Class Action Lawsuits

The latest birth defects lawsuits this week are concerning Depakote and side effects on babies born to mothers who took the drug during pregnancy.  Depakote is an anticonvulsant used to treat symptoms of epilepsy and of the manic phase of bipolar disease.  It is manufactured by Abbott Laboratories, and was first approved in 1983.  Since initial FDA approval, Depakote has also become available in generic form and also under other brand names.  Abbott Laboratories is the defendant named in any birth defects lawsuit, however.

Depakote side effects include birth injuries or birth defects such as cleft palate, skull and face deformities, neural tube malformations, and cardiovascular malformations.  The FDA issued a warning in December 2009 on drugs containing valproate sodium, the main active ingredient in Depakote.  The FDA warning was over birth defects and warned against increased risk in women taking the drug during pregnancy.  Since there were no warnings and both patients and doctors were allegedly kept in the dark concerning birth injuries, Abbott Laboratories has been named in birth defects lawsuits.

Women who were prescribed Depakote during pregnancy for treatment of migraines may also participate in a birth defects lawsuit against the drug company.  Treatment for migraines is an off label use for Depakote, which means it was not FDA approved for this use, but doctors prescribed it anyway since it seemed to work.

Taco Bell is the center of the legal news right now, over whether their beef tacos contain real beef.  The fast food company was sued in Federal court in the State of California by an Alabama law firm earlier this year.  The Taco Bell lawsuit has generated much fanfare and public interest.

This Taco Bell class action alleges that the beef tacos are advertised as filled with ground beef when in fact they are only 35% beef.  The rest is fillers and extenders, according to plaintiffs, like water, maltodrextrin, wheat oats, soy lecithin, and preservatives.

The FDA regulates what can be called ground beef, and Taco Bell’s seasoned beef do not meet the requirements, say analysts who studied a beef taco recently.  Lead plaintiff in the Taco Bell lawsuit is Amanda Obney and she isn’t asking for damages or money, surprisingly.  She’s simply asking that Taco Bell properly label its food so consumers know what they’re getting.  The USDA’s website states that for something to be labeled ground beef, it must not contain phosphates, extenders, binders, or water.

A spokesman for Taco Bell stated that lawyers for the plaintiff opted to sue first and then investigate the fact afterward.  He claims that the Alabama law firm got the fact wrong, and that Taco bell uses 100% USDA ground beef simmered in their special spices to achieve the seasoned taco meat.

Women who received breast implants in the 1970s and 1980s may have been part of the now famous breast implant class action that is just now coming to a close.  Last December 2010 was the cutoff date for new cases and the company that made the silicone implants up until 1992 has since gone bankrupt.  That was Dow Corning, a major corporation, which has since paid out $1.2 billion to plaintiffs in the Dow Corning class action settlement.  That case was first filed in 1998, clearly showing that any breast implant class action lawsuit takes years to come to an end.

Back in the late 1908s, when the first breast implant class action began to take shape, the problem was leaking silicone from the implants.  The medical and scientific communities were never in total agreement over whether the leaking silicone caused the health problems reported by plaintiffs, but Dow Corning settled nevertheless.  Hundreds of thousands of women joined the breast implant class action at the time, which was 1998, six years after the implants were pulled from the market by the FDA.

Dow Corning class action settlement claims ranged from $5,000 to $25,000.  Women claimed the leaking implants had caused autoimmune disease and other medical complications.

Beginnings of the end of the 1990s breast implant class action lawsuit come just as news of a possible link between implants and a rare form of cancer hit the airwaves.  Just last week, Federal health officials reported that there were 60 cases of anplastic large cell lymphoma in women who had implants.  The rare form of cancer showed up in women who had both silicone and saline-filled breast implants.

60 cases out of an estimated5 to 10 million women who have breast implants today is a medically noteworthy statistic.  The FDA is following the reviewing the cases, and is going to require that Allergan Inc. and Johnson & Johnson’s Mentor Corp., makers of today’s breast implants, put a warning about the risk of a link to cancer.

Avactis issued a Fentanyl recall after the FDA informed the drug maker that some patches caused Fentanyl overdose.  The transdermal patch that issued the pain medication can in some cases release too much at once, causing severe health side effects.  To avoid Fentanyl overdose, adverse side effects, and a Fentanyl recall lawsuit, Avactis is doing everything they can to warn the public, health care professionals, and customers to return defective patch lots to them.

Only some lots of the transdermal patch are affected by the Fentanyl recall, and no patches in Europe are being recalled.  The lots are of 25 mcg/h, but not all of them.  To find out which lots of the Fentanyl patch are being recalled, go to the website of the drug maker Avactis and there you will find a list of the lot numbers, which can be found on the the side of the package of patches.

Fentanyl is an opioid, a narcotic which is a Schedule 2 controlled substance.  Patients who receive Fentanyl are experiencing moderate to severe chronic pain.  They need round the clock pain killer relief and cannot get it from opioid combination products, non-steroidal analgesics, or immediate release opioids.

Some patients who experienced adverse effects after administration of the Fentanyl patch have pursued an individual Fentanyl recall lawsuit to recover medical costs and other loss encountered by a Fentanyl overdose.  A fentanyl class action lawsuit has yet to be formed.

GlaxoSmithKline, the British drug company and manufacturer of some of the world’s top selling drugs, announced today that it would set aside billions of dollars for legal costs.  The GlaxoSmithKline class action is costing the company most of its fourth quarter profits, as it faces rising numbers of lawsuits over Avandia and Paxil.

Today’s amount set aside for legal costs totals $3.4 billion, and that comes no less than six months after another announcement of  billions of dollars worth of legal fees.  Last summer, GlaxoSmithKline announced that it would spend $2.36 billion for legal defense and ongoing Federal investigation over off label marketing charges and alleged doctor payments regarding Avandia and Paxil.

That means the GlaxoSmithKline class action and Federal investigations in the United States have so far cost the company $5.76 billion in legal fees, settlements, and other legal costs.

Avandia was once the top selling diabetes drug in the world, but has fallen off since discovery of possible serious health concerns.  In 2007 a doctor’s analysis revealed a 43% increase in risk of heart attack in patients taking Avandia.  Since then, GlaxoSmithKline class actions have been on the rise.  And judging from today’s announcement, GlaxoSmithKline doesn’t see an end to legal woes anytime soon.

GlaxoSmithKline also faces allegations of marketing Avandia for treatment of things for which it was not FDA approved.  Doctor payments for promoting Avandia are also under investigation, as this practice is against the law in the United States.  The British drug company is facing GlaxoSmithKline class action in the US as well as legal woes in the UK.  The FDA has severely restricted use of AVandia and in Europe it has been banned altogether by the European Medicines Agency.

Johnson & Johnson faces another possible class action lawsuit, this time over failed hip implants.  The De Puy Articular Surface Replacement was recalled and now the company faces what seems like a De Puy lawsuit in every state.  The subsidiary of Johnson & Johnson, called De Puy Orthopaedics, faces major uphill legal battles for its failed hip implants, which had been described previously as the breakthrough implant for hip surgery patients.

The Articular Surface Replacement was supposed to last fifteen years and create more natural movement for the patient.  The ASR implant was also supposed to last longer than older types of implants.  However, they lasted hardly at all in many patients who have formed several De Puy lawsuits in several states.

Major news agencies are now picking up the story as they scrutinize the process that allowed the faulty hip implant to reach operating tables around the world.  The FDA had approved the ASR hip implant, but why?  The answer lies in the fact that approval processes are very fast and easy for devices that are very similar to already approved devices.  In fact, if it’s similar to an approved device, the new product such as the De Puy hip implant, doesn’t even have to be tested.

The system creates loopholes, where totally new and untested developments can be bundled onto already-approved devices ( in this case, implants), and approved without testing.  And this is how the faulty ASR came to be found in patients’ bodies, alleges the De Puy lawsuit.  About one third of the roughly 93,000 ASR De Puy hip implants worldwide were implanted into US patients, says representatives at De Puy.

But there’s no independent database where doctors could track success and failure rates of the ASR implants, so they had no idea that others were failing, even as they were operating on more patients and implanting the ASR system.  The entire process is under intense scrutiny thanks to the Dr Puy lawsuit formed in nearly every  region of the US.

Zyprexa is a Diabetes drug made by Eli Lilly & Company.  It’s an extremely profitable product for the drug maker, bringing in 4.9 billion dollars in sales just last year.  That makes it the top selling product of one of the top drug makes in the world.  The drug, however, is at the heart of an ongoing struggle to form a Zyprexa class action lawsuit.

The drug was approved by the FDA to treat bipolar disorder and schizophrenia.  It’s heavily marketed by Eli Lilly, and there is strong demand for the drug.  The marketing features impressive claims as to the effectiveness of the drug in treating the serious bipolar disorders and schizophrenia.  The Zyprexa class action claims that this marketing was exaggerated, which increased demand, which caused the price of the drug to go higher.

The Zyprexa class action was brought by plaintiffs representing unions, insurers, and pension funds who claim that the exaggerated advertising of the effectiveness of Zyprexa caused them to have to pay more for the drug.  In 2008, their case was granted class action status.  However, that ruling of status has just been overruled and the Zyprexa class action is no longer on the dockets in Federal court.

The Zyprexa class action status was denied because the individuals who purchased Zyprexa did not have enough in common with the insurers, pension funds, and unions who represented the other portion of the group of plaintiffs.  For a class action to be certified, the many plaintiffs must have enough in common for them to be represented together as a group.  This Fall, the Federal Appeals Court of New York overturned the class action status of the Zyprexa lawsuit, about two years after the status had been granted to the case.  Members of the Zyprexa class action plaintiffs had been, among others, the United Federation of Teachers Welfare Fund and a group that represent retired NY police sergeants and their families.

A Sacramento woman is bringing what she hopes to be a Happy Meal class action lawsuit against McDonald’s.  It’s not over hot coffee, but rather calories.  Specifically the calories, fat and sugar contained in Happy Meals aimed at kids.  Her Happy Meal lawsuit claims the toys are used by the fast food giant to entice kids to beg for Happy Meals.  She says she already finds it very difficult these days to say no to her kids, and McDonald’s is making it harder yet.  The suit alleges McDonald’s uses the toys inside Happy Meals as temptation or bait, to get kids to beg for the meal, which is full of unhealthful food like french fries and sugary sodas.

The Happy Meal class action is being brought to light by the Center for Science in the Public Interest.   They hope more people will come forward so that their suit can gain class action status.  Just one month ago the City of San Francisco voted to limit toy giveaways in food targeted at the kids’ market and which are loaded with calories, fat and sugar.

But not everyone agrees that legislature is the way to keep kids eating healthy.  Sarah Palin for one calls on people to leave the choices to parents, not the government.  And of course when contacted, McDonald’s agreed.  They responded to this Happy Meal class action in a statement, in which they said that they believe the parents should be making choices, not the Center for Science in the Public Interest.  McDonald’s also said that there are more choices than ever these days when it comes to Happy Meals.

Indeed, the Happy Meal has come a long way since it first appeared on the menu at McDonald’s.  These days they advertise that Happy Meals contain such healthful foods as Apple Dippers and lowfat milk.  However, the Happy Meal class action claims that it’s up to the employees of any particular McDonald’s restaurant to fill the Happy Meals.   More often than not, it is alleged, it’s french fries and sugary sodas you get when you buy the Happy Meal.

To some, Fentanyl is a gift from the heavens.  Offering relief from chronic pain and delivering 80 times the power of morphine, Fentanyl is prescribed today mostly through a transdermal patch.  It’s the most widely used synthetic opioid.  It is truly in some ways a symbol of the power of modern science and medicine.

On the other hand, Fentanyl has caused tragedy and horror to others, who unsuspectingly suffered a Fentanyl overdose due to faulty delivery systems.  The Duragesic brand patch system of delivering Fentanyl through the skin had some problematic batches that caused a hole in the reservoir of the patch, causing too much drug to enter the systems of patients, who died as a result.  The Fentanyl overdose lawsuit that took place after each case raised heads around the country in the medicine world, as well as the legal system.

Millions of dollars have been awarded to plaintiffs who brought Fentanyl overdose lawsuits in the past few years.  The first suit was in 2003, involving the death of a man who overdosed on the Fentanyl patch.  The Duragesic patch, now involved in so many Fentanyl overdose lawsuits, was first introduced in the 1960s.  It was used as a general anaesthetic,   and not until the 1990s was Fentanyl administered via a patch.   But it was not until the turn of the century, early 2000s, that Fentanyl became a prescription drug, which meant really widespread use.   Now there is also a Fentanyl  lollipop and a spray.

Fentanyl is quick-acting and highly addictive.  It’s an opioid, and works on the brain censors causing a state of euphoria.  Fentanyl has the ability as a chemical to pass quickly from the blood to the brain, hence the quick-acting component that makes it a useful and popular drug with doctors.  It’s used in the operating room, intensive care units, cancer pain, and chronic pain management.  Dentists also use it in root canal procedures.  Patients who cannot take morphine, hydromorphone or oxycodone will be prescribed Fentanyl.

With these new and wider-range uses of Fentanyl, and more prescriptions which means more of the drug in personal situations and in households, there have been more Fentanyl overdose lawsuits these past five years or so.  The Duragesic patch that malfunctioned was recalled in 2004 but lawsuits continue.

Risks of heart problems have led the FDA to request a Darvon recall from its manufacturer.  Xanodyne, maker of Darvon and also of Darvocet, another version of the drug, is cooperating with the FDA suggestion of recall.  The recall suggestions came last month after new studies suggested a link between Darvon and heart problems.  The main active ingredient in Darvon is propoxyphene, which is the cause of possible heart problems and of possible fatal overdose as well.

Darvon is prescribed for mild to moderate pain and when combined with acetaminophen, is called Darvocet.  There is also a Darvocet recall, also recommended by the FDA and carried out by the manufacturer Xanodyne.

Propoxyphene, the main ingredient in both Darvon and Darovocet, is an opioid and was first approved by the FDA in 1957.  Starting in 1978, however, hints of problems with the drug began to emerge, and various groups over the years have asked the FDA to review or even suggest a Darvon recall.  These past worries were tied to the potential for fatal overdose, but in all cases the FDA concluded that the benefits of the painkiller outweighed the risks.

In 2009 the FDA told Xanodyne to put warnings on the boxes of Darvon and Darvocet, indicating risk of fatal overdose.  They also required Xanodyne to perform studies on effects of propoxyphene on the heart.  The results of the study are what have caused to the FDA to issue the current voluntary Darvon recall.

Darvon, Darvocet, and generics are to be recalled.  The FDA has sent notice to the makers of the generic versions of the pain killers, informing the companies of Xanodyne’s decision to cooperate with the Darvon recall.  It is expected that the generic manufacturers will follow suit.

Propoxyphene was found to be linked to heart problems in the studies performed by Xanodyne in 2009 and 2010.  Specifically, it is believed to cause heart rhythm abnormalities, which can be serious if not fatal.  Last month’s Darvon recall will have great effect on some patients, who have been taking the drug for a long time.