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In a widely discussed article on Bloomberg.com, Judge Jack Weinstein, an outspoken U.S. District Judge  from New York, has stated that he does not want to allow patients and insurers who paid for Zyprexa for uses approved by the U.S. Food and Drug Administration, including schizophrenia and bipolar disorder, to sue as a group. Further he does not feel that the purchasers of the Zyprexa drug are entitled to  claim punitive damages. The case ``ought to be settled,'' said the judge to both Plaintiff and Defense lawyers. "I really think that we're not dealing with very much money.''

In a blog post on the Pharmaceutical Blog Pharmalot, the author mentions that a lawyer for Zyprexa purchasers, is pushing for Judge Weinstein to certify classes of individual Zyprexa users and third-party payers, such as insurers. He believes that Zyprexa maker, Eli Lilly exaggerated the effectiveness of the drug; failed to adequately warn about side effects including weight gain, diabetes and other illnesses; and promoted Zyprexa for off-label use, including for treating elderly dementia patients and children.

Drug manufacturer, Eli Lilly has paid over $1billion to settle over 30,000 claims brought by patients stating they were not given adequate warning about the side effects of Zyprexa.

Judge Weinstein is supposed to issue a ruling sometime soon.. Everyone is waiting to see if justice will be served for the purchasers.  Stay tuned...

Bloggers for the Drug and Device Law Blog have some interesting comments on the subject. It is nice to see a healthy discussion between bloggers and readers...

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Concerned Citizens, Health Care Personnel, the FDA wants your opinion on the new FDA Proposed Guidance for Dissemination of Information on Unapproved Uses of Medical Products. Public Comments will be accepted for 60 days. 

"Articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care," said Randall Lutter, FDA deputy commissioner for policy. "This guidance also safeguards against off-label promotion."

Previously, Section 401 of the Food and Drug Administration Modernization Act set out guidelines that allowed the dissemination of information on unapproved uses of FDA-approved products. As long as the guidelines were met by the manufacturers, the dissemination of such materials was not viewed by the FDA as evidence of an intent to promote the product for an "off-label" use. However, Section 401 expired on Sept. 30, 2006.

Comments via the Internet:  go to Docket Number FDA-2008-D-0053 on the Regulations.gov Web site.

Comments via mail:
Submit comments to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

All comments should be identified with the docket number, FDA-2008-D-0053. For single copies of the draft guidance, call 301-827-3360 or contact: Office of Policy, Food and Drug Administration, 5600 Fishers Lane, Room 14-101, HF-11, Rockville, MD 20857.

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A recent report by the FDA links the multiple sclerosis drug natalizumab (Tysabri) to liver injury. It can occur as early as six days after the initial dose, per reports from the FDA.

The drug's marketers, Biogen Idec and Elan,issued a letter to clinicians,  stating a warning about liver toxicity has been added to the natalizumab label.

The new warning informs the user that signs of liver injury "including markedly elevated serum hepatic enzymes and elevated total bilirubin" not only occurred within six days of initial doses, but also had "been reported for the first time after multiple doses."

One can only wonder how someone can feel safe taking this drug after reading such a warning.  I applaud the manufacturer for at least including the warning on the label now, so that the consumer can be fully aware of risks and side effects of this drug.

Click here to read more from Medpage Today on this new warning for natalizumab or click here to read more on Tysabri.

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There is a recent report that 257 patients have died after receiving intense therapy to lower their blood sugar. As a result,  the National Institutes of Health has discontinued a portion of major study on diabetes and heart disease. The study was aimed at reducing to normal levels the blood sugar of type 2 diabetics at especially high risk of heart attack and stroke.

It is important to note that NHLBI officials stressed that they have been unable to link the increased deaths in the study to any drug, including Avandia. There are over 18 million Americans that have been diagnosed as having diabetes, with type 2 the most common form.

Click here to read more from the Associated Press and MSNBC on the recent deaths from dug intense therapy to lower blood sugar.

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Merck and Schering plough are being sued for misleading consumers into believing their drugs were  more effective than generic ones. According to an Associated Press article, Four lawsuits have been filed in New Jersey, New York, Florida and Washington state. They were filed on behalf of patients and medical insurers who paid for the expensive cholesterol drugs.

In the Florida Lawsuit, the plaintiff seeks to recoup the difference in cost between generic cholesterol drugs that cost about one-third as much Vytorin or Zetia. According to the Plaintiff's Attorney, Tim Howard, "The cost of those drugs is two-thirds more than the generics, which has the same benefit." Lead Plaintiff in the Florida lawsuit, Marion Greene, stated that she felt misled by using a drug that cost three times as much as a generic without additional benefits.  

Earlier this month, Merck/Schering Plough released a study named Ehance  (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia) Trial.  Merck/Schering-Plough have requested permission to present findings from the ENHANCE trial at the American College of Cardiology meeting, which will be held in March 2008. In wake of the new developments and lawsuits surrounding Vytorin, since the abstract was released, time will tell, if their request will be granted.

Merck and Schering Plough is also under fire with a Congressional inquiry led by  Rep. John D. Dingell (D-MI), Chairman of the Committee on Energy and Commerce, and Rep. Bart Stupak (D-MI), Chairman of the Subcommittee on Oversight and Investigations. After the Merck and Schering-Plough’s release of the ENHANCE study results the Congressmen issued a statement to the fact that their investigation into the ENHANCE trial would continue.

According to a Forbes.com article, Congressman, Bart Stupak of Michigan made the following statement "You bring in an independent advisory panel to 'put the lipstick on the pig' to salvage Vytorin, and you can't do that right."  

Merck stock closed at $49.56 yesterday. Schering Plough stock closed at $20.17 yesterday.

We will keep our eye on the developments surrounding Vytorin and report them to our readers on the LaBovick Injury Law Blog.

To read more on the information in this post, Click here for Forbes.com, US News, ABC News, CNNMoney

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Bayer's liquid formulation of Leukine, a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function has been withdrawn from the market. The product was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the formulation of liquid Leukine to include edetate disodium (EDTA). The upward trend in adverse reaction reporting rates has not been observed with the use of lyophilized Leukine. The product should not be used by anyone and all unused vials must be returned to the manufacturer.

Bayer letter regarding withdrawal of Leukine

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One of our favorite Bloggers, Blawgletter wrote a post about Tort Reform and the rights of trial by jury. Although his post is re: a securities fraud case against University of Phoenix, it also rings true that jury trials are important for personal injury cases. Without them, who would be held accountable? Ted Frank at Points of Law.com, chimed into the jury trial discussion by adding "trials remain a risky business for both plaintiffs and defendants", in a recent post. 

Pointsoflaw.com, provided an excellent summation of the Vioxx litigation in their  vioxx roundup yesterday. They cited several cases pending trials and gave updates on Merck. All eyes are on Merck. Let's see if their proposed vioxx settlement of $4.85 billion will make the jury trials go away. In a newswire release, Merck indicated that there are 50,000 Vioxx claimants. 

Only time will tell how this saga will end. Stay tuned...

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Merck has agreed to pay a fixed amount of $4.85 billion into a settlement fund for qualifying Vioxx claims that enter into the resolution process. This is not a class-action settlement. Claims will be evaluated on an individual basis. According to Richard T. Clark, chairman, president and chief executive officer of Merck, "This is a good and responsible agreement that will allow the Company to concentrate even more fully on its mission of discovering, developing and delivering novel medicines and vaccines."

The conditions in the agreement, is open only to those cases filed or tolled on or before 
November  8, 2007.

Click here to read full release from Merck re: Vioxx settlement.

Click here to read Merck Final Vioxx Agreement Signed for outstanding product liability claims.

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This week, The House of Representatives approved legislation that gives the FDA more power to police the safety of prescription drugs, sending the measure to the Senate for final approval.

What if the the Food and Drug Administration required drugmakers to study the safety of their products after they go on the market? Would that be so terrible? Would it be a bad thing for regulators to order warnings added to prescribing information? If these measures can help save lives and prevent more illnesses, I think not.

This new legislation may be able to prevent future repeats of what happened with Vioxx, the Merck & Co. painkiller, allegedly linked to heart attacks and strokes, and Avandia, GlaxoSmithKline Plc's diabetes pill linked in some studies to a risk of heart attacks.

I hope that  Representative Henry Waxman, a California Democrat, is correct in his assessment that the legislation ``provides FDA with critical tools the agency has been desperately lacking in its efforts to protect the American public from unsafe drugs". Now let's see if the Senate agrees.

Click here to read more on this new FDA legislation from Bloomberg News.

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This week there were two major articles discussing the safety of  AstraZeneca's Prilosec and Nexium, one in Forbes written by Matthew Harper, "Averting another Avandia" and on the Star-Ledger of New Jersey's Pharmalot.com written by Ed Silverman, " Will Nexium become the new Avandia"?  

The articles were discussing the newly released public notice from the FDA on the "Early Communication About an Ongoing Safety Review Omeprazole (Prilosec) and Esomeprazole (Nexium)"

In the FDA public notice there is an alarming statement as to increased heart attacks and heart failure. An excerpt from the FDA public notice states "The results from the study of Prilosec and analyses from an ongoing study of Nexium raised concerns that long-term use of Prilosec or Nexium may have increased the risk of heart attacks, heart failure, and heart-related sudden death in those patients taking either one of the drugs compared to patients who received surgery."

However, on the other hand,  Paul Seligman, an associate director in the FDA’s Center for Drug Evaluation and Research, tells reporters “It’s hard to know how this process will play out” and that “this is something of a moving target." This public notice was released to make the pubic aware the FDA is looking into this and will have results from more tests in about three months.

Should the public be alarmed? Is the FDA trying to prevent another Avandia? Time will tell.

On a positive note, it is good that the FDA released this public information rather than an independent source.  The FDA communicated this new information in a somewhat timely manner. On May 29, 2007, AstraZeneca, the manufacturer of Prilosec and Nexium sent FDA  their preliminary review of new data from two studies about the potential heart risks. Since that time, the FDA has been going over the data.

FDA "thank you" for making a bold step in sharing this information about Nexium and Prilosec to the public. We remain hopeful that you will honor your obligations to the public and find out if these two drugs are safe for the public or are they detrimental to increasing a patient's heart risks.

Let's all hope that Neium and Prilosec do not become the new Avandia.

Click Here to read more on Prilosec or Nexium from Forbes and from the  Star-Ledger of New Jersey's Pharmalot.com.

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The Executives at GlaxoSmithKline  must be breathing a huge sigh of relief. They only received a mere minor setback with the new Food and Drug Administration decision. Yesterday, The FDA  advisory panels called  for new warnings for the widely used diabetes drug Avandia. New evidence has shown that it significantly raises the risk of heart attack, however, they stopped short of recommending that the drug be pulled from the market, as some FDA officials had urged. I wonder why and how they managed to get a 22 to 1 vote to allow continued sales of  Avandia?

There has been controversy among regulators, drug company officials, physicians and advocates for patients, who have offered dueling interpretations of contradictory safety studies. Maybe it is because it is a "Billion Dollar Baby" for the North Carolina Drug Maker, GlaxoSmithKline. Last year, Avandia produced $3 billion in sales for the company. Today, stock for GlaxoSmithKline closed at $51.08, an increase of $1.64 per share. I think that shareholders must be happy with the news of the new FDA warning.

                                           
The company that produces Tums and other well known brands have been given another chance to make a difference in the lives of millions of people around the world. Let's hope that this miracle they received, will keep them in check and make them proactively share critical information to unsuspecting consumers before they take a GSK drug or product, instead of after the fact. Good corporate citizenship requires as much, if not more.Click Here to read more from the Washington Post on the Avandia FDA Warning.

The LaBovick Injury Law Blog is presented as a service of the Private Law Firm, LaBovick & LaBovick, P.A., Civil Justice Prosecutors. 

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Avandia, a popular diabetes drug, has just been dealt another strike. A new report from the FDA on Wednesday, finds that  patients who take Avandia, face an increased risk of heart attacks over those who take Actos, a similar drug.  According to a recent New York Times article, one review in the study included the following statement: "Patients with heart disease and those taking insulin should not take Avandia". 

Avandia increases the risks of heart attacks by as much as 40 percent in most diabetes patients. In those taking insulin or nitrates, the risks are higher, according to the drug agency’s analysis.  Most diabetics die of heart disease. This news is unsettling, given that the drug was created to save lives, not help cause greater risks.

The FDA is stepping up and diligently trying to ensure the safety of Avandia patients. After the harsh but necessary criticism from Iowa Republican Senator  Charles E. Grassley. Mr. Grassley said. “If F.D.A. leaders are asleep at the switch, it’s a dereliction of duty. But if they’re knowingly suppressing information about risks to public safety, then it’s morally corrupt.” We need more lawmakers to stand up and hold agencies in charge with protecting the public accountable. This should be a bi-partisan issue. It affects everyone.

Unfortunately, this news does not bode well for the drug maker, Glaxo Smith Kline, since the drug is billion dollar producer for the company. Last year Avandia had sales over $3.4 billion. Upon news of this new report, the shares of stock fell $1.40, closing at $51.23.  I am sure the company executives and shareholders are nervous. If the full report that comes out on Monday, and shows more risks for Avandia patients, the drug could be in more danger.  All eyes are on Avandia and the FDA report that comes out on Monday. Should GSK be nervous?  Is there really a reason for this alarm?  Time will tell if GSK will hit a base hit or a sacrificed fly and score a run with this billion dollar drug? I don't really see how they can hit a home run with this one. The other side seems to have scored a few good runs, with these new findings.  Time will tell... Stay tuned....

Click Here to read more on Avandia from the New York Times article

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Merck's former billion dollar baby, Vioxx, arthritis Medicine, is still making headlines, despite having been pulled off the market for several years.  A recent 2,434-patient study, published on Wednesday in the New England Journal of Medicine, finds that increased heart risk begins much earlier than after 18 months of use, as previously indicated by the drug maker. Of course, Merck is denying the relevancy of this study. According to Merck, the study is not conclusive.

There are over 27,000 lawsuits against Merck from people who claim to have been harmed by the drug. I wonder if this new study will impact these lawsuits or not.   A few months ago, a jury awarded a man $47.5 million verdict  against Merck for Vioxx, finding it responsible for his heart attack.  The replacement for Vioxx, ARCOXIA, was not approved by the  Food and Drug Administration's (FDA) Arthritis Advisory Committee. They voted against recommending approval  of ARCOXIA® (etoricoxib) for the symptomatic treatment of osteoarthritis in the United States.  ARCOXIA has been under review by the FDA as an investigational selective COX-2 inhibitor since the New Drug Application (NDA) was submitted in December 2003 and is currently available in 63 countries. On a more positive note, Merck's stock is doing great.The stock closed at $53.38, this is an increase over prior trading. There must be promising new drugs in the pipeline that are keeping everyone optimistic and hopeful.

Time will tell. Let's see if if the former billion dollar baby, Vioxx,  will continue to make headlines.

 Click here to read more on Vioxx from Reuters or the New York Times.

The Private Law Firm, LaBovick & LaBovick, Civil Justice Prosecutors, is a Plaintiff’s firm. The firm focuses on fighting for personal injury victim’s rights in Florida and on qui tam (whistleblower claims) nationwide.  Visit our firm website at www.LaBovick.com for more injury information

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The widow and son of a Beaumont man are suing the maker of the popular diabetes drug Avandia, GlaxoSmithKline PLC, challenging it contributed to the man's death from a heart attack.

Larry Alan Stanford, 60, died in May, which was around the same time a scientific analysis was published in the New England Journal of Medicine saying that Avandia was linked to a greater risk of heart.

The deceased victim had taken Avandamet, a form of Avandia mixed with another diabetes drug, since early 2005.

Click Here to read more about the case in a recent AP article.

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Drug developer Wyeth lost a lawsuit alleging damage from the diet drug Pondimin, which the company previously marketed.

The jury awarded the plaintiff Virginia Cavender $75,000 in the case, tried in the U.S. District Court for the Eastern District of Missouri in St Louis. She alleged heart valve injury from use of the drug.

Click Here to read more about this Wyeth lawsuit.

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A Wisconsin Attorney requested Madison County Circuit Judge Daniel Stack to give his client a new trial, alleging the judge did not weigh all evidence when granting a directed verdict for Merck on one count of defective design during the county's first Vioxx trial.

At trial, lawyers for the Plaintiff alleged that Vioxx was defectively designed, inadequately tested, dangerous to human health, and lacked proper warnings, which subjected users to risks of heart attacks, strokes and other illnesses.

Merck argued that the Plaintiff''s preexisting risk factors -- a family history of heart disease, morbid obesity, diabetes, high blood pressure and sedentary lifestyle -- were responsible for her tragic unfortunate, sudden cardiac death

The trial ended in favor of Merck on March 27 after a seven-woman, five-man jury rejected the Plaintiff's claim that his wife's sudden heart attack at age 52 was caused by taking Vioxx.

Click Here to read more about this request for a new Vioxx trial in the Madison Record.

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I am feeling Sick-O. After being an attorney for the Department of Justice and always feeling like I was in the right, I moved over to the private sector to help people in civil areas of law. After a few years of general practice, I realized that I enjoyed personal injury law the most, so we (my wife and I) started to concentrate on handling only personal injury related cases. This was about the time that the Corporatist Party of American (formerly known as Republicans) came to power and began a campaign of hate and lies against personal injury plaintiffs and their lawyers. Certainly they had some ripe fruit to pick from. This area of the law is fraught with fraud. As a loyal Republican the attack on injured individuals and Plaintiff’s attorneys was a bit of a disconnect. Why are the perssonal injury attorneys so bad? Why are they hurting American business so greatly. Being in the industry, I just did not see it.

Of course everyone wants to rid the world of fraudulent personal injury cases. Those cases are the ones that make helping a truly injured person so difficult today. But the solutions being offered by the Corporatist Party of America were not aimed at stopping fraud. They were aimed at stopping lawsuits of value and significance. Fraudulent injury cases almost always settle for small sums of money. It is virtually impossible to sell a fraudulent injury case to a jury today. How, therefore, will “capping damages” help to cure fraud? It only caps the recovery for the most injured people! The real cases get hurt while the fraud cases go unpunished.

Meanwhile, under our noses, corporate America began an attack on the American stock shareholder and the American citizen taxpayer, which is unprecedented in our history. After working with hundreds of injured people and sifting through many hypochondriac jokers and having to kick some cases to the curb, I have come to the absolute conclusion that the true harm to the average American today is squarely in corporate fraud against our own government and against our own people. The worst thing about this is that our government is in on the plan. Our legislators and administrators are in bed with the corporate big wigs that cheat the little guy out of health and retirement plans, stock ownership or even savings.

The level of fraud in America today is sickening. There is no comparison between the fraud of corporate America and the fraud of fake injury “victims”. I guarantee you the damage done to the American economy, the American ideal and the American tax system from corporate fraud is 1000 times greater than all of the insurance scams put together. The fraud is so disturbing that it is actually hard to believe.

Coming this summer is a movie called Sicko. It is a documentary about the health and drug industry. I am almost certain it will document the conspiracy going on between doctors, drug manufacturers and the FDA.

As we speak (or rather, as you read) the drug lobby and their corporatist party lackeys are trying to make the FDA the final oversight of the drug industry and take away a injured victims right to sue if they are hurt by a drug. It is my prayer that this movie spurs politicians NOT to permit the drug lobby to have the FDA be there ONLY oversight. We must keep the drug companies honest and the only way they will be an honest broker is if they are held accountable through civil lawsuits. Is the system perfect? Certainly not. But it is far better than any other system out there. It is only through the power of the pocketbook that we can control the moral-less corporate beast.

So, you ask, why am I so “up in arms” about the FDA issue right now?

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The maker of the powerful painkiller OxyContin and three of its current and former executives pleaded guilty to misleading the public about the drug's risk of addiction, and agreed to pay $634.5 million to settle lawsuit.

The Purdue Pharma L.P company will have help in paying this fine, the president, top lawyer and former chief medical officer, will also share in paying the $634.5 million in fines for claiming the drug was less addictive and less subject to abuse than other pain medications, according to U.S. Attorney John Brownlee.

"With its OxyContin, Purdue unleashed a highly abusable, addictive and potentially dangerous drug on an unsuspecting and unknowing public," Brownlee said. "For these misrepresentations and crimes, Purdue and its executives have been brought to justice."

Ken Jost of the Justice Department's Office of Consumer Litigation said "this case should put pharmaceutical companies on notice that they won't be able to get away with breaking the law to make a profit".

Click here to read more on this story from Associated Press and Law.com

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AstraZeneca was hit with over 350 products Liability cases from Plaintiff's in Delaware state court for their anti-psychotic drug Seroquel. This is more than the total number of cases filed in AstraZeneca's home state in the last two years. A defense observer thinks that plaintiffs counsel may be trying to force the company into an early settlement of the Delaware cases and to avoid the federal multidistrict litigation. But a defense attorney says AstraZeneca has no plans to settle.

Click here to read full text  from National Law Journal (subscription required)

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