospitals or distributed for use in other medical settings. The use of these products could lead to adverse medical events which range in severity from minor to life-threatening.

Dangerous and defective drugs: legal remedies for Xarelto injury

Problems with a popular blood thinner has pushed the drug's name into national headlines throughout the year. The use of the medicine Xarelto, while originally believed to help prevent the formation of blood clots, has reportedly led to serious bleeding issues and, ultimately, adverse medical events or even death to numerous patients. Legal remedies may be available to Connecticut residents who have been injured or lost a loved one due to the use of dangerous and defective drugs, such as Xarelto.

Xarelto was released for consumption back in 2011. It, like many other drugs of its type, was created to reduce a patient's risk of developing deep vein thrombosis, stroke and a variety of other blood-clot-related injuries. The manufacturers of this product promoted it as a superior medication compared to others of its kind. Since its release, millions of consumers have been prescribed this medication, but, unfortunately, numerous patients have also come forward claiming the use of this drug has caused severe medical issues -- or worse.

Manufacturer may remove drugs from market for a number of reasons

It seems that, on a weekly to monthly basis, drug recalls are reported in the news. These can be for prescription medications or even over-the-counter drugs or supplements. As these recalls occur quite frequently, Connecticut residents may wonder why a manufacturer may decide to pull a product from the market.

When it comes to pharmaceutical grade drugs, manufacturers have a responsibility to ensure product safety before allowing it to be released for consumption. A significant amount of time is taken and money is spent on clinical trials before sending products to the FDA for approval. Monitoring the safety of prescription drugs, however, doesn't end with approval. Prescription drugs are always monitored for safety and effectiveness. If issues are suspected, a recall may be issued.

Infant suffers fatal reaction to dietary supplement

It is not uncommon for healthcare providers to utilize dietary supplements when treating patients in hospital settings. Unfortunately, a recent incident is bringing awareness to the dangers this practice can pose. A premature infant reportedly suffered a fatal reaction to a powdered dietary supplement he or she was given while in the hospital. As this particular supplement may be used in Connecticut medical facilities, readers should know about this incident.

A recall was issued for ABC Dophilus Powder after an infant died when given this supplement as part of his or her hospital treatment. This supplement, which apparently contains live yeast, was found to have mold in the container. The mold caused the infant to suffer from gastrointestinal issues that, ultimately, claimed the baby's life.

Manufacturer responsibility regarding dietary supplements

We've had several posts regarding issues with popular dietary supplements. As supplements are readily available in mass quantity to the general public, we feel it is important to inform Connecticut consumers of manufacturer responsibilities regarding these types of drugs. Too many consumers feel that over-the-counter drugs and supplements are safe for consumption, but it is important for supplement users to do their due diligence and research products before purchase.

Supplement manufacturers are responsible for declaring all ingredients on a product label. From active ingredients down to preservatives, flavors and stabilizers, manufacturers are required per the Food and Drug Administration to include every ingredient on a supplement's label. Failure to do this could result in harm to consumers. Manufacturers are also not allowed to label products as a cure or treatment for specific diseases.

Fear of injury leads to recall of epilepsy drug

It seems that most medication recalls are due to sterility issues or problems with the product's chemical makeup, both of which can cause serious injury to consumers. A recent drug recall, however, wasn't for either of these issues. Complaints haven't been made over the efficacy of the medication but over the fact that empty capsules have been included in certain lots of this specific drug, which could lead to consumer injury. This medication has been shipped to retailers nationwide, and Connecticut consumers may be affected.

Aurobindo Pharma USA announced a voluntary recall after receiving complaints about bottles containing empty capsules. The drug in question is gabapentin, which is used to treat both epilepsy and shingles. Patients who unknowingly ingest the empty capsules could experience short-term withdrawal symptoms or long-period seizures. Seizures like this can be life-threatening.

Defective medical devices are a problem in hospitals

Hospitals use so many different types of medical equipment, it would be impossible to list them all here. Suppliers and department managers are responsible for maintaining equipment and ensuring all products used on the floor are safe for patient use. This includes paying attention to any issued recalls and reporting defective medical devices to manufacturers. Unfortunately, this isn't always happening. Hospitals across the country, possibly including some here in Connecticut, may be using defective devices on patients.

In 2012, a total of 1,190 medical devices were recalled. That was considered a significant increase compared to previous years. This year, the number of medical devices and medications recalled have already passed the number of recalls issued in 2013. Even with increased safety regulations, medical recalls are still a major issue.

Manufacturer recalls ventilator due to power issues

Ventilators are life-saving devices often used in facilities such as hospitals or long-term care settings. These medical machines will keep a person breathing when they are incapable of doing so on their own. Any issue that would cause a machine like this to fail could put patients in danger of serious injury or even death. One manufacturer recently issued a recall due to issues found with two different ventilator models. As this company provides medical equipment to healthcare facilities across the country, patients in Connecticut may be affected by this recall.

Philips Respironics produces various types of medical equipment. The machines produced by this company can be found in hospitals and other care facilities worldwide. In a recent turn of events, two ventilator models produced by this manufacturer were recalled due to a power issue. The FDA labeled this a Class 1 recall due, as device failure could have life-threatening consequences.

Undeclared drugs in bodybuilding supplement may cause harm

A popular bodybuilding supplement, which is available over-the-counter here in Connecticut and across the country, was recently recalled due to issues with its chemical makeup. According to a recent report, the Mayhem bodybuilding supplement may contain prescription level drugs which are not included on the product label. The use of these drugs could cause harm to consumers.

Chaotic Labz is the manufacturer of Mayhem dietary supplements. Products by this manufacturer can be found both in-store nationwide and online at various retailers. The product that has been recalled is packaged in a clear container with yellow capsules and have an expiration date of June 2016.

Medication use can have fatal consequences

Prescription and over-the-counter medications are developed to improve lives. When designed and used properly, these drugs can reap positive benefits for consumers. Unfortunately, far too many American consumers, which may include some here in Connecticut, die annually from the use of these medications. When the use of a medication has fatal consequences, many consumers may want to know who can be held responsible.

According to recent data, approximately 105 deaths occur daily in the United States from the use of prescription drugs. Some of these deaths result from combining medications with other substances, while others occur from taking inaccurate doses. Three of the most popular prescription drugs that can have fatal consequences include:

  • Opioids (pain medications)
  • Benzodiazepines (tranquilizers or depressants)
  • Stimulants (amphetamines)
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