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 K-S:


 

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.


 

Levaquin tendon injuries Stevens-Johnson Syndrome product liability attorneyLevaquin® (fluoroquinolone) Antibiotics

Levaquin is a member of the fluoroquinolone family of antibiotics prescribed to treat bacterial infections of the lungs, urinary tract and skin. Levaquin is sold by Johnson & Johnson and Ortho-McNeil and has been linked to hundreds of cases of serious tendon injuries and tendon ruptures, as well as a serious skin disorder called Stevens-Johnson Syndrome.
In 2008 the FDA required the manufacturers to place a Black Box warning on Levaquin regarding its link to tendon damage and particularly ruptures of the Achilles tendon. But because the companies did not adequately warn patients and their doctors about these potential side effects prior to the FDA order thousands of people have suffered debilitating injuries; in many instances tendon ruptures related to Levaquin have required victims to undergo surgery and many Levaquin users never completely recover from their tendon injuries.

Many other antibiotics cost less and are safer than Levaquin, but Johnson & Johnson and Ortho-McNeil persuaded doctors that Levaquin offered patients some advantage over less-costly alternatives.

All fluoroquinolone antibiotics have been linked to tendon ruptures, but Levaquin is the one most commonly associated with this side effect. By 2008, the FDA's database showed 262 reported cases of tendon ruptures, 259 cases of tendinitis and 274 cases of other tendon disorders associated with these drugs with 61 percent being tied to Levaquin.
Stevens-Johnson Syndrome and toxic epidermal necrosis (TEN) are also associated with Levaquin.
Both of these disorders are often caused by severe drug reactions; in Stevens-Johnson Syndrome a person experiences blistering of mucous membranes and patchy areas of rash, typically in the mouth, eyes, and vagina. TEN is a more severe form of Stevens-Johnson Syndrome in which the entire epidermis peels off in sheets from large areas of the body. The mortality rate for persons suffering with Stevens-Johnson Syndrome is between 25-80%.

Some of the factors that determine a person's likelihood of survival include the severity of the disorder and the amount of skin that the victim looses. Because Stevens-Johnson Syndrome and TEN are so dangerous, Levaquin patients and their caregivers must be aware of their symptoms so they know when to seek medical attention. It is important to seek medical care and discontinue use of Levaquin IMMEDIATELY if these disorders develop.


 

Lexapro product liability attorneyLexapro (Escitalopram Oxalate) ®

Lexapro is an antidepressant medication used to treat the symptoms of depression. It is manufactured by Forest Pharmaceutical and it is a member of a class of medications known as SSRI's, or Selective Serotonin Reuptake Inhibitors. SSRI's all generally work in the same manner in that they help to regulate the chemistry in the brain that can otherwise lead to depressive thoughts and episodes.
Unfortunately, as more people have begun to use Lexapro to treat their depression, reports of side effects have arisen. These alleged Lexapro side effects including the potential for birth defects in children whose mothers used Lexapro and other SSRI drugs during the third trimester of their pregnancies. Specifically, these examples of these Lexapro side effects include PPHN and abdominal, cranial or heart defects. Many Lexapro lawsuits have already been filed around the United States and many Lexapro settlements have already been agreed upon by the parties involved.


 

Lipitor product liability attorneyLipitor (atorvastatin calcium) ®

According to the CDC more than 70 million American adults have high levels of LDL or 'bad' cholesterol. Only one-third of those people have the condition under control, and less than half of those with this health problem even seek treatment.
During the first decade of the 21st century the number of people seeking treatment has increased and one of the leading cholesterol medications in recent years has been Lipitor, manufactured by Pfizer, Inc.

Lipitor was originally approved for use by the FDA in 1996 and since then it has generated more than $125 billion in sales. Before generics and other competitors hit the market, Lipitor was generating approximately $1 billion in revenue every month. Millions of people have depended on Lipitor to help lower their cholesterol levels and minimize their chances of problems associated with high cholesterol, including heart attacks and strokes.
Some of the alleged Lipitor side effects are relatively minor in nature, but one alleged side effect – the tendency for people to develop Type 2 diabetes – is anything but. Type 2 diabetes, ironically, can lead to many of the same dangers as high cholesterol if it is not treated.

Given the prevalence of Lipitor and the potential dangers associated with undiagnosed Type 2 diabetes caused by Lipitor side effects, Pfizer and the FDA publicized changes early in 2012 to the product's label. These changes clearly warned patients of these potential Lipitor side effects and hopefully helped at least some people steer clear of this danger. Unfortunately, many people have not been so lucky, and they now face the prospect of taking on one of the most powerful corporations in the world.

If you have become the victim of personal injury in the state of Texas it is important that you seek advice from a legal professional; you may be entitled to claim compensation if you have suffered physical or mental injury that has stemmed from the use of a defective product, drug or medical device.


 

Plavix product liability attorneyPlavix (Clopidogrel) ®

In recent years medical research has seen enormous breakthroughs in regards to medications available to help prevent heart attacks, strokes and other cardiac events. Many of these medications have provided people with the safety and comfort they needed.

One company to come out with a product designed to protect against cardiac events is Bristol-Myers Squibb. This company formed a partnership with Sanofi-Aventis, a French company, and the two of them collaborated to release a medication known as Plavix. Plavix was designed to protect a patient's heart, and it was highly successful. Over the years, the medication generated several billion dollars in revenue and it was largely seen as a success in terms of its results.

Plavix is generally taken with aspirin to help protect the heart from enduring future cardiac events, and many people who have already suffered a heart attack or stroke use it. But two recent studies have concluded that the use of these two medications together lead to serious risks of permanent, if not life-threatening, harm.

In 2012 The New England Journal of Medicine published a study which concluded that the use of Plavix with aspirin not only failed to protect patients from suffering second heart attacks, but that using these two medications concurrently actually doubled the risk of patients suffering another cardiac event: "Among patients with recent lacunar strokes, the addition of clopidogrel to aspirin did not significantly reduce the risk of recurrent stroke and did significantly increase the risk of bleeding and death. (Funded by the National Institute of Neurological Disorders and Stroke and others; SPS3 ClinicalTrials.gov number, NCT00059306.)"

In addition, The National Institute of Neurological Disorders and Stroke released a study that actually did not even progress to the point where it reached a definitive conclusion, because the study was stopped when it became clear to researchers that subjects who were using Plavix with aspirin faced an increased risk of internal bleeding and even death. "For all stroke therapeutics, there is a need to balance the potential benefits against the risks. The SPS3 findings establish that for lacunar stroke, dual therapy with aspirin and clopidogrel carries significant risk and minimal benefit"
NIH also issued a clinical alert, warning that there was "little likelihood of benefit in favor of aspirin plus clopidogrel for recurrent stroke should the study continue to conclusion."

Lawyers are reviewing potential lawsuits for people who have been injured or died after using Plavix, claiming that the drug-makers "rushed the drug to market and then launched an aggressive marketing campaign touting Plavix as providing greater cardiovascular benefits than aspirin, while being safer and easier on a person's stomach." The lawsuit contends that these claims are false, and the drug-makers knew about the serious side-effects, but they intentionally withheld important safety information. Furthermore, although the drug-makers were warned by the FDA to correct their advertising campaign, they did not comply. These actions misled countless consumers, leading to injury and death.


 

Pradaxa product liability attorneyPradaxa (dabigatran etexilate) ®

Pradaxa was approved by the FDA for use in the United States in October of 2010. By August 2012, more than 3.7 million U.S. patients had filled prescriptions for Pradaxa. In 2011, Boehringer Ingelheim, the German manufacturer of Pradaxa, spent $464 million to promote the drug, and it paid off; in the first quarter of 2012, worldwide sales reached $209 million. The anticoagulant therapy market is estimated to bring in $10 billion a year in the United States alone.

Pradaxa is a blood thinner that is used to help avoid blood clots in people who suffer from health conditions such as atrial fibrillation. Unfortunately, lawyers heard terrible stories from clients including allegations that this medication had led them to suffer from internal bleeding, ulcers and cerebral hemorrhaging. Just two years after its arrival Pradaxa was blamed for more than 500 deaths.

In response to these allegations, Pradaxa attorneys began to file lawsuits against the manufacturer; alleging among other things that the company knew or should have known about the potential for Pradaxa side effects, and that it spent nearly a half-billion dollars in promoting the medication during 2011 alone. One non-profit group alleged that more people died as a result of using Pradaxa than because of any other drug during that year. The drug maker settled more than 4,000 of these claims in May 2014, agreeing to pay $650 million to get rid of all existing multi-district litigations that were created. The company admitted no fault as part of the agreement and in fact pointed out that the benefits of Pradaxa far outweigh the negative side effects. It cited an FDA study of Medicare patients as proof.


 

Prilosec product liability attorneyPrilosec (Omeprazole) ®

Within the past 20 – 25 years several medications have been released onto the market to treat gastroesophageal reflux disease, or GERD. One of the leading medications in this regard is known as Prilosec. People who used Prilosec have generally reported positive results with regards to the medication.

Prilosec is manufactured by Procter & Gamble Pharmaceuticals, although there are now multiple equivalents available on the market. Prilosec is a member of a class of drugs that's known as proton pump inhibitors, which help to block the acid that builds up in the stomach. Minimizing this acid alleviates the painful symptoms that accompany severe cases of heartburn and gastroesophageal reflux disease.

Unfortunately, proton pump inhibitors not only block the excess acid production that leads to the conditions Prilosec is intended to treat, but they also block the absorption of calcium. Calcium is needed to protect bone density, bone strength and overall bone health, and a lack of it in the system can lead to serious risks of bone fractures. In 2010, the FDA began to require the manufacturers of Prilosec and other proton pump inhibitors to publish clear warnings of the dangers associated with these medications on the labels of their containers; while these warnings could help prevent future damage from being done in the future, it does not help those who have already suffered as a result of Prilosec side effects.


 

Propecia product liability attorneyPropecia (finasteride) ®

Millions of men suffer from male pattern baldness and general hair loss, and many try to stop their hair loss and even have hopes of reversing the condition. A multitude of different products and medications have been available to consumers over the generations, and as expected these products produced mixed results.

One more recent medication that has been heavily marketed is Propecia. Unfortunately, serious side effects eventually began to be reported which have led to a serious loss in the enjoyment of life for those who have encountered them.
Propecia is manufactured by Merck, a giants in the pharmaceutical industry. It is available only via prescript io ne. Propecia works by helping a patient lower the amount of a hormone that exists in males known as Dihydrotestosterone, or more commonly known as DHT. DHT generally will reduce the size of hair follicles near the scalp, so reducing the amount of DHT in the system will halt and in some cases reverse the balding process.

Propecia side effects relate to the ability of the men using the product to function sexually. There are several different problems reported, include ding diminished libido, erectile dysfunction, decreased arousal and orgasm difficulties. Worse, it appears that although Merck initially reported small percentages of men affected by these side effects, independent studies that have been done since indicate that the percentages are much higher. One of the developing issues with regards to Propecia side effects involves the duration of these sexual problems. Warnings regarding this product in Europe state that the sexual issues encountered could be permanent, but the warnings issued in the United States state that these problems are reversible.


 

Prozac product liability attorneyProzac (Fluoxetine Hcl) ®

Several medications have come to market in recent years that have helped people suffering from depression to live a better and healthier life. Prozac is one of the longest-standing medications designed to treat depression on the market.

Prozac is manufactured by Eli Lilly & Company, and it was originally approved for use in the United States by the FDA in 1987. Over the past 24 years, millions of people have trusted Prozac to help with their symptoms of depression. Prozac works to regulate the chemical processes in the brain so that the patient can minimize his or her depressive symptoms.

More than 50 million people have used Prozac around the world since it was approved for use, and reports of serious Prozac side effects have included suicide and Primary Pulmonary Hypertension (PPHN). Despite being one of the few antidepressants that has been deemed as safe for use by children, younger people who have used Prozac have shown a propensity to be more at risk for suicide. Eventually, the FDA required Eli Lilly & Company to include a warning on all containers of Prozac to alert consumers of this heightened risk.
PPHN is an otherwise rare disease that attacks a patient's lungs and respiratory system. PPHN was discovered as a potential Prozac side effect of infants whose mothers had used Prozac during the third trimester of their pregnancies. PPHN is a serious disease that can lead to respiratory and heart failure and in many cases death.

These Prozac side effects came to light before additional information was released and discovered. There have been allegations that Eli Lilly & Company were aware of the potential for these side effects as early as 1988, but that the company did not share this information with the public.


 

Risperdal product liability attorneyRisperdal (Risperidone) ®

Since mental conditions such as schizophrenia, bipolar disorder and autism have been discovered to involve problems with the chemistry in the brain, years of specialized research has led to the formulation of medications designed to treat them. One of the primary medications used in their treatment is Risperdal, manufactured by Johnson & Johnson.

According to reports, Risperdol generated as much as $4.5 billion of revenue in a single year before its patent protection expired. Attorneys investigating personal injury claims soon began to discover that Johnson & Johnson was also marketing the drug for off-label purposes, and these off-label uses allegedly led to more people suffering from Risperdal side effects. Eventually, in 2013, Johnson & Johnson agreed to pay a total of $2.2 billion to settle charges being pursued by 45 different jurisdictions and the federal government that it was illegally marketing this medication for off-label purposes. Risperdal side effects may include:

  • Diabetes
  • Seizures
  • Cognitive impairment
  • Gynecomastia
  • Breast cancer
  • Pituitary gland tumors
  • Hyperglycemia
  • Hyperprolactinemia
  • Sudden changes in blood pressure

Attorneys learned that the drug was allegedly being marketed for use with such conditions as anxiety and dementia, and that sale representatives were allegedly encouraged to employ aggressive sales tactics in order to move into these new uses. This was allegedly done despite the fact that the risks for Risperdal side effects were rapidly becoming known in both the medical and legal communities.


 

New England Compounding Center (NECC) steroid injections meningitis outbreak  product liability attorneyContaminated Steroids (methylprednisolone acetate )

Beginning on May 21, 2012 the Massachusetts-based New England Compounding Center (NECC) sent three lots of preservative-free methylprednisolone acetate to medical facilities across the country, much of which seems to have been used as epidural steroid injections for treating pain. These steroid injections were found to be contaminated with a fungus which has caused a multi state meningitis outbreak.
Preliminary data based on MRI findings in Michigan, Tennessee and North Carolina have provided additional evidence that a substantial proportion of patients have developed localized infections including epidural abscess, phlegmon, arachnoiditis, discitis, or vertebral osteomyelitis following exposure to contaminated injections from NECC. These conditions are serious disorders that require prompt medical attention. CDC and public health officials are referring any patients who have symptoms that suggest possible infections to their physicians, who can evaluate them further.

Fungal meningitis outbreaks from these contaminated steroid injections has been documented in at least 20 states, infecting 750 people and killing 64 people as of September 2013. The CDC continues to receive reports of patients presenting with paraspinal/spinal infections with and without evidence of fungal meningitis.

It is believed that contaminated methlprednisone steroid injections were sent to 75 clinics in 30 states. In the wake of the outbreak, the pharmacy issued a voluntary recall for the tainted steroids and surrendered its license. According to the CDC, states that received the tainted steroids include: California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Texas, and West Virginia.
In Texas the contaminated steroids are known to have been shipped to Dallas Back Pain Management in Dallas, TX. and Harris Methodist Southlake Center in Southlake, TX.

Meningitis involves inflammation of the meninges, membranes that cover and protect the spinal cord and brain. Fungal meningitis is an infection from a fungus which has either traveled through the bloodstream or been introduced directly into the central nervous system, as is the case with epidural steroid injections into the spinal column.

If you have received a steroid injection and experienced any combination of symptoms including fever, headaches, nausea, neck stiffness, dizziness, confusion and sensitivity to bright lights within one or two weeks after the injection, see your doctor right away.

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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