Think This Election Doesn’t Matter? Think Again!
October 7, 2008
I typically avoid politics in this blog. Sometimes, though, politics affect my clients. Okay, most of the time.
The next President will undoubtedly select judges for Federal courts, including the United States Supreme Court. That Court has done its share of judicial activism. Here is what the St. Louis Post-Dispatch said today, and why the Court is important to injury victims:
Is there anyone left in America who still thinks that just because a medication is approved for sale by the U.S. Food and Drug Administration it’s perfectly safe and without product defects? If so, he or she should type the words “heparin recall” or “Vioxx recall” or “Zyprexia weight gain” into a search engine. The FDA approved all of those drugs, and all of them turned out to cause big problems. The companies that made the drugs found themselves defending thousands of product-liability lawsuits.
But next month, the U.S. Supreme Court will hear what could turn out to be a landmark case. At issue is whether people harmed by prescription drugs should be allowed to recover damages for their injuries by suing in state courts.
The pharmaceutical industry says that such suits should be prohibited because drugs must be approved for sale by the FDA. That approval, the industry says, should protect drug-makers from liability.
Last spring, the Supreme Court ruled in favor of the manufacturers of medical devices, which made a similar argument. A similar decision in this case effectively would grant “get-out-of-responsibility free” cards to makers of drugs that turn out to be dangerous.People such as Diana Levine, a 62-year-old musician from Vermont, would be out of luck.
Make that “former musician.” In 2000, Ms. Levine lost her right hand after receiving an injection of an anti-nausea drug. That ended her career as a guitarist and pianist.
The drug she received, Phenergan, usually is injected into a muscle. Sometimes, it is injected into a vein. But if it comes in contact with oxygen-rich arterial blood, it causes gangrene — a condition in which bone, muscle and skin tissues die. Affected limbs must be amputated.
The drug’s label, also approved by the FDA, warned that mistakenly injecting the drug into an artery can cause “gangrene requiring amputation.” But it did not include a similar warning about a method of administration called “IV push,” which is what caused Ms. Levine to lose her hand.
A jury in Vermont awarded Ms. Levine $6 million in damages. The Supreme Court is being asked to overturn the judgment — not because she wasn’t harmed, but because the FDA-approved label didn’t warn against the IV-push method.
Drugs are tested for safety on small groups of people before being approved for wider distribution; testing on larger groups would be cost-prohibitive and potentially dangerous. But sometimes, the number of test subjects is so small that side effects don’t become apparent.
Drug companies pay for those safety tests and control how the results are written and distributed, and some firms have been known to play down problems. In some instances, problems have come to light only after injured people brought lawsuits for the damage the drugs caused.
Recent revelations about the health effects of a psychiatric medicine called Zyprexia, which can cause rapid and uncontrolled weight gain leading to diabetes and increased risk of heart attack, came about that way.
Vioxx was a best-selling arthritis and pain drug before a broader FDA study revealed in 2004 that Vioxx users were more likely to suffer a heart attack or sudden cardiac death than those taking other types of drugs. And earlier this year, the FDA came under criticism for mistakenly approving distribution of a shipment of defective Chinese-made heparin, a blood-thinning agent.
Prohibiting suits in state court by people injured by prescription drugs is profoundly unfair, particularly when drug-safety tests are considered “proprietary information” owned by drug companies. The larger question is whether the justices will require manufacturers — of all sorts — to stand by their products, or allow them to blame government for their failures.
The problem for most injury victims is that they don’t know that they need the courts until it is too late. Rather, the courts are like fire hydrants- you don’t notice them until your house is burning, then you hope they work right. If you care about the civil justice system (your right to trial by jury) at all, remember and protect it when you vote in November.
Doctors Support Plaintiff in Wyeth Drug Case
October 6, 2008
Attorneys who take on the pharmaceutical industry as a voice for consumers injured by medications found an unlikely ally this week, in doctors. Noting that the U.S. Food & Drug Administration is often “overwhelmed” by drug safety problems ranging from serious side effects to unsafe manufacturing facilities, editors of the New England Journal of Medicine said patients benefit from information uncovered by attorneys during liability investigations, according to an Associated Press report released Friday.
Journal editor Dr. Jeffrey M. Drazen says the litigation process and the court system is a “key defense mechanism” to insure drug safety and to obtain justice if drug manufacturers have not made the risks involved with its product clear.
The doctors say the FDA is incapable of being the sole guardian of drug safety and that without the information supplied by liability litigation, “the American public would be deprived of a vital deterrent against pharmaceutical company misconduct.”
The opinion was submitted to the Supreme Court as a friend-of-the-court brief in the matter of Wyeth v. Levine, a case expected to be heard later this year. According to the AP story, the case involves Diana Levine, a guitarist who lost her right arm below the elbow after an injection of Phenergan. She sued the drug’s manufacturer, Wyeth, alleging the company had not adequately warned consumers of the risks associated with its product. The case was tried in Vermont, and the court agreed, awarding Levine $7 million.
Wyeth is appealing the case, saying the FDA had approved the drug, and that the state court could not overrule the FDA’s judgment.
However, the editors of the New England Journal of Medicine sided with 47 state attorneys general and two former FDA commissioners in supporting Levine’s position, the AP report states.
Medications and Stevens-Johnson Syndrome
October 6, 2008
Stevens-Johnson syndrome, or SJS (also called erythema multiforme) is a serious disorder of the skin and mucous membranes. The most severe cases are called toxic epidermal necrolysis.
Often, Stevens-Johnson syndrome begins with several days of flu-like symptoms, followed by inflammation of your mucous membranes and a painful red or purplish rash that spreads and blisters, eventually causing the top layer of your skin to die and shed. Many SJS victims are treated at Burn centers because the disease resembles the aftermath of a burn.
- Tongue swelling
- Facial swelling
- Hives
- Skin pain
- A red or purple skin rash that spreads
- Blisters on your skin and mucous membranes, especially in your mouth, nose and eyes
- Shedding (sloughing) of your skin
If you have Stevens-Johnson syndrome, several days before the rash develops, you may experience:
- Fever
- Sore throat
- Cough
- Burning eyes
Drugs associated with SJS
No cause is ever diagnosed for some Stevens Johnson Syndrome and toxic epidermal necrolysis victims - between 25 to 50%. However, certain drugs have been linked to this painful and deadly disease:
- Some seizure medications including Tegretol. The FDA released an alert related to these drugs. http://www.fda.gov/cder/drug/InfoSheets/HCP/carbamazepineHCP.htm
- Arthritis/pain relieving drugs like Bextra (valdecoxib) and Celebrex (celecoxib ) have been associated with SJS. The manufacturers of these drugs began warning patients in 2002. http://www.fda.gov/medwatch/SAFETY/2002/bextra.htm
- Many over the counter non-steroidal anti-inflammatory drugs (NSAIDS) now contain warnings of the risk of SJS with use. These include Daypro, Motrin and Children’s Motrin, Advil and other drugs, including drugs with ibuprofen as the active pain reliever ingredient, may be at risk of developing Stevens Johnson Syndrome.Zyloprim, also known as Allopurinol, a medication for gout and kidney stones. It has been linked to SJS.
- A high-percentage of SJS victims took Antibiotics, including those based on sulfa, phenytoin or penicillin, prior to their diagnosis.
If your doctor links SJS to drug use, stop the drug immediately! Although it is somewhat rare, occurring in about five in one million users, users who continue to take such drugs can develop toxic epidermal necrolysis, and this is fatal in up to one-third of cases.
If you or a loved one has been diagnosed with Stevens-Johnson Syndrome, contact The S.E. Farris Law Firm for a Free consultation. You may reach us at 314-A-LAWYER or by clicking here.