Drugs/Medical Archive
Levaquin Side Effects Risky—not Rare—for the Elderly
April 5th, 2011. By janem
According to the Levaquin manufacturer and even some government agencies, Levaquin side effects are rare. But tell that to possibly thousands of people who have suffered tendon rips and ruptures after taking Levaquin, sometimes for a slight sinus infection. (By September 2010, more than 1,000 reports of tendon problems had been documented.)
Elderly people are at risk for a few reasons. It’s easy to chalk up a torn Achilles tendon to simply old age and overuse; they could be on a number of meds so the finger can’t be pointed directly at Levaquin; they could have other, ongoing problems.
I also found out that Levaquin is over-prescribed and should only be used as a last resort, when other antibiotics fail. So why have I interviewed a number of people (like Marcia, a ballet teacher ) who took it for a minor sinus infection? And by all accounts, their doctors are not aware of Levaquin side effects because they aren’t being told by the drug maker! Sure, we could argue that our health providers should know, but how many hours are there in a doctor’s day to research all the meds they prescribe? I can understand their logic: If it ain’t in the big blue book, it’s OK by me.
I interviewed 73-year-old Carol (not her real name) yesterday—yet another Levaquin victim. (BTW, I –personally–must have interviewed dozens of Levaquin victims in the past few years, so how can the side effects be rare?) Anyway, her story is a typical example of Levaquin’s serious side effects, and how the drug company is getting away with so many injuries…
Carol took the 5-day course of Levaquin in January 2009 and her infection cleared up right away. Then she took it again in May for a bout of bronchitis. “In November I had some trouble with my ankle,” says Carol. “I just figured I had overused it (I live in New York and walk everywhere) and could just walk it off; apparently it’s common to have foot problems when you get older. Close to Christmas I ended up at the podiatrist: he took an x-ray, said it appeared to be inflamed and put me in a walking boot to keep my ankle stable, and sent me to physical therapy…
In September I was at the beach with my friends and I was limping due to a back problem. My friend asked if anything was wrong with my ankle. Then she said, ‘ Have you ever taken Levaquin because I took it and my ankle starting aching right away so my doctor told me to stop taking it—ASAP.’ I’d never heard of such a thing!”
What really amazes me is why so many people still don’t know about Levaquin and its link to tendon ruptures and rips—an injury that is not only very painful, but hard to recover from when you get older…
“Now I find out, through a friend who worked at J&J for years, that Levaquin has a black box warning,” says Carol. “Besides a recall, that’s the worst thing that can happen to a drug.” And potentially the worst thing that can happen to the consumer. (Incidentally, a lawsuit accused J&J of pushing Levaquin on to senior citizens, who didn’t even need the drug.)
“The first time I looked up Levaquin’s black box warning, it was contraindicated for people over 60,” Carol points out. “Now young people are being warned. My friend has a 24-year-old daughter who was given Levaquin and her doctor told her not to run while taking it. Ah hah, now the warnings are for young people too.
All I can prove is that I took Levaquin twice and had tendon problems—I had my entire left foot rebuilt and spent 10 weeks in a wheelchair. But whether I can connect the two—that’s up to the attorneys. However, if I am deemed eligible and can join a class action, then I will.”
Botched Procedure: When Corrective Surgery Doesn’t Correct
April 5th, 2011. By LucyC
What would you do if you couldn’t fully close your eyes? Personally, I can’t imagine how awful that would be. And what if this condition was a result of surgery—surgery that was meant to correct an existing problem?
These days, the news is full of ‘bad plastic surgery’ stories, complete with some pretty horrifying images. In the case of New Jersey resident, Marilyn Leisz, the outcome is particularly tragic, and resulted in her suing her plastic surgeon for medical malpractice.
The back story is that six years ago Leisz had a condition known as ptosis which weakens the eyelids, eventually causing them to droop. Having tried for years to correct the condition, she eventually decided to go the cosmetic surgery route and in 2000 had her first eyelift. All went well. In 2005 she had a second eyelift. But shortly after this surgery Leisz began to grow concerned because she noticed the development of small bumps along the creases of her eyelids. She became concerned about her vision.
So Leisz consulted with a new plastic surgeon (Dr. Paul Parker), who recommended trying a scar removal product before embarking on more surgery. She tried the product and it didn’t work. Then, in consultation with her new surgeon, she underwent a procedure called blepharoplasty in which the excess tissue and fat is removed from around the eye. That’s when things started to go horribly wrong.
According to a story on MSNBC.com, Leisz said was led to believe the procedure was minor and that there shouldn’t be any problems. If anything—it should give her a more youthful appearance.
We all know where this is going. Following the surgery, Leisz found she couldn’t close her eyes completely. This resulted in her eyes burning, and her tear ducts not functioning as they were supposed to. Her surgeon allegedly told her this was part of the healing process. But when that healing process turned out to be never-ending, she sought the opinion of another plastic surgeon. He must have confirmed her worst fears—telling her she should never have undergone the blepharoplasty which this doctor testified to in court. Reportedly, Leisz has undergone a total of 30 surgeries, which have enabled her to partially close her eyes.
She did sue the surgeon who performed the blepharoplasty, and was recently awarded $115,000. In fact they found that the surgeon had deviated from the accepted standard of care in this instance.
While she said she is glad she had her day in court, the fact is Leisz’s ordeal is far from over. She has to use a special gel and vaporizer to keep her eyes moist, and she has to sleep with a mask at night to prevent her from scratching her corneas.
Leisz told TODAY’s Ann Curry “To take a shower, I have to put gel into my eyes so the water and the soap doesn’t get into my eyes. Then by the time the shower is done, the gel’s washed out.” Worse, she lives with the fear of infection, glaucoma, corneal ulcers and blindness which could result from her medication.
In the MSNBC story, Leisz said her life has been thrown into shambles. “I feel like my whole life has been stolen from me,” she told NBC News. “Your eyesight affects everything that you do.”
Tenet Healthcare Katrina Class Action at Tentative Settlement
March 28th, 2011. By LucyC
Six years later and counting—the mess from Hurricane Katrina drags on. This month, one of America’s largest health care corporations was due to go to court over allegations that it is responsible for deaths and injuries at a hospital in the Big Easy during the hurricane.
However, in the middle of jury selection last week, Tenet Health/Memorial Medical Center reached a tentative settlement—the details of which will not be disclosed until it has received final court approval.
The class action lawsuit is brought on behalf of people who were essentially marooned at the Memorial Medical Center during the storm of the century. It alleges that the hospital had insufficient electrical back-up in place to deal with the events, as well as failed plans for patient care and evacuation, which resulted in death and in injuries. The hospital sheltered about 1,800 people during the hurricane.
Memorial hospital was owned by Tenet Healthcare Corporation, but has since been sold, along with the company’s other Louisiana hospitals, interestingly. At the time, Tenet reportedly did not have an emergency command system set up to deal with the catastrophe —but instead instigated a plan during the hurricane. While officials at Tenet lobbied to get federal rescuers to help out—and who ultimately did not—the company, realizing it was on its own, spent something like $1 million Read the rest of this entry »
Understand the Pharmaceutical Representative Overtime Lawsuits? Here’s Help
March 25th, 2011. By Kristine B
If not, you’re not alone. In fact, even the courts have reached contradictory rulings in the pharmaceutical representative overtime lawsuits they’ve seen. While the pharma reps won the Novartis lawsuit, they lost the Johnson & Johnson and GlaxoSmithKline lawsuits. Those losses, however, don’t mean that pharmaceutical sales reps should just give up. In each case, the judges relied on different legal issues and exemptions, which is how such different results were achieved. Pleading Ignorance takes a look at what’s been going on…
First, the Backstory: the Fair Labor Standards Act
Under the Fair Labor Standards Act, certain employees are considered exempt from overtime pay. Those exemptions include outside sales employees and people who are considered “administrative”. Outside sales employees are considered exempt because they are paid on commission and therefore have an unlimited earning potential. Furthermore, many outside sales people work independently of an office and therefore have a say in what hours they work and how they go about their job. To be considered exempt from overtime pay, however, outside sales people must spend at least 50 percent of the time in their job involved in sales.
Administrative people are those who exercise independent authority, judgement or discretion in their job. They have a great deal of discretion in their job activities and how they fulfill their employment requirements.
Lawsuits have been filed against various pharmaceutical companies alleging that pharmaceutical sales reps do not fit either the outside sales exemption or the administrative exemption.
Novartis Sales Rep Overtime Lawsuit
In the Novartis lawsuit, the court found that the pharmaceutical reps were misclassified as exempt from overtime pay—meaning they should receive pay for overtime hours worked. In reaching the decision, the court found that Novartis sales representatives were not directly involved in the sales transaction. Instead, the reps informed physicians of a product’s benefits and encouraged physicians to prescribe Novartis products. At no point during the visit did the sales rep actually engage in a sales transaction.
Furthermore, the court found that the Novartis reps didn’t fall under the administrative exemption because Novartis controlled the sales pitches and reps were not allowed to deviate from that pitch. Additionally, the reps did not have the authority to in any way direct or interpret Novartis policies or procedures. Because the courts found the Novartis reps were not exempt under the outside sales or administrative rules, the reps are therefore, according to the courts, eligible for overtime pay.
Johnson & Johnson Sales Rep Overtime Lawsuit
A lawsuit against Johnson & Johnson, however, resulted in a different decision. In that case, the pharmaceutical sales representative was found to be exempt from overtime pay under the administrative employee guidelines. In that case, the court found that the plaintiff was able to develop her own itinerary, could visit some doctors more frequently than others and was expected to develop a plan to obtain more sales. The court found that the plaintiff worked without direct oversight most of the time and therefore had discretion and independent judgment required for the administrative exemption.
GlaxoSmithKline Sales Rep Overtime Lawsuit
In GlaxoSmithKline’s lawsuit over pharmaceutical representative overtime pay, the courts backed GlaxoSmithKline’s decision not to pay the reps overtime. In this case, unlike Johnson & Johnson, the court determined that GSK sales reps fall under the guidelines of outside sales representatives because they are motivated by commissions and they have freedom to work outside the office.
So it currently appears that whether or not a pharmaceutical rep is eligible for overtime pay is somewhat determined by which court hears the lawsuit and by which company you work for and how much authority you have in your job.
The court’s decision in GSK actually contradicted a brief filed by the US Department of Labor that supported pharmaceutical reps being paid overtime. So, even though the Department of Labor supports overtime for pharmaceutical reps, there’s no guarantee that the courts will agree with it. More lawsuits are still to come and the Supreme Court might wind up determining the whole thing in the end. As of now, though, there’s no reason for pharmaceutical representatives to give up the fight.
Medical Malpractice: It Takes Two, Baby
March 24th, 2011. By Kristine B
If you’ve ever watched any of the seemingly endless supply of medical dramas on television (Grey’s Anatomy, House, Private Practice…) you’ve probably heard the phrase “medical malpractice”—or some variation of it—tossed about threateningly. It’s also a popular plot twist in soap operas—General Hospital fans will recall Dr. Patrick Drake (and his half-brother, Matt) being sued for malpractice. 
Great as it may be for adding intrigue to a plotline, medical malpractice—or at least the true meaning of it—tends to get lost and twisted in the drama. So this week, Pleading Ignorance shines a light on what medical malpractice, otherwise affectionately known as “med mal”, is…
Let’s start with the more technical version: medical malpractice is either an act or failure to act on the part of a health care provider, where that act or omission deviates from reasonable standards of care in the field and causes harm to the patient. Got that? Basically, medical malpractice has two parts. First, the negligence and second, the harm to the patient.
1. Medical Malpractice: The Negligence
The negligence part of medical malpractice is the first part of the explanation above. Negligence is any act or failure to act by a medical professional where the care provided does not meet generally accepted standards of practice. So, what does that mean? It means that person providing the health care—a doctor, nurse, dentist or any health care professional—does not provide care that meets accepted standards.
That’s important, because there’s a difference between a medical professional being negligent and a medical professional who has done all he can to help a patient but still can’t find the answers.
Say a patient, we’ll call her Sarah, goes to the doctor with a variety of symptoms. Dr. A runs test after test, has follow-up visits, consults with other doctors and still can’t determine the cause of Sarah’s problems. Finally, after a long process, Dr. A determines that Sarah has cancer and the cancer has progressed too far to be operable. Dr. A is not necessarily guilty of medical malpractice because he has met an accepted standard of care by sending Sarah for tests, scheduling follow-up appointments and so on.
Now, say Sarah goes to Dr. B. Dr. B listens to Sarah for a while but ultimately decides that her pain is in her head. So he sends her home without requesting any tests and does not offer to follow up with her. Sarah repeatedly sees Dr. B with the same complaints, but is always dismissed by the doctor. Eventually, a different doctor diagnoses Sarah with cancer, but by then the cancer is not treatable. Dr. B may be guilty of medical malpractice for not meeting a reasonable standard of care in Sarah’s situation.
Whether or not a doctor is negligent depends on whether a reasonably competent doctor who has Read the rest of this entry »
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