Court Rules Paxil Manufacturer Can’t Hide Behind Preemption

Paxil Preemption Defense Denied Drug Toxic Chemicals

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Court Rules Paxil Manufacturer Can’t Hide Behind Preemption

A Pennsylvania court recently ruled that GlaxoSmithKline (GSK), the manufacturer of the popular antidepressant drug Paxil, cannot claim that those injured by the drug are preempted from suing the company.
No preemption
The Philadelphia, PA court denied GSK’s request to dismiss a case brought by the parents of Harold Garrison, a 16 year-old who committed suicide after taking Paxil (generically known as paroxetine hydrochloride) for approximately nine months. According to the judge in the case, “The evidence suggests a triable issue of fact as to whether GSK indeed possessed information, not available to the FDA [U.S. Food and Drug Administration], upon which it could have unilaterally added a warning to its labeling, consistent with FDA regulations.”
The FDA’s position
The FDA has been investigating whether antidepressant drugs such as Paxil increase the risk of suicide in children. The FDA issued a warning in September 2004 for Paxil stating that the drug can cause suicidal behavior in minors. That warning followed a study from Great Britain which reported that over 1,000 children taking Paxil had an increased rate of suicidal behavior.
The FDA issued another warning for Paxil in May 2006 after a different study showed that young adults ages 18 – 30 also showed an increased rate of suicidal behavior. The court’s ruling to let the lawsuit go forward was partially based upon the fact that the FDA had not yet taken a position on antidepressants prescribed for children at the time of Garrison’s suicide in 2002. However, the issue of preemption and drug manufacturers will be decided by the U.S. Supreme Court in the next few months.
Why didn’t GSK warn consumers?
That’s what the parents of Garrison want to know. In fact, many others in the U.S., Canada and the Great Britain also want to know. While GSK states that it wasn’t required to warn consumers about suicidal behavior in children because the FDA hadn’t required it to, the court disagreed and stated that the FDA’s rules allow drug manufacturers to “unilaterally add a warning on a drug, so long as the drug manufacturer has reasonable evidence of an association of a serious hazard with a drug.”
According to news reports, GSK faces several lawsuits in each country alleging that Paxil causes suicidal and homicidal behavior and is an addictive drug. They claim that GSK knew of the increased risks of suicide in minors, but kept that information to itself to boost sales.
If you or a loved one has been injured due to Paxil use, contact an attorney whose practice focuses in this area of the law to discuss your situation. Consultations are free, without obligation and are strictly confidential. To contact an experienced attorney, please click here. We may be able to help.

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Ortho Evra Lawsuit – Overview/Update

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Ortho Evra Lawsuit – Overview/Update

Individual actions have been filed, and a class action consumer fraud lawsuit is currently being investigated, against Ortho-McNeil Pharmaceutical, Inc., a division of Johnson and Johnson, Inc., by people who have developed serious medical problems as a result of the use of the Ortho Evra Birth Control Patch. These problems include life-threatening blood clots, fatal heart attacks, and pulmonary embolisms.

Suffered harm from Ortho Evra? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.

A class action lawsuit would combine a large number of Ortho Evra claims brought by separate individuals under one representative lawsuit. The action is brought in the name of a class representative who is selected to represent the interests of all the members who have the same claim against the same defendant. If successful, the court judgment or settlement is distributed among the class members.

Is it worth it to file as a member of a class? There are advantages to an Ortho Evra class action lawsuit over an individual action. It makes sense when a Ortho Evra injury is too small to justify an individual/separate lawsuit. Combining smaller claims into a representative class adds more clout in terms of numbers, which increases the likelihood of recovery and the size of the recovery. Aggregating also conserves resources and lowers the costs of litigation.

The major downside to an Ortho Evra class action is the chance that your damage award or settlement will be somewhat lower than what you would have received had you filed separately. In a class action, you recover only what was provided for in the large class action suit; you cannot later sue for a larger amount. Also, you lose some flexibility when you join a class action suit, since you are bound to the class timetable and the class outcome collectively. In an individual action, your attorney will work up the unique aspects of your case and separate you from the pack. Personalized legal representation is given to your specific injury and circumstances; you are not lumped in with all others having comparable claims. In a class action you are represented by attorneys you may never see or deal with. For more information, read our sections on Filing a Lawsuit and Select an Ortho Evra Lawyer.

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Consumer Group Tells FDA That Ortho-Evra Birth Control Patch Is Dangerous

Consumer Group Tells Fda Ortho Evra Birth Patch Is Dangerous Drug Toxic Chemicals

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Consumer Group Tells FDA That Ortho-Evra Birth Control Patch Is Dangerous

The consumer group, Public Citizen, nonprofit consumer advocacy organization, has asked Congress to pull Johnson & Johnson’s birth control patch, Ortho-Evra, off the market because it poses significant health risks to women.
Too much estrogen?

The consumer group says that Johnson & Johnson’s birth control patch, which is worn for three weeks straight, then not worn for a week, delivers 60 percent more estrogen than traditional birth control pills – which significantly increases a woman’s risk of developing blood clots that may result in a heart attack or stroke. It points to studies that show women using the Ortho-Evra patch were twice as likely to develop blood clots.
Although Johnson & Johnson maintains that the patch is safe if used as directed, the following warning appears on the drug’s website (www.orthoevra.com):
Hormones from ORTHO EVRA get into the blood stream and are processed by the body differently than hormones from birth control pills. You will be exposed to about 60% more estrogen if you use ORTHO EVRA than if you use a typical birth control pill containing 35 micrograms of estrogen. In general, increased estrogen may increase the risk of side effects. The risk of venous thromboembolic events (blood clots in the legs and/or the lungs) may be increased with ORTHO EVRA use compared with use of birth control pills.
Studies examined the risk of these serious blood clots in women who used either ORTHO EVRA or birth control pills containing one of two progestins (levonorgestrel or norgestimate) and 30-35 micrograms of estrogen. Results of these studies ranged from an approximate doubling of risk of serious blood clots to no increase in risk in women using ORTHO EVRA compared to women using birth control pills.
Sales of the patch have decreased significantly in the past few years due to damaging studies and the U.S. FDA’s (Food and Drug Administration) enhanced labeling requirement that tell users of the patch’s potential dangers and clarifies that the patch must be used exactly as directed to avoid injury.
If you believe that you’ve been injured due to Ortho-Evra, contact an attorney to discuss your situation. Consultations are strictly confidential, without obligation and free of charge. To contact a qualified attorney whose practice focuses in this area of law, please click here.

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What actions must a creditor take in a bankruptcy case?

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What actions must a creditor take in a bankruptcy case?

The most common participation by a creditor in a consumer bankruptcy case is to file a proof of claim and share in the liquidation of the bankruptcy estate or under a proposed plan. The bankruptcy estate is overseen by the trustee who distributes the bankruptcy estate to the creditors after deducting trustee expenses, administrative costs, and paying priority claims, such as those made by the government. In most Chapter 7 bankruptcies there are few or no assets in the bankruptcy estate.

A proof of claim that is properly filed in accordance with the rules governing bankruptcy cases is evidence of the claim’s validity and amount and is deemed allowed unless the debtor or an interested third party objects. Unsecured creditors will not receive a distribution from the bankruptcy estate unless a proper proof of claim has been filed. The proof of claim must be filed within 90 days of the date when the meeting of creditors was first set (not including any continuances).

(Reviewed 11.3.08)

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Johnson & Johnson’s Ortho Evra Birth Control Patch: A Catch 22?

Ortho Evra Birth Control Patch Catch 22 Drug Toxic Chemicals

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Johnson & Johnson’s Ortho Evra Birth Control Patch: A Catch 22?

Johnson & Johnson’s Ortho Birth Control Patch was supposed to provide the same amount of estrogen as birth control pills. At least that’s what Johnson & Johnson told the U.S. FDA (Food and Drug Administration) at first.
Years later, documents have surfaced showing that J&J’s Ortho Evra birth control patch actually delivers much more estrogen than birth control pills and has an increased risk of causing blood clots and strokes. Injured women have sued J&J, but the manufacturer is simply pointing its corporate finger at the FDA.
Catch 22?
The FDA is responsible for consumer safety regarding foods, drugs and medical devices. In many cases, manufacturers are not held responsible for their products if the FDA takes responsibility for approval – regardless of whether the product is later found to be dangerous or cause injuries. It’s a catch 22 known as preemption.
Preemption
Preemption prohibits consumers from filing lawsuits against manufacturers. However, consumer advocate groups say that the FDA actually relies on manufacturers’ data in approving many products – especially drugs. In fact, the FDA has said as much itself and claims that it does not have the resources to adequately protect consumers. Industry analysts say that manufacturers know this and use it to their advantage – then claim that consumers are preempted from suing them. Unfortunately, this claim has been upheld.
Supreme Court upholds preemption
The U.S. Supreme Court, the nation’s highest court, recently upheld a preemption argument earlier this year. In February 2008, the Court ruled that consumers could not sue medical device manufacturers if the FDA was responsible for approving the device. The Court will hear another case later this year concerning preemption and drug manufacturers and only time will tell how the Court will rule.
Where does that leave consumers?
Consumers who have been injured due to bad medical devices and dangerous drugs may still have recourse against manufacturers – especially in situations where those manufacturers didn’t provide the FDA with correct data or withheld relevant data about their products. If you’ve been injured due to a medical device or drug, contact an attorney to discuss your situation. We may be able to help. Consultations are strictly confidential and are without charge or obligation. To contact a qualified attorney whose practice focuses in these areas of law, please click here.

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What is the Fair Credit Reporting Act?

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What is the Fair Credit Reporting Act?

The Fair Credit Reporting Act (FCRA) is a federal law that regulates the activities of credit reporting bureaus. Private credit reporting bureaus, such as TRW Information Services, Equifax Credit Information Services, and Trans Union Credit Information Company, maintain records of financial payment histories, public record data (such as unlawful detainer (eviction) actions taken against you, or money judgments (entered against you), along with personal identification information. Credit reporting bureaus sell the information to creditors so the creditors can make decisions about whether or not to offer you credit.

The FCRA punishes unauthorized persons who obtain credit reports, as well as employees of credit reporting bureaus who furnish credit reports to unauthorized persons. The Act also specifies responsibilities of those supplying the reporting bureaus with information.

If the information about you from a credit reporting bureau is all good, there’s no need to worry about it. You should be able to obtain credit to purchase goods and services, rent an apartment, obtain a home mortgage loan, apply for insurance, and even obtain employment.

Negative information on file with credit reporting bureaus may be used against you to deny you credit, employment, or even the ability to rent an apartment. It is a good idea to check your credit reports on an annual basis, so that you know what creditors are being told before the information is disclosed to them. Credit reporting bureaus are allowed to charge you a reasonable fee to obtain a copy of your credit report in this situation.

When credit is denied to you based upon information obtained from a credit reporting bureau, the creditor must provide you with the credit reporting bureaus’ name and address. If you request (by telephone, mail or in person) a copy of your credit report from the credit reporting bureau within thirty days of the denial, the bureau must send your credit report to you for free, including the names of creditors who have provided the information to the bureau, and the names of everyone who has received a credit report on you in the last six months, or an employment report in the last two years.

If the information provided in a credit report turns out to be inaccurate and corrections are made or the consumer inserts an explanation, the credit reporting bureau must notify the recent recipients of information (as specified by the consumer) of the corrections or explanation.

The consumer reporting bureau must delete information about events that happened more than 7 years before from a report (or 10 years in case of bankruptcies).

(Reviewed 10.31.08)

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What is APR?

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What is APR?

APR is the acronym for annual percentage rate. The APR is a reference to a federally required calculation of the yearly cost of a loan that includes interest rates and other fees.

The requirement for APR disclosure was intended to help consumers compare loans. Unfortunately, the requirements for what is included in the calculation of APR are not sufficiently standardized to create a reliable comparison guide. Some fees are included, such as processing and underwriting fees, but other fees may or may not be in the APR calculation. For example, fees for title or abstract, notaries, inspections, and so on, may or may not be included. So be sure you ask what is included in an APR before you use it to compare loans or credit.

An APR on a credit card will not include late fees, over-the-limit fees, or finance charges you may incur by not paying off your balance each month. So the APR may not reflect the entire cost of the credit.

(Reviewed 10.31.2008)

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MRI Dye/Gadolinium Side Effects

Mri Dye Side Effects Drug Toxic Chemicals

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MRI Dye/Gadolinium Side Effects

Gadolinium is a contrast agent used to enhance the images on MRIs and MRAs. While there are several companies that manufacture gadolinium products, all of these products have the potential to lead to Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) – a serious and potentially deadly side effect of gadolinium exposure. Dan Thornburgh, a Florida attorney whose practice focuses in drug and medical device litigation, provided more information in a recent interview.
What is gadolinium?
Gadolinium is a contrast agent used to enhance the images on MRIs (magnetic resonance imaging) and MRAs (magnetic resonance angiography), according to Thornburgh. “When a doctor orders an MRI to rule out or rule in certain conditions, they use a type of x-ray machine to enhance images. Gadolinium is a contrast agent used in these procedures to enhance those images. It’s a chemical or toxin that is not found in the human body.”
Who manufactures gadolinium?
There are several manufacturers, according to Thornburgh. “General Electric manufactures Omniscan, Bayer manufactures Magnivist, Tyco manufacturers OptiMark and Bracco manufactures both Multihance and Prohance.”
Potential deadly side effects
Thornburgh told us that gadolinium, when used in patients with certain health conditions such as kidney failure, kidney insufficiency and liver transplant cases, the toxic gadolinium doesn’t move through the body as fast as somebody with normal kidney functions. He explained:
As a result, some people have developed conditions called Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD). People with underlying kidney or liver disease are at an increased risk of developing this condition which can be life altering and can even result in death.
People with this condition develop sort of a woody hard skin, lesions on their body, dark patches on the body and have burning and itching sensations. The hardening process also causes contractures which can become so serious that individuals have a hard time moving, and in some cases, can’t ambulate at all.
Unfortunately, it doesn’t stop there. The lesions that develop on the skin can also develop in organs of the body and this can lead to organ failure. So some of the cases where we see people dying from the drug or from the condition have been from organ failure because it has moved to organs or due to falls because the contractures are so bad that their ability to move has become so limited that they fall and suffer a head injury.
No cure for NSF/NFD
There is no cure for NSF/NFD, according to Thornburgh. “NSF is a fairly new disease. There are no cures to my knowledge. There are treatments but they are limited and are really done to help alleviate the pain and the suffering that these people are going through.”
400 product liability lawsuits filed
There are approximately 400 product liability lawsuits currently pending against gadolinium manufacturers which allege that these companies knew about the risks, but failed to warn consumers. Thornburg said, “It’s terrible and again, we see the same problem in this drug as we do in all these cases. The companies who manufacture these products have a duty to find out what risks are associated with the product. Yet, they either find out what the risks are and don’t warn consumers about it or they do everything they can not to test for the risks.”
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What types of consumer credit are available?

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What types of consumer credit are available?

There at least three basic types of consumer credit:

Noninstallment credit is the simplest form of credit and is usually for a very short term, such as 30 days. The buyer makes one payment at or before the end of the credit period. This kind of credit enables consumers to take possession of property immediately and pay for it within a short time. Many department stores offer noninstallment credit to their regular customers; this enables the store to make sales and get the money in the near future, thus generating better cash flow for the business than might otherwise occur.

Installment closed-end credit is another form, where only a specified amount of money is lent to the consumer, typically the total purchase price of the goods. This kind of credit is also used by department stores for the sale of large items and by auto dealers for the sale of automobiles. For example, if you purchase a sofa and chairs at a furniture store, the store might give you credit up to the full amount of the sale, which will be repaid with interest, but the store does not make further credit available to you under that agreement. The full amount of the principal and interest must be paid within a pre-determined time period. In this kind of credit the lender usually retains title to the purchased goods until all the payments have been made. If the purchaser defaults on payments, the seller can repossess the property.

Revolving open-end credit is found with most credit cards. In this kind of credit the lender extends credit for use by the consumer, with an outside limit that depends on the debtor’s credit history and ability to handle the debt repayment. The financial institution gives the debtor a credit card with a credit limit, such as $1,000, $5,000, or $10,000, and the debtor can choose how much of the available credit s/he will use at any given time. The debtor makes periodic (usually monthly) payments, and continues to use the available credit as needed, as long as each periodic payment meets pre-determined minimum amounts.

Revolving open-end credit requires active management by the debtor. The debtor can decide to pay off the entire outstanding debt when the statement is presented, pay off more than the required minimum payment (but not the entire amount), or simply make the minimum required payment. The debtor thus can determine how much credit will be available to him/her at any given time.

Other credit cards, like travel and entertainment accounts with American Express or Diners Club, may have an open ended amount of credit, but the card holder is expected to pay the balance off each time period, usually each month.

(Reviewed 10.31.2008)

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Gadolinium Manufacturers Settling Lawsuits

Gadolinium Manufacturers Settling Lawsuits Drug Toxic Chemicals

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Gadolinium Manufacturers Settling Lawsuits

Gadolinium manufacturers such as Bayer HealthCare Pharmaceuticals, General Electric, Tyco Healthcare and Bracco Diagnostics have been sued by hundreds of injured victims alleging that they’ve contracted serious skin and organ conditions after using the companies’ products while undergoing MRIs (magnetic resonance imaging) and MRAs (magnetic resonance angiography). One of those companies is now settling cases – and the others are likely to follow.
Contrast dye product liability cases are settling
That seems to be the case according to various credible news agencies. According to Bloomberg news and Reuters, Bayer HealthCare Pharmaceuticals has begun to settle gadolinium cases over its contrast dye agent, Magnevist. Hundreds of lawsuits have been filed against Bayer alone alleging that patients developed serious skin conditions known as Nephrogenic Systemic Fibrosis (NSF) and Nephrogenic Fibrosing Dermopathy (NFD) which, according to an FDA (U.S. Food & Drug Administration) alert, symptoms may include:
For the bones, joints and muscles: joint stiffness; limited range of motion in the arms, hands, legs, or feet; pain deep in the hip bone or ribs; and/or muscle weakness
For the skin: burning or itching, reddened or darkened patches; and/or skin swelling, hardening and/or tightening
For the eyes: yellow raised spots on the whites of the eyes
Other manufacturers likely to follow
While Bayer HealthCare Pharmaceuticals is the only manufacturer reportedly settling lawsuits, other manufacturers such as Bracco Diagnostics, GE Healthcare and Tyco Healthcare are likely to follow suit. Lawsuits against these companies allege that they knew about the dangers of gadolinium based contrast agents and their links to NSF/NFD for years, but failed to warn consumers.
Here’s a list of manufacturers, their products and links to additional information:
Bayer HealthCare Pharmaceuticals – Magnevist
Bracco Diagnostics Products – Prohance and Multihance
GE Healthcare – Omniscan
Tyco Healthcare – Optimark
Find out more
If you’ve been injured due to a gadolinium based contrast agent, contact an experienced products liability attorney whose practice focuses in drug litigation to discuss your situation.

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