Fort Worth Injury Lawyer Blog

The Levine v. Wyeth case before the United States Supreme Court could effectively end the chance to litigate against a pharmaceutical drug company if that company produces a harmful drug when it had previous knowledge that the drug was dangerous. These types of cases are called “product liability” lawsuits and the general theory asserted is that the drug manufacturer “failed to warn” about the drug’s dangerous (and oftentimes fatal) side effects. Over the years, these types of cases have helped flush out many dangerous drugs, and thousands of victims of these drugs have been able to recover compensation for their injuries.

The drug manufacturers have complained that the Federal Drug Administration (FDA) approval process is strict enough, and if the warning label meets the FDA’s approval, then the drug is good enough to market. These drug companies have been arguing that federal law “preempts” a person’s right to sue in a state court action. Stated another way, the drug companies say you can’t sue them if they have obtained FDA approval. Since no drug can be sold without FDA approval, this means there would not be any way to sue a drug company if it put out a dangerous drug. Besides the drug companies, this position of “federal preemption” is supported by the Bush Administration (no surprise there—he hates plaintiff lawyers) and by the U.S. Chamber of Commerce (which lobbies hard against all types of lawsuits).

Is federal preemption a good thing? Absolutely not. There have been countless drugs sold in America which should not have been on the market. For example, American Home Products (now Wyeth) sold Fen-Phen and Redux despite having knowledge that the drugs caused valve problems and deadly primary pulmonary hypertension. Thousands of innocent people were hurt by those drugs and Wyeth did nothing but continue to rake in the profits until the FDA stepped in. Other drugs, like Vioxx, have similar stories. There are currently several other drugs in the early stages of litigation, building up to be more claims of profits over people. (Examples of such drugs include: Avandia, Chantix, Digitek and Heparin).

So, is it just the supposedly “greedy” plaintiffs lawyers who want to be able to continue bringing lawsuits? No. All consumer groups are strongly against federal preemption. Even the editors of the prestigious New England Journal of Medicine realize the good that comes out of lawsuits against bad drugs, and they have filed a brief with the U.S. Supreme Court asking for the court to rule against federal preemption.

Oral arguments in the Levine v. Wyeth case are set for November 3, 2008. This case is extremely important to the safety of the American public. Last term, the U.S. Supreme Court issued a decision finding federal preemption in cases of FDA approval of medical devices (Reigel v. Medtronic, 128 S. Ct. 999 (2008)). Let’s hope that the court departs from its inclination to help businesses at the cost of injured parties and rules that federal preemption does not apply. If the court rules in favor of Wyeth and applies federal preemption in all “failure to warn” drug caes, it will be a sad day for the safety of Americans.

For more information about federal preemption or your rights to bring a claim for a dangerous drug, please contact Board Certified Personal Injury Attorney Mark A. Anderson at 817-294-1900 or Contact Me Online.

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In an attempt to get information to the public at an earlier stage than ever before, the Federal Drug Administration (“FDA”) has announced that it will post a listing every three months of the prescription drugs which are being investigated by the FDA. The listing will be posted on the FDA’s Web site. The first list can be found below.

While inclusion on the listing will not mean that a drug is dangerous, it does mean it is under investigation and this step of informing the public is quite an improvement in open government. People should not panic if they are taking a drug that is on the list, but they should be aware of the reported side affects and talk to their doctor about it. Plus, each person should monitor their own health closely if they are taking a drug on this list or any future list published by the FDA.

I know all too well from representing many families where a loved one was injured or died from taking a dangerous drug that sometimes the risk benefit of taking these drugs is just not worth it. I don’t trust drug companies and I know first hand that they can sometimes put profits over people. Just recently I wrote in Dangerous Drug Vioxx Had Misleading Study about the initial Vioxx study that was for marketing purposes instead of safety reasons like Merck had reported.

Here is the first listing of drugs under investigation and the potential problems of the drugs:

Arginine Hydrochloride Injection (R-Gene 10)---Pediatric overdose due to labeling / packaging confusion
Desflurane (Suprane) Cardiac arrest
Duloxetine (Cymbalta) Urinary retention
Etravirine (Intelence) Hemarthrosis
Fluorouracil Cream (Carac) and Ketoconazole Cream (Kuric) Adverse events due to name confusion
Heparin---Anaphylactic-type reactions
Icodextrin (Extraneal)---Hypoglycemia
Insulin U-500 (Humulin R)---Dosing confusion
Ivermectin (Stromectol) and Warfarin---Drug interaction
Lapatinib (Tykerb)---Hepatotoxicity
Lenalidomide (Revlimid)---Stevens Johnson Syndrome
Natalizumab (Tysabri)---Skin melanomas
Nitroglycerin (Nitrostat)---Overdose due to labeling confusion
Octreotide Acetate Depot (Sandostatin LAR)---Ileus
Oxycodone Hydrochloride Controlled-Release (Oxycontin)---Drug misuse, abuse and overdose
Perflutren Lipid Microsphere (Definity)---Cardiopulmonary reactions
Phenytoin Injection (Dilantin)---Purple Glove Syndrome
Quetiapine (Seroquel)---Overdose due to sample pack labeling confusion
Telbivudine (Tyzeka)---Peripheral neuropathy
Tumor Necrosis Factor (TNF) Blockers---Cancers in children and young adults

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Last November, Merck reached a tentative settlement to resolve most of the outstanding claims it had against it due to the dangerous drug Vioxx. The settlement was contingent on the number of participants. Approximately 50,000 claimants registered for the settlement and earlier this month, Merck waived it right to walk away from the settlement. Today, the first payments are scheduled to be sent out by the administrator to the claimants’ lawyers. It should be about 40% of the total payout for those receiving these checks, but it is currently unclear how many of the claimants will actually be receiving these checks.

To get to this stage of actually distributing checks only eight months after the tentative agreement was reached is really impressive. I know that sounds like a long time, but there are millions of pages of documents to process. Let’s hope all continues to go “fast” and the victims are able to receive all of the money due them very soon. Of course, if these drug companies would put people over profits, instead of the other way around, we would not have to have any of these types of claims. But like I talked about last week when news came out about the real reason for an early Vioxx study (marketing driven), the safety of its customers is not always what these companies put as it tops priority.

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Late this week, the Federal Drug Administration informed healthcare professionals that an ongoing study has uncovered a possible link between the cholesterol lowering drug Vytorin and various forms of cancer. The study, called Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial, is designed to see if the drug will reduce the risk of heart problems in people with narrowing of the arteries. The results of the study will not be ready for 3 more months and it will take the FDA another 6 months to evaluate the results. In the meantime, there is no one calling for patients to stop taking the drug, but patients and doctors are encouraged to monitor and report any side effects.

In related news, other researchers who last year said there may be a link between statins (including Vytorin and Zocor) have now said additional work has shown that there is no such link. This report is found in the Journal of American College of Cardiology.

So what should you do if you are on Vytorin, Zocor (or its generic simvastatin) or another statin? I say keep an eye on your health and talk to your doctor if you are concerned. I am taking simvastatin and I plan on keeping track of the results of the study. I know from handling many cases involving dangerous drugs that you have to keep an eye on these things and don’t be afraid to ask questions. As I wrote about earlier this week, you can’t always trust what the pharmaceutical companies are telling you.

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According to researchers, the main purpose behind a 1999 clinical study (called Advantage) done by Merck on Vioxx was not to test potential side effects, but instead, it was meant to support a marketing campaign before the launch of this once-popular pain killer. Merck sold about 2.5 billion dollars-worth of this dangerous drug annually before the Food & Drug Administration ("FDA") called for its withdrawl in September, 2004. That's when another study showed that long-term Vioxx users had twice the risk of strokes and heart attacks.

The researchers published their findings this week in the Annals of Internal Medicine Journal. The researchers said that "seeding" (or marketing) studies such as this had long been suspected, but there had not been a "smoking gun" like this before. The original Merck study was also published in the Annals of Internal Medicine. The editor of this journal says Advantage's main purpose was not disclosed to it when the journal published the original article.

Frankly, I am not surprised by this news. Merck does put out some effective drugs, but efficacy is not the same as safety. Unfortunately, safety often gets in the way of making a profit.

It's no wonder that Merck agreed to pay 4.85 billion dollars in a massive settlement of claims last year. Considering this "smoking gun" evidence of greed, it was probably a wise move to enter into that settlement. This is just another unfortunate example of considering profits over the lives of consumers.

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Yesterday, the Federal Drug Administration (“FDA”) issues a warning about the use of Simvastatin and Amiodarone together. The FD warned that these two drugs used together can cause a muscle injury called Rhabdomyolysis, which can lead to kidney failure of even death. This wrning, which is issued to healthcare professionals, says the risk is dose related and increases when the dose of Simvastatin is greater than 20 mg per day.

So who is taking these two drugs together? Simvastatin is used to lower cholesterol. It is marketed under the trade names Zocor, Simvastatin, Simlup and Simcard. It is designed to decrease the user’s LDL level. Amiodarone is a medication used to treat irregular heart beat.

So if you are being treated for high cholesterol and irregular heart beat, take a look in your medicine cabinet. If you are taking these two drugs, call your prescribing doctor and talk about this new warning. They should know about the new warning, but it is good to bring it to their attention. And don’t underestimate the problem of Rhabdomyolysis just because it is defined as muscle injury. It can indeed be minor soreness, but I know from first hand experience the dangers of “rhabdo.” A few years ago I represented many individuals (and their families) who had rhabdo which lead to kidney failure and death after they took the cholesterol lowering drug Baycol. That drug caused so many problems, it was taken off the market. So again, I stress, don’t be a victim, take matters in your own hands and talk to your doctor about your medication options.

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