Drug Injury Attorney Blog

The Food and Drug Administration’s top staff regulators were against shielding drug makers from lawsuits, the Los Angeles Times reports.

Internal documents released by Rep. Henry A. Waxman (D-Beverly Hills) reveals that top FDA regulators did not trust pharmaceutical companies to warn patients of new risks associated with prescription drugs. However, Bush Administration appointees argued that, under the legal doctrine known as preemption, the FDA process approving drug labels should be sufficient to shield drug makers from consumer lawsuits.

But the FDA’s own experts on the drug approval process disagreed.

Dr. John Jenkins, director of the Office of New Drugs, wrote in a 2003 memo:

"The premise of the basis for much of the argument for why we are proposing to invoke preemption seems to be based on a false assumption that the FDA-approved labeling is fully accurate and up-to-date in a real-time basis. We know that such an assumption is false."

As the LA Times’ reporter David Savage points out, the FDA has regulated new drugs for more than 100 years. At the same time, the FDA did not attempt to block lawsuits filed against drug makers by patients who were hurt by dangerous drugs.

Now that right is at stake. In a case before the U.S. Supreme Court, Wyeth is asking the Court to shield it from a lawsuit filed by a musician who lost her arm as a result of gangrene caused by an anti-nausea drug.

Like the experienced staff regulators at the FDA, attorneys who represent victims who have been harmed by dangerous drugs understand that drug makers are not eager to disclose all the risks associated with their medicines. Lawsuits play a vital role in protecting the American consumer.

My law firm currently represents victims and their families in lawsuits against most of the major drug companies including Merck, Pfizer, Bayer, Eli Lilly and others. The lawyers of The Lowe Law Firm are experienced in helping people injured by dangerous prescription drugs. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases.

A woman who claimed diet drugs caused her lung-destroying disease has been awarded $3 million by a New Jersey jury, Bloomberg News reports.

The verdict against Wyeth, the maker of Pondimin, was handed down on Oct. 22. The plaintiff, Gloria Stribling filed suit in Bergen County Superior Court after she was diagnosed with primary pulmonary hypertension, an often-fatal illness.

Pondimin and another Wyeth-made drug, Redux, were often combined with phentermine to form the appetite suppressant fen-phen. More than six million people were described the diet-drug cocktail before Wyeth pulled the drugs from the market in 1997 after researchers linked the treatment to heart damage and PPH.

Stribling took the fen-phen combination from November 1995 to October 1996. She was diagnosed with PPH a decade later. The trial against Wyeth began on Sept. 3. The jury concluded that Pondimin was a “substantial contributing factor” in causing the lung disease.

Wyeth, which has set aside $21 billion to cover costs associated with fen-phen litigation, is reviewing post-trial options.

It is now well-established that new cases of PPH caused by the diet drugs are now being diagnosed for the first time. This is because there may be a latency of 10-20 years after cessation of the diet drugs before the PPH disease occurs.

The Lowe Law Firm has tried and or resolved Fen-Phen opt-out cases . We are dedicated to obtaining compensation for people who have this disease through the negligence or deceit of drug companies. Although drug company executives were warned of the dangers of these drugs and knew of many cases of Fen-Phen-related PPH, they hid this information from the public.

If you believe that you or a loved one has contracted PPH from using Fen-Phen, contact The Lowe Law Firm today. We can help you obtain the compensation you're entitled to by law.

Pfizer Inc. has agreed to pay $894 million to settle personal injury and consumer fraud claims involving pain medications Bextra and Celebrex.

The announcement, made on Oct. 17 by New York-based Pfizer, will settle about 90 percent of the lawsuits filed against the drug maker over the COX-2 inhibitor. The Cox-2 family of drugs is suspected of increasing heart attacks.

In 2005, the Food and Drug Administration asked Pfizer to remove Bextra from the market. It has been associated with Stevens-Johnson syndrome and toxic epidermal necrolysis, a pair of rare and potentially deadly skin diseases.

Celebrex is still on the market despite claims that it patients risk blood clots, heart attacks, strokes and other cardiovascular problems if they use the drug.

From the settlement, about $745 million will be used to resolve the personal injury lawsuits. Approximately $60 million will be used to settle claims brought by 33 states and the District of Columbia alleging that Bextra was inappropriately marketed. Another $89 million will be used to settled consumer fraud cases.

My law firm currently represents Bextra and Celebrex victims and their families in lawsuits. The lawyers of The Lowe Law Firm are experienced in helping people injured by defective and dangerous drugs. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases.

Transvaginal mesh has resulted in over 1,000 Reports of Complications in 3 Years. That number should be multiplied because epidemiologist in the medical field acknowledge that adverse events are under reported usually by a factor of ten. Consequently there may have been an additional 9,000 complications which were not reported.

FDA has issued a public health notification concerning serious complications associated with transvaginal placement of surgical mesh used in the repair of pelvic organ prolapse (POP) and urinary Stress Urinary Incontinence.

Over the past 3 years, FDA has received more than 1,000 reports from 9 surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement.

The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.

Treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.

My law firm currently is handling cases for the defective Kugel Mesh and we are investigating cases involving other defective mesh products. The lawyers of The Lowe Law Firm are experienced in helping people injured by Defective Mesh Products. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages.

We offer a free initial consultation for victims harmed medical products. If you cannot make it to our office, we will come to you where ever you are.

Last month, the preliminary results of a German study were released that suggest stroke patients who take certain anti-anemia drugs increase their chances of dying.

The U.S. Food and Drug Administration warned on Sept. 26 that a clinical trial investigating the use of high doses of epoetin alfa to treat acute ischemic stroke found that patients who received the drugs died nearly twice as often as the patients who received the placebo. Sixteen percent of patients who received the anti-anemia drugs died. Patients who received a placebo had a nine percent death rate.

According to the U.S. News & World Report, epoetin alfa is used in drugs such as Aransep, Procrit and Epogen. Although the drugs are on the U.S. market, they have not been approved for use in stroke recovery.

This past July, the FDA required the makers of Aransep and Procrit warning that the drugs can cause cancer tumors to spread and raise the risk of bleeding. Although an FDA advisory committee recommended keeping the drugs on the market, the committee urged that they not be used in people with curable cancer.

In its most recent safety warning, the FDA indicated it will be reviewing additional data over the course of several weeks. Once the review is complete, the FDA will issue conclusions and recommendations.

The Lowe Law Firm offers a free initial consultation for victims harmed pharmaceutical products. If you cannot make it to our office, we will come to you at the hospital or your home.

On Nov. 3, the U.S. Supreme Court will hear oral arguments in an important case which could threaten the rights of consumers to sue drug makers over dangerous prescription medicines.

In 2000, musician Diana Levine went to the hospital complaining of nausea associated with a migraine headache. Doctors injected the anti-nausea drug Phenergan, which is made by Wyeth, into her muscles. When the medicine failed to rid Levine of her nausea, her physicians decided to administer the drug a second time. Instead of using an IV drip, her doctors gave her the drug by using an “IV push” method in which the medicine is delivered directly into the vein. The drug made contact with her arteries causing gangrene. Her arm had to be amputated as a result.

Levine sued Wyeth in Vermont state court alleging that the drug company failed to warn of the risks associated with an IV push of Phenergan.

The Phenergan label had been approved by the Food and Drug Administration in 1955 and re-approved in the 1980s. Although Wyeth knew that the anti-nausea drug could cause gangrene if it reached the arteries, it did not mention the dangers associated with the IV push method. In addition, there was no evidence that the FDA ever considered whether the label should have contained such a warning.

The jury sided with Levine and awarded her $6.7 million. Wyeth appealed, arguing that the FDA approval process overrides state tort law. The Virginia Supreme Court disagreed, concluding that nothing in federal law prevented Wyeth from providing additional warnings.

On Jan. 18, the U.S. Supreme Court agreed to take the case, Wyeth v. Levine, to consider the preemption issue.

The stakes are high. Friend of the court briefs urging the Court to adopt Wyeth’s position have been filed by pharmaceutical groups, the U.S. Chamber of Commerce and the Bush administration. Amicus briefs urging the Court to uphold the jury award have been filed by a number of consumer groups.

My law firm currently represents victims and their families in lawsuits against most of the major drug companies including Merck, Pfizer, Bayer, Eli Lilly and others. The lawyers of The Lowe Law Firm are experienced in helping people injured by dangerous prescription drugs. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases. This legal argument of preemption is the result of an expansion of power by the Bush Administration. Hopefully the Supreme Court will not decide in favor of this unjustified protectionism of drug companies.

My prediction is that there will be limited preemption but not total preemption. Based on the facts of the case the Supreme Court took I think they will hold in a 5-4 decision that if the drug company provided all of the required information to the FDA and the FDA considered it, that an injured person will not be able to claim that the warning is inadequate. We will just have to wait until January 2009 to see. Also if they completely preempt prescription drug cases it looks like there will be a democratically controlled House, Senate, and Presidency, and they can write new legislation overturning the Supreme Courts ruling.

Medtronic and the Food and Drug Administration (FDA) issued a Class I Recall of the Medtronic Neuromodulation INDURA IP. The recall of the Medtronic device was prompted by potential for life-threatening blockages.

A Class I Recall is the most serious of type of product recall issued by the FDA, and involves situations in which there is a reasonable probability that use of the product will cause serious injury or death.

The pain pumps are often used in patients who have spasticity related to cystic fibrosis, traumatic brain injury, multiple sclerosis and chronic pain. About 25,000 devices have been sold since May 2007.

This recall was prompted by potential misconnections of the Medtronic sutureless connector ("SC") catheters from the catheter port on the pump. These misconnections have resulted in a blockage between the sutureless pump connector and the catheter port on the pump and disconnection from the pump connector.

The Medtronic Neuromodulation INDURA IP consists of 2 models of intrathecal catheter, the sutureless pump, and the intrathecal catheter pump segment revision kit.

The intrathecal catheter or intrathecal catheter revision kits use a sutureless connector for the final connection to the implanted Medtronic SyncroMed II, SynchroMed EL, and IsoMed infusion pumps. The catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space.

The product models included in the recall are: Intrathecal Catheter, Model 8709SC; Intrathecal Catheter, Model 8731SC; Sutureless Pump; Connector Revision Kit, Model 8678; and Intrathecal Catheter Pump Segment Revision Kit, Model 8596SC.

My law firm currently represents numerous victims and their families in lawsuits against Medtronic. The lawyers of The Lowe Law Firm are experienced in helping people injured by Medtronic. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases.

We offer a free initial consultation for victims harmed pharmaceutical products. If you cannot make it to our office, we will come to you.