Defective Drug Pharmaceutical Attorney

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.

Specific information on claims involving Fosamax and Darvocet is contained on separate pages of the Foley & Small website.  Click on the buttons below for access.  Other drugs that are the subject of claims by users for being defective are listed farther below on this page.

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.

Drug List

Some of the drugs involved with recalls or the subject of claims for injury or death due to adverse side effects include:

Accutane. Treatment for acne. Increased occurrence of suicide, birth defects and fetal death. Accutane has also been linked to inflammatory bowel disease and lupus.

Avandia. In May 2007, a New England Journal of Medicine report states that the diabetes drug Avandia may pose risks to the heart. In response, the FDA has issued a health alert to consumers.  The FDA issued a May 21, 2007, alert about safety data from clinical trials that showed a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.  On Wednesday, July 14, 2010, following two days of extensive investigation and discussion, the majority of a federal medical advisory panel recommended that Avandia have sales restricted and additional label warnings added or be completely withdrawn from the market because the drug may increase risks associated with heart attacks.

Fosamax. Produced by Merck, Fosamax is prescribed for osteoporosis. Studies suggest Fosamax increases the risk of osteonecrosis (ONJ), an infection and eventual rotting of the jawbone.  Studies have also been published on the occurence of spontaneous femoral (thigh bone) shaft fractures by those who have taken Fosamax for a number of years. 

Darvocet & Darvon.   Xanodyne Pharmaceuticals, Inc. is cooperating with the FDA in recalling Darvocet and Darvon, their versions of the pain killer propoxyphene. Darvon, which is also sold as Darvocet (with acetaminophen added), can cause serious and potentially fatal heart rhythm abnormalities, according to clinical data reviewed by the FDA. The recall occurrd in November, 2010.

Gadolinium. Gadolinium is a contrast dye used in certain (MRI) and magnetic resonance angiography (MRA) procedures. Gadolinium has been linked to nephrogenic systemic fibrosis/nephrogenic fibrosing dermopathy (NSF/NFD), a disease that can lead to death in patients with kidney disorders, along with liver disorders.

Ketek. Ketek is an antibiotic used for bacterial infections in adults. Ketek has been linked to dozens of cases of severe liver injury, been the subject of a series of increasingly urgent safety warnings, and sparked two Congressional investigations of the FDA's acceptance of fraudulent safety data submitted by its manufacturer, the French pharmaceutical company Sanofi-Aventis, and inappropriate trial methods when it reviewed the drug for approval.

Ortho Evra. Ortho Evra is a hormonal contraceptive skin patch. Ortho Evra releases progestin, a synthetic hormone, and estrogen. On May 8, 2008, the Public Citizen Health Research Group filed a petition on behalf of 80,000 consumers urging the FDA to recall Ortho Evra within six months, pointing to problems with the birth control patch which result in greater variations of estrogen entering the blood stream. On average, the Ortho Evra birth control patch delivers 60% more estrogen than the birth control pill, which could lead to twice the risk of serious blood clots, which can lead to heart attack or stroke.

Paxil. Along with the companies that produce several other antidepressants, Paxil manufacturer SmithKline Beecham was required by the FDA to put a warning on its label about the risk of suicide. Paxil may also increase the risk of birth defects if taken during pregnancy. Serious physical Paxil withdrawal symptoms can include nausea, vomiting, dizziness, sweating, motor system disturbances, fever, chills, tremors, sleep disturbances, gastrointestinal problems, flu-like symptoms, vertigo, and the feeling of "electric zaps" throughout the body. Paxil withdrawal symptoms can also cause serious psychological symptoms such as: confusion, anxiety, irritability, panic attacks, uncontrollable moods, depression, suicidal ideations, and aggressive thoughts and actions.
One of the most serious Paxil withdrawal symptoms is a condition known as akathisia. This condition is marked by extreme agitation and motor restlessness.

Trasylol. Bayer Pharmaceuticals, the manufacturer of the anti-bleeding drug, Trasylol, is facing many lawsuits in the U.S. The FDA ordered sales of Trasylol suspended in the U.S. when a Canadian government study was stopped for ethical reasons because Trasylol was causing too many deaths.
A major 2006 Trasylol study concluded an estimated 22,000 people died from Trasylol use between 2006 and November 2007.

Yaz® and Yasmin®. These are combination birth control pills made by Bayer Healthcare. These are the most widely prescribed birth control pills in the world, with Yaz® alone generating sales of more than $600 million in 2008. There can be serious side effects associated with their use, including heart attack, stroke, kidney damage, pulmonary embolism, deep vein thrombosis, gallbladder disease, and sudden death.

Contact Foley & Small

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