Pharmaceutical Litigation

We know the pharmaceutical industry is profitable. Very profitable.

FiercePharma takes a look at the biggest CEO salaries in Big Pharma. Following a mega-merger in 2009, Fred Hassan’s salary was bumped into first place. Formerly of Schering-Plough, Hassan made close to $50 million last year as the highest paid pharmaceutical CEO.

Novartis’ Daniel Vasella moved to the number four spot, up three places. But we won’t see him next year. Vasella stepped down as CEO of Novartis in January.

Why should we care? A good deal of wealth is built on the backs of company employees who lost their jobs during mergers. Research, development, and high salaries all keep the prices of essential drugs artificially high and out of reach of the average American, especially someone without insurance. Ultimately, we all pay in increased hospitalizations for those who go without medications. The high cost of medication and health care is one factor that is also driving home foreclosures.

Americans spent about $251.8 billion on prescription drugs in 2005, accounting for nearly 42% of global pharmaceutical sales. In the last decade the wholesale price of more than 150 popular brand name drugs rose an average of 35%. This is an escalation that is unsustainable.

It just doesn’t look good for Johnson and Johnson and its subsidiary, McNeil Healthcare. Thursday afternoon, May 27, a House Committee on Oversight and Government Reform concluded that the Food and Drug Administration needs mandatory recall powers after a report found a series of secret maneuvers on the part of the company and a failure to notify regulators when the company received adverse reports. A document surfaced that shows when a problem was learned about Motrin in 2008, a subcontractor was called in to purchase Motrin from store shelves to determine whether a recall was needed. But the employees were told, “THERE MUST BE NO MENTION OF THIS BEING A RECALL OF THE PRODUCT” in the (note by the contractor). And this was just a “phantom recall.” Motrin was not formally recalled until July 2009.

The FDA is considering criminal penalties after four recalls in eight months by J & J. Appearing on behalf of the company, Colleen Goggins, insists that no children have been harmed by the latest production problems found at a Pennsylvania plant, including bacterial contamination, filthy conditions, and inconsistent formulations leaving some liquid medications “super potent.” That plant has been shut and so has production of about 70% of children’s cold and allergy medications including Tylenol, l, Motrin, Benadryl and Zyrtec. Six key quality control personnel have been changed and by July 15th, she promises the company will have a “master plan” in place to clean up all of the problems with production and product.

A number of lawmakers concluded that the FDA needs mandatory recall capability and they will work to introduce such legislation. Joshua Sharfstein, the deputy commissioner of the agency says they also need access to records in a timely manner. Otherwise it’s the tail wagging the dog and the FDA must follow the lead of pharmaceutical and medical device makers who get to decide when and if a recall takes place. If you or a family member has been harmed by a defective medication, you need to contact the manufacturer as well as the pharmacy that sold it to you. And a Florida drug injury attorney can advise you of the rights you retain. In the meantime, follow the advice of the FDA and ditch the J & J and McNeil brand and purchase generics.

The University Of Florida School Of Veterinary Medicine says it’s likely that too much selenium in a compound given to 21 polo horses is what killed them. The 21 polo horses were getting ready to compete in a Florida match on April 19, according to an article.

They all had received an injection only described as a compound consisting of vitamin B12, along with a form of selenium and vitamins and minerals. A similar drug is Biodyl, a French-made compound not approved in the U.S. The horses not injected did not die.

The 21 horses were preparing for a championship match and were flown in from Venezuela. Shortly after being given the unnamed drug, they began crumpling to the ground to the shock of the well-heeled crowd at the International Polo Club Palm Beach in Wellington.

We now know that Franck’s Pharmacy in Ocala prepared the compound. It is a retail compounding pharmacy used by veterinarians and physicians considered one of the biggest and best in the country to create customized formulas.

Franck’s admitted it made an error in the mixture.

Every year in the U.S. there are about 30 million dispensing errors out of three billion prescriptions, according to the National Patient Safety Foundation. Some errors are minor, but others can be serious.
A 2006 Institute of Medicine report called, “Prevention Medication Errors,” points out that these sorts of human errors in medical settings harm at least 1.5 million every year, while more than half of medication errors result in “adverse outcomes” such as death or serious illness.

Prescription errors can be considered negligence or medical malpractice in Florida. Whether dispensing the wrong medication or in the wrong dosage, highly paid professionals should be expected to meet professional standards and show a level of caring.

If you or a loved one has suffered as the result of a prescription error, you may have a claim for medical negligence against the pharmacist, pharmacy, or drug maker. Our skilled Jacksonville pharmaceutical litigation lawyers at Farah and Farah are experienced in investigating claims of medication mistakes resulting in serious injury and wrongful death. Call us today for a case evaluation.

You know the Vytorin commercials – comparing eating fettucini alfredo with your Uncle Alfredo – both are sources of high cholesterol, the ads said. Food and family are both to blame.

Now the lawsuits against the drug are piling up higher and Merck & Co and partner, Schering-Plough Corp have to answer questions to the Justice Department about whether the promotion of Vytorin made false claims. Read the rest »

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.

Read the rest »

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.

Read the rest »

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:

Read the rest »

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.

Read the rest »