Defective Drug Pharmaceutical Attorney - Foley & Small

Foley & Small has handled defective pharmaceutical and drug claims in state and federal court and nationwide claims as part of the multi-district litigation claim process. If you or a family member has been injured due to use of a pharmaceutical or drug be sure to contact Foley & Small.

Foley & Small is serving as lead counsel in the State of Indiana in litigation involving the distribution and purchase of contaminated epidural injections manufactured by the New England Compounding Center (NECC). This includes involvement in the bankruptcy proceedings and the multi district litigation (MDL) pending in Massachusetts and the prosecution of claims against the local clinics in Indiana who purchased and administer the injections. Foley & Small has been and is is also involved in MDL proceedings in claims involving Vioxx, Yaz and Yazmin and others.

Below is information on the FDA pharmaceutical approval process and what occurs when a drug is recalled for being found defective.

Legal Background

Modern medicines can save lives and improve the quality of life. While most drugs are safe and effective, some are not. Each year thousands are injured and some die due to a drug that proves defective or is found to have injurious adverse side effects.

Drug manufacturers have an obligation to provide safe and reliable products that work as advertised. Even when they do work, there may be dangerous side effects and other risks that must be disclosed. The law requires that manufacturers disclose known issues about side effects or other risks associated with the use of their drugs.

FDA Drug Approval Process

It takes on average 12 years and purportedly over $350 million to get a new drug from the laboratory onto the pharmacy shelf. Once a company develops a drug, it undergoes approximately three and a half years of laboratory testing, before an application is made to the U.S. Food and Drug Administration (FDA) to begin testing the drug in humans. Only one in 1000 of the compounds that enter laboratory testing will ever make it to human testing.

If the FDA gives the green light, the "investigative" drug will then enter three phases of clinical trials:

  • Phase 1 uses 20-80 healthy volunteers to establish a drug's safety and profile. (about 1 year)
  • Phase 2 employs 100-300 patient volunteers to assess the drug's effectiveness. (about 2 years)
  • Phase 3 involves 1000-3000 patients in clinics and hospitals who are monitored carefully to determine effectiveness and identify adverse reactions. (process takes about 3 years)

The company then submits an application to the FDA for approval, a process that can take up to two and a half years. After final approval, the drug becomes available for physicians to prescribe. At this stage, the drug company will continue to report cases of adverse reactions and other clinical data to the FDA.

Drug Recalls

Where patients suffer injury or death due to taking a drug, such adverse results can result in a drug recall. A manufacturer can voluntarily recall a defective drug. If the FDA gets involved, it can request a recall, which companies usually follow. This is the fastest way to remove a harmful drug from the market.
Under the Federal Food, Drug and Cosmetic Act, the FDA has the power to take the manufacturer to court and force it to comply. The FDA is authorized to sue to achieve the following:

a. Request a formal recall

b. Confiscate the product

c. Request an injunction to stop the manufacturer from making more of the product

Once the FDA requests a prescription drug recall, companies are responsible to ensure the recall is handled successfully. When the recall is completed, the FDA oversees the destruction of the dangerous prescription drug.

The FDA then begins an investigation to see why the prescription drug recall was necessary and to find out what made the prescription drug risky.

Prescription Drug recalls are classified into three types:

  • Class I: Recalls for unsafe or defective products that cause serious health problems or death.
     
  • Class II: Recalls for products that might cause a temporary health problem and have a low risk of creating a serious problem.
     
  • Class III: Recalls for products that violate FDA labeling or manufacturing regulations. Examples include a container defect, wrong color, or odd taste.

Criticism of the FDA and Manipulation by Drug Companies

The FDA currently has regulatory oversight over a large array of products that affect the health and life of American citizens. There are many criticisms and complaints lodged against the FDA from patients, economists, regulatory bodies, and the pharmaceutical industry. A $1.8 million 2006 Institute of Medicine report on pharmaceutical regulation in the U.S. found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA.

Nine FDA scientists appealed to then president-elect George W. Bush over pressure from management to manipulate data, mainly in relation to the review process for medical devices. These concerns were highlighted in the 2006 report on the agency as well.

Injured by a Defective Pharmaceutical Drug?

If you or a loved one has been injured by a defective or recalled drug, you may be entitled to compensation from those responsible for your injury. If a loved one has died, the surviving spouse or other family members may be entitled to bring a wrongful death action against the responsible parties.

Damages can include past and future medical expenses, loss of past and future earnings, pain and suffering, emotional distress, and even punitive damages awarded to punish the responsible parties.

Contact Foley & Small

If you or a family member has suffered adverse effects from using a pharmaceutical that has been recalled or undergone required FDA labeling changes, contact your doctor. You should consult your doctor to learn more about the problems and side effects from use of such drugs.

Foley & Small can help if you or a family member has suffered injury or other adverse effects from the use of such drugs. Please contact us for a free case evaluation and consultation.

Click on the link at the top right of this page for a live chat with a member of our staff or email us from our Contact page. You can also call us at 800-276-2525.
 

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