Category: Pharmaceutical injury

How Can We Solve Generic Pharmaceutical Issue?

May 11, 2012   Staff   No comments
dangerous pharmaceuticals

New Jersey recently became grouped with a number of states whose judges have upheld the controversial Mensing ruling. The Mensing ruling refers to a Supreme Court decision reached last summer in which the justices ruled in favor of a generic pharmaceutical manufacturer that they cannot be held liable for harm caused to patients based on their labeling. The decision cited that these manufacturers are required to provide the exact labeling of their name-brand counterpart and therefore are not responsible for inadequate labeling.

For more background information surrounding this ruling, check out this article from the American Lawyer Academy.

The main issue with this entire debate lies with the fact that often times patients are given the generic brand of a medication from their pharmacy without being specifically informed. This is largely due to the fact that many health insurance companies will not cover the brand-name version of the medication and also that the generic-brand is more affordable.

Since the brand name manufacturers are responsible for the labeling, the problem then becomes that patients can be harmed by both the name-brand and the generic but only those who took the former will have the right to seek compensation. This is detrimental to the patient alone as the generic pharmaceutical company will not suffer in any way if the consumer cannot sue. The name-brand company does not suffer any hardships either as the patient who took the generic cannot sue them.

How is this fair? Who does this ruling really protect? The answer is that it is not fair and it only encourages the generic manufacturers to sell dangerous medications because they know they cannot be reprimanded for it.

Here is a scenario to highlight this unfair ruling: Say a generic manufacturer knows of a medication that has been linked to dangerous, adverse side-effects. They then decide they too want to market this drug even though they are aware it causes harm to their consumers. The harm is done to the patients, but the generic drug maker just gets to rake in the profits and not have to worry about the damage they have caused because it is the name-brand company that mislabeled or originally sold the medication.

There are currently bills in both the Senate and the House that seek to overturn the Supreme Court ruling, but with parties on opposing sides of the issue, it is unclear if or when these bills will come into effect. Pharmaceutical injury can be devastating. If you or someone you love has been injured as the result of taking a dangerous or defective drug, contact the New Jersey pharmaceutical injury attorneys at Console & Hollawell. Call us today for your free and confidential consultation at (866) 778-5500.

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FDA Questions Safety of Inhalable Caffeine

February 22, 2012   Staff   No comments
dangers of inhalable caffeine

Ever have one of those days where you just wish you could inject caffeine into your system and be on your way? Well, while you can’t get a direct shot to your blood apparently you can just breathe in the caffeine without the damaging effects of drinking energy drinks, shots, or pills. AeroShot is a revolutionary product that dispenses caffeine and B vitamins into your mouth without any calories.

While this may seem like a blessing in disguise, the Food and Drug Administration (FDA) is not so sure. According to a CNN report, the Administration is planning on investigating this new form of caffeine intake because they question its safety. The report explains that consumers can currently purchase the AeroShot, a lipstick-shaped container that dispenses the caffeine and vitamins, online or at convenience stores in both New York and Boston. And the kicker of it all—it only costs $3.

A single tube of AeroShot can be consumed all at once or in small doses according to the product’s website. In the CNN report one New York Senator, Charles Schumer, is very wary of the consequences of a product like this.

He told CNN that, “This product could be very dangerous. There might be legitimate uses. The business man staying up late who doesn’t want to drink that cup of coffee, that’s OK. But what about kids who go to bars and take several shots of AeroShot so they can drink more?”

The Senator brings up a valid point. There has been a lot of attention in the media of the dangerous of mixing caffeine and alcohol—remember the Four Loko scandal? Even with caffeine / alcohol combination drinks being altered to be less dangerous people are still dying.

Just this past weekend there was a 13-year-old boy from Maryland who died after consuming Four Loko according to news reports. So what is going to stop individuals from abusing the ease of this caffeine intake? After all, it won’t be like pounding down a Red Bull which could make you full and unable to drink as much. Senator Schumer took his concerns to the FDA by writing them a letter and the FDA reported that they will investigate his concerns and send him a response directly.

Although it is an energy supplement, in the FDA’s eyes energy pills, shots, etc. fall under the same regulations as dietary supplements. CNN reported that:

The company making them is responsible “for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading,” according to the FDA website.

It’s rare for the agency to prohibit a supplement. In 2004, it stopped the sale of the diet supplement Ephedra, but only after deaths and other serious side effects were reported.

“Manufactures are free, basically, to sell almost any product they want and to make any claims they want about dietary supplements” [David Schardt, from the Center for Science in the Public Interest] said. “It’s the burden of the Food and Drug Administration to prove that a product is unsafe and the dietary supplement industry has lawyers to defend their products and it’s a long involved process.”

At this point it is just a game of wait and see. The product has not been removed from the market, but depending on what the FDA concludes in its investigation inhalable caffeine may become just another failed product.

The FDA plays a very important role and in conjunction with other government agencies helps protect consumers from hazardous or harmful products. If you or someone you love has been injures as the result of a dangerous or defective product of any kind you may be entitled to compensation. Contact the Philly accident lawyers at Console & Hollawell today to find out what your legal rights and options are. Call us today at (866) 778-5500 to set up your free consultation.

All photos from AeroShot website.

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Pfizer Recalls Birth Control, May Cause Unintended Pregnancy

February 02, 2012   Staff   No comments
pfizer recall

There was a packaging mix up with two types of birth control pills manufactured by Pfizer. They said that they are issuing the recall of almost 1,000,000 birth control pills because the placebo pills were placed in the slots for active pills making them unable to prevent pregnancy.

The recall is for the birth control LO/OVRAL and Norgestrel/Ethinyl Estradiol. The full list of lot numbers can be found here. While these pills are manufactured by Pfizer they are sold under the label of Akrimax Pharmaceuticals, and the recall affects the products nationwide.

Pfizer asks that any and all adverse events that arise due to this recall should be reported to Akrimax Medical Information by calling 1-877-509-3935 (M-F 8 a.m. to 7 p.m. CST) or to FDA’s Med Watch Program.

The company also stressed that in order to best protect yourself from an unintentional pregnancy a backup form of birth control should be utilized. ABC News reported that birth control pills typically come in a package with 21 active pills and 7 placebo pills, but that taking them in the wrong order lowers its effectiveness. They spoke with Dr. Adam Jacobs who is an assistant professor of obstetrics, gynecology and reproductive science at Mount Sinai Medical Center in New York.

He explained that, “If this is the case, patients may be experiencing irregular bleeding and may be at higher risk for unintended pregnancy. If a patient has this lot number they should stop taking the pills immediately and discuss other birth control options with their physician including emergency contraception, if necessary.”

Pfizer reported that the error was discovered, addressed, and reported immediately. Any women who have taken the affected birth control should inform their doctor and return the pills to their pharmacy; also if you believe you have been affected by this recall and are experiencing any pregnancy symptoms you should take a pregnancy test.

Recalls should always be taken seriously in order to avoid injury or any adverse effects. If you have been the victim of pharmaceutical injury the responsible parties should be held accountable. Contact an injury lawyer in New Jersey to find out all of your legal rights and options. Call us today at (866) 778-5500.

Photo credit: US Recall News.

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$4,100,000 Settlement for Man Who Overdosed On Stolen Drugs Sparks Controversy

January 12, 2012   Staff   No comments
Harding Pharmacy & Liquors

This New Jersey case raises some questions that may never be answered since it was settled out of court. The Record reported that on September 24, 2007 Saddle River resident, Scott Simon (then 17) attended a party at Donny Nuckel’s home. At the party another guest brought Xanax that he had stolen from Harding Liquor & Pharmacy (located in Ridgewood, NJ, pictured left) where he was previously employed.

Simon took the stolen medication which resulted in him slipping into a coma. The guests at the party did not call emergency responders; instead they waited a while and then drove him to the hospital. Simon suffered permanent nerve damage that has impaired his ability to walk and talk as the result of the pharmaceutical injury.

Simon’s lawyer, John Schepisi, said, “He stays at home now, trying to recuperate. He can’t walk without help. He has been declared incompetent.”

His lawyer also asserted that Simon’s doctors have said his injuries would not have been permanent had he received immediate medical assistant. Had the party guests called 911, he may not have ended up in this permanent state.

Simon brought suit against the pharmacy for not taking proper precautions to avoid the drugs being stolen, as well as Nuckel, Nuckel’s mother (who was away for the weekend at the time of the party), the guest who brought the stolen drugs, and other party guests who failed to call for help.

All parties involved decided to settle rather than go through the lengthy and expensive process of a trial. The pharmacy is to pay $1,900,000; Nuckel and his mother will pay $1,200,000; and the remaining $1,000,000 will be paid by the remaining defendants.
Simon’s other attorney, Silvana Raso, explained that he client does share some responsibility for ingesting the drugs.

This leaves the question of, just how much fault lies with the pharmacy? They are paying the most in the settlement, which means they do recognize some fault. It remains unknown to the media what position the person who stole the drugs was in. Was he a pharmacy worker or merely a cashier? If he wasn’t qualified to be in the pharmacy portion, how was he able to get a hold of the Xanax in the first place?

Also, it is unclear why the person who actually provided the stolen drugs wasn’t held more accountable. It is unknown as to how much of the million dollars he or she will pay. With so much gray area, who really is to blame for Simon’s tragic injury? What do you think?

Photo credit: Ridgewood Patch.
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Drug Recall for Excedrin, NoDoz, Bufferin, and Gas-X—Discontinue Use

January 10, 2012   Staff   No comments
excedrin recall

The Food and Drug Administration reported yesterday that Novartis Consumer Health, Inc. has issued a voluntary recall of four of their over the counter medications. They decided to issue the recall because they have reason to believe that some of these medicines may have stray capsules from other medications or contain broken or chipped tablets. Novartis has also suspended operations at their Lincoln, NE plant where the recalled drugs were manufactured.

A full list of the affected sizes and medications can be found here.

The FDA stresses that anyone in possession of the affected medicines should discontinue use of these products immediately and contact Novartis for a refund. The Novartis Consumer Relationship Center can be reached at 1-888-477-2403 Monday through Friday from 9 a.m. to 8 p.m. EST. Contact your physician if you are experiencing problems that may be related to these medications.

Novartis will be working closely with the FDA to implement changes at the aforementioned plant before resuming operations. If you have experienced adverse effects from these recalled drugs, report it to the FDA’s MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm.

Pharmaceutical injury and recalls should be taken extremely seriously. Do not risk injuring yourself by taking recalled medications. To stay up to date on all drug recalls visit fda.gov.

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Unreleased Pain Killer Already Triggering Controversy

December 28, 2011   Richard Console   No comments
hydrocodone

With the growing abuse of pain killers and other prescription medications in this country it is no wonder that medical experts are up in arms about the development of a new super pain killer. There are four separate pharmaceutical companies that are currently conducting patient testing of a new drug formulation that is pure hydrocodone—a highly-addictive drug that is an ingredient in more than 400 pain killing medications.

If the medication gets approval from the U.S. Food and Drug Administration this would allow patients to legally obtain pure hydrocodone—something never allowed before. To illustrate just how powerful this pain killer would be, it would have 10 times the amount of hydrocodone than is currently found in Vicodin.

Currently, drug manufacturers try to combat the abuse of these medications by making them time released, but addicts are able to overcome that by crushing the pill. Those opposed to the medicine are particularly worried about the drug that is in the works called Zohydro. This specific version is being developed and tested by Zogenix in San Diego.

(Above) Zodenix plant in California. Photo credit: San Francisco Examiner.

Zogenix is hoping to apply early next year to begin marketing the drug. The company has already been meeting with the FDA about their application, and if they are approved the medication could be on the market as early as 2013. The aim of Zohydro is to manage moderate to severe pain through time-released administering. However, what makes this drug different than the others that are being abused?

(Below) Photo credit: Washington State University.

The Associated Press reported that the president of the National Coalition Against Prescription Drug Abus, April Rovero expressed apprehension about this medication.

“I have a big concern that this could be the next OxyContin,” she said. “We just don’t need this on the market.”

The Drug Enforcement Administration named oxycodone the most abused drug in the United States with hydrocodone coming in second.

The companies developing this pure hydrocodone claim that it will reduce the liver problems that are found with high doses of acetaminophen, which most pain killers on the market combine with the hydrocodone.

ABC News interviewed Dr. Lloyd Saberski who is the medical director of the Advanced Diagnostic Pain Treatment Centers in New Haven, Connecticut. He expressed that he does not think this medication should be discriminated against because the pain killers that are already on the market are highly addictive as well. He went on to say that the FDA has regulations for a reason.

“If the controls in place are failing, then we need to look at how to improve them for all the opiod class medications,” he explained. “Curtailing the availability of opioid would not help us provide medical care.”

Opiates are the cause of countless deaths in this country each year. With their high rate of abuse it is understandable that experts are hesitant to accept the idea of a more powerful pain killer.

Medication, especially powerful ones, can be over prescribed and cause harm to those taking them. More than 100,000 deaths are caused by prescription medications each year.

Richard Hollawell, a personal injury attorney who recently won $1.5 million in a wrongful death case that involved the over prescribing of narcotic medication, stated, “It’s astounding that licensed medical professionals are continually disregarding the serious risk of narcotic pain medications.”

If you or a loved one has been injured as the result of a pharmaceutical injury, contact one of the New Jersey pharmaceutical injury attorneys at Console & Hollawell.

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