drug manufacturing

Published on: October 18, 2011

Man Receives $48 million Award for Motrin Related Injury Lawsuit

A man, who suffered severe skin rashes and blood blisters from the use of the painkiller Motrin, has been awarded $48 million for his injuries.The verdict came in California in a product liability lawsuit that has been closely watched by Atlanta personal injury lawyers. There are significant number of product liability claims arising out of ibuprofen pending in the United States. These cases include both serious personal injuries and wrongful death claims.

The plaintiff, a 22-year-old Southern California man says that he was 16 years old when he took Motrin for the treatment of aches and fever.That was in October 2005.What happened next was something he did not expect in his wildest dreams.His skin quickly erupted into lesions, and his mouth started filling up with blood blisters.

The man filed a lawsuit against McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson and the manufacturer of Motrin.According to the lawsuit, the drug, which is easily available over the counter, did not come with enough warning about side effects.

Published on: May 30, 2011

Product Liability Actions Likely after Popular Diabetes Drug Avandia pulled from Shelves

by Robert N. Katz, Esq.

Soon the popular diabetes medication Avandia will no longer be available on the shelves of drugstores, says the U.S. Food and Drug Administration. As an Atlanta injury lawyer, I am glad to see the drug off the shelves. In my opinion, the risk of serious injury appears too great. Formerly known asRosiglitazone, GlaxoSmithKline began marketing the product under the trade name Avandia in 1999, following initial approval by the FDA. Annual sales reached a high of $3.2 billion in 2006, but declined after reports of adverse effects. In fact, the drug has been plagued with liability issues ever since 2007 when a study was released by Dr. Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic. The study showed the drug increased risk of heart attack by 40 percent in people who had Type II Diabetes, prompting the FDA to require that it be packaged with a Black Box Warning.

Between 60,000 to 200,000 people suffered heart attacks and/or death, during the 11 year span that Avandia monopolized the market, and millions were prescribed the drug.

Beginning November 18, 2011, the drug will only be available through doctors who have fully disclosed the risks to their patients and are certified to prescribe it.Under the new Avandia-Rosiglitazone Medicines Access Program, the FDA will limit the drug’s use to patients who have already been safely treated with it, those whose blood sugar can’t be controlled with other medications and those who, when informed of the risk, still prefer Avandia to other drugs. Rosiglitazone will only be available to enrolled patients by mail order from certified pharmacies participating in the programand Avandia and Actos, which was approved in 1999, will be offered as its alternative.

Published on: March 17, 2009

Judges Uphold Right to Sue Drug Makers in Wyeth vs. Levine

by Robert N. Katz, Esq.

Earlier this month, justices of the Supreme Court ruled that patients injured through use of a drug can sue the drug maker even when the drug has been approved by the Food and Drug Administration. It’s a landmark judgment, and it promises to offer patients who suffer when a pharmaceutical company is negligent, the right to seek civil justice. .

The ruling upheld the $7 million awarded to musician Diane Levine who lost her arm to gangrene after being injected with Wyeth’s Phenargan medicine.Levine had been prescribed the drug for nausea, and was administered the drug through a method called "IV push."Phenargan is not meant to be administered though this method. Levine filed a product liability lawsuit alleging that the warnings against the IV push method specified on the box, weren’t strong enough. At the time, the drug’s warning label did not include specific warnings against using the IV push method. Levine was awarded damages of $6.7 million, but Wyeth argued that FDA approval should give the company immunity against product liability lawsuits.The SC decision had been eagerly waited by Georgia product liability attorneys and patients who have filed or are in the process of filing personal injury lawsuits against pharmaceutical companies for injuries caused by their drugs. The court in a 6-3 ruling has now ruled in favor of Levine, and the larger patient community.

The decision is one product liability lawyers had hoped for.In the past, the SC has shown a slant towards big business interests, and recent attempts in Georgia to grant immunity to pharmaceutical companies in case of injuries caused by drugs approved by the FDA, had many of us very worried. As expected, pharmaceutical companies aren’t too pleased with the Supreme Court decision, and we don’t blame them.After all, this means that these companies will not be able to use FDA approval for their drugs as a screen to shield them form lawsuits. For thousands of patients around the country who have been waiting for the Wyeth vs. Levine decision to proceed with their lawsuits against pharmaceutical companies, much uncertainty has been lifted with the Supreme Court ruling.

Published on: February 19, 2009

Georgia Introduces Pharmaceutical Immunity Bill

by Robert N. Katz, Esq.

Earlier this month, we reported on Governor Sonny Perdue’s proposed legislation granting immunity from civil liability to pharmaceutical companies and medical device makers if their products had already received FDA approval. Earlier this month, a bill was introduced outlining many of the same proposals that the governor mentioned, and underscoring the fears of patients, civil justice advocate and Georgia product liability attorneys.

The Bill, Senate Bill 101 grants immunity to these companies from any injury lawsuit brought by Georgia residents if the injury was caused by a pharmaceutical drug or medical device that had FDA approval. It’s clearly aimed at attracting Big Pharma investment into the state with civil liability immunity being the Unique Selling Proposition (USP). What it essentially does, however, is sacrifice patients’ rights to hold these companies accountable for injuries or deaths caused by their products. At the risk of sounding dramatic, we believe victims of device and pharmaceutical injury will be at the mercy of these companies.

The bill relies on a foundation that has been found to be increasingly fragile in recent years. FDA approval of drugs and devices has come under the scanner after several drugs and devices were forced off the market when injuries and risks associated with their use came to light. Do the names Vioxx, Heparin and Medtronic defibrillator leads ring a bell?

Published on: January 30, 2009

FDA Reviewing Drug Labeling Charges

by Robert N. Katz, Esq.

Product and pharmaceutical liability lawyers have been seriously worried about the impending outcome of Wyeth vs. Levine and the preemption doctrine.

In December, this blog discussed the case of Wyeth and Levine and federal/state preemption issues. We await the United States Supreme Court’s decision on this issue. Meanwhile, the FDA is having to answer to these problems.

The New York Times is reporting that the U.S Food and Drug Administration may be launching criminal investigations into complaints made by several scientists against agency officials. The complaints go back to November of 2008 when the House Energy and Commerce Committee received a letter from scientists at the FDAs Center for Devices and Radiological Health division. The letter made serious allegations that management at the CDRH had been interfering with the process of approving medical devices. The scientists complained that they were being "forced" into rushing ahead to approve devices, bypassing standard procedures. The letter galvanized the ECC committee to launch an enquiry. Now, nine scientists who had made that complaint have written a letter to President Obama alleging that FDA officials may launch criminal investigations into those complaints. The letter states that it is "an outrage that our agency would step up the retaliation to such a level because we have reported their wrongdoing to the United States Congress."

Published on: January 16, 2009

Eli Lilly Agrees To $1.42 Billion Fine to Settle Zyprexa Litigation

by Robert N. Katz, Esq.

Eli Lilly & Co. has agreed to a settlement with federal regulators that will include a fine of $615 million to settle criminal lawsuits, and a further $800 million to resolve civil litigation related to injuries caused by its anti psychotic drug Zyprexa.That makes the total fine amount to close to $1.5 billion, said to be the largest criminal fine for an American company. The company will plead guilty to one misdemeanor charge, and will not plead guilty to wrongdoing in any civil case.

The punishment is for the company’s indulgence of off-label use of its Zyprexa medication. Off-label use is the promotion of a drug by a company for purposes other than that for which it has been approved.It’s not prohibited for doctors to prescribe drugs for purposes other than that for which it was specified, but pharmaceutical companies are expressly forbidden from promoting such off label use of the drug.

Zyprexa is an anti psychotic drug that is meant for use by patients who suffer from schizophrenia or bipolar mania, but that didn’t stop Eli Lily from promoting the product as a sleep medication for elderly dementia patients. Between 1999 and 2003, thousands of Eli Lilly representatives were urged to promote use of Zyprexa for use in dementia patients.Documents produced in court have shown that the company greedily pushed Zyprexa to treat a variety of disorders that it was never approved for, including aggression, dementia and dementia related to Alzheimer’s Disease.The company began promoting the medication in assisted living facilities and long term care nursing homes. Effects of the medication like weight gain were already becoming evident, but Eli Lilly’s representatives pooh poohed these, saying these were part of the benefits of taking the medication.Representatives were urged to market the drug for symptomatic treatment, even in cases where the drug had not been approved. Incidences of patients dying from heart attacks and infections after using the drug began to surface, and finally in 2006, the FDA ordered the company to have strong warning labels that cautioned patients of the drug’s risk for elderly patients. Since then, the company has paid out $1.2 billion in settlement of at least 32,000 injury claims that were brought against it.This new settlement is in addition to the previous one.

Published on: December 9, 2008

Supreme Court to Consider Drug Labeling

by Robert N. Katz, Esq.

The United States Supreme Court heard oral argument in November in a case called Wyeth vs. Levine.The case comes out of a Vermont Supreme Court decision.Diane Levine was a musician who suffered from migraine headaches.A physician’s assistant administered the drug Phenergan during a “push-IV” injection.The PA accidentally injected the drug into Levine’s artery instead of a vein.This caused tissue necrosis, gangrene, and the eventual amputation of her hand and forearm.

The drug Phenergan, manufactured by Wyeth, had a warning label that warned of this risk if the drug was injected into an artery.The Federal Drug Administration (FDA) had approved the label.Levine warned that the label did not warn of the risks associated with hitting an artery during a push-IV. A Vermont jury awarded Levine $6.8 million against Wyeth.Wyeth argued that the approval by the FDA constituted pre-emption by federal law of state law tort claims.The Vermont appellate courts upheld the verdict, and Wyeth appealed at the federal level.

The United States Supreme Court is now considering whether federal law supersedes state law in drug labeling cases.Currently, state law could supercede federal requirements if new information became available about the drug or the FDA failed to disclose certain risks. In this case, however, Wyeth knew of the risk of harm and did in fact warn of the risk.The risk of harm caused by injecting into an artery is a 1 in 20 million chance of a gangrene adverse reaction. Levine argues the warning should have been stronger, specifically that the push-IV method increased the risk of hitting an artery.

Published on: April 11, 2008

Product Liability Suit Fails Against Anti-Depressant Manufacturer

by Robert N. Katz, Esq.

Drug manufacturer GlaxoSmithKline won a significant ruling this week in the Third Circuit of the United States Court of Appeals in Colaccio vs. Apotex.SmithKline, the manufacturer of the anti-depressants Paxil and Zoloft, defended two separate state tort claims that the manufacturer failed to warn of the risk of suicide from taking the drug.Plaintiffs product liability suits failed.

In a split decision, the Third Circuit ruled that federal regulatory law pre-empted state tort law claims in cases against manufacturers of anti-depressants for failure to warn of the risk of suicide.

Anti-depressants are drugs known as selective serotonin re-upate inhibitors (SSRIs).The drugs block the re-absorption of serotonin into the brain.Serotonin is a natural body chemical that regulates mood, sleep and appetite.By blocking the re-absorption the brain cells get an extra dose of a feel-good chemical.Some experts believe that the increase in serotonin causes a drop in the natural chemical dopamine. Dopamine regulates cognition and behavior.