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.

Agency working with trade associations to increase company vigilance and protect public

In a letter sent to dietary supplement manufacturers, the U.S. Food and Drug Administration expressed concern about undeclared or deceptively labeled ingredients in products marketed as dietary supplements. These substances include the active ingredients in FDA-approved drugs or their analogs (closely-related drugs), or other compounds, such as novel synthetic steroids, that do not qualify as dietary ingredients.

In recent years, FDA has alerted consumers to nearly 300 tainted products marketed as dietary supplements and received numerous complaints of injury associated with these products.

The FDA’s letter emphasizes that manufacturers and distributors are responsible for ensuring that their products comply with the law. Five major trade associations – Council for Responsible Nutrition, Natural Products Association, United Natural Products Alliance, Consumer Healthcare Products Association and American Herbal Products Association– are joining FDA on a call for media and have agreed to share the letter widely within the industry.

The FDA has noted the three most common categories of these illegal products:

* Weight loss products containing active ingredients such as sibutramine: Sibutramine is the active ingredient in the drug Merida, which was recently withdrawn from the market due to increased risk of heart attack and stroke. The FDA has discovered dozens of products, such as Slimming Beauty, Solo Slim, Slim-30, and others, which contain sibutramine or closely related drugs (analogs).
* Body-building products containing anabolic steroids or steroid analogs: These products can cause acute liver injury and increase the risk for heart attack, stroke and death. Products like Tren Xtreme, ArimaDex, and Clomed have been labeled to contain either anabolic steroids or aromatase inhibitors, which prevent anabolic steroids from being converted to estrogen.
* Sexual enhancement products that contain the same active ingredient or an analog of the active ingredient in the approved drugs Viagra, Cialis, and Levitra. The approved products are available only by prescription, and they should not be used by people who have certain medical conditions, such as cardiovascular disease. Products determined to be in violation of federal law by the FDA include Vigor-25, Duro Extend Capsules for Men, Magic Power Coffee, and others.

“The labeling of these tainted products may claim that they are ‘alternatives’ to FDA-approved drugs, or ‘legal’ alternatives to anabolic steroids,” said Michael Levy, director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research. “Consumers should avoid products marketed as supplements that claim to have effects similar to prescription drugs. Consumers should also be wary of products with labeling only in a foreign language or that are marketed through mass e-mails.”

Source: U.S. Food and Drug Administration

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

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.

According to a recent study, DES (diethylstilbestrol) may increase breast cancer risks for DES Daughters, as well as their mothers.

DES, a synthetic form of estrogen, was widely prescribed to prevent premature delivery and miscarriage. However, when given during the first five months of a pregnancy, DES could interfere with the development of the reproductive system in a an unborn child.

Between 5 and 10 million pregnant women were treated with the drug from 1938 to 1971. Studies conducted in the 1950s showed the drug was not all that effective in preventing complications of pregnancy so its use declined — but did not completely stop — until 1971.

A recent study provides initial results linking exposure to DES before birth with increased rates of breast cancer.  The study found that among participants, DES Daughters were more likely to experience breast cancer than were unexposed women.

Further, the study did find that, in women over 40 years old, DES Daughters were two-and-a-half times more likely than unexposed women to be diagnosed with breast cancer.

According to the National Cancer Institute, 16 percent of women prescribed DES during pregnancy developed breast cancer, in comparison with 13 percent of women not prescribed DES. Therefore, it is estimated that one in six women who were prescribed DES will develop breast cancer, whereas one in eight women in the general population will develop the disease.

The Food and Drug Administration has seized several plants belonging to the drug manufacturer Caraco Pharmaceutical Laboratories Ltd. for manufacturing violations.

The FDA cited multiple violations of manufacturing standards and seized approximately 33 different generic drugs at three different plants. The FDA will prevent Caraco from distributing anything until they have assurance that the company will comply with FDA standards in the future.

The drugs that were seized were generic forms of heart, pain, and psychiatric medicines. Caraco was accused of poor handling of drug ingredients and varying tablet-manufacturing processes.

People currently taking drugs made by Caraco should not be concerned and should continue to take their medications as prescribed. Any defective drugs should have been weeded out of the market already by recalls.

The seizure of these drugs could cause a shortage of choline magnesium trisalicylate oral tablets. If you are currently taking this medication and experience a supply shortage in your area, talk to your doctor about an alternative drug.

The Heart Rhythm Society has said that defibrillator lead wires need better surveillance to detect defects, and has called on hospitals to train doctors in the delicate procedure of removing such wires from patients.

The lead is a wire that connects an implantable defibrillator to the heart. If a lead breaks, the defibrillator can emit a massive and painful shock, and in the worst case scenario, preventing a defibrillator from sending a necessary shock to the heart.

In 2007, Medtronic Inc.’s Sprint Fidelis lead was removed from the market following reports of 5 deaths due to lead fractures with another 13 deaths caused by “possible or likely contributing factor” of defective leads.

Before the recall, Sprint Fidelis leads had been implanted with 90% of Medtronic’s defibrillators, and around 150,000 people are still implanted with a Sprint Fidelis lead.

The Heart Rhythm Society used the Sprint Fidelis recall in its request for a surveillance system to track lead performance in order to spot defective devices earlier. The group also said hospitals need to train more doctors to remove faulty defibrillator leads.

During the Sprint Fidelis recall, four deaths occurred when doctors tried to remove defect leads from patients. The group said physicians should perform at least 40 extractions under expert supervision before operating on their own. Supervising physicians should have performed at least 75 extractions with a high rate of success, the group states. They also recommended that such training take place only medical centers that perform a large number of lead extractions each year should train physicians to perform the surgery.

Finally, the group called on the FDA to require that new defibrillator leads be tested in humans before they are approved. Currently, most leads are approved through the agency’s fast track process, which is reserved for devices that are considered modifications of existing products. The fast track process does not require human studies.

If you or someone you love has been injured by a defective medical device, it’s important to seek out expert advice of an experienced defective drug attorney for valuable insight.

The drug approved to treat lung and pancreatic cancers called Tarceva has been linked to serious side effects including potentially fatal digestive tract perforations, skin reactions and eye problems. The complications from this defective drug have prompted the Food & Drug Administration to announce new warnings for the drug’s label.

The drug Tarceva is one of a class of cancer drugs known as epidermal growth factor receptor (EGFR) trosine kinase inhibitors, which are treatments designed to block the EGFR protein. This protein is believed to play a role in cancer cell growth.

The risk for gastrointestinal perforations while undergoing Terceva therapy is greatest in patients receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs, and/or taxane-based chemotherapy, or who have prior history of peptic ulceration or diverticular disease. According to the letter, some instances of perforation had been fatal.

In addition, some Tarceva patients had developed bullous, blistering and exfoliative skin conditions, even suggestive of Stevens-Johnson syndrome or toxic epidermal necrolysis. Some of the defective drug cases have resulted in deaths.

Once again, the blood-thinning drug heparin has been linked to fatalities in patients. Five patients at Beebe Medical Center in Delaware fell ill after being treated with heparin IV bags. Two of the patients have died.

The IV bags contained diluted heparin that has been approved for a number of blood-thinning purposes. All five bags came from the pharmaceutical company Baxter International. This is not the first time that Baxter has been linked to heparin fatalities. In 2008, they had to recall thousands of cheap, tainted heparin products.

These two recent deaths have prompted the Food and Drug Administration to launch an investigation into the incident. So far, the FDA has not accused Baxter of distributing tainted heparin, nor have they implied that heparin itself may be less safe than previously thought. They said that it was only  “unusual” circumstances in the Delaware deaths that made them decide to investigate.

An independent lab is currently testing the Baxter heparin used at Beebe.

The Food and Drug Administration has announced that the deaths of two patients treated with possibly contaminated heparin may have been an isolated incident.

Five patients recently fell ill in a Delaware medical center after being treated with heparin IV bags supplied by Baxter International. Two of the patients, a 71-year-old man and a 64-year-old woman, have died, and a third patient remains hospitalized. These three people all suffered cerebral hemorrhages.

However, the FDA has found no evidence of contamination, nor have they received additional reports of fatalities or other serious injuries linked to heparin use. The FDA has determined that this incident alone is not enough to make any decisions about the production of heparin. FDA representatives have issued statements that patients should not worry about being treated with heparin.

Anyone who has suffered a defective drug injury should contact an experienced lawyer immediately as they may be eligible to receive compensation through a defective drug lawsuit.