Pharmaceutical Litigation

Coming up next week is an issue that affects all Americans who take any kind of drug- virtually all of us.

The case is Wyeth v. Levine and it will be before the U.S. Supreme Court on November 3rd. Now a prestigious medical journal is taking the side of consumers, which puts them squarely against the pharmaceutical industry. That’s a rare position for doctors to take.

In this case, Diana Levine, 62, was given a Wyeth drug for a migraine after she was taken to an emergency room. The Wyeth drug was a secondary drug given to minimize nausea. Now Levine wishes she had opted for the nausea.

Wyeth’s label doesn’t warn against administering the drug as she received it, through something called an IV push. The drug turned her arm gangrenous then she lost much of her right arm, a terrible tragedy for a musician.

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Florida has joined eight states all suing drugmaker Merck & Co alleging deceptive marketing of the recalled painkiller Vioxx.

The lawsuit claims that while Merck offered Vioxx to the Medicaid program it was hiding the drug’s adverse effects in direct violation of the state’s Deceptive and Unfair Trade Practices Act.

Florida’s Attorney General Bill McCollum says the state wants to be reimbursed for more than $80 million spent on health programs, such as Florida’s Medicaid program, which included Vioxx as an approved drug. He wants that money back plus interest and he seeks civil penalties of up to $10,000 per violation.

Vioxx was pulled from the market in 2004 after patients taking the drug for arthritis pain began having heart attacks and stroke. Merck says its own research showed the pill doubled the risk.

Merck’s promotional campaign convinced doctors and patients that the drug was safe and desirable, and McCollum says in a statement that “The company also allegedly tried to intimidate physicians and researchers who questioned the safety of Vioxx.”

Whitehouse Station, N.J.-based Merck said in a statement that Merck acted responsibly. “We intend to defend ourselves against the complaint,” said Ron Rogers. Merck has already agreed to settle about 50,000 claims for damage from Vioxx for $4.85 billion, all being handled out of a New Orleans District Court. At the present time the heart attack victims, or their survivors, are supposed to be receiving payments.

Florida joins Alaska, Louisiana, Michigan, Mississippi, Montana, New York, Texas, Utah and New York City which have all brought substantially similar complaints against Merck. #

Last May the Florida Legislature passed the Pharmacy Technician Act.  

It is a significant piece of legislation that should keep us all safer from the medication errors made by pharmacy technicians. Florida Governor Charlie Crist signed SB 1360 into law in July 2008.

Senate Bill 1360 brings some justice to the Hippely family. Back in the summer of 2002, Beth Hippely of Lakeland, Florida was undergoing treatment for breast cancer. She was taking chemotherapy and the blood thinner, Warfarin, also known as Coumadin.

The pharmacy tech at Walgreens gave her a refill order at ten times the dose for Warfarin. Three weeks on the medication and Beth suffered a massive cerebral hemorrhage. She went into a coma after suffering brain damage and then was put on life support.

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Alcohol and prescription drugs don’t mix.  

Public Citizen has issued its annual “Worst Pills, Best Pills” report and the nonprofit consumer group warns against mixing alcohol with certain medications, even if you are a light drinker.  Most patients don’t read the product inserts where this information is sometimes included. 

Worst Pills, Best Pills” lists 273 drugs that shouldn’t be mixed with alcohol including antibiotics, antidepressants, narcotics and anti-ulcer drugs.

“While the more important alcohol-medication interactions are listed in the table, it is not an exhaustive list,” writes Dr. Sidney Wolfe of the Health Research Group. Patients should also check with a health care professional before taking alcohol with any drug. 

There are a few problems patients should know about:

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Patients in need of an MRI, or magnetic resonance imaging, need to be on alert.

A contrast agent may be injected into the veins of patients about to undergo an MRI to help technicians and doctors to see a detailed image of tissues, bones and vessels.  One in particular, gadolinium, also known as Omniscan, has been connected to a skin disorder called Nephrogenic Systemic Fibrosis (NSF).  

In December 2006, the FDA issued a public health advisory after 90 patients with moderate to end-stage kidney disease developed NSF and another condition known as Nephrogenic Fibrosing Dermopathy (NFD).

The symptoms include thickened, rough and hard skin which sometimes turns dark. Also patients may have difficulty moving.

NSF is progressive and can lead to death. There is no effective treatment for this serious, debilitating disease.

Other symptoms include itching, swelling, tightening of the skin, red patches on the skin, yellow spots in the whites of the eyes, pain deep in hips or ribs, and muscle weakness. Patients typically see these reactions two days to 18 months after they’ve been exposed to a gadolinium-based contrast agent such as Omniscan. 

An earlier warning was issued by the FDA in June 2006.

Currently there are five FDA approved gadolinium-based contrast agents, Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance.  These contrast agents are FDA approved for use during an MRI scan, but not for use during an Magnetic Resonance Angiography (MRA) scan.  Although NSF/NFD has been reported for only 3 of the 5 gadolinium-based contrast agents, FDA believes that there is a potential for the skin disease to occur following the use of any of the approved gadolinium-based contrast agents. 

Doctors should be screening all patients for kidney health, regardless of medical history, if the patient is scheduled for an MRI.

The Mayo Clinic weighs in  saying that there is no special concern regarding kidney problems if you are having an MRI and do not have any kidney problems. Not all MRIs require a contrast agent.

In May 2007, the Food and Drug Administration (FDA) issued a black box warning that gadolinium-containing contrast agents may increase the risk of the rare but serious NSF in people with severe kidney failure. No warnings were issued for any other contrast agents.

Farah and Farah can help if you are suffering any symptoms following an MRI or MRA. Call us.

A drug given to treat Parkinson’s disease and restless leg syndrome is the focus of a number of trials underway in the District Court of Minneapolis.

More than 200 plaintiffs are taking their case forward in so-called bellwether jury trials to determine the stregnth and weakness of the cases.

The cases have been consolidated against the drug, Mirapex.

So far it’s not good news for drug makers Pfizer and Boehringer Ingelheim. This week a federal jury agreed the drug contributes to compulsive gambling and awarded a man $8.2 million.

Many people responding to the story think this is a joke, but it’s not.  Compulsive behavior can not only bankrupt you but destroy marriages and lives. Drug makers denied they knew about the potential side effects, but attorneys for the plaintiffs have shown that the drug makers had knowledge of these compulsive side effects back into the 1990s. Apparently the jury agreed.

Mirapex was approved in 1997, but a warning of compulsive behavior was not issued until 2005.  All the while, millions of patients, trying to relieve the tremors of Parkinson’s, took the drug.  Compulsive behaviors observed include not only gambling, but shopping, eating, hypersexuality, porn, and many repetitive behaviors.

The drug makers blamed the compulsive behavior on the patients.

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Expect Allergan, the maker of Botox Cosmetic, to fight the lawsuit filed by users who claim they were injured or by survivors of Botox victims. 

The suit claims that Allergan failed to warn of the dangers of the drug, used to relax wrinkles both for aging skin and for some medical uses it’s not recommended for as well.

While Botox has been used successfully by millions around the world, there have been exceptions.

In Orange County Superior Court, the suit links Botox to three deaths; last March a 69-year old Texas nurse who received injections for pain in her neck and shoulder and died; a 7-year-old with cerebral palsy who died in 2004; and a third death that occurred just last week in Arizona of a 71-year old who was unable to swallow, speak, breathe or eat before she died.

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We hear it all the time. People come into our office and say they are not the type of person who files a lawsuit.  We tell them, it’s okay, you are an American and the courts are set up for citizens to find a remedy when they’ve truly been injured.    It’s an American right. 

It was an American right for the widow of Charles Riegel. The New York man died after a balloon catheter made by Medtronic burst in his chest after it was inserted during an angioplasty.  She sued, but in February, the U.S. Supreme Court sided with Medtronic.

The reason is enough to scare everyone in this country.  Since the medical device was approved by the FDA, the court decided that the states (in this case New York where the suit was filed) don’t have the right impose liability over a faulty product.  In other words- the FDA is the final word on medical devices.  

Now another issue is going before the Supreme Court and the business community will be watching this case hoping to use federal preemption, as it’s called, to short circuit product and drug liability.  

A Vermont musician won $6.8 million during a jury trial against Wyeth after her arm was amputated because a Wyeth anti-nausea drug was injected.  Wyeth wants to overturn the case so will ask for blanket immunity before the Supreme Court. The drug was approved by the FDA, after all.  

All this is happening at a time when we are beginning to understand just how overwhelmed and underfunded the FDA is to do an adequate job to ensure safety.  

The business community will be waiting, hoping to use that reasoning to short circuit hundreds of product liability and wrongful death claims filed against drug companies and medical device manufacturers.

The outcome of the Wyeth case may seal the fate for hundreds of other lawsuits, filed by people who are hurt.  

Legislation is pending called the Medical Device Safety Act of 2008, that would overrule the Riegel decision, restoring the right for the injured to seek compensation from medical device manufacturers.

If you ever contact your Congressman or woman, this would be the issue that merits a call. It’s called HR 8381 and is sponsored by Rep. Henry Waxman and Frank Pallone.

It basically says that traditional state common-law remedies that the injured have always turned to should be restored, and that right doesn’t undermine the FDA’s powers to protect consumers.

Product liability lawsuits are intended to compensate people –  the kind of people who are truly injured, the kind of people who tell us, “I’m not the sort of person who sues.” #

A report released this week by the Florida Department of Law Enforcement and the Florida Medical Examiner’s Commission concludes that prescription drugs killed more Floridians in 2007 than illegal drugs.

In fact, the rate of death is reported to be over three times as high as deaths caused by all illegal drugs combined.

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Merck and its aggressive legal team are on a roll, overturning jury verdicts across the country that ruled in favor of patients injured by the arthritis drug, Vioxx. 

Last Thursday, the Fourteenth Court of Appeal in Texas overturned a $26 million verdict brought by Carol Ernst. Her husband, Robert died after taking Vioxx in 2001. The three judge panel threw out the conclusions of a jury and the plaintiff’s expert and ruled there was no evidence that the drug caused the blood clot that killed Ernst. 

And the same day, a New Jersey Appellate Court overturned a $9 million punitive damage verdict awarded in 2006, saying that the jury shouldn’t have been allowed to award punitive damages against Merck, or find the drug maker committed fraud.  

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