Posted on behalf of Cappolino Dodd Krebs LLP.

That pharmaceutical companies occasionally manufacture a dangerous drug or that a defective drug slips through the system isn’t really news.

We’ve known for some time that there were serious problems with dangerous drugs like Paxil and Avandia.

Now, we’re learning that GlaxoSmithKline, a British drug giant, has agreed to pay $750 million to settle criminal and civil complaints that the company for years knowingly sold contaminated baby ointment and an ineffective antidepressant made in their Puerto Rico plant, despite warnings from their own quality control manager that the plant had problems.

Cheryl D. Eckard, GlaxoSmithKline’s quality manager, asserted in her whistle-blower suit that she had warned of the problems but the company fired her instead of addressing them. Among the drugs affected were Paxil, an antidepressant; Bactroban, an ointment; Avandia, a troubled diabetes drug; Coreg, a heart drug; and Tagamet, an acid reflux drug. No patients were known to have been sickened, although such cases would be difficult to trace.

In a rising wave, recent lawsuits have asserted that drug makers misled patients and defrauded federal and state governments that, through Medicare and Medicaid, pay for much of health care.

Ms. Eckard’s role in the case began in August 2002 when GlaxoSmithKline sent her to Cidra, south of San Juan, to lead a team of 100 quality experts to fix problems cited by an F.D.A. warning letter a month earlier.

This was GlaxoSmithKline’s premier manufacturing facility, producing $5.5 billion of product each year. But Ms. Eckard soon discovered that quality control was a mess: the water system was contaminated; the air system allowed for cross-contamination between products; the warehouse was so overcrowded that rented vans were used for storage; the plant could not ensure the sterility of intravenous drugs for cancer; and pills of differing strengths were sometimes mixed in the same bottles.

Although F.D.A. inspectors had spotted some problems, most were missed. And the company abandoned even the limited fixes it promised to conduct, the unsealed lawsuit says. Ms. Eckard complained repeatedly to senior managers; little was done. She recommended recalls of defective products; recalls were not authorized. In May 2003, she was terminated as a “redundancy.”

She complained to top company executives, but she was ignored even after warning that she would call the F.D.A. So she called the F.D.A. and sued. The agency began a criminal investigation and used armed federal marshals in 2005 to seize nearly $2 billion worth of products, the largest such seizure in history. Unable to fix the plant, GlaxoSmithKline closed it in 2009.

If you or someone you love has been harmed by one of these defective drugs, you may be entitled to financial compensation. Please contact an experienced defective drugs attorney for professional insight.

Source: GARDINER HARRIS and DUFF WILSON of The New York Times.

The U.S. Food and Drug Administration in September announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications.

These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.
 
Rosiglitazone also is available in combination with other diabetes medications, metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.

Avandia, manufactured by GlaxoSmithKline (GSK), is in a class of drugs known as thiazolidinediones, or TZDs. It is intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in patients with Type 2 diabetes mellitus.
 
Doctors will have to attest to and document their patients’ eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks. The agency anticipates that the REMS will limit use of Avandia significantly. 
 
“Allowing Avandia to remain on the market, but under restrictions, is an appropriate response, given the significant safety concerns and the scientific uncertainty still remaining about this drug,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

If you or a loved one has been injured as the result of taking a dangerous drug, seek out an experienced defective drug attorney for professional insight.
 
Source: U.S. Food & Drug Administration

Pfizer Inc. says it is pulling its blood pressure drug Thelin off the market and stopping all clinical trials because the drug can cause fatal liver damage.

Thelin is sold in the European Union, Canada, and Australia as a treatment for pulmonary arterial hypertension, or high blood pressure in the pulmonary artery. Pfizer says a review of clinical trial data and other reports showed a new link to liver injury. Liver toxicity was a known side effect of the drug, the company says.

Since there are other treatment options, Pfizer says the benefits of Thelin don’t outweigh the risks. It is stopping all studies of the oral drug, which Pfizer acquired in 2008 when it bought Encysive Pharmaceuticals Inc.

Copyright 2010 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Paxil is a popular antidepressant that has a several dangerous side effects, birth defects, pregnancy risks, birth injuries and may even cause death.

Persistent primary hypertension, also called PPHN, is another danger to newborns whose mothers are prescribed the drug during pregnancy

Although Paxil is used primarily to treat depression, many doctors use it to also treat panic disorders, anxiety, and post traumatic stress disorder in millions of people around the world. The Food and Drug Administration advised doctors that prescribing Paxil to children and teenagers could significantly increase the likelihood of violence and suicidal tendencies.

Furthermore, Paxil may also cause a number of serious birth defects. Recent studies have shown that Paxil significantly increased the number of congenital heart defects such as primary pulmonary hypertension in developing fetuses. Two independent studies revealed that among women who took the during their first three months of pregnancy had babies with Paxil heart birth defects at 1.5 to 2 times the rate of normal births.

If you or someone you love has been injured after being prescribed Paxil, or any other defective drug or prescription medication, please contact an experienced defective drug attorney for professional insight.

In August, Johnson & Johnson issued a voluntary recall for up to 93,000 artificial hips that had been surgically implanted since 2005.

The popular hip implant, the DePuy ASR XL Acetabular hip socket implant system, has an unacceptably high rate of failure. In fact, according to one study, one in eight of the implants have failed.

“That’s really a terrible track record,” said Richard Dodd, a senior partner with the Cappolino Dodd Krebs law firm in Cameron. The firm has extensive experience helping patients recover from the fallout of defective medical devices. “Most hip implants are given to older people for whom second surgeries can be life-threatening.

According to Dodd, symptoms of an implant failure include infection, bone fracture, dislocation and pain. In some cases, the implant can became loose in the socket which creates even more problems. Other complications of a failure of the DePuy Hip Implant include bone staining, necrosis, swelling, nerve damage, tissue damage and/or muscle damage. Increased metal toxicity from chromium and cobalt debris entering the blood stream of an unsuspecting patient can also lead to problems, even patients who have experienced no other symptoms.

Dodd said that many patients have received a recall notice, typically from the patient’s treating orthopedic surgeon, and urges patients to discuss any problems or symptoms with a doctor.  Of note, the letter indicates that DePuy will pay for the medical examination and any medical follow up listed in an “Information for Patients” sheet which should accompany the letter.

The letter also includes a medical release form. Dodd cautioned patients against signing the release form without consulting an attorney about it.

“We’re finding that DePuy is using this private medical information to twist the claim back on the patient,” he said. “I know it sounds strange but DePuy’s attorneys can and will use this information to build the case that the patient abused the implant.”

Even if DePuy does cover the costs of a revision surgery, Dodd warned that a second hip surgeries are technically more difficult, take longer to perform, place the patient at risk of higher complications and take longer to recover from.

“That’s in addition to the pain and suffering, invasive surgery, risk for infection, general complications and even risk of death,” he said.

Dodd urged patients who have had implant surgery since 2005 and know that it was a DePuy implant, to call your doctor right away. “Don’t sign anything that would let anyone other than your doctor have access to your medical records without first talking to an attorney.”

The popular painkillers Darvon and Darvocet (propoxyphene) have been pulled from the market because of their association with serious or even fatal heart rhythm abnormalities.

The US Food & Drug Administration (FDA) is also asking the manufacturers of generic propoxyphene-containing products to remove those products from the market.

Darvon and Darvocet are both made by Xanodyne Pharmaceuticals Inc. Propoxyphene is an opium-derivative used to treat mild to moderate pain. First approved by the FDA in 1957, propoxophene is sold by prescription under various names both alone (e.g., Darvon) or in combination with acetaminophen (e.g., Darvocet).

The US Food and Drug Administration has since reviewed the data from a recent study, which show that, even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart. These changes, which can be seen on an electrocardiogram (ECG), can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death, the FDA said.

The available data also indicate that the risk of adverse events for any particular patient (even patients who have taken the drug for many years) is subject to change based on small changes in the health status of the patient, such as dehydration, a change in medications, or decreased kidney function, the agency said. As a result of these data, combined with other information, including new epidemiological data, the agency concluded that the risks of the medication outweigh the benefits.

Lasko Products has been ordered to pay a $500,000 fine for not quickly responding to problems with it’s portable box fans. The fans have been overheating and causing fires,.

Lasko received 42 complaints involving nine injuries and property damage from 2002 through 2005 as a result of defects in the fans they manufacture.

Federal law requires that companies report potential hazards to the U.S. Consumer Product Safety Commission within 24 hours; Lasko did not fully report the problems until September of 2005.

The box and floor fans were sold under the brand names Lasko, General Galaxy and Air King from 2000 to 2004. They were sold at discount stores for between $10 and $25. In 2006, 5.6 million of the fans were recalled because of an electrical failure in the motor.

A baby crib linked to the deaths of several  babies, has been recalled by the US Consumer Product Safety Commission.

Delta Enterprises cribs have been linked to several infant deaths because of an allegedly faulty drop-side rail and peg mechanisms. In December 2008, the U.S. Consumer Product Safety Commission (UPSC) along with Delta recalled the cribs due to “side rails on certain Delta cribs that were breaking in ways that could trap and kill babies,” according to the Chicago Tribune.

However, according to an in-depth investigation by the Chicago Tribune there were a “long trail of warning signs that began at least a decade before this fall’s recall.”

If you or a loved one has been harmed by a defective product or fallen victim to the crib’s dangers, are encouraged to contact an experienced defective products attorney for professional insight on the development of a potential crib recall lawsuit, which may offer monetary compensation to pay for any treatments of injuries caused by the crib’s dangers.

The dangerous chemical melamine that has recently been found in several goods originating from China has also been found in an infant formula made by an American manufacturer.

The discovery was found in late November, and involves a single sample of infant formula that was found to contain trace amounts of the dangerous chemical.

The US Food and Drug Administration (FDA) quickly pointed out that the amounts of the chemical were too low to be considered a heath threat, but it should be noted that the increased testing for melamine is a result of a rise in tainted products from around the globe.

Earlier this year, thousands of pets had been sickened or killed by the presence of melamine in pet food, and the source of this melamine was linked to imported wheat gluten from China. Also this year, China has had serious children’s toys, tainted toothpaste, heparin, pet food, and milk recalls. 50,000 infants became ill from the tainted milk, and 4 died.