Injury Law Blog : Florida Injury Lawyer & Attorney : LaBovick & LaBovick Law Firm: Serving West Palm, Boynton, North Palm, West Palm Beach, Jupiter

One of the current hot legal topics is the lawsuit against Pfizer and their wonder drug, Neurontin. Neurontin had been marketed by Pfizer as a drug that treated multiple conditions prior to the Food and Drug Administration’s (FDA) approval of the drug to treat these various symptoms and ailments. While the drug was approved to treat epilepsy, it was not approved by the FDA to treat either mood swings or arthritis as its advertising indicated. Presently under investigation is whether or not a side effect of Neurontin is an increase in suicidal thoughts and tendencies of those taking the drug. This issue surfaced after the family of a 39-year old woman that committed suicide while taking Neurontin filed a lawsuit against its maker, Pfizer. The deceased was taking the drug to treat several health issues including epilepsy, mood swings, and arthritis. There are approximately 1200 additional lawsuits pending against Pfizer and their drug, Neurontin.

The first lawsuit against Pfizer, in regard to Neurontin, to be heard before the court was the case of Susan Bulger, the 39-year old woman that committed suicide. After the first day of trial, the lawsuit brought against Pfizer by Ms. Bulger’s family was dropped after an anonymous donor agreed to provide monies to the family with the stipulation that the monies be put into a trust for Ms. Bulger’s daughter. The family determined that this would be in the best interests of the child and chose not to proceed with their lawsuit. The court dismissed the case. The attorneys for Pfizer continue to assert that there is no evidence that Neurontin increases or causes suicidal thought or behaviors. However, no real answer has been provided to this question. With the first lawsuit being so quickly dismissed, the mysteries and unanswered questions regarding Neurontin may have to wait to be discovered and answered until further lawsuits come before the courts.

It appears that with so many other lawsuits pending against Pfizer regarding Neurontin that this story is long from over. If Neurontin truly is a potentially dangerous drug, the public needs to be made aware of this before more innocent people are affected.  Attorneys on both sides of the arena seem ready and willing to share their perspectives and evidence with the courts and their juries. How this legal saga is going to play out is anyone’s guess. At this point, there are still more questions than answers. It is important to note that in 2004, Warner-Lambert paid $430 million in to settle allegations involving Neurontin related to off label marketing, in a case handled by the Justice Department. 

Click here to read more on the Neurontin case from Bloomberg.

Pfizer's stock closed at $16.07 today.

Stay tuned...

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Today it was announced that Pfizer was going to take a $2.3 billion earnings hit over government investigations of their drugs Celebrex and Bextra.  You can't help but wonder if they are profitable.  Look no further, they recentely announced their attempt to make a $64 billion purchase of Wyeth Pharmaceuticals.  The combined merger would layoff 18,000 people. 

Our interest on the Injury Law Blog is Consumer Safety and making sure that Companies pay for their wrong doings. In fact, everyone celebrated last year when Pfizer announced that it would pay $745 million to settle personal injur suits over Bextra and Celebrex. They also paid $60 million to 33 state Attorney Generals and $89 million for class actions.  This is a lot of money for hurting unsuspecting people with a harmful drug,

The disbelief to all of us at the Injury law Blog is that this company still has $68 billion to purchase another pharma company, Wyeth.  Are they keeping consumers safe with their drugs?  Are the pharma companies taking the necessary steps in doing enough clinical trials to ensure there will be no deaths or loss of limbs or serious impairments from taking their drugs?

The questions remain to be answered.  It is nice to see articles such the one from the WSJ Blogs by Sarah Rubenstein discussing all of the money Pfizer stands to make if their merger is successful.

Let's hope that the American public's safety is not an expense to this merger and this pharma giant flexing its muscles that it can afford $68 billion for an acquisition of a competitor.

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According to the research article, “Inhaled Anticholinergics and Risk of Major Adverse Cardiovascular Events in Patients With Chronic Obstructive Pulmonary Disease” written by Sonal Singh, MD; Yoon K. Loke, MD; and Curt D. Furberg, MD, and published in the Journal of the American Medical Association, people using the Spiriva inhaler possibly face the following risks: cardiac death, heart attacks or strokes. Alarmingly, the risks are greater for the Spiriva inhaler users than inhaler users using a placebo or other drugs. This study published in the September 24, 2008 issue of JAMA denotes that although the risks were small, the popular inhalers could lead to potentially life threatening side effects.

The German Manufacturer, Boehringer Ingelheim Pharmaceuticals Inc. makes Spiriva Handihaler (tiotropium) and the  generic drug for Atrovent, Ipratropium, approved  for treating COPD.  In the United States, they have a joint marketing partnership with Pfizer Pharmaceuticals. In 2004, the inhaler was approved for a daily long-term treatment of bronchospasm, which is linked with COPD, chronic obstructive pulmonary disease.

It is important to note that both drugs have been used by approximately 8 million people worldwide. They are both known for helping to open passages and preventing spasms that decrease airways in the lungs to increase effective breathing.

The JAMA article details how authors, Sonal Singh, MD; Yoon K. Loke, MD; and Curt D. Furberg, MD analyzed the data from 17 randomized studies, and compared it to primarily older people on either Spiriva or Ipratropium, to people using placebos or other drugs. Their research found that patients had an increased risk over 50% in developing both fatal and non fatal heart problems, including heart attacks when they used Ipratropium or Spiriva.

Researchers are quick to add that additional studies are required to further evaluate the safety of the drugs. However, they recommended individuals with COPD to take precautionary measure prior to starting drug therapy that includes stop smoking, control blood pressure and cholesterol and the use of oxygen.

There was a statement issued by Boehringer and Pfizer indicating that disagreed with the analysis of the new study. They cited an analysis of 30 clinical trials that confirmed the safety of the Spiriva Handihaler and that showed no increased risk of all-cause death or cardiovascular death to the inhaler users.

However, the Food and Drug Administration, FDA issued an early communication in March 2008, that indicated they are evaluating the potential connection between the side effects of the the Spiriva Handihaler and strokes. The March 2008 FDA communication was quick to point out that their investigation was precautionary and did not mean that Spiriva causes strokes. They encouraged people on the drugs to not stop taking their drug based on the FDA early communication, in March but to wait until they have confirmed conclusions and recommendations.

We can only hope that the FDA’s conclusions will not be too late for some individuals.

 

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