Drug Injury Attorney Blog

The Supreme Court’s recent ruling that excludes generic drug companies from liability in Reglan side effects lawsuits has the plaintiffs’ lawyers trying to negotiate for settlements rather than going to trial.

Back in June, the Supreme Court gave a 5-4 ruling that allowed generic drug makers to be released from liability in regard to their lack of providing proper warnings on their drug labels. Since the side effects linked to generic versions of Reglan are the same as in the brand name versions, the ruling sparked frenzy among plaintiffs, who now fear that the ruling will have a devastating effect on their ability to receive proper compensation in Reglan settlements.

Reglan, which is also known as metoclopramide, is a drug that is used to treat various conditions associated with acid reflux. Tardive Dyskinesia (TD) is a major side effect of the drug when it is taken for periods longer than 12 weeks. Symptoms of TD include uncontrollable limb spasms, facial twitching, tongue writhing and lip smacking. The condition is incurable. It is that condition and others that have caused thousands of plaintiffs to file lawsuits in the first place.

The plaintiffs all claimed that the drug companies didn’t properly warn them of the side effects linked with Reglan before they took it. Many plaintiffs are also claiming that the drug companies failed to update the warning labels even after the FDA issued a black box warning against the drug. The defendants claimed that they didn’t update their labels because they didn’t have to unless brand name drug makers did it; they are only obligated to print the same warnings as the brand name versions do.

Lawyers representing both sides of Reglan lawsuits are now trying to sort out the financial repercussions of the Supreme Court ruling in an effort to work out a compensation agreement. Naturally, the generic drug companies are not being very co-operative as they do not want to negotiate for settlements without a trial since the plaintiffs will have a hard time convincing a jury that they deserve compensation for their injuries when the Supreme Court ruled against it. Right now everyone is watching with concern, but there is no real way to predict the outcome.

As a Levaquin injury attorney, I was interested to read about a jury verdict that came down in favor of Levaquin (levofloxacin) maker Johnson & Johnson. According to Bloomberg News, a New Jersey jury decided this month that the manufacturer had not failed to adequately warn patients about Levaquin’s risk of tendon problems. The decision rejects the claims of Robert Beare and Paul Gaffney, both of whom had an Achilles tendon snap after they took Levaquin, leaving them unable to walk. The dispute was not over whether Levaquin caused the injuries, which are a known risk of the drug, but over whether the warnings on the drug’s label were sufficient. The case was at least the third case to go to trial on similar claims, but Johnson & Johnson faces more than 2,600 lawsuits over Levaquin across the United States.

Levaquin is a flouroquinolone antibiotic, a class of drugs used when other antibiotics have failed, but which carry varying degrees of risk for tendonitis and tendon injuries. In 2008, after more than a decade of requests from activists, the U.S. Food and Drug Administration required all flouroquinolones to carry a black box warning, the agency’s strongest, about the risk of tendon damage. The risk is especially high in people taking corticosteroid drugs, certain transplant patients and patients over age 60. Gaffney is 67 and Beare is 72. Both were originally prescribed Levaquin to treat sinus infections that developed into pneumonia, and both required surgery in order to walk again after their tendons snapped. Their attorneys argued that Johnson & Johnson knew Levaquin posed the highest risk of tendon rupture of any flouroquinolone antibiotic, but failed to say so, depriving doctors and patients of needed information. But the jury sided with the manufacturer, which argued that it was not federally required to make that warning.

Unfortunately, the jury was right. As a dangerous drug lawyer, I know very well that there’s a difference between what the FDA requires and the information needed to help patients and doctors make well-informed decisions about their care. And thanks to recent Supreme Court rulings, it has become easier than ever for drug manufacturers to argue that they should not be held responsible for any actions that stay within federal regulatory boundaries. Ideally, the FDA would respond to this by tightening its regulations, but past history suggests that this is unlikely. For example, for flouroquinolone antibiotics, the FDA said in 1995 that it would add warnings about tendon rupture to the drugs’ labels; name-brand drugs got those warnings in 2008, 13 years later. Histories like this make it difficult to trust that federal regulators are enough to protect the public.

At Carey, Danis & Lowe, we help victims of severe drug injuries by holding drug manufacturers responsible for selling defective and dangerous products. This includes cases of failure to warn about a serious risk, like that of Levaquin, but also of drugs that were defective in the first place or negligently treated. We take medications our doctors prescribe because we trust that they will help, but sometimes that trust is misplaced. When it is, patients can suffer real harm — an injury or a serious illness, sometimes turning into a new lifelong health problem. In a lawsuit, our defective drug attorneys can help patients claim money for all the medical costs of the injury and any related financial costs, such as losing a job. You can also claim compensation for your pain, emotional suffering, loss of quality of life and more.

Continue reading " Jury Finds for Pharmaceutical Company in New Jersey Levaquin Side Effects Lawsuit " »

Every year it seems more and more women are diagnosed with depression. While depression is a debilitating condition to live with on a daily basis, it can downright brutal when the woman is pregnant — and depression during pregnancy is becoming all the more common. In fact, according to research by the American Congress of Obstetricians and Gynecologists, as many as 14 to 23 percent of women will combat depression while they are pregnant.

Women are generally advised not to take SSRI antidepressant medications like Paxil and Effexor while they are pregnant because of an increased risk of birth defects occurring to their babies. Some of the birth defects that SSRIs like Paxil and Effexor can cause include cleft palate, neural tube defects, PPHN and heart, brain and lung defects. Regardless of those birth defects risks, many doctors will still prescribe SSRI medications if the depression symptoms described are severe enough, and if the patient asks them to.

This is alarming since some of those women don’t fully understand the serious potential consequences the drugs can have on their babies when they ask for it; and worse still, some women may not know that they are pregnant when they ask. This is very dangerous since the risk of birth defects to the fetus is at its highest point during the first trimester of pregnancy. This is why doctors should require women of childbearing age to take a pregnancy test before prescribing those SSRI medications like Paxil or Effexor.

If you are wondering why a doctor would still prescribe potentially dangerous SSRI medications to a pregnant woman even when they know the risks the drugs pose on the baby, a statement made by the FDA earlier this year during an updated warning announcement may hold the answer. The FDA basically stated that in some cases, the benefits of continuing to take the drugs may outweigh the potential risk to the fetus.

In the most recent Levaquin lawsuit to reach trial, a New Jersey jury has returned a verdict in favor of defendant Johnson & Johnson.

This is the third Levaquin lawsuit to reach the courtroom out of thousands that have been filed. The case began with Paul Gaffney and Robert Beare, who both alleged that the drug giant didn’t properly warn them of the risks associated with Levaquin, which they claim caused them to develop ruptured tendons.

To date, as many as 2,500 people have filed Levaquin lawsuits with similar claims. All of the plaintiffs have stated that they never would have taken the antibiotic if they knew the real risks associated with it. A great deal of research has been conducted to verify that Levaquin causes an increased risk of people suffering from tendon ruptures, which is even higher in seniors and those taking corticosteroids, but patients have been claiming for years that the manufacturers of Levaquin have been downplaying those risks. Back in July 2008, the FDA issued a black box warning against Levaquin and made Johnson & Johnson update the drug's labels to include the risk information.

With the black box warning issued and the labels updated, people who suffered from tendon started filing lawsuits. This trial is the third one to have a decision reached and it was one that many were waiting for. The jury found that the plaintiffs didn’t properly prove that Johnson & Johnson gave inadequate warnings about the risks associated with Levaquin. This case was seen as a tie-breaker case since the first two Levaquin suits resulted in a plaintiff win and a plaintiff loss. This most recent win for Johnson & Johnson just goes to show that there is no precedent to be set with drug injury lawsuits, since each individual case is unique.

District Court Judge William Sanchez has made a ruling in a multi-million dollar wrongful death Paxil lawsuit. Judge Sanchez has ruled that the plaintiffs, Anthony and Cheng Silva, whose daughter committed suicide after taking Paxil, will get 2 percent in pre-judgment interest from a jury verdict that totaled $3 million last month.

Susan Silva killed herself in 2006 after taking the controversial antidepressant Paxil to treat her anxiety symptoms. Silva’s parents sued Lovelace Health System Inc. amid claims that they were negligent in prescribing the Paxil since they didn’t properly inform her of the side effects linked to the drug. Silva's parents also claimed that Dr. Isabel Lopez-Colberg (who prescribed the Paxil to Silva) didn’t warn her that she was vulnerable to committing suicide when taking Paxil.

When Silva complained that the Paxil made her feel ill and uncomfortable, the doctor prescribed her generic version of Paxil instead. Judge Sanchez could have awarded the family as much as 10 percent interest, but opted for two instead. This means that the plaintiffs will receive about $46,000 a year for the next three years. Had they received the full 10 percent they would have gotten $230,000 a year.

One of the plaintiff’s attorneys has stated that Lovelace should be forced to pay out all of the interest because the healthcare company didn’t want to offer a fair settlement in the first place (Lovelace originally offered the plaintiff $100,000).

"We could still argue that 10 percent is appropriate in this case," the attorney said. "There is a reason the Legislature says you can go up to 10 percent. That is to foster settlement. That is what exactly didn't happen in this case."

Thousands of Paxil lawsuits have been on behalf of patients that have committed suicide. Suicidal thoughts and behavior is one of the adverse side effects of taking the drug. Most of the lawsuits allege that the makers of Paxil didn’t properly warn patients of the dangers linked to the medication.

Expert testimony at trial is very important to my work as a defective drug attorney. Because individual jurors rarely have a background in the medical field, an expert is not only a good idea but sometimes even required, in order to explain the issues the jury is being asked to decide. But in hotly contested pharmaceutical cases, disputes sometimes arise over the standards for which evidence is admissible — who is qualified to testify. That was the issue in Williams et al. v. Baxter Healthcare Corp. et al., a Nevada Supreme Court decision filed by two families with members infected by hepatitis C. The Williams, Allen, Bilger and Pagan plaintiffs allege that the infections were caused by contaminated doses of the anesthetic propofol, and claim that the four pharmaceutical defendants were partly at fault for marketing it in sizes big enough to reuse and thus contaminate.

The four plaintiffs brought two separate actions against the drug makers in response to an outbreak of hepatitis C at an endoscopy clinic in Las Vegas. The medical personnel allegedly spread the disease by inserting contaminated needles into containers of propofol, then reusing the containers with new needles and patients. They alleged defendants’ 50 mL containers were so big that they encouraged this type of unsafe reuse, and their claims alleged design defects, failure to warn and breach of implied warrantly of fitness. Defendant pharmaceutical companies sought to rebut these claims with expert testimony from David Hambrick, a registered nurse, and Dr. Jonathan Cohen, a professor of medicine. Both sets of plaintiffs moved to exclude the testimony, with the Williams plaintiffs arguing that nurses cannot give testimony, and both sets arguing that the experts could not pinpoint a cause with a reasonable degree of medical probability. The Pagan plaintiffs’ motion to exclude was granted. Both cases were appealed to the Nevada Supreme Court, where they were consolidated.

The high court first ruled that a nurse is qualified under Nevada law to give expert testimony, though only within his or her field of expertise. The court said caselaw sets forth the standards for who may give expert testimony, and those standards look for relevant skills, experience and knowledge. Under some circumstances, the Supreme Court said a nurse could meet those guidelines; it called on courts to evaluate each nurse’s qualifications on a case-by-case basis. However, it said Hambrick does not meet the guidelines because he has no experience diagnosing the cause of hepatitis C, which was the subject of his testimony. The court turned next to whether Cohen, the medical professor, can testify with a reasonable degree of medical probability as to the cause of the infection. It found that this standard should be applied when the defense is offering an independent alternative theory of causation, but not when the defense is rebutting the plaintiffs. In this case, the court found, the defense does not need to show that its theory is more likely than not, as long as it’s competent and supported by relevant research or evidence. Thus, it ordered the lower courts to exclude Hambrick’s testimony on causation but allow Cohen’s testimony.

As a pharmaceutical liability lawyer, I would have preferred not to split the standard of evidence for expert testimony. Though the Nevada court took pains to emphasize that the stricter standard still applies to alternative theories of causation, it’s not hard to imagine this ruling muddying the waters. One might argue that it’s also unwise to split the standard of evidence between rebuttals and new theories because both are evidence submitted to the jury — and thus, both should be required to be relevant enough to be useful to the jury. The split allows rebuttals to be introduced regardless of whether they are more likely than not, and relies on juries to sort out probability. As a dangerous drug attorney, I believe juries are usually made of reasonably intelligent people who do their best to decide cases fairly — but they aren’t composed entirely of medical experts.

Continue reading " Court Rules Nurse May Testify Within Medical Specialty in Pharmaceutical Liability Cases – Williams v. Baxter Healthcare Corp. et al. " »

Drug giant Pfizer is in more hot water after the company has been accused of paying so-called “administration fees” to pharmacists in Australia in order to get its hands on patient information.

What Pfizer is basically doing is paying pharmacies a $7 ''administration fee'' for every patient who signs up for a support program which allows the drug company to market their medications (like Effexor) directly to the patient. Some pharmacists are saying that this deal (struck between Pfizer and the Pharmacy Guild of Australia) is a lot like the Blackmores deal they got rid of that had allowed companies to market dietary supplements alongside prescription medicines.

The chief executive of the Association of Professional Engineers, Scientists and Managers, Australia, Chris Walton, says, ''Just like the failed Blackmores deal, this uses a computer system to try to bypass the advice from a professional pharmacist. Instead of delivering better patient outcomes, this just aims to stuff more money into the pharmacy guild.''

How it works is that Pfizer gets patient information, such as cell phone numbers and email addresses, which it then uses to send patients information about their individual conditions so that Pfizer can then push their medications to them as a solution. In a similar fashion to the Blackmores deal, whenever any one of Pfizer’s nine drugs is given out, the guild's computer system offers up a prompt to the pharmacists that lets them know which patients are eligible for a support program.

Should a patient sign up for the 12-week support program, he or she receives a gift (for example, if a patient is taking Lipitor, he or she gets a lowfat cookbook) and also will be sent emails every week that offer different health advice. The other drugs manufactured by Pfizer that are included with this program are Champix, Xalatan, Viagra, Lyrica, Pristiq, Aricept, Celebrex and Effexor XR.

While some are accusing Pfizer of backdoor marketing, the drug company spokeswoman says that the programs were meant to help patients and not to gain any commercial objectives. She also says, ''Under no circumstances does Pfizer market its medicines (like Effexor) directly to patients.''

If you thought that the FDA’s relative silence about Yaz blood clots meant that the agency had lost interest, think again. Recently, the FDA announced that it "remains concerned" that birth control pills containing drosperinone (i.e., Bayer-made Yaz and Yasmin) could pose a higher risk of blood clots than the pills that don’t contain drosperinone.

In an effort to reiterate that thought, the FDA is also planning to put together an outside panel of medical experts on Dec. 8 so the matter can be discussed thoroughly. So far, the FDA said that the preliminary results of a study that was conducted by an outside agency suggest there is a 1.5-fold increase in the chances of women suffering from blood clots after taking birth control pills that contain drospirenone as opposed to those women taking different types of birth control pills that don’t contain drosperinone. The study was based on data collected from 800,000 women.

Drospirenone is a synthetic progestin that is used in oral contraceptives like Yaz, Yasmin and the generic version, Ocella. While the regulators have been studying these pills, they haven’t yet made a final decision on whether the drugs are more likely to cause blood clots.

The FDA has stated that there is much conflicting information about the blood clot risk linked to drosperinone; officials base that opinion on the results of six previous studies. While some studies say drosperinone-containing pills are more likely to cause blood clots than older pills containing levonorgestrel, there are other studies that dispute that finding. Bayer chooses to follow the studies that claim that drosperionone is no more dangerous than other pills and because of this, the company has been subject to thousands of lawsuits from women and their families who claim that the drug giant didn't properly warn them of the risks involved in taking Yaz and Yasmin. Those risks include blood clots, deep vein thrombosis, strokes, heart attacks and gallbladder disease.

Now that the summer is over and it’s back to life as usual, some people are enjoying the cooler temperatures and back-to-school routines, while others are not taking it so well. This condition is generally referred to as “seasonal affective disorder.”

Seasonal affective disorder at this time of year is generally brought on by a person’s reduced exposure to the sun (and heat that stems from it). As the autumn and winter months start getting cooler, there is generally less direct sunlight as well. This weather can often make some people feel the same sort of “funk” that are felt on a rainy day. The lack of sunlight can cause some people to feel depressed, more anxious and fatigued. As the cooler weather causes many people to begin an early hibernation period, it can also cause some people to gain weight and experience insomnia.

When this happens, some patients will seek refuge in the form of antidepressants like Paxil and Effexor on the advice of their doctors. These SSRI drugs are often used to help to block a receptor in the brain that absorbs the chemical serotonin which helps elevate a patient’s mood. Doctors are starting to prescribe these drugs and others whenever a patient complains of suffering from depression-like symptoms and anxiety. The concern here is the safety behind prescribing SSRI drugs.

SSRI drugs like Paxil and Effexor have been linked to serious side effects including aggressive behavior and suicidal thoughts and behavior. The drugs have recently been linked to birth defects when taken by pregnant women, as well. The birth defects include cleft palate, PPHN, neural tube defects and others. For patients who experience seasonal affective disorder, it may be better to ride it through rather than risk the severe health problems linked with SSRI drugs. Some doctors even suggest that patients exercise instead, which may also be useful. However, if you are determined to take antidepressants, be wary and only take them under a doctor's supervision.

Obsessive Compulsive Disorder (OCD) is a common affliction that can affect children as young as three or four. Adults are often treated for OCD with antidepressants like Paxil; should it be used to treat children’s OCD symptoms, as well?

OCD is believed to affect as many as 1 in every 100 kids, according to information by the International OCD Foundation. When it comes to diagnosing children with OCD, doctors generally lean toward an OCD diagnosis when kids start behaving in a repetitious way that borderlines on obsession because of how time-consuming it is for them (such as chronic hand washing). Kids often don’t realize that there is something strange about the way they are behaving.

"For the most part, adults realize that these symptoms don't make any sense," says Jeff Szymanski, executive director of the International OCD Foundation. "Kids don't necessarily have that perspective."

When treating OCD in children, things can get a little bit tricky since adult treatments, like Paxil, have been proven to be very dangerous medications. Some doctors prefer to use a behavioral treatment to decrease the child's anxiety levels associated with the behavior. Doing this usually requires the children to refer to their OCD as a “bully” and then mentally chase it away. This is meant to help the kids deal with whatever scary and unwanted thought causing the repetitive behavior.

Sometimes this doesn’t work as a lone treatment, and this is where some doctors could turn to medications to help. However, according to information from a recent study in the Journal of the American Medical Association, kids who were treated for OCD with cognitive behavioral therapy combined with medication showed more improvement than those who took medication alone. Those medications, antidepressants and SSRI medications like Paxil, have been proven to cause patients to experience suicidal thoughts and aggressive behaviors — particularly in kids. This seems like an awfully large risk when compared to the benefits.

For those parents and health care professionals who are hoping to get some information about children with OCD, you can find an abundance of information and other resources at the International OCD Foundation's new OCD in Kids website. Here you can find stories from other children struggling with OCD so that kids can learn about their peers' experiences. This website was launched earlier this week as a part of OCD Awareness Week, which will end with a national event hosted in Boston this Saturday. The International OCD Foundation’s website will be streaming video from that celebration on its website.

As a dangerous drug attorney in St. Louis, I have followed the trials and tribulations of local pharmaceutical company KV Pharmaceutical. KV and its subsidiaries, Ethex Corp. and Ther-Rx Corp., were heavily disciplined and even shut down for major manufacturing defects that posed a risk to consumers, such as oversized pills that could create an accidental painkiller overdose. That situation led to several lawsuits, including LeFaivre v. KV Pharmaceutical et al, a proposed class action that found its way to the Eighth U.S. Circuit Court of Appeals. LeFaivre did not claim any injuries, but rather, breach of implied warranty of merchantability and violation of the Missouri Merchantability Practices Act. The companies argued that because the claims stem from federal regulatory compliance, they were federally preempted; but the Eighth Circuit ultimately disagreed.

The drug underlying the dispute is the generic metoprolol succinate ER, for treating high blood pressure. LeFaivre purchased and used it several times in his home state of Rhode Island. In 2009, KV signed a consent decree and recalled many months’ worth of drugs to settle FDA claims that it had violated manufacturing standards. LeFaivre sued KV in Missouri federal court, alleging that KV sold “unmerchantable” drugs and failed to disclose that the drug was adulterated as a matter of federal law. He sought damages for the difference between the price of drugs that were up to standards and the price of the adulterated drugs. KV moved to dismiss, arguing that because LeFaivre’s claims rested on violations of FDA law, they were essentially an attempt to privately enforce federal drug laws, a right that does not exist. The federal district court agreed and dismissed the case. LeFaivre appealed to the Eighth Circuit.

That court reversed, finding that federal preemption did not apply. Any preemption would be implied preemption, the court said, since there is no express preemption in the relevant statute. And on implied preemption, the Eighth was able to rely on the Supreme Court’s recent ruling in Wyeth v. Levine, which found express Congressional intent not to preempt state laws. The appeals court found that the federal district court was wrong when it relied on the 2001 U.S. Supreme Court ruling in Buckman Co. v. Plaintiffs’ Legal Committee. That case sought to hold a company responsible for making fraudulent representations to the FDA about another company’s products, but the Supreme Court ruled that the claims were preempted by federal law. A concurrence in that case specifically distinguished its facts, which included no FDA enforcement action, from a hypothetical case in which the FDA did take enforcement action and a plaintiff brought state-law claims on the same issues afterward. This is basically that hypothetical case, the Eighth said. Furthermore, Buckman concerned fraud on the FDA, whereas this case alleges fraud against consumers. Thus, the Eighth reversed the dismissal and sent the case back to district court.

As a defective drug lawyer, I applaud the Eighth Circuit for giving this plaintiff a chance to prove his case. As the plaintiff argued, a contrary ruling would leave people who have suffered economic injuries from dangerous drugs without a legal recourse. This may seem like a small matter compared to people who have suffered serious health consequence or even death. But as a pharmaceutical liability attorney, I know those injuries and illnesses often go hand in hand with serious financial problems. Someone who develops even a mild chronic condition can expect medical bills for a lifetime. And even those who suffered no health injury should have a remedy against a manufacturer that intentionally deceived them.

Continue reading " Eighth Circuit Allows Proposed Class Action for Drug Manufacturing Defects – LeFaivre v. KV Pharmaceutical et al. " »

Now that the U.S. Department of Health and Human Services has announced its intention to include birth control pills to the list of free medications provided by health insurance companies, the numbers of women who will begin taking Yaz and Yasmin may increase significantly.

According to a recent HHS announcement, health insurance companies are going to have to offer free birth control by August 2012. This may be just the encouragement that some women needed to finally start asking their doctors for Yaz or Yasmin by name. There is no doubt that Yaz is still one of the most popular birth control pills on the market today regardless of the deadly side effects linked to the pill.

While free access to birth control might sound like a great idea to women, it can also have lasting and even fatal consequences. Women may be more inclined to take Yaz and other oral contraceptives that contain drosperinone as a result of this new legislation, but these pills have been proven to cause heart attacks, strokes, deep vein thrombosis, pulmonary embolisms and gallbladder disease. Those risks may be ignored by women who wish to use Yaz for its other advertised benefits, which had been aggressively marketed in the past.

Bayer, the makers of Yaz and Yasmin, has previously marketed Yaz as a cure for moderate acne and severe PMS as well as a birth control method. Many women may recall those ads, which have been altered since their first incarnations to include the drug’s risks. The biggest problem with this is that some of these women may not realize just how dangerous the pills are. Even though the FDA has forced Bayer to change the ads that downplay the risks associated with Yaz, women may not realize this and take the drug anyway. That could end up being a tragedy for them in the long run and doctors should warn women before prescribing it.

According to information found in a new study, patients that have had a heart attack are at an increased risk of bleeding if they take antidepressant medication in combination with anti-platelet drugs.

The study, which appears in the Sept. 26 issue of the Canadian Medical Association Journal, shows that heart attack patients taking both SSRI medications (like Paxil, Zoloft and Prozac) along with anti-platelet drugs (aspirin, Plavix) are at a higher risk of bleeding than the patients that only take the anti-clotting drugs. Anti-platelet drugs are used to prevent blood cells from sticking together and forming a blood clot. The anti-platelet drugs are generally given to heart attack patients as a means of preventing another heart attack, but it also leaves them open to more bleeding. However, when the anti-platelets are taken with SSRIs, the bleeding is even more likely.

According to researchers at McGill University in Montreal, heart attack patients are often found to develop depression and prescribed antidepressants. Dr. Kirk Garrett, clinical director of interventional cardiovascular research at Lenox Hill Hospital in New York, says, "We're always concerned about how other medicines might interact with the medicines we know are essential to heart health and recovery after heart attack. Although SSRIs are used in only a few cardiac patients, learning that SSRIs can increase (the) risk of bleeding complications could have important implications for how we care for patients after stents and other heart procedures."

In the study, the researchers collected data from 27,000 heart attack patients aged 50 and older. They learned that the patients taking aspirin or Plavix on its own had the same chance of bleeding, but those that took SSRI antidepressants and the aspirin/Plavix had a 42 percent higher chance of bleeding. Finally, the patients that took an SSRI with both aspirin and clopidogrel (dual anti-platelet therapy) had a 57 percent higher risk of bleeding. Some of the bleeding that occurred during the study included gastrointestinal bleeding and hemorrhagic stroke.

If you or a loved one has taken an SSRI like Prozac, Zoloft or Paxil and suffered from adverse side effects as a result, contact the attorneys at Kell Lampin. We will help you understand your condition while working hard to get you the compensation you deserve for your injuries.

A Los Lunas jury has issued a verdict in favor of the family of a woman who committed suicide while taking Paxil. The woman’s family was awarded more than $3 million.

Susan Antoinette Silva was 30 years old when she committed suicide in 2006 by slashing herself with a razor blade while she was taking the controversial antidepressant Paxil. Her family has since filed a medical malpractice lawsuit as a result of her death. The family says that Silva had started behaving bizarrely after she started taking a Paxil before moving onto the generic version of the drug.

Silva’s family stated that the woman was prescribed the drug in 2004 by her doctor, Isabel Lopez-Colberg, who at the time was working at Lovelace Health Systems. At the time, Silva was given the Paxil to treat anxiety. Silva’s estate lawyer has said that the doctor prescribed the woman “a year’s worth of pills, (and) never referred her to a specialist and failed to monitor her.”

The attorney also stated that "this girl carved deep gashes in her leg. She was calling in sick to work once every week. Even (the defense) expert said she was going psychotic for several months prior to her death.”

A spokeswoman for Lovelace Health Systems has released a statement that said that an appeal is currently being considered. Before developing her condition and subsequent being placed on the medication, Silva worked at the University of New Mexico as a mental health technician. The lawsuit complaint stated that she started to experience symptoms of restless leg syndrome while taking Paxil, which is what caused her to switch to the generic version of it. The generic version made her feel sick and generally uncomfortable and her family claims that they noticed her acting erratic while on the medication.

Silva’s behavior continued to remain "odd" and on April 13, she mutilated herself with the razor blades until she died. In the end, jurors awarded a total of $3.02 million to Silva’s estate, with $100,000 given to each of her parents and another $20,000 given to each of her siblings. As for liability, the jury gave 75 percent of the blame to the doctor and the facility at which she worked and 25 percent of the blame went to Silva.

As a dangerous medical device lawyer, I was extremely disappointed by the U.S. Supreme Court’s 2008 ruling in Riegel v. Medtronic. That decision said injured people may not bring medical device lawsuits because of a loophole in federal law. The federal law on medical devices expressly preempts state laws; thus, any state-law claim that the manufacturer was negligent must be dismissed, no matter how badly injured victims may be or how clear the manufacturer’s negligence was. That was the fate of Degelmann et al. v. Advanced Medical Optics. Alexis Degelmann brought a proposed class action on behalf of a group of contact lens wearers, alleging false advertising by AMO after one of its products was associated with a breakout of serious eye infections. The Ninth U.S. Circuit Court of Appeals upheld dismissal of their claim, but on a different basis from the one the trial court cited.

In 2007, the CDC reported that AMO’s Moisture Plus contact lens solution was associated with an amoebic eye infection called Acanthamoeba keratitis. AMO recalled Moisture Plus and refunded the money of purchasers; various people who had contracted the infections filed suit. Degelmann and the proposed class did not get the infection, but had used Moisture Plus. Their complaint alleged that AMO falsely advertised Moisture Plus as an effective disinfectant and cleaner even though users were seven times more likely to develop an infection than users of other brands. AMO misled consumers, they alleged. The trial court invited AMO to file for summary judgment and then granted that motion, finding the plaintiffs did not have standing to sue because they had suffered no eye infections or financial losses. AMO’s motion mentioned federal preemption, but the trial court did not reach it. The plaintiffs appealed.

The Ninth Circuit agreed that the suit should be dismissed, but found a different basis than the one the trial court used. In fact, the appeals court disagreed that the plaintiffs suffered no injury in fact under California’s Unfair Competition Law. While the law does require injury in fact, the court said, a claim that they were misled into purchasing Moisture Plus is sufficient to show an economic injury. However, the Ninth Circuit went on to dismiss the claim based on federal preemption, noting that appeals courts may uphold trial courts based on anything in the record. AMO’s contact lens products are regulated by the Medical Device Amendments of the Food, Drug and Cosmetic Act. AMO has shown that it met FDA regulatory requirements, the Ninth said. But those amendments say state and local governments may not further regulate already-regulated devices. And in order to win their lawsuit, the court said, the plaintiffs would have to be able to show that California law requires something different from what the Medical Device Amendments require. Thus, the lawsuit cannot stand, the court said, and the district court was correct in dismissing it.

I cannot argue with the Ninth Circuit’s legal logic. But as a defective medical device attorney, I believe the legal situation that created this ruling is dangerous for American patients. By removing patients’ ability to file any lawsuit at all against medical device makers, the Supreme Court has absolved those manufacturers of responsibility for their actions. Thus, while the lawsuits over the Acanthamoeba keratitis infections may have prevailed in 2005, the same lawsuits cannot prevail today. That’s true no matter how clear it is that the manufacturer’s negligence caused the injury. This is undoubtedly advantageous for manufacturers, but it leaves Americans at the mercy of FDA regulations, which are frequently disinterested (and often declawed when the presidency changes). As a pharmaceutical liability lawyer, I hope Congress passes a law to correct this situation before their hand is forced by a widespread health emergency.

Continue reading " Ninth Circuit Upholds Dismissal of Contact Lens Case Based on Medical Device Preemption – Degelmann v. Advanced Medical Optics " »

With thousands of lawsuits being filed against Bayer, the makers of Yaz and Yasmin birth control pills, one question seems to pop up often in the courtroom: “Are Yaz and Yasmin the same?”

One clue that gives you an idea of what the answer to that question is can be found in the drugs' names. While Yaz and Yasmin have similar names that only vary slightly, the same can be said about the differences between the two pills. While both pills’ main medicinal ingredient is comprised of drosperinone, a synthetic progestin, it is the pills’ composition of estrogen that marks the largest difference between the two.

Yaz and Yasmin are generally referred to as “combined one-a-day birth control pills” due to the fact that they both made up of a combination of drospirenone and estrogen. Yasmin is composed of a larger dose of estrogen than Yaz, and Yasmin uses more placebo pills for each cycle (Yasmin uses 7 placebos while Yaz uses only 4). Another difference between the two pills can be found in the pills’ off-label uses. Yasmin is only used as a means of preventing pregnancy, but Yaz’s off-label uses get just as much attention as the pill’s contraceptive capabilities.

One thing that Bayer comes under fire for in recent lawsuits is its previous marketing campaign that aggressively promoted Yaz’s ability to help clear up moderate acne and severe PMS — all while downplaying the drug’s adverse side effects. It is these side effects that make both Yaz and Yasmin so dangerous to take. This is what brings us to what makes both pills so similar. Yaz and Yasmin are both comprised of the same dosage of drosperinone. It is the drosperinone that causes the severe and potentially fatal side effects such as heart attacks, strokes, pulmonary embolisms, deep vein thrombosis and gallbladder disease.

This information shows that while there are some minor differences between the both Yaz and Yasmin, the pills are identical in just how dangerous they are.

According to a new study on SSRIs (a class of medication that includes drugs like Paxil and Effexor), babies that are exposed to the drugs while still in utero appear to experience alterations to their neurobehavioral development. This is the result of a study that was published online in Neuropsychopharmacology.

The study shows that fetuses that were exposed to standard and high doses of SSRIs seemed to exhibit “disrupted emergence of quiet, non–rapid eye movement (non-REM) sleep during the third trimester, characterized by continual bodily activity and, thus, poor inhibitory motor control during this sleep state near term."

So far, it is not clear just how significant this information is; it may be able to help predict troubles in sleep patterns in children in the future according to Eduard J. Mulder, Ph.D., and colleagues from University Medical Centre, Utrecht, the Netherlands.

But another doctor doesn’t think that too much should be read into this information just yet.

Tim Oberlander, MD, FRCP, of the Child and Family Research Institute, University of British Columbia, says, "This is one step in a long series of human studies to figure out what is happening at a neurobehavioral, biologic and molecular level. At the macro level, it's important to recognize that mother's mental health is really the critical issue here and there are downstream effects of the mood disturbances themselves that need to be carefully considered.”

Oberlander wasn’t a part of this study.

When taken by pregnant women, SSRI medications like Paxil and Effexor have already proven to be dangerous for fetuses. Studies have shown that Paxil causes birth defects in children who are exposed to it while in utero. Some of those defects include oral clefts, cleft palate, PPHN, neural tube defects and heart defects. This new study just points out another potential danger to newborns exposed to the drugs, but more research needs to be conducted to verify this finding.