There are more product liability lawsuits filed against prescription drug manufacturers than against all other industries combined. Under strict product liability laws, drug manufacturers may be held liable for ANY serious injuries or deaths caused by their products regardless of the care they took to prevent defects.

Hazardous waste presents serious problems not only to humans but to the environment as well. Environmental law matters are particularly complex, not only due to the maze of federal, state and local laws involved but also because these laws are often highly technical in nature.

Brent Cordell

Attorney at Law

Board Certified Specialist in Personal Injury Trial Law

1 844 - 8LEGAL8 (1 844 853-4258)

Recalled Drugs D-J:


 

PLEASE NOTE: This is not a comprehensive list of FDA drug recalls. For current information on drugs recalled by the U.S. Food and Drug Administration visit FDA.gov.

A drug is considered "defective" in cases when its potential risks or side effects are determined to outweigh its intended benefits, or when the manufacturer fails to provide adequate warning of the risks. In many of these cases the plaintiffs allege that manufacturer was aware of the dangers posed by the product but deliberately chose to conceal that information from consumers.

All pharmaceutical drugs introduced to the U.S. market must be pre approved by the Food and Drug Administration (FDA). Drug manufacturers are required to adequately test each product before seeking FDA approval, and their labels must properly disclose all information involving potential side effects in order to reduce the risks of misuse and adverse events. However, drug manufacturers can and do minimize or conceal adverse side effects to facilitate this approval process. Furthermore, the FDA lacks the time or resources to perform rigorous follow-up research and screening of the product.

In cases where a significant number of serious injuries or deaths are discovered to be related to a drug, the FDA will normally launch an investigation to determine if the drug is actually defective. In severe cases the FDA will issue a Drug Recall and pull the drug from circulation. But in other cases additional warnings may simply be required and the drug may continue to be marketed to consumers.


 

Depakote product liability attorneyDepakote® (divalproex sodium)

Depakote is an anticonvulsant medication which helps people avoid seizures and other problems that affect the brain. Specifically, Depakote has been prescribed to help people deal with manic episodes associated with bipolar disorder and with the symptoms of migraine headaches. For more than 30 years, Depakote has been one of the leading anticonvulsant medications available on the prescription market.

Depakote is manufactured by Abbott Laboratories. It was originally approved for use in the United States in 1983,and despite many years of allegations of side effects that include birth defects, the medication remains on the market. Some problems have resulted from the use of this medication in its intended purpose, while other Depakote side effects allegedly arose after consumers had been given Depakote for 'off-label' or unapproved uses.
The danger appears to be particularly high for children whose mothers used Depakote during the first trimester of pregnancy. Specifically, using this drug during the early stages of pregnancy can lead to a malformation of the neural tube, which ultimately develops into the brain and spinal cord. When a neural tube defect occurs the resulting birth defects can be devastating and include:

  • Spina bifida – A lifelong condition that can lead to the inability to walk and other problems
  • Anencephaly – A failure of the brain to develop that often leads to stillbirth or death shortly after birth
  • Heart malformations – Heart malformations can also lead to fetal death
  • Cleft palate – An opening at the top of the throat that requires surgical correction

The FDA has required Abbott Laboratories to place warnings on the labels of Depakote several times over the years in response to these alleged birth defects.


 

Digitek digoxin product liability attorney Digitek® (digoxin)

DIGITEK (digoxin) is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term "digitalis" is used to designate the whole group of glycosides. The glycosides are composed of two portions: a sugar and a cardenolide (hence "glycosides"). Digitek is also known as Cardoxin, Digitek, Lanoxicaps or Lanoxin.

All Digitek digoxin tablets on the U.S. market were recalled by their manufacturer, Actavis, in late April 2008. According to the Food and Drug Administration, a manufacturing mistake led to some of the Digitek digoxin tablets being made with twice the intended level of the active ingredient, digoxin (digitalis). The double dose of digoxin in the tablets is toxic. Digitalis is a very powerful chemical; even its source, the flowering plant foxglove (Digitalis purpurea), is poisonous. Digitek digoxin tablets are a prescription-only treatment for heart conditions such as irregular heart beat and heart failure. Although the generic drug digoxin is sold by various pharmaceutical companies under different names (such as Lanoxin and Digitek) and in various forms (tablet, elixir, liquid-filled capsules, intravenous injection), it is only the Digitek digoxin tablets that were recalled. All lots and all dosage strengths of the Digitek digoxin tables were recalled. The nationwide Digitek recall was of the Digitek tablets distributed by UDL Laboratories under the label "UDL" and Mylan Pharmaceuticals under the label "Bertek." If you as a patient have been prescribed either of these brands of Digitek digoxin tablets, contact your physician immediately.

If you took Digitek, Cardoxin, Lanoxin or Lanoxicaps and suffered from overdose, it could be due to taking defective tablets containing twice the active ingredient as approved.

Symptoms of digoxin overdose may include any of the following: nausea, vomiting, decreased appetite, diarrhea, confusion, seizures, hallucinations, light "halos" around objects, green or yellow vision, fatigue, irregular heartbeats, and abnormally fast or slow heartbeats.


 

Duragesic  product liability attorneyDURAGESIC® (fentanyl transdermal system)

The Duragesic patch is indicated for the management of severe, chronic pain (such as cancer pain) that cannot be managed with less powerful drugs. Only patients who are already tolerant to opioid therapy and require continuous opioid administration should use the patch. Approved by the U.S. Food and Drug Administration (FDA) in 1990, Duragesic releases fentanyl, a strong opioid, through the skin at a fixed rate for 72 hours. The patch is made by Janssen Pharmaceutical and available by prescription only.

In February 2004, Janssen and the FDA notified healthcare professionals of a Class I recall of DURAGESIC 75 mcg/h. Only Control Number 0327192 (expiration October 2005) is subject to this recall. A potential seal breach on one edge may allow the drug to leak from the patch and could result in an increased absorption of the opioid component, fentanyl, leading to increased drug effect, including nausea, sedation, drowsiness, or potentially life threatening complications. Over 400,000 patches were included in the recall. In April 2004, Janssen expanded the Duragesic patch recall to include a total of 2.2 million patches. Health officials believe that over 20 percent of the recalled patches are still in use.

In July 2005, the FDA issued a Public Health Advisory regarding the safe use of transdermal fentanyl patches in response to reports of deaths in patients using this potent narcotic medication for pain management. The FDA is conducting an investigation into the deaths associated with these patches. The Agency has been examining the circumstances of product use to determine if the reported adverse events may be related to inappropriate use of the patch or factors related to the quality of the product. It is possible that some patients and their health care providers may not be completely aware of the dangers of these potent narcotic drug products and the important recommendations regarding their safe use.

On June 19, 2007, a $5.5 million jury verdict was awarded in a US case against Johnson & Johnson subsidiaries, Alza Corporation and Janssen Pharmaceutical Products, the manufacturers of the Duragesic fentanyl transdermal pain patch. This case, the first Federal trial involving the Duragesic fentanyl patch, was tried in the Federal District Court for the Southern District of Florida, West Palm Beach Division.

In February 2011, the manufacturer suspended production of all Duragesic patches due to quality control issues involving unspecified "microscopic crystallization" detected during the manufacturing process of the 100 µg/h strength. According to the Ortho-McNeil-Janssen Pharmaceuticals Scientific Affairs Public Information Center (800-526-7736) the issues were resolved and existing stocks were released for shipment beginning mid-April for the 25 & 50 µg/hr strengths. The remaining strengths are scheduled to resume distribution in late April. Widespread rumors circulating about the manufacturer discontinuing this product line are completely false. 100 µg patches have also returned to the market, along with many other doses/preparations of Fentanyl, however it is not known whether the aforementioned 100 µg patches are actually Duragesic products, or simply a generic alternative.

In its June 6th, 2012 enforcement report the US FDA announced that J&J recalled more than 53,000 Duragesic (Fentanyl Transdermal System) patches because of crystallization. The FDA announcement mentioned as reason for the recall that one lot of Duragesic 25 mcg/h (fentanyl transdermal system) exhibited white spots, which were determined to be small fentanyl crystals.
On January 3rd, 2012, a California man, Jose Campuzano filed a lawsuit (case no 120100086) at the Philadelphia Court of Common Pleas alleging that his wife, Charlene Manzo, died as a result of using a Fentanyl pain patch.


 

Effexor product liability attorneyEffexor® (venlafaxine HCl)

Successful management of depression can make all the difference in someone's life, and a leading medication in the treatment of depression is known as Effexor. Effexor is manufactured by Wyeth Pharmaceuticals, now owned by Pfizer -one of the largest pharmaceutical companies in the world.
Effexor is an antidepressant medication known as SNRI's, or Serotonin Norepinephrine Reuptake Inhibitors. SNRI's work by helping a patient's brain regulate and balance norepinephrine and serotonin. When these substances fall out of balance, they can create problems with the brain's functions and lead to conditions such as depression.

Side effects have appeared in the form of severe birth defects in infants whose mothers had used this medication while they were pregnant. Common examples of serious Effexor birth defects include:

  • Heart defects
  • PPHN
  • Neural tube defects
  • Skull malformations
  • Abdominal defects
  • Club foot
  • Cleft lip and/or palate
  • Spina bifida

Any or all of these Effexor birth defects can be extremely debilitating in severity, and some of them have led to the death of the child.


 

Fentora product liability attorney.Fentora®(Fentanyl Buccal Tablets )

FDA states that most recent adverse events and deaths associated with use of Fentora were caused by improper patient selection, incorrect dosing, and inappropriate substitution of Fentora for other pain medications. Fentora is intended only for treatment of "breakthrough pain" in cancer patients, meaning intense increases in pain that occur with rapid onset.

Cephalon, Inc., in collaboration with the U.S. Food and Drug Administration (FDA), has issued a letter in response to recently reported serious adverse events, including some deaths in patients who were not appropriate candidates for FENTORA. These events appear to have occurred as a result of improper use in patients who were not already taking opioids around-the-clock (opioid non tolerant); improper dosing of the medication; and/or improper substitution of FENTORA for other fentanyl-based medications.

FENTORA is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. FENTORA must only be prescribed to patients who are routinely taking around-the-clock opioids. FENTORA should not be prescribed to patients for acute pain, postoperative pain, headache/migraine, or sports injuries. Only one tablet per episode should be taken once a dose is established and patients must wait at least four hours before taking another dose of FENTORA.

FENTORA contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. FENTORA can be abused in a manner similar to other opioid agonists, legal or illicit.

Because life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients, FENTORA is contraindicated in the management of acute or postoperative pain. This product is not indicated for use in opioid non tolerant patients.


 

Bisphosphonates Fosamax product liability attorneyFosamax® (Bisphosphonate)

Bisphosphonates including Fosamax, Actonel, Boniva, Didronel, Aredia, Bonefos, Zometa, and Skelid are intended to fight bone loss from diseases such as osteoporosis. However, it has recently been discovered that these drugs may actually cause bones to break. Further, research suggests that the types of breaks allegedly caused by taking drugs like Fosamax may be worse than the fractures patients were trying to prevent by using the drug.

Numerous studies have shown bisphosphonate drugs to be associated with atypical thigh fractures during normal activity. Bisphosphonates have also been linked to a disfiguring jaw disease and musculoskeletal pain. Bisphosphonate side effects can include femur fractures, osteonecrosis of the jaw/ Dead Jaw Syndrome, esophageal cancer, atrial fibrillation and severe musculoskeletal pain.
Several lawsuits have been filed over femur fractures allegedly caused by drugs such as Fosamax; in 2010, the FDA updated the safety label on Fosamax and other bisphosphonate drugs to warn that they can increase the risk of atypical femur fractures; long-term use of Fosamax, Fosamax plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and Reclast have been linked to subtrochanteric and diaphyseal femur fractures.

In May 2012 the FDA also published a review in the New England Journal of Medicine stating there is little evidence to support use of bisphosphonates for periods longer than five years. Another study in Archives of Internal Medicine in June 2012 compared atypical femur fractures to "classic" fractures and found that 82 percent of the patients with atypical fractures had taken a bisphosphonate drug. This data strongly suggests that instead of preventing bone breaks bisphosphonate medications seem to be causing them. Studies have also found that more than half of the patients experienced groin or thigh pain for a period of weeks or months before their fractures.

Bisphosphonates' Other Side Effects Include Osteonecrosis of the Jaw, an excruciatingly painful and disfiguring bone disease in which the jaw's bone tissue fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. This can eventually lead to infection and fracture, and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. An increased incidence of ONJ has been associated with the use of high dosages of bisphosphonates required by some cancer treatment regimens as well as post-menopausal women taking the drugs for osteoporosis.

In September 2010, a study published in the British Medical Journal raised questions about a possible link between long-term use of bisphosphonates and cancer of the esophagus. The FDA reported that there had been 23 cases of the cancer in Fosamax users in the U.S. between 1995 and 2008; 31 additional cases of the cancer were reported among bisphosphonate users in Europe and Japan. Since 2008 several more cases of esophageal cancer associated with bisphosphonate use have been reported to the FDA.

In 2008, a study conducted by researchers at the University of Washington found that treatment with Fosamax could double the risk of atrial fibrillation in women who had taken the drug. In 2007 the New England Journal of Medicine also found that bisphosphonates appeared to increase the risk of irregular heartbeats in some older women.

In January 2008, the FDA warned that use of bisphosphonates had been linked to severe and sometimes incapacitating bone, joint, and muscle (musculoskeletal) pain. The agency said that the severe musculoskeletal pain associated with bisphosphonates may occur within days, months, or years after starting a bisphosphonate and recommended that healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug.


 

Granuflo/ NaturaLyte product liability attorneyGranuflo/ NaturaLyte ®

Granuflo and NaturaLyte are chemical products used in dialysis machines to help clean the blood of patients with kidney impairment. These ingredients are intended to prevent the buildup of dangerous acids that are naturally removed in people whose kidneys function normally. Recent information has come to light, however, that these products may also increase patients' risk of having heart attack or other serious cardiovascular problems.
Fresenius Medical Care, the maker of Granuflo and NaturaLyte, is one of the largest dialysis product manufacturers in the world. Fresenius owns a majority share in the multiple billion dollar dialysis market and operates dozens of dialysis centers across the country, providing dialysis for over 100,000 people in the US alone.

On March 29, 2012, the U.S. Food and Drug Administration (FDA) issued a recall of GranuFlo and NaturaLyte, stating that the use of these products can result in dangerously high levels of bicarbonate, which can cause metabolic alkalosis – a condition associated with low blood pressure, cardiac arrhythmia, heart attack, cardiac arrest, and other cardiovascular problems. It is unclear how many dialysis patients have been injured as a result of Fresenius's failure to warn of the risks associated with their dialysis products. Although Fresenius Medical Care voluntarily changed the labels on its NaturaLyte and GranuFlo products, the GranuFlo recall did not involve removal of the products from the market.

GranuFlo and NaturaLyte are still being used in dialysis clinics. Fresenius has even applied to the FDA for approval a new dialysis solution that does not contain the substance linked to cardiovascular injury. GranuFlo was an extremely prevalent product, as estimates indicate that as many as 125,000 people have used it in a given year, and by using it that means people allow it into their bodies regularly. As such, the possibility of suffering from GranuFlo side effects was quite high.
If you have undergone kidney dialysis and you have suffered heart problems, you should check to see if GranuFlo or NaturaLyte was part of your protocol.


 

Incivek product liability attorneyIncivek (Telaprevir) ®

Some of the most dangerous diseases we face are those that do not lead to any outward symptoms. One such disease is Hepatitis C, commonly known as HCV. Hepatitis C is contracted when someone comes into contact with contaminated blood, usually through a contaminated blood transfusion or by sharing or otherwise using contaminated needles. HCV attacks the liver of a person and may eventually lead to liver failure, but it can take decades to discover because of its lack of symptoms.


Incivek is produced by a Massachusetts drug company known as Vertex Pharmaceuticals, Inc. and was approved for use by the FDA in May of 2011. It is given in pill form and it is always used with two other medications known as peginterferon alfa and ribavirin. These medications combine to work by preventing the replication of the virus in the body, thereby limiting any damage done to the liver.

In December of 2012 the FDA issued a public health alert and ordered a Black Box Warning to be affixed to all containers of Incivek that warned people of the potential for side effects when taken in conjunction with peginterferon alfa and ribavirin. There is growing evidence that using these drugs simultaneously can lead to severe skin reactions known as toxic epidermal necrolysis (TEN) and drug rash with eosinophilia and systemic symptoms, or DRESS. These skin reactions can cause severe damage and they can even be fatal in some circumstances.

If you have used these medications to treat hepatitis C and you are experiencing severe rash featuring bumps, rash that persists for more than three days, mouth sores swelling of the face, diarrhea, nausea or fever seek immediate medical attention.


 

Januvia product liability attorneyJanuvia (sitagliptin phosphate) ®

Januvia is currently one of the 15 highest-selling pharmaceutical medications for the treatment of Type II Diabetes in the United States.

Januvia belongs to a class of drugs that work by slowing down the metabolism of naturally-occurring hormones known as incretins - specifically Glucagon-Like Peptide-1 (GLP-1). Typically, diabetics do not produce enough of these hormones on their own, and drugs such as Januvia allow these hormones to stay active in the bloodstream longer to reduce blood sugar levels. In doing so, Januvia will increase the patient's GLP-1 receptor activity. It has been theorized, however, that this increased activity may put the user at a greater risk of developing pancreatic cancer.

Various academic and post-marketing studies have established a possible link between Januvia (sitagliptin) and pancreatic cancer. This link is particularly troubling because pancreatic cancer is one of the most lethal malignant diseases, due to the high rate of advanced stage disease at the time of diagnosis and the lack of effective medical therapies.
In 2009 the FDA reviewed 88 cases of acute pancreatitis reported to the agency's adverse event reporting system between late 2006 and early 2009. According to the reports, 58 patients required hospitalization, four of whom ended up in the intensive care unit. The FDA announced that it was recommending its revisions to alert the medical community to "this potentially serious adverse drug event."

In 2011 the FDA threatened repercussions for Merck & Co. after the company neglected to complete a required animal study concerning the pancreatitis risk associated with Januvia (sitagliptin) after Merck's initial design proposal was rejected as inadequate. Merck then reportedly submitted results of an independent study, which the FDA did not accept. The FDA then demanded that Merck submit a new proposal and begin the study within six months: results of that study have yet to be released.
By 2013 the FDA had announced that it would be reviewing new research suggesting an increased risk of pre-cancerous cell chances and pancreatitis in Type 2 diabetes patients using Januvia, Byetta and similar diabetes drugs. According to the agency, these findings were "based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes."

Personal Injury lawyers around the United States have represented clients who had suffered severe and permanent damage as a result of using this medication. Januvia attorneys have also represented families who suddenly found themselves grieving the loss of a loved one who simply started using a new diabetes medication. These situations are only made worse when those consumers realized that they were dealing with a multi-billion-dollar corporation that was not going to make it easy for them to recover compensation.

Under strict product liability laws, drug manufacturers may be held liable for ANY serious injuries or deaths caused by their products regardless of the care they took to prevent defects.

 

Drug related product liability claims fall under three basic headings:

  • Defectively manufactured pharmaceutical drugs claims involve injuries caused by drugs that have been improperly manufactured or have become contaminated in the manufacturing process. This may occur at the manufacturing facility, during shipping, through a compounding pharmacy or at any point between the manufacturing facility and the location where you actually receive the drug.
  • Pharmaceutical drugs with dangerous side effects claims involve drugs that may be properly manufactured but still have side effects which result in injury. These cases often involve drugs that have been on the market for a long time before research shows that they increase risks of injury. In some cases victims may claim punitive damages if they can show that a manufacturer knew of the danger but deliberately concealed it.
  • Improperly marketed pharmaceutical drugs. The "marketing" of a pharmaceutical drug refers to the warnings, instructions, or recommendations concerning the use of that drug. This category often involves injuries caused by a failure to provide adequate or accurate warnings regarding a dangerous side effect or a failure to provide adequate instructions regarding the safe and appropriate use of the drug. The "bad advice" may have been given by the manufacturer or by a doctor, pharmacist, sales rep, or some other medical provider.

A defective product lawsuit may include a combination of these claims; i.e., claims based on a drug with a dangerous side effect may be coupled with a claim based on the failure to warn of that side effect.

If you believe that you or a loved one has suffered serious personal injury from a defective drug, you may be eligible to seek compensation for your medical expenses, pain and suffering, loss of income, diminished earning capacity and more. Under product liability laws the manufacturer, distributor and seller can all be held liable for your injuries.

 

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