Pharmaceutical Litigation

An estimated 20,000 patients took the pain reliever, Vioxx, also know to double the risk of heart attack and stroke. Despite that, Merck & Co. kept on marketing the blockbuster that made Merck $2.5 billion annually before thousands suffered heart conditions and died, with Vioxx being recalled in September 2004.

The Department of Justice (DOJ) is wrapping up its settlement with Merck and on Tuesday, November 22, the DOJ announced Merck & Co. of Whitehouse Station, N.J., will plead guilty to charges it illegally promoted the drug and pay $950 million to settle criminal charges of illegal promotion, a misdemeanor, and a civil settlement to reimburse the U.S. and 43 states as well as the District of Columbia regarding false statements and off-label marketing.

Merck is accused of promoting Vioxx for off-label use for rheumatoid arthritis, even though the drug had not been approved for RA until April 2002.

This $950 million is among the top five settlement records in history. Merck insists the settlement is not an admission of liability, however, as part of the settlement Merck & Co. will enter into an integrity agreement with the Office of Inspector General and HHS. As part of the settlement, Merck has also agreed to enter into an expansive corporate integrity agreement that requires top company officials to file compliance certificates annually and Merck to post payouts to physicians on its website, a possible conflict of interest admission.

In November 2007, the pharmaceutical giant agreed to pay $4.85 billion to settle personal injury claims of those harmed by the recalled product, an estimated 27,000 people. Many others did not file claims because they ran out of time or live in Michigan, which does not allow citizens to file any lawsuits against pharmaceutical companies. About $4 billion went to patients who suffered heart attacks and $850 million went to stroke patients.

The Tallahassee medical malpractice lawyers with Farah & Farah can help you in your injury claim. Call us for a consultation on your case today at (800) 533-3555.

Source: http://www.news4jax.com/health/Merck-to-pay-950-million-for-illegal-marketing-of-Vioxx/-/475590/4808698/-/ptud49z/-/index.html; http://www.justice.gov/opa/pr/2011/November/11-civ-1524.html;

The drug Gardasil has been controversial ever since its approval by the U.S. Food and Drug Administration (FDA) in 2006 for the prevention of genital warts and cervical and vaginal cancer, but on Wednesday, December 33, an FDA press release announced the approval of the vaccine for the prevention of anal cancer due to the human papillomavirus (HPV) virus types 6, 11, 16, and 18 in people ages 9 through 26 years.

The HPV virus is associated with about 90 percent of anal cancers. It’s estimated about 5,300 people are diagnosed every year in the U.S., with the number of women diagnosed outnumbering men.

Since its approval, more than 65 million doses of Gardasil have been distributed to young women. Manufacturer Merck and Co. has been criticized for aggressively marketing Gardasil through the “One Less” campaign, which targeted adolescent and teenage girls, and Merck lobbied female legislators unsuccessfully to introduce state laws to make the cervical cancer vaccine mandatory.

In January 2009, Merck was denied expanded approval for Gardasil by the FDA, who required more data on whether the drug would be effective if used by women who were already sexually active at ages 27 to 45. It is currently only approved for use in young women ages 9 to 26.

Additionally, the nonprofit group Judicial Watch has made public the FDA’s internal reports showing at least 10 deaths related to use of the drug since September 2007 among young users after being vaccinated, along with more than 140 serious adverse events.

If you or a loved one has suffered an adverse side effect because of using Gardasil or another dangerous drug, an experienced Florida pharmaceutical litigation attorney will want to hear the specifics of your injury to help build a strong case on your behalf.

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 »