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The Food Drug and Cosmetic Act was initiated to keep foreign particles out of medicines by creating guidelines to use when judging a product’s safety. The International Association for Pharmaceutical Science and Technology states that particulate matter can occur in three forms:
- Inherent: Meaning a part of the formula, such as a protein agglomerate
- Extrinsic: A contaminate from the outside environment, like hair or paint
- Intrinsic: Parts related to the process, such as a glass or rubber
The rules are meant to prevent contamination that could cause harm, but there have still been instances when safety precautions fail and particles are found in prescription drugs. In 2012, glass particles were discovered in cancer drugs, according to Natural News. Medications, including four cancer drugs, were recalled by the manufacturer.
Safe Manufacturing Operating Procedures
The U.S. Food and Drug Administration (FDA) has created the Current Good Manufacturing Practice regulations to ensure that pharmaceuticals meet minimum quality standards. There are two aspects of the medicine that must be verified in order for the manufacturer to market the product.
The first is safety. There is no way for a consumer to tell if a drug is safe, simply by tasting, touching or smelling it, so there must be guidelines to determine whether or not a medicine is consumable. The FDA will not only test a small batch of the medicine itself, but also verify that the manufacturing facility and processes are safe and reliable.
The second is efficacy. Another benefit of having controlled regulations on pharmaceuticals is that companies are not allowed to market medicines as FDA approved unless they have been proven effective. Tests and studies must be able to verify that the drug product treats conditions as advertised.
When a company is incompliant with regulations and requirements, serious complications can occur in patients. Whether the medicine causes harmful side effects or fails to be effective in treating the patient’s condition, severe health risks accompany manufacturing neglect.
Dangerous Drug Lawsuits
Consumers around the country are becoming more educated on the dangers that can accompany prescription medicines and are turning to dangerous drug attorneys to seek compensation for damages that have affected their quality of life. Natural News reported that in 2012 alone, fraud settlements for five pharmaceutical manufacturers totaled $5.5 billion in fines.
Furthermore, between 2004 and 2010, major drug companies paid out $7 billion in fines, penalties and lawsuits for allegedly fraudulently marketing their drugs, making misleading claims about the drugs safety and hiding or altering studies which indicated evidence of harm. The Federal Drug Administration and attorneys work together to ensure that drug manufacturers comply with regulated guidelines and protect the public from any possible harm.
Attorneys are alleging serious injuries and other complications in New Jersey dangerous drug lawsuits being filed on behalf of affected patients.
How A New Jersey Dangerous Drug Attorney Can Help
Holding a pharmaceutical company liable for dangerous drugs is a difficult task. These are large corporations, with both the financial and legal resources to fight back against any claims made against them. Yet you needn’t go through this process alone. A New Jersey dangerous drug attorney can provide assistance to you throughout the entirety of your case. He or she could be a valuable resource in helping to determine the extent of harm you were forced to endure, to assess how much is needed to compensate for your injuries, to negotiate with the drug company in an attempt to settle your claim, and to represent your interests at trial if necessary.
Injured Patients May Be Entitled to Compensation
Drug manufacturers have a duty to ensure their products are accompanied by full and accurate instructions and warnings to guide prescribing doctors and other health care providers in making treatment decisions. If a drug maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
Patients who have been injured by dangerous drugs may be entitled to compensation for damages, including:
- Medical expenses
- The permanency of the injury
- Pain, suffering, and mental anguish
- Loss of income or ability to work
If a patient dies from complications after taking a dangerous drug, his or her family members may be able to pursue claims for their loved one’s wrongful death. Compensation may include:
- Pain, suffering, and mental anguish from the loss of a loved one
- Loss of financial support of a loved one
- Funeral expenses
Affected patients are encouraged to speak with a New Jersey dangerous drug attorney to learn more about their rights and remedies.