The Injury Lawyer Directory Blog

Last month, the FDA issued a warning letter to Bayer, the pharmaceutical company that manufactures the birth control pills Yaz and Yasmin, detailing several problems at a plant in Germany which produces drospirenone, one of the active ingredients in these products. The FDA released the letter to the general public on their website last week.

The accusations against Bayer indicate that the company has not adhered to good manufacturing practices which should have prevented the shipment of several batches of the product to the United States. The letter alleges that Bayer hid the results of several tests which indicated some batches of the drug did not meet company specifications.

According to the FDA, Bayer took out-of-specification (OOS) test results and mixed them in with good test results, reporting the average of the two groups instead of reporting the instances where a batch did not meet proper quality standards. As a result, Bayer was able to release OOS batches to the general public that should have never reached the United States.

The FDA has ordered Bayer to produce a list of all active ingredient batches shipped to the United States that contained OOS test results in preparation for a potential Yaz and Yasmin recall. The pharmaceutical company has also been ordered to generate a plan to bring its manufacturing practices up to standards dictated by the FDA.

This is not the first time problems have been reported with Yaz and Yasmin. Bayer currently faces more than 50 defective drug lawsuits related to these birth control products which claim the pharmaceutical company failed to properly warn consumers about side effects that may result in:

• Heart attacks
  
• Stroke
  
• Deep vein thrombosis
  
• Pulmonary embolism
  
• Gallbladder disease
  
• Death
  

It is expected that many more pharmaceutical injury lawsuits will be filed in the near future. If you have developed a serious illness or injury from taking Yaz or Yasmin, an experienced defective drug lawyer can help you receive the compensation you deserve.

If you have a Yaz or Yasmin claim in the Norfolk, Virginia area, please contact the Virginia pharmaceutical injury lawyers at Kalfus & Nachman today to schedule your complimentary initial consultation.

Pharmaceutical company Roche Holding AG, the makers of the acne drug Accutane, has announced that they will be pulling the drug from the U.S. market. They informed the Food and Drug Administration (FDA) of their decision this week.

The product recall has come as a result of the large number of lawsuits filed against Roche for pharmaceutical injuries sustained from taking Accutane. Currently, the company has paid over $33 million in damages over Accutane, and there are still more than 5,000 defective drug lawsuits pending against the drug.

Accutane has been linked to the development of inflammatory bowel disease. The majority of lawsuits against the drug claim that Roche failed to properly warn consumers of the dangers of developing this serious condition. Accutane has also been linked to depression and birth injuries.

Roche has also pulled Accutane from the market in 11 other countries, including France, Spain, Denmark, Germany, Austria, Portugal, and Norway.

Despite pulling the drug from the market, Roche has not admitted that the drug poses a danger to consumers. They claim that the primary motivation for the recall is financially-based. In recent years, Accutane has lost a sizeable portion of their market share to generic competitors. This, coupled with the large amount of money Roche has paid in damages and legal fees, has prompted them to abandon their acne medication.

If you have developed a serious condition from taking Accutane, you may be eligible to receive compensation for your damages. It is important to consult an experienced defective drug lawyer at once to see if you have a valid claim.

If you have an Accutane claim in the Denver, Colorado area, please contact the Law Offices of Burg, Simpson, Eldredge, Hersh & Jardine, P.C. today to schedule a consultation.

Genetech, the pharmaceutical company that manufactures Raptiva, has just announced a voluntary recall for their psoriasis drug due to the risk of developing a rare but serious condition from taking the dangerous drug. The Raptiva recall will take effect on June 8, 2009.

Raptiva has been linked to the development of a condition called progressive multifocal leukoencephalopathy (PML), a progressive neurologic disease affecting the central nervous system. PML causes permanent impairment of neurologic functioning and in some cases leads to death. The disease usually develops in people who already have weakened immune systems before taking Raptiva.

Raptiva is a drug administered once a week by injection to adults suffering from moderate to severe plaque psoriasis. If you are currently taking Raptiva, you should contact your doctor immediately to discuss alternative treatment options.

There have already been at least three reported incidents of Raptiva patients dying after developing PML from taking the drug. It is uncertain how many other patients have been harmed.

If you have developed PML from taking Raptiva, you should consult an experienced pharmaceutical liability lawyer at once. You may be entitled to receive compensation for your injuries.

If you have a Raptiva claim in the Oklahoma City, Oklahoma area, please contact Stipe Injury Law today to schedule a consultation.

There is mounting evidence that Raptiva, a psoriasis drug manufactured by Genetech, may cause a rare brain infection in patients who take the drug. In October 2008, the Food and Drug Administration (FDA) placed a "black box" warning on Raptiva. This is the FDA's strongest warning and is reserved for drugs that may cause life-threatening conditions.

This past February, the FDA went a step further and issued a public health advisory for Raptiva after receiving reports of several people developing progressive multifocal leukoencephalopathy (PML) after taking Raptiva for three or more years. Three people have died from contracting PML after taking the defective drug.

PML develops as a result of a virus that affects the central nervous system, and it usually arises in people with weakened immune systems. PML can cause permanent damage to neurologic function and in severe cases, death. Symptoms of PML include unusual weakness, loss of coordination, changes in vision, difficulty speaking, and personality changes.

Raptiva is taken once a week by adults suffering from moderate to severe plaque psoriasis. The drug is injected into your body, and it suppresses T-cells, a part of your immune system, in an attempt to control psoriasis. By suppressing T-cells, Raptiva increases your vulnerability to infections.

The FDA is trying to take the appropriate steps to ensure that psoriasis patients understand the risks associated with taking this dangerous drug, and it is urging doctors to more carefully monitor patients taking Raptiva for symptoms of PML.

If you have developed PML or any other dangerous condition from taking Raptiva, you should consult an experienced pharmaceutical liability lawyer immediately. You may be eligible to receive compensation for your damages.

If you have a Raptiva claim in the Oklahoma City, Oklahoma area, please contact Carr & Carr, Attorneys at Law today to schedule a consultation.

John Pettigrew, a 58-year-old British plumber, has been seeing blue for several weeks after overdosing on Viagra. The divorced man hadn't had sex in over a year. When the time came to get back on the horse, he struggled with his performance, prompting him to seek a prescription for Viagra. He also obtained additional Viagra pills illegally through the Internet.

According to Pettigrew, the drug was doing its job properly, so he figured he may as well increase the dose: "I admit I ignored the advice on the packet -- I was having too much fun."

Blue vision is one of the more rare side effects caused by Viagra. Others include headaches, facial flushing, and upset stomach. However, perhaps the most alarming side effect linked to the erectile dysfunction drug is the development of Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION), a sudden vision loss caused by a blockage of blood flow to the optic nerve.

NAION blindness has been reported to be 18 times higher in Viagra users than for other prescription medications approved for use by the Food and Drug Administration (FDA). It is important to consult an experienced pharmaceutical injury lawyer if you have suffered an adverse reaction to taking Viagra. You may be eligible to receive compensation for your damages.

If you have a defective drug claim in the Mobile, Alabama area, please contact the Law Offices of Long & Waite, P.C. today to schedule a consultation.

Last week, the New Jersey Appellate Court overturned a verdict against Hoffman-LaRoche, the makers of Accutane, and remanded the case for a new trial. This ruling comes directly on the heels of the Supreme Court's decision in Wyeth v. Levine, which dealt a major blow to pharmaceutical companies hoping to avoid product liability claims by using the controversial preemption defense. In many ways, the New Jersey Appellate Division's ruling has given pharmaceutical companies a major jolt in their time of need.

The court overturned a New Jersey jury's verdict in McCarrell v. Hoffman-LaRoche that awarded Andrew McCarrell $119,000 in medical expenses and $2.5 million in compensatory damages in a product liability lawsuit over injuries he sustained from taking Accutane. After using Accutane to treat his acne, McCarrell developed inflammatory bowel disease, causing him to have his colon surgically removed.

The appellate court ruled that the judge in the trial court made a mistake in allowing expert testimony for the plaintiff detailing the number of incidents where Accutane has led to harmful side effects in consumers, while omitting Hoffman-LaRoche's rebuttal testimony indicating the relatively small percentage of Accutane patients who actually suffer harmful side effects. This ruling will most likely benefit other pharmaceutical companies who have experienced similar restrictions in expert testimony.

The appellate court also ruled that the trial court must examine Hoffman-LaRoche's preemption defense based on the Supreme Court's recent decision in Wyeth v. Levine. The trial court must decide whether Hoffman-LaRoche can clearly prove that the FDA would not have approved an alteration to the Accutane label.

Ultimately, this isn't a clear-cut victory for pharmaceutical companies. This case will go to trial again in the state of New Jersey, and Hoffman-LaRoche may still find themselves facing a hefty settlement payment at the conclusion of the second trial. However, this appellate victory will clearly help pharmaceutical companies in future defective drug claims.

When prescription drugs cause you to develop a serious illness or injury from their consumption, pharmaceutical companies must be held accountable. You may be eligible to receive compensation for your damages. Given the complex nature of the laws governing these claims, it is important to hire an experienced pharmaceutical liability attorney who is up-to-date on the rapid developments regarding these lawsuits.

If you have a defective drug claim in the Denver, Colorado area, please contact the Law Offices of Burg, Simpson, Eldredge, Hersh, & Jardine, P.C. today to schedule a consultation.

Recently, the U.S. Supreme Court ruled on two cases that have serious implications for defective drug and defective medical device lawsuits in our country. Interestingly, the two decisions were rather contradictory -- one expanded the rights of victims while the other limited their ability to receive compensation for their injuries.

In Riegel v. Medtronic, the Supreme Court ruled that federal approval of medical devices preempts state laws governing litigation of these products. In other words, if you have been injured by a defective medical device that was federally approved for use with your medical condition, you will not be able to collect damages because the device had been previously approved for use.

In Wyeth v. Levine, the Supreme Court ruled in favor of the victim, stating that defective drugs that have received FDA approval will not be given preemption benefits. In other words, even if a drug has been approved for use, the pharmaceutical company can still be held liable for damages suffered if the drug is defective.

Clearly, the Supreme Court is making a distinction between the laws governing drugs and medical devices. But why have they done so, and is this distinction appropriate?

There is a legal basis for this distinction. The Medical Device Amendments of 1976 contain a preemption clause, which led to the Supreme Court ruling in favor of medical device manufacturers. However, the Food, Drug, and Cosmetic Act, which governs the regulation of pharmaceutical products, does not contain a similar clause, resulting in the ruling in favor of injured consumers.

In the wake of these two decisions by the Supreme Court, Congress has revisited this question. They have recently introduced the Medical Device Safety Act of 2009, which would eliminate the preemption laws that provide protection for medical device manufacturers against lawsuits when their products are defective. If this law passes, drugs and medical devices will be regulated by the same principles.

Congress should be applauded for proposing legislation that will expand the rights of victims injured by defective medical devices. It seems absurd that manufacturers are not held responsible when their devices fail to function properly. Making manufacturers accountable for the safety of their products would undoubtedly raise quality control standards and help provide victims of defective devices with the compensation they need to cover medical expenses and lost wages incurred as a result of their injuries.

Given the complex and intricate laws governing these products, it is essential that you consult an attorney who specializes in product liability law if you suffer an injury from a defective drug or medical device. The success of your claim will likely hinge on your attorney's ability to navigate through these complicated laws.

If you have a defective drug or defective medical device claim in the Jacksonville, Florida area, please contact the Law Offices of Hardesty, Tyde, Green, & Ashton, P.A. today to schedule a consultation.

The Supreme Court upheld a $6.7 million damage award to Diana Levine, a Vermont musician who had her arm amputated after suffering gangrene from an injection of an anti-nausea drug. The Supreme Court verdict will have a major impact on future pharmaceutical liability lawsuits.

The decision to reject limits on defective drug lawsuits based on previous FDA approval is an important step in defending the rights of many injured victims of dangerous drugs. The Supreme Court had previously ruled in favor of limiting lawsuits for FDA approved defective medical devices, a decision closely aligned with the Bush administration's agenda of limiting such lawsuits based on the doctrine of pre-emption -- a policy that supported the legitimacy of a medical device, no matter how dangerous or defective it proved to be, so long as it received FDA approval.

Fortunately, the Supreme Court ruled more responsibly on this case. As a result, others who have suffered serious injuries from taking dangerous or defective drugs will be able to hold pharmaceutical companies responsible for their actions and receive the compensation they deserve.

In the current case before the Supreme Court, Diana Levine had sued Wyeth Pharmaceuticals after she had contracted gangrene from injecting their anti-nausea drug, Phenergan, into her arm. Levine's attorney argued that Wyeth did not sufficiently warn consumers of the risks associated with using injection as a delivery method for Phenergan. Wyeth's attorneys claimed that FDA approval of Phenergan and its warning label should have prevented this lawsuit from going forward. The Supreme Court upheld the Vermont jury's award in a 6-3 ruling.

It is important to consult an experienced pharmaceutical liability attorney if you have suffered an illness or injury as a result of taking a prescription drug. Often, you may be entitled to receive compensation for the injuries you have suffered.

If you have a dangerous drug claim in the Chicago, Illinois area, please contact the Law Offices of Barry G. Doyle, P.C. today to schedule a consultation.

The Food and Drug Administration (FDA) has issued a "black box" warning for drugs containing metoclopramide. This is the strongest warning issued by the FDA.

Metoclopramide speeds up the movement of stomach muscles, causing the contents of the stomach to enter the intestines quicker. It is generally used to treat gastroesophageal reflux disease and diabetic gastroparesis. This drug should not be taken for more than three months.

Some of the most commonly used drugs containing metoclopramide are Reglan tablets, Reglan oral disintegrating tablets, metoclopramide oral solution, and Reglan injection. The FDA estimates that over two million Americans consume these products.

The FDA has issued a black box warning due to a link between long-term or high dosage use of metoclopramide and the development of tardive dyskinesia. Tardive dyskinesia is a disorder marked by repetitive movements of the extremities, lip smacking, grimacing, tongue protrusion, blinking, puckering, or impaired finger motion.

The majority of metoclopramide users who develop tardive dyskinesia have used the product at high doses or for longer than the recommended three month usage period. Unfortunately, this disorder is usually permanent, and there is no known treatment.

If you are using a drug containing metoclopramide, consult your doctor immediately to see if there is a better option to treat your gastric disorder. If you have developed tardive dyskinesia from taking a metoclopramide drug, it is important to consult an experienced defective drug attorney at once. You may be eligible to receive compensation for the damage caused by this dangerous drug.

If you have a pharmaceutical liability claim in the Denver, Colorado area, please contact the Law Offices of Burg, Simpson, Eldredge, Hersh, & Jardine, P.C. today to schedule a consultation.

In February, the U.S. Supreme Court ruled 8-1 that a patient injured by a balloon catheter manufactured by Medtronic Inc. was not entitled to damages because Medtronic was shielded from liability. The Supreme Court ruled in Medtronic's favor because the device in question met the specifications of the Food and Drug Administration (FDA). Early last week, former U.S. Solicitor General Paul Clement spoke to the Philadelphia chapter of the Federalist Society that this ruling may be a precursor of "sweeping protections for pharmaceutical makers." Clement served as solicitor general from June 2005 until June of this year.

Clement stated that a case involving a pharmaceutical is up for review this fall and bears a striking resemblance to the Medtronic case last February. In the case coming up, a patient sued Wyeth, alleging the anti-nausea drug Phenergan injured her. She contends Wyeth, the drug's maker is liable, while Wyeth contends the patient violated FDA rules and administered the drug in an unsafe way. Wyeth is based in Madison, N.J. and employs 5,300 people at its pharmaceutical headquarters.

As solicitor general, Clement filed a brief in favor of liability protection for manufacturers of pharmaceuticals. He believes that because the Supreme Court relied on the finding that the FDA extensively tested medical devices in the Medtronic ruling, they will apply the same kind of protections for drug makers. This principle is known as preemption.

Perhaps in a related note, both Chief Justice John Roberts and Justice Samuel A. Alito Jr. were once active members of the Federalist Society, a conservative legal group that leans toward siding with pro-business concerns, and has been the source for many of the Bush administration's judicial nominees and the top executive branch. However, Clement notes that the assumption of the Roberts court being pro-business many not be correct because they have ruled against corporate defendants in many employment cases.

As has been noted elsewhere, the FDA may not be the best judge of what is ready for the market. They are admittedly understaffed and underfunded, and we can assume this will affect all aspects of the agency's oversight, including what medical devices and pharmaceuticals are used by consumers.

If you or a loved one has been injured by a defective pharmaceutical or medical device, please contact an experienced injury lawyer in your area to find out if you have a claim.

A Los Angeles County Superior Court jury voted 9-3 to deny the family of 11-year-old Sabrina Johnson an award, stating that Johnson & Johnson, as well as McNeil Consumer & Specialty Pharmaceuticals were not liable for Sabrina's blindness.

The parents of the girl sued Johnson & Johnson for $1 billion, claiming Children's Motrin nearly killed Sabrina and left her legally blind. Their attorney says he will appeal the ruling. Their lawsuit claims that in 2003, Sabrina, then six-years-old, suffered a rare allergic reaction after being given Children's Motrin. The reaction, called Stevens-Johnsons syndrome, caused inflammation of Sabrina's mouth, mucous membranes, and eyes. This is a potentially deadly syndrome experts believe may be caused by reaction to some drugs, including antibiotics, anticonvulsants, and anti-inflammatory medications. It may also be caused by infections.

Sabrina testified during the trial that her eyes became so sensitive and painful that she spent the daylight hours inside a cardboard box for several weeks. Doctors testified that the chances of having a reaction to ibuprofen like Sabrina did are one in a million.

The jury found that Children's Motrin carried a "substantial and dangerous" risk to consumers and that Johnson & Johnson failed to properly provide warnings. However, they found that this lack of warning was not a "substantial factor in causing harm" to Sabrina. One juror stated that Joan Johnson, Sabrina's mother, failed to follow directions by giving her daughter the medicine after she woke up with puffy eyes.

The suit was asking for $14 million in actual damages, $103 million for pain and suffering, and $950 million for punitive damages.

Although the Johnson family was denied an award, there are many defective drugs out there that are not properly labeled and have caused serious injury. If you or a loved one has been harmed by a defective pharmaceutical, please contact an experienced injury lawyer in your area.

The Food and Drug Administration issued a black box warning, the most "urgent" warning they can give, on a class of antibacterials called flouroquinolone drugs. This includes Cipro and other antibiotics. The FDA cites evidence that using these drugs can lead to tendon ruptures, which can leave patients in need of extensive surgery.

Cipro is made by Bayer, while Ortho-McNeil markets the drug under the name Levaquin. Cipro is an effective drug against the effects of the anthrax bacteria, and is stockpiled by local governments in case of a biological terrorist attack. It became well-known in the media during the fall of 2001 during the anthrax scare. It is also used to treat urinary tract infections. Levaquin is used to treat respiratory infections.

Two Years Late

Public Citizen, a consumer group, petitioned the FDA two years ago to ask for this kind of warning. FDA action came only after Public Citizen sued. However, Sidney Wolfe, head of Public Citizen's health section believes that action came too late and that many of the tendon rupture injuries could have been avoided had the FDA acted sooner. The FDA counters that there is already a warning in the prescription literature about tendon rupture, but acted due to doctors and patients not getting the message. Wolfe believes that, in addition to issuing a warning, the FDA should require the makers of the drugs to send letters to the doctors about the risks. The FDA thinks this should be voluntary and that the manufacturers can send them on their own.

Wolfe claims that 407 tendon ruptures had been reported by the end of 2007, and that there were an additional 341 reports of tendonitis after using the drugs. The FDA says they have received "several hundred" reports of ruptures but have not cited a specific number.

Tendon ruptures are more common with sports injuries occurring to men in their mid-30s. Scientists are unsure why the tendon ruptures occur while taking the antibacterials, and believe the link is "highly unusual." Those patients who have the highest risk of tendon ruptures include people over 60-years-old, those with heart and lung, and kidney transplants, as well as those taking steroids. Some of the ruptures also came without warning. There was simply a snap or pop after the patient started using the drugs. The FDA believes that flouroquinolone may be toxic to some individuals.

While the FDA believes that the injuries are probably preventable if patients stop taking them and switch to another medication at the first sign of pain or swelling, there are many who have already suffered injuries. There may even be some who are unaware that their injury is drug-related.

If you or a loved one has been injured by pharmaceuticals, such as Cipro or Levaquin, please contact an experienced injury lawyer in your area. If you are taking Cipro or Levaquin, contact your physician immediately to discuss changing medication.

In 2007, the Food and Drug Administration (FDA) approved 19 new drugs. This was the fewest number of new medicines approved in 24 years. At the same time, they announced nearly 75 new or revised black-box warnings about the risks of side-effects. Furthermore, approvable letters the FDA sends out when they believe more data is necessary, increased 40%. According to drug makers the FDA's focus on safety is delaying new drugs, and many of these drugs are potentially life-saving. So what's with the delay?

In 2004, the drug maker Merck, withdrew the painkiller called Vioxx after it was reportedly linked to heart attacks and strokes. As a result, Merck was flooded with criticism and 28,000 lawsuits. Accusations about the drug maker putting profits ahead of customers' safety and the FDA allowing the drug onto the market were made very public. While the FDA may hold some of the responsibility, the drug industry has allegedly manipulated data, concealed dangerous side-effects, and promoted products it knows are dangerous. Evidence points to this episode beginning a sea-change in policy at the FDA. According to Kenneth Kaitlin, director of the Tufts Center for the Study of Drug Development, the FDA is "viewed as an agency that is supposed to keep unsafe drugs off the market, not to speed access to life-saving drugs." Either situation is not likely to gain the government agency points with an already wary public.

While Vioxx is one of the most widely publicized drug recalls, others, such as GlaxoSmithKline's diabetes drug, Avandia, Pfizer Inc.'s smoking-cessation drug, Chantrix, and the recent contaminated heparin debacle have all become part of the public record. As a result, several senators have taken the FDA to task for not being vigilant enough.

Matter of Balance

Though the FDA has approved drugs whose side-effects have led to devastating injuries and death, one of the central parts of this story is that of balancing risks that may affect only a small percentage of users against the possibility of improving quality of life, or even saving lives of hundreds of people. However, the problem certainly goes beyond this. According to the FDA, they have 500 vacancies for its staff of reviewers, and claim that having to train new hires delays the reviewing drug applications. They also claim that the low number of approved drugs is simply because fewer new drugs were proposed. According to Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, 33% fewer applications were submitted in 2006. Still, is this an industry response to fears of lawsuits when side-effects do harm users? Or is it that research showed the drugs had problems, and would never be green-lighted by the FDA? Dr. Woodcock denies that the FDA has become more conservative in its approvals, so it's unclear.

What is clear is that there are several drugs being held up that may, or may not, benefit users. Recently, Novartis quit trying to gain US approval for the diabetes drug Galvus and the painkiller Prexige even though Galvus is already on the market in Europe and Prexige has been approved in 50 countries. Glaxo's cancer vaccine Cervarix, Schering-Plough's sugammadex, a post-surgical drug designed to negate muscle relaxants, and Merck's pain medicine Arcoxia, were either delayed or rejected outright. These drugs are also on the market in Europe.

The outcome between balancing drugs to help people and drug safety is important, and this is part of the FDA's job. However, we, as current and potential future users need to know that we have access to them. And the drug makers and doctors need to rest assured that they will not encounter lawsuits for putting them on the market or prescribing the dosage.

Still, if you or a loved one has been harmed in anyway by a defective drug, please contact an experienced personal injury lawyer in your area.

Infants born with congenital anomalies, such as microtia, an ear deformity, and cleft palate, may have gotten them due to exposure to mycophenolate mofetil (MMF). According to the FDA, MMF is the active drug in CellCept, manufactured by Roche Pharmaceuticals, and part of the chemical makeup of metabolite mycophenolic acid (MPA) in Myfortic, manufactured by Novartis Pharmaceuticals. Both CellCept and Myfortic are immunosuppressants. Links have also been made between MMF and MPA, and spontaneous abortion in the first trimester.

Expectant mothers were taking these drugs as part of their treatment following organ transplant, lupus, and erythema multiforme, a type of skin disorder caused by an allergic reaction. It has been noted that treatment for these conditions began before the women became pregnant, but continued into the first trimester.

Labeling of both MMF and MPA was revised in November 2007, showing the Pregnancy Category as "D." This rating means that there is "positive evidence of human fetal risk, but potential benefits may warrant use of the drug in pregnant women despite the potential risk." The FDA is currently working with the manufacturers of these drugs to reduce fetal exposure and lowering risks.

Notes for Women from the FDA

If you have a child born with birth defects or have miscarried, and you believe the cause was MMF or MPA, please contact an experienced injury lawyer in your area to see if you have a claim.

Atrium Medical Corporation has announced it is recalling lots of its Hydraglide brand heparin-coated Thoracic Drainage catheters due to contamination of the blood thinner. The contamination only affects selected lots of Atrium's catheters, and they have not received any reports of patients who have had adverse reactions. However, because they have found contaminated samples, they are proactively recalling all lots.

This stems from the high-profile heparin recall that has killed at least 81 people. Drug maker Baxter International who manufactures heparin has been at the center of an investigation first announced in February. Since the heparin recall it has been reported that the contaminant is hypersulfated chondroitin sulfate, and may have been fraudulently added somewhere between China, where the raw ingredient is manufactured, and a facility in this country. While the original recall was for single- and multi-dose injections used in cardiac surgery and kidney dialysis, the Atrium recall is new. While the heparin-coated catheters are not considered a high dose, as are the previously recalled syringes, the potential risks of what this contamination means to patients is still too great.

Atrium has requested that those with contaminated lots stop using them immediately.

If you or a loved one has been injured by tainted heparin, please contact an experienced injury lawyer in your area to find out if you have a claim.

The recent recall of Digitek (digoxin) due to twice the appropriate dosage goes back to March 2006. The FDA issued a recall notice at the beginning of May and stated that the distributer, Mylan Pharmaceuticals, and its manufacturer, Actavis Totowa, were voluntarily complying. The drug was distributed under the "Bertek" label. The drug was also marketed under a "UDL" label and distributed by UDL Laboratories, Inc., but no mention of this label is part of the recall.

However, the tablets have been distributed since 2006, more than two years before the recall was announced by the FDA. In class-action lawsuits that have been filed against Actavis, it is alleged that the FDA found problems with Digitek in 2006 at the manufacturing plant in Little Falls, NJ. There is also some concern that there were "unexpected adverse drug events" that go back to 1999.

Since the news of the Digitek recall, users who have been injured have come forward to complain about many of the symptoms of digitalis toxicity, including dizziness, nausea, and kidney damage. If you feel you have suffered "unexpected problems" due to taking Digitek, please contact an experienced injury lawyer in your area.

The FDA has announced that, Actavis Totowa, formerly Amide Pharmaceutical, Inc., has recalled all Digitek (digoxin) tablets due to a double dose of the active ingredient, digitalis, in each tablet. This is a Class I recall, meaning the level of toxicity in each tablet may cause serious health problems or even death, especially to those with renal failure or impaired kidney function.

Digitek is distributed by Mylan Pharmaceuticals with the "Bertek" label and UDL Laboratories, Inc., with the "UDL" label. It has been reported that these double-dose tablets may have been sold for the past year.

Digitek is used to treat abnormal heart rhythms and heart failure, and digitalis toxicity can lead to low blood pressure, an irregular pulse, heart palpitations, and bradycardia. Other symptoms may include:

• Blurred vision
  
• Blind spots
  
• Halos
  
• Dizziness
  
• Nausea
  
• Vomiting
  
• Diarrhea
  
• Breathing problems
  
• Body swelling
  
• Decreased urine flow
  

Digoxin was used in a series of murders in the '80s and '90s committed by Charles Cullen, a nurse who claimed to have killed as many as 45 patients in New Jersey and Pennsylvania.

The active ingredient, digitalis, comes from the foxglove plant (digitalis purpurea). All parts of the plant can be poisonous when ingested by people or animals.

If you or someone you know has been taking Digitek, consult your physician as soon as possible. Retailers carrying this drug should take it off the shelves and return it to the manufacturer immediately. Inadvertent overdosing on this drug can be lethal.

If you or a loved one has suffered adverse effects from the use of Digitek (digoxin), please contact an experienced personal injury lawyer in your area as soon as possible. You may be entitled to compensation and there may be time limits in filing your claim.

A congressional subcommittee allowed the families of victims who died due to tainted heparin to say their piece today. They told stories of family members looking forward to birthday dinners planned for the night of the day they died, and of multiple family members lost for the same reason.

According to Bart Stupak (D-Mich.), chairman of the House Energy and Commerce subcommittee on oversight and investigations, the blood thinner's contamination has led to the deaths of 81 people and another 785 severe allergic reactions. The victims were either heart patients or those receiving dialysis.

In several of the stories, family members relate similar symptoms suffered by those who died: severe diarrhea, abdominal pain, and trouble breathing. The victims then became unconscious and CPR failed to save them. In all cases the family members stated they never thought heparin might be the cause of death. Johanna Marie Staples, whose husband, Dennis, died on his 60^th birthday, may have said it best when she told the subcommittee "we have a false sense of security" in a country where people expect to be safe and protected from contaminated drugs.

Janet Woodcock, the FDA's director at the Center for Drug Evaluation and Research, told the subcommittee that there have been several major changes recently where drugs are made. She used as an example that the agency only received 150 generic drug applications from US makers in 2007 while receiving over 400 from India, and nearly 500 from China. Authorities believe China is the source from which the tainted heparin ingredients came.

Baxter International, the Illinois-based company with a majority stake in the Chinese company that allegedly sold the tainted heparin was also allowed to speak. Company president, Robert L. Parkinson Jr. said the company is concerned that the addition of hypersulfated chondroitin sulfate to heparin may have been deliberately added in a fraudulent manner. He went on to state that, "the complexity of the global drug supply chain creates new and emerging risks that call for new ways of thinking about, identifying and addressing vulnerabilities."

Until companies like Baxter figure out their problems with how globalization is killing innocent Americans, we'll be hearing about these things now and again.

If you or a loved one has had a severe allergic reaction you believe was brought about by tainted heparin, please contact an experienced injury lawyer in your area.

As the Chinese government continues to insist that it had nothing to do with the tainted anti-coagulant heparin supplies found in stocks in the U.S. supply, officials have found contaminated heparin in 11 other countries. Meanwhile, the tainted heparin is now suspected in 81 deaths here. The Food and Drug Administration has identified 12 Chinese plants that have supplied tainted heparin to Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand, and the U.S. However, the origin of the contaminant is still being investigated. It is suspected that the added ingredient, hypersulfated chondroitin sulfate, is the culprit and that it was fraudulently added into the supply chain at some point.

The U.S.-China heparin row has taken on a new dimension with the Chinese government insisting that it be allowed to inspect the New Jersey plant where finished heparin vials are made. The plant is run by Illinois-based Baxter International. Ning Chen, second secretary at the Chinese Embassy states, "We don't have strong evidence to show that it is heparin or its contaminant that caused the problem." He states further that the problem has only been in the U.S., and refutes the finding that other nations were affected.

This seems to add to the fuel already on the fire regarding the safety of products from China. Lately products as diverse as tainted fish, toxins in pet food, lead in toys, and poisonous toothpaste have created problems between China and the U.S. This week has already seen the FDA send a warning letter to Changzhou SPL, the plant in China tracked down as the probable source of contaminated heparin. The letter states that the plant is unclean, the ingredients to make heparin, pig intestines, were received from an unacceptable vendor, and that the plant has no way to remove the impurities.

China has promised reforming the way products imported into the U.S. are created, going as far as executing the top Chinese food and drug regulator for taking bribes, but they also accuse "foreign forces" of making something out of nothing.

Another part of this issue that has come to light is that the FDA is badly underfunded. It is believed that, at the current pace, it will take the FDA over 25 years to inspect every foreign plant that exports medicines to the U.S., 13 years for every foreign drug plant, and almost 2,000 years to check out every foreign food plant. The Bush administration has acknowledged the problem, but Bush's current budget does not provide funds for the FDA to hire more inspectors. Should we get used to hearing more about substandard products from places like China?

If you or a loved one has been sickened by tainted heparin, please contact an experienced injury lawyer in your area.

Members of both political parties believe that the Food and Drug Administration needs further funding if it is to continue to protect American lives. As it stands now, a report sent out last year by a panel of outside advisers stated the FDA does not have the staff, scientific expertise, or the money to do all it can. The Appropriations subcommittee, which oversees the agency's funding, met with Dr. Andrew C. von Eschenbach yesterday to decide just how much money the FDA needs. All in attendance believe the White House suggestion of an increase of three percent in next year's allocated budget is not nearly enough. Dr. von Eschenbach said the agency wanted to hire an additional 700 people this year, but the proposed White House budget won't even cover expected increased costs.

Citing the heparin controversy, Dr. von Eschenbach said the FDA wants to open three new offices in Beijing, Shanghai, and Guangzhou, China. They will increase their Chinese staff to 13 with five native Chinese hired locally. This will hopefully lessen the chances that tainted products, such as the blood-thinner heparin, will make it to American markets.

It isn't only tainted heparin, but a plethora of other items, that are investigated by the FDA. Pharmaceuticals, food, medical devices, and even cosmetics are OK'd by the agency. Without the necessary funding, we may see an increase in the numbers of people injured and killed by products that had no business being sold, or given, to consumers.

If you or a loved one has been injured or sickened by a defective product or pharmaceutical that could have been removed from the market by the FDA, please contact an experienced injury lawyer in your area.

Clinical trials of Exubera, an insulin inhaler, have shown an increased incidence of lung cancer. Exubera is made by Pfizer, Inc. in a partnership with Nektar Therapeutics. The findings have lead Nektar to end talks about marketing Exubera with potential partners.

Trial Findings

According to Pfizer, six of 4,740 patients treated with Exubera developed lung cancer, while one of 4,292 patients untreated by Exubera developed lung cancer. One case of cancer apparently developed after Exubera was placed on the market. However, Pfizer claims that those who developed lung cancer were smokers and that there were too few cases to determine a concrete link, and states this on Exubera's warning label.

Health and Money

Though Pfizer said it would stop marketing Exubera in October, this story stems from the FDA's ongoing review of the trial and post-marketing investigation. Sales of Exubera were also less than stellar, and promises of helping diabetics avoid needles never really came to fruition. What was once thought to have the potential to be a $2 billion windfall has now become a problem for Pfizer who must now explain the timing of the marketing authorization withdrawal with regulatory agencies. Nova Nordisk and Eli Lilly have also abandoned insulin inhaler programs since Pfizer quit last year.

If you, or a loved one, believe your lung cancer can be linked to Exubera, please contact an injury lawyer with experience in pharmaceutical liability.

Federal officials have announced that a fairly common ingredient in nutritional supplements has been identified as the contaminant in heparin, a blood thinner used in surgery and kidney dialysis. Heparin helps to prevent blood clots that may cause heart attacks and strokes. The contaminant known as hypersulfated chondroitin sulfate, or chondroitin sulfate, is made from animal cartilage and is an ingredient in several nutritional supplements used to promote healthy joints. However, the hypersulfated chondroitin sulfate is not approved for use in the U.S. Levels of the contaminant ranged from 2% to 50% in lots of heparin tested.

Unknown Origin

It is believed that this substance is the culprit that sickened and killed hundreds of patients across the U.S. How it got into heparin is a question authorities are still investigating. The contaminant originated in China, and there are several theories about how it made its way into the drug. There may have been some kind of "mishap." Or perhaps it was an experiment gone awry. However, it may have also been deliberately added to the heparin to boost profits of middlemen. FDA officials may never find out due to difficulties in back-checking.

Sen. Edward Kennedy, chairman of a panel overseeing the FDA, stated, "it is unacceptable that Americans have died and been seriously injured by what appears to be deliberate tampering." He went on to say that those responsible must be brought to justice. Independent experts tend to agree that this is deliberate tampering, and akin to the pet food case in which thousands of cats and dogs were sickened by food ingredients from China last year.

Heparin manufacturer, Illinois-based Baxter Healthcare Corp., believes the contaminant was introduced before raw heparin ingredients reached its supplier, Scientific Protein Laboratories. Scientific Protein Laboratories is a joint venture partner with the Chinese facility that supplied the heparin in question.

Chinese Cooperation

It is hoped that this case will lead to better cooperation between the U.S. and China regarding imports. The last year has seen several high profile examples of the poor monitoring of products from China, including tainted pet food and lead in children's toys, as well as this case. But Chinese officials expedited the visas of FDA investigators. Their Chinese counterparts seem to have been more helpful with this case than others.

Rep. John Dingell wants a more stringent system that will oversee imports from other countries. It is unknown if the Bush Administration will go for it because the system would need to be financed by new industry fees.

If you, or a loved one, have been sickened by tainted heparin, please contact an experienced injury lawyer in your area.

Imports of heparin, a blood thinner used in surgery and kidney dialysis to prevent clotting, have been stopped at the border by the FDA to test for a contaminant. The contaminant was found in the drug thinner's raw ingredient, pig intestines, and is linked to hundreds of allergic reactions and 19 deaths.

The contaminant was found in 20 of 28 samples of raw heparin tested by the FDA. The raw ingredient is supplied by a Chinese factory, which is owned by Scientific Protein Laboratories in Wisconsin. Illinois-based Baxter International Inc. then supplies heparin to hospitals around the country. They are one of the main suppliers of heparin in the U.S.

This latest news stems from an earlier suspension and recall of heparin announced in February by the FDA. At the time that story broke, almost 450 allergic reactions and 21 deaths had been linked to contaminated heparin. The deaths have apparently been revised down to 19. No additional deaths and only two allergic reactions have been reported since last month's recall. Allergic side effects include increased heart rate and lower blood pressure.

Prime Suspect

When the FDA and Baxter announced the recall, the link between the contaminant and the allergic reactions and deaths was "tenuous." And because scientists have yet to identify what the contaminant is, there is still some uncertainty as to whether it caused the reactions and deaths. The uncertainty is due to the contaminant closely mimicking heparin's structure so it is not caught by standard drug-purity tests. FDA drug chief, Dr. Janet Woodcock, believes they are close to identifying the substance, as well as determining if it got into the heparin accidentally or through fraud.

The pig intestines used in heparin come from small family-run workshops in China. These are located near slaughterhouses, where the ingredients are then given to middlemen before they reach larger factories. The FDA hasn't inspected these workshops, so it isn't clear exactly where the contaminant might be. It has been surmised that due to pig diseases that depleted the stock of healthy animals used, the Chinese were buying sick pigs in the market. This forced Chinese producers to look for alternative sources, which often are located in villages with unsanitary conditions.

While worldwide testing has begun to make sure heparin is contaminant-free, five of the nation's leading heparin manufacturers will perform the testing on imports. The FDA will not name these five companies and do not plan on spot checking the quality of the tests.

If you, or a family member, believe you have suffered an allergic reaction due to contaminated heparin, please contact a personal injury lawyer with experience in pharmaceutical liability.

An Associated Press investigation has shown that drinking water supplies in at least 24 major metropolitan areas across the country have trace amounts of a variety of pharmaceuticals in them. These 24 cities supply drinking water to 41 million Americans. While the concentrations are miniscule, with quantities measuring in parts per billion or trillion, the type of drugs found in the water is troubling to scientists. But the question many people are asking, or should be asking, is how these drugs got into the water in the first place.

Over-the-Counter, Into the Water

Drugs like mood stabilizers, anti-convulsants, antibiotics, and sex hormones are in the water. So are acetaminophen, ibuprofen, and even caffeine. How these drugs got into the water supply may seem like common sense at first glance to many: We take the pills, our bodies absorb what they can, and the rest is flushed out of our systems, down the toilet, and into the water, which is then treated for drinking. Though the water is treated before it gets to reservoirs, lakes, and rivers, there are still trace amounts of whatever it is people are taking. Another way is when we flush old unused prescriptions down the drain.

It is reported that researchers do not yet know all of the risks involved with having trace amounts of these drugs in our water supply, and this has scientists worried about the long-term effects on both humans and wildlife. In fact, fish in many of the affected waterways have the pharmaceuticals in them. But so do organisms as far flung as earthworms, sharks, and even vegetables. What this means to the food pyramid remains to be seen, but the EPA has been looking closely for at least a year.

While the animal world may show the immediate evidence of what drug residue in the water can do, there is some worry about how this might affect the young, the elderly, pregnant women, and those whose immune systems are already compromised.

Key Results

• Philadelphia, Pennsylvania - 56 pharmaceuticals found in treated drinking water, including medicines for heart problems, mental illness, pain, infection, high cholesterol, epilepsy, and asthma.
  
• Southern California - 18.5 million people in have traces of anti-anxiety and anti-epileptic medicine in their water.
  
• Washington, D.C. metro area - Six different pharmaceuticals found.
  
• San Francisco, California - Traces of a sex hormone were found.
  

This is only a partial list. What might be even more disturbing is that of the 62 water providers contacted for this study, only 28 tested their water for this investigation. Major cities left off the list include New York, Boston, Chicago, and Miami. Further areas that have not been tested include bottled water and rural wells. One of the possible reasons for the lack of testing is that the federal government doesn't require it. They also do not require setting safety limits on drugs in the water supply.

Potential Problems

One problem might lie in how these drugs are absorbed into our bodies in the first place. It would be nice to assume that every drug we take is absorbed 100% into our body. However, that doesn't happen. And it leaves one wondering what percentage is absorbed. Seventy-five percent? Fifty percent?

Another problem might be that doctors over-medicate the population. It probably comes as no surprise that some people are given antibiotics for the common cold. And maybe you aren't surprised that some people don't take all of their medicine. Where does the rest of it end up? Flushing them is a direct route to the water supply, and throwing them into the landfill will leech them into the ground, and onward into rivers, lakes, and reservoirs.

Or maybe this is making an ocean out of a water dish. After all, what's one part per billion or trillion? And do the researchers, scientists, and federal government have the means, and the will, to figure out what types of pharmaceuticals and medications are in all waterways and watersheds in the country?

Regardless, if you feel that you, or a loved one, have been harmed by pharmaceuticals or medicine you don't believe you needed to take, please contact an experienced personal injury lawyer in your area to find out what your legal options are.

How the mighty fall. Dr. Robert Jarvik was recently fired as the pitchman for Lipitor by Pfizer. The advertising practice Pfizer used for its cholesterol lowering drug, Lipitor, has been called into question by a Congressional committee investigating the ads' credibility. The problem is that the ads are deceptive.

Dr. Jarvik helped to pioneer the artificial heart, and was then used by Pfizer to pitch Lipitor. The drug company offered Jarvik a contract, worth $1.35 million over a two year period, if he used his face and name to hype the pros of using Lipitor. However, the ad doesn't tell the audience that Jarvik only started using Lipitor a month after being offered the contract. The ad also shows Jarvik rowing across a mountain lake. But a stunt double was used in place of Jarvik. On top of all of this, while Jarvik has a medical degree, he did not go through training as a resident, and is not licensed to prescribe drugs - or practice medicine. Jarvik is a researcher, as well as an inventor. Since January 2006, Pfizer has spent $258 million on advertising Lipitor, and most of this went to the campaign starring Jarvik without telling consumers who he really is.

The Consumer Issue

Though Congress, and probably some people, might take issue with these technicalities, what the New York Times brings to light is the issue of how consumers view drug ads. While people should look at all advertising with a critical eye, and not necessarily believe everything they see and hear, drug ads are especially brought into focus here. How many times have you seen a drug advertisement on television that shows someone, a look of contentment on their face, walking through a field while a voice over mentions the name of the drug and then gives you a list of the side effects? How often have you wondered what the drug was even for? While listing the side effects is a good thing, showing a minimalist idea of what the drug is doesn't help. It's enough to make one yearn for the days when you knew exactly what medication, like Alka-Seltzer (plop, plop, fizz, fizz), was for and what it would do to you when you took it.

While the Lipitor ad starring Dr. Jarvik lets the average consumer know what the drug is, the fact that Jarvik is not "a doctor" and is taking Lipitor because he got over a million dollars for it, raises questions that Congress wanted answers for. And, while the idea that Congress is taking deceptive practices to task is interesting in itself, what it comes down to is that Pfizer was lying to consumers. As an answer to the House Energy and Commerce Committee, Pfizer simply shut down the Lipitor/Jarvik ad campaign. Such is life. Next time maybe they'll use Shaq. Or even Lou Reed.

If you feel you've been deceived, led astray, or lied to about the way a product or drug is supposed to work, or you've been injured by its use, please contact an injury lawyer with experience in product liability or pharmaceutical injury.