Houston Personal Injury Lawyer - Defective Drugs

Paxil Preemption Ruling Overturned

Scott Kappes — Thu, 24 Jul 2008 16:17:55 GMT

A federal judge in Indiana has vacated his previous ruling that wrongful death claims brought against the makers of Paxil were preempted by federal regulations. This reversal will now allow the claims to be heard. The judge, David Hamilton, said that in the previous ruling the “court failed to appreciate the significance of the fact” that a drug manufacturers can modify the label of a medication without FDA approval, if they have reasonable evidence of serious harm that could be inflicted on patients. In the case of Paxil, SmithKline Beecham Corp. (now GlaxoSmithKline), failed to revise the label when they were well aware potential harm to recipients of the drug.

In the next term the Supreme Court will address the issue of preemption related to pharmaceuticals in the case Wyeth v Levine. The basic question that the court will have the duty of answering is whether the FDA’s approval of a medication should preempt state product liability lawsuits brought over injuries incurred by recipients but not specifically warned of on the label of a drug.

This is a very serious and intricate question that court must address in the coming months. If the court were to decide that lawsuits would be preempted by FDA approval, as they did for certain medical devices in Riegel v Medtronic, it would be a catastrophic blow to the plaintiffs’ rights. Hopefully the court will not be influenced by big pharma’s attempt to demonize the trail lawyers and product liability lawsuits.

While it is true that some trial attorneys have brought forth frivolous lawsuits that have given the entire industry a bad name, they are very much in the minority. Most plaintiffs’ attorneys truly do care for their clients and have chosen to work in the field that they do out of compassion for victims.

Pharmaceutical companies are amongst the richest companies in the world. Their greed and desire for profit transcends all barriers. On numerous occasions pharmaceutical companies have concealed evidence of adverse effects from their products, all in an effort to make more profit off of a medication that they knew was placing innocent victims in harm’s way.

These business giants must be held accountable for the injuries incurred from the medications that they make. If the tens of millions spent on lobbying each and a small portion of the multi-billion dollar profits seen by some companies each and every year were to go into making safer more effective drugs and better research, maybe there would not be a great need for plaintiffs’ law in this area. But as it stands now, the victims of defective medications need help more than ever.

Originally posted at InjuryBoard by Scott Kappes

FDA Deadlines May Affect Drug Safety

Scott Kappes — Fri, 28 Mar 2008 14:55:02 GMT

According to a study published in the New England Journal of Medicine deadlines for response to new drug applications may be causing the agency to make hasty decisions. The study suggests that drugs approved closer to the deadline end up having more safety issues once on the market than drugs that are approved earlier in the process. The study shows that of the 97 drugs that were approved within two months of the deadline since 1993, 14 percent went on to be associated with serious safety problems. Of the 216 other drugs that were approved earlier in the 10-month approval window only 3 percent ended up being associated with serious safety problems.

The deadlines are part of what's known as PDUFA, a program where drug makers fund the agency and the agency is obliged to meet tight deadlines for decisions in most cases. The authors write that their findings "suggest potential adverse effects of the deadlines governing FDA drug review," and say higher levels of staffing and less adherence to strict deadlines might allow the agency to review applications quickly without compromising safety.

The FDA says that their database does not support the article. The FDA is sending a detailed letter to the NEJM disputing the results of the Harvard based study.

Originally posted at InjuryBoard by Scott Kappes

FDA To Investigate Singulair-Suicide Link

Scott Kappes — Thu, 27 Mar 2008 13:50:06 GMT

Today the FDA announced that they would be launching a probe to investigate a possible link between Merck's asthma medication Singulair and suicidal ideation and action. The agency is reviewing the issue due to reports of mood and behavioral changes, including suicidal thoughts and action, associated with the drug. Singulair is most commonly used to treat asthma but is also often used to treat allergy symptoms such as a runny nose. No link has been established in the case, but an FDA probe should provide greater insight into possible adverse reaction related to Singulair.

The FDA said it is also reviewing reports of behavioral changes in patients taking other similar drugs, including AstraZeneca's Accolate and Critical Therapeutics Inc's Zyflo but has not yet decided whether further investigation is needed.

Merck had previously added information about the risk of depression, tremors, anxiousness, and suicidal behavior to the medication's label. No official comment has been release by the company regarding the probe.

Originally posted at InjuryBoard by Scott Kappes

Gadolinium Based Contrast Agent Prompts Lawsuit

Scott Kappes — Mon, 17 Mar 2008 15:55:14 GMT

A San Francisco couple has filed a lawsuit against Bayer and other drug manufacturers alleging that gadolinium based contrasted agents manufactured and distributed by the Defendants can cause patients to develop a severely painful and debilitating disease. William Paschal claims that he contracted Nephrogenic Systemic Fibrosis (NSF) from an intravenous injection of a gadolinium based contrast agent in January of 2008. Attorneys for the Paschals allege that the defendants failed to adequately test the compound on patients with kidney problems before introducing it to the market, placing millions of patients at risk.

NSF is characterized by discoloration, thickening, tightening and swelling of the skin after injections, according to the complaint. When NSF progresses it leads to painful inhibition of the ability to use the arms, legs, hands feet and other joints. When NSF progresses to the scarring of other body organs such as the lungs, heart, liver, it can lead to their inability to function properly and may lead to death.

Last year the FDA added its strongest, black box," warning to the label of gadolinium contrast agents to warn of an elevated risk of NSF associated with the imaging agents.

The plaintiffs' attorneys have charged the manufacturers with allegation that they failed to warn, design detect, and adequately test the compounds prior to their introduction to the U.S. market. They are also accused of negligence, concealment, and suppression of material facts.

No official response to the lawsuit has been issued by the defendants.

Originally posted at InjuryBoard by Scott Kappes

Connecticut Sues Zyprexa Maker

Scott Kappes — Tue, 11 Mar 2008 15:31:00 GMT

Today the state of Connecticut filed a lawsuit against Eli Lilly and Co. The lawsuit accuses the company of illegally marketing and obscuring negative side effects of the best selling drug Zyprexa. The lawsuit seeks to recover money spent on treating patients that have developed conditions as a result of taking Zyprexa and millions more spent on the drug as a result of illegal marketing practices. Lilly is currently defending itself in a similar trial brought by the state of Alaska.

Zyprexa is by far Lilly's number one seller, with over $4.67 billion in sales in 2007 alone, despite the drug being linked to an increased risk of diabetes, weight gain, and heart problems. The company has already spent some $1.2 billion to settle about 30,000 claims of people who allegedly developed diabetes as a result of taking Zyprexa.

Between 1996 and 2006, the Connecticut Medical Assistance Programs spent more than $190 million on Zyprexa, according to the news release announcing the lawsuit.

Shareholders have also enacted similar litigation in the state of Pennsylvania.

By the time all is said and done Lilly could be looking at another multibillion-dollar settlement.

Originally posted at InjuryBoard by Scott Kappes

Lawyer For Alaska Says Eli Lilly Hid Zyprexa Risks

Scott Kappes — Fri, 07 Mar 2008 11:23:49 GMT

In an ongoing trial between the State of Alaska and Eli Lilly a lawyer for the State, Scott Allen, said Wednesday that Eli Lilly systematically hid the risks associated with the popular anti-psychotic Zyprexa. The drug has been linked to an elevated risk of developing diabetes. The state is asking Lilly to pay for the medical expenses of Medicaid patients that developed diabetes and other ailments resulting from taking Zyprexa. Allen said that Lilly deliberately attempted to downplay the existence of dangerous side effects in order to keep drug sales high. This is the first Zyprexa case of its kind to reach a jury trial, so the outcome will set a precedent for the way similar trials are addressed in the future.

If it finds Lilly liable, a second jury will be chosen to hear a trial that will determine whether Zyprexa caused the maladies of people who took it and how much the company must pay in restitution.
The state has not made a specific demand for restitution. Ed Sniffen, the senior assistant attorney general for Alaska, said that damages could rise to the "hundreds of millions" of dollars if the state wins and is awarded treble damages for the cost of the care it has provided.

Zyprexa is one the best selling medications in the world, with over $4.8 billion in sales in 2007 alone. Lilly has paid out over $1.2 billion to settle some 30,000 claims from people who alleged that Zyprexa caused them to develop diabetes and other diseases.

Federal investigators are also currently conducting an investigation as to whether Lilly marketed Zyprexa for "off-label" uses. For years Lilly gave little weight to allegations claiming that the drug attributed to diabetes development. Last year under pressure from the FDA the company finally admitted that Zyprexa appears to have a greater risk of high blood sugar that other schizophrenia medications.

Originally posted at InjuryBoard by Scott Kappes

Flu Meds Tied to Neuropsychiatric Events

Scott Kappes — Tue, 04 Mar 2008 17:23:19 GMT

Millions of people the world over catch the flu each year. Many experience extremely debilitating symptoms from the influenza virus. Drugs like Tamiflu and Relenza have been developed to treat these symptoms and offer those infected some relief from the relentless illness. Recent news however has linked these treatments to neuropsychiatric events in some instances. Post-marketing reports, mostly coming out of Japan, have tied the medications to delirium and other abnormal behaviors that have in some cases resulted in fatal outcomes.

Most of the reported events occurred in pediatric patients and often characterized as having an "abrupt onset and rapid resolution." Patients taking Tamiflu or Relenza should be closely monitored for changes in behavior. The FDA advises patients taking the medications to evaluate the risks and benefits of continuing treatment if abnormal behavior is observed.

Changes have been made to the labels of both medications to warn of the newfound risks.

Originally posted at InjuryBoard by Scott Kappes

Heparin Related Deaths Prompt Recall

Scott Kappes — Mon, 03 Mar 2008 17:05:52 GMT

Thousands of Americans depend on the popular blood thinner Heparin to help them survive, but over the past few weeks the drug has been linked to 21 deaths and hundreds of adverse reactions likely due to contamination during the manufacturing process. Nearly half of all of the raw ingredients used to make Heparin are produced in China. The main active ingredient, which is derived from pig intestines, is thought to be likely culprit of the contamination and in turn the adverse events associated with the medication.

Until last week, leading manufacturer Changzhou Scientific Protein Laboratories had no operating license and had been completely unregulated, either by Chinese authorities or the Food and Drug Administration, a violation the FDA's own inspection policy.

The FDA inspection discovered that the factory was used material from what they called an "unacceptable vendor" and had not taken the adequate steps to "identify impurities and deficiencies" associated with manufacturing equipment.

Baxter International, a major manufacturer, has halted sales of the product and issued a voluntary nationwide recall of all lots of Heparin. The investigation to find the source of the problem is still ongoing.

Originally posted at InjuryBoard by Scott Kappes

Tysabri Linked to Liver Damage

Scott Kappes — Fri, 29 Feb 2008 10:18:47 GMT

This week federal health officials updated the prescribing information of Tysabri to warn of a possible link to severe and potentially fatal liver damage. Tysabri, used to treat multiple sclerosis, was recently approved to treat Crohn's disease, but now officials say that a patient can begin to experience liver damage within six days of the first dose of the drug. Tysabri was pulled from the U.S. market in 2005 after being tied to a rare brain disease, but was reintroduced in 2006 under a strict safety program that has eliminated the occurrences of the disease.

In a letter posted on the FDA's Web site, Elan and Biogen Idec, which co-market the drug, warned that some patients have showed signs that are "generally recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients."

Liver damage associated with Tysabri is rare, with less than one in one thousand being affected, but with the drug's checkered past the news could have a substantial affect on the future Tysabri. According to the manufacturer, Biogen Idec, none of the reported liver damages have warranted a liver transplant. The company warns doctors and patients alike to discontinue therapy if a patient becomes jaundiced or displays other signs of liver damage.

Originally posted at InjuryBoard by Scott Kappes

Trasylol Contributed to 1,000 Deaths a Month

Scott Kappes — Wed, 27 Feb 2008 16:29:56 GMT

A couple of weeks ago the popular news program "60 Minutes" aired a story on Bayer's Trasylol. The broadcast told the tragic story of Joseph Randone and his experiences following heart surgery where Trasylol was used to reduce bleeding during the surgery. Physicians told the Randone family that the risk associated with the surgery was around five percent and that Joe would likely be able to return home in less than a week. Immediately following the surgery doctors made the family aware of complications during the surgery and alerted them that making it through the night would be the first challenge that he would face. The physician told the Joe's wife and daughter that he believed Trasylol was responsible for the complications.

Ten days after Joe's surgery the New England Journal of Medicine published the results of the largest Trasylol study ever conducted at the time. The study, conducted by Dr. Dennis Mangano, "showed an important association between Trasylol use and kidney failure requiring dialysis." The study also showed an increased risk of death in patients who were given Trasylol.

Researchers in Germany expressed concerns about Trasylol's effect on kidney function as far back as the early 1980's, long before the drug was ever introduced to the U.S. market. In 1992 a small study conducted by one this country's leading heart surgeons, Dr. Kouchoukos, Trasylol was administered to 20 patients. Of the 20 involved in the study 13 experienced kidney problems after the procedure.

The FDA approved Trasylol for high-risk patients in 1993 and approval was expanded to cover all heart bypass patients in 1998. By 2005 Trasylol sales were at a one third of a billion per year with projections of three quarters of a billion in 2006, but then along came Mangano's study.

After the study was published in the NEJM, Bayer hired Harvard professor Dr. Alexander Walker to review the records of almost 70,000 patients. This was an effort to determine the accuracy of Mangano's study before the FDA advisory panel meeting, scheduled to convene in eight month's time. The results of the Bayer sponsored study suggested the same risks that Mangano had seen to in his study.

At the FDA advisory hearing Bayer representatives made no mention of the study that had been conducted on their behalf.

Over this period Joe Randone had undergone 19 operations including the sewing shut of his eyelids, the removal of his gall bladder, and the amputation of his legs.

In 2007 a Canadian study on Trasylol had to be stopped because the patients involved in the trail were dying. This prompted German authorities to ban Trasylol and Bayer temporarily suspended marketing for the drug in both the US and Canada.

"Between my study and November 5, when it was taken off the market, there were approximately 431,000 patients who received the drug. As I calculated, 22,000 lives could have been saved. It's about a 1,000 lives saved per month delay in taking that drug off the market," [Mangano] says.

Joseph Randone died in August of 2006. His family has filed a lawsuit against Bayer.

Originally posted at InjuryBoard by Scott Kappes