Drug Injury Attorney Blog

Two different medications from the same manufacturer will get a “black box” warning from the FDA, the Washington Post reported Dec. 11. The FDA issued the warning for OsmoPrep and Visicol, drugs used to clear out the bowels before a colonoscopy, after discovering a strong association between the drugs and acute phosphate nephropathy (acute kidney damage). Both drugs are made of sodium phosphate by Salix Pharmaceuticals. The FDA has ordered the manufacturer to distribute materials informing patients of the problem and conduct a new clinical trial of the drugs.

According to an FDA doctor quoted in the article, the agency has received 20 reports of kidney injury associated with OsmoPrep, with an onset ranging from several hours to 21 days after use of the drug. The agency in 2006 warned patients with kidney problems to avoid the drugs, and has now added children, older patients and patients with certain health problems or taking certain medications to that list. Patients and their doctors can choose alternative drugs not containing sodium phosphate.

It is interesting to me, as a dangerous drug lawyer in Missouri and Southern Illinois, that this is the second warning in two years about this drug and acute kidney damage. The article doesn’t say whether or when Salix and the FDA knew that the high levels of phosphates in the drug could be harmful for everyone. But in general, pharmaceutical companies have a legal and ethical responsibility to disclose serious health risks of their drugs as soon as they know of them. All too often, they choose not to because of concerns about how bad PR could affect their profits.

When manufacturers place their profits over patient safety, they are legally liable for any deaths or injuries that result. Patients who are harmed in this way have the right to file a defective drugs lawsuit to recover their financial costs (including medical costs and time off work they wouldn’t have otherwise incurred), as well as compensation for a wrongful death or permanent disability.

At the Lowe Law Firm, our experienced dangerous drug lawyers have handled many such cases, including a large confidential settlement for six clients who suffered permanent heart damage from using diet drug Fen-Phen. If you or someone you love has been hurt by a drug whose dangers you believe were covered up and you’d like to discuss your case with us, please contact us for a free initial consultation. We offer house calls and hospital calls for potential clients who are not able to travel.

Avastin one of the new generation of gentler cancer drugs according to a report published in the Journal of the American Medical Association called for a “black box” warning -- the FDA’s strongest, according to USA Today
-- the Nov. 18 report was an analysis of studies on the drug Avastin, which is approved for breast, colon and lung cancer patients.
In the new report, scientists found that about 12% of patients using Avastin developed potentially life-threatening blood clots, giving them a rate of blood clots that was 30% higher than the rate among cancer patients not using the drug. Blood clots can be dangerous because they can block blood flow completely, causing tissue death or a pulmonary embolism that cuts off the patient’s oxygen.

Blood clots are a common problem among cancer patients, according to the newspaper -- but evidence from this study shows that they are more common among cancer patients using Avastin. Because the clots are potentially life-threatening, the study’s authors called for an FDA “black box” warning about the risk for patients and their doctors. A spokesperson for Avastin’s maker, Genentech, demurred, pointing out that the FDA already runs a warning about the risk of blood clots on the drug’s label.

As a Missouri defective drug attorney, I hope patients take that warning seriously. In our prescription drugs practice at the Lowe Law Firm, we represent patients of all kinds who have been seriously hurt by prescription drugs that had serious dangerous side effects. In many cases, we have been able to prove that the manufacturer knew about the problem in advance but didn’t disclose it publicly -- sometimes, not until after an aggressive marketing campaign. This dishonest behavior betrays the patients and doctors who trust drug makers, and puts patients in serious danger.

At the Lowe Law Firm, we help victims of this dishonest behavior hold manufacturers legally liable for their actions. To speak with one of our experienced defective drug attorneys about your own case and your legal options, please contact us online or call us toll-free at 1-877-678-3400.

Pharmaceutical company Wyeth is the subject of a Congressional investigation for its use of ghostwriters to publish favorable articles in medical journals, the New York Times reported Dec. 12. The newspaper reported that Sen. Chuck Grassley, a Republican from Iowa, has asked With and its ghostwriting services company to disclose the roles of the doctors and the amounts of payments made for the articles.

The ghostwritten articles were on hormone replacement therapy Prempro, for women undergoing menopause. The drug’s sales dropped sharply after a federal study linked it to an increased risk of breast cancer, heart attacks and strokes. However, the ghostwritten articles were favorable to the drug. One that was published more than a year after the federal study said that there was no definitive evidence that the drug caused cancer, and that hormone users had a better chance of surviving cancer.

The senator requested the disclosures after Congress received documents from a personal injury lawyer investigating ghostwriting by Wyeth. According to those documents, Wyeth planned and commissioned at least 10 medical journal articles before those articles were even seen by the doctors who “wrote” them. Revisions by those doctors were subject to Wyeth’s final approval, the documents said. This contradicts medical journals’ ethical standards, which generally forbid ghostwriting, according to the New York Times.

As a Missouri dangerous drug attorney, I am extremely interested in this ongoing story, but not as surprised as I could be. Thanks to my pharmaceutical liability practice, I’ve known for some time that some drug makers are willing to actively mislead the public about their drugs’ safety. In fact, this isn’t the first dangerous drug that has benefited from medical ghostwriting -- articles have also been ghostwritten for Redux and Pondimin (also Wyeth products) and Vioxx (Merck). All three of these have since been withdrawn from the market after being linked to serious heart and lung problems.

Prempro is still on the market, but doctors have been advised to prescribe it only at low doses and for patients with severe symptoms. If the Congressional investigation finds that Wyeth knew about its health problems and intentionally covered them up by paying for favorable reports, the drug manufacturer may be hit with a new round of Prempro lawsuits. There is also anecdodal evidence that breast cancer rates in woman over 50 are declining because of reduced use of Hormone replacement therapy to "treat" the symptoms of menopause.The Lowe Law Firm represents clients who have been hurt by a prescription drug whose dangers were hushed up in this manner by manufacturers eager to protect their profits. If you believe you may have a defective medication case and you’d like to talk more about your options, please contact our firm online or call us at 1-877-678-3400 to set up a free initial consultation.

The Minneapolis Star-Tribune reported that a doctor from the Minneapolis Heart Institute Foundation expressed grave doubts this week about the safety standards for a new breed of defibrillators. In the Dec. 11 edition of the New England Journal of Medicine, Dr. Robert Hauser (writing with Dr. Adrian Almquist of the Heart Institute) warned that FDA regulations for the medical devices must be strict -- or patients could suffer lethal consequences.

The defibrillators at issue are an improved version of existing implanted defibrillators (ICDs), which are implanted directly into patents’ chests. The devices work by monitoring patients’ heartbeats and sending electric shocks to the heart if they detect missing or irregular heartbeats. Unfortunately, some existing models of ICDs had to be recalled after a lead -- the wire that leads from the device to the patient’s heart -- turned out to be likely to break. This has caused at least five deaths and sent other patients to emergency rooms with uncontrolled and random electric shocks.

Dr. Hauser was among the first to blow the whistle on past ICDs; he and a colleague went public with concerns in 2005 after a patient died due to a defective implanted defibrillator. His current concern, according to the Star-Tribune, stems from the fact that new devices can be approved by the FDA with little testing or review if they’re similar to existing devices. He writes that the new design, which features more leads attached to the patient’s heart, is different enough to require new studies before the FDA can safely approve it. A representative from the FDA wrote that no final decision has been made.

A representative from the medical device industry also told the newspaper that the manufacturers themselves test the devices thoroughly before they reach market. Unfortunately, this is cold comfort for victims of defective medical devices and unsafe prescription drugs. As a Missouri medical device defect lawyer, I have seen many situations in which pharmaceutical companies know all about problems with a device or medication, but intentionally do not disclose them to the public in an effort to keep profits high.

When this irresponsible behavior kills or seriously hurts patients, victims and their families have the right to sue the manufacturer over their physical, financial and emotional injuries. My law firm represents victims of several defective medical devices, including the defective Guidant defibrillator Dr. Hauser warned of in 2005. If you believe you’ve been hurt by a defective implanted defibrillator and you’d like to learn more about defending your rights, please contact the Lowe Law Firm for a free initial consultation.

A federal advisory panel concluded that two drugs, Serevent and Foradil, should be banned for use in the treatment of asthma, according to Reuters.

Studies have shown that when Serevent and Foradil are used without a steroid, the drugs can trigger more severe, life-threatening asthma attacks.

The panel of safety experts also recommended that two other asthma drugs, Advair and Symbicort, continue to be used on adults and children. However, the votes were far from unanimous on the question of use by children.

Advair is approved for children ages four and older. The advisory panel voted 13-11 with three abstentions to allow children in the youngest age group to use Advair.

Symbicort is approved for children ages 12 and older. The advisory panel voted 20-5 with two abstentions to allow children that age to use Symbicort.

The four asthma medications contain a drug known as long-acting beta agonist. The drug safety questions were raised after a study showed that Serevent could worsen asthma and even cause death, National Public Radio reports.

Adverse reactions to prescription drugs cause more injuries and deaths in the United States than illegal drugs. If you have suffered medical complications from a prescription medicine or over-the-counter drug, an attorney with experience can advise you on your right to recover compensation for medical expenses, lost wages and pain and suffering.

For more information, fill out our online contact form or call 314-678-3400 or toll free 877-678-3400.

A study released on Dec. 2 confirms what many previous studies have already found: Patients given the anti-bleeding drug Trasylol have a higher risk of dying than those who receive less expensive clotting drugs.

Canadian and Australian researchers reviewed findings from 49 randomized clinical trials. While Trasylol (aprotinin) was found to be more effective at controlling blood loss than lysine analogues, the higher fatality rate associated with the drug as well as its expense outweighed the benefits.

Dr. David Henry, one of the co-authors of the study which will be published in the Jan. 20 issue of the Canadian Medical Association Journal, concluded:

"Lysine analogues are almost as effective as aprotinin in controlling blood loss, are cheaper, and appear not to increase mortality."

Since 2006, several studies have linked Trasylol to an increased risk for kidney damage, stroke and death. If Bayer, the maker of Trasylol, had removed the drug from the market when it learned of the health dangers, it is estimated that 22,000 lives could have been saved.

My law firm currently represents several Trasylol victims and their families in lawsuits against Bayer. 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.