Medtronic Pumps

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The Medtronic SynchroMed II is a drug infusion pump, commonly known as a pain pump, which delivers pain medication directly into the spinal fluid.

Approved by the Food and Drug Administration (FDA) in 2004, the surgically implanted device is inserted under the patient’s skin and is used to treat patients with cancer, muscle spasms, or chronic pain.

Since its approval, the Medtronic SynchroMed II has been mired with problems, many of which have resulted in serious complications. Since 2009, design defects in the SynchroMed II have led to accidental overdoses, underdoses, life-threatening withdrawals, and patient deaths.

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Medtronic Synchromed II linked to serious design flaws

The SynchroMed II has been linked to two serious problems:

  1. Pocket fills– A design defect that can cause the pain medication to be injected into the area under the patient’s skin during refills (instead of into the device itself). “Pocket fills” can lead to overdose and patient death.
  2. Battery failures– In some implants, a film develops in the battery compartment that can reduce battery performance and lead to underdosing, the resurgence of symptoms, and life-threatening drug withdrawal.

In April 2015, the FDA and Medtronic came to an agreement after Medtronic repeatedly failed to correct violations over a seven-year period between 2006 and 2013. Multiple inspections of Medtronic’s Minnesota Neuromodulation facility turned up a host of violations regarding complaint handling and corrective actions. Due to the failure to correct the violations on several occasions, Medtronic will not be allowed to manufacture and distribute their SynchroMed II pain pump until they are permitted by the FDA.

Unfortunately, the recalled pain pump was linked to 14 deaths and more than 100 other adverse events, according to Medtronic.

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A tort is a civil wrongful act committed by a person or company that results in harm to another person. A mass tort is when multiple victims are injured by the same single tort.

A court will consider if a mass tort lawsuit is permissible by determining:

  • whether a large number of plaintiffs are involved
  • whether the plaintiffs are located near or far from each other;
  • whether the injuries sustained are similar among the plaintiffs;
  • whether the claims arose from the same cause (defective toy, car part, oil spill, etc.)
  • Defective products, such as car parts, toys, or other consumer goods.
  • Pharmaceutical drugs, such as those that are later linked to severe or fatal health consequences
  • Environmental hazards, such as polluted water sources contaminated by nearby industrial sites or an oil leak.

Thousands of lawsuits across the country may be filed with a mass tort. These lawsuits are filed in numerous federal district courts. In a mass tort, federal judges will consolidate the thousands of lawsuits into a single proceeding. One judge in a single federal district court will oversee litigation, allowing for consistent rulings and a more expeditious process for the plaintiffs.

In a mass tort, each plaintiff (injured person) has an individual claim resulting from their unique damages. In a class action, many plaintiffs are considered collectively. Similarly, in a mass tort, each individual’s claim “value” is unique to the severity of their injuries. In a class action, plaintiffs generally suffer injuries of similar severity, resulting in the same amount of compensation value.

If you have been injured or suffered illness due to a recalled drug, having an expert witnesses can be essential to proving your claim. Thomas J. Henry has spent decades building professional relationships with leading experts including:

  • Pharmacologists
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  • Biomechanics

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$50 Million

Net to Client: $27 Million

Expenses: $1.1 Million

Attorney Fees: $21 Million

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Trucking Accident
$35 Million

Net to Client: $22.2 Million

Expenses: $100 Thousand

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Product Liability
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Net to Client: $20.1 Million


Expenses: $39.6 Thousand

Attorney Fees: $10.1 Million

SPINE & BACK INJURIES

Premises Liability
$14.8 Million

Net to Client: $6.7 Million

Expenses: $652 Thousand

Attorney Fees: $7.4 Million

TRAUMATIC BRAIN INJURY

Medical Malpractice
$12.7 Million

Net to Client: $10.4 Million

Expenses: $300 Thousand

Attorney Fees: $2 Million

SPINE & BACK INJURIES

Company Vehicle Accident
$10 Million

Net to Client: $5.6 Million

Expenses: $125 Thousand

Attorney Fees: $4.3 Million

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San Antonio

1 year ago

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