Showing posts with label lawsuit. Show all posts
Showing posts with label lawsuit. Show all posts

Thursday, August 23, 2012

Patient Diagnosed w/ Cancer After Humira Treatment - Abbott Labs Lawsuit for Many Claims

Entire Article Below :)    


Reading articles like this one doesn't shock me.  I know everything about these drugs and it's only a matter of time before we start seeing similar sad effects from these horrible toxic drugs.  Watch....  you will see this happen for yourself as time goes on.  
The effects of the drug are available if you search, and I always take time to read about the drug I plan to be putting in my body.  NEVER trust your doctors word... even if he is the greatest doctor.  You have no idea if your doctor is recommending Humira  (or any other drug for that matter) because they are getting "kick backs" - it's discussed in the article below,  a short definition of the meaning - a KICKBACK is a payment made to someone who has facilitated a transaction or appointment, esp. illicitly.  Illegal Yes, paying physicians money to recommend a drug so sales will increase, is not the correct reason to suggest a treatment.  That's why It's so important to do your homework before saying "yes" to a treatment.  It doesn't matter how many positives your doctor tells  you about and that he told you it is a SAFE option .  

I CANNOT STRESS THIS ENOUGH - Do yourself a huge favor, find out the facts for yourself.


This is how---->  Read non biased information (a biased source -  the pharmaceutical company's website about the drug.  Of course they will shed light on mostly the benefits).  Read information from a reputable source (a peer review journal article, Pubmed (where you can find published research results.  Looking up specific keywords of your choice - Pubmed is linked on my side bar for easy access.).  

Once you've gathered and read through enough information , next weight the positives of taking the medication and the negatives (risks). Are the possible dangers worth it for the condition you have, is there a safer option available,  Have you tried all other treatments for your condition and seem to be hitting a wall in regards to medications thatwill bring you relief. What natural therapies are available to treat the condition, who would be a good candidate to take a medication with dangerous side--effects like Humira (your genetics matter)







Arthritis Drug Humira Blamed for Cancer


 CHICAGO (CN) - Abbott Laboratories' blockbuster arthritis drug Humira gave a woman cancer, she claims in Cook County Court.

     Carolyn and Eric Shaw sued Abbott Laboratories for product liability, product defects, failure to warn, misrepresentation, negligence, breach of warranty and loss of consortium.
     "Plaintiff Carolyn Shaw was prescribed Abbott's blockbuster arthritis drug 'Humira' and received bi-monthly injections from October 2008 to August 2010 when she was diagnosed with B-cell non-Hodgkin's follicular lymphoma. She underwent surgery and chemotherapy treatment, and luckily her cancer went into remission. Unfortunately, she will have to undergo treatments every five months for the rest of her life to ensure the cancer will not return," the complaint states.
     The FDA approved Humira to treat arthritis in December 2002. It is Abbott's best-selling drug, according to the complaint.
     "(I)n 2011, Humira's worldwide sales were $7.9 billion," the Shaws say.
     The complaint states: "the data from Humira clinical trials and other peer-reviewed medical literature show that the rate of malignancies in the group of patients treated with Humira was significantly higher than the rate of malignancies in the group that were treated with placebo. The increased rate of lymphomas was statistically significant. This differential in rate was a significant safety signal. It should have prompted a significant clear warning from Abbott to both physicians and patients about this potential side effect.
     "Although the clinical trial data alone should have prompted both a stringent warning and proactive study, instead of conducting further studies and/or otherwise calling attention to the increased risk of life-threatening side effects front and center in the label, and communicating same to Dr. Suarez [Carolyn Shaw's nonparty rheumatologist] Abbott buried and information regarding malignancies in the label. Further, what 'warning' information was mentioned severely downplayed the risk and confused the issue, consistent with its sales message, in RA [rheumatoid arthritis] data."
     The complaint adds: "It is widely recognized within the pharmaceutical industry that adverse side effects of medication are vastly unreported. The industry accepted rule of thumb is that the MedWatch system captures somewhere between 1 percent and 10 percent of real world events. Therefore, the MedWatch reports put Abbott on notice that, in fact, there were somewhere between 250 and 2,500 real world Humira patients who had experienced Humira-related lymphomas or other malignancies.
     "Because FDA regulations require the drug manufacturer to add a warning - in the warnings section of the label - whenever there is a 'reasonable association' between the drug and a dangerous side effect, and further state that 'a causal relationship need not be established' before a warning is required, this information from the adverse event database should have prompted Abbott to issue strong, clear warnings about the risk of lymphomas and other forms of malignancies due to the use of Humira. But Abbott failed to do so until many years later, when the FDA made them do it."
     The Shaws say: "Not until August 4, 2009 - almost a year after Carolyn Shaw began taking Humira - did Abbott put a black box warning on their label alerting patients and doctors of cases of leukemia, hematological cancer, in adults, adolescents, and children."
     Carolyn Shaw developed an enlarged lymph node in her neck in 2010 and was diagnosed with Stage IIA lymphoma. "When Carolyn and Wayne asked Dr. [Mark] Freidman what he thought caused her lymphoma, his answer was 'Humira,'" the complaint states.
     The Shaws claim that Abbott aggressively markets Humira and makes "widespread use of direct payments to physicians utilized by Abbott to both sell more Humira and increase prescriptions across the country."
     "Needless to say, these financial inducements and payments provide incentives, perhaps on a subconscious level but real nonetheless, to skew the 'informed consent' discussion in favor of the benefits of Humira, at the expense of the risks. More importantly, patents are not aware of these types of 'behind the scenes' payments being made to physicians. ... It most certainly was not disclosed by either Abbott or the prescribing physicians to the individual plaintiff and/or patient."
     Abbott Laboratories is the only defendant. Neither of the Shaws' doctors is a party to the case.
     The Shaws claim that Abbott withheld critical information that would have enabled Carolyn to make an informed decision about whether to take Humira: "Although physicians prescribe medications, it is patients who have the ultimate authority to decide whether to put them into their bodies or not. Because of the dangerous side effects of Humira, it is extremely important that both physicians and patients be fully informed - not only about the potential benefits of the drug, but also about the risks of side effects. Neither Carolyn nor her physicians were warned in any meaningful or legally adequate manner about the risk of lymphoma when she began taking Humira," the Shaws claim.
     The Shaws are represented by Gary McCallister.


Courthouse News Service:

'via Blog this'

Wednesday, April 27, 2011

Yuck = Biologic Drugs-Article states Humira causes permanent nerve damage


Abbott Labs Sued on Claim Humira Caused Lasting Nerve Damage


Abbott Laboratories (ABT) was sued on claims that its top-selling drug Humira caused permanent nerve damage in the feet of a Montana woman who took it for Crohn’s disease.
Two doctors who treated Kara Mae Pletan at the Mayo Clinic in 2008 said the nerve damage in her feet “was most likely due to Humira,” according to the lawsuit, which was filed today in state court in Chicago, near the company’s headquarters in Abbott ParkIllinois.
The complaint also alleges Abbott knew that Humira, which had 2010 worldwide sales of $6.5 billion, could cause peripheral neuropathy before it began marketing the drug to Crohn’s patients in 2007. Earlier this year, Abbott was sued by two arthritis sufferers in Texas andMassachusetts who claim Humira gave them cancer.
“Abbott has downplayed the risk of side effects, including the very real risk of permanent neuropathy,” Andy Vickery, Pletan’s lawyer, said in an e-mail.
Abbott initially sold Humira in 2003 as a treatment for rheumatoid arthritis. The U.S. Food and Drug Administration now approves Humira for the treatment of five additional autoimmune diseases, including Crohn’s.
Humira is expected to outsell Roche Holding AG (ROG)’s Avastin cancer medicine by 2016 to become the world’s most lucrative drug, according to a May 2010 forecast by research company EvaluatePharma.

Safety Data

“Humira has more than 12 years of clinical and safety data and best-in-class efficacy,” Adelle Infante, an Abbott spokeswoman, said in January, after the filing of the first lawsuit claiming Humira caused a Texas woman’s cancer. “The therapeutic risks associated with Humira are well known and documented in the prescribing label.”
Infante today declined to comment on the nerve-damage suit because Abbott hasn’t read the complaint.
Humira’s full package insert as of July 2004 warned that patients in clinical trials of similar types of drugs had developed more cancers than patients receiving other rheumatoid arthritis treatments. The class of drugs, known as tumor necrosis factor-blockers, prevent the body’s cancer-killing cells from working.
“The FDA has yet to focus in on the risk of neuropathy and other forms of neurological side effects, and Abbott has chosen to provide little if any information about these risks to either physicians or patients,” Pletan said in the complaint.

Issued Report

Doctors at Angers University in France issued a report in April 2006 suggesting that Humira could cause peripheral neuropathy, Pletan said in court papers.
“Abbott was actually aware of this article prior to the 2007 launch for Crohn’s,” she said.
In January, Gayathri Murthy, a Houston hospital worker, sued Abbott claiming she developed lymphoma while taking Humira for arthritis in 2005 and 2006. Earlier this month, a Massachusetts arthritis patient, Maureen Calisi, sued the company for allegedly causing her lymphoma after she took Humira from 2003 until 2008. Both cases are pending.
Both Murthy and Calisi are represented by Vickery, of Vickery, Waldner & Mallia LLP in Houston, who said he has “more than a dozen clients with legitimate legal claims involving Humira.”

Months of Injections

Pletan, 32, claims she developed small fiber peripheral neuropathy after receiving three months of Humira injections in 2008. The resulting “stabbing pains and hypersensitivity” in her feet forced her to give up outdoor activities and sell her family’s retail furniture store in Bozeman,Montana, when she could no longer work on her feet, she said in her complaint.
“The progression of the nerve damage seems to have stopped” after ceasing Humira injections, Pletan said in the filing. The nerve damage “appears to be permanent,” she said. Pletan is seeking both economic and punitive damages.
The case is Pletan v. Abbott Laboratories, 2011L004270, Circuit Court of Cook County, Illinois (Chicago).
To contact the reporters on this story: Laurel Brubaker Calkins in Houston atlaurel@calkins.us.com; Margaret Cronin Fisk in Southfield, Michigan, atmcfisk@bloomberg.net.
To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net