U.S. District Judge Sidney A. Fitzwater recently approved the settlement which was filed in Wichita Falls in North Texas.

A Fort Worth Texas lawyer, Art Brender represented 369 plaintiffs and said that the supplement was on the market for four and half months before it was recalled in April 1984. Health officials have since linked E-Ferol to the deaths of up to  40 infants. Originally marketed as a way to prevent or reduce blindness in premature infants E-Ferol was sold without FDA approval.

Research has since determined the chemical agent which made the vitamin E water soluble was causing complications including kidney and liver failure in the infants.

“I think it’s one of the worst cases of corporate greed and malfeasance in history,” Brender said.

The drug which was manufactured by Carter-Glogau Laboratories of Glendale, Ariz., and its distributor O’Neal, Jones & Feldman Pharmaceuticals of Maryland Heights, Mo., are no longer in business. The attorney who representing the companies, said both stopped doing business about 20 years ago but that their liability insurance would pay the settlement.

Taylor said his clients were relieved to get a resolution.

One of the problems was that dosage instructions were unclear and the more doses an infant was given, the higher the probability of injury or death. Many children who received the supplement were not harmed most likely because they received a low dosage.

Indictments were handed down in 1987 for Carter-Glogau and its former president, Ronald M. Carter, along with the former president of O’Neal, Larry K. Hiland. They were convicted of conspiracy, marketing an unapproved drug and misbranding the drug. The company was fined $130,000 in 1989, and both executives were sentenced to 6 months in jail.

The drug has been controversial since its introduction by Eli Lilly and especially after the Japanese Health and Welfare Ministry as well as the Great Britain Medicines Control Agency issued emergency warnings due to numerous diabetes reports in 2002. A 2002 Duke University Zyprexa study also documented cases of diabetes, which were supported by numerous other studies. A class action Zyprexa lawsuit has now been filed against Eli Lilly on behalf of all Zyprexa users.

Eli Lilly is accused of promoting the drug Zyprexa as safe and effective for psychotic disorders while essentially concealing the known risks of side effects from both doctors and patients. In a recent lawsuit, the courts agreed with consumers and found that prior to 2003, Eli Lilly did not properly disclose the risks and known side effects of Zyprexa.

In September 2005 Eli Lilly and Co. finalized a settlement of $700 million in a lawsuit charging the pharmaceutical company of failing to disclose health risks in Zyprexa labeling. $690 million in settlement funds will be dispersed to the 8,000 plaintiffs.

Although steroids are considered safe for brief use to reduce inflammation, when taken for longer periods they can cause serious side effects like weight gain, fluid retention often visible in the face, sudden mood swings, muscle weakness, blurry vision, increased body hair, osteoporosis (bone weakening), high blood pressure, stomach irritation, and/or glaucoma. Consequently, NSAIDs are used to reduce inflammation if steroids can be avoided.

Vioxx works by preventing the formation of ‘inflammatory’ prostaglandins. These compounds are produced by the enzyme ‘cyclooxygenase 2′, commonly referred to as ‘Cox-2′, and are believed to cause pain and inflammation, as well as prevent blood cells from sticking together. Vioxx is part of a group of drugs known as Cox-2 inhibitors.

Unlike other NSAIDs, Vioxx does not also block a second enzyme, commonly called ‘Cox-1′, that monitors and maintains stomach tissue. Since this protects the stomach lining, Vioxx has been promoted as being able to reduce pain and inflammation without also causing ulcers and gastrointestinal bleeding.

In November 2000, the Vioxx Gastrointestinal Outcomes Research (VIGOR) study was published in the New England Journal of Medicine. The study compared approximately 4000 patients on 50 mg. of Vioxx per day (twice the highest approved dose) to approximately 4000 patients on the standard dose of Naprosyn (naproxen), an older NSAID. VIGOR was a one-year, ‘double-blind’ study, meaning that neither the patients nor the investigators knew who was getting which treatment. ‘Double-blind’ is considered the most impartial type of study. According to study results, Vioxx had a much lower incidence of digestive tract punctures, bleeding and/or blockages than naproxen.

However, another finding in the VIGOR study was that there was a higher incidence of cardiovascular problems in the Vioxx group than the naproxen group. The report concluded that the relationship between cardiovascular distress and the use of Vioxx was still unknown. This outcome surprised many heart experts, who then wanted more research done to assess the cardiac risk Vioxx posed.

Nonetheless, after reviewing the results of that study, the FDA agreed with the 2001 Arthritis Advisory Committee that the label for Vioxx should simply include information about possible cardiovascular complications. Also, it ruled that the warning about the risks of ulcers and gastrointestinal bleeding found on all NSAIDs should be modified, but not removed, from the label. Finally, in addition, the new label was to present comparison results showing that Vioxx was related to more incidences of high blood pressure than naproxen in studies of patients with rheumatoid arthritis.

Nonetheless, health concerns continued to arise regarding Vioxx. In June 2001, an article published in the medical journal The Lancet, reported on a woman who suffered kidney failure after taking Vioxx. While reversible, this incident raised questions about Vioxx’s effect on kidney cells.

In August 2001, Vioxx was linked in a study by researchers from The Cleveland Clinic to an increase in the risk of blood clots, heart attacks and strokes. Their study was published in the Journal of the American Medical Association and was based on a review and analysis of previous clinical trials.

Additional study results and articles continued to appear in medical journals, further supporting suspicions about Vioxx’s effect on the heart. In September 2001, the American Heart Association, the National Stroke Association and the Arthritis Foundation asked Merck to test whether Vioxx increased the risk of heart attack and stroke.

After it reviewed all of its Vioxx studies, Merck claimed there was no evidence that, in comparison with other NSAIDs, the drug increased the risk of heart problems. The company argued that Vioxx only appeared to increase the risk of a heart attack in the study because Naproxen thins the blood much like aspirin does, thus reducing heart attack risk. Merck maintains that Vioxx’s effect on the heart is minimal.

Meanwhile, because Vioxx and Pharmacia’s drug Celebrex are so similar chemically, both Merck and Pharmacia had tried to promote their drugs by emphasizing subtle differences between them. The FDA discovered that Merck was suggesting in promotional audio conferences that Vioxx and other Cox-2 inhibitors were safer than older NSAIDs. Also, Merck sales representatives were promoting Vioxx for unproven uses like cancer, Alzheimer’s disease and gout. Although both Celebrex and Vioxx are being studied for such applications, these claims have not yet been proven.

Upset that Merck was minimizing the potential safety risks of Vioxx and promoting it for unapproved uses, the FDA sent Merck a ‘Warning Letter’ dated September 17, 2001. The letter demanded that Merck discontinue promoting Vioxx to doctors for unofficial uses. It also required Merck to send letters about the deception to the medical community.

In April 2002, the FDA announced that it had added rheumatoid arthritis to the list of approved uses for Vioxx. It also presented the new labeling and warnings for Vioxx, based on the results of the VIGOR study.

Available patient information about Vioxx, derived from FDA-approved labeling, states that it can cause discomfort and may cause gastrointestinal bleeding, despite studies to the contrary. The labeling does acknowledge that while very rare, gastrointestinal bleeding may result in hospitalization and even death. Also, since serious ulceration and bleeding can develop with little or no symptoms, patients should be especially alert for anything that indicates gastrointestinal problems, and should seek medical treatment immediately.

In addition, patients should promptly report skin rash, unexplained weight gain, or excessive fluid and swelling in the body’s tissues, called ‘edema’ to their physicians. Patients should also be wary of any warning signs of liver damage such as nausea, fatigue, unexplained itching, jaundice, tenderness in the body’s upper right side, and flu-like symptoms. In late pregnancy, Vioxx should be avoided because it may cause problems with a baby’s blood circulation.

Merck & Co. voluntarily ceased worldwide Vioxx sales on September 30, 2004, citing risks of heart attack and stroke.

While all medications have certain, anticipated side effects, a drug manufacturer has a duty to inform physicians adequately regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a product liability theory. Drug manufacturers can also be held liable for injuries to consumers based on theories of negligence, or even intentional or malicious conduct.

If you have taken Vioxx and experienced any unusual side effects, you should contact your physician at once. In addition, you should contact an attorney experienced in product liability litigation to discuss potential legal claims you might have, which could allow you to recover for the harm Vioxx has caused you.

To qualify for benefits, Class Members must prove that they were implanted with one of the hip or knee replacements involved in the Settlement. These products include specific hip replacements known as an Inter-Op™ Acetabular Shell and specific knee replacements known as a Natural Knee II® Tibial Baseplate. Class Members must submit Claim Forms and medical records proving that they were implanted with the specific products, known as “Affected Products” and that they otherwise meet the criteria spelled out in the Settlement Agreement necessary to receive a payment. The range of benefits depends on whether the Class
Member can prove implantation of an Affected Product, whether the Affected Product has been removed and replaced in a subsequent surgery, and whether there have been further medical complications arising from the surgery or condition.

“Today’s payment is a tribute to Judge O’Malley’s hard work in approving a Settlement that provided compensation quickly and fairly to deserving claimants,” said Eric Kennedy, lead Class Counsel with Weisman, Goldberg & Weisman Co., in Cleveland. “Claimants getting paid today have worked hard to complete their claim forms and send in all of the necessary paperwork to allow the Claims Administrator to issue a determination that they are qualified for benefits.”

The Settlement Agreement contains specific deadlines by which Claimants must act to file their Claims. For further information, contact the office of the Claims Administrator at (800) 683-1861.

The new label required by the FDA includes the following:
Cases of life-threatening hepatic failure have been reported in patients treated with SERZONE. . . . This represents a rate of about 3-4 times the estimated background rate of liver failure. This rate is an underestimate because of under reporting, and the true risk could be considerably greater than this.

It was only after the government’s forced Black Box Warning that Bristol-Myers Squibb told physicians and other health care providers that Serzone could cause liver failure and death. According to the manufacturer and the government, the side effects of Serzone include jaundice (yellowing of the skin and eyes), dark colored urine, loss of appetite, abdominal pain, and physical discomfort or uneasiness.

Serzone is administered in tablet form, in dosages of 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg. Sales of Serzone were $409 million worldwide in 2001. Other common Serzone side effects include headache, constipation, dry mouth, drowsiness, insomnia, nausea, vision problems, agitation, dizziness, fatigue, confusion, hypotension, rash or hives, seizures, and lightheadedness. In a study performed on Serzone prior to the marketing of the drug found 16% of the 3,496 patients taking Serzone discontinued their use due to side effects.

Serzone, once considered to be an alternative to other SSRI antidepressant drugs, has been withdrawn voluntarily by the manufacturer from all countries except Australia and the United States. Australians are warned of the potential for severe liver injury from using Serzone and in the US, Serzone carries a black box warning advising patients that possibly life-threatening liver failure can occur with the use of the drug. The drug, sold under the name Serzone by Bristol-Myers Squibb is known generically nefazodone.

On May 19, 2004, the company announced that it would withdraw Serzone from the US market next month, blaming a decline in sales rather than the risks of liver damage.

Several lawsuits are pending against both Bristol-Myers Squibb and the U.S. Food and Drug Administration (FDA). Serzone will remain available as a generic medication (Nefazodone), and  attorneys report that they will continue their suits against the FDA until the drug is banned from the market entirely.

The reported rate of liver failure in the United States is about 1 case resulting in death or transplant per 250,000 – 300,000 patient-years of Serzone treatment. The dozens of deaths resulting from Serzone use has prompted Serzone lawsuits to be filed by family members. Serzone deaths continue despite the black box warnings because it’s impossible to tell which patients will get liver damage from Serzone. While a given patient has a very low risk of liver failure, those who do get liver failure may not see any warning signs until it’s too late.

Rezulin was approved for use in the U.S. in January, 1997 after ‘fast-track’ approval by the FDA. The first medical examiner for the FDA who investigated the drug concluded that it was too dangerous to approve. He was stripped of the assignment, and his report was purged from agency files and withheld from an FDA advisory committee.

Finally, on March 21, 2000, Rezulin was withdrawn from the U.S. market. The FDA has estimated that two million people used Rezulin.

When Rezulin was approved, the manufacturer’s chief executive told investors he saw it as a ‘billion-dollar blockbuster.’ In fact, in three years on the market, Rezulin generated more than $2 billion in sales.

A variety of lawsuits have been filed against Janssen Pharmaceutica and Johnson & Johnson over the effects of Propulsid.

There are four different hormone formulations used in these type of drugs: estrogen only, progestin only, an estrogen/progestin combination, and an estrogen/testosterone combination. Estrogen and progesterone are female hormones produced by a woman’s body. Progestin is a synthetic version of progesterone. Women’s bodies also produce a small amount of the male hormone testosterone.

The Prempro results came from a five-year-long study on the effects of hormone replacement therapy. The study was scheduled to run another three years, but investigators abruptly ended the study after they determined that the results are so negative.

Studies have reported that taking PPA increases the risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk.

Although the risk of hemorrhagic stroke is very low, FDA recommends that consumers not use any products that contain PPA.

If you have experienced a stroke and have taken a drug containing PPA you may have a claim.

Congenital malformations are physical defects present at birth and may involve the brain, heart, lungs, liver, bones, or intestinal tract. Congenital malformations are currently the leading cause of infant deaths in the U.S.

Paxil, an antidepressant drug, is used by millions of people worldwide and generates more than $1 billion toward GlaxoSmithKline’s annual sales. Paxil has previously been in the news for complaints of severe withdrawal symptoms as well as risks of suicidal behavior and increased violence in children and adolescents. Paxil is known as a Selective Serotonin Reuptake Inhibitor (SSRI) similar to Prozac, Zoloft, Celexa and Lexapro.

The FDA warned physicians to carefully weigh the potential risks and benefits of prescribing or renewing Paxil prescriptions to women during pregnancy or while breast-feeding. It is important that all patients are aware of the side effects, risks, and treatment alternatives.