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Fairfield Pharmaceutical Products Law Blog

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)

Manufacturer recalls another lot of improperly designed drugs

In a previous post, we discussed several medications that were recalled on a national level due to dissolution issues. Drugs with dissolution problems or that are improperly designed, are likely to be ineffective and can have temporary to severe adverse health consequences to consumers. Forest Laboratories, the manufacturer of Bystolic -- one of the many drugs included in our previous post -- recently issued another recall for the same drug. This is the second recall of this medication in the last three months and, as the company ships nationwide, consumers in Connecticut may be affected.

Forest Laboratories which is now a unit of Actavis, issued an expanded recall of Bystolic. This is, again, due to dissolution issues with the products in question. The first recall issued a few months ago affected approximately 90,000 sample bottles, and this recall is much the same. More than 94,000 cartons of 20-mg tablet sample bottles are included in this recent recall.

What can I do if a generic medication causes injury?

Generic medications are big in the United States. While some Connecticut residents would rather have a brand-name, the expense of buying a medication based on brand can simply be too much for a majority of people. Generics are supposed to be just as good and offer the same effects as brand-name drugs. As with all other medications, certain standards apply to these drugs before they can be used by consumers, but what happens if a generic drug is suspected of causing injury to a consumer?

According to the FDA, an estimated eight out of every 10 prescriptions filled are substituted with generic medications. These drugs are typically less expensive because they are cheaper to produce. Generic drug makers are not required to conduct clinical trials, and most do no spend money on marketing. The use of generic medications reportedly saves American consumers an average of $8 to $10 billion a year on medications.

How can filing a wrongful death claim help me?

In a previous post, we discussed the statute of limitations set on wrongful death claims. This week, we'd like to go into further detail about why a wrongful death claim may be filed and what type of compensation may be granted for filing such a claim. For Connecticut residents who have lost a loved one due to the use of a defective or dangerous medical product, this information may be able to help them decide if a wrongful death claim will benefit their situation.

Connecticut residents who have lost a loved one due to another person's intent to cause harm, or negligent or reckless behavior may be entitled to file a wrongful death claim for any damages they themselves have suffered as a result of their loss. A successful wrongful death claim is comprised of several key elements. Some of these elements include the death of an individual, fatality that is caused by negligence or intent to harm and proof that monetary harm has been encountered by surviving family members. For our purposes, we would look for negligence on part of a medical product manufacturer or supplier when considering a wrongful death action.

Manufacturer of defective hip implants agrees to settlement

In a previous post, we discussed the issue of hip implants, the number of Americans that require this type of device and those injured as a result of defective products. Recently, the manufacturer of another widely used hip implant has agreed to a settlement that will affect an estimated 3000 patients. Even though this case was filed out-of-state, this was a federal lawsuit and the results of this case may benefit patients in Connecticut who have been negatively impacted by this brand of hip implant.

According to recent news reports, Stryker Corp. has agreed to pay $1 billion to patients who have been negatively affected by the use of its Rejuvenate and ABG II hip implants. While over 20,000 patients are reported to have had these implants installed before the products were recalled in 2012, only a small fraction of them meet the criteria for the settlement terms. Those who do meet the required criteria must have had additional surgery to repair or replace the defective implants or have been found medically unfit to undergo the necessary surgery to remove the device.

Hormone Replacement Therapy and pharmaceutical liability

Millions of women across America, including many right here in Connecticut, may find themselves in need of Hormone Replacement Therapy, or HRT. The physical changes women go through either as they age or due to other medical conditions can be severe, and these therapies are meant to take the edge off, so to speak. However, when these therapies cause more harm than good, who is responsible? As with other forms of medications, when something goes wrong, manufacturers may be held accountable and pharmaceutical liability claims may be filed against them.

Several different forms of HRT have been available over the years, and it is likely that as advances in medicine are made, more HRT medications will be developed. While many women have been greatly helped by the use of these drugs, others have been negatively affected. In the beginning, HRT medications were marketed for long-term use even though there was little data available to verify the safety of prolonged exposure. Studies have since been performed, and it has been found that those using HRT which combine both estrogen and progesterone are more likely to develop breast cancer. The types of cancer found are believed to be more invasive and aggressive than they would be without the use of HRT.

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.

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