Drug recalls | Console & Hollawell Blog

Category: Drug recalls

How Can We Solve Generic Pharmaceutical Issue?

May 11, 2012 Staff No comments

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.

Pfizer Recalls Birth Control, May Cause Unintended Pregnancy

February 02, 2012 Staff No comments

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.

Drug Recall for Excedrin, NoDoz, Bufferin, and Gas-X—Discontinue Use

January 10, 2012 Staff No comments

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.

6 Notorious Drug Recalls of the 2000s

December 28, 2011 Staff No comments

Drug recalls are scary. It can be hard to understand how a drug was approved by the Food and Drug Administration and then later be found to be dangerous, but over time some medications show their true dangers that were not originally seen or anticipated. All recalls are reported on the FDA website, and everyone should stay diligent with checking for health alerts and recalls. Each year about 106,000 deaths are caused by prescription drugs each year.

When pharmaceuticals are found to be defective, dangerous, or contaminated they could cause harms more serious than the ailment they were meant to treat. There are many recalls issued each year, but these notorious drug recalls are ones that will go down in infamy.

Photo credit: Current Class Action.

1. Darvon, Darvocet (Propoxyphene)
Manufacturer: Xanodyne Pharmaceuticals Inc. (Darvocet), Eli Lilly and Company (Darvon), and others
Recalled: November 2010
Propoxyphene is an opioid that was used to treat mild to moderate pain, which was taken off the market in November 2010. Xanodyne Pharmaceuticals, which manufactured the brand version of the medication, decided to voluntarily remove the medication from the market after it was learned that the medication caused serious and fatal heart rhythm abnormalities. The FDA also informed companies that produced generic medications containing propoxyphene of the risks and asked that they too remove their products from the market after Xanodyne’s decision. The drug was banned in the UK and Europe before it was in the United States.

This video helps explain the dangers of this drug and information about its ban: FDA Pulls Popular Painkiller off Market

Photo credit: Ivstatic.

2. Vioxx
Manufacturer: Merck & Company Inc.
Recalled: September 2004.
Vioxx was an arthritis and acute pain medication. It was recalled in 2004 because serious concerns arose during a clinical trial where they were testing its effectiveness for helping with colon polyps. It was discovered that this medication significantly raised the risk of heart attack and stroke. The drug was linked to 27,000 heart attacks and cardiac-related deaths. The BBC reported that as of November 2007, the company had already paid out $4,850,000,000 to settle lawsuits brought up because of Vioxx.

Photo credit: Just How.

3. Bextra
Manufacturer: G.D. Searle & Company, now part of Pfizer
Recalled: 2005.
Very similar to Vioxx, Bextra was used as an anti-inflammatory and painkiller. It was removed for the same reason as Vioxx, a link to increased risk of heart-attack and stroke. The infamy surrounding this recall came about when it unveiled a larger problem—the drug was being promoted for uses it was not approved for. The New York Times reported that the company settled with 33 states who were investigating Pfizer for $60,000,000.The NYT also reported that in 2008, Pfizer set aside $894,000,000 in order to settle the many personal injury lawsuits brought up against the company.

Photo credit: Life.

4. Lipobay, Baycol
Manufacturer: Bayer
Recalled: August 2001.
Lipobay (also known as Baycol and Cerivastatin) was a medication that treated high cholesterol. It was recalled because it was linked with a severe muscle disorder known as rhabdomoyolysis. This disorder causes the kidneys to clog with protein from dying muscle tissue, which can cause kidney failure and death. The New York Times reported in 2003 that the medication was linked to more than 100 deaths. The article also explained that the recall and lawsuits over Baycol had cost them $150,000,000—and that was when there were still more than 8,000 lawsuits pending against Bayer.

Photo credit: Ivstatic.

5. Able Laboratories generic prescription drugs
Recalled: May 2005.
Able Laboratories was a company that manufactured generic prescription drugs. In 2005 the FDA notified consumers and healthcare professionals that there was a nationwide recall issued. There were serious apprehensions about the drugs not being produced according to quality assurance standards. The drugs were found to either be too potent or not potent enough. The massive recall seriously impacted Able Laboratories and was the reason for their suspension of production.

Photo credit: Ivstatic.

6. Tylenol
Manufacturer: McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson
Recalled: January 2010, April 2010, June 2010, October 2010.
Many have a hard time forgetting the notorious Tylenol contaminations in the 80s, but various forms of Tylenol have been recalled in recent years. The April 2010 recall was issued when fears of a Burkholderia cepacia (B. cepacia) contamination arose. This recall affected Children’s and Infant’s Liquid products. B. cepacia is known to be resistant to antibiotics; the bacteria was really only a threat to those with weakened immune systems. The January 2010 recall was issued when various Tylenol products were found to have trace amounts of a chemical that is applied to wood pallets. They smelt moldy and caused various gastrointestinal problems—though they reported none were severe. The June 2010 recall was an expansion of the January recall adding several more products that had been contaminated. Then in October 2010 they had to issue another recall because of a moldy and musty smell caused by a chemical, 2, 4, 6-tribromoanisole.

While this is not a comprehensive list of the drug recalls issued in the 2000s, they are some of the largest. In the end, medications should help you, not harm you, and if you are injured by a dangerous or defective pharmaceutical you should contact a skilled attorney.

If you or someone you love has been injured or has died because of the consumption of a dangerous medication you deserve compensation. The Pennsylvania pharmaceutical injury lawyers at Console & Hollawell have the knowledge and experience needed to protect your rights and recover the damages you deserve. Call us today at (866) 778-5500 to set up your free, no-obligation consultation.