Mississippi Injury Lawyer Blog

Oregon jury awards 4.5 million to pain pump victim

An Oregon jury awarded $4.5 million to a man injured by a pain pump manufactured by I-Flow Corp. of Lake Forest, California. In 2004, Matthew Beale hurt his right shoulder while playing football. After surgery, doctors inserted a pain pump, which delivered pain medication directly into his shoulder through a catheter. Over the next few months, Beale complained of continued pain. Doctors found the cartilage in his shoulder joint was almost completely worn away, a condition known as chondrolysis. At trial, attorneys for Beale proved the unapproved use of the pain pump caused the chondrolysis, a permanent injury.

The case was considered a test case for many other lawsuits pending against the manufacturer of the pain pump for an unapproved use of the medical device. The pain pump was only approved by the FDA for use in soft tissue, but I-Flow marketed it directly to doctors without informing them of the risks of using it on joints. In fact, I-Flow had previously request the FDA to approve it for use in joints, but the request was denied. Other lawsuits are pending against I-Flow, Stryker, Sorenson and other manufacturers of these pain pumps. I-Flow was acquired by Kimberly-Clark last year.

If you have been injured by a pain pump, or other medical devices, call the Kisselburgh Law Firm for a free consultation to discuss your legal rights.

FDA steps up enforcement against prescription drug manufacturers

In the first year of the Obama administration, enforcement letters from the Food and Drug Administration to drug manufacturers nearly doubled for improper marketing to healthcare professionals and patients. The FDA sent 41 enforcement letters in 2009 compared with 21 in 2008. The action shows the FDA under the Obama administration is going to be tougher on the drug manufacturers. It is about time.

The effects of these enforcement letters can be seen in some of the T.V. commercials for prescription drugs. Commercials for Pfizer's drug Chantix, marketed as a smoking cessation drug, now show one minute of safety warnings in comparison to its previous 14 seconds of safety warnings. The drug was linked to suicides in 2008. Plavix commercials now devote one-half of the commercial to safety warnings. Plavix, marketed by Bristol-Myers Squibb as protecting against future heart attacks and strokes, is linked to serious injuries including heart attacks, strokes, and internal bleeding.

When Margaret Hamburg was confirmed as FDA Commissioner in May 2009, she promised the FDA would more aggressively enforce existing guidelines and she has lived up to the promise, at least when it comes to drug marketing.

Source: Reuters, Bloomberg News

Reported by: Robert Kisselburgh, Mississippi Defective Prescription Drug Lawyer

Meridia banned in Europe, only gets contraindication in U.S.

Last week, European drug regulators advised doctors to stop prescribing the European equivalents of Meridia, a drug designed for weight loss. The Food and Drug Administration, on the other hand, only required a new contraindication that the drug not be used by people with a history of heart attacks or strokes, or who have uncontrolled high blood pressure. The amazing thing is the reactions by both drug regulators were due to the same data.

Raw data from a recent study indicated that people with certain health problems who took Meridia had more heart attacks, strokes, and cardiovascular problems than people getting a placebo. Europe bans the drug and America just adds a contraindication. I smell politics at work again at the FDA. The study was a first of its kind in that it tried to verify the claims of drug manufacturers that weight loss drugs, such as Meridia, could reduce cardiovascular risks. The results showed just the opposite for Meridia--it increases the risk of heart attack, stroke, and other cardiovascular problems.

Source: New York Times

Reported by Robert Kisselburgh, Mississippi Defective Prescription Drug Lawyer

New initiative intended to reduce deadly medication errors

The U.S. Food and Drug Administration estimates that medication errors cause at least one death per day and injure approximately 1.3 million people annually in the United States. Today's Wall Street Journal says a new effort is underway to spread the word about medication errors and offer advice to prevent similar mistakes. Read about the effort here.

Information provided by Robert Kisselburgh, Mississippi Medical Malpractice Attorney

U.S. Attorney brings charges of kickbacks against J&J in nursing home prescription drugs

The U.S. Attorney in Boston brought charges against Johnson & Johnson and two of its subsidiaries for paying kickbacks to Omnicare, Inc., the biggest dispenser of prescription drugs in nursing homes. The article says prosecutors alleged Omnicare pharmacists recommended nursing home patients with signs of Alzherimer's to be put on Risperdal, a powerful schizophrenia drug linked to increased deaths.

This filing comes on the heels of the Food & Drug Administration claiming Johnson & Johnson's delayed its recall of Tylenol and other over-the-counter medications for over a year given J&J first knew of problems in September, 2008.

Reported by: Robert Kisselburgh, Mississippi Accident Injury Lawyer

Fifth Circuit Court of Appeals disagrees with Reglan generic drug manufacturer on preemption issue

The U.S. Supreme Court, in Wyeth v. Levine, ruled that the FDA regulations governing pharmaceuticals does not preempt a state-law failure-to-warn claim against the manufacturer of a name brand drug. However, the generic manufacturer of Reglan, Actavis, argued that the Food and Drug Administration (FDA) requires the generic drug manufacturer to use the same drug label as the name brand drug manufacturer. Reglan, a drug intended to treat gastroesophageal reflux, has been associated with tardive dyskinesia, an incurable neurological movement disorder. Actavis produced and sold a generic form of Reglan known as Metoclopramide Tablets.

The arguments by Actavis were spurious at best. The fact is the FDA regulations allow a name brand drug manufacturer to change a label if important safety information needs to be communicated. I've never heard of the FDA later stating warning doctors and consumers about adverse effects of a drug is mislabeling a product. Rather, the federal regulations allow changes to the label without prior FDA approval if the labeling "adds or strengthens a contraindication, warning, precaution, or adverse reaction." In reality, what you usually find, as I found in previous lawsuits against drug manufacturers, is the drug company is doing everything in its power to keep the warning as watered down as possible. Why? Because the bad effects of the drug means less sales.

Further, drug manufacturers know that the federal regulations regarding labeling for safety issues are the minimum standard. At the deposition of an American Home Products, now Wyeth, employee charged with supervising labeling changes, he admitted to me that the FDA labeling regulations are minimum standards that can be exceeded by the drug manufacturer as well as admitting that a labeling change seeking to add or strengthen a warning could be made by a manufacturer without prior FDA approval. Only their executives and lawyers seem to think otherwise.

So how did the Fifth Circuit rule in this case? Last week in Demahy v. Actavis, Inc., the Court held the FDA regulations do not prohibit a generic manufacturer from changing the labeling for safety related issues. In fact, the FDA regulations only require that the initial labeling for the generic drug be the same as the name brand drug. The regulations are silent as to whether further changes are prohibited. The Court found the FDA regulations make clear that "the manufacturer bears responsibility for the content of its label at all times. It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market." The Court further held that, "as for maintaining an adequate label, the regulatory framework makes plain that manufacturers-name brand and generic alike-must act to warn customers when they learn that they may be marketing an unsafe drug."

This case is another example of the Bush Administrations' attempts to have federal law preempt state product liability law fail. Thankfully, in Wyeth v. Levine, the U. S. Supreme Court stopped the swing of the pendulum towards preemption of state product liability laws. Name brand and generic drug manufacturers will have to face state court juries when they fail to warn doctors and consumers of safety information and consumers are later harmed by their failure to warn.

The Kisselburgh Law Firm is a Mississippi injury law firm that handles all types of cases involving serious injury or death including defective prescription drugs, car accidents, tractor-trailer accidents, motorcycle accidents, drunk driving accidents, and injuries from defective products. If you have questions, call us at 601.936.4040 or contact us online.

Tylenol & other drugs feared contaminated; J&J expands recall

Johnson & Johnson has expanded a previous recall of Tylenol to include the following medications: Children's Motrin, Children's Tylenol, Benadryl, Extra Strength Tylenol, Tylenol 8 Hour, Tylenol Arthritis, Tylenol PM Motrin IB, Regular Strength Tylenol, Rolaids, Simply Sleep and St. Joseph Aspirin.

The recall is due to possible contamination by a chemical called 2,4,6-tribromoanisole that causes an unusual odor and has caused some customers to experience nausea, stomach pain, vomiting, or diarrhea. Customers are advised to stop using the product and contact the company either www.mcneilproductrecall.com or 1-888-222-6036

Information provided by Robert Kisselburgh, Mississippi Injury Lawyer

Drug companies slapped by FDA

The FDA slapped the hands of some drug companies who just couldn't help themselves by claiming their drugs could do things that had not be proven, from unproven weight loss to better looks. The best one, as highlighted in the article, was Bayer which claimed women were "looking and feeling great" when they took its contraceptive Mirena. The FDA, not amused by the claims, told Bayer:

FDA is not aware of any evidence suggesting that women who are using Mirena for birth control look great or feel great. Patients using Mirena may experience various side effects, such as irregular bleeding, ovarian cysts, back pain, weight increase, breast pain/tenderness, and acne, in addition to the side effects indicated above.... If you do, in fact, have data to support these claims, you should submit them to FDA for review.

Keep up the vigilance, FDA.

Reported by Robert Kisselburgh, Mississippi Injury Attorney

Drugs may not work for mild to moderate depression

Use of drugs in treating mild to moderate depression has been called in question with a new study released in The Journal of the American Medical Association. The study, which looked at the effectiveness of antidepressants such as Paxil, Lexapro, and Prozac, found these antidepressants failed to outperform placebos in patients with mild to moderate depression. One of the studies authors, Dr. DeRubeis, said "The message for patients with mild to moderate depression is 'Look, medications are always an option, but there's little evidence that they add to other efforts to shake the depression--whether it's exercise, seeing the doctor, reading about the disorder or going for psychotherapy.'"

What remains to be seen is how this new study will impact the prescribing habits of those doctors whose first line of defense for depression is medication. We live in a country where it seems the quick answer, both for doctors and patients, is medication. With the television filled with drug ads enticing consumers to find the answers to their problems in a pill and prompting patients to ask their doctors about prescribing the medication, maybe this study will make doctors, as well as patients, re-evaluate the standard protocol of prescribing medication and seek out other treatment options.

I'm also sure the drug companies will have their spin on this study and find a way to tell doctors that study really doesn't say what it says.

Source: New York Times

Attorneys beware--watch out for those subrogation liens.

Two days ago, the Sixth Circuit Court of Appeals affirmed a summary judgment where a plaintiff's attorney was found liable to the ERISA health plan for settlement funds he disbursed. A fellow blogger, Health Plan Law, has a great discussion of the case here.

For those with personal injury lawsuits, if your health insurance company pays for your medical and you ultimately recover money from the person who caused those injuries, your health insurance company has a subrogation lien for the amount of medical paid. That means you could possibly have to pay the insurance company for the amount it paid for medical expenses you ultimately recovered from the liable party.

In the case above, the client did recover monies and the attorney disbursed the settlement funds without paying the insurance company back for the medical it paid on behalf of the client. The plan ultimately sued the client and attorney for the money. Lesson to all parties. Prior to settling a personal injury case or disbursing funds from a personal injury settlement, make sure you have paid all liens.

Reported by: Robert Kisselburgh, Mississippi Accident Injury Lawyer

Drug company paid doctor almost a half a million dollars to promote Seroquel

When is a doctor's independent medical judgment jeopardized? When the drug company pays him almost $500,000.00 to promote their drug? Most would probably think so. As reported by the Chicago Tribute in a recent article, the manufacturer of Seroquel, AstraZenca, paid a Chicago psychiatrist $496,000 over a ten year period to promote its leading antipsychotic drug, Seroquel. During that time, Dr. Reinstien did research and promotional work for the company in addition to providing the drug manufacturer a vast customer base--thousand of mentally ill residents of Chicago-area nursing homes.

Interviewed for the story, Dr. Reinstien said he does not "accept any money from corporations to study their medications. This eliminates any possible conflicts of interest." But wait. How did Dr. Reinstien get his money from the drug manufacturer for his research? Through a different company, Uptown Reseach Institute. It was paid to do research by the drug manufactuer and in turn paid Dr. Reinstien a monthly consulting fee. Further, AstraZenaca paid Dr. Reinstien for promotional work on the drug. All of this evidence came to light in a recent lawsuit.

The Kisselburgh Law Firm is a Mississippi drug injury law firm which handles all types of cases involving serious injury or death including injuries from prescription drugs, car accidents, tractor-trailer accidents, motorcycle accidents, drunk driving accidents, and injuries from defective products. If you have questions, call us at 601.936.4040 or contact us online.

Tort Reform debate is a red herring in Mississippi and other states

Over the last couple months, the "Tort Reform" debate has heated up again. With Washington looking at health insurance reforms, the U.S. Chamber of Commerce and their many mouthpieces are talking about the need for more tort reform. Folks, it's a red herring. The high cost of health insurance is not due to out-of-control lawsuits brought by evil plaintiff attorneys. The facts prove it.

One of the great myths perpetuated during these tort reform debates is that doctors are practicing defensive medicine because they are afraid if they don't run the test, they will be sued. This myth was busted by a number of reports showing defensive medicine is motivated more by profits for doctors who are making money when they send patients for medical imaging. The New Yorker ran a great piece about the high costs of medical care in McAllen, Texas, the Dallas Morning News reported on the increase of medical imaging in the Dallas-Fort Worth metroplex and doctor discussed his first-hand experience with over-utilization as a patient.

Indicative of the myth is a great exchange between local two McAllen, Texas doctors in the New Yorker article:

"McAllen is legal hell," the cardiologist agreed. Doctors order unnecessary tests just to protect themselves, he said. Everyone thought the lawyers here were worse than elsewhere.

That explanation puzzled me. Several years ago, Texas passed a tough malpractice law that capped pain-and-suffering awards at two hundred and fifty thousand dollars. Didn't lawsuits go down? "Practically to zero," the cardiologist admitted.

"Come on," the general surgeon finally said. "We all know these arguments are bull---t. There is overutilization here, pure and simple." Doctors, he said, were racking up charges with extra tests, services, and procedures.

Another great myth perpetuated during the tort reform debate is that doctors are leaving the state due to out of control lawsuits. This was a big one used by Mississippi's governor. However, facts prove otherwise. A recent article reported there was no decrease in the number of doctors in Mississippi. It stated, "Information compiled by the American Medical Association ... shows that the number of physicians in Mississippi rose steadily in years leading up to tort-reform legislation in 2004, and even slowed its increased following 2004."

So let's put the "tort reform" punching bag away and get down to studying the true problems of our health care system and the need for reform.

h/t: ThePopTort.com has a number of articles on this issue at here, here, here, and here.

Information provided by Robert Kisselburgh, Mississippi Accident Injury Attorney

Another new diet drug being tested

Reminiscent of the fen-phen diet drug, phentermine (the "phen" of "fen-phen") is being used in combination with the anticonvulsant drug topiramate in hopes of being the new diet drug. In a recent announcement, Vivus, the developer of the drug combination known as Qnexa, says patients lost an average of 37 pounds a year. In the first trial, EQUIP, of the drug involving 1,200 obese patients, there was an average of 14.7 percent weight loss, but only at the higher doses. In the second trial known as CONQUER, approximately 2,500 patients received the drug combination and showed an average of 30 pounds of weight loss, again at the highest doses.

Phentermine, a stimulant, has the ability to act as an appetite suppressant. But it can also increase blood pressure and heart rates. That was why it was prescribed with fenfluramine during fen-phen. The fenfluramine, Pondimin, counteracted the stimulant effect. In this new drug combo, Topiramate is the downer. Topiramate is best known as an epilepsy drug which gained increased off-label use when some studies showed it had a beneficial "effect on binge eating and weight reduction."

The worrisome aspect is the lack of reliable long-term safety data. If Vivus decides to go ahead with further testing of the combination and get approval for the combination, then the Food and Drug Administration (FDA) will require further safety testing. However, that is a big IF. And the fact is that Phentermine and Topiramate are FDA approved drugs. While they have not been approved in a combination form by the FDA, there is nothing which prevents doctors from prescribing the combination now. That is what happened in Fen-Phen. Two FDA approved drugs were used in combination for long term use without reliable long term safety data. When the studies were finally done, they showed major problems with cardiovascular risk as well as increasing the risk of a deadly disease known as primary pulmonary hypertension.

The weight loss industry is a billion dollar industry and our society is always looking for the quick fix. Unfortunately, the answer does not lie in a drug combination. If a drug were the answer, you would have to take the drug for the rest of your life. I have yet to see any study showing any drug or drug combination keeps weight off after you quit taking the drug. In fact, studies upon studies have shown that when a person quits taking a pill or goes off their diet, the weight is regained plus more. This is called the rebound effect. The only way to counteract that rebound effect is exercise and changes in eating habits.

So there is the problem. If you have to take these drugs for a long period of time to lose the weight AND keep it off, where is the safety data showing long term safety? Currently, there is none. Until there is long-term safety data showing the safety of using these drug in combination for long period of time, people should not take the combination for weight loss nor should doctors prescribe it.

Hopefully, the FDA will closely monitor any future trials as well as step up vigilance to ensure the manufacturers of Phentermine and Topiramate are not promoting this off-label combination use of the drugs.

Reported by Robert M. Kisselburgh, Mississippi Injury Attorney

FDA looking into reports of liver damage from use of diet pills alli and Xenical

The Food and Drug Administration is reviewing the safety of Orlistat (alli and Xenical) due to more than 30 reports of liver damage in patients taking the drugs. Orlistat is marketed in the United States in the prescription form as Xenical and as an over-the-counter drug alli. alli is half the strength of Xenical.

According to the FDA,

Between 1999 and October 2008, 32 reports of serious liver injury, including 6 cases of liver failure, in patients using orlistat were submitted to FDA's Adverse Event Reporting System. Thirty of the 32 reports occurred outside the United States. The most commonly reported adverse events described in the 32 reports of serious liver injury were jaundice (yellowing of the skin or whites of the eyes), weakness, and abdominal pain. Hospitalization was reported in 27 of the 32 cases.

In addition to the 32 reported cases, this issue was discussed at the CDER Drug Safety Oversight Board in April 2009, and FDA is reviewing other data on suspected cases of liver injury submitted by the manufacturers of orlistat. FDA's analysis of these data is ongoing and no definite association between liver injury and orlistat has been established at this time.

Both of these drugs were approved by the FDA for weight loss, although it is highly suspect how effective these medications can be. Unfortunately, people are led to believe that weight loss can be found in a pill. The facts usually show that the weight loss from such drugs is negligible and not worth the risks of taking these drugs.

If you or a loved one has been injured while taking either of these medications, you should consult with an attorney. At the Kisselburgh Law Firm, we have years of experience in representing those injured by the use of prescription medications. Contact us online or call 601-936-4040 for a free consultation.

Weight Loss Drugs recalled given link to liver injury and one death

Today the FDA issued a warning to consumers to stop using Hydroxycut products by Iovate Health Sciences, Inc. of Oakville, Ontario and distributed by Iovate Health Sciences USA, Inc. According to the reports, the FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes to liver damage and failure. One death due to liver failure has also been reported.

Marketed heavily as America's #1 weight-loss drug, the Hydroxcut brand was sold at national chain stores including GNC and the Vitamin Shoppe. The list of products being recalled include:

Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
Hydroxycut Regular Drink Packets
Hydroxycut Caffeine-Free Drink Packets
Hydroxycut Hardcore Drink Packets (Ignition Stix)
Hydroxycut Max Drink Packets
Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink)
Hydroxycut Max Aqua Shed
Hydroxycut 24
Hydroxycut Carb Control
Hydroxycut Natural

If you or a loved one has been seriously injured by the use of prescription drugs or dietary supplements, you need to speak with an experienced pharmaceutical lawyer. You can contact us at 601-936-4040 or contact us online for a FREE CONSULTATION.

FDA Consumer Warning-Hydroxycut
FDA Hydroxycut Products Page