Drug Injury Attorney Blog

Bayer, the makers of the controversial birth control pills Yaz and Yasmin, has funded a new study that demonstrates that while Yaz is dangerous, pills containing drosperinone are better at protecting women from unwanted pregnancies.

The study finds that birth control pills that utilize a drug-free time period for shorter periods of time (drosperinone has a longer life span in the blood stream), mixed with those pills like Yaz that contain drosperinone, also can act as diuretic because drosperinone is a long-lasting progestin. Right now Yaz, Yasmin and Beyaz are the only drugs on the market that can contain drosperinone.

Basically, Bayer paid German researchers to study a database that had more than 52,000 patient files of women that were taking Yaz. The study was conducted by comparing the rates of failure or how many unwanted pregnancies occurred in women taking different birth control pills. According to the information from the study, the women that were taking pills that contained drosperinone has less failure than those that took other progestins.

Even though this news should be worth celebrating for Bayer, it doesn't take away from the fact that the company has thousands of lawsuits being filed against it by women who have suffered from the adverse side effects of Yaz or Yasmin. Some of these side effects include heart problems, gallbladder problems, strokes and blood clots.

While there are plenty of studies that show the dangers of drugs like Yaz that contain drosperinone, Bayer could care less. In a previous statement made when addressing the risks of Yaz, Bayer's then lawyer, David Stewart, stated, "The reality is that Yaz and Yasmin are far more aggressive birth control drugs than previous generations."

Bayer officials completely maintain their belief that all birth control pills contain the potential to cause severe health risks. In fact, Bayer is so steadfast in that belief that they released more drugs with droperinone in them, Beyaz and Safyral.

One thing certain: While Bayer is ready and willing to defend its birth control drugs against all lawsuits and claims against them, the new study does nothing to help the company see the error of their ways. If anything, this new study just encourages Bayer to think that it has done nothing wrong. For Bayer, at least, the risks are worth it.

Judge David Herndon, who will be presiding over all of the Yaz/Yasmin lawsuits filed against Bayer, has ordered the company to pay for its German executives to fly into the U.S. and give depositions for the trial.

As previously reported, Herndon will be utilizing the "bellwether approach" to begin the Yaz/Yasmin trials this fall. Bayer has already sought a protective order to prevent it from having to produce all of the documents of discovery in the case, claiming that in paper format they would weigh as much as 200 tons. The company tried this tactic again when, during a telephone conference in November 2010, the Bayer's reps were ordered by Herndon to bring Joachim Marr, Hartmut Blode and Ilka Schellschmidt in the United States because he said that "equities favor the depositions being held in the U.S."

Bayer had already said that Marr, Blode and Schellschmidt could be used as representatives in talking about pre-clinical and clinical developments discussion topics. However, German law prevents American-styled depositions to be held in Germany, so Bayer offered to bring the three to Belgium. The idea was outright rejected by the plaintiffs’ lawyers, who claimed that the cost of flying all of the lawyers to Belgium would be prohibitive.

Bayer argued that both the jet lag as well as the time it takes to travel to the U.S. from that far away would prevent the executives from doing their jobs for too long. Bayer had no choice but to file another protective order. By the time the phone conference had ended, Herndon denied Bayer's protective order and told the company to have them flown to the U.S. for the depositions. Herndon asserted his jurisdiction to the dismay of Bayer and their lawyers.

While the Yaz/Yasmin lawsuits have yet to get to trial, there are plenty of pretrial activities going on and Bayer seems bent on dragging its feet during the process. So far, Herndon isn't letting the company's excuses get very far.

As a dangerous drug attorney, I was very pleased to see a ruling from a federal appeals court confirming Americans’ right to sue drug manufacturers who fail to warn them about known safety problems. As the San Francisco Chronicle reported Jan. 25, the Ninth U.S. Circuit Court of Appeals ruled that day that a family may sue an over-the-counter drug maker for not marking the label of its ibuprofen to let patients know that it shouldn’t be mixed with other drugs that affect the liver. In the ruling, the Ninth Circuit said over-the-counter manufacturers are subject to the same rules as prescription manufacturers requiring them to issue warnings with new safety information. The ruling applies in the western states covered by the Ninth Circuit, but may be applied as guidance in other areas.

Ibuprofen, which is a common over-the-counter painkiller, is known to have effects on the liver at high doses. In fact, the FDA considered warning patients about the problem in 2002, but decided it didn’t have enough information. In this lawsuit, the son of Margaret Gaeta underwent minor surgery when he was 10 and was given an anesthetic that can harm the liver. He was prescribed ibuprofen for post-surgical pain and took it for four days. A week after surgery, he suffered liver and kidney failure and septic shock. As a result, he needed a liver transplant and has also had some fingers and toes removed. The family alleged that Perrigo Pharmaceuticals Co. should have included a warning on the label not to mix the drug with other drugs that can cause liver failure.

The trial judge dismissed their claim, saying a 2009 Supreme Court ruling did not apply. In that case, the court said FDA approval of a prescription drug’s label didn’t shield it from failure to warn claims based on new information. The Ninth Circuit applied the same logic to over-the-counter drugs, saying it found no indication that Congress intended to keep drug costs low at the expense of safety.

As a defective prescription drug lawyer, I am very pleased with this court decision. It seems like common sense, as well as the intent of Congress, that safety should come first. That may be especially important with over-the-counter drugs, because they are not necessarily prescribed and taken under a doctor’s supervision. Unless the patient happens to be an ardent watcher of FDA safety news, he or she has no way of knowing anything that the drug’s label doesn’t disclose. To make matters worse, the list of things ibuprofen might interact with to cause liver damage includes alcohol, one of the nation’s most common drugs, as well as other common over-the-counter remedies like acetaminophen (the active ingredient in Tylenol) and naproxen sodium (the active ingredient in Aleve). Patients taking these drugs deserve tools they can use to make good decisions.

Continue reading " Appeals Court Rules Drug Makers Can Be Sued Even When Labels Meet FDA Standards " »

In early January 2011, the popular and long-running news show 60 Minutes aired a segment on the whistleblower case against drug manufacturing giant GlaxoSmithKline, the makers of problem-plagued drugs like Paxil and Avandia.

During the segment, interviewer Scott Pelley got up close and personal with whistleblower Cheryl Eckard, who was the star witness in a class action lawsuit that was filed against Glaxo. Eckard told Pelley what she saw was wrong when she conducted her survey of the facility. She mentioned that she saw that the pills were being manufactured using tainted water, that Avandia and Paxil were being mixed up in packages together and that some of the Paxil was being produced in the wrong dosages.

Eckard mentioned that when she tried to inform Glaxo officials of the problems, they ignored her and shipped the drugs anyway. She went on to say that conditions in the Cidra, Puerto Rico, plant were the worst that she had ever seen in her entire career as a quality control manager.

As a result of her survey, Eckard took part in a large class action suit that was filed against Glaxo. The suit was settled when Glaxo decided to agree to a payout that totaled almost $1 billion. Glaxo ended up paying $150 million to the federal government in fines and another $600 million in damages. The lawsuit wasn't just about the manufacturing conditions of the Cidra plant; it also alleged that Paxil caused birth defects for the babies of women that took the drug while they were pregnant.

While Glaxo officials deny accusations that they lied to the FDA about conditions at the Cidra plant, they go on to say that the drugs that were shipped from Puerto Rico were never shown to hurt anyone. As far back as October 2010, Glaxo officials issued a statement with regards to the manufacturing mistakes made at the Cidra plant that said, "We regret that we operated the Cidra facility in a manner that was inconsistent with current Good Manufacturing Practice (cGMP) requirements and with GSK's commitment to manufacturing quality."

The whistleblower in the GlaxoSmithKline class action suit, Cheryl Eckard, recently appeared on the popular news show 60 Minutes to talk about the case with interviewer Scott Pelley. During the interview, she mentioned that she was fired after urging Glaxo officials to do something about the conditions in a Glaxo manufacturing plant in Cidra, Puerto Rico.

She stated that from August 2002 all the way up until she was fired in May 2003, she had tried to get Glaxo managers to shut down the Cidra plant because of what Pelley referred to as them practicing "bad medicine." Pelley was referring to what Eckard claimed she found wrong with the production and packaging of drugs like Paxil and Avandia during a survey she conducted that led her to take action. She was referring to her claims that the plant:

1. Used tainted water in the production of Avandia and Paxil
2. Shipped Paxil that was packaged in the wrong dosages
3. Mixed Avandia and Paxil together in the same packages

Eckard ended up having to make a full report to Glaxo's Compliance Department when the company managers continued to ignore her warnings. In the end, Eckard says that they acted as if her complaints about the plant were unsubstantiated. That is what eventually led her to report the situation to FDA officials in San Juan. She also implied that these actions are what got her fired.

Glaxo denied that implication in a press release.

"The company strongly rejects any claim of retaliation for whistle-blowing,” the Glaxo statement says. “In fact, employees are encouraged to report any concerns they might have to management or through a confidential compliance hotline. Issues raised are investigated, and company policy prohibits any retaliation against employees."

As a result of these claims made against the Cidra plant, Glaxo settled the class action lawsuits that were filed against them for $750 million. Of that money, $150 million went toward paying fines and the other $600 million went toward participants in the class action. Whistleblower Eckard received $96 million.

Many drug injury lawsuits are being filed against drug manufacturing giants such as Bayer, Johnson & Johnson, Wyeth and GlaxoSmithKline. In 2010 alone, billions of dollars have been settled against these companies. These lawsuits have one thing in common: They were filed because plaintiffs accuse the drug manufacturers of hiding data that proved that popular drugs like Effexor, Paxil, Levaquin, Reglan and Yaz/Yasmin had devastating and potentially life-threatening side effects.

Antidepressant SSRIs like Paxil and Effexor took fire under claims that they hid their severe side effects such as seizures, hallucinations, birth defects, PPHN, severe mood swings and even suicide. In fact, the manufacturer of Paxil, GlaxoSmithKline, has paid out as much as $1 billion in damages to settle various claims against the drug, including a $750 million settlement the company reached over its "bad" manufacturing procedures at Glaxo’s Cidra, Puerto Rico, plant. The whistleblower in that case recently appeared on 60 Minutes.

Johnson & Johnson lost its first lawsuit regarding its popular antibiotic Levaquin in 2010. Eighty-two-year-old plaintiff John Schedin won his claim that the company did not properly disclose the fact that the drug caused tendon ruptures in certain patients. In addition, Bayer has taken on a series of lawsuits that have yet to be decided regarding its birth control pills Yaz and Yasmin; in these suits, plaintiffs claim that Bayer hid the fact that the pills can cause heart attacks, strokes and blood clots.

All of these companies have been accused of hiding the adverse side effects that these drugs pose from the public. Some companies were accused of going out of their way to hide this information completely; others were accused of burying the black box warnings deeply within package inserts; and still other companies were accused of using clever marketing techniques as a means of hiding the severe side effects of their drugs from the public.

While the future of all of these lawsuits cannot be determined with accuracy until they either are settled or go to trial, one thing remains certain: 2010 was a landmark year for lawsuits being filed against drug manufacturers.

The U.S. Food and Drug Administration recently made an order that should get attention from ordinary Americans as well as dangerous drug attorneys like me. As the Washington Post reported Jan. 13, the FDA on that day said it has asked drug makers to restrict the strength of products containing the painkiller acetaminophen. Acetaminophen is the active ingredient in Tylenol and is also used in prescription drugs such as Vicodin or Percocet, which combine it with opioid painkillers. The FDA has restricted it to no more than 325 mg per dose out of concerns about liver toxicity from overuse. That’s a reduction for many prescription painkillers, which can contain as many as 750 mg of acetaminophen.

Acetaminophen’s negative effect on the liver has been understood for years, but a 2005 study shed more light on the issue. That study found that acetaminophen was the most common cause of liver failure in the United States, with nearly half of all cases resulting from an accidental overdose. Patients can accidentally overdose if they take too many products that contain acetaminophen at once, exceed the maximum dose or combine acetaminophen with alcohol. An FDA statement issued with the safety alert noted that acetaminophen overdoses caused an estimated 450 deaths per year between 1990 and 1998. The labels of prescription drugs containing acetaminophen must also carry a “black box” warning about the potential for liver injury, and doctors were asked to advise patients to limit their doses to no more than 4,000 mg a day.

The move does not affect over-the-counter painkillers containing acetaminophen -- just their prescription-only cousins. This has raised criticism from public safety groups such as Public Citizen, and also concerns me as a defective drug lawyer. Over-the-counter drugs can contain high levels of acetaminophen too. Extra-strength Tylenol, for example, contains 500 mg per pill, which is above the 325-mg limit for prescription drugs. Patients are instructed to take two extra-strength Tylenols every four to six hours, which could mean as much as 6,000 mg in a 24-hour period. That’s over the 4,000 mg maximum dose in the instructions for doctors. And this is assuming that patients pay attention to dosing information, something that is not likely to always be true. The FDA should be commended for this move, but we hope it follows with action on OTC medicines.

Continue reading " FDA Orders Cap on Strength of Prescription Painkillers Containing Acetaminophen " »

When Plaintiff John Schedin, now 82, won his lawsuit case against the makers of Levaquin, he wasn't the only person excited. His own doctor, who testified on Schedin's behalf during the trial, was over the moon about the win.

A few years ago, Schedin's doctor testified that he prescribed Schedin a combination of Levaquin and a steroid as treatment for an infection. He stated that he knew that there was a potential risk of tendon ruptures, but he also said that he didn't know that the risk was higher if it was given to seniors or if they were taken in combination with a steroid. Only three days after taking the prescription by his doctor, Schedin suffered from two tendon ruptures of both of his Achilles’ heels. As a result of his injuries, Schedin now has to crawl on his hands and knees up the stairs in his house.

During the trial, lawyers argued about how much information was given to doctors and the public ahead of time by Levaquin manufacturers and their reps. Naturally, the defense’s lawyers claimed that all of the information was provided in an insert that came with the medication, and Schedin's lawyers argued that the information (even the black box warning) was buried within the inserts and impossible to see.

During testimony the doctor also said that he couldn't remember the rep ever telling him about the tendon ruptures while at his office. Fortunately for the plaintiff, the rep couldn't remember if she slipped the information in with the free samples or if she said anything verbally either. The rep also stated that she likely didn't have the time to because of time constraints during the appointments with the doctors. She said that with everyone's busy caseloads, she would have considered herself lucky to get 30 seconds with the doctor during their meeting.

While a doctor needs to know everything about a medication before prescribing it, the rep stated that you just can't give that much information in 30 seconds. In the end it doesn't matter since the doctor is mortified for Schedin's injuries and the fact that his prescription of Levaquin and a steroid may have caused it.

The Supreme Court in Washington, D.C., has agreed to make the decision about whether the makers of the popular drug Reglan as well as other manufacturers can be sued over claims that they mislabeled Reglan's side effects.

According to an ABC News report, the Supreme Court is set to consider if federal law is at least partially responsible for the many lawsuits coming out against the drug, since the FDA originally approved the drug for sale in the first place. Most of the lawsuits being filed against the makers of Reglan claim that the manufacturers did not properly label the side effects on the packaging.

The manufacturers that filed the appeals case were: Teva Pharmaceutical Industries, Mylan Inc.'s UDL Laboratories and Actavis Inc. Actavis' home base is in Iceland. In that company's case, the U.S. appeals court made a ruling that Actavis could be sued by a specific woman that claimed that she was not warned properly about the risks of taking Reglan by the company. Julie Demahy is a claimant that is filing her lawsuit under a Louisiana law, and she claims that she was not properly warned about the risks involved in taking Reglan. She has suffered from a neurological disorder after taking the drug. Another of the serious side effects that occur in those patients that take Reglan is Tardive Dyskinesia. It is a disorder that causes uncontrollable facial movements.

While there is no set date as to when the Supreme Court will be hearing the case, it is bound to cause more controversy for the makers of Reglan. While the manufacturers always stand behind their products and their marketing of them, the past year has been rough on many drug makers. Countless lawsuits have been filed in 2010 alleging dishonest marketing; indeed, many drug manufacturers have been accused of not properly warning the public about the potential dangers of taking their drugs. Since 2010 was a busy time for lawsuits being filed, 2011 could see many drug companies losing billions in payouts.

As a defective drug attorney, I was displeased to see reports of death and serious illness from a prescription painkiller. As MedPage Today reported Jan. 11, the FDA has ordered new labels for an oral morphine sulfate drug sold by Roxane Laboratories. The drug had been labeled as 100 mg per mL, which apparently confused some users. That confusion led to drug overdoses with as much as 20 times the ordered amount of the drug, causing deaths and serious illnesses, the FDA said. The 100 mg/mL drug may also have been mistaken for a less concentrated version, also leading to overdose. The agency ordered a new label for the morphine sulfate distinguishing the 100 mg/mL version from less potent versions. An oral syringe will come with the drug to make correct administration easier.

Morphine was sold throughout the 20th century, but the morphine sulfate preparation sold by Roxane was approved by the FDA only in 2010, because drugmakers had never applied for FDA approval. That approval was important, because morphine is a powerful opioid painkiller with potential for both addiction and overdose. At high doses, morphine can cause breathing problems leading to death or brain damage. The 100 mg/mL morphine sulfate solution that got the label change is already a high dose. It is intended for people who are known to have an opioid tolerance, and thus need a higher dose, and for people who are receiving hospice or palliative care. The old label reportedly made that problem worse by giving the strength in mg/mL even though dosages are ordered in mg. As a result, people unfamiliar with the drug gave the doses in mL, increasing its already strong potency considerably.

The FDA’s order for a new label takes several steps to ensure that the high-potency morphine sulfate is hard to confuse for lower doses, and includes an oral syringe so that users have the tools to give the correct dose. As a pharmaceutical liability lawyer, I’m pleased that the FDA is taking these steps -- but I’m surprised it was necessary. Most Americans don’t use the metric system, so it’s not a surprise that some users were confused by the dosage instructions for this morphine. Furthermore, calculating a dosage in mg from a drug measured in mg/mL requires math that most people won’t have memorized. It’s not hard to predict that busy or distracted users could miss the distinction and simply measure out a dose. Unfortunately, with such a powerful drug, the consequences of this kind of casual mistake can be deadly.

Continue reading " FDA Orders New Label for Powerful Painkiller After Several Reports of Overdose " »

Bayer’s new birth control pill has many people wondering if it will pose the same adverse side effects as the company’s controversial Yaz/Yasmin. And there is good reason to wonder, since the pill is exactly the same as Yaz except it has one added ingredient: vitamin B9.

Yaz has suffered through a lot of controversy in 2010 with women filing lawsuits against Bayer. The women claim that they weren't properly warned about the adverse side effects of taking the drug, which include an increased risk of heart complications, pulmonary embolisms, strokes, severe depression that may lead to suicide and blood clots.

Even with the lawsuits piling up, Bayer has refused to take the popular birth control pill off the market. Instead, the company decided to release a "new" pill. Beyaz, which has been approved by the Food and Drug Administration, contains folate (folic acid). Folic acid is basically just a form of vitamin B9 which is a natural nutrient the body needs. It is a vitamin that can be found in healthy foods like broccoli, asparagus, lentils and spinach.

The addition of folate is the big selling point for Bayer's new Beyaz because Bayer is claiming that since no birth control method can be 100 percent effective at preventing pregnancy, this new pill helps the woman taking Beyaz to stock up on the vitamin that doctors prescribe to pregnant women to prevent birth defects like spina bifida should they become pregnant.

That may be an odd selling point for a birth control pill, but considering all of the negative press that the original Yaz/Yasmin is getting, Bayer officials clearly feel that anything is better than Bayer simply admitting that Beyaz is the exact same pill as Yaz/Yasmin with the addition of folate. In the end, Bayer's stubborn unwillingness to admit failure and get rid of Yaz altogether may cost them.

Those women that have been suffering from blood clots or strokes from taking Yaz/Yasmin have finally found out when their Yaz lawsuits will go to trial. Judge Nerndon has decided to enforce the Bellwether approach as a means of deciding which trials will reach trial first.

The Bellwether approach is used by the majority of courts when there is a significantly large number of cases where all of the plaintiffs that are filing lawsuits are doing so for the same reason. For example, in the Yaz/Yasmin cases, all of the lawsuits being filed are making the same claim against Bayer, the makers of the popular birth control pill. They are all claiming that Bayer failed to properly warn the public about the adverse side effects associated with Yaz/Yasmin. Taking the Bellwether approach will help the courts to handle the large caseload.

How it works is that a group of Yaz/Yasmin cases will be picked to reach trial before all of the rest of them. These first cases will be expected to represent the whole of the others. This method is chosen because it is meant as a way for the lawyers involved in the filing of claims to get a better understanding of what to expect. Basically it is used to help plaintiffs to predict what the potential outcomes will be for their own claims.

When the trials are set to begin, each side of the lawsuit will choose 12 case claims to take to trial. This means that a total of 24 plaintiffs will see their cases go to trial before the rest of them do. Under the Bellwether approach, the first Yaz cases to go to trial will be as follows: the Pulmonary embolism case will begin on September 12, 2011. The gallbladder case will begin on January 9, 2012. The thromboembolic (VTE) case will begin on April 2, 2012.

Investors in Yaz/Yasmin are suing the drugs’ manufacturer, Bayer, claiming Bayer purposely deceived them in order to get them to invest in the popular birth control pills.

Bayer already has been sued by a countless number of young women that have suffered from various health problems after taking Yaz and Yasmin. The lawsuits likely will keep on coming until the statute of limitations runs out on filing. Now, to make matters worse for Bayer, some of its investors also are bailing on the company and filing lawsuits of their own.

A lot of the investors are feeling as if Bayer deceived them just as much as the public was in terms of the harmful side effects of the drug. Some of the investors even contend that they may not have invested in the drug had they known that the drug can cause such harmful adverse effects on young women as heart complications, strokes, gallbladder disease, pulmonary embolisms and blood clots.

On October 13, 2010, a lawsuit was filed against Bayer with the claimants saying that Bayer knowingly hid the adverse effects of the drugs Yaz and Yasmin just to boost sales. Bayer also has been accused of deceiving its investors. Some of the investors that had invested in Bayer include two firefighter pension funds as well as Pennsylvania city employees.

Investors are claiming that since Bayer hid the negative side effects from its investors, the company basically defrauded them by giving false estimates on how much the pharmaceutical company was worth as well as the worth of the birth control products that it makes. With Bayer going through all of these lawsuits, it stands to reason that investors in the drug have likely suffered from the negative press Yaz and Yasmin have gotten. They may also be feeling as if they are being linked (at least in the public's mind) to the alleged deception. In this case, there is no surprise that investors are suing.

There is quite a bit of buzz going around that since Johnson & Johnson has lost its first Levaquin side effects trial, more settlements may be just around the corner.

It was a big blow to Johnson & Johnson and its subsidiary, Ortho-McNeil-Janssen Pharmaceuticals, to have lost their first Levaquin trial to 82-year-old John Schedin, having to pay him more than $1 million dollars in damages. However, the loss was more monumental than just the amount of money the company had to shell out: It could spark a losing trend for the companies that may have them fearing that they will wind up losing billions of dollars like GlaxoSmithKline has over Paxil and Avandia.

Johnson & Johnson is facing many lawsuits that have been filed against them over the harmful side effects of several of its popular drugs, including Levaquin and Yaz/Yasmin. Many of the claimants are alleging that Johnson & Johnson purposely tried to hide the dangerous potential side effects that can occur from taking the drugs. Yaz/Yasmin can cause heart problems, pulmonary embolisms, gallbladder disease, strokes and even blood clots in its users, while Levaquin has been proven to cause tendon ruptures in its users.

It takes just one successful case against drug makers to draw out many more payouts and settlements to patients that have suffered injuries, and Johnson & Johnson has just lost its first Levaquin tendon rupture case to Schedin. While plaintiffs are claiming that Johnson & Johnson hid the dangerous side effects from them, the drug makers stand by the labeling of their products, which do list the potential tendon ruptures of Levaquin (though these warnings are buried on the fourteenth page of the insert). Even the black box warning was similarly buried. These facts alone will likely spell more payouts being awarded against Johnson & Johnson.

While the company may not have completely hidden the warnings against its products, it certainly didn't go out of its way to show them, either. This fact alone could spell more losses for them.

As a defective medical device attorney, I was interested to see news reports about a second FDA warning for a company that makes artificial joints. As Reuters reported Dec. 29, Smith & Nephew, a British medical device company, received an FDA warning letter Dec. 21 saying the FDA was not satisfied with the company’s quality control. Smith & Nephew’s regulatory problems date from the summer of 2010, when the FDA inspected a plant in Germany and found problems with the way artificial hips were being sterilized. The new warning letter says the FDA feels the steps Smith & Nephew has taken are inadequate. The warning is not expected to make the artificial hips unavailable, as Smith & Nephew also has plants in Tennessee and Britain.

The problem is specifically with the manufacturing of the company’s R3 Ceramic Acetabular Systems, artificial joints used in hip replacement surgery. The FDA inspected the German plant in mid-July of 2010 and found that sanitizing procedures were not up to the legal standards required of all medical device manufacturers. For example, the FDA said Smith & Nephew’s irradiation procedures didn’t meet the specified minimum dose of radiation, which is intended to prevent infection. Despite this, the company also allegedly used those inadequately irradiated products. Smith & Nephew said it addressed those and other issues raised by the FDA, but in the Dec. 21 letter, the agency said those measures were not adequate. The company must contact the FDA within 15 days to explain what steps it is taking to solve the problems.

This back-and-forth between the FDA and the company looks familiar to me, as a dangerous medical device lawyer, because something very similar happened with the McNeil/Johnson & Johnson recall of many over-the-counter medicines. Unlike that case, however, this one involves medical devices that patients receive surgically rather than buying at a drugstore. That limits our ability to protect ourselves from potential health effects by throwing out or returning tainted products. And patients receiving artificial hips must rely on doctors to make sure the products they’re surgically implanting are safe and free of infection. An infection is particularly serious after an artificial joint replacement because the body can only fight off infection of its own tissues -- not of the artificial materials in the false joint. As a result, the artificial hip would most likely need to be removed in the event of infection, a painful and expensive prospect.

Continue reading " Artificial Hip Manufacturer Gets Second FDA Warning Letter for Sterilization Problems " »

According to a study that was published in the New England Journal of Medicine, one of the more serious birth defects that can be linked to Effexor is Persistent Pulmonary Hypertension of the Newborn (PPHN). An FDA health advisory agrees, stating that women who took drugs that were similar Effexor in the second trimester of pregnancy were 6 times more likely to give birth to babies that suffered from PPHN.

Babies that are born with PPHN find it harder to process oxygen while in the womb than babies whose mothers didn't take the popular antidepressant. While babies are still in the womb, oxygen is sent to the baby through the umbilical cord rather than the lungs and the pulmonary artery is what circulates oxygen to the heart through the ductus arteriosus. Once the child is born, the oxygen stops moving through the ductus arteriosus and into the lungs instead. If the baby is born with PPHN, the ductus arteriosus doesn't close. This stops the blood flow from getting into the baby’s lungs, leaving the baby's oxygen supply very low.

Some of the symptoms associated with PPHN include rapid breathing, rapid heart rate, difficulty breathing and bluish skin. Babies that are born with heart murmurs and low oxygen levels in their blood also may have PPHN. Most of the babies that are born with PPHN can't survive it, but those who do often suffer from long-term health problems like breathing problems, developmental complications, hearing difficulties and seizures.

If you have been taking Effexor while in the second half of your pregnancy and your baby is suffering from any of the above-listed symptoms, or if your child has been diagnosed with PPHN, you might be eligible to receive some financial compensation. You should talk to your doctor and seek a lawyer’s assistance.

The state of New Hampshire has recently been awarded the sum of $1.7 million against GlaxosmithKline, the makers of the popular antidepressant drug Paxil.

The lawsuit was brought against two prescription drug makers because the state claims that their Medicaid Program was billed for drugs like Paxil that were marketed wrong and for drugs that were in some cases of substandard quality. Glaxo has to pay its share of the money because it was decided that at least four of the drugs that the company was marketing back from 2001-2005, including Paxil weren't as strong or as pure as they were supposed to be. These standards were in accordance to what the FDA deems as appropriate.

Jeff Cahill, The Senior Assistant Attorney general pointed out the fact that no one in New Hampshire was hurt due to the drug fraud. Cahill also said that the investigation into the matter really started when whistleblowers told the federal authorities about how the drug manufacturer was acting with regards to the sale. The share that New Hampshire received as part of the settlement money is just a small piece of a much larger pie. It comes from a national case that was filed against against both of the drug makers.

What it boils down to in a nutshell according to Cahill is that, "The states didn't get what they paid for." At least some of the money that was awarded in this settlement is toward penalties because of the abuses. Glaxo has been under fire a lot lately because of its handling and marketing of the drug Paxil and Avandia. They have had numerous lawsuits filed against them because of it. Recently they admitted to manufacturing violations that involved of Paxil in their Puerto Rico plant and were fined $750 million in damages. For now at least, the hits keep on coming for GlaxoSmithKline over Paxil.