March 11, 2010

Zinc in Dental Adhesives Can Cause Injuries

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.

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January 19, 2010

Lawsuits Filed Over Drug Side Effects

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.

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November 23, 2009

Study on Merck Pill Zetia Raises New Questions

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.

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November 20, 2009

FDA Discovers Pieces of Steel and Rubber in Genzyme Drugs

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.

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November 19, 2009

FDA Says Heartburn Drugs Can Interfere with Plavix

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.

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October 30, 2009

PA Prempro Cancer Case: Jury Weighs Damages

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.

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October 27, 2009

First Paxil Lawsuit Results in Plaintiff's Favor

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.

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October 6, 2009

Merck to Pay 3,100 Vioxx Claims

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.

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October 1, 2009

Trial Opens in Philadelphia in Paxil Lawsuit

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.

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September 28, 2009

Phenergan Ordered to Display Black Box Warning

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.

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September 3, 2009

Ghostwriting Used by Glaxo to Market Paxil

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.

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August 20, 2009

FDA Warns About Supplements with Steroids

The Food and Drug Administration issued a public health advisory warning consumers to stop using products containing steroids or steroid-like substances, many of which are labeled as dietary supplements. According to an article, the advisory came after FDA investigators raided the offices of American Cellular Labs, looking for evidence the company sells steroids under the guise of a supplement.

The FDA sent a warning letter to the company, saying it was selling unapproved and misbranded drugs and telling the company to explain how to prevent the recurrence of violations. Those products include TREN-Xtreme, MASS Xtreme and six others. The FDA received several reports of adverse effects over two years, including serious liver injury, from the American Cellular products and 15 from similar products made by other manufacturers.

These defective products may be popular among athletes in high school, especially football players, who may not be subjected to a thorough drug-testing program. The FDA warned consumers to be cautious when they buy any dietary supplements, not just the ones that claim to build muscle. Many can be contaminated with potentially dangerous substances.

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July 23, 2009

FDA Recommends Ban on Painkillers

An FDA advisory panel recommended banning Vicodin and Percocet because they contain acetaminophen, which can cause liver damage if taken at higher-than-recommended doses. According to this article on Philly.com, the panel also urged the FDA to lower maximum doses for acetaminophen (also known as the branded drug Tylenol).

The FDA is not required to follow the panel’s advice, but usually does follow their recommendations. Vicodin and Percocet were recommended for a ban because some research has showed greater evidence of drug injury and liver damage with these medications. It could be because many patients take painkillers over the long term, while also taking other medicines they do not realize contain acetaminophen, such as NyQuil and Theraflu.

If the FDA bans Vicodin and Percocet, doctors may need to explore other ways to manage their patients’ pain. Vicodin contains hydrocodone and acetaminophen. Acetaminophen was included as an ingredient in the two drugs because it acts on different pain receptors than do hydrocodone and oxycodone. Other painkillers like aspirin and nonsteroidal anti-inflammatory drugs also come with risks, such as kidney problems and gastrointestinal bleeding.

Experts said there are solutions that could reduce the chance of acetaminophen overdose, such as making sure all labels list acetaminophen. This could reduce the possibility that a patient might take too much of the drug. Doctors could also ask more questions about which drugs patients are taking. Doctors need to know how often a person takes Tylenol and NyQuil.

The pharmaceutical industry likely will fight the proposed ban since prescription drugs containing acetaminophen generated $1.4 billion in 2008 sales.

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July 16, 2009

Zicam Defective Drug Recall

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.

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June 25, 2009

Chelation Heart Disease Study Investigated by Government

The government is investigating if heart attack survivors enrolled in a controversial federal study of an alternative treatment were told about possible health risks.

According to this article, the $30 million study with 1,500 participants, is one of the largest alternative medicine experiments. It tests high doses of vitamin and mineral supplements and chelation, a treatment used for lead poisoning. It has not been proven safe or effective for heart disease and has the potential to cause drug injury.

Last August, the federal Office of Human Research Protections began a probe into whether the people in the study were being fully informed of risks and adequately protected. Researchers then suspended enrollment.

Chelation involves intravenous doses of a drug, in this case disodium EDTA. Proponents claim it can flush out calcium that has built up in artery walls.

According to the article, the study’s consent form does not tell participants that others have suffered wrongful death from chelation. More than half of the doctors running the study make money by selling chelation treatments, which is a conflict of interest.

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June 24, 2009

Zicam Nasal Spray Linked to Loss of Smell

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.

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June 5, 2009

Hydroxycut Linked to Liver Damage

According to this article that appeared in the Philadelphia Inquirer, the popular bodybuilding and weight-loss supplement, Hydroxycut, has been linked to liver damage. It is uncertain exactly how many people have suffered Hydroxycut drug injury, although a few incidents have been noted. For instance, a 33-year-old woman went to the emergency room at Yale-New Haven Hospital because of dark urine, yellowish skin, and profound fatigue. Her lab results showed she had acute liver inflammation.

Joseph Lim, a liver specialist at Yale on the woman’s case, noted that the woman had been taking Hydroxycut supplements for weight loss for two weeks. Several reports in the medical literature had linked Hydroxycut (which is used for both bodybuilding and weight loss) to liver damage. His patient improved after she stopped taking the supplement.

In May, the Food and Drug Administration (FDA) warned consumers to stop taking Hydroxycut, which had been linked to liver damage and jaundice in 23 case reports received by the agency. These complaints included one liver transplant and one fatality. Those who have suffered injury due to using Hydroxycut in Pennsylvania would be well advised to contact a Philadelphia Hydroxycut recall attorney to help them receive compensation for any medical costs, treatment, or lost wages from not being able to work.

Iovate Health Sciences, the manufacturer, voluntarily recalled 14 Hydroxycut products. According to the article, the company sold more than nine million bottles of Hydroxycut in 2008. It is unclear how many people Hydroxycut may have injured or even which of its ingredients are dangerous. Although Hydroxycut was pulled from drug store shelves, many of its ingredients were widely available in other products still for sale. The FDA said that the agency was investigating those ingredients and other products that contain them.

The Hydroxycut ingredient that shares the product’s name is hydroxycitric acid or HCA. Two other ingredients in Hydroxycut could also be toxic: the mineral chromium and Camellia sinensis, the tea plant. They could be potential liver toxins. Recalling Hydroxycut does not fully protect the public if consumers buy another weight-loss supplement. Weight-loss and bodybuilding supplements may all be dangerous and have the potential to cause personal injury in Pennsylvania and throughout the nation. Unfortunately, adverse events are dramatically underreported because patients often fail to tell their doctors about supplement use.

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April 16, 2009

Philadelphia Seeks Action against CVS for Selling Expired Products

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.

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April 13, 2009

Digoxin Heart Drug Recalled

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.

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April 9, 2009

Pharmaceutical Litigation of Drug Injury Won by NY Man with Polio

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.

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February 4, 2009

Lilly Settles Zyprexa Suit For $1.42 Billion

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.

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