FDA Announces Voluntary Recall of Defective EpiPens

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By: Marilyn McGoldrick, Esq.

Published on April 27, 2017

On March 31, the U.S. Food and Drug Administration (FDA) announced a manufacturer’s voluntary recall of a popular brand of auto-injector medical device – the Epipen – used to treat patients with severe allergies. This announcement came nearly two weeks after a similar recall was issued for the same devices in seven other countries. The recalls were a direct response to consumer complaints that the devices failed to operate as marketed.

Mylan Acknowledges Some EpiPen, EpiPen Jr Units May Have Defective Parts

Mylan NV sells the EpiPen and EpiPen Jr auto-injectors, which are actually manufactured by Pfizer. Both devices are designed to inject epinephrine–adrenaline–into patients who suffer from severe allergic reactions. When a patient goes into sudden anaphylactic shock, pressing the EpiPen or EpiPen Jr into the thigh is supposed to deliver an instant dose of epinephrine.

But according to news reports, Mylan admitted there have been at least two cases where the EpiPens failed to work. The company said the two affected patients “were able to use different EpiPens” and did not suffer any permanent damage. Nevertheless, Mylan issued a voluntary recall on March 20 for approximately 80,000 EpiPens sold in Australia, New Zealand, Japan, Denmark, Norway, Finland, and Iceland.

The March 31 notice extended that recall to the United States. The FDA said that at the present time, 13 specific lots of EpiPen and EpiPen Jr distributed between December 17, 2015, and July 1, 2016, were under recall. This includes devices with the following lot numbers:

  • 5GN767
  • 5GN773
  • 5GM31
  • 5GM639
  • 6GN215
  • 6GM082
  • 6GM072
  • 6GM081
  • 6GM088
  • 6GM199
  • 6GM091
  • 6GM198
  • 6GM087

Mylan claims the defective EpiPens “may contain a defective part” that prevents them from activating correctly. If that happens, the FDA warns there is a “life-threatening risk” of an improperly treated allergic reaction. Mylan is offering free replacements of any defective units. Customers can contact Mylan online or call 877-650-3494 for more information.

Have You Been Injured Due to a Defective Drug or Medical Device?

Even before these recalls, Mylan was already facing public scrutiny for its marketing of the EpiPen. Last year, the per-pen price rose more than 600 percent–from $47 to $284–and since the company only sold the EpiPen in pairs, many consumers were paying more than $600 to fill a prescription. Following a Congressional investigation, Mylan promised to “reimburse consumers for some of their out-of-pocket costs.”

Regardless of cost, drug manufacturers have a legal and moral obligation to produce safe, effective products. If you have been injured due to a defective EpiPen or any other medical device, it is important to speak with a Boston defective drug lawyer as soon as possible. Call Thornton Law Firm, LLP today at 888-341-1405 to schedule a consultation with one of our attorneys, or tell us your story here and we’ll call you to discuss your legal options..

FDA Backs Xarelto Despite Flawed Clinical Trial

Thornton Law Firm is no longer accepting new Xarelto cases.

By: Marilyn McGoldrick, Esq.

Published on February 1, 2017

Recently, issues were raised concerning the results of a clinical trial for the blood thinning drug Xarelto. It was discovered that a medical device used during the study was faulty and was later recalled. The effect this may have had on the study is especially concerning as more than 13 million prescriptions have been written for the drug nationwide.

Original Xarelto Clinical Trial

The results of the clinical trial in question were published in 2011. That study led to the approval of the drug’s use in patients with atrial fibrillation who were at risk of suffering a stroke. The study included over 14,000 patients and concluded that Xarelto and its predecessor Warfarin both prevented strokes. It also concluded that there was no major difference between the two medications in regards to the risk of major bleeding, although bleeding in the brain occurred less in the group which took Xarelto.

However, in 2014 a medical device used to test for blood clotting during the study was later recalled for giving inaccurate results, a problem that dated back to 2002.

Reviewing the Trial

Although Duke University’s Clinical Research Institute, which conducted the original trial, recently published a letter stating that researchers had reanalyzed the results and stood by their original conclusions, concerns still remain regarding the drug’s risks. For instance, one medical journal hypothesizes that the use of faulty equipment during the study may have led doctors to think the Warfarin levels in certain patients were lower than they actually were. As a result of this misleading data, some patients may have been given additional doses. According to the journal’s editor, this could explain why the older drug caused more bleeding than Xarelto in the trial.

Both the European Medicines Agency and the US Food and Drug Administration reviewed the results of the reanalyzed trial and concluded that the drug was safe. Still, multiple plaintiffs have come forward claiming that the drug’s manufacturer, Bayer, and its marketer, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, failed to warn users of the risks of bleeding associated with Xarelto.

Contact Thornton Law Firm, LLP to Speak With a Dedicated Defective Drug Attorney

If you have experienced internal bleeding as a result of taking Xarelto, you may have a claim for damages. Please contact Thornton Law Firm, LLP at (888) 341-1405 to speak with an experienced attorney who can help you seek the compensation you deserve. All legal claims have short time limits, so do not delay seeking legal advice.

Thalidomide, Frances Oldham Kelsey, And The Pharmaceutical Industry

By Michael A. Lesser, Esq.

Posted on Sep 25, 2013

 

 

 

 

 

 

 

Dr. Frances Oldham Kelsey

Released in Germany in 1957 as an all-purpose sedative, but later widely used as a preventative treatment for “morning sickness,” Thalidomide caused an estimated 10,000 – 20,000 severe birth defects worldwide. The injuries associated with a mother’s ingesting Thalidomide while pregnant included birth without limbs, shortened limbs, deformed hearts and eyes, and blindness and deafness. It is estimated that 39-50% of babies born with Thalidomide-related birth defects died within a few months of birth. Thalidomide’s use increased after the drug became available over-the-counter in 1960. Before its use was banned, however, Thalidomide had been linked to birth defects in more than 39 countries.

The pharmaceutical company Richardson-Merrell (now Marion Merrell Dow) sought approval for sale of Thalidomide in the United States in June 1960. Because of a loophole in the approval process, however, Richardson-Merrell was able to distribute millions of doses of Thalidomide to more than a thousand doctors in the United States while the drug was being investigated. About 20,000 patients in the United States took Thalidomide as a result. Despite efforts to win quick approval from the Food and Drug Administration, Richardson-Merrell ran into an immovable force in the person of Frances Oldham Kelsey. Dr. Kelsey, who had only recently joined the FDA as a reviewing pharmacologist, resisted the requests for approval to market the drug and instead asked for more controlled studies related to Thalidomide’s risks. When studies showed that the drug’s use had lead to more than 10,000 severe birth defects worldwide, Richardson-Merrell pulled their application for approval. In 1962, Thalidomide was banned worldwide. Compared to other countries, only a relative handful of children in the United States were born with Thalidomide-related injuries. For her efforts, Frances Oldham Kelsey received the President’s Award for Distinguished Federal Civilian Service from President John F. Kennedy in 1962 and continued her work at the FDA.

As a result of the Thalidomide tragedy, many new regulatory reforms were enacted in order to better protect American consumers. Congress passed new rules related to testing and licensing of drugs.

Unfortunately, the potential for birth defects resulting from a mother’s use of pharmaceutical drugs is still present today. A new, peer-reviewed study has found that children born to mothers who took common prescription painkillers, like Vicodin, Oxycontin, or Percocet, at or near the time of conception were more than twice as likely to be born with neural tube defects such as spina bifida. The scientists found a strong association between mothers who took these prescription opioid painkillers and a significantly increased risk of having a child with one of these serious neural tube birth defects.

If you took an opioid painkiller around the time of conception and your child was born with a neural tube birth defect, please contact attorneys David Strouss or Marilyn McGoldrick at 888-341-1405 to discuss your legal rights with our experienced team of birth defect lawyers.

DePuy ASR: First Bellwether Trial Postponed For Two Weeks

By Marilyn T. McGoldrick, Esq.

Posted on Sep 9, 2013

The first DePuy ASR bellwether trial over Johnson & Johnson DePuy Unit’s hip implants, scheduled to begin today, September 9th in the consolidated federal Multi-District Litigation, has been adjourned for two weeks.

The Court must address pre-trial matters that must be resolved before the trial can start. The judge must rule on outstanding issues ranging from choice of law, expert witness testimony and exhibits to be offered at trial. Jury selection is now scheduled to begin the week of September 23, 2013.

If you or a loved one have been injured by a defective hip implant, contact the hip implant lawyers at Thornton Law Firm for a free, no-obligation consultation. You can tell us your story online or call Attorney Marilyn McGoldrick at 888-341-1405 for a confidential evaluation of your legal case. Time limits for filing claims are short, so seek legal advice without delay.

Depuy Hip Recipients Prepare For More Trials In Hip Implant Litigation

By Marilyn T. McGoldrick, Esq.

Posted on Sep 3, 2013 

The first bellwether trial in the federal court Multi-District Litigation over Johnson & Johnson’s DePuy Unit’s metal hip implants is scheduled to begin on Monday, September 9, 2013. The plaintiff is Ann McCracken, a woman from Rochester, New York who underwent a DePuy ASR XL Acetabular Hip System replacement in 2009. She , in 2011. While this is the first trial of the federal MDL cases, 2 other cases have already been tried to verdict in the state courts and other cases have trial dates scheduled for later this fall. These other cases include the New Jersey Multi-County Litigation (MCL) Bergen County Superior Court, bellwether case set for trial on October 21, 2013; the San Francisco Superior Court, coordinated California proceedings, bellwether case set for trial in October of 2013, and the case scheduled for trial on November 8 in West Palm Beach, Florida.

J&J’s DePuy unit began manufacturing the metal-on-metal hip implants – the ASR XL Acetabular System, and the ASR Hip Resurfacing System – less than a decade ago. The ASR XL Acetabular System was submitted to the FDA for so-called 501(k) approval, meaning that J&J claimed that the product was substantially similar to products already on the market so did not require clinical trials before being sold to the public. [The ASR Hip Resurfacing System was submitted to the FDA in 2007, but that application was withdrawn and it was never sold in the U.S. However, Americans who went abroad for a hip resurfacing procedure could have gotten an ASR Hip Resurfacing System, as it was sold in other countries.]

Unfortunately, for the 93,000 people in the United States who did receive an ASR metal-on-metal hip implant, the change from the older hip implant sold by DePuy was not a minor change but a major change and, ultimately, a major defect which render the devices dangerously unsafe. J&J recalled the ASR hip implants in 2010, but at that point the damage was already done.

At the time of the recall, DePuy cited revision rates double what was expected. Unfortunately, more recent studies in the United Kingdom have shown a failure rate as high as 49%, an astonishingly high failure rate for a device that was meant to be better than the old conventional hip replacements that failed 1% to 2% of the time.

The ASR was recalled on August 24, 2010. If you received one of these hip implants and have not seen a doctor recently, we urge you to see your doctor and have your hip implant evaluated. You should ask the doctor to perform a metal ion test to see if you have elevated levels of chromium or cobalt in your blood.

Call the Boston hip implant lawyers at Thornton Law Firm for a free and confidential evaluation of your case. Ask for attorney Marilyn McGoldrick when you call 888-341-1405 and we will put our hip implant legal team to work for you.

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