Medical Malpractice Claim

Stephenson was hired by the Estate of “D.P.” to pursue a medical malpractice claim against 'ABC Hospital', as well as a claim against a surgeon who failed to timely identify a small bowel obstruction. The matter went to trial, and a jury returned a verdict in favor of the estate for $8.5 million.

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Defective Medical Devices Lawyer

We’re fortunate in the United States that we have access to the miracles of modern medicine, and that includes medical devices that replace body parts or to otherwise treat or prevent disease. Many thousands are helped each year by medical devices – unfortunately, many thousands are injured when something goes wrong in the design, manufacture or implantation of defective medical devices.


When that happens, the Indianapolis defective medical device lawyers at McNeely Stephenson can step in to obtain fair compensation for those harmed by the devices, including bereaved families grieving the loss of a loved one killed by the failure of medical equipment. Call Mike Stephenson at 1-855-206-2555 for a free and confidential consultation.

What is a “medical device”?

A wide range of equipment used to diagnose and treat patients falls into the category of “medical device” – from simple tongue depressors to pacemakers and defibrillators. In addition, laboratory equipment, in vitro and test kits, ultrasound equipment, X-ray machines and medical lasers are classified as medical devices. Drugs and blood products are not considered to be medical devices.

Who regulates the manufacture and sale of medical devices?

Medical devices are among the products regulated in the U.S. by the Food and Drug Administration (FDA). Their Center for Devices and Radiological Health (CDRH) oversees firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States.

Medical devices are classified into Class I, II, and III, with regulatory control increasing from Class I to Class III.

  • Class I medical devices are simple in design and have little to no potential risk. Although they are not life-supporting or life-sustaining, they still must be registered and properly branded, labeled, manufactured and marketed. In Class I are items such as tongue depressors, elastic bandages, slings, splints, hand held instruments and examination gloves.
  • Class II medical devices are more complex and may pose some risk to users. Most medical devices fall into this category, including hip and knee replacements, surgical mesh, X-ray machines, powered wheelchairs, infusion pumps, surgical needles and sutures, and acupuncture needles. Class II devices require special labeling, must meet mandatory performance standards and undergo post-market surveillance. They can be cleared for marketing through the streamlined 510(k) process.
  • Class III medical devices are intricate in design and have the strictest guidelines because they pose the greatest risk. Before they are marketed, they must be scientifically reviewed in clinical trials and receive pre-market approval by the FDA. Class III devices include pacemakers, replacement heart valves, silicone breast implants, and implanted cerebral stimulators.

What is the 510(k) process?

To speed up the pre-market approval of Class II moderate-risk devices (and some Class III devices), Congress established an evaluation procedure commonly referred to as 510(k) approval. To gain FDA clearance through the 510(k) process, a medical device manufacturer must only demonstrate that their device is “substantially equivalent” to another device already approved for sale. They do not have to prove that the new device is effective, nor are they required to guarantee that it will not cause injury or death to patients.

The 510(k) process has come under scrutiny in recent years. In 2009, an Institute of Medicine committee was tasked by the FDA and Congress to review the 510(k) approval process. After a two-year study, they recommended that the process be replaced as it does not adequately protect the public from device failure, but the 510(k) procedure has not yet been abandoned.

What is a medical device failure?

Regrettably, medical devices don’t always perform as they were intended to. Sometimes this is due to a defect in the initial design of the product or its component materials; at other times, a manufacturing defect can cause the medical device to endanger the patient. And in other situations, the device may malfunction as a result of software failure.

When the FDA becomes aware that a medical device is defective or could be a risk to health, it may address the problem through a recall. You can read about some of the medical devices recently recalled by the FDA or withdrawn by the manufacturers.

real-life cases

“B.K.” was driving on a two-lane road one Sunday afternoon with his mother in the front seat and his brother and sister-in-law in the back seat when his life was forever changed. B.K. was struck head on by D.C.

D.C. had spent the day drinking with a friend and had stopped at a restaurant less than five miles from the point of the accident where D.C. had been served several drinks. D.C.’s blood alcohol level was more than twice the legal limit.

As a result of the terrible wreck, B.K. received devastating injuries, which included multiple broken bones, facial fractures, and loss of vision. B.K.’s mother, brother, and sister-in-law were all killed in the accident.

As one would anticipate, D.C. had virtually no insurance. Stephenson, through his thorough and detailed investigation, was able to prepare claims against the restaurant and those that provided the alcohol.

Stephenson pursued dram shop claims against those responsible CASE SUMMARY

D.H. was a competitive bicyclist who was riding in preparation for a cross-country fundraising ride. In the spring of 2010, D.H. was riding across an old steel-grated deck bridge in Shelby County when he hit a hole in the bridge and flipped over the handlebars of his bike. The impact to the bridge decking caused severe injuries to his face, teeth, tongue, and elbow.

Through the investigation, they were able to learn as early as 1998, the bridge inspection reports showed the bridge in question needed to be replaced. The county never authorized additional inspections. The county obtained $844,000 in funding for the replacement of the bridge in 2000, but the Historical Society and adjacent property owners wanted the bridge repaired rather than replaced.

This crash could have been avoided if the inspectors and county had done their jobs. CASE SUMMARY

Our client (“D.W.”) was a front-seat passenger in a vehicle that was struck by a UDF truck making deliveries. D.W. received broken arms and legs, as well as internal injuries. Stephenson was retained by D.W.’s personal counsel to prepare and try the case. Discovery determined that the UDF driver had multiple driving violations. Stephenson retained numerous experts to show the jury the devastating effects of the injuries. Before trial, the defendant’s company stated that a jury in a small southern county in Indiana would never return a verdict for $1 million in this case.

The defendant was correct; the verdict was twice that amount. CASE SUMMARY

Defective Medical Device Lawsuits

Medical device manufacturers have a responsibility, imposed both by law and by ethics, to make products which are safe and which will provide the intended benefit. When they fail to adequately investigate their product before putting it on the market or lack quality controls in manufacture or packaging, when they attempt to skirt the regulations established by the FDA or fail to report adverse effects of which they become aware, they deserve to be held accountable in a court of law.

Victims of faulty medical devices may seek compensation for their injuries, pain and suffering, medical expenses, rehabilitation, loss of income and reduced quality of life. Mike Stephenson has been successfully litigating personal injury cases in Indiana since 1982, and he is dedicated to seeing that those who have been harmed by the negligence of other individuals or corporate entities are compensated for their injuries. If you or a loved one has been harmed by a defective medical device, call McNeely Stephenson, Indiana product injury lawyers, at 855-206-2555 or use the convenient online contact form to arrange for a free evaluation of your injury claim.

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Mike Stephenson is a Super Lawyer in Indiana along with many of his peers at McNeely Stephenson. This is one of the highest honors an attorney can achieve


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