Supreme Court Rejects Major Humira Lawsuit Involving Patents

In a recent landmark decision, the Supreme Court refused to hear a claim from pharmaceutical giant Johnson and Johnson alleging that a rival company stole its drug technology.  Johnson & Johnson originally sued Abbott Laboratories for $1.67 billion, saying that Abbott infringed on its Humira patents.


Humira, with sales of nearly $8 billion last year, is Abbott’s best-selling drug. The controversial medication is used to treat a variety of conditions, including Crohn’s disease and rheumatoid arthritis.

While we’ll never know for sure what went into the Supreme Court’s decision, I certainly hope the judges took Kara Mae Pletan into consideration. Pletan, who took Humira for Crohn’s disease, is one of dozens of people who’ve come forward saying that Humira causes severe nerve damage.

“Perhaps Humira is...efficacious in the treatment of Crohn’s Disease,” said Pletan’s court papers, filed in Cook County, IL, where Abbott is located.
 
“However, it is an extremely potent drug with a number of different, very dangerous side effects. One of these effects (that is the subject of pending litigation in other forums) is lymphomas and other forms of malignancies. Another dangerous side effect is the risk of permanent neurological damage.”

Rosenfeld Injury Lawyers is currently evaluating claims for various types of injuries including vision loss, demylination and other types of neurological injuries experienced following the use of Humira.

 Related Rosenfeld Injury Lawyers Posts:

Humira Complication Primer: Multiple Sclerosis

Memphis Man Sues Abbott, Saying Humira Caused Histoplasmosis

Multiple Lawsuits Claim Humira Caused Permanent News Damage

Memphis Man Sues Abbott, Saying Humira Caused Histoplasmosis




[CAPTION: Fred Delano says Humira weakened his immune system, therefore leaving him vulnerable to histoplasmosis. (Photo Courtesy of the Memphis Flyer)]


For people living in the Mississippi River Valley, histoplasmosis remains a fairly serious threat. Histoplasmosis is a fungal infection spread by airborne spores. It’s especially prevalent in places with bird droppings, such as bat caves and chicken coops.

Though Fred Delano worked in an advertising agency, he claims he contracted histoplasmosis as a result of taking the Abbott Laboratories drug Humira. Delano, who lives in Memphis, said he began taking Humira in late 2008 to help with his arthritis. Within months, Delano began experiencing bizarre symptoms, including night sweats, migraine headaches and pronounced weight loss. Fearing for his life, Delano checked himself into a hospital in February 2009.

After conducting several tests, doctors diagnosed Delano with the most severe form of histoplasmosis, called “disseminated histoplasmosis.” Delano believes Humira weakened his immune system, and therefore made him vulnerable to contracting the disease.

“Medicines like Humira keep your immune system from killing your own body, and as a result, the overall immune system is weakened,” said infectious disease specialist Michael Gelfand. “One doesn’t get an immune response to histoplasmosis, and it is able to progress, spread and cause trouble.”

Delano claims that when he received his prescription, there were no warnings about contracting histoplasmosis as a result of taking Humira. According to lawsuit papers, the FDA had ordered Humira to warn patients about an increased risk 26 days before Delano received his first prescription. An actual warning didn’t come until two years later, in 2010.

Rosenfeld Injury Lawyers is presently review claims involving complications following the use of Humira including: multiple sclerosis (MS), histoplenic T-Cell Lymphoma (HSTCL), histoplasmosis, nerve damage and brittle bones / fractures.  Our Humira litigation team stands ready to answer any questions you may have regarding your condition and the status of this litigation.

Delano v. Abbott et al (Complaint) PDF

Multiple Lawsuits Claim Abbott's Humira Caused Vision Loss & Neurological Injury

Two separate lawsuits are alleging that Abbott Laboratories’ best-selling Humira drug, used to treat Crohn’s disease, caused lasting nerve damage in patients’ feet and eyes.


The first lawsuit, filed in April by Kara Mae Pletan of Montana, claims that Humira was responsible for “stabbing pains and hypersensitivity” in her feet.

“The progression of the nerve damage seems to have stopped [after ceasing Humira injections],” Pletan said in court documents. “But the nerve damage appears to be permanent.”

According to the Humira lawsuit papers, Pletan began developing severe nerve problems during her third month of Humira treatment in 2008. Along with suing Abbott for peripheral neuropathy (painful numbness in feet), Pletan claims that the pharmaceutical giant knowingly withheld information about the side effects of Humira.
Screen shot 2011-09-18 at 7.07.43 PM.png
“Abbott has downplayed the risk of side effects, including the very real risk of permanent neuropathy,” said Pletan’s lawyer, Andy Vickery.

The second lawsuit, filed in Illinois by New York resident Jamie Bixby, claims that Bixby suffered permanent damage to her optic nerve as a result of taking Humira in 2008.

“[If I had known] that Humira could be the source of my eye pain, I would have immediately discontinued taking the drug and would have immediately obtained proper emergency medical treatment,” Bixby said in her complaint.

Like Pletan, Bixby claims that Abbott did not give proper warning about the possibility of permanent nerve damage.

“Other competitor drugs in the same class have a specific warning about the risks of optic nerve damage,” Bixby said in her complaint. “Humira does not.”

In an e-mail statement, Abbott spokeswoman Adelle Infante claimed that “the therapeutic risks associated with Humira, including disorders of the nervous systems, are well-known and documented in the prescribing label.”

Humira was initially developed as a treatment for rheumatoid arthritis in 2003. In 2007, Abbott began marketing Humira as a treatment for Crohn’s Disease. In the past four years, Humira has become Abbott’s best-selling drug, with worldwide profits of $6.5 billion in 2010.  

Beginning in 2008, the FDA required Humira to include a “black box” warning about possible side effects. A black box warning is the most serious warning the FDA can issue for a prescription drug.

Recent have shown that patients may be developing resistance to Humira.
For more information on the suspected correlation between Humira and complications such as: vision loss, brain injury and development of Multiple Sclerosis following Humira usage vist Humira Neurological Injury.

FDA Issues Warning About Humira, Saying Drug May Pose Cancer Risk to Teens

A recent warning issued on the FDA’s Web site says Humira, a drug used to treat Crohn’s disease and other inflammatory bowel diseases, may put teens at risk for developing cancer.  

“The FDA continues to receive reports of a rare cancer of white blood cells, primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis, with medicines known as tumor necrosis factor (TNF) blockers,” the FDA said in its statement. “[We] believe the risks and benefits of using TNF blockers...should be carefully weighed when prescribing these drugs to children and young adults.”

Humira, first developed in 2002 by Abbott Laboratories, helps block “TNF,” a protein in the body that causes inflammation. (TNF stands for “tumor necrosis factor.”) Excess TNF causes common symptoms of Crohn’s disease, like abdominal pain and diarrhea. Other “TNF blocker” medications include Remicade, Enbrel, Cimzia and Simponi. TNF blockers are also referred to as “immunosuppressants,” since they decrease the body’s ability to fight off diseases and infections.

As of December 31, the FDA had linked more than 20 cases of teen lymphoma to various TNF blockers. The type of lymphoma the FDA studied, commonly referred to as HSTCL (Hepatosplenic T-Cell Lymphoma) is particularly deadly for teens.

“HSTCL is an aggressive cancer and is usually fatal,” the FDA said in a statement in April.

In August, 2009 the FDA issued a “black box warning” for Humira, saying that users should be aware of “an increased risk of lymphoma and other malignancies in children and adolescents.” A black box warning is the most serious warning the FDA can require for a prescription drug.

Humira (also called “adalimumab”) is Abbott’s best-selling product, with more than $6.5 billion in sales in 2010. Humira accounts for nearly twenty percent of Abbott’s revenue.

Common side effects of Humira, listed on Humira’s official Web site, include:

  • Rashes
  • Upper respiratory infections (including sinus infections)
  • Headaches
  • Nausea


Other, more severe side effects, include:

  • Tuberculosis
  • Hepatitis B
  • Allergic reactions
  • Vision problems
  • Heart failure
  • Psoriasis

Humira is normally delivered by injection every two weeks, and costs approximately $1,500 per month, without insurance. 

Rosenfeld Injury Lawyers is currently evaluating claims for various types of injuries including, vision loss, demylination and other types of neurological injuries experienced following the use of Humira.

Related:

Research Supports The Connection Between Humira Usage And Development Of Cancer In Children

Multiple Lawsuits Claim Abbott's Humira Caused Permanent Nerve Damage

Humira Neurological Injury

Multiple Lawsuits Claim Abbott's Humira Caused Permanent Nerve Damage

HumiraTwo separate lawsuits are alleging that Abbott Laboratories’ best-selling Humira drug, used to treat a variety of medical conditions including arthritis and Crohn’s disease, caused lasting nerve damage in patients’ feet, eyes--- and complete neurological system.

 

The first lawsuit, filed in April by Kara Mae Pletan of Montana, claims that Humira was responsible for “stabbing pains and hypersensitivity” in her feet.

“The progression of the nerve damage seems to have stopped [after ceasing Humira injections],” Pletan said in court documents. “But the nerve damage appears to be permanent.”

According to lawsuit papers, Pletan began developing severe nerve problems during her third month of Humira treatment in 2008. Along with suing Abbott for peripheral neuropathy (painful numbness in feet), Pletan claims that the pharmaceutical giant, Abbott, knowingly withheld information about the side effects of Humira.

“Abbott has downplayed the risk of side effects, including the very real risk of permanent neuropathy,” said Pletan’s lawyer, Andy Vickery.

The second lawsuit, filed in Illinois by New York resident Jamie Bixby, claims that Bixby suffered permanent damage to her optic nerve as a result of taking Humira in 2008.

“[If I had known] that Humira could be the source of my eye pain, I would have immediately discontinued taking the drug and would have immediately obtained proper emergency medical treatment,” Bixby said in her complaint.

Like Pletan, Bixby claims that Abbott did not give proper warning about the possibility of permanent nerve damage associated with Humira usage.

“Other competitor drugs in the same class have a specific warning about the risks of optic nerve damage,” Bixby said in her complaint. “Humira does not.”

In an e-mail statement, Abbott spokeswoman Adelle Infante claimed that “the therapeutic risks associated with Humira, including disorders of the nervous systems, are well-known and documented in the prescribing label.”

Humira was initially developed as a treatment for rheumatoid arthritis in 2003. In 2007, Abbott began marketing Humira as a treatment for Crohn’s Disease. In the past four years, Humira has become Abbott’s best-selling drug, with worldwide profits of $6.5 billion in 2010.  

Beginning in 2008, the FDA required Humira to include a “black box” warning about possible side effects. A black box warning is the most serious warning the FDA can issue for a prescription drug.

Recent research studies have also shown that patients may be developing resistance to Humira.
As this lawsuit moves though the discovery phases, we may learn how much information Chicago-based, Abbott Laboratories, had with respect to the potentially devastating nerve damage inflicted by Humira.  If indeed Abbott knew of the dangerous side-effects such as: vision loss, brain damage and peripheral neuropathy, they should be held accountable for these horrific injuries inflicted on a predominately young group of users.
Rosenfeld Injury Lawyers is the the process of evaluating potential claims against Abbott for patients injured after they took Humira. In particular, we are carefully examining cases involving vision loss and neurological injury where the side-effects were not fully disclosed.
Related:

Research Supports The Connection Between Humira Usage And Development Of Cancer In Children

humiraI recently met with a family who's teenage daughter developed multiple lesions on her lungs and significant vision loss after taking Humira for treatment of her Crohn's Disease.  

Turns out, her situation is not unique. A substantial number of children, teens and adults who have taken Humira for various types of arthritis and other types of inflammatory conditions have now developed cancer and other debilitating neurological complications within several years of their usage.

Lawyers are currently investigating how much knowledge Humira's manufacturer, Abbott Laboratories, had with respect the increased risk of cancer in the drugs users.  However, the medical community has now conclusively established a connection between Humira usage and cancer, infection and autoimmune disorders.

Use of Humira (generic name Adalimunab and a similar drug Remicade) has been linked to a significant rise in the development of the following types of cancers:

  • Lung tumors
  • Skin
  • Gastrointestinal
  • Breast
  • Lymphoma
  • Leukemia
  • Organ caners
  • Melanoma

The medical assumption for the increased risk of cancer for Humira users is that as a TNF blocker (tumor necrosis factor), Humira severely suppresses the bodies immune system. In June, 2008 the FDA ordered a 'black box' warning be placed on the drug due to heightened risk of developing cancers.

If you or your child has developed cancer following use of Humira or Remicade, you may be entitled to pursue the a lawsuit or claim against the drugs' manufacturers for damages. Rosenfeld Injury Lawyers, always offers free legal consultation to perspective clients. Moreover, our services are free unless there is a recovery for you.  Talk with experienced Humira litigators today. (888) 424-5757.

Related:

Follow-up to the June 4, 2008 Early Communication about the Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) FDA, August 4, 2009

FDA Investigates Link Between TNF Blockers and Pediatric Cancer

Questions and Answers - TNF Blockers 8/25/2009, FDA

Humira Neurological Injury

About Jonathan Rosenfeld

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About Jonathan Rosenfeld My law practice is focused on representing the most vulnerable members of our society in claims and lawsuits...

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