Missouri Injury Lawyer Blog

The Associated Press reported yesterday that eight lawsuits have been filed against Bayer AG over the controversial blood-clotting drug Trasylol.

The suits were filed in Florida federal court by attorneys with the St. Louis-based law firms Carey & Danis and The Lowe Law Firm. Brought on behalf of Trasylol (aprotinin) victims and their families, the suits allege that Bayer sold an unsafe drug and failed to warn of the risks associated with its use.

The AP story noted that several studies have documented the dangers associated with Trasylol.

The lawyers of The Lowe Law Firm are experienced in helping people injured by Trasylol. 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 at the hospital or your home.

Eight lawsuits alleging that the anti-bleeding drug Trasylol also known by it generic name aprotinin have been filed in a federal court in Miami, Fla., against Bayer AG.

The lawsuits were filed April 17 on behalf of alleged Trasylol victims and their families for injuries and deaths that occurred in California, Georgia, Indiana, Florida, Missouri, New Mexico and Wisconsin between 2000 and 2007. Specifically, the suits allege that:

On April 27, 2000, Nada McIntosh was given Trasylol during open-heart surgery at St. Mary’s Medical Center in Madison, Wis. Soon after the surgery, kidney failure developed, and McIntosh died on May 8, 2000. Suit was filed on behalf of her next of kin, Sandra Boxrud.

• On May 29, 2002, Nina Roberts was given Trasylol during open-heart surgery at Orlando Regional Medical Center, in Orlando, Fla. Shortly after surgery, she experienced kidney failure and underwent dialysis. Suit was filed on her behalf.

• On July 7, 2004, Ruthe Sherman was given Trasylol during open-heart surgery at the University of California at Los Angeles Medical Center. The day after surgery, she experienced kidney failure and underwent dialysis. She died on Aug. 2, 2004. Suit was filed on behalf of her children Judy Sherman and Robert Sherman.

• On Dec. 16, 2005, Samuel Nakis was given Trasylol during open-heart surgery at St. Luke’s Hospital in Chesterfield, Mo. Shortly after the surgery, kidney failure developed, and Nakis underwent dialysis. He died a short time later. Suit was filed on behalf of his widow, Genevieve Nakis.

• On June 19, 2006, Dorothy Gallipeau was given Trasylol during open-heart surgery at Hoag Memorial Hospital Presbyterian, in Newport Beach, Calif. She experienced kidney failure the day after surgery and died less than a week later. Suit was filed on behalf of her son Shawn Gallipeau.

• On Oct. 19, 2006, Richard Clark was given Trasylol during open-heart surgery at Presbyterian Hospital in Albuquerque. Soon after surgery he experienced kidney failure. Clark died the day after surgery. Suit was filed on behalf of his widow, Karla Clark.

• On Feb. 6, 2007, James McLendon was given Trasylol during surgery to replace a heart valve at Atlanta’s Emory Crawford Long Hospital. Shortly after the surgery, kidney failure developed. McLendon died a week after surgery. Suit was filed on behalf of his widow, Kathy McLendon.

• On July 3, 2007, Marcia Moyer was given Trasylol during open-heart surgery at The Indiana Heart Hospital, in Indianapolis. Soon after surgery, kidney failure developed, and Moyer must now undergo dialysis. Suit was filed on her behalf.
The suits were filed in the U.S. District Court for the Southern District of Florida, pursuant to a transfer order issued by the United States Judicial Panel on Multidistrict Litigation. The plaintiffs are represented by St. Louis lawyers John J. Carey of Carey & Danis and Jeffrey J. Lowe of The Lowe Law Firm.

The suits claim that Bayer failed to warn prescribers and consumers of the dangers associated with the drug, defectively designed the drug, fraudulently concealed the dangers of the drug, breached the implied and express warranties and violated various state laws. The plaintiffs seek compensatory damages and damages for aggravating circumstances.

The U.S. Food and Drug Administration approved Trasylol (also known as aprotinin), a clotting drug used to prevent bleeding, in 1993. On Jan. 20, 2006, an article suggesting a link between Trasylol and renal toxicity was published in the medical journal Transfusion. Later that same month, the New England Journal of Medicine published an article, co-authored by Dr. Dennis Mangano of the nonprofit Ischemia Research and Education Foundation, linking Trasylol to a higher risk of stroke, heart attack and kidney failure.

In the fall of 2006, an FDA advisory board met to decide whether the warning on Trasylol needed to be changed. At the meeting, Bayer failed to disclose the findings of a Trasylol study it had funded. In that study, Dr. Alexander Walker—a professor at the Harvard School of Public Health—reviewed the hospital records of 67,000 patients and found that those given Trasylol had a risk of death 64 percent higher than that of patients who received a comparison drug. It wasn’t until November 2007 that the drug was finally pulled from the market.

On Feb. 21, the New England Journal of Medicine released the study by Walker and a second study, conducted by Duke University Medical Center researchers. Both showed that patients given Trasylol during heart surgery were more likely to die than patients given a comparable drug.

The federal lawsuits filed against Bayer AG over the anti-bleeding drug Trasylol have been consolidated and transferred to a Miami federal court.

On April 7, the transfer order was issued by the United States Judicial Panel on Multidistrict Litigation. Because of the national scope of the litigation, the common factual questions regarding the drug’s safety profile, and the similar questions raised over the adequacy of the warnings provided by Bayer, the panel concluded that consolidation was appropriate.

In addition, the panel ruled that the U.S. District Court for the Southern District of Florida is a convenient forum. The Miami metropolitan area is easily accessible and the district has a low number of MDL dockets, the panel wrote. It assigned the litigation to U.S. District Court Judge Donald M. Middlebrooks.

On March 10, John J. Carey of Carey & Danis and Jeffrey J. Lowe of The Lowe Law Firm filed suit in the U.S. District Court for the Eastern District of Missouri on behalf of a widow whose husband died of kidney failure after open-heart surgery.

On Dec. 16, 2005, Samuel Nakis, 81, underwent open-heart surgery at St. Luke’s Hospital in Chesterfield, Mo. During the surgery he was given Trasylol (also known as aprotinin), a clotting drug used to prevent bleeding. Shortly after the surgery, Nakis experienced kidney failure and underwent dialysis. He died a short time later.

The suit alleges that Bayer failed to warn prescribers and consumers of the dangers associated with the drug, defectively designed the drug, fraudulently concealed the dangers of the drug, breached the implied and express warranties and violated the Missouri Merchandising Practices Act. The suit seeks compensatory damages and damages for aggravating circumstances.

The lawyers of The Lowe Law Firm are experienced in helping people injured by Trasylol. 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 at the hospital or your home.

Trasylol also known as Aprotinin was recalled by Bayer in November 2007. Trasylol is a drug used to reduce the risk of post operative bleeding. Two more Trasylol studies have concluded that patients are more likely to die if treated with the defective drug. Trasylol, manufactured by Bayer AG, was the subject of an FDA Advisory Committee Safety Review that held its hearings in September 2006.

Prior to this hearing Bayer retained a professor to conduct a study to refute an earlier study that raised concerns of Trasylol's safety, especially in regard to caused renal or kidney failure. Instead of informing the FDA Advisory Committee of the results of the study Bayer failed to make any mention of it to conceal that the study it funded also questioned the safety profile of Trasylol.

Bayer evenrtuall suspended sales of Trasylol at the request of the FDA after Canadian health officials halted a portion of a clinical trial after it was determined that patients in the study treated with Trasylol where more likely to die.

Trasylol was approved in 1993, and was used to prevent bleeding during open heart surgeries. Since its approval, about a third of all heart surgery patients in the US have been treated with Trasylol. In December 2006, following the September meeting, the FDA updated the Trasylol label to include a black box warning - the agency’s strictest safety notice - stating that the drug placed patients at a high risk of kidney failure and death. The black box warning also cautioned that the use of Trasylol should be reserved only for patients who were at risk for significant blood loss during bypass surgeries.

Another FDA advisory panel that met in September 2007 agreed with the assessment that Trasylol had a high risk of causing serious side-effects, and it recommended that Trasylol undergo further clinical testing. However, the FDA panel also voted that Trasylol should stay on the market. Then in November, the Canadian Data Safety Monitoring Board had stopped a Trasylol trial - known as the BART clinical study - after a data analysis indicated that the 30-day mortality risk in the study’s Trasylol patients was nearing “statistical significance”. Following the revelations over the Canadian Trasylol study, Bayer suspended sales of the drug in the US, Canada and Germany.

Now two more studies have added to fears that Trasylol is dangerous. Bayer funded one of the two new studies, and had the preliminary results ready before the September 2006 federal hearing on the drug’s safety, but did not present them at the meeting. Bayer has defended its actions by saying the study results at the time where only preliminary and the study itself was flawed. The Bayer study looked at more than 78,000 patients nationwide in a period from January 1, 2003 to March 31, 2006. After adjusting for other factors, the researchers found the risk of death after surgery was 64 percent higher in the Trasylol group than in those taking a comparison drug.

The second Trasylol study looked at more than 10,000 patients who had bypass surgeries at Duke University Medical Center from 1996 through 2005. It found that 6.4 percent of patients who were given Trasylol died within 30 days of the surgery, a rate nearly 2½ times higher than patients who got another drug or who received no treatment for excessive bleeding. At one year after surgery, almost 16 percent of Trasylol patients had died — again, roughly 2½ times higher than the other two patient groups.

A spokesperson for the consumer advocacy group Public Citizen told the Associated Press that the latest Trayslol studies are convincing confirmation of the drug’s dangers. “I just don’t know how much further evidence you need,” said Dr. Sidney Wolfe. Wolfe added that federal health officials should pursue criminal charges against Bayer for withholding information from its own study from the FDA panel in 2006.

The lawyers of The Lowe Law Firm are experienced in helping people injured by Trasylol. 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 at the hospital or your home.

As a lawyer who handles medical malpractice cases in Illinois, Missouri as well as many other states, I was surprised by the new study which concluded that medicine mix-ups, overdoses and adverse drug reactions hurts one out of every 15 hospitalized children, the Associated Press reports.

The study, which appears in the April issue of the journal Pediatrics, shows that previous error estimates were much too low. To expose the alarming rate of mistakes, researchers shied away from the voluntary reports of hospital staff. Instead, they developed a methodology that outlined 15 specific triggers that could signal a drug-related error.

The triggers included the use of the drug naloxone, an antidote for the overdose of morphine and other painkillers; the use of vitamin K, used as an antidote for an overdose of the blood thinner Coumadin; and the use of two different lab tests, one that detects insulin overdoses and another that detects heparin overdoses.

Actor Dennis Quaid’s newborn twins received life-threatening doses of heparin last November. The babies eventually recovered. In response to the harrowing event, Quaid and his wife formed a foundation to prevent medical errors. His advice to parents of hospitalized kids:

“Every time a caregiver comes into the room, I would check and ask the nurse what they’re giving them and why.”

Quaid’s experience and the new study make clear that adults aren’t the only ones hurt by preventable medical mistakes. When avoidable mistakes are made, the medical profession should be held accountable.

The lawyers of The Lowe Law Firm are experienced in helping people injured by medical malpractice. 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 of medical malpractice. If you cannot make it to our office, we will come to you at the hospital or your home.

Trasylol also known as Aproptinin was recalled in November 2007 after it was linked to kidney damage which is also referred to as renal failure. My law firm represents over fifty plaintiffs who have suffered renal failure after being given Trasylol during cardiac artery bypass surgery. Below is a time line for the events leading to its recall

Dec. 30, 1993 – Aprotinin (Trasylol) Receives FDA Approval

The Food and Drug Administration announces the approval of Trasylol (Aprotinin). The drug is used to control excess bleeding in bypass heart surgery patients but the FDA also states that Trasylol should be reserved for heart surgery patients with a high risk of excessive bleeding. The FDA notes that kidney toxicity was reported as a problem in some patients during clinical trials.

Jan. 20, 2006 – Trasylol (Aprotinin) Associated With Renal Toxicity

A study is published in the medical journal Transfusion by Keyvan Karkouti and several other researchers suggesting that there is a link between Aprotinin and kidney problems among cardiopulmonary bypass patients.

Jan. 26, 2006 – Risks Associated with Aprotinin (Trasylol) in Cardiac Surgery

The New England Journal of Medicine publishes an article by Dennis Mangano and several other researchers with the Multicenter Study of Perioperative Ischemia Research Group and the Ischemia Research and Education Foundation. The researchers find a link between Trasylol and serious kidney problems and heart attacks. The study finds that patients who were given Aprotinin were more than twice as likely to have kidney failure requiring dialysis, a 55 percent increase of heart failure and a 181 percent increase in stroke. The authors advise against further use of the drug, since safer, cheaper alternatives are available.

Feb. 8, 2006 – FDA Public Health Advisory

Following two studies associating the use of Trasylol (Aprotinin) with increased risk of kidney failure, heart and central nervous problems after heart surgery, the FDA issues a public health advisory. The FDA recommends limiting Trasylol use to those situations where the clinical benefit of reduced blood loss outweighs the potential risks.

Sept. 21, 2006 –Cardiovascular and Renal Drugs Advisory Committee
The FDA holds a public meeting to discuss the safety of Trasylol. The committee effectively endorses the safety of Trasylol.

Sept. 27, 2006 – Additional Study Revealed by Bayer
Bayer reveals to the FDA that it had conducted an additional Trasylol safety study. The study of a 67,000-patient database shows use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes. The study was not disclosed to the FDA committee that met only the week before to discuss the drug’s safety. The failure of Bayer to disclose the data ignites a furor within the FDA.

Sept. 29, 2006 – FDA Public Health Advisory

The FDA announces that Bayer failed to disclose a Trasylol study prior to the Sept. 21, 2006 public meeting held to discuss the drug’s safety. The FDA warns doctors who administer Trasylol to carefully monitor their patients for any adverse events, in particular, problems with the kidneys, brain or heart. Physicians treating Trasylol patients are also encouraged to report any Trasylol problems to the FDA or Bayer Pharmaceuticals.

Oct. 13, 2006 – Bayer Suspends Employees over Trasylol Study

Following the failure to disclose the Trasylol safety study, Bayer suspends two employees who are members of the Germany Drug Safety Group.

The Federal Drug Administration begins a review of Trasylol after two published studies associated the drug with serious side effects including kidney damage, heart attacks, and stroke.

Dec. 15 2006 – FDA Revises Trasylol Labeling and Strengthens Safety Warnings

Following a review of safety information, the FDA strengthens Trasylol’s warning label. The label advises physicians that the drug increases the possible risk for kidney damage.

Nov. 5, 2007 – Bayer Agrees to Suspend Trasylol Marketing

Bayer agrees to suspend the marketing of Trasylol until a review of the preliminary results of a Canadian study is completed.

Feb. 21, 2008 – Two Studies in NEJM Confirm Trasylol Increases Risk of Death
The New England Journal of Medicine releases the Bayer-funded study and a second study conducted by Duke University Medical Center researchers. Both confirmed that patients given Trasylol during heart surgery were more likely to die than patients given a comparable drug.

The lawyers of The Lowe Law Firm are experienced in helping people injured by Trasylol. 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 at the hospital or your home.

Celebrex is risky choice for patients with heart problems,. According to a recently released study, the pain reliever increases the odds that people with heart problems will suffer a heart attack or stroke.

The study of the Pfizer-made drug was supported by the National Cancer Institute. It analyzed six studies conducted of 7,950 patients. Citing the Wall Street Journal, Reuters reported that researchers found that Celebrex “was associated with an increased risk of cardiovascular death, heart attack, stroke, heart failure or thromboembolic event, or events related to blood clots, compared to patients not taking the drug.”

Moreover, patients who received 400 milligrams of Celebrex twice a day had a three times higher risk of heart attacks and strokes compared with patients who had not taken the drug. Patients who were only given the 400 milligram dosage once a day had a 10 percent higher risk of a cardiovascular event.

Celebrex belongs to a class of drugs known as COX-2 inhibitors. Vioxx, also a COX-2 inhibitor, was removed from the market in 2004 after it was linked to heart attacks and sudden cardiac deaths. Another COX-2 inhibitor, Bextra, was also pulled from the market.

The lawyers of The Lowe Law Firm are experienced in helping people injured by a dangerous prescription drug. 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 of dangerous medications. If you cannot make it to our office, we will come to you at the hospital or your home.

Contact the lawyers at The Lowe Law Firm today by calling 877-678-3400.

A lawsuit has been filed in a St. Louis federal court against Bayer AG, the maker of the anti-bleeding drug Trasylol, on behalf of a widow whose husband died of kidney failure after open-heart surgery.

On Dec. 16, 2005, Samuel Nakis, 81, underwent open-heart surgery at St. Luke’s Hospital in Chesterfield, Mo. During the surgery he was given Trasylol (also known as aprotinin), a clotting drug used to prevent bleeding. Shortly after the surgery, Nakis experienced kidney failure and underwent dialysis. He died a short time later.

The U.S. Food and Drug Administration approved Trasylol in 1993. On Jan. 20, 2006, the medical journal Transfusion published an article suggesting a link between Trasylol and renal toxicity. Later that same month, the New England Journal of Medicine published an article, by Dr. Dennis Mangano of the nonprofit Ischemia Research and Education Foundation, linking Trasylol to a higher risk of stroke, heart attack and kidney failure.

In the fall of 2006, an FDA advisory board met to decide whether the warning on Trasylol needed to be changed. At the meeting, Bayer failed to disclose the findings of a Trasylol study it had funded. That study, conducted by Dr. Alexander Walker, a professor at the Harvard School of Public Health, reviewed the hospital records of 67,000 patients and found that those given Trasylol had a risk of death 64 percent higher than that of patients who received a comparison drug. It wasn’t until November 2007 that the drug was finally pulled from the market.

On Feb. 21, the New England Journal of Medicine released the study conducted by Walker and a second study conducted by Duke University Medical Center researchers. Both confirmed that patients given Trasylol during heart surgery were more likely to die than patients given a comparable drug.

A lawsuit was filed by Nakis’ widow, Genevieve Nakis, on March 10 in the U.S. District Court for the Eastern District of Missouri. She is represented by John J. Carey of Carey & Danis and Jeffrey J. Lowe of The Lowe Law Firm.

The suit alleges that Bayer failed to warn prescribers and consumers of the dangers associated with the drug, defectively designed the drug, fraudulently concealed the dangers of the drug, breached the implied and express warranties and violated the Missouri Merchandising Practices Act. The suit seeks compensatory damages and damages for aggravating circumstances.

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Media Contact: Geri L. Dreiling
Legal Media Matters LLC
314.743.3851 or 314.520.3897
legalmediamatters@sbcglobal.net

Wyeth and Pfizer must pay more than $27 million in punitive damages to a woman who claimed her breast cancer was linked to the menopause drugs they made, the Wall Street Journal reports.

The award was made last Thursday by a federal jury in Little Rock, Ark. The same jury previously awarded the woman, Donna Scroggins, $2.75 million in compensatory damages for the hormone replacement drugs Premarin, Prempro and Provera.

In making the punitive damages award, the jury concluded that Wyeth and Pfizer’s Pharmacia & Upjohn acted with “reckless disregard” when it came to the health risks posed by the hormone replacement drugs. Wyeth was ordered to pay $19.4 million in punitive damages to Scroggins. Pfizer was ordered to pay more than $7.8 million.

The companies said they would appeal the ruling.

The lawyers of The Lowe Law Firm are experienced in helping people injured by a dangerous prescription drug. 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 of dangerous medications. If you cannot make it to our office, we will come to you at the hospital or your home.

Contact the lawyers at The Lowe Law Firm today by calling 877-678-3400.

The Safety of Trasylol was put at issue by Doctors from Duke University Medical Center who played high-profile roles in the debate over the safety of the anti-bleeding drug Trasylol, Pharmalot notes.

Duke’s chief of thoracic and cardiovascular surgery, Dr. Peter Smith, is a consultant for Bayer AG, the company that makes Trasylol. Last fall, Smith appeared before an FDA advisory committee and testified that the drug is safe and effective.

However, 11 of Smith’s colleagues who work in the anesthesiology and surgery departments co-authored the recent study that concluded patients given Trasylol were 2.5 times more likely to die than those given a rival drug.

The lawyers of The Lowe Law Firm are experienced in helping people injured by a dangerous prescription drug. 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 of dangerous medications. If you cannot make it to our office, we will come to you at the hospital or your home.

Contact the lawyers at The Lowe Law Firm today by calling 877-678-3400.

Trasylol is a drug manufactured by the German Pharmaceutical company Bayer. It was typically used during heart bypass surgey to prevent bleeding. Recently, two studies were released that linked Trasylol to higher risks of death and kidney disease. Bayer AG, the maker of Trasylol, claims those studies are flawed.

The two studies were released on Feb. 21 in the New England Journal of Medicine. As I noted in a previous entry, a study of 10,000 bypass patients at Duke University Medical Center found that 6.4 percent of the patients who were given Trasylol died within 30 days of surgery. That rate was nearly 2.5 times higher than patients who received a different drug or no anti-bleeding treatment.

The second study looked at 78,000 patients nationwide and found that the risk among patients given Trasylol was 64 percent higher than in those taking a different drug.

Bayer funded the second study -- one of the two it now claims is flawed. But Public Citizen’s Health Research Group disagrees. An article in LawyersandSettlements.com notes that the consumer advocacy group believes the studies are convincing. The article also notes that the studies were rigorous enough for the editors of the New England Journal of Medicine.

The two latest studies are convincing. They are also consistent with the findings of Dr. Dennis Mangano of the Ischemia Research and Educational Foundation and a Canadian study that was halted because of deaths among Trasylol patients.

The lawyers of The Lowe Law Firm are experienced in helping people injured by a dangerous prescription drug. 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 of dangerous medications. If you cannot make it to our office, we will come to you at the hospital or your home.

Contact the lawyers at The Lowe Law Firm today by calling 877-678-3400.

Trasylol the anti-bleeding drug used during heart surgery is more likely to cause patients to die, according to two new studies published last week in The New England Journal of Medicine.

The first study involved 10,000 patients who had bypasses at Duke University Medical Center from 1996 through 2005. It found that 6.4 percent of patients who were given Trasylol died within 30 days of the surgery, a rate nearly 2.5 times higher than patients who got another drug or who received no treatment for bleeding.

The second study looked at about 78,000 patients nationwide from 2003 to 2006. Researchers found the risk of death was 64 percent higher in the Trasylol group than in those taking another drug.

Made by Bayer, Trasylol received approval from the Food and Drug Administration in 1993. Last year, a Canadian study was stopped because of deaths among patients taking Trasylol. Reacting to the reports of higher deaths and the increased risk of serious kidney damage, the FDA requested that it be taken off the market last November.

The lawyers of The Lowe Law Firm are experienced in helping people injured by a dangerous prescription drug. 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 of dangerous medications. If you cannot make it to our office, we will come to you at the hospital or your home.

Contact the lawyers at The Lowe Law Firm today by calling 877-678-3400.

The manufacturers of hormone replacement drugs lost their second case regarding the allegations that their drugs Premarin, Prempro, and Provera caused breast cancer. A federal jury awarded $2.75 million in actual damages to a woman who alleged her breast cancer was caused by hormone replacement drugs, Bloomberg News reports.

The suit was filed against Wyeth and a unit of Pfizer. The verdict is the first federal-court defeat for the two companies that make menopause drugs.

The plaintiff, Donna Scroggins, took a combination of hormone replacement drugs for ten years to ease her menopause symptoms such as hot flashes, night sweats and mood swings. She eventually developed breast cancer and underwent a double mastectomy.

In 2002, the Women’s Health Initiative study found that women who took a combination of estrogen and progestin hormones to relieve menopause symptoms increased their risk of invasive breast cancer by 24 percent.

Upjohn, a Pfizer unit, manufactures the progestin drug Provera. Wyeth makes the estrogen drug Premarin and Prempro, a drug that combines estrogen and progestin.

The federal jury in Little Rock, Arkansas that handed down the award is not done with Scroggins’ case. On March 3, jurors will hear evidence on whether the two companies handling of the drugs merits a punitive damages award.

The lawyers of The Lowe Law Firm are experienced in helping people injured by a dangerous prescription drug. 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 of dangerous medications. If you cannot make it to our office, we will come to you at the hospital or your home.

Contact the lawyers at The Lowe Law Firm today by calling 877-678-3400.

Over the course of five days, two fentanyl patches have been recalled because of defects that could lead to respiratory depression and fatal overdoses.

The first recall was announced on Feb. 12 and covers Duragesic pain patches. Made Ortho-McNeil-Jannssen Pharmaceuticals, a unit of Johnson & Johnson, Duragesic is a powerful opioid drug used to treat moderate to severe chronic pain. The recall impacts the 25 mcg/hr fentanyl patches that have expiration dates on or before December 2009. The recall was prompted by concerns that the patch may have a cut along one side of the drug reservoir which could expose patients or caregivers directly to the dangerous gel. The same recall also covers generic patches sold by Novartis AG's Sandoz unit.

The second fentanyl patch recall was announced on Feb. 17. It applies to 14 lots of fentanyl patches sold in the United States by Actavis South Atlantic, formerly known as Abrika Pharmaceuticals. The pain patches may have a fold-over defect that could cause the patch to leak and expose patients and caregivers directly to the dangerous gel.

This past summer, juries in Florida and Texas concluded that leaking fentanyl patches made by Johnson & Johnson led to the deaths of at least two people.

The lawyers of The Lowe Law Firm are experienced in helping people injured by a dangerous prescription drug. 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 of dangerous medications. If you cannot make it to our office, we will come to you at the hospital or your home.

Contact the lawyers at The Lowe Law Firm today by calling 877-678-3400.

Colchicine is a drug used to treat gout which frequently results in inflammation of the joints in the fingers and toes. Last week, the U.S. Food and Drug Administration announced it would go after companies marketing unapproved uses for the injectable gout drug, Colchicine.

Colchicine is a highly toxic drug that can easily be administered in excessive, toxic doses. The FDA indicated that it has received 50 reports of adverse events associated with the use of the drug, including 23 deaths. Potentially fatal effects include low blood cell counts, cardiac events, and organ failure.

Injectable colchicine is sometimes used to treat back pain. Three of the reported deaths occurred in March and April of 2007 and were associated with the use of compounded colchicine that, due to an error in preparation, was eight times more potent than the amount stated on the label. The FDA has not approved colchicine for the treatment of back pain.

The enforcement action means that individuals and companies must stop making the product within 30 days and stop shipping the product within 180 days or face regulatory action which could include seizure, injunction or other legal action deemed appropriate by the agency.

The FDA’s action does not affect tablet form colchicine which is frequently used to prevent gout attacks.

The lawyers of The Lowe Law Firm are experienced in helping people injured by a dangerous prescription drug. 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 of dangerous medications. If you cannot make it to our office, we will come to you at the hospital or your home.

Contact the lawyers at The Lowe Law Firm today by calling 877-678-3400.

Lawsuits against Davol, the maker of the Kugel Mesh Hernia Patch, was expanded to include other hernia patches made by the company.

On Jan. 10, U.S. District Court Judge Mary M. Lisi ruled that a lawsuit alleging the Davol-made Composix EX Mesh Patch was defective could proceed as part of the Kugel Mesh Hernia Patch multi-district litigation pending in Rhode Island. In her ruling, Lisi noted that both hernia patches involved the interplay of three elements: the polypropylene mesh, an expanded polytetrafluoroethylene layer, and a memory recoil ring.

The Davol hernia patches made news in 2005 when the U.S. Food and Drug Administration recalled the Kugel Mesh Patch after it was discovered that the memory coil can break, leading to serious injuries such as bowel perforations. The FDA subsequently expanded the recall to include certain Bard, Composix and Kugel patches.

The FDA also warned patients who had the device implanted to seek immediate medical attention if they experienced unexplained or persistent abdominal pain, fever or tenderness at the implant site.

The lawyers of The Lowe Law Firm are experienced in helping people injured by a dangerous medical device. 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 of dangerous medications. If you cannot make it to our office, we will come to you at the hospital or your home.

Contact the lawyers at The Lowe Law Firm today by calling 877-678-3400.

A study conducted by the Boston Collaborative Drug Surveillance Program confirms that the birth control patch Ortho Evra Contraceptive Transdermal (Skin) Patch increases the risk of developing serious blood clots.

Ortho Evra is a birth conrtrol patch manufactured by Johnson and Johnson, and has been linked to blood clots known as deep vein thrombosis or DVT's, as well as pulmonary embolisms which if untreated can be fatal. On Jan. 18, the U.S. Food and Drug Administration approved changes to the drug’s label to include the results of the study.

Ortho Evra releases an estrogen hormone, ethinyl estradiol, and a progrestin hormone, norelgestromin, into the bloodstream through the skin. Because the body processes the hormones through the skin different than the hormones from birth control pills, women are exposed to about 60 percent more estrogen.

An earlier study conducted by i3 Ingenix, showed that women who use the patch were twice as likely to develop serious blood clots, also known as venous thromboembolisms (VTE), as women who take oral contraceptives. If the VTE travels to the lungs and triggers a pulmonary embolism, it can kill. The BCDSP study, which looked at women aged 15 to 44, supported the i3 Ingenix findings.

Ortho Evra is made by Ortho McNeil Pharmaceuticals, a Johnson and Johnson division. According to Bloomberg News, the company has been sued by more than 1,500 women who alleged they suffered strokes or blood clots in their lungs or legs after using the patch. Last October, Bloomberg News reported that the company agreed to pay $1.25 million to settle a suit filed by the family of a 14-year-old girl who died after she developed two blood clots in her lungs.

There’s more. Last fall, a New Jersey judge also made public a letter from a former Johnson & Johnson executive who alleged that the company improperly downplayed the risks associated with the Ortho Evra patch. The author of the letter said that he had investigated an “unusually high number” of blood clots and indicated that more than 20 deaths had been linked to the patch, according to an article in Bloomberg News.

A prescription drug that raises the risk of strokes and deadly blood clots is disturbing. The suggestion that the company misrepresented the risks of the patch to the public of a potentially fatal illness under most circumstance would be unbelievable. But with the examples of Vioxx, Bextra, Fen Phen, Baycol, Reszulin, Zyprexa and many more, drug companies ignoring or hiding risks in order to keep a block buster drug on the market to keep making profits instead of withdrawing the drug to keep patients safe appears to be the norm and not the exception. As a lawyer who practices in the area of pharmaceutical liability, I don't find the fact that a drug company hid the fact that healthy young women were dying from strokes and blood clots after using the Ortho Evra patch surprising. If you took Ortho Evra and had a stroke or pulmonary embolism and would like more information regarding whether you have a case against Johnson and Johnson, please contact Jeffrey J. Lowe at 877-678-3400.

After a two-year wait, the makers of the cholesterol drug Vytorin finally released the results of a study that showed the drug is no better than the generic for reducing plaque buildup in the carotid arteries. In fact, Vytorin did slightly worse. And Vytorin is ten times more expensive than the generic alternative.

Vytorin combines the cholesterol drug Zetia and generic statin drugs. It is jointly marketed by Merck and Schering-Plough. The results were released from a study known as the ENHANCE trial which ended nearly two years ago.

In an interview with WebMD, Dr. Steven E. Nissen, a cardiologist, chair of cardiovascular medicine at the Cleveland Clinic, and past president of the American College of Cardiology, called the findings a “stunning reversal for Zetia and Vytorin.”

Nissen added:

“Zetia works only by blocking the absorption of cholesterol, but it has not been shown to produce any health benefits. I have been skeptical of these drugs from the beginning because I wasn’t sure that Zetia’s mechanisms of cholesterol lowering would produce the same benefits we see with statins.”

This amounted to the second piece of bad news for Vytorin. A congressional committee recently launched an investigation into the reasons behind the delay in releasing the study results.

Rep. John Dingell, D-Mich, and Rep. Bart Stupak, D-Mich, the leaders of the investigation for the Committee on Energy and Commerce subcommittee, issued a joint statement after the study results were released.

Dingell said:

“Today’s announcement that the ENHANCE study failed to find any positive benefit from the addition of Zetia to a common, inexpensive, generic therapy raises concerns that attempts were made to mask the minimal value of this new drug. Additionally, Merck and Schering-Plough’s delay in releasing study results, as well as their attempt to manipulate the data is, quite frankly, suspicious.”

Stupak added:

“In light of today’s results, which were released nearly two years after the ENHANCE trial ended, it is easy to conclude that Merck and Schering-Plough intentionally sought to delay the release of this data.”

The congressmen vowed to press on with the investigation.

This study and the investigation highlight on ongoing problem in the pharmaceutical industry. Drug companies understand that once the patent on a prescription drug expires profits drop. To boost income and fight off generic competition, drug companies may combine the effective generic drug with a new prescription drug and market the combination as more effective than the stand-alone generic alternative. As the study in Vytorin shows, those claims don’t always hold up.

The diabetes drugs Avandia and Actos significantly increase the odds of suffering a heart attack, congestive heart failure and death for older diabetic patients according to a study in the Journal of the American Medical Association.

Both drugs, known as thiazolidinediones, or TZDs, increase the body’s sensitivity to insulin. Avandia is made by GlaxoSmithKline. Takeda Pharmaceutical North American Inc. is the maker of Actos. Both drugs carry the Food and Drug Administration’s black box warning about heart failure. This past summer, Avandia made headlines after an FDA panel launched an inquiry into the drug’s safety.

According to the Chicago Tribune, the December study found that patients over 65 who took TZDs had a 60 percent increased risk of heart failure compared with patients prescribed oral hypoglycemic drugs. The patients treated with TZDs had a 40 percent increased risk of heart attack and a 29 percent increased risk of dying.

In a statement, the study’s leader, the Institute for Clinical Evaluative Services in Toronto, said the risks were predominantly among those taking Avandia.

Even though demand for Avandia dropped after a spate of studies linked it to increased heart attacks and death, its sales figures were still staggering. Avandia recorded over $3 billion in worldwide sales last year. Actos raked in more than $2 billion, the Chicago Tribune reports.

But the sales represent more than profits. They represent people with diabetes who were looking for a way to control their disease and enhance their quality of life. Unfortunately, this new study confirms that these new diabetes drugs that diabetics had hoped would help may them may end up costing them their lives.

The manufacturers of Epogen, Aranesp, and Procrit used to treat anemia, strengthened the warnings to drugs yesterday, to warn that the drugs could cause heart attacks, worsen cancer and even cause death.
The changes, were made after they submitted data to the Food and Drug Administration which evidenced that the drugs can be dangerous if overused. The new warnings also state for the first time that the drugs’ risks for cancer patients cannot be excluded even at doses previously considered safe and routinely used.

The drugs are used by about one million Americans a year, mostly people with anemia caused by cancer chemotherapy or kidney failure. Combined sales worldwide were nearly $10 billion last year.

For cancer patients, the new label calls for using the lowest possible dose that allows a patient to avoid blood transfusions, with hemoglobin levels not to exceed 12 grams for each deciliter. “The label gives physicians discretion between 10 and 12,” Kevin W. Sharer, Amgen’s chief executive, said yesterday. “ “This is not a target,” Dr. Richard Pazdur, the director of the agency’s cancer drug office, said about the hemoglobin level of 12. “This is an upper boundary for safety concerns.”

The new labels came after the F.D.A. held two advisory committee meetings to consider the safety of the drugs. The agency had first slapped a so-called black box warning, the toughest kind, on the drugs in March as an interim measure.

For patients with kidney failure, the label calls for hemoglobin levels to be maintained at between 10 and 12. That is perhaps a bit less restrictive than the label in March. But new wording in the label calls for doctors to exercise restraint or possibly discontinue use for patients who do not reach the desired hemoglobin levels after 12 weeks of treatment. Until now, dialysis centers have tended to give such patients very large doses in an effort to raise their hemoglobin levels.

This along with all of the other new warnings and limitations on drugs after they have been on the market demonstrate the weakness in drug safety in the United States. To get a drug approved the FDA does not require studies of a sufficient number of patients to demonstrate safety risk that occurs infrequently. This gap in our drug safety system is part of the cause of all of recent drug debacles such as Vioxx, Bextra, Avandia, Fen Phen, Baycol, etc.... This problem keep on occurring until the system is fixed.

Gadolinium a contrast used in MRI's can cause nephrogenic systemic fibrosis and kidney failure. NSF is a tightening and swelling of the skin and other organs, including the lungs and heart. The American Journal of Dermatopathology, suggest a possible explanation for why some patients on kidney dialysis who are injected with a "contrast agent" during a magnetic resonance imaging (MRI) develop nephrogenic systemic fibrosis (NSF).

The U.S. Food and Drug Administration now requires a warning about the potential risk on the products' labels. NSF leads to thickened, rough or hard skin usually on the arms, legs or trunk. In some cases, the limbs can become difficult or even impossible to move.

It has not been known what causes NSF, but a risk factor is exposure to gadolinium, an agent injected into patent's veins during some MRI procedures to help improve the visibility of internal organs during the test. The condition occurs in about 2 percent to 4 percent of kidney patients on dialysis who are exposed to gadolinium.

The researchers tested the hypothesis that TG2 may be involved in the response. The enzyme is found throughout the body and is involved in blood clotting and wound healing. They hypothesized that gadolinium may activate the enzyme and cause NSF.

The group obtained skin biopsies from five people with NSF and three healthy people. All NSF patients had renal failure and had previously had imaging procedures using gadolinium. The researchers tested for the presence of TG2 in the skin samples.

"Compared to the healthy subjects, there was a marked increase in TG2 in the subjects with NSF," said Sane. "This suggests that activation of TG2 can produce the syndrome. TG2 is expressed in virtually all tissues and may explain why the fibrosis can occur in the heart and lungs, as well as the skin."

Two more studies published in yet another prominent medical journal have raised questions about the safety of Avandia, a once-popular diabetes medicine. One study found that Avandia, made by GlaxoSmithKline, doubled the risks of heart failure and raised the risks of heart attack by 42 percent. A second study found that Actos, a similar drug made by Takeda, actually lowered the risks of heart attacks, strokes and death but, like Avandia, also raised risks of heart failure.

Taken together, some of the authors said, the two studies in The Journal of the American Medical Association confirm what doctors and patients using Avandia have already done in great numbers, that is, switch to another drug. Sales of Avandia have plunged.

GlaxoSmithKline said in a written statement that the studies were flawed and “offered no new information on the safety of Avandia.” The company “continues to support Avandia as safe and effective when used appropriately,” the statement said. In July, a federal advisory panel voted overwhelmingly that Avandia should remain on the market even though it raised the risks of heart attacks. In June, the Food and Drug Administration said it would place its strictest warnings on the labels of both Avandia and Actos because of heart failure risks.

Riven by internal disagreements, the drug agency is still pondering further regulatory actions regarding Avandia. Some in the agency say that the drug should be withdrawn, while others say that all diabetes drugs have risks and that doctors need a variety of options.

The controversy began in May when The New England Journal of Medicine published a combined analysis of more than 40 studies of Avandia that found that it significantly raised the risks of heart attacks. The study attracted wide attention, but it was also criticized by the company and some on Capitol Hill as flawed.

In the study’s aftermath, the drug agency said that it had been told in 2005 of a similar study conducted by GlaxoSmithKline that came to a similar conclusion. Critics denounced the agency’s delay in alerting patients.

Dr. Richard Hellman, president of the American Association of Clinical Endocrinologists, said that the new studies were “more evidence that we should have a very high level of caution” regarding the use of Avandia. The drug agency should further strengthen the warnings on Avandia’s label to make it clear that the drug should be used very sparingly.

In the first study, researchers from Wake Forest University did yet another combined analysis of Avandia studies, this time limiting themselves to four long-term studies. The authors’ hope was that, by focusing on such a select set, their analysis would avoid some of the limitations of the May analysis.

The redo came to a conclusion almost identical to that of the study published in May. Dr. Sonal Singh, an assistant professor of internal medicine at the Wake Forest School of Medicine and a co-author of the study, said the drug agency should consider withdrawing Avandia from the market.

In addition to its deleterious effects on the heart, Avandia can cause blindness, and it doubles the risks of bone fractures in women, Dr. Singh said in an interview. “If you use Avandia to treat patients with Type 2 diabetes,” he said, “their chance of getting heart failure due to Avandia is one in 30 and their risk of getting a heart attack is one in 220. All due to the drug.” Dr. Singh added, “There are older and cheaper drugs that are far better to treat diabetes.”

In the second study, researchers at the Cleveland Clinic combined data from 19 trials of Actos and found that the drug seemed to lower the risks of heart attack, stroke and death by about 20 percent. The study confirmed that Actos increased the risks of heart failure, but this problem is mostly reversible.

“I think this shows that these drugs aren’t the same,” said Dr. A. Michael Lincoff, vice chairman for research in the department of cardiovascular medicine at the Cleveland Clinic. Dr. Lincoff said that Actos not only appeared to be safer than Avandia, but also offered some protection to the heart. Most diabetics die of heart disease. In an accompanying editorial, two doctors from Brigham and Women’s Hospital in Boston wrote that Avandia would probably not have been approved in 1999 had its heart risks been known.

In an interview, Dr. Daniel H. Solomon, a co-author of the editorial, called Avandia “a drug of last resort.” Dr. Solomon wrote that the Avandia situation should be used to improve the nation’s drug-safety system. Among his proposals is that when several drugs are available to treat a condition, new drugs must prove that they improve or extend people’s lives before they are approved. Now, many drugs are approved only after they improve laboratory results, like blood sugar or cholesterol levels.