Product Liability Attorney Blog

When it comes to the gastroesophogeal prescription medication known as metoclopramide, information commonly found about it is usually associated with the gastrointestinal drug Reglan. However, it should be known that Reglan is not the only metoclopramide drug on the market that is linked with its adverse side effects.

Metoclopramide was first introduced to the market in the 1960s. Back then it was known to help stop vomiting and decrease acid buildup. It was approved by the FDA in 1985 as a short-term treatment of diabetic gastroparesis as well as GERD. It is still used for those treatments. In 1999, the brand name metoclopramide drug Reglan hit the market and was approved quickly; however, the drug has also been associated with tardive dyskinesia (TD).

This isn’t new information; scientists have long known that metoclopramide can cause TD. That is why the drug was only approved as a short-term (no more than 12 weeks) treatment in the first place. The problem is that most patients had taken it for far longer than that (months to even years) before the FDA finally issued a black box warning against such prolonged uses.

While Reglan is the most-commonly-used version of metoclopramide, it isn’t the only one. Other forms of metoclopramide used in hospitals include: Metozolv ODT, Maxolon and Octamide. These are just brand name versions of metoclopramide. There are various generic versions out as well. All of these brands also include TD risks; Maxolon was discontinued.

Generic versions of the drug cause the same risks as Reglan and the other brand name. However, the Supreme Court recently ruled that lawsuits can’t be filed against generic manufacturers. That means little as many Reglan victims are now adjusting their lawsuits to file against the brand name manufacturers instead. All is not lost for patients suffering from TD caused by Reglan use, and the drug companies will not get away with it. Patients should know that if they took Maxolon or Octamide they may have liability lawsuits as well.

It looks like Bayer just isn’t getting off the hook any time soon when it comes to Yaz. Another 53 people from all across the United States filed a lawsuit on Aug. 8 against Bayer, the makers of the controversial birth control pills Yaz and Yasmin.

Lead plaintiff Wendy Ridge and 52 others are suing Bayer for the same reason that thousands of other women and their families are: This suit alleges that they have suffered from blood clots and gallstones after taking Yaz.

The plaintiffs in this case live in various states across the country and this suit comes after a commercial aired (alerting people of the dangers involved in taking the drug) that weren’t being warned about a few years ago. In fact, Bayer was ordered by the FDA to correct the original ad which claimed that Yaz was good for treating acne, severe PMS and disphoric disorder as well as birth control. The new ad states, "You may have seen some Yaz commercials recently that were not clear. The FDA wants us to correct a few points in those ads." Even that admission shows that Bayer is forced and not being sincere.

That correction came a little too late for these plaintiffs since their lawsuit is claiming that Bayer and their $20 million ad campaign didn’t warn them about the dangers associated with the pill before they started taking it. The lawsuit complaint states "Defendant knew or should have known that the use of drospirenone in Yaz/Yasmin causes arrhythmia, cardiac arrest/heart attack, intracardiac thrombus, pulmonary embolism, deep vein thrombosis, stroke and/or gallbladder disease."

The complaint continues by stating, "Despite the wealth of scientific evidence, Defendants have not only ignored the increased risk of the development of the aforementioned injuries associated with the use of Yaz/Yasmin, but they have, through their marketing and advertising campaigns, urged women to use Yaz/Yasmin instead of birth control pills that present a safer alternative."

These points made in the complaint demonstrate this when they point out that from 2004 through 2008, the birth control pill Yaz is reported to have caused as much as 50 deaths and that some of those deaths occurred with women as young as 17.

As the New Jersey Levaquin trial continues in court, the plaintiffs’ lawyer alleges that drug giant Johnson & Johnson failed to properly alert them of the drug’s risks to tendon ruptures.

The lawsuit alleges that officials of New Brunswick, New Jersey-based J&J and its Ortho-McNeil-Janssen Pharmaceutical unit tried to downplay just how dangerous Levaquin was on the drug’s label. This, the lawyers say, happened even after they received European reports about the tendon ruptures, says the lawyer for the plaintiffs.

Paul Gaffney and Robert Beare are saying in their lawsuit that they have suffered from severe tendon ruptures after taking Levaquin. In his opening statement to the jury, their attorney said, “J&J officials knew there was a problem and did everything they could to hide it to protect Levaquin’s sales.”

The lawyer for Johnson and Johnson, meanwhile, said that Johnson & Johnson warned both doctors and patients of the tendon risks repeatedly ever since the drug was approved for sale the U.S. in 1996. “From the very first label, Johnson & Johnson included information about reports of ruptures of the shoulder, hand and Achilles tendon.”

This is only the third Levaquin case to reach a courtroom. The first resulted in a $1.8 million award for plaintiff John Schedin. Most recently, the lawyers for the defendants in that case tried to get an order to vacate, but the judge upheld Schedin’s verdict. Levaquin lawsuits have been filed by the thousands amid similar claims that drug makers failed to warn the public and doctors of the risks associated with it. While this case isn’t the last in that long list of lawsuits, the verdict will be closely followed by many as everyone waits for another verdict that may hold the drug company liable for the damage patients have suffered.

Ortho-McNeil, the makers of the controversial antibiotic drug Levaquin, has been denied its motion to vacate by a federal judge.

The motion was filed against a jury award that gave one Levaquin lawsuit plaintiff, John Schedin, almost $2 million. Schedin’s lawsuit claimed that the drug company didn’t properly warn him about the risks of developing Levaquin-related tendon ruptures when taking the drug. A jury agreed with Schedin and he was awarded $1.8 million in damages. Schedin’s case was picked to be the first bellwether trial to take place after a group of cases were consolidated into an MDL for pre-trial coordination.

The drug maker’s lawyer tried to argue that the jury’s verdict in favor of Schedin went “against the clear weight of the evidence.” It was also argued that the drug makers didn’t get a fair trial because of “erroneous evidentiary rulings,” and that the plaintiff’s lawyers didn’t present proper closing arguments. Ortho-McNeil insisted in the motion to vacate that Schedin’s lawyer didn’t meet the burden of proof in presenting his client’s case.

However, the drug maker’s arguments fell on deaf ears as District Court Judge John R. Tunheim upheld the jury’s ruling. The judge stated that the testimony given at the trial proved that if nothing else, Schedin’s doctor didn’t know about the “revised” warning, which was added to the Levaquin label in 2001. The warnings included the increased risks of patients developing tendon ruptures — especially in the case of patients older than 60 years old and those taking corticosteroids.

Tunheim stresses the fact that the “duty to warn rests on the manufacturer” to keep the labels updated and he says that he agrees with the jury that the “fine print changes to the label of a drug that had been on the market for years with no other communication to prescribers failed to fulfill that duty.”

The state of Kansas is about to receive more than $700,000 from drug maker GlaxoSmithKline as part of a settlement from a lawsuit that also included defendant SB Pharmco Puerto Rico Inc.

Information that was released by the office of the Kansas Attorney General, Derek Schmidt, says the settlement is meant to solve the problem of the allegations that were made against the manufacturing practices that caused some of Glaxo’s drugs to be tainted. The actual settlement of more than $40 million was to be distributed to many different states. In Schmidt’s explanation to this, he says, "Consumers expect medications prescribed by their doctors to be effective and safe. This settlement holds drug manufacturers accountable for providing safe, reliable products."

In the lawsuit, GlaxoSmithKline and SB Pharmco Puerto Rico were accused of using deceptive practices when it came to the making and selling of various different batches of different drugs including Paxil CR. The manufacturing plant that they were talking about in the lawsuit has been closed since 2009. The claims also said that the companies used poor manufacturing techniques when they made the drugs, causing them to become tainted.

A release from the Kansas attorney general's office states that every tainted drug from this incident has been recalled and are all past their expiry dates by now. Regardless, the AG still wants patients who were taking any of the drugs that were mentioned in this incident to talk to their doctors if they think that they were taking any of the tainted drugs.

This case is not the first time that Glaxo has gone under the gun for problems associated with Paxil. They have been dealing with lawsuits against the drug’s side effects for years. Most recently, Paxil birth defects have been making the news. The hits just keep on coming over Paxil, yet Glaxo continues to claim that these drugs are safe.

The "Paxil Defense" has been shot down after Jolene Marie Harris, Rocky Mount, Va., was found guilty Aug. 29 of assaulting a police officer and a social worker. The judge rejected her claim that she was "involuntarily intoxicated" after she argued that having taken Paxil as well as some other prescription medications earlier that day caused her to be unable to understand the consequences of her actions. When you hear the rest of the story, you may be inclined to believe the woman.

Harris, 28, could spend at least six months in jail for the assaults, which involved her “kicking a Rocky Mount police officer in the groin and throwing a bottle of juice at a social worker on Dec. 10, 2010.” Her lawyer tried to convince the judge that Harris was intoxicated after taking the 40 mg of Paxil and Dexatrim Max earlier in the day by saying, "The combination of prescription medications caused a toxic reaction and rendered her unable to understand the consequences of her actions."

Harris herself testified that she took 40 mg of Paxil and Dexatrim Max on December 10 in the morning. By that afternoon, she says she filled many more prescriptions that included Imitrex, Benedryl, Buspar and Phenergan and took each of them at 1 p.m. Harris also says that she didn’t consume any illegal drugs or alcohol. According to the woman and her lawyer, she doesn’t remember anything that happened. After taking all of those medications, it certainly makes sense. However, according to the police officer and two social workers, she smelled of beer at the time of the assaults.

The "Paxil Defense" is becoming a common thing these days as the side effects of the drug have been proven to cause some patients to suffer from aggressive behavior and even violence toward themselves or others. Research has shown that Paxil and other SSRI medications can cause people to exhibit aggressive behavior, suicidal thoughts and behavior; the drug has even been linked to countless murders by patients taking it. It is that fact (coupled with the studies to back it up) that makes the "Paxil Defense" so credible in the first place. Judges all over the country have begun to realize that SSRIs like Paxil have the potential to cause some people to act out in violent ways, and are making judgements with that knowledge in mind.

Ever since GlaxoSmithKline won FDA approval for its controversial antidepressant Paxil in 1992, the company has spent much of its time educating consumers on various mental disorders just so they could promote their Paxil solution to them.

Through creative and in-your-face advertising campaigns, Glaxo has been able to convince not just the public, but doctors, too, that Paxil is a cure-all for symptoms of various “treatable” conditions. Because of this creative marketing effort, Glaxo was able to get Paxil approved to treat just about every possible type of anxiety such as:

Depression
Panic disorder
Social anxiety disorder (SAD)
Obsessive-compulsive disorder (OCD)
Post-traumatic stress disorder (PTSD)
Generalized anxiety disorder (GAD)

This is a common practice among drug makers, which prefer to use direct-to-consumer marketing. An example can be found in those commercials that ask you if you are suffering from any myriad of conditions and then promote a certain drug as the answer. Marcia Angell, former editor of the New England Journal of Medicine, says that this type of marketing is used as a tool to get people to think that they have some sort of mental disorder. She has written a best-selling book about this type of marketing: "The Truth About the Drug Companies: How They Deceive Us and What to Do About It."

"If you can define everyone who has the blues as having depression that needs to be treated, you've created a huge market," she says. "If you define everyone who is shy as having social anxiety disorder that enlarges the market. There's probably not a soul alive who hasn't felt shy. If you listen to the pharmaceutical industry, many of the ordinary discontents of life are medical conditions that require drugs."

Angell has a point. Everyone has seen the commercials that asks you if you have experienced a common symptom and then says that you may have a disorder that can be treated with some drug like Paxil. This may have worked as a marketing tool, but it caused thousands of patients to experience harmful side effects that resulted in deaths for many. This should alert people to the fact that medication should not be prescribed just to treat symptoms, but real conditions.

Judge David R. Herndon, who is presiding over the Yaz Bellwether trials, has announced that he intends to push for “meaningful” settlement negotiations at the end of the initial trials. This move is meant to aid in gauging just how the juries are going to reply to all of the evidence and testimony that is likely to be similar to what would be offered in other Yaz cases.

So far, more than 6,350 lawsuits have been filed in federal district courts all over the United States. Just about all of those cases allege the same thing: That Bayer, the maker of Yaz and Yasmin, didn’t properly warn them of the dangers associated with Yasmin and Yaz. The side effects include heart attacks, strokes, pulmonary embolisms, gallbladder disease and deep vein thrombosis.

Back in October 2010, Herndon instituted the Bellwether trials as a means of handling the overwhelming number of lawsuits that were expected to be filed. Bellwether trials take a couple of the different lawsuits and use them as a means of getting an idea of how future trials may go. This often prevents having to try all of the cases. It also gives drug makers a chance to settle all of the cases that are similar rather than keep going to trial over and over again.

The first of these trials is set to begin early next year and will be about pulmonary embolisms caused by Yaz. Next will be the gallbladder trial and then it’s on to the DVT case. Lawyers for the plaintiffs asked the judge recently to consolidate many cases for the second and third trials by stating that only trying one case would “commit this litigation to a lifespan of eternity.”

The reason for that statement is because they say that Bayer won’t offer any settlement so it would be a lot more efficient to try many cases at the same time. Herndon rejected the plaintiff’s request and stated “The Court has no intention of presiding over anything into eternity, let alone this litigation, and the Court is presently working on a process that will engage the parties in settlement discussions following the Bellwether trials in a meaningful way."

When it comes to helping menopausal women cool down their hot flashes, many ideas have come across the table. For a while, soy and flaxseed were thought to be helpful, but research showed that they didn’t work any better than placebos. The hormones estrogen and progestin may wind up continuing to be the safest treatment for the condition since prescription medications like Paxil and Effexor have proven too dangerous for the task.

Some studies have shown that antidepressants like Paxil, Effexor and Pristiq can reduce hot flashes by as much as 60 percent. They have even proved useful for women with breast cancer or blood-clot disorders that can’t take any of the hormone drugs. However, those antidepressants have also proven themselves to be far more dangerous insofar as harmful side effects go. For some women, taking the antidepressants could prove deadly. Somehow, hot flashes don’t seem quite as uncomfortable when compared to the potentially deadly consequences of taking antidepressants.

Some doctors are really frustrated by the idea of women being encouraged to undergo some of these more drastic or potentially useless methods because they prefer that women take the hormone treatments. Dr. Holly Thacker, director of the center of specialized women’s health at the Cleveland Clinic, has said that most of the benefits for women taking the hormone treatments (which have been proven to work) hold more weight against the risks associated with the treatment. She encourages women to take the hormone treatments and hope that they are not scared off into taking vitamin supplements that don’t work or potentially life-threatening antidepressants like Effexor or Paxil.

Thacker knows that hot flashes are causes by an imbalance of hormones, so it seems natural that hormone treatments could fix it.

“It would be like telling someone with insulin-dependent diabetes that they should try to use other things besides insulin," she says. "I see women look to alternative agents and coming in with bags of things, and they have no idea what they are putting into their body. There has been so much misinformation, and they are confused.”

St. Clair County, Ill., courts are busy as more plaintiffs joined a lawsuit filed against Johnson & Johnson, Ortho-McNeil Pharmaceutical and Johnson & Johnson Pharmaceutical Research and Development. The suit alleges that the controversial antibiotic Levaquin caused the plaintiffs to suffer from tendon damage.

All of the plaintiffs are saying that after taking Levaquin, which is usually prescribed to treat upper respiratory infections and bacterial infections, they suffered from tendon ruptures and injuries. Each plaintiff claims that they did know about the potential for tendon damage before he or she took the medication. They also say they didn’t know that the risk was even higher in patients 60 and older or if they were taking corticosteroids.

The plaintiffs who have joined in the Levaquin lawsuit include Allan Booth Jr. of Rhode Island, Michael Faulkenberry of South Carolina, Carol Leflay of Arkansas, Constance J. Lund of Wisconsin, Peter Pearson of New York, Walter Prim of New York and Teresa Tacey of Michigan, court documents show.

Levaquin was first brought to the American market in 1997; at that time, warnings about the side effects to the tendons were required to be on all fluoroquinolone labels. That is not what happened, though. The warnings ended up being hidden in a long list of possible side effects instead. According to the plaintiffs, the warnings didn’t even mention that the potential for tendon injury increased by three times for people older than 60 and in those who were also taking corticosteroid therapy.

To make matters worse for the manufacturers, Johnson & Johnson actually seems to have marketed the drug specifically to seniors who were suffering from upper respiratory infections. This is significant because those patients with the infections were also likely taking corticosteroid to treat their infections also. The complaint specifically says that "more disturbingly, Defendants' promotional campaign was themed on Levaquin's excellent safety profile and failed to disclose the risks of tendon injury."

St. Clair County, Ill., courts are busy this week as more plaintiffs joined a lawsuit filed against Johnson & Johnson, Ortho-McNeil Pharmaceutical and Johnson & Johnson Pharmaceutical Research and Development. The suit alleges that the controversial antibiotic Levaquin caused the plaintiffs to suffer from tendon damage.

All of the plaintiffs are saying that after taking Levaquin, which is usually prescribed to treat upper respiratory infections and bacterial infections, they suffered from tendon ruptures and injuries. Each plaintiff claims that they did know about the potential for tendon damage before he or she took the medication. They also say they didn’t know that the risk was even higher in patients 60 and older or if they were taking corticosteroids.

The plaintiffs who have joined in the Levaquin lawsuit include Allan Booth Jr. of Rhode Island, Michael Faulkenberry of South Carolina, Carol Leflay of Arkansas, Constance J. Lund of Wisconsin, Peter Pearson of New York, Walter Prim of New York and Teresa Tacey of Michigan, court documents show.

Levaquin was first brought to the American market in 1997; at that time, warnings about the side effects to the tendons were required to be on all fluoroquinolone labels. That is not what happened, though. The warnings ended up being hidden in a long list of possible side effects instead. According to the plaintiffs, the warnings didn’t even mention that the potential for tendon injury increased by three times for people older than 60 and in those who were also taking corticosteroid therapy.

To make matters worse for the manufacturers, Johnson & Johnson actually seems to have marketed the drug specifically to seniors who were suffering from upper respiratory infections. This is significant because those patients with the infections were also likely taking corticosteroid to treat their infections also. The complaint specifically says that "more disturbingly, Defendants' promotional campaign was themed on Levaquin's excellent safety profile and failed to disclose the risks of tendon injury."

A Florida woman named Tiffany Littles has filed yet another lawsuit against Bayer amid claims that she suffered from severe and lasting injuries after taking the company’s controversial oral contraceptive Yaz. The woman claims that Yaz is dangerous and shouldn’t be sold without correct warnings about how dangerous the pills are.

It all started in July 2008 after Littles wound up suffering from a bilateral pulmonary embolism and deep vein thrombosis (DVT), which can be deadly if the blood clots break off and reach the heart or lungs. Of her lawsuit, Littles said, "I am bringing this lawsuit so that this traumatic event does not happen to anyone else. I nearly died from taking this medication — the hospital even brought in a priest for me."

In her complaint, Littles' attorney says that she wouldn’t have gotten hurt at all if she was properly warned by Bayer about the dangers of Yaz.

"The FDA's adverse event database for Yaz and Yasmin reveal a very high number of serious adverse events associated with these drugs, including strokes, heart attacks, blood clot formation, and sometimes death," the suit says. "Bayer failed to warn doctors and consumers, we allege, that Yaz and Yasmin pose a greater risk of serious injuries than earlier generation oral contraceptives."

This lawsuit was filed in the Philadelphia Court of Common Pleas.

Yaz lawsuits have been filed all across the country after patients have suffered from severe blood clots, heart attacks, strokes, DVT and more. Some patients have even died after taking the drug, even if they were healthy before starting the drug. So many lawsuits have been filed that many have been consolidated into MDL and Bellwether Trials which are slated to begin early next year. The sheer number of lawsuits have many wondering if Yaz, Yasmin and other birth control pills containing drospirenone will be removed from the market.

A Florida woman named Tiffany Littles has filed yet another lawsuit against Bayer amid claims that she suffered from severe and lasting injuries after taking the company’s controversial oral contraceptive Yaz. The woman claims that Yaz is dangerous and shouldn’t be sold without correct warnings about how dangerous the pills are.

It all started in July 2008 after Littles wound up suffering from a bilateral pulmonary embolism and deep vein thrombosis (DVT), which can be deadly if the blood clots break off and reach the heart or lungs. Of her lawsuit, Littles said, "I am bringing this lawsuit so that this traumatic event does not happen to anyone else. I nearly died from taking this medication — the hospital even brought in a priest for me."

In her complaint, Littles' attorney says that she wouldn’t have gotten hurt at all if she was properly warned by Bayer about the dangers of Yaz.

"The FDA's adverse event database for Yaz and Yasmin reveal a very high number of serious adverse events associated with these drugs, including strokes, heart attacks, blood clot formation, and sometimes death," the suit says. "Bayer failed to warn doctors and consumers, we allege, that Yaz and Yasmin pose a greater risk of serious injuries than earlier generation oral contraceptives."

This lawsuit was filed in the Philadelphia Court of Common Pleas.

Yaz lawsuits have been filed all across the country after patients have suffered from severe blood clots, heart attacks, strokes, DVT and more. Some patients have even died after taking the drug, even if they were healthy before starting the drug. So many lawsuits have been filed that many have been consolidated into MDL and Bellwether Trials which are slated to begin early next year. The sheer number of lawsuits have many wondering if Yaz, Yasmin and other birth control pills containing drospirenone will be removed from the market.