Personal Injury Lawyer Blog
Hospitals Ill-Equipped to Deal with Psychiatric Emergencies - Thursday, December 13, 2007
The family of a man who threw himself from a 10th floor balcony at the Tripler Army Medical Center, almost exactly as he described, is suing the hospital for carelessness and medical negligence. The man had been undergoing treatment for depression from 1999 until 2006, but like many bipolar individuals his depression treatments probably exacerbated his manic episodes, increasing his mood swings. In December 2006 his condition worsened and he appeared in the emergency room of the medical center on December 16 and 26, saying he needed help. He demanded treatment, saying that he would kill himself by throwing himself off the top of the hospital. However, he did not get help on either of these occasions, despite having waited five hours on the 16th and three hours on the 26th before leaving in disgust. On the 16th he was admitted to see a doctor training to be a psychiatrist. On the 26th he left angry, telling doctors and nurses that he was going to jump from the top of the hospital. When the man did see a psychiatrist on the 27th, he concealed his suicidal thoughts. Then, on January 3, 2007 he threw himself from the 10th floor balcony, killing himself.
This case reveals that emergency room personnel are ill-equipped to deal with psychiatric emergencies. Although it seems unlikely that every hospital could maintain a psychiatrist on the emergency room staff, it does seem that every hospital should train its triage nurses in recognizing psychiatric emergencies, and the hospital should be able to arrange for someone with such an emergency to see a real psychiatrist in less than five hours. With the high incidence of suicidal ideation attendant on depression treatments, such as that with SSRIs like Paxil or other classes of drugs like Zyprexa, hospitals that prescribe such medication have to be prepared to deal with the consequences of these often injurious pharmaceuticals. Sadly, though, most hospitals are not, and if someone with a psychiatric problem comes to the emergency room, they may be luckier if they don't see the staff psychiatrist, who will give them a potent dose of mood controllers that may stabilize them temporarily, but often have serious side effects later.
If you or someone you love has experienced this form of medical malpractice in the emergency room, contact PersonalInjury.com today to get in touch with a local lawyer who can help you get compensation for your mistreatment.
Labels: defective pharmaceutical, medical malpractice, psychiatric treatment, SSRIs
Health Canada Shows Its Strength - Wednesday, December 12, 2007
A recent study by the Canadian Institute for Clinical Evaluative Sciences (ICES) has not only increased concerns about Avandia and drugs in its class that are used to treat type 2 diabetes, but also raised increased concerns about why the FDA has not pulled the drug. The study compared patients treated with glitazones and those treated with other classes of diabetes drugs. The glitazone patients had a 60 percent higher risk of heart failure requiring hospitalization. They also had a 40 percent higher risk of heart attack, and a 30 percent higher risk of premature death compared to those on the other drugs. The study was conducted by analyzing data for 160,000 diabetics aged 65 and older from the Ontario Drug Benefit (ODB) database.
The data represents a study that is more than an order of magnitude larger than the largest prior study of Avandia. It definitively shows the heart risks attendant on the use of the class of medications and raises questions as to why this dangerous drug is still on the market. The figures show that there were three additional cases of heart failure, four additional heart attacks, and five premature deaths whose cause might be attributed to the drug for every 100 patients taking the drugs for the four years covered by the study, or approximately 8,000 deaths total. Health Canada withdrew approval of the drug for all but patients who could not tolerate other diabetes drugs early in November, but the US Food and Drug Administration (FDA) has been reluctant to do so, although it did put a black-box warning on the drug.
Is this an example of the FDA maintaining too close a relationship with the pharmaceuticals industry? It is impossible to say, but it sure seems likely. The study also points out the disparity between the weak, decentralized regulatory agency in the United States, and the comprehensive, independent, powerful health department in Canada. Although those whose wealth and power would allow them to buy expedited care in the US might complain that socialized medicine makes them wait in line with the hoi polloi, this case shows that the agency seems better equipped to look after the health of the population as a whole. In this country we rely on small studies, usually sponsored by the industry, of barely 14,000 individuals, and the majority of the studies are "inconclusive." Health Canada, on the other hand, is able to draw conclusions based on its own, wide-ranging data, data that cannot be concealed or cooked by pharmaceutical companies.
It is probably impossible that we would ever be able to reform the US health care system into anything like the socialized care in Canada. Instead, our only recourse to do the job that the FDA is either reluctant or unwilling to do is through the court system. Litigation is our last lever of power against major corporate interests in this country. Remember what Archimedes said, "Give me a lever long enough and a fulcrum on which to place it, and I shall move the world." If you or someone you love has suffered as a result of a defective pharmaceutical drug, contact PersonalInjury.com today, to get in touch with a local lawyer who can find his own fulcrum.
Labels: Avandia, Canada, defective pharmaceutical, FDA, federal government
Supreme Court may ban lawsuits on FDA-approved drugs - Tuesday, December 11, 2007
The Supreme Court has yet to give a verdict in the case of Riegel v. Medtronic. In this case, the wife of a man who claims he was injured when a balloon catheter burst in his artery. The defense being used by Medtronic, the maker of the catheter, is that the catheter was approved by the FDA and therefore should be immune to liability under state laws. Essentially, this is another case of an industry attempting to use Federal preemption to protect itself from litigation. If this defense is granted, it could have grave implications for people seek restitution for injuries suffered as a result of defective pharmaceuticals or medical devices, including another Medtronic product, defective defibrillators and leads.
The industry charges that the FDA is responsible for making sure drugs are safe for marketing, and if an industry does its best to comply with FDA guidelines, it should not be held responsible for unforeseen side effects that become evident after the product comes into common use.
However, as I discussed in yesterday's entry, the FDA works closely with drug companies, and actually allows drug companies to do most of the testing of their products. This testing, although expensive for drug companies, is worth it to them, because it gives them the opportunity to falsify data or use incomplete or poorly-recorded results to get their drugs approved. In fact, it is often only through litigation that the truth has come to light.
The outcome of this case, and another one on the docket for later this session, involving the drug Rezulin, might be bad news for people who are prescribed defective drugs by their doctors, as it might remove the last avenue for recompense they have: the courts. If you or someone you love has been injured by a defective drug or medical device, the time to act is now. Contact PersonalInjury.com today to get in touch with a local defective pharmaceuticals lawyer to get your voice heard.
Labels: defective pharmaceutical, defective product, FDA, federal government, preemption
Does the FDA serve us or the drug companies? - Monday, December 10, 2007
According to many industry critics, the FDA has conceded too much power to drug companies in the battle between safety and profits in the pharmaceuticals market. Essentially, critics say, the FDA "has allowed companies to set the standards and handle the reviews." Drug companies conduct their own trials of drugs, at their own expense, and usually report the results they want.
Most revelations about defective drugs show not only that the drug is unsafe, but that its manufacturer knew it was unsafe. Most recently, documents have revealed that Johnson & Johnson altered or withheld numerous reports that would reveal the serious health risks that went along with its Ortho Evra birth control patches. In addition, it has been shown that the makers of Premarin and Prempro (Wyeth), Vioxx (Merck), Baycol (Bayer AG), and Avandia (GlaxoSmithKline), all had reason to believe their drugs were more dangerous than their marketing implied, and many of them asked employees to play down risks to the point of being deceptive. Essentially, all drug manufacturers seem to put profits before patient safety. By allowing drug companies to do their own studies, critics charge, the FDA essentially lets the companies write checks to themselves, leaving patients to pay the bill.
In addition, many critics charge that the FDA itself tries to squelch critics within its organization that attempt to raise alarms about unsafe drugs. And the recent drug-safety bill passed by congress is seen by some as a public-relations move posing as real reform. Although the bill allows for tracking of adverse reactions after a drug is approved, a measure long-fought by the pharmaceuticals industry lobbyists, it does not reform the drug approval process. Nor does it alter the membership of drug-review panels, which often have significant ties to the industry. For example, a panel re-approved Trasylol on September 13, despite studies that linked the drug to kidney failure and death, asking only that additional studies be done. Then, only a month and a half later, Bayer decided to pull the drug voluntarily, rather than reveal what it must already have known about the drug.
With the FDA too close to the pharmaceutical companies, personal injury lawyers may be the last line of defense against dangerous drugs. If you or someone you love has been injured as a result of taking one of these drugs, you have a responsibility to pursue your suit to protect others who may be affected. Contact PersonalInjury.com today to get in touch with an experienced defective drug lawyer in your area.
Labels: defective pharmaceutical, FDA
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