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DOJ Files Injunction Against Medtronic

medtronic synchromed

Recently, the US Government filed an injunction against Medtronic requesting that the company stop selling its SynchroMed II and SynchroMed EL lines of implantable pain pumps. This measure was taken after years of Medtronic flouting federal regulations related to the design, manufacture, and sale of its medical devices. In response to the injunction, Medtronic agreed to enter into a consent decree. In order to answer any questions Medtronic pain pump users may have, Ashcraft & Gerel attorney Peter Anderson answers some of the most common questions we’ve been asked:

  1. What is an Injunction?

According to the FDA, an injunction is “a civil judicial process initiated to stop or prevent violation of the law, such as to halt the flow of violative products in interstate commerce, and to correct the conditions that caused the violation to occur.” Injunctions are only used in instances when a drug or device manufacturer has demonstrated a pattern of uncorrected violations that may create a health hazard. Injunctions are filed by the Department of Justice, which is the US Government’s legal enforcement arm.

  1. Why did the Government File an Injunction Against Medtronic?

The US government filed an injunction against Medtronic because the company has a long history of violating FDA’s quality system regulations. The FDA performed inspections of Medtronic manufacturing plants on June 2006, January 2007, January 2011, May 2012 and April 2013. In each instance, the FDA found violations of quality regulations that could lead to the SynchroMed pain pumps delivering excess or insufficient medication to device users.

  1. What is a Consent Decree?

On the same day the government filed the injunction, Medtronic signed a consent decree. A consent decree is an agreement or settlement to resolve a dispute between two parties without admission of guilt or liability. The plaintiff (in this case the US Government) and the defendant (Medtronic) asked the court to enter into their agreement  The court maintains supervision over the implementation of the decree in interactions between parties. Consent decrees are frequently used by federal courts to ensure that businesses and industries adhere to regulatory laws.

  1. What Are the Terms of the Consent Decree?

As long as the court approves the decree, Medtronic will no longer sell the SynchroMed pumps, except under special circumstances, such as when a treating physician certifies that a SynchroMed pump is medically necessary. Medtronic must hire an expert to correct its regulatory violations and may not resume distribution of the product until the FDA allows it.

  1. Have People Been Injured by the SynchroMed Pain Pumps?

The FDA has issued several Class I recalls and warning letters to Medtronic based on the potential for the company’s pain pumps to cause serious injury or death. Below is a brief timeline of events:

  • June 2009 The FDA sent Medtronic a Warning Letter after finding that pumps manufactured in the company’s Puerto Rico plant were “misbranded” under FDA regulations because they were manufactured in violation of the FDA Current Good Manufacturing Practices.
  • January 2011 The FDA issued a recall after it discovered that “pocket fills” (the unintended injection of drugs or fluids into the patient’s subcutaneous tissue at the pump pocket site instead of the pump) may result in patient harm, serious injury, and/or death due to drug overdose or underdose.
  • February 2011 — Medtronic reported that nearly 300 people were injured and 8 died from “pocket fill” overdoses created by doctors mistakenly injecting painkillers directly into the patient instead of the infusion pump. Medtronic issued new instructions to physicians to correct the information gap.
  • September 2011 — Another recall was issued because the batteries on the pain pumps could fail prematurely, causing insufficient medication delivery.
  • July 2012— The FDA sent Medtronic a Warning Letter after finding that the company knew as early as October 2007 that corrosion problems could cause the pain pumps to fail, but they failed to fix the problem. The FDA received 567 complaints about corrosion.
  • June 2013 – The FDA found a potential for electrical shorting, internal to the SynchroMed infusion pump. This could result in a loss of or reduction in therapy, leading to serious injury or death.
  • June 2013 — At least 14 deaths have been linked to the SynchroMed pumps since 1996, according to Bloomberg. Most of the deaths involve overdoses or under-doses of medications.
  1. What Should I do if I, or a loved one, Have Been Injured by a Medtronic SynchroMed Pump?

First, you should make sure that you retain any evidence that might be related to your injuries. This means keeping your pain pump and any accessories that came with it, including tubing and instruction manuals. Second, you should gather any medical records or bills related to your injury. These likely will become evidence in your case. Finally, you should contact an attorney who is experienced in handling complex medical devices. The attorneys at Ashcraft & Gerel have a long history of success in defective drug and device cases and have the resources to properly handle your claim.

If you have been injured by Medtronic’s SynchroMed II or SynchroMed EL devices, please contact Ashcraft & Gerel’s experienced and skilled medical device lawyers either online or by calling 800-829-7037 for a free and confidential consultation.