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Fairfield Pharmaceutical Products Law Blog

Approval of take home HIV test under consideration in U.S.

It is estimated that as many as 240,000 people who are living in the U.S. are not aware that they are carriers of HIV. However, if the U.S. Food and Drug Administration does decide to approve a new take home HIV test called OraQuick, health advocates believe that more people in Connecticut and throughout the entire country would test themselves for the virus because they could take the tests in the privacy of their own homes without an appointment at a doctor's office or other facility.

If more Americans choose to test themselves for HIV on a regular basis, it is estimated that as many as 4,000 new transmissions of the virus could be prevented each year. However, those who are not in favor of approving the use of the rapid, take home HIV test claim that consumers might not administer the tests correctly or might not receive accurate results if the test that is purchased and used is a defective product. This could result in some people spreading the virus while under the impression that they tested negative as a carrier of HIV.

Fentanyl patch can cause harm to children from accidental exposure

Patients in Fairfield, Connecticut, certainly deserve to be made aware of any side effects they could experience after starting a new medication. Prescription drugs often pose health risks, but consumers deserve to know what these risks are so that they can make informed decisions when it comes to taking medications to treat their health conditions.

However, a recent safety alert issued by the U.S. Food and Drug Administration also suggests that it is equally important for pharmaceutical companies, doctors and medical device manufacturers to give patients instructions on how to properly use, store and discard medications and medical devices. Last month, the FDA warned consumers that children could suffer serious injuries or death if they are accidentally exposed to fentanyl patches.

Connecticut will receive $6 million from Depakote settlement

As we have mentioned before on our Fairfield pharmaceutical products law blog, drug companies do not always put consumer safety before profit. Although a prescription drug may be approved by the U.S. Food and Drug Administration to treat a certain medical condition, a pharmaceutical company might attempt to market the drug for other purposes that have not yet been approved by the FDA in order to increase sales and earn more money from Medicaid reimbursements.

Over the past few months, we have mentioned several settlements that have been reached in other states regarding drug manufacturers' illegal marketing practices. These practices not only mislead patients about the effectiveness of certain prescription drugs, but encouraging medications to be used for other purposes that have not been approved by the FDA can also result in patients being exposed to dangerous drugs that they should not be using.

Although many settlements have been reached in other states over the past few months, it was reported this week that Connecticut has finally reached a settlement with Abbott Laboratories after the company illegally marketed its bipolar drug Depakote to healthcare professionals and patients throughout the state.

Contaminated Tylenol led to infant's wrongful death, couple says

Any new parent in Fairfield, Connecticut, might tell you that one of the hardest things to watch is a newborn or infant getting his or her vaccinations during the child's first few checkups with a pediatrician. Some moms or dads might even admit to shedding a few tears of their own as they watched their babies cry and scream in pain. Fortunately, the little ones probably got over the pain rather quickly once they were back in their parents' arms, and a doctor might have even told parents to give their children a small dose of Tylenol to ease their discomfort from the vaccinations.

On April 14, 2010, a couple experienced this very situation that millions of other parents -- including those in Fairfield -- experience each year. They took their child to the pediatrician for his two-month checkup. The doctor confirmed that their son was healthy and developing normally. After examining the baby, the doctor gave the child routine vaccinations and prescribed Concentrated Tylenol Infants' Drops to help alleviate the baby's pain and other minor side effects from the shots. But instead of easing the child's discomfort, the Tylenol caused the child to suffer serious injuries that led to the child's wrongful death, the boy's parents now claim.

Doctors: Patients need to know about ACE inhibitor side effects

When physicians prescribe new medications to their patients in Connecticut, they are required to inform their patients about any side effects they may experience after taking a new drug, especially if a side effect could lead to the serious injury or death of a patient. Additionally, the U.S. Food and Drug Administration may require drug companies to put specific warnings on the labels of prescription drugs so that patients are fully aware of any risks associated with taking their medications.

But what if even doctors are not aware of dangerous side effects that could potentially harm patients? And what if the FDA fails to include concerning risks on the labels of potentially dangerous drugs?

St. Jude: Medtronic underreported failure rates of defibrillators

A recent dispute between the medical device maker St. Jude Medical and the medical journal HeartRhythm has highlighted some concerning issues that might give some Fairfield, Connecticut, residents reason to worry about their health and safety when using medical devices.

Last month, the journal published the results of a study online that compared the safety of St. Jude's Riata defibrillator leads to Medtronic's Quattro Secure leads. According to the study's author, information regarding the companies' implantable defibrillators was taken from the U.S. Food and Drug Administration's Manufacturers and User Facility Device Experience database.

This information revealed that St. Jude's Riata leads had been linked to causing more than 20 patients to suffer fatal injuries after the devices allegedly malfunctioned. According to researchers, only five deaths were linked to malfunctions in Medtronic's leads. However, St. Jude claims that it actually found more deaths linked to Medtronic's device.

Johnson & Johnson fined $1.1 billion in recent Risperdal case

If you or a loved one have suffered injuries from a defective medical device or experienced painful side effects from a dangerous drug, you know first-hand that no amount of money from a pharmaceutical liability settlement or fine by the state of Connecticut or federal regulators could ever right a negligent company's wrongdoings.

However, when pharmaceutical giants and medical device manufacturers are ordered to compensate victims of dangerous drugs and medical devices, or when these companies are ordered to pay other fines for negligence, it is the hope of many that these companies will take a greater responsibility to put the safety of consumers first.

While pharmaceutical giant Johnson & Johnson continues to face numerous lawsuits over injuries suffered by consumers who have used a variety of the company's products, the company has also been under fire by several states for illegally marketing its antipsychotic drug Risperdal. A total of 11 states have accused J&J of misleading doctors and consumers about the safety and effectiveness of the drug. Not only did this result in consumers being misinformed about the drugs they were taking, but it also led to fraudulent Medicaid reimbursements, U.S. state attorneys general claim.

Suit over toddler's death caused by tainted medical wipes settled

A few months ago on our Fairfield pharmaceutical products law blog, we mentioned that several lawsuits had been filed against Triad Group and H&P Industries by individuals who suffered serious injuries after using contaminated medical wipes that had been manufactured by the companies. After an investigation by the U.S. Food and Drug Administration, it was discovered that the companies has distributed medical wipes that were possibly contaminated with dangerous bacteria to hospitals, medical clinics, stores and homes all across the U.S. and the world.

At least 11 lawsuits filed against the companies claim that the contaminated products have caused the wrongful death of a loved one or serious illnesses in other consumers who had used the medical wipes that were later recalled in January 2011. One of the lawsuits, which involved the death of a toddler, was finally settled last week. Although the parents of the 2-year-old boy did reach a settlement in their case, they said that more actions must be taken against Triad and H&P in order to truly hold these companies accountable for the injuries and deaths the companies have caused.

Warnings of additional side effects to be added to Propecia labels

Earlier this week on our Fairfield pharmaceutical products law blog, we discussed the U.S. Food and Drug Administration's decision to require Bayer to update the warning labels on birth control pills that contain drospirenone. This decision was made after thousands of women filed lawsuits against the company claiming that Bayer knew about the increased risk of developing blood clots when taking contraceptives such as Yaz and Yazmin but failed to inform women about these risks.

Another recent decision made by the FDA will now require another company to provide adequate warnings of side effects men may experience on the labels of Propecia, which is a popular drug manufactured by Merck to treat men who are balding. The FDA's decision was made after more than 400 complaints were filed by men using Propecia who experienced sexual dysfunction after taking the drug.

Bayer ordered to add warning of risk of blood clots to Yaz pills

Thousands of women in the U.S. who have filed lawsuits against Bayer over the last few years regarding the dangerous side effects of Yazmin and Yaz birth control pills finally got what they wanted last week: The U.S. Food and Drug Administration ordered the company to add additional warnings of potential risks and side effects on the labels of its Yazmin line of birth control pills. These new warnings include the increased risk of suffering blood clots from taking Yaz and Yazmin.

Adding the new warnings to the labels of the contraceptives will help to better inform women who take the pills about the real risks and dangers of the drug. Unfortunately, this change to Bayer's labels and the labels of other birth control pills that are manufactured with a synthetic hormone called drospirenone comes too late for those who have already been affected and injured from using these types of contraceptives.

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