As a dangerous medical device attorney, I am concerned that Baxter International Inc. has chosen to continue marketing these machines in the face of this Class I Recall. According to the FDA, a Class I Recall is "the most serious type of recall" that involves "situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death." Baxter says that it will add alarms, messages, and software modifications to the device so that patients and caregivers will be able to stop fluid accumulation in time. Patients and caregivers who continue using the machines, as Baxter suggests, should be aware of danger signs such as vomiting, difficulty breathing, or feeling bloated. Children treated with this machine should be monitored as well, and danger signs for them include crying during therapy or reporting a "funny feeling" in the abdomen.

This is not the first time Baxter's products have been under scrutiny as dangerous medical devices or dangerous drugs. Most recently, in 2008, Baxter came under fire for failing to make obvious the difference between adult and children's doses of its anticoagulant drug heparin, resulting in overdose and death for a number of babies in several states. This included the newborn twins of actor Dennis Quaid, who eventually sued Baxter. The company did make the adult and children's labels more distinct from one another, but not before these terrible tragedies occurred. And in 2001, Baxter's dialysis machine caused several deaths.

Most importantly, the Finance Committee found that GSK knew Avandia carried heart risks for several years before Nissen’s study. It accused GSK of trying to intimidate doctors who came to negative conclusions about the drug and minimizing or misrepresenting scientific evidence. It also said from U.S. Food and Drug Administration employees want the drug taken off the market. The FDA released a statement Monday telling patients not to quit taking Avandia without talking to their doctors, and announcing a panel meeting in July to discuss the results of a long-term, GSK-funded study of the cardiovascular risks of Avandia in Type II diabetics. The results are already in, but the agency said it needed more time to analyze them. An earlier panel voted 20-3 that Avandia does raise risk of heart attacks, but voted 22-1 to recommend keeping it on the market. It currently has sales of $1.19 billion in the United States.

Also on Feb. 22, the New York Times ran a related piece about a meeting between Nissen and GSK, just 11 days before Nissen’s study was published. Nissen legally audiotaped the meeting, concerned about intimidation by the company. He said executives made several false claims, including suggesting they had contradictory information that they could publish jointly with his study. According to the Congressional report, GSK already had the results of Nissen’s study, thanks to a journal reviewer who was also a consultant to the company. But it pretended it did not at the meeting. And even though GSK publicly criticized Nissen’s evidence and methodology, Congress found that GSK’s own scientists said Nissen’s work was sound.

We still don’t have the final results of the RECORD study, and the Times said its interim results were not conclusive. But as a pharmaceutical liability attorney, I don’t believe the public can trust a study funded by GSK. If the claims made by Congress and Nissen are true, GSK has repeatedly attempted to cover up, misrepresent or downplay scientific evidence that Avandia is dangerous, sometimes through intimidation. That behavior casts doubt on any conclusions reached by scientists on GSK’s payroll. Given that patients may risk death or lifelong heart problems from taking Avandia, the risk is just too great. If the existing evidence is not great enough to justify pulling Avandia from the market, as some regulators and safety groups want, the FDA should severely limit its use while it conducts a rigorous independent study.

This announcement is important for cancer patients, because ESAs are frequently prescribed to them. Cancer itself can cause anemia in some patients, and chemotherapy causes it in many others. Prior to the invention of ESAs, the Associated Press reported Feb. 16, the only treatment available was blood transfusion. Not all ESAs are approved for use in cancer patients in the United States, but they are prescribed with the goal of improving patients’ energy levels and quality of life. As a dangerous prescription drug attorney, however, I have been following this issue since 2007, when evidence emerged that ESAs may increase risks for cancer patients without increasing quality of life. That year, the FDA ordered “black box” warnings on this class of drugs, and Congress launched an investigation into off-label use and allegedly false quality-of-life claims.

This new order strengthens patient protections considerably. Doctors treating cancer of the lungs, head, neck, cervix and breasts will not only have to talk to patients about the risks, but document those talks. Every doctor who prescribes the drugs will have to join a safety register and complete education offered by drug makers Amgen and Johnson & Johnson. The manufacturers will also distribute a pamphlet on the risks.

As a defective medication lawyer, I am surprised only that this announcement took so long. Drug industry watchers have expected it since 2008. While I am pleased that the FDA’s action will do more to increase public awareness of the risks, I am concerned that it fails to address problems on several other fronts. This action affects only the risks suffered by cancer patients; patients taking ESAs for other problems must wait for an FDA ruling. But perhaps more importantly, the FDA’s action ignores clinical trials showing weak, if any, evidence that ESAs improve patients’ quality of life. If there is no benefit, why should patients assume the well-documented risks of taking ESAs? This is especially important considering their expense and the allegations of kickbacks raised in a 15-state lawsuit against manufacturers.

The study, conducted at Sunnybrook Health Sciences Center in Toronto and published in the Feb. 8 issue of the British Medical Journal, looked at the medical records of 2,430 women taking tamoxifen for breast cancer between 1993 and 2005. About thirty percent of the patients were also taking an antidepressant, with Paxil the most common antidepressant. The risk of dying from breast cancer went up significantly for the patients taking Paxil, the study found, and the risk was greater the longer patients took both drugs. Paxil, a selective serotonin reuptake inhibitor, inhibits a bodily enzyme needed to process tamoxifen, the researchers said. This was not seen with other SSRIs, like Effexor or Celexa. Lead researcher Dr. David Juurlink suggested that patients and doctors discuss transitioning to an antidepressant other than Paxil, but warned that quitting the SSRI cold turkey can cause withdrawal.

This study interests me as a defective prescription drug lawyer because it may help settle a debate in the medical community. Scientists already knew that SSRIs can interfere with the enzyme described above, but two 2009 studies conflicted about whether this lead to an increased risk of death. This study provides strong evidence that Paxil, at least, may interfere with the effectiveness of the breast cancer drug. And that means that thousands of patients may have been put at an unnecessary risk of dying. It also means that breast cancer patients may have been unnecessarily exposed to the numerous serious side effects of Paxil. Paxil already carries a warning about increased risk of suicidal thoughts and can cause reproductive and sexual problems in both men and women. As the article mentioned, it can also cause severe withdrawal symptoms.

Zyprexa is an atypical antipsychotic approved for use in patients with bipolar disorder or schizophrenia. Research has connected its long-term use among adults to weight gain, high blood sugar, diabetes and pancreatitis. According to a Jan. 29 article on the Los Angeles Times blog Booster Shots, a study published in October showed an even more dramatic weight gain in teenagers taking Zyprexa -- an average of 17 pounds over 12 weeks. The teenaged participants also had more dramatic increases in triglycerides (fats in the blood) and cholesterol levels than adult patients. The FDA cited that study in its letter informing drug maker Eli Lilly about the label order. A year ago, Lilly settled a federal lawsuit claiming it put adults at unnecessary risk of these injuries by illegally marketing Zyprexa for off-label uses like dementia and anxiety. The new FDA letter also mentions Zyprexa’s greater potential for liver damage and sedation in teenagers.

I am pleased that the FDA is taking the risk of metabolic problems from Zyprexa seriously. But as a dangerous prescription medication lawyer, I’m disappointed that the label wasn’t stronger. For one thing, seventeen pounds in 12 weeks is a very dramatic weight gain -- 1.4 pounds a week. By contrast, scientists believe the average, non-dieting American adult gains half a pound to two pounds a year. With Zyprexa use, that weight gain is associated with life-altering or even life-threatening disorders like pancreatitis and diabetes. For another, the FDA’s warning entirely omitted mention of the results showing higher risks of sedation and liver damage in teenagers. Liver damage can cause permanent, lifelong disabilities, and while sedation itself may not be dangerous, it can impair judgment and motor skills, leading to dangerous situations.

A relative of antidepressants, Meridia works by blocking brain chemicals that influence appetite. According to a Jan. 26 article on Time magazine’s Wellness blog, scientists knew more than a decade ago that it could raise blood pressure, and the American Heart Association issued a warning about it to heart patients. European regulators asked Abbott in 2002 to study the issue. It responded with the long-term SCOUT study, following 10,000 patients with a history of heart disease or diabetes. Over the six years of the study, 11.4% of participants taking sibutramine suffered death, heart attacks or strokes. By contrast, just 10% of the participants using a placebo suffered one of those events. The FDA’s new warning label saying the drug is contraindicated for patients with a history of congestive heart failure, stroke, coronary artery disease, heart arrhythmias, uncontrolled hypertension and peripheral arterial disease.

As a pharmaceutical liability attorney, I applaud the FDA’s action -- but I wonder why it didn’t follow the Europeans’ lead and consider a ban on sibutramine. The human body works the same on both continents; the difference is only how the regulatory agencies chose to respond. The safety advocacy group Public Citizen has long asked the FDA for a ban on Meridia, claiming it has caused at least 80 deaths, including 30 deaths of patients under age 50. The SCOUT study data only adds to the evidence that this drug has serious safety problems. This is particularly true considering that sibutramine’s target market, obese people, is statistically more likely than average to have a heart problem. By continuing to allow sales of sibutramine in the United States, the FDA and Abbott may be exposing patients to deadly and unnecessary risks.

Consumers can find a list of the recalled drugs on the FDA’s Web site and learn more at mcneilproductrecall.com.

TBA is a flame retardant and pesticide. It is not well studied, but was not proven to cause harm to humans before this recall. According to a Jan. 15 Associated Press article, 70 consumers have complained to the FDA about the smell or an illness related to a TBA-tainted McNeil product. According to the warning letter, an FDA investigation of McNeil’s Puerto Rico manufacturing facility found that McNeil began receiving complaints over four months in 2008. Nonetheless, McNeil stopped its investigation after tests failed to find microbial contamination. The FDA called this decision, and the failure to look for other causes, premature and unjustified. Further complaints let to tests that fingered TBA, but the FDA said McNeil didn’t test drugs other than specific lots of Tylenol Arthritis Caplets for the chemical. Nor did it submit a report to the FDA within three working days of identifying the problem, as required by law -- instead, it waited at least a year.

The FDA’s letter raises disturbing questions for pharmaceutical liability lawyers like me. The recall currently includes more than 50 million bottles of popular over-the counter products, including Tylenol, Rolaids, Motrin and St. Joseph Aspirin. McNeil’s apparent year-long delay in addressing the problem means millions of consumers were likely exposed to TBA, possibly multiple times. It’s not clear what effect that might have on them, but the gastrointestinal reaction by some consumers, and the fact that it’s poorly studied, suggests that it’s better to stay away. If later investigations show that McNeil failed to take quick action on a serious health threat, the company could face thousands of lawsuits from sickened consumers.

Atypical antipsychotic drugs such as Risperdal and Abilify are used to treat mental illness. They are also widely used off-label to control the behavior of people with dementia, despite the health risks. A series of FDA actions throughout the decade warned patients that atypical antipsychotics increased their risk of strokes; metabolic problems like hyperglycemia and diabetes; and increased mortality among older people with dementia. They also carry a warning about the risk of tardive dyskinesia, involuntary repetitive movements that appear or continue even after the drug is stopped.

The study, from the University of Massachusetts Medical School in Worcester, found that almost a third of all nursing home patients were prescribed atypical antipsychotics for any reason. Of these, the study said, one-third did not have a diagnosis of schizophrenia or dementia. They also found that patients were more likely to be put on antipsychotics if they entered a nursing home where antipsychotics were already heavily used, suggesting that “organizational culture” rather than patient care was driving the decisions.

As a pharmaceutical liability attorney, I’m concerned about the continued use of these medications, particularly in patients with no mental illness or dementia to justify it. As the article notes, no medication is approved for controlling the behavior of people with dementia. One scientist said in the article that antipsychotics are the only drug known to work for this purpose -- but as another one noted, nursing home residents are a vulnerable population. In an institutional setting, without family members watching, it’s all too easy for caregivers confronted with difficult behavior to simply drug patients. But given the risk of death or permanent disability, this is a dangerous and irresponsible use of caregivers’ power over their charges.

A total of 718 patients were in the analysis, conducted by scientists at the University of Pennsylvania. The studied compared both Paxil (paroxetine) and the 1950s-era drug imipramine to placebos over a six-week period. Patients’ depression was measured by a Hamilton score, with the most severely depressed scoring at 24 or higher and the mildly depressed scoring at 18 or below. Among the most severely depressed, those taking genuine antidepressants saw their Hamilton scores drop by 13 points, while patients on placebos saw a drop of 9 points. By contrast, people with Hamilton scores of 23 or below saw an 8-point drop for patients on antidepressants and a 7-point drop for those on placebos. In other words, it concluded that antidepressants work best for the most depressed patients, but aren’t much better than non-pharmaceutical treatment for the mildly depressed.

This is important for two reasons. Robert DeRubeis, a study author and Penn psychologist, told Reuters that most drug approval studies focus on the most severely depressed, even though most depressed Americans have only mild to moderate depression. This suggests that drug approval studies may not serve the majority of the patients. DeRubeis also noted that studies have shown that talk therapy, exercise and even self-help books have shown some effectiveness in fighting depression, without the negative side effects drugs can cause. As a pharmaceutical liability attorney familiar with the dangerous effects of Paxil, I couldn’t agree more. Paxil already carries a black box warning about the risk of suicidal thoughts, and is believed to cause birth defects as well as several other dangerous risks. If it turns out that pharmaceutical companies have exaggerated its effect for most patients, they would have exposed patients to these severe risks in exchange for next to no benefit.

Byetta is jointly manufactured by Eli Lily & Co. and Amylin Pharmaceuticals. In its Oct. 30 approval letter, the FDA told the manufacturers that it had post-marketing reports of the three serious diseases. They included reports of hemorrhaging or necrotic pancreatitis, both of which can be fatal; acute kidney failure leading to death or kidney transplants; and thyroid neoplasms, which can lead to thyroid cancer. Because this was new safety information not known when Byetta was approved, federal law required new studies to ensure that the drug’s benefits outweighed its risks. According to the letter, some of these studies are already in progress or even completed. But because this requirement was not mentioned in the manufacturers’ approval announcement, the new announcement before Christmas caused a drop in Amylin’s stock prices.

This is disturbing news not just for investors, but also for patients and defective drug lawyers like me. Byetta’s manufacturers almost certainly withheld the information because they didn’t want to hurt the drug’s sales or their stock prices. They may have achieved those goals -- at least until the financial analyst found the publicly available approval letter -- but they have also withheld safety information that can help patients make the best possible decisions about their own treatment. All three of the diseases that triggered the new studies are life-altering and potentially fatal. Acute pancreatitis, a sudden and serious digestive problem, can lead to the pancreatic tissue dying (necrotizing) and bleeding into the abdomen (hemorrhaging), both of which increase the chance of death significantly. Given the risk of death or disability from these diseases, patients and doctors should know about that risk so they can discuss alternatives.

CT scans (formerly called CAT scans) use computer technology and X-rays to create detailed pictures of the inside of patients’ bodies. Dr. Rebecca Smith-Bindman, a lead author on one study, said doctors have lowered their thresholds for using CT scans so much that some patients get no real benefit from them. In fact, her team’s study said the use of the scans has grown dramatically in the past 30 years, from 3 million a year in 1980 to nearly 70 million in 2007. That’s a problem because the dose of radiation a patient receives during an abdominal scan can be as high as 90 millisieverts, which the article said was equivalent to thousands of X-rays. Radiation doses vary according to the type of scan, and tolerance varies across patients. One doctor quoted said that patients could expect to be exposed to that amount of background radiation over 30 years -- but with a CT scan, it comes all at once and focused on the body.

And this, the two studies said, can cause cancers. Smith-Bindman’s team found that one in 270 women and one in 600 men who undergo a coronary angiography CT scan at age 40 will develop cancer. That risk was doubled for 20-year-old patients and halved for 60-year-olds. The other study, headed by Amy Berrington de Gonzalez of the National Cancer Institute, broke down cancer risks according to gender, age and the type of scan. They predicted that CT scans performed in 2007 alone would result in 29,000 cancers, 14,500 of which would be fatal. The highest risks came from chest, head, abdominal and pelvis scans -- all of the most commonly performed. Women bore the greatest risk because they get the scans more often and are more likely to develop breast and abdominal cancers. In addition to warning patients and considering whether CT scans are truly necessary, study authors suggested tracking radiation exposure through a searchable database of medical records.

Radiologists stressed that fear of cancer should not stop patients from getting CT scans that help doctors address other major health issues, like heart disease. But as a dangerous medical device lawyer, I wonder how many patients have already developed life-threatening cancers because they submitted to a scan their doctors recommended. As a rule, patients trust that treatments and diagnostics their doctors recommend are safe and effective, or at least worth the risk. However, the oldest CT equipment, which tends to deliver the highest doses of radiation, is still in use, and patients are unlikely to be told how old the equipment is. That’s true even though the cancer risk from radiation is well understood and has been for decades. Going forward, patients can ask careful questions and give informed consent to CT scans. But for those already exposed, it may be too late to do anything more than assign responsibility after the disease develops.

Norpramin (sold as Pertofrane outside the U.S.) is primarily used for treating depression, but also in patients with nerve pain, cocaine withdrawal or attention deficit disorder. It is part of the tricyclic class of antidepressants, which were widely used until the introduction of the newer selective serotonin reuptake inhibitors. Along with the warning on heart problems, the FDA letter announcing the labeling changes (PDF) added a general warning to health care professionals that some patients who suffered death and cardiac arrhythmia have suffered seizures beforehand. Because an overdose of Norpramin has shown a higher risk of death than overdoses of other tricyclic antidepressants, the label also included specific instructions for doctors to treat overdose patients. Finally, the label changes deleted previous treatment advice that narrowed doctors’ options for treating an overdose.

As a dangerous drug lawyer, I hope doctors and patients take quick action on this warning. Prior to this announcement, the primary known safety problem with Norpramin (and other tricyclic antidepressants) was a heightened risk of depression, particularly in children. With this announcement, it appears that adults with a family or personal history of heart problems, a very different group, may have been lulled into a false sense of security. The FDA letter did not say how it and Sanofi-Aventis discovered the elevated cardiac risks, but as a rule, major safety changes like this are announced only after multiple reports of patient safety problems or new scientific studies. That means the chances are good that thousands of patients were unknowingly exposed to the cardiac risks of Norpramin. And because overdose of tricyclic drugs is a significant drug poisoning problem -- British and Australian studies found that 8 to 12 percent of drug overdose deaths were from tricyclic antidepressants -- the risk of death may be greater still.

The entire class of imaging contrast agents already carries a black box warning disclosing that they increase risk of nephrogenic systemic fibrosis in patients with kidney problems. NSF is a disease that builds up collagen in the skin, eyes, joints and internal organs. The hardening of the skin and contracture of the joints can leave patients disabled by limited movement, physically scarred and with chronic pain. In its memo, the FDA announced that the greatest number of NSF cases were linked to use of GE Healthcare’s Omniscan -- the first contrast agent given to our own client. The FDA also found a greater risk for Bayer AG’s Magnevist and Covidien’s Optimark. Its review recommended labels on those products warning of the greater risk. At an already-scheduled meeting Dec. 8, the agency plans to ask an expert panel for advice.

As a dangerous drug lawyer, I am extremely pleased that the FDA is taking aggressive steps to limit kidney patients’ exposure to this toxic substance. In this, our government is just a short step behind the European Medicines Agency, which on Nov. 20 classified gadolinium-containing agents into low-, medium- and high-risk agents for kidney patients based on their chemical content. All three of the agents the FDA found associated with higher numbers of NSF cases are on EMEA’s high-risk list. With so much evidence against these higher-risk agents, I hope the FDA takes steps to end their use entirely, or at least require very strong warnings about the risk to people who have -- or may have -- kidney problems. Otherwise, far too many people may suffer preventable but life-altering problems similar to our client’s, which include permanent disability, disfigurement and many thousands of dollars in medical bills.

Prempro was once widely recommended for post-menopausal women, to treat symptoms of life after menopause. However, that changed after the 2002 study from the Women’s Health Initiative at the National Institutes of Health. That long-term study showed a substantially increased risk of breast cancer, heart attacks and strokes among users of Prempro, Provera and Premarin. In fact, that study was ended early because of concerns for the participants’ health. Later studies confirmed the link and suggested that Prempro may also raise women’s risk of blood clots and dementia. Perhaps most damningly of all, later evidence showed that Wyeth, a unit of Pfizer, paid medical ghostwriters to plant articles in medical journals under doctors’ names. At least some of the articles denied the breast cancer link altogether, triggering multiple lawsuits and a Congressional investigation.

As a pharmaceutical liability attorney, I am pleased to see the justice system doing its job with these drugs. By now, most observers agree that the FDA approval process, while important, is not enough to ensure that drugs are safe. Too many drugs have slipped through the cracks in recent years, including drugs that have since been linked to life-threatening diseases. In a few cases, pharmaceutical companies have also been caught misleading the public, as with Prempro, using deceptive advertising, biased medical studies and unethical corporate policies. In addition to causing unnecessary deaths and lowered quality of life to patients and their families, these drugs can also trigger six or even seven figures in bills for medical care that patients would never have otherwise needed. As the FDA itself once acknowledged, lawsuits like this one help incentivize drug companies to stay honest by generating severe financial costs and negative publicity when the issues are publicly and fully aired.

The drugs in the FDA’s announcement include bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine, all widely used local anesthetics. The FDA’s announcement noted that these drugs have been used safely for years or decades, but in smaller, short-term doses. They are not approved for continuous use or use in pain pumps, which deliver constant flows of medication over two or three days. In fact, the pain pumps themselves are not approved for use in joint (intra-articular) areas, the uses that generated the cartilage damage reports. Dr. Constance Chu, a cartilage restoration specialist the University of Pittsburgh, told the Wall Street Journal that local anesthetics are toxic to tissues at high doses and not intended for continuous use. The Canadian version of the FDA issued a warning about cartilage damage in January, following studies and reports on the issue.

Almost all (97%) of the surgeries the FDA reviewed were shoulder joint surgeries. Patients reported stiffness, loss of motion and joint pain as soon as the second month after their surgeries. About half needed additional surgeries to relieve the pain and symptoms, including joint replacements (arthroscopy). Cartilage damage and loss is not life-threatening, but it has an immense effect on the patient’s quality of life. Without cartilage, the bones in joints grind against one another, causing pain, swelling, loss of mobility and thus severe restrictions on the patient’s movement. Osteoarthritis, a common complaint among older Americans, is a form of cartilage loss with similar symptoms. A newer treatment called articular cartilage repair can mend some of the damage to cartilage, but this cannot restore cartilage. Expensive joint replacement surgery may be necessary to restore patients’ normal movements.

The Wall Street Journal noted that pain pump manufacturers are already facing hundreds of lawsuits around the United States over post-operative cartilage damage. As a southern Illinois pharmaceutical liability attorney, I expect the FDA’s warning to add to that number. If the FDA is correct, both the pain pumps and the anesthetics are apparently being widely used for off-label, unintended purposes. This report makes it explicit that the FDA does not approve of those uses, and is even taking steps to warn doctors and patients against them. In fact, medical studies turned up these problems as early as 2006, but manufacturers failed to warn patients about them -- and doctors continued to prescribe pain pumps full of anesthesia.