Pennsylvania Personal Injury Blog

In New Jersey, a product liability trial is under way to conclude whether Merck & Co. are liable for a woman’s jaw loss. According to an article in The Philadelphia Inquirer, studies have shown that many Fosamax patients suffered femur-fractures after low-impact falls and “jaw death.” Merck may have been too slow in warning its patients of any risks.

Fosamax (alendronate) is prescribed for osteoporosis, a disease in which bones become increasingly fragile. Drugs such as Fosamax, which is in the bisphosphonates category, are prescribed to increase bone density. However, in 2004 the U.S. Food and Drug Administration (FDA) expressed concerns to the drug manufacturer regarding a possible link between bisphosphonates and osteonecrosis of the jaw (ONJ). Symptoms of ONJ include loose teeth, jaw pain, exposed bone, severe mouth infections, swelling in the mouth, ulcers, and sores.

If you or a loved one have suffered from any of the side effects caused by taking Fosamax, or have experienced any other serious health-related side effects as the result of using a medication that may be dangerous, you should contact a Philadelphia adverse drug reaction lawyer at Cherry Fieger & Marciano, LLP for a free case evaluation.

If a manufacturer produces drugs that are found to be defective or dangerous, they can and should be held responsible for the injuries their products cause. The pharmaceutical manufacturers have an obligation to create, produce, and sell safe products, which includes affixing an appropriate label on the drug’s packaging. It is very important to hire a skilled PA drug injury attorney to help you prove that a drug manufacturer was responsible for producing a defective product. Contact Cherry Fieger & Marciano, LLP today for a free consultation.

The teenage daughter of a Pennsylvania family has been suffering with residual seizure disorder since she was 6-months-old, says UPI.com, and her parents believe the illness is due to a vaccination she received as an infant. The preventative was ordered in the mid-90s to shield the child from diphtheria, tetanus and pertussis. But instead of simply providing the family’s new daughter with immunity from disease, the vaccine allegedly had other negative physical, mental, and emotional side effects on the girl during her formative years. The childhood impacts caused irreversible damage and left the girl a life-long dependent.

In 2009, the Pennsylvania family sued the vaccine manufacturers, Wyeth, who had become a branch of larger brand Pfizer Inc. that same year. But the suit was overruled by federal legislation that cited a 1986 law, the National Childhood Vaccine Injury Act that protected vaccine manufacturers from product-liability lawsuits. The act stated that makers of an anti-body could not be brought to trial if their product caused immediate harm or long-term damage to recipients. However, on Monday, March 8, 2010, the Supreme Court took a harder look at the case to decide if the 1986 law did not actually interfere with the family’s lawsuit. The trial will go forth in spring or autumn 2010.

Continue reading "Supreme Court Reviews Pennsylvania Product-Liability Suit" »

Hundreds of people nationwide said they were poisoned by their denture cream. According to this article in the Philadelphia Daily News, lawsuits filed against GlaxoSmithKline, maker of Poligrip, and Procter & Gamble, manufacturers of Fixodent, allege that the companies knew their products were dangerous and did not protect consumers.

The suits allege that adding zinc to the products had adverse health effects on some users. Zinc helps bond dentures to gums.

Among the lawsuits is a woman who is now classified as a quadriplegic and others whose hands have deteriorated and look like claws.

According to the article, GSK launched a voluntary recall of Poligrip EX in Japan last week. However, the product was not recalled in the U.S.

A larger suit involving 75 plaintiffs is in federal court in Miami.

Plaintiffs in the lawsuits allege that they were unclear about how much product was safe to use until it was too late and their bodies had been damaged.

Late last year, GSK began including an insert in its denture packaging, noting that even the smallest size tube (0.75 oz). is meant to last about three weeks.

By the time the insert was released, many people’s bodies were already damaged.

Continue reading "Zinc in Dental Adhesives Can Cause Injuries" »

A Philadelphia jury ordered Pfizer Inc.’s Wyeth unit to pay $9.45 million to an Alabama woman who claimed that the company’s hormone-replacement drug caused her breast cancer. According to this article in the Philadelphia Inquirer, the woman was awarded $3.25 million in compensatory damages and $6 million in punitive damages. The verdict also included $200,000 to the woman’s husband for loss of consortium.

More than six million women took the pills to treat symptoms such as hot flashes and mood swings before a 2002 study highlighted the drugs’ links to cancer.

Before 1995, many patients combined Premarin, Wyeth’s estrogen-based drug, with progestin-laden Provera, made by Pfizer’s Pharmacia & Upjohn unit. Wyeth combined the two hormones in Prempro.

Approximately 8,000 people who used Pfizer’s and Wyeth’s hormone-replacement drugs filed suit against the company. Many were filed as suits for dangerous drugs in Philadelphia.

The woman in this particular case, a mother of three, began taking Prempro in August 1997. Results of a mammogram at that time were normal. She stopped taking the drug in January 2004 after her breast cancer diagnosis.

Continue reading "Philadelphia Jury Awards $9.45 Million in Wyeth-Hormone Suit to Alabama Woman" »

On January 7, a Philadelphia law firm filed 10 lawsuits on behalf of boys and young men who developed serious side effects (including the growth of breasts) while taking the antipsychotic medications Risperdal and Invega. According to this article in the Philadelphia Inquirer, the suits were filed in Philadelphia and one attorney said he expected to file an additional 20 to 30 similar cases in Philadelphia in the next two months. There are also cases involving boys who took Risperdal and another medication pending in New Jersey.

The drugs in the cases are made by Janssen (of Ortho-McNeil-Janssen Pharmaceuticals) and are part Johnson & Johnson. All of the companies are based in New Jersey, but Ortho-McNeil-Janssen is incorporated in Pennsylvania.

One young man from Philadelphia took Risperdal in his teens. The lawsuit says he experienced rapid weight gain and developed breasts that will require surgical removal.
Some of the clients grew significant bosoms, a fact their doctors may not have taken seriously enough because of the weight gain.

The suits also named Excerpta Medica, Inc. and Elsevier Science Publishing Co., Inc. because the companies were involved in publishing ghostwritten studies that were misleading or exaggerated.

Continue reading "Lawsuits Filed Over Drug Side Effects" »

A new study raises new concerns about Zetia and Vytorin, drugs taken by millions of Americans to lower cholesterol. According to an article by the Associated Press on Philly.com, Zetia failed to shrink buildups in artery walls while a rival drug, Niaspan, did so significantly. Zetia users also suffered more heart attacks and other problems although the numbers of these events were too small to draw firm conclusions.

A preventive cardiology chief at Johns Hopkins University said that in the seven years Zetia has been on the market, it hasn’t proven that it improves clinical outcomes.

Lipitor and Crestor (statins) have long been used to lower LDL, or bad cholesterol, and are known to cut the risk of heart problems. Because many statin users still suffer heart attacks, doctors have been testing adding a second medicine to further lower risk.

They are trying Niaspan, a slow-release version of niacin, a type of B vitamin that raises HDL, or good cholesterol. The other is Zetia, which lowers bad cholesterol in a different way than statins do, by blocking its absorption in the gut.

Vytorin is a pill that combines Zetia with a statin.

Abbott Laboratories sponsored the new study in which researchers enrolled 363 people with heart disease or a high risk for it who had been taking statins for six years on average.

Half were given Niaspan and the others, Zetia. Ultrasound images of neck arteries showed that Niaspan shrank buildups by about 2 percent, while Zetia had no effect on this even though it lowered bad cholesterol as expected.

Continue reading "Study on Merck Pill Zetia Raises New Questions" »

Federal health regulators have found tiny particles of trash in drugs made by Genzyme, a biotechnology company. This is the second time this year the company has been cited for contamination issues. According to an Associated Press article, on November 13, the Food and Drug Administration said that bits of steel, rubber, and fiber found in vials of drugs used to treat rare enzyme disorders could cause serious adverse health effects for patients.

The FDA said the products would remain on the market because there are few alternative treatments. They also said doctors should closely inspect vials for particles before injecting them into patients. Doctors should return the defective pharmaceutical to Genzyme if they suspect contamination and watch for potential allergic reactions, blood clots and other problems in patients.

In June, Genzyme was forced to shut down a key production facility due to viral contamination.
The drugs affected by the latest announcement include: Cerezyme, Fabrazyme, Myozyme, Aldurazyme and Thyrogen. All are manufactured at a biotech plant in Allston Landing, Mass., where FDA regulators are conducting an inspection.

Genzyme specializes in biotech drugs to treat rare diseases.

Continue reading "FDA Discovers Pieces of Steel and Rubber in Genzyme Drugs" »

On November 17, federal health officials said that a popular variety of heartburn medications can interfere with the blood thinner Plavix, a drug taken by millions of Americans to reduce risks of heart attack and stroke. The Associated Press reported in an article that the Food and Drug Administration said the drugs Prilosec and Nexium cut in half the blood-thinning effect of Plavix, known generically as clopidogrel.

Regulators said the key ingredient in the heartburn medications blocks an enzyme the body needs to break down Plavix, muting the drug’s full effect. Procter & Gamble’s Prilosec OTC is available over-the-counter and AstraZeneca’s Nexium is only available with a prescription.

The FDA said that patients at risk for heart attacks or strokes who use clopidogrel to prevent blood clots would not get the full effect of this medicine. Because Plavix can upset the stomach, it is often prescribed with stomach acid-blocking drugs.

The FDA recommended that patients who need to reduce their acid should take drugs from the H-2 blocker family. These include Mylanta and Zantac. FDA scientists said there is no evidence those drugs interfere with Plavix’s anti-blood clotting action.

FDA regulators said they don’t have enough information to say whether other drugs in the same class as Nexium and Prilosec (proton pump inhibitors) shouldn’t be used with Plavix. The warnings on Plavix have been strengthened based on a 150-patient study submitted over the summer. Some consumer advocates argued that regulators should have placed the information in a “black box” warning label.

It was reported last year that taking Plavix with Nexium significantly increased patients’ chances of being hospitalized for a heart attack, stroke or chest pain. Plavix’s labeling was updated to advise against using it in combination with certain heartburn drugs.

Continue reading "FDA Says Heartburn Drugs Can Interfere with Plavix" »

A Philadelphia jury is weighing punitive damages against drugmaker Wyeth. According to an article by the Associated Press, there is link between the Illinois woman’s breast cancer and the hormone-replacement drug she took.

The woman’s case is one of many Prempro lawsuits to go to trial out of several thousand filed across the country. About 1,500 are pending in Philadelphia.

The Philadelphia jury awarded $3.75 million in compensatory damages on October 23. According to the article, they said the company’s actions were willful and warrant punitive damages.

The 64-year-old woman is a retired hospital records clerk from Peoria, Illinois. She took Prempro for five years before her 2002 cancer diagnosis.

People of all ages take prescription drugs, non- prescription drugs, and supplements on a daily basis in the United States to prevent and treat various illnesses. Although these medications are supposed to help people, many people have suffered serious side effects, and even death. To help innocent consumers who have been injured by a defective or dangerous pharmaceutical receive the compensation they need, experienced PA drug injury attorneys may be of great assistance.

Continue reading "PA Prempro Cancer Case: Jury Weighs Damages" »

A Philadelphia jury awarded $2.5 million to a woman from Bensalem. The jury found that Paxil had caused heart problems in her 3-year-old son who required several surgeries after his birth to fix his heart. They ruled out additional punitive damages.

The case was the first of about 600 lawsuits to go to trial on claims that the GlaxoSmithKline’s Paxil antidepressant caused birth defects in children whose mothers took the drug during pregnancy.

According to an article in The Philadelphia Inquirer, legal experts saw the 10-2 jury decision as a big win for plaintiffs in the remaining cases, even though the jurors awarded only compensatory damages.

Jurors linked the plaintiff’s problems to Paxil and said GlaxoSmithKline was negligent in not properly warning the woman’s doctor of the drug’s risk. They did not find the company’s behavior “outrageous,” which would have been necessary to award punitive damages.

The standard for finding punitive damages requires evidence that a company knew about problems but ignored them or covered them up because the product was so profitable.

Continue reading "First Paxil Lawsuit Results in Plaintiff's Favor" »

According to an article on Philly.com, a $4.85 billion fund was set up so that Merck & Co. Inc. can compensate kin of those who died of heart attacks or strokes.

The claims are from the families of more than 3,100 users of its Vioxx painkiller who died of heart attacks or strokes because of the drug.

The fund will pay about 3,000 claims for heart-attack deaths and at least 122 for strokes.
Merck launched Vioxx in 1999 and withdrew it in 2004 when a study showed the drug doubled the risk of heart attacks and strokes. Merck set up the fund in 2007 after reserving $1.9 billion to fight 26,600 Vioxx lawsuits.

The facts of each case determine the extent of Merck’s liability, which analysts once estimated to be as much as $20 billion overall.

Families of heart-attack victims who died will get an average payment of about $374,000. The amount will depend on the Vioxx user’s age, how long he or she took the drug, and whether the person had health risks such as obesity or hypertension.

Continue reading "Merck to Pay 3,100 Vioxx Claims" »

On September 15, an attorney told a Philadelphia jury that GlaxoSmithKline P.L.C. ignored evidence for years that its antidepressant Paxil may have caused birth defects. According to an article in The Philadelphia Inquirer, this attorney represents a woman who says that taking the drug during her pregnancy caused her three year-old son’s heart problems.

The Bucks County resident, a former cheerleader for the Philadelphia 76ers, is making the claim for her son who appeared briefly in the courtroom this morning. According to her attorney, Glaxo told its scientists to avoid disclosing possible risks associated with the drug’s use by pregnant women.

An attorney for GlaxoSmithKline is claiming there is no evidence that Paxil caused the child’s heart problems. The case is being heard in Common Pleas Court.

The woman’s attorney showed the jury a series of documents that showed that Glaxo knew before Paxil went on the market that rats administered the drug were more likely to have pups that didn’t survive past four days and that the rate of death increased with higher doses of Paxil.

In the late 1980s, at about the same time as the rat study, an internal Glaxo scientist warned that “there remains the possibility that this compound could be teratogenic (meaning can cause birth defects) at higher dose levels.”

The trial is the first of more than 600 cases alleging that Glaxo knew Paxil caused birth defects and hid those risks to pump up profits. Approved for U.S. use in 1992, the drug generated about $942 million in sales last year, 2.1 percent of Glaxo’s total sales.

Continue reading "Trial Opens in Philadelphia in Paxil Lawsuit" »

On September 16, the FDA ordered the drugmaker Wyeth to put the strongest warning possible about the risks of IV push and Phenergan (promethazine) on the drug label. According to an article that appeared in the Philadelphia Inquirer, the drug caused one woman, a Vermont musician, to lose her arm. Levine fought drugmaker Wyeth all the way to the Supreme Court and won.

In the spring of 2000, this particular woman had a migraine headache and got the drug Phenergan to treat associated nausea. The drug was administered via a method known as intravenous push, which can cause infection and gangrene. That happened to her and doctors amputated her lower right arm.

She sued Wyeth and the Supreme Court decision in her favor was viewed as upholding all consumers’ rights to sue drug companies.

The article stated that although Wyeth no longer sells Phenergan, many makers of generic drugs still do, and the FDA ordered them to put the strongest warning possible about the risks, sometimes called a “black box,” on the label.

The stronger warning would let medical professionals know that the preferred way to administer promethazine is through intramuscular injection.

Continue reading "Phenergan Ordered to Display Black Box Warning" »

According to court documents obtained by The Associated Press, drugmaker GlaxoSmithKline used a “ghostwriting program” to promote its antidepressant Paxil. This allowed doctors to take credit for medical journal articles mainly written by company consultants.

An internal company memo instructs salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing the drug.

The document was uncovered by a Los Angeles law firm, which is representing hundreds of former Paxil users in personal injury and wrongful death suits against GlaxoSmithKline. The firm alleges the company downplayed several risks connected with its drug, including increased suicidal behavior and birth defects.

Ghostwriting is legal in principal, but that said, it could contribute to illegal activity if the information is misleading and causes harm.

Articles from the company’s program appeared in five journals between 2000 and 2002, including the American Journal of Psychiatry and the Journal of the American Academy of Child and Adolescent Psychiatry.

Continue reading "Ghostwriting Used by Glaxo to Market Paxil" »

Matrixx, the manufacturer of Zicam intranasal cold remedies, is issuing a voluntary recall of all Zicam Nasal Gel and Zicam Cold Remedy Gel Swabs, according to this news report. The U.S. Food and Drug Administration (FDA) had issued an alert warning consumers that these Zicam products were unsafe and unlawfully marketed by Matrixx. FDA officials have received numerous complaints from consumers who say that they have lost their sense of smell as a result of Zicam drug injury.

Matrixx has disagreed with the FDA's assessment that these zinc-containing cold remedies are hazardous to consumers. However, the company has restated that it is conducting this drug recall because it wants to cooperate with the FDA. Matrixx officials also plan on meeting with FDA officials to present "comprehensive scientific and medical data and analyses, demonstrating that these products are safe," the news report states.

Losing one's sense of smell not only destroys an individual's quality of life, but also puts him or her in a potentially dangerous situation if not able to smell smoke or a gas leak. The Zicam drug recall has already sparked numerous complaints and class-action lawsuits across the nation.

Continue reading "Zicam Defective Drug Recall" »

On June 16, federal health regulators said consumers should stop using Zicam Cold Remedy nasal gel and related products because they can permanently damage the sense of smell. According to this article by the Associated Press, scientists said the zinc in these over-the-counter products might damage nerves in the nose needed for smell. The FDA said about 130 consumers have reported a loss of smell after using Matrixx Initiatives’ Zicam products since 1999.

Other products affected by the FDA’s announcement are adult and kid-size Zicam Cold Remedy Nasal Swabs.

Loss of the sense of smell is potentially life threatening because people without the sense of smell may not be able to detect life dangerous situations, such as gas leaks or something burning in the house.

The article stated that Zicam Cold Remedy was never formally approved because it is part of a small group of remedies that are not required to undergo federal review before launching.

Known as homeopathic products, the formulations often contain herbs, minerals, and flowers.

The FDA issued a warning letter to Matrixx asking the company to stop marketing its zinc-based products. The agency did not issue a formal recall.

According to federal regulators, Matrixx would have to submit safety and effectiveness data on the drug. And, if they wish to continue marketing Zicam intranasal zinc products, they need to seek FDA approval.

Continue reading "Zicam Nasal Spray Linked to Loss of Smell" »

Hydroxycut, the number one weight loss supplement in the world, was recalled on May 1st by the FDA. The FDA reports that there are at least 23 reports of serious liver injuries and death, including jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a serious type of muscle damage that can lead to other serious health problems such as kidney failure.

This Hydroxycut recall applies to the following products, which are being removed from the market:

• Hydroxycut Regular Rapid Release Caplets
• Hydroxycut Caffeine-Free Rapid Release Caplets
• Hydroxycut Hardcore Liquid Caplets
• Hydroxycut Max Liquid Caplets
• Hydroxycut Regular Drink Packets
• Hydroxycut Caffeine-Free Drink Packets
• Hydroxycut Hardcore Drink Packets (Ignition Stix)
• Hydroxycut Max Drink Packets
• Hydroxycut Liquid Shots
• Hydroxycut Hardcore RTDs (Ready-to-Drink)
• Hydroxycut Max Aqua Shed
• Hydroxycut 24
• Hydroxycut Carb Control
• Hydroxycut Natural

If you or anyone you know have been using Hydroxycut, you are advised to stop using it immediately. Symptoms to watch for include jaundice (yellowing of the skin or whites of the eyes), brown urine, light-colored stools, fatigue, stomach cramps or pain, weakness, nausea, and vomiting.

If you have any symptoms of liver injury, or any other of the symptoms listed in the FDA report, you should see your doctor immediately. Keep any unused portions of the product for evidence.

If you have suffered any of these symptoms or injuries contact our experienced Dangerous Pharmaceutical and Personal Injury Lawyers and click here to visit our website for more information.

On March 25, Philadelphia City Council members and community groups held a conference to urge the city’s law department to take action against CVS drugstore for repeatedly selling expired products.

According to this article in the Philadelphia Inquirer, the State of New York sued CVS in December over the chain’s sale of expired products and California is in the process of suing the drugstore. The purpose of the press conference on the 25th was to seek help from the city. Philadelphia council members want to encourage the city solicitor to follow the similar legal actions of those two states.

Council members are willing to take necessary legislative action including fines for the sale of expired medicines causing adverse drug reactions in Pennsylvania.

The conference had a display of 36 expired items bought at 15 CVS drugstores around Philadelphia from January to March. They included over-the-counter medications and infant formula to dairy products.

Allergy tablets had expired over a year before purchase and an infant’s gas relief medicine was close to two year’s outdated.

According to one of the Councilmen, legal action is needed to protect the community from the dangerous products in Pennsylvania sold at CVS drugstores. Citizens are at risk.

Continue reading "Philadelphia Seeks Action against CVS for Selling Expired Products" »

Caraco Pharmaceutical Laboratories Ltd. is recalling all lots of Digoxin tablets because the defective product in Pennsylvania and throughout the nation might vary in size and deliver different doses of the drug.

According to an article that appeared on FoxBusiness.com on March 31, there have been “several adverse events” linked to the recalled heart medication. The adverse events include complaints reported by patients about side effects and may or may not be attributable to the product. So far there have been no reported deaths.

Digoxin is a prescription drug used to treat heart failure and abnormal heart rhythms. A higher than labeled dose might pose a risk of toxicity in patients with renal failure. According to the company, this can cause nausea, vomiting, dizziness, low blood pressure, and cardiac instability. Excessive digoxin intake can result in Philly wrongful death. A lower than labeled dose could cause decreased drug effectiveness, possibly resulting in cardiac instability.

The recalled items include Caraco Digoxin, USP, 0.125 milligrams and Caraco Digoxin, USP, 0.25 milligrams.

People of all ages take prescription drugs, non-prescription drugs, and supplements on a daily basis in the United States to prevent and treat various illnesses. Although these medications are supposed to help people, many people have suffered serious side effects, and even death.

If you or a loved one has been injured as the result of a dangerous drug reaction in Pennsylvania, the skilled Pennsylvania pharmaceutical drug litigation attorneys at Cherry Fieger and Marciano, LLP may be able to help you recover the monetary compensation that you deserve.

Continue reading "Digoxin Heart Drug Recalled" »

A voluntary recall of Raptiva (efalizumab) from the U.S. Market has been initiated by the drug’s manufacturer, Genetech Inc. Raptiva is used as a once-weekly injection for adults eighteen years old and over suffering from chronic plaque psoriasis; a disease with no known cure that affects 2.3 million Americans.

A report has stated that Genetech has recalled Raptiva due to a potential risk of patients developing progressive multifocal leukoencephalopathy (PML), which is a rare and typically fatal disease caused by a virus that affects the central nervous system.

"The risk that an individual patient taking Raptiva will develop PML is rare and is generally associated with long-term use," the FDA said. "Generally, PML occurs in people whose immune systems have been severely weakened and often leads to an irreversible decline in neurologic function and death. There is no known effective treatment for PML."

FDA officials have asked prescribers not to start new Raptiva treatment and to initiate discussion with patients currently using the medication on an appropriate alternative management plan. Abrupt discontinuation of Raptiva may worsen severe psoriasis conditions, which is why a transition period for the drug is in place with Raptiva being no longer available by June 8, 2009.

Continue reading "Raptiva Recalled, Linked to PML" »

Dominick Tenuto, a 61-year-old New York man with polio, has won a multimillion-dollar pharmaceutical drug litigation lawsuit against a drug maker claiming he contracted the disease 30 years ago from the polio vaccine given to his infant daughter. According to the article on Philly.com, he was awarded $22.5 million in March in a New York state court.

Tenuto’s lawsuit claimed that the live virus oral vaccine given to his daughter passed through her body and infected him while he was changing her diaper. He filed the suit after contracting polio and losing his job.

Representatives of drug maker Lederle Laboratories said it plans to appeal.

If you or someone you know has been injured due to negligence, the top personal injury lawyers in Pennsylvania of Cherry, Fieger & Marciano can assist you in evaluating your case. They will use their knowledge, their aptitude, and their ability in pursuit of obtaining considerable damages for the injured party.

Pennsylvania personal injury law encompasses a vast assortment of injuries ranging from burns to spine injuries, brain injuries, and wrongful death. When someone is determined to be legally responsible for injuring someone else, they are liable for the injury, and may be made to pay the injured person compensatory damages. Compensatory damages attempt to put an injured person back in the position he or she was in before being injured.

Continue reading "Pharmaceutical Litigation of Drug Injury Won by NY Man with Polio" »

According to the article by the Associated Press on Philly.com, this week there have been several recalls due to defective products in Pennsylvania and throughout the nation.

Baby Necessities pacifiers, manufactured in China and imported by OKK Trading of Los Angeles, Calif. were recalled because they failed federal safety tests. The pacifiers can separate from the base and pose a choking hazard. The recalled pacifiers were sold between August 2007 and January 2009.

About 24,000 3-in-1 high chairs, imported by Fisher-Price of East Aurora, N.Y. and manufactured in Mexico were recalled because the seat can fall backward from the frame if the release is unlatched while a child is inside. The seat back can also detach if not snapped fully into place. The company has received one report of a detached seat back that resulted in a fractured skull.

Watson Pharmaceuticals, Inc. recalled one lot of Propafenone HCL 225 milligram tablets, a prescribed drug used to treat cardiac arrhythmia, sold in 100 count bottles in the United States. Some of the tablets may contain higher levels of the active ingredient than specified, causing serious drug injury in Philadelphia and in any other states where the drug is used. Some patients who are particularly sensitive to small variations in dose might experience serious side effects, including irregular heartbeat or low blood pressure.

Torres Hillsdale Country Cheese LLC is recalling Asadero and Oaxaca soft Mexican-style cheeses due to possible listeria contamination. Eating food contaminated with listeria monocytogenes can cause listeriosis, a potentially fatal disease.

Continue reading "Defective Product Recalls Update: Pacifiers, High Chairs, Heart Drug" »

The FDA had concerns about new antipsychotic drugs shortly after they came on the market in the 1990s. According to this article in the Philadelphia Inquirer, the agency was worried they might trigger diabetes in some patients.

In 2000, the FDA asked AstraZeneca P.L.C. to share data on cases of new-onset diabetes and related illnesses in patients taking the antipsychotic drugs. AstraZeneca told the FDA that patients and doctors had reported 12 new cases of diabetes and five cases of related illnesses among the 623,000 who had taken its drug Seroquel.

However, court documents showed that the company had reported the number as 27 cases of diabetes and two of hyperglycemia.

The article stated that these documents surfaced in lawsuits filed in Orlando, Florida. The suits were filed by patients who claimed taking Seroquel caused their diabetes. Last month, the FDA required AstraZeneca to make information about Seroquel and weight gain more prominent on the drug’s label.

In 2000 AstraZeneca told the FDA it was “unlikely” that taking Seroquel led to diabetes.

A lawyer who wrote the document for plaintiff firm said AstraZeneca should have reported the larger number.

Documents released last week contained AstraZeneca e-mails in which employees discussed “buried” studies showing connections between Seroquel and weight gain.

AstraZeneca faces personal-injury claims from about 15,000 people who took Seroquel and say it caused diabetes.

If you or a loved one has suffered adverse reactions from taking Seroquel and would like to be kept informed about the most recent developments, news, or to discuss your legal options, please call Cherry, Fieger, and Marciano.

People of all ages take prescription drugs, non-prescription drugs, and supplements on a daily basis in the United States to prevent and treat various illnesses. Although these medications are supposed to help people, many people have suffered serious side effects, and even death.

If you or a loved one has been injured as the result of a dangerous drug reaction in Pennsylvania, the skilled Pennsylvania pharmaceutical drug litigation attorneys at Cherry, Fieger, and Marciano, LLP may be able to help you recover the monetary compensation that you deserve.

If a manufacturer produces drugs or supplements that are defective, they can and should be held responsible for the injuries they cause. As a manufacturer of pharmaceuticals, the company has an obligation to make a safe product, which includes various aspects such as thoroughly inspecting the product and affixing an appropriate label on the packaging. It is extremely important that you hire a skilled Philadelphia defective product lawyer to prove that the manufacturer was responsible for producing an unsafe product, as this is a very complicated and difficult part of the case.

It is essential to have representation on your side that has extensive experience representing people in similar matters. Contact Cherry Fieger and Marciano, LLP today for a free consultation.

Eli Lilly & Co. of Indianapolis, settled a $1.42 billion pharmaceutical drug lawsuit after selling and marketing the drug Zyprexa for dementia, which it was not approved for.

According to a report from MSNBC, the company salespeople used a slogan “5 at 5”, meaning 5 miligrams at 5 p.m. to help dementia patients sleep.

Regulators never approved selling the drug for dementia and federal prosecutors say this type of marketing led to the lawsuit.

Lilly agreed to plead guilty to a misdemeanor charge of introducing misbranded drugs into interstate commerce and pay $615 million to resolve the criminal case.

Although Eli Lilly said it admits no wrongdoing, they also agreed to pay roughly $800 million to resolve a civil case.

Zyprexa is approved by the U.S. Food and Drug Administration to treat schizophrenia and bipolar disorder. However, court documents showed Lilly sales representatives also pushed it to treat generalized sleep disorder, aggression, Alzheimer’s-related dementia and depression, among other unapproved uses, from 1999 through 2003. Although doctors can prescribe drugs for unapproved uses, companies aren’t allowed to market drugs for those uses.

Continue reading "Lilly Settles Zyprexa Suit For $1.42 Billion" »

The PriCara division of Johnson & Johnson recalled two lots of the pain patch Duragesic, or fentanyl. According to this article in the Philadelphia Inquirer the patch was recalled because of tears in the products that could expose users directly to the product's effective gel, causing an overdose.

The company issued a similar defective pharmaceutical product recall in February, but it was on a larger scale for a less potent dosage of the drug. In a statement, the company said the latest manufacturing problems have been corrected.

Duragesic, or fentanyl, is a potent opioid pain reliever and skin exposure directly to the gel within the patch can lead to respiratory problems and a fatal overdose.

The company said Duragesic 50 mcg/hr patches under the lot number 0817239 are being recalled. Anyone who comes in contact with fentanyl gel should thoroughly wash exposed skin with water only as anything else may only increase the medicine’s ability to go through the skin. Patches with cut edges should be carefully disposed of by flushing them down the toilet, without directly handling them.

The recall is being conducted in conjunction with the Food and Drug Administration. Other strengths including 12.5, 25, 75 and 100 mcg/hr are not affected, the company added.

Continue reading "Duragesic Pain Patches Recalled" »

A jury ruled that two Johnson & Johnson subsidiaries that make Duragesic, a painkilling skin patch, must pay nearly $16.6 million to the family of a woman who died from a drug overdose while using the defective pharmaceutical product.

According to this article in the Philadelphia Inquirer, Janice DiCosolo, a 38-year-old mother of three, died in 2004 while using a patch that her doctor prescribed to reduce pain caused by a neurological condition called reflex sympathetic dystrophy.

An Illinois Circuit Court ruled that DiCosolo died because the patch delivered a fatal dose of its main ingredient, the powerful narcotic pain reliever, fentanyl.

The lawsuit claimed that Janssen Pharmaceutical Inc. and ALZA Corp. knew about problems with the Duragesic patch. It allowed it to leak fentanyl in doses large enough to kill patients.

An attorney for DiCosolo's family said, "They knew this patch was dangerous and defective but they continued to sell it and make money, and that's the only reason Janice DiCosolo is dead.”

The companies are considering options for an appeal.

An independent expert and company expert inspected the patch that DiCosolo used and concluded there was no defect. The companies believe DiCosolo's cause of death was "a mix of multiple and potentially incompatible medications.”

Duragesic is a prescription-only product that is intended for cancer patients and others with chronic pain and is designed to dispense the medicine slowly through the skin. The patches were first approved under the brand name Duragesic in 1990. A generic version hit the market in 2005.

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A panel of government health advisers urged the Food and Drug Administration (FDA) to revise information for consumers and doctors about facial fillers, which are injected into the face to smooth away wrinkles. According to the article in the Philadelphia Inquirer, they want the product label to include the risk of long-lasting reactions such as bumps under the skin, blotches, and scars.

Wrinkle fillers are injected and include such products as Juvederm, made by Allergan, Inc., and Restylane, from Medicis Aesthetics Holdings. Most patients get a couple of touchups a year, which may cost more than $1,000 each.

Manufacturers and plastic surgeons say fillers have an excellent safety record. But the FDA hearing questioned unapproved uses, untrained technicians giving injections, and a lack of long-term safety data. The FDA is considering whether to regulate fillers more closely.
FDA officials are concerned that fillers are being used for purposes they were never tested nor approved for, such as plumping the lips, cheeks, and breasts.

According to the article, plastic surgeons performed some 1.5 million cosmetic surgery procedures with fillers last year alone.

The FDA presented data on 823 patients who suffered serious reactions after treatment with fillers between 2003 and this September. Nearly all were women, and the most common age group was 50- to 60-year-olds. A total of 638 of the patients required follow-up medical treatment.

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In the next few months the U.S. Supreme Court will rule on Wyeth Vs. Levine and will decide under what circumstances a consumer can sue a drug company for damages. The justices may even eliminate certain pharmaceutical lawsuits.

The Philadelphia Inquirer reported that Diana Levine won a $6.7 million dollar judgment in Vermont against Wyeth Pharmaceuticals, which Wyeth appealed. According to the article, Levine took Phenergan, a drug for nausea, to treat a migraine headache. After several weeks, her lower arm became purple and then black as gangrene set in. Eventually doctors had to amputate her arm. Levine sued Wyeth after she found out they knew about this risk.
Wyeth has argued that the Food and Drug Administration (FDA) had the final say over the risks Wyeth put on the Phenergan label.

Wyeth and its backers, which include FDA leadership, the Bush Administration, and the US Chamber of Commerce argue that the FDA is best able to assess the risks of drugs and that juries may be too sympathetic to an injured patient. Their case is based on “preemption,” which says that federal law overrides state law. Therefore, Wyeth claims that they could not comply with both the FDA and the jury’s verdict that says the label warning should have been stronger. Levine and her supporters disagree because they think juries serve as “an important check” on the drug approval system. According to the article, she and her supporters argue that a ruling for Wyeth could severely limit consumers’ ability to sue any company, as preemption becomes a ruling principle.

In previous years the FDA supported similar claims because these types of defective pharmaceutical drug litigations complement the FDA’s job of protecting consumers. In briefs supporting Levine, two FDA former commissioners stated, “risks that are rare, have long latency periods, result from drug interactions, or have adverse impacts on sub populations often go undetected in clinical testing.”

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Johnson & Johnson-Merck Consumer Pharmaceuticals Co recalled about 12,000 units of Mylicon drops to relieve gas for infants. According to this article, certain bottles of nonstaining Mylicon gas-relief dye-free drops were recalled because some bottles could include pieces of metal. The recalled children's product was sold in 1-ounce plastic bottles that were distributed to stores and pharmacies after Oct. 5. They were sold over the counter.

The recalled bottles are from lot numbers SMF007 and SMF008, which are printed on the bottom of the box and on the lower-left side of the sticker on each bottle.

The companies said that some bottles could include metal fragments that were generated during the manufacturing process.

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Cephalon Inc., a Frazer, PA–based pharmaceutical company plead guilty in federal court for marketing 3 drugs for uses other than they were approved for. According to an article in the Philadelphia Daily News, Cephalon has agreed to pay $437 million in fines, forfeitures, interest, and civil claims for distributing these misbranded drugs.

Cephalon, which develops and markets drugs to treat cancer, epilepsy, and sleep disorders, to name a few, marketed Actiq, Gabrivil, and Provogil for uses other than what was approved by the US FDA. Although doctors may prescribe drugs for uses other that what has been approved by federal regulators, pharmaceutical companies may not promote “off-label” uses.

The Philadelphia Daily News reported that the off-label marketing began in January 2001 and continued through 2006, but the plea agreement stated that the conduct went from January 2001 to October 1, 2001. Cephalon has not admitted any wrong doing as part of the civil settlement tentatively approved last November. US Attorney Laurie Magid said, “…The company put patients’ health at risk for nothing more than boosting its bottom line.”

Actiq, dispensed as a lollipop, is only approved for cancer patients and is a highly addictive narcotic. Cephalon marketed it for maladies including migraines and injuries. Gabrivil is an anti-epilepsy drug used to treat seizures, but was promoted as a remedy for anxiety, insomnia, and pain. Provogil is for excessive sleepiness associated with narcolepsy and sleep apnea. This was promoted for the treatment of sleepiness, lack of energy, and fatigue.

US Attorney Magid also said that authorities had reports that patients who had been taking the drugs for off-label issues were harmed or even died. However, she did not say at this time if the off-label use was the result of the marketing.

After reports of seizures in patients without epilepsy taking Gabrivil, Cephalon was ordered by the FDA to send warning letters to doctors. They also then stopped promoting the drug.

Cephalon was also instructed by the FDA to stop promoting Provogil off-label, but according to authorities, they ignored the letter. The feds said in the plea agreement that Provogil sales increased from 146.2 million in 2001 to $691.7 million in 2006.

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