Category Archives: Drug Defect Lawsuits

News and Information for Drug Defect Lawsuits

Eli Lilly, Endo Pharmaceuticals Reach Tentative Testosterone Settlements to Resolve Axiron, Testim Lawsuits

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Eli Lilly and Endo Pharmaceuticals have reached tentative agreements to settle hundreds of testosterone lawsuits involving Axiron, Testim and other male hormone replacement treatments.

Testim and Axiron Lawsuits Stayed Pending Testosterone Settlement Talks

The claims, which are among more than 6,000 testosterone lawsuits centralized before U.S. District Judge Matthew Kennelly in the Northern District of Illinois, where filed on behalf of men who suffered heart attacks, strokes, and blood clots (including deep vein thrombosis and pulmonary embolism) allegedly due to the side effects associated with prescription testosterone replacement therapy.

The proposed Axiron settlement was disclosed in December. While no details of the agreement have been made public, the Court has stayed all proceedings involving Axiron cases until March 31st to facilitate settlement discussions.

The tentative agreement to resolve Testim lawsuits and other claims involving Endo Pharmaceutical’s testosterone products was announced in February. The proposed settlement would also cover claims pending against Endo’s Auxilium subsidiary and GlaxoSmithKline, which co-promoted Testim from 2012 through 2015. In addition to Testim, Endo’s other testosterone replacement drugs include Foresta, Testopel, and Striant.

All testosterone lawsuits involving the Endo defendants have been stayed for 45 days while the parties work to finalize the settlement agreement.

While terms of the proposed Endo testosterone settlement remain confidential, the company recently announced that it had increased its legal reserves by $200 million, in part due to the proposed agreement.

Testosterone-Induced Heart Complications

Prescription testosterone products include:

· Androderm
· AndroGel
· Axiron
· Bio-T-Gel
· Fortesta
· Striant
· Testim
· Testopel

Millions of men have been prescribed these drugs to relieve symptoms associated with age-related drops in testosterone, including low libido, weight gain, fatigue and reduced muscle mass. However, the medications have never been approved for this purpose, and are only indicated to treat men who have been diagnosed with hypogonadism (low testosterone) secondary to another medical condition.

Plaintiffs who have filed testosterone lawsuits claim that sales of AndroGel, Testim and other drugs in this class were driven by misleading advertisements that characterized prescription testosterone replacement therapy as a safe and effective remedy for age-related symptoms. They further claim that the drugs’ manufacturers concealed their association with serious cardiovascular problems and failed to adequately warn doctors and patients about their possible heart risks.

In March 2015, the U.S. Food & Drug Administration (FDA) required all testosterone drug manufacturers to update their product labels with information about a possible increased risk of heart attack and stroke. The mandate followed the agency’s review of several studies, including one that linked testosterone replacement therapy to a 40% increased risk for heart attack, stroke or death. In men aged 65 and older, the risk more than doubled within the first 90 days of treatment. The risk almost tripled in men under 65 who had a history of heart disease.

Contact an Attorney Today

Gilman Law LLP is aggressively investigating testosterone lawsuits involving heart attacks, strokes and blood clots. For a no-obligation evaluation of your case, or to learn if you might qualify to participate in a potential testosterone settlement, please fill out our free consultation form or call us direct to speak with one of our attorneys at (888) 252-0048

AZOR ALERT

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Class Action Lawsuit Filed Alleging Azor Causes Serious Gastrointestinal Problems

Plaintiff alleges Azor, used to treat high blood pressure, caused sprue-like enteropathy including severe diarrhea, weight loss and malnutrition.

If you or a family member has used Azor and have been injured, you may be entitled to compensation.

DON’T DELAY – CALL US 888-252-0048 OR COMPLETE AND RETURN THE CLAIM FORM
AZOR ALERT

AZOR ALERT

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  • Our clients have received millions of dollars in lawsuits involving defective drugs.
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About Azor

Azor (olmesartan/amlopidine) is a combination of the drugs Benicar and Norvasc and is used to treat high blood pressure. Azor is manufactured by Daiichi Sankyo, Inc. and was approved by the FDA in 2007 for the treatment of high blood pressure. In 2013, the FDA issued a warning that Azor, and other drugs that contain olmesartan, may increase the risk of sprue-like enteropathy.

In 2014, a complaint was filed against Daiichi Sankyo, Inc. in the United States District Court for the Eastern District of Louisiana. The plaintiff alleges Azor caused him to develop sprue-like enteropathy which included severe diarrhea with substantial weight loss and malnutrition. Plaintiff claims the company failed to adequately research the possible side effects of Azor or warn the public of the risks associated with the drug.

SECONDARY EXPPOSURE TO ANDROGEL ALERT

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Secondary Exposure to AndroGel Can Cause Various Irregularities in Women and Children

Black-Box Warning Issued By the FDA for Secondary Exposure to AngroGel in Women and Children

If you or a family member has experienced secondary exposure to AndroGel and have been injured, you may be entitled to compensation.

DON’T DELAY – CALL US 888-252-0048 OR COMPLETE AND RETURN THE CLAIM FORM
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About Secondary Exposure to AndroGel

AndroGel is used to treat low testosterone (“Low T”) and is prescribed as a testosterone-replacement drug, mostly to men who cannot produce enough amounts of the male hormone. It is a synthetic hormone in gel form that is absorbed through the skin and increases the total amount of testosterone in the body to a normal range.

AndroGel contains a Black-Box warning for secondary exposure to women and children. This warning states that women and children should avoid contact with any unwashed application sites or unwashed clothing of men using the drug. Women and children may show symptoms of secondary exposure to AndroGel including:

  • Enlargement of genitals
  • Early development of pubic hair in children
  • Increased erections
  • Increased libido
  • Aggressive behavior
  • Advanced bone age in children
  • Increased acne and body hair in women

JANUVIA, BYETTA, JANUMET AND VICTOZA ALERT

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Class Action Lawsuits Filed Against the Makers of the Diabetes Drugs Januvia, Byetta, Janument and Victoza Claiming They Cause Serious Side Effects Such as Pancreatitis and Pancreatic Cancer

According to class action lawsuits filed nationwide against Merck, Amylin, Eli Lilly, Bristol-Myers Squibb and Novo Nordisk A/S, the makers of the diabetes drugs Januvia, Byetta, Janument and Victoza, the companies marketed these medicines as safe knowing they were dangerous and failed to warn the public of the increased risks of pancreatic cancer and pancreatitis.

If you or a family member has taken Januvia, Byetta, Janumet and/or Victoza and have been injured, you may be entitled to compensation.

DON’T DELAY – CALL US 888-252-0048 OR COMPLETE AND RETURN THE CLAIM FORM
  • Our firm is vigorously pursuing this matter.
  • Our clients have received millions of dollars in lawsuits involving defective drugs.
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CONTACT US NOW! Do Not Delay As The Applicable Statute Of Limitations May Result In A Complete Bar To Your Claim Regardless Of Its Merit.

About Januvia, Janument, Byetta and Victoza

Januvia, Byetta, Janumet and Victoza are prescription drugs used to treat Type 2 diabetes. Merek is the maker of Januvia and Janument. Byetta is manufactured Amylin, Eli Lilly and Bristol-Myers Squibb. Victoza is manufactured by Novo Nordisk A/S. The FDA approved the use of Byetta, Januvia, Janument and Victoza in 2005, 2006, 2007 and 2010, respectively. All of these drugs are classified as incretin mimetics. The FDA has issued warnings stating these drugs can cause serious medical problems such as pancreatic diseases.

Plaintiffs in class action lawsuits filed nationwide against the makers of these drugs have claimed they developed pancreatitis and pancreatic cancer due to the use of the drugs. Plaintiffs also allege the drugmakers knew or should have known about the dangerous side effects, failed to test the drugs adequately and monitor the side effects and failed to warn the public of the increased risks of developing pancreatic diseases and cancer.

XOLAIR SIDE EFFECTS ALERT

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Xolair Can Increase the Risk of Severe Heart Problems, Brain and Blood Vessel Problems and Cancer

According to class action lawsuits filed against Genentech and Novartis, the makers and marketers of Xolair, the companies knew of the serious risks of the medication but failed to warn the public.

If you or a family member has taken Xolair and have been injured, you may be entitled to compensation.

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XOLAIR SIDE EFFECTS ALERT

XOLAIR SIDE EFFECTS ALERT

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About Xolair

Xolair (omalizumab) was approved by the FDA in 2003 to treat patients 12 years and older with moderate to severe asthma caused by allergens also called allergic asthma. Xolair is an injection which helps reduce the number of asthma attacks for those who are still suffering from asthma symptoms even though they are taking inhaled steroids. Xolair is also approved for use with those who suffer from chronic hives and are not helped by taking H1 antihistamine treatments.

The possible side effects of Xolair include:

  • Heart attack
  • Mini-strokes
  • Transient ischemic attacks (TIAs)
  • Chest pain
  • Pulmonary hypertension
  • Blood clots in lungs and veins
  • Cancer

In 2009, the FDA required the makers of Xolair, Grenentech, Inc., to perform a 5-year study regarding the safety of the drug. Due to the data from this study, the FDA ruled in September 2014 that new warnings on Xolair package inserts and prescribing information need to be added detailing the risks of serious complications caused by the drug’s side effects. During the same time, the FDA issued a drug safety warning that Xolair’s side effects can cause the serious complications listed above. The new safety warnings join a black box warning added in 2007 regarding the risk of severe and life threatening allergic reaction called anaphylaxis.

TRIBENZOR ALERT

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Tribenzor May Lead to Kidney Failure and Cause Serious Gastrointestinal Problems

Studies show Tribenzor, used to treat high blood pressure, may lead to kidney failure and/or sprue-like enteropathy including severe diarrhea, weight loss and malnutrition.

If you or a family member has used Tribenzor and have been injured, you may be entitled to compensation.

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TRIBENZOR ALERT

TRIBENZOR ALERT

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About Tribenzor

Tribenzor, made by Daiichi Sankyo, Inc., was approved by the FDA in 2010 to treat high blood pressure. The drug is an angiotensin II receptor blocker that lowers blood pressure by relaxing the blood vessels and eliminating some of the salt and water in the bloodstream. Studies show that, Tribenzor, which contains olmesartan, can cause sprue-like enteropathy which causes severe diarrhea and severe weight loss. Tribenzor can also cause muscle damage that can lead to kidney failure. In 2013, the FDA issued a warning that Tribenzor, and other drugs that contain olmesartan, may increase the risk of sprue-like enteropathy.

DILANTIN ALERT

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Dilantin Can Cause Stevens Johnson Syndrome and Toxic Necrolysis Syndrome, Potentially Deadly Skin Diseases

According to class action lawsuits filed against Pfizer, the makers of Dilantin, the drugs have caused severe skin diseases caused by and allergic reaction.

If you or a family member has taken Dilantin and have been injured, you may be entitled to compensation.

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DILANTIN ALERT

DILANTIN ALERT

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About Dilantin

Dilantin (generic: phenytoin) is a commonly prescribed medication used to treat epilepsy and seizures. Dilantin was approved by the FDA in 2001. Since then there have been numerous reports of severe side effects affecting the skin. A major side effect is Stevens Johnson Syndrome (SJS), a potentially deadly skin disease which produces burn-like rashes, open sores and skin peeling. SJS is deadly between 5%-15% of the time. The drug has also been linked to Toxic Necrolysis Syndrome (TENS) which is deadly in 40%-40% patients. The side effects to these severe skin diseases include:

  • Flu-like symptoms (fever, sore throat, cough)
  • Red or purple skin rash
  • Hives
  • Blisters on the skin or mucous membranes, especially in the mouth, nose and eyes
  • Facial swelling
  • Tongue swelling
  • Skin pain
  • Skin shedding

Those taking Dilantin may also face cellulitis, sepsis, eye problems which can lead to blindness, internal organ damage and permanent skin damage. These side effects can last a lifetime.

Plaintiffs in class action lawsuits claim Pfizer, and the generic drug makers Mylan Pharmaceuticals and Baxter Healthcare, were aware of the drugs dangers but failed to adequately warn the public about the increased risks of the severe skin diseases.

DEPAKOTE ALERT

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Depakote, Taken While Pregnant, Increases the Risk of Severe Birth Defects

According to class action lawsuits filed against Abbott Laboratories, the makers of Depakote, risks of having a baby born with birth defects are increased for mothers who took the drug while pregnant.

If you or a family member has taken Depakote prior to 2010 while pregnant and have a baby born with birth defects, you may be entitled to compensation.

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DEPAKOTE ALERT

DEPAKOTE ALERT

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  • Our clients have received millions of dollars in lawsuits involving defective drugs.
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CONTACT US NOW! Do Not Delay As The Applicable Statute Of Limitations May Result In A Complete Bar To Your Claim Regardless Of Its

About Depakote

Depakote is a popular anticonvulsant drug used to treat epilepsy, migraine headaches and bipolar mania. The drug was approved by the FDA in 1983 to treat certain seizure conditions in adults and children 10 years and older. The drug was later approved to prevent migraine headaches as well as a long-term treatment for severe manic episodes of bipolar disorder. Depakote is the brand name for the generic drugs divalproex sodium, valproate and valproic acid.

Birth defects allegedly caused by Depakote include heart defects, brain defects, spina bifida and other spinal defects and face or skull defects. There have been a number of studies showing mothers are at an increased risk of giving birth to babies born with birth defects than those mothers who did not Depakote while pregnant.

In 2006, the FDA added a black-box warning regarding potential birth defects. The warning came as the result of a study reporting incidents of birth defects in 20% of women who gave birth while taking Depakote. In 2009, the FDA specifically warned about potential neural tube defects, heart defects and craniofacial birth defects.

In a 2010 study published in the New England Journal of Medicine, European researchers reported an increased risk of six different birth defects when Depakote is taken during the first trimester. The risk for spina bifida, in particular, increased 12 times for mothers who were prescribed the drug. In 2011, the FDA warned about a potential link between Depakote and decreased cognitive functioning. Studies have shown that, compared with children of women who did not take the drug, children born to mothers who took Depakote during pregnancy tended to score lower on IQ and other cognitive tests.

Plaintiffs in class action lawsuits claim Abbott Laboratories failed to adequately warn the public about the increased risks of birth defects in pregnant women taking Depakote prior to 2010.

CYMBALTA ALERT

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Lawsuits Are Being Filed Against Eli Lilly, the Makers of Cymbalta, Claiming Serious Antidepressant Withdrawal Symptoms

According to class action lawsuits filed nationwide, Cymbalta has caused serious withdrawal symptoms including severe nausea, vomiting, dizziness and vertigo, hot/cold flashes, mood swings, nightmares, brain “zaps”, paresthesia (tingling, tickling, prickling or burning sensation of the skin), shaking hands and visual disturbances.

If you or a family member have used Cymbalta and have experienced withdrawal symptoms, you may be entitled to compensation.

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CYMBALTA ALERT

CYMBALTA ALERT

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About Cymbalta

Cymbalta (duloxetine) is a serotonin-norepinephrine reuptake inhibitor (SNRI) made by Eli Lilly and is prescribed to treat major depression and generalized anxiety disorder. It is also approved to treat diabetic nerve pain, fibromyalgia and musculoskeletal pain associated with osteoarthritis and chronic lower back pain.

Studies have shown that 50%-78% of Cymbalta users experience antidepressant withdrawal symptoms after stopping the drug. However, the label states that only 1%-2% of users experience withdrawal symptoms. The class action lawsuits claim Eli Lilly failed to warn the public that the severity of the withdrawal systems were so severe that it was given its own diagnosis: Cymbalta Discontinuation Syndrome.

In 2009, the FDA issued a report that stated the Cymbalta withdrawal symptoms can be severe and last weeks or even months. The FDA also stated the company’s sales representatives and marketing materials do not adequately warn of the withdrawal symptoms and they have not developed a safe protocol for safely stopping Cymbalta. Furthermore, a study funded and conducted by Eli Lilly states up to 41% of Cymbalta users have antidepressant withdrawal symptoms and of those, 46% were moderate and 17% were severe. But the company still states on the drug label that these withdrawal symptoms are rare and only occur in about 1% of the users.

NEURONTIN ALERT

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Neurontin Can Increase the Risk of Severe Birth Defects

According to some studies, Neurontin taken during pregnancy can increase the risk of babies being born with congenital birth defects.

If you or a family member has taken Neurontin while pregnant and have given birth to a baby with congenital defects, you may be entitled to compensation.

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NEURONTIN ALERT

NEURONTIN ALERT

  • Our firm is vigorously pursuing this matter.
  • Our clients have received millions of dollars in lawsuits involving defective drugs.
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CONTACT US NOW! Do Not Delay As The Applicable Statute Of Limitations May Result In A Complete Bar To Your Claim Regardless Of Its

About Neurontin

Neurontin (Gabapentin) was developed to treat epileptic seizures but is also used to treat chronic nerve pain caused by shingles, diabetic neuropathy, peripheral neuropathy, trigeminal neuralgia, multiple sclerosis and sciatic nerve pain. The drug is also used off-label for treatment of restless legs syndrome, anxiety disorders, insomnia and bipolar disorder.

Neurontin falls under the FDA pregnancy category C meaning animal reproduction studies have shown an adverse effect on the fetus. However there are no adequate studies in humans. Pregnancy C drugs should only be taken by women who are pregnant when the potential benefits of taking the drug outweigh the risks.

Birth defects associated with anticonvulsants, such as Neurontin, include:

  • Cleft palate
  • Skull malformations
  • Other bone malformations
  • Heart defects
  • Hydroureter and/or hydronephrosis
  • Abnormality in the opening of boy’s urethra
  • Extra fingers and toes
  • Spina bifida
  • Other congenital defects