Fairfield Pharmaceutical Products Attorneys Blog

Generic Lipitor manufacturer pleads guilty in Federal Court

2013-05-19T06:10:01Z

Patients in Connecticut with high cholesterol may be interested that the manufacturer of generic Lipitor has pleaded guilty to "selling adulterated drugs with intent to defraud" in Federal Court. Ranbaxy is now facing $500 million in fines from these criminal charges and a whistleblower suit. This pharmaceutical company from India has been having quality problems and has produced defective drugs in past years.

The Food & Drug Administration actually barred 30 drugs made in two of the Indian factories from coming into the United States in 2008. Subsequently, the FDA has required the company to provide evidence of its truthfulness before they were willing to consider new drug applications from this manufacturer. Ranbaxy was placed under a consent decree from the U.S. Department of Justice in 2012 and could not sell drugs from a number of Indian plants in the U.S. until the quality was assured.

]]> The company overcame these difficulties and was awarded the first generic version of Lipitor by the FDA in 2011. The medication is to treat high cholesterol. One year after it started selling the drug, Ranbaxy recalled several lots of generic Lipitor that had serious quality issues regarding glass in the medication. The FDA once again allowed them to sell this drug in 2013 and it was reported that they have a large contract with the U.S. Dept. of Veterans Affairs.

Many patients may rely on generic medications because they are less expensive than the originally formulated drug. A generic drug, though, must still meet the formulation and quality standards of the originally patented drug by FDA regulations. When taking any drug, patients may want to stay vigilant to their reactions and get medical advice right away if anything seems wrong. If patients become ill or injured because of medication that is not up to standards, they may want to consider the assistance of an experienced drug litigation lawyer.

Source: CNN Money, "Maker of generic Lipitor pleads guilty to selling 'adulterated drugs'", Katherine Eban, May 13, 2013

Buyers beware of buying online prescriptions

2013-05-17T06:10:01Z

Connecticut residents should be warned that purchasing online prescriptions can be dangerous. Consumers may not be getting the drugs that they think they are when they choose to buy them from online retailers.

Experts say that most online pharmaceutical products are actually counterfeits of the real versions, and those counterfeit versions can lead to serious complications. They say that while the counterfeit versions of the drugs may look identical to the real drugs, they could be dangerous and defective drugs that contain harmful substances such as rat poison or metal in them. According to one study, only 3 percent of the online pharmaceutical companies are legitimate in the products they sell. Health care professionals advise that it's okay to purchase prescriptions online but that consumers should thoroughly research companies before doing so to prevent themselves from taking counterfeit versions that could harm them.

]]> People who have purchased counterfeit drugs and developed injuries or serious conditions due to the drugs might be eligible to file medical malpractice lawsuits against the pharmaceutical companies that sold them the drugs. Such lawsuits claim that the person's conditions were caused by or made worse by the drugs that the pharmaceutical company sold them and that the company was negligent in selling drugs that were not thoroughly researched and deemed to be safe.

Those wanting to seek compensation for side effects from counterfeit drugs might want to consider consulting with a medical malpractice attorney who may help them determine whether or not they have the grounds to file such a lawsuit. If they do have a possible claim, the attorney may then help them compile and then present the evidence that proves their claim to the court.

Source: CBS 5 WDTV News, "Buying Prescriptions Online Can Be Dangerous", Erin MacPherson, May 09, 2013

FDA recalls Covidien ventilator

2013-05-15T06:10:01Z

Connecticut readers who use ventilators may be interested to learn of a recent recall issued by the Food and Drug Administration. In April, Covidien plc recalled its HT70 Ventilator and the HT70 Plus Ventilators Power Pack batteries. The ventiliators are used to provide positive pressure mechanical ventilation, either continuously or intermittently. Customers have reported that the ventilators are giving off alarms or using backup battery support when still being used by the regular battery. The FDA believes that using batteries to operate these defective medical devices poses a danger to the user. The FDA has issued a Class I recall, which means that the FDA believes it is probable that using the product could result in death or serious heart problems. Class I is the most serious recall the FDA issues. The FDA is asking that anyone who uses a ventilator verify the serial number. Any device numbered between 2096134110001 and 2292048120050 is being recalled. Any home user, distributor or health care provider that has one of these devices may contact Newport Medical Instruments to request replacement batteries at no cost. The law provides that a company that manufactures or distributes a defective product may be strictly liable for any injuries that result. An injured party may sue anyone in the chain of commerce, which can include the store that sold the product. Any person who has been injured by a defective medical device may benefit from speaking with a local attorney about the available options. Damages may include medical bills, lost wages and pain and suffering. When death results, the victim's family may be entitled to additional compensation to cover funeral costs. ]]> Source: Boston Business Journal, "Covidien ventilator gets FDA?????????s most serious recall tag, Class I", Patricia Resende, May 02, 2013

FDA says pregnant women should not take valproate drugs

2013-05-10T06:50:03Z

The Food and Drug Administration issued a warning on May 6 that women should not take drugs containing valproate sodium while pregnant because the drugs may lead to a lower IQ for their children. Drugs with valproate are typically produced by manufacturers to treat migraines, epilepsy and manic episodes associated with bipolar disorder. Affected drugs include Depacon, Depakote, Depakote CP, Depakote ER, Depakene and Stavzor.

The FDA based its warning on a new study called Neurodevelopmental Effects of Antiepileptic Drugs that showed that children whose mothers took valproate drugs prenatally may suffer lower IQ's. In the study, children whose mothers had taken the drugs in question had an IQ up to 11 points lower at age six than children whose mothers had taken other antiepileptic drugs. Another recent study showed that children whose mothers had taken valproate drugs had a five times greater chance to have autism compared to children who were not exposed to the drugs.

]]> Valproate drugs already come with a warning label that when taken prenatally the drugs can lead to birth defects and other risks. That label was added in June 2011 when a study suggested that the drugs could lower IQ scores in children by the age of three years old.

Prescription drugs can cause severe damage when they are prescribed in an inappropriate situation or when their side effects are not fully known. Patients who take drugs with dangerous unknown side effects may suffer chronic medical problems, long-term disability or death. Victims of defective drugs or dangerous drugs may be entitled to compensation and may benefit from meeting with an attorney. An experienced attorney could evaluate the case and advocate on behalf of the victim. If enough people have suffered, the attorney could organize a mass tort or class-action suit and negotiate a settlement on behalf of all victims.

Source: CBS News, "FDA: Pregnant women taking valproate for migraines risk child's IQ", Michelle Castillo, May 06, 2013

Defective hearing aid manufacturer ordered to pay for damages

2013-05-03T22:14:17Z

A partial recall of hearing implants may be cause for Connecticut residents with a hearing impairment to worry. Over 1,000 cochlear implants from medical device manufacturer Advance Bionics have so far caused serious problems for people with the implants. In the latest lawsuit, a federal jury ruled the company negligently sold the defective medical device that was surgically implanted in a four-year-old girl and malfunctioned two years later.

The mother reported that her daughter began screaming and convulsing when the device malfunctioned. The symptoms stopped with removal of the magnet used to activate the implant. According to the family's attorney, surgical removal and inspection discovered that the device had taken on "60 times the allowable amount" of moisture. The jury awarded the family almost a million dollars in compensation. The jury also levied $6.25 million against the company for punitive damages.

]]> The implant device was originally designed to admit only .5 percent moisture. Problems were noticed as early as 2004 when the company issued a limited medical device recall. However, the company continued shipping the devices until it issued another recall in 2006. An FDA lawsuit against the negligent medical device manufacturer followed. That suit was settled out of court and concerned the company's failure to seek FDA approval for a new component supplier.

A defective medical product may potentially result in serious injury and multiple surgeries to correct the problem. When a defective medical device results in medical expenses, pain and suffering, lost wages and other associated costs, patients may be eligible to receive compensation. A productive liability attorney may be able to help victims recover damages from a negligent medical device manufacturer.

Source: Claims Journal, "Kentucky Jury Awards $7.2M for Defective Hearing Aid," Brett Barrouquere, April 23, 2013

Pharmacy recalls potentially defective sterile products

2013-05-02T12:09:10Z

Balanced Solutions Compounding Pharmacy is recalling its sterile non-expired drug products because the drugs and supplies may have been exposed to bacteria. The drugs may have been used by Connecticut health care providers. In a recent inspection, FDA officials discovered gram-negative bacteria while sampling one of the company's chromium chloride injections. Gram-negative bacteria can cause disease, but typically, it does not cause infection in humans. FDA officials indicated that substandard practices and conditions led to the manufacturing of the dangerous and defective drugs.

The FDA is advising health care providers to check their supplies for Balanced Solutions products and to immediately return those products per the company's recall instructions. Patients who have recently been treated with the recalled products should contact their healthcare provider. More information about the recall can be found on the FDA's recall site.

]]> Defective drugs and contaminated medical supplies can lead to disease and unexpected side effects. In serious cases, unsafe medication may cause disability or even death. Negligent manufacturers of medical supplies can be held responsible for their products' damage. Victims of defective drugs may be able to pursue financial compensation to cover costs like medical expenses and a decrease in quality of life.

Patients who have been treated with defective drugs or supplies could benefit from speaking with an experienced attorney. An attorney could determine a claim's likelihood of success and estimate the potential financial compensation. The attorney could also present supporting evidence and negotiate a settlement to maximize compensation. If a large number of people have been treated with the defective drug, the attorney may organize a mass tort or class-action lawsuit.

Source: BioFarmInternational, "Balanced Solutions Voluntarily Recalls Sterile Products," April 23, 2013

PIP faulty breast implant trial begins in France

2013-04-27T15:49:21Z

The trial of executives from a company accused of marketing faulty breast implants over a 10-year period has begun and is expected to take at least several weeks. The manufacturer, French company Poly Implant Prothese, is accused of fitting more than 300,000 women worldwide with the implants, and 5,000 defendants are named in the civil suit.

According to reports, the industrial-grade silicone mixture in the cosmetic implants was a homemade concoction invented by PIP's CEO and that the implants may leak or burst. The faulty devices were taken off the market in 2010. The CEO and four executives have been charged with aggravated fraud. They face fines and up to five years in jail if convicted.

]]> PIP was once the third-largest supplier of breast implants, and reports say that its CEO has to be transported to and from the trial via police escort because the courtroom is full of angry victims who sometimes yell obscenities at the defendants. Victims say that they are frightened and angry, and many of them have had the implants removed as a precaution. Medical experts, however, say that, while the implants have an "unusually high" rupture rate, there is no evidence of a cancer risk from the silicone implants.

Those who have experienced side effects or injury from a defective medical device or pharmaceutical drug may be worried and wonder if they can receive compensation for illness or serious injury suffered as a result of the defective product. Contacting a knowledgeable attorney in Connecticut is an ideal first step in the litigation process.

Source: Reuters, "Makers of fraudulent breast implants on trial in France," Jon Campisi, April 17, 2013

Defibrillator manufacturer faces lawsuits

2013-04-26T15:45:51Z

St. Jude Medical, the manufacturer of Riata leads for defibrillators, is facing many lawsuits after more than 30 people died. The devices are intended to deliver a small jolt of electricity to the heart in order to restore a regular heartbeat. The deaths were allegedly caused by the defibrillator leads failing, delivering jolts of electricity too often or delivering too much electricity to patients. The problem is believed to have been caused by wires coming through the silicon coating. Medtronic faces liability along with St. Jude Medical as they distribute defibrillators.

The Riata leads were the subject of a defective medical device recall in December. St. Jude Medical stopped selling the product in 2010. A medical journal article published in March linked 22 deaths to the Riata leads. Doctors who implant such devices are leery of St. Jude Medical's newer Durata leads as the design is quite similar to the Riata leads.

]]> One person who survived problems with her defibrillator reported that she was randomly shocked several times in a 25-minute period. Doctors who removed the defibrillator from the 55-year-old patient discovered faulty wiring.

The stock prices of St. Jude Medical and Medtronic fell significantly after news of the lawsuits was released. The burden of proof is quite high for plaintiffs in such cases, so it may be difficult to prove absolutely that the Riata leads were the direct cause of the deaths. Patients who learn that they have a defective implant device may wish to consult with an attorney who has experience with defective medical device litigation as well as their own attorney.

Source: Barron's - Stocks to Watch "St. Jude, Medtronic Drop After Lawsuits Filed," Sam Mamudi, April 5, 2013

Potentially fatal hepatitis infections cost insurer millions

2013-04-19T16:44:14Z

Connecticut residents may have heard about an extreme case of negligence currently in the national spotlight. The case involves a doctor accused of transmitting hepatitis infections to patients, and he may end up costing UnitedHealth Group Inc. over a billion dollars in punitive damages above the millions already awarded to plaintiffs. So far, the jury hearing the case in a Nevada court has found the health insurance company liable for $24 million in compensatory damages. Hepatitis is a potentially fatal disease, which may be made worse by other health conditions.

The case was brought against the insurer by two former patients. They claim that Sierra Health Services and Health Plan of Nevada, both divisions of UnitedHealth, were negligent in overseeing the doctor, a gastroenterologist. Specifically, the doctor was said to have exceeded the number of colonoscopy patients one doctor could safely process in a day. He also faces federal fraud and second degree murder charges, which may or may not be related to this case.

]]> UnitedHealth has argued against the ruling by stating that insurers being held liable for physician errors sets a "dangerous precedent." However, a Nevada jury previously held Teva Pharmaceutical Industries liable following the same doctor's use of an anesthetic manufactured by the company.

When patients are harmed by doctor negligence, the need for compensation is sometimes overwhelming. Claims of serious injury and wrongful death often request compensation for medical expenses, long-term care, funeral expenses and families grieving the loss of a loved one. The jury in this case was asked to find the insurer, which profited from the doctor's unsafe practices, liable for the damage to patient health. This increases the potential sources of compensation for malpractice claims, and it also sends a stern warning to other insurers that profit does not come without responsibility.

Source: Minneapolis St. Paul Business Journal, "Hepatitis doc costs UnitedHealth $24 million, for starters," Mark Reilly, April 5, 2013

Defective defibrillator lawsuits filed against St. Jude

2013-04-17T16:41:57Z

Connecticut residents may have heard about lawsuits recently filed in California courts targeting St. Jude Medical for manufacture of a defective implant. Several plaintiffs are seeking compensation for injuries related to the Riata defibrillator. These defective medical devices first caused problems for St. Jude in 2010. The publicly traded company halted sales of Riata at that time, and the Food and Drug Administration subsequently oversaw a medical device recall. Shares of both St. Jude Medical and Medtronic fell following publicity of the lawsuit. Products from both companies used the Riata wire design.

Riata wire leads in the device were found to have broken through the silicone coating. A 55-year-old plaintiff in the lawsuit against St. Jude claimed to have been injured by several shocks over less than a half hour. This prompted doctors to remove the device. They discovered faulty wiring was the problem.

]]> A study published after the FDA recall found the defective defibrillator was implicated in 22 deaths. St. Jude has since adopted a new design that incorporates Durata wire leads, but some medical professionals remain worried that the new design is too much like the Riata.

With failure of an implant device, patients may suffer more than missing out on a potentially beneficial treatment. A defective medical device design may cause serious injury and even death. Correction of the problem often entails a surgical removal. Victims of this defective medical product underwent one surgery to implant the device and another to remove it, and they may still be in need of a defibrillator implant. Patients in this situation may be able to receive compensation for the damages, including increased medical expenses and the emotional trauma of multiple surgeries.

Source: Barron's, "St. Jude, Medtronic Drop After Lawsuits Filed," Sam Mamudi, April 5, 2013

Lawsuit filed against Walgreens and other medical providers

2013-04-12T15:06:11Z

Family members in one state have filed a wrongful death suit alleging inadequate care of a patient from several health care providers, a drug manufacturer, and Walgreens Pharmcacy, a large pharmacy chain with stores in Connecticut and throughout the U.S. The patient committed suicide by gunshot.

The main allegations in this lawsuit concern medications that were prescribed for the man by his physician and supplied through the health care services and Walgreens. The patient had been prescribed a daily Depakote dosage of 1,000 milligrams in addition to being given an antidepressant medication and a medication indicated for Bipolar disorder. The suit claims that these were defective drugs as they were dispensed with the appropriate warnings of their potential serious side effects.

]]> This wrongful death suits sets forth claims that all of the defendants were negligent by giving the patient drugs that had not been tested satisfactorily before being released to the public. Furthermore, it claims that the patient and his family members were not given warnings as to potential dangerous side effects from these medications, and they relied to their detriment on the pharmacological experts. Alleging that these experts violated regulations in their administration of medication, the plaintiffs ask for punitive damages and actual damages.

If the plaintiffs in the above case can prove their allegations, it could be found by the court that the patient's suicide was a result of these medications and how they were prescribed. Large pharmacies as well as hospitals are expected to be diligent with the medication that they supply. Patients who have been injured by being prescribed defective or wrongly labeled drugs may want to seek out a pharmaceutical liability attorney regarding possible compensation.

Source: Valencia County News Bulletin, "Valencia Co. family claim wrongful death," Brent Ruffner, March 27, 2013

International Johnson & Johnson glucose meter recall

2013-04-10T15:02:29Z

Johnson & Johnson recently announced recalls on its OneTouch blood glucose meters. The recalls apply to an estimated 2 million meters in the United states, Asia, Europe, and the Middle East. Connecticut residents that have the meters can contact Johnson & Johnson to have their meters replaced free of charge.

The recall of the defective medical devices applies to the OneTouch Verio IQ, which was sold in the U.S., and the OneTouch Verio Pro and Pro+ glucose meters, which were sold in the Middle East, Asia and in some European countries. The company alleges that there have not been any deaths or injuries reported in the U.S. due to the malfunction, and there was one report of an adverse event in another country. The company maintains that there was not enough evidence to support a claim that the meter was at fault for that incident, however.

]]> Johnson & Johnson has submitted notifications to registered users, healthcare facilities, and the FDA about the faulty devices, which reportedly shut off when readings of 1024 milligrams per deciliter and higher are registered. The company cites the importance of its patients' health as a main reason for the medical device recall. Patients are still able to use the glucose meter as long as they are aware of the fault.

Individuals who are injured as a result of a defective medical device could receive compensation with the help of an attorney who is familiar with pharmaceutical products liability. A drug litigation attorney may assist with understanding warranties and liabilities, and they might also uncover warranty breaches and determine if a manufacturer has prior or existing negligent medical device recalls on their record or other claims filed against them in order to bolster a case that hinges on the manufacturer's lax and potentially harmful quality assurance protocols.

Source: RedOrbit, "Johnson & Johnson Recalls Glucose Meters Due To Equipment Malfunction," Brett Smith, March 25, 2013

FDA warns patients and doctors following Avastin drug recall

2013-04-05T20:31:52Z

A pharmaceutical drug produced by Roche is the subject of a recall by Clinical Specialties Compounding Pharmacy. The FDA issued the warning following reports that the dangerous and defective drugs, which were repackaged for use in treatment of wet macular degeneration, caused eye infections in five patients. Avastin injections are a low cost alternative to the virtually identical Lucentis, according to the American Academy of Ophthalmologists. Patients and doctors using Avastin are warned to check lot numbers to avoid the dangerous and defective drugs.

Severe macular degeneration is a condition that often results in blindness for the elderly. Infections caused by the treatment drug may also result in blindness. According to the company's news release, its products are distributed nationwide. The FDA stated that the recall involves 40 batches of Avastin shipped to doctors in four states.

]]> Less than a week before the Avastin recall began, a Connecticut hospital prompted Med Prep Consulting Inc. to initiate a recall by reporting mold in bags of medications. The FDA increased its inspections of compounding pharmacies as a result of an ongoing incident that began five months before the Avastin recall. Epidural steroids shipped by New England Compounding Center have so far resulted in 50 deaths and over 700 illnesses.

Patients may face serious injury before and after the initiation of a recall. Injuries can result in permanent disability, further medical expenses, loss of companionship and even death. The victims of defective drugs or their families may be entitled to compensation from the negligent drug manufacturer.

Source: The Times-Picayune, "FDA warns of Avastin drug recall in Louisiana and three other states," March 20, 2013

Source: Los Angeles Times, "Another nationwide recall of compounded medication," Melissa Healy, March 21, 2013

Recall may prompt pharmaceutical liability suits across country

2013-04-03T21:11:21Z

A string of injuries and deaths resulting from poor operating conditions at compounding pharmacies has caused the FDA to step up monitoring efforts. The latest case involved Clinical Specialties Compounding Pharmacy, which was packaging the cancer treatment drug Avastin for treatment of wet macular degeneration. The company recalled all shipments of Avastin over a five month period after five patients receiving the drug were diagnosed with potentially serious eye infections. The recall is taking place in Connecticut and nationwide.

Data on the five injuries, which could result in pharmaceutical liability lawsuits against the company, was collected by the Centers for Disease Control and Prevention. Data was then sent to the FDA, which alerted the company. An FDA inspection of the company revealed "practices at the site that raise concerns about a lack of sterility assurance."

]]> Compounding pharmaceutical companies handle the preparation of already-manufactured prescription medications for doctor or consumer use. Four days prior to this recall of Avastin syringes, another compounding pharmacy recalled medicine bags containing mold that were shipped to Connecticut and three other northeastern states. Five months prior, a pharmacy was closed by the FDA after shipping epidural steroid syringes that caused hundreds of fungal meningitis infections. Almost 50 people have died so far as a result of those infections.

The FDA lacks the manpower and resources to constantly monitor operating conditions at all pharmacies and prescription medication manufacturers. Unfortunately, the negligence and recklessness of some companies results in drug contamination and adverse health effects for patients. As the above cases show, some patients suffer serious injury well before FDA acknowledgment and recall efforts. Patients injured by negligent drug manufacturers may find compensation for their injuries with the assistance of a pharmaceutical liability attorney.

Source: Los Angeles Times, "Another nationwide recall of compounded medication," Melissa Healy, March 21, 2013

GNC supplements may have led to unexpected deaths

2013-03-30T18:33:34Z

The use of dimethylamylamine, or DMAA, in supplements sold by "health" stores such as GNC in Connecticut and across the country may be responsible for sudden deaths due to cardiac arrest. At least one wrongful death lawsuit has already been filed over the company's product "Jack3d," which allegedly led to the fatality of a young Marine who took it just before running.

DMAA is advertised as a product that boosts workout energy and increases stamina. However, the chemical may have the same effect on the body as a dose of amphetamines. Professional organizations and military physicians are lining up behind the parents in this particular case, stating that GNC's product may be dangerous and cause sudden death.

]]> However, GNC's attorneys deny that the product has anything to do with deaths if it is used as instructed. The company claims that it has no evidence that DMAA is dangerous although military installations have removed all products containing the substance from their shelves. The product is still available over the web and in other GNC stores.

Consumers who are injured and the families of those who die from taking such supplements may have options when it comes to collecting damages from manufacturers who market these dangerous products. Victims of these supplements or other defective products or drugs may benefit from talking with a drug litigation attorney. The attorney may be able to help victims recover damages to pay for medical bills and living expenses including lost wages, or he or she may represent family members who have lost a loved one in a wrongful death suit against companies that distribute dangerous products.

Source: The New York Times, "Is the Seller to Blame? Workout Supplement Challenged After Death of Soldier," Natasha Singer, March 15, 2013