Ohio Medical Device Litigation and Product Liability Lawyer investigating device defects for injured plaintiffs nationwide

Technological advancements in medical science have delivered hundreds of new medical devices in recent years. When they are necessary for ailing patients, health care providers and patients rely on the judgment, honesty, and skill of medical device manufactures to offer safe products.

However, not all of these medical devices have been tested, and many have proved defective, injuring thousands of patients who trusted the companies who marketed the so-called safe products.

Because many of the medical devices on the market may be inadequately tested and rushed to the consumer to make a profit, victims and attorneys have filed many claims against the responsible companies. When manufactures are negligent and injure patients with defective medical devices, litigation is often necessary to restore the financial and human loss that is endured.

Although the U.S. Food and Drug Administration (FDA) is responsible for making sure that medical devices are adequately tested, device recalls have become increasingly common. Device manufacturers are often slow to respond to consumer complaints and must be held responsible for injuries caused.

Joe Lyon is a highly-rated Cincinnati recall lawyer and Ohio medical device attorney who has successfully represented individuals throughout the United States in complex product liability litigation.

The Lyon Firm works with medical specialists, metallurgists, and engineers to determine the root cause of a medical device failure.

Ohio Medical Device Lawyer Medical Device Litigation

Defective Medical Devices

Manufacturers often voluntarily recall defective products when they discover a known defect or injury risk. Other times, the FDA, consumer safety advocates and a medical device defect lawyer may apply pressure to get the devices removed from the market. In recent years, the following devices have been recalled for defects and safety risks:

Defective Medical Devices Complications

The FDA recognizes thousands of adverse event reports associated with medical devices each year. Some patients may face greater risks of complications than others, though device implants almost always carry some level of health risk. Some of the most common injuries and complications of defective medical devices include the following:

•    Metallosis
•    Severe Infection
•    Revision Surgery
•    Chronic Pain
•    Bone Fractures
•    Allergic reactions
•    Nerve Damage
•    Formation of cysts or pseudo-tumors
•    Perforation of organs
•    Device Migration
•    Lasik Surgery Error
•    Wrongful Death

Due to corporate negligence and safety loopholes made available by the FDA approval process for new medical devices, many medical devices are defective and injure American patients.

Injured plaintiffs nationwide may consult with an experienced medical device defect lawyer and potentially file a personal injury and product liability lawsuit. Device litigation helps protect consumers in the future and forces medical device companies to claim responsibility and compensate the victims for damages.

Ohio Medical Device Lawsuits

Defective Medical Device: Zirconium Hip Fracture and Failure. The Lyon Firm litigated and settled a case for a local Cincinnati man who suffered a catastrophic hip replacement failure due to a defective manufacturing process. The manufacturing process affected the physical integrity of the hip.

Specifically, the ceramic part of the implant more fragile following a change in the heating process, and the femoral head (“ball portion”) of the hip shattered when the patient was simply exiting the shower. The case was resolved at mediation for a confidential amount.

Medical Device Defect Cases

In Re: Sprint Fidelis Leads: (Nationwide Consolidation in U.S District Court, Minnesota)   Medtronic entered into a global settlement that provided $268 million to plaintiffs who suffered injuries arising from the 2007 global recall of the “Sprint Fidelis” leads.

The recall and claims were focused on reports that the leads were unsafe and prone to fracturing after being implanted in the patient. The settlement came three years after Medtronic halted distribution of the devices, known as leads, to the market. The defective devices may be linked to 13 deaths, according to the independent physician panel monitoring the matter for Medtronic.

In Re: Kugel Mesh: (Nationwide Consolidation in U.S District Court, Rhode Island). Bard entered into a global settlement for $184 million.

The Lyon Firm investigates each medical device recall and your defective medical device injuries to determine if a product liability lawsuit is viable. Holding large medical device companies accountable for defective product injury is essential to protecting patients in the future.

What is the FDA 510K Approval Process?

There are two ways in which the FDA can approve a medical device for marketing and sale in the United States. The less rigorous process is the 510K process. The 510K process essentially allows medical devices to obtain FDA approval without submitting safety and efficacy testing data. Companies prefer the 510K process to avoid delay in sales, as well as to avoid the cost to perform safety and efficacy studies.

Consequently, the 510K process allows a company to introduce a new medical device if the device is a “substantial equivalent” to another device that previously went through the more rigorous Pre-Market Approval process discussed below.

Medical devices that were approved via the 510K process are not FDA approved in the traditional sense, and it may be an important distinction in certain cases.  Importantly, there is no immunity or preemption for medical products that go through the 510K process.

The development of Preemption and the Supreme Court ruling in Riegel v. Medtronic has severely limited certain claims where products are approved subject to the Pre-Market Approval process.  This is a very complex area of law and the application of pre-emption depends on many factors.

There has been a large public outcry from the medical community and defective medical device lawyers in medical device litigation and other consumer advocacy groups to implement new legislation that clearly allows State law claims to exist.

Notwithstanding the challenges, claims that arise from defective medical devices approved through the 501k (grandfather process) or based upon a “parallel claims” (e.g., manufacturing defect) are not preempted.

FDA Pre-Market Approval

The pre-market approval process requires a medical device company to submit safety and efficacy data on the propose device in the traditional sense. It is a rigorous and expensive process. Typically, PMA products include innovative and first of kind medical device products that are cutting edge technology.  In return, these products are immune from lawsuits in most cases.

The question of preemption is one of the most technical questions in product liability law and should be directed to a well-qualified federal medical device attorney.

There are some developing exceptions to the general rule on preemption in PMA products, but, unfortunately, absent Congressional action, the vast majority of cases where the product was PMA approved are preempted, and there is no viable cause of action.

We strongly encourage patients with preempted medical device cases to write to Congress in an effort to change this draconian law. 

Ohio Class Action Lawsuits

Most personal injury cases are not appropriate for class action treatment because there are too many case specific facts that come into play when dealing with the human body. The different issues make broad class certification inappropriate. However, there is often consolidation in medical device litigation for the purposes of discovery. This is done in both State and Federal Courts around the country, and it can benefit the parties in preserving costs and ensuring consistent rulings.

The federal system for consolidation for per-trial discovery is the Judicial Panel for Multidistrict Litigation.  In the event a case is consolidated and multidistrict litigation (MDL) is established, all federal cases in the country will be centralized before one federal Judge. This procedural mechanism allows plaintiff attorneys to file cases and represent plaintiffs from across the county in an efficient manner.

While certain rulings will impact the entire MDL, each case remains a separate lawsuit and retains control over accepting or opting out of any proposed settlement.  In summary, medical device litigation is similar to a class action which benefit the plaintiff and the system as a whole in terms of efficiency and consistency, which are goals of class action, but the cases remain individual actions with the client retaining more control than in a class action.

In a sense, multidistrict litigation is a blended system and when managed appropriately it can offer the best of both worlds. However, the large number of cases involved in an MDL can delay the process.

Cincy at Night

Proving a Defective Medical Device Claim

Defective Medical device litigation involves complex questions of science and facts.  Often there is coordination amongst counsel around the country to help build the liability case in the most efficient and thorough manner.  The evidence necessary to prove a medical device involves:

  1. The product at issue. Be sure to preserve the product to the best of your ability. failure to do some may preclude you from making certain arguments, may limit the basis of your experts, and may result in spoliation and possibly dismissal. It is critical to preserve the evidence.
  2. Regulatory Documents. The first set of documents in a medical device case are documents obtained from the FDA’s website and in response to a request directed to the FDA. These documents can prove insightful to understand the type of approval process the device went through, any adverse events reported by physicians and consumers, any warning letters issued to the company related to manufacturing processes or advertisements, and any testing that was or was not performed prior to marketing.
  3. Corporate Documents.  The document production is often in the millions of pages produced. Teams of lawyers coordinate with the assistance of third party discovery vendors to compile the production and review and code the documents for relevant materials.
  4. Corporate Representative Depositions. 30(b)(6).   Companies will be asked to designate individuals to testify on certain topics ranging from regulatory affairs, science and research, marketing and sales, and post market surveillance. Depositions of the representatives will be taken to present at trial.
  5. Expert Witnesses. Each party will designate experts on critical evidentiary topics related to liability, causation and damages.  The experts will review certain pieces of evidence and draw on their background and experience to form an opinion that will be offered into evidence. Each party may challenge the basis of the expert’s opinion to preclude the submission.
  6. Treating Physicians. In most jurisdictions, the treating physician will be required to be deposed on damages. If there is a claim based on warning, the physician will need to testify that a different warning or instruction would have changed the manner in which the device was used and therefore would have prevented the injury in the specific case.
  7. Lay Witnessses. Lay witnesses, friends, family, and non 30(B)6) designees with knowledge, e.g., sales representative.
  8. Demonstrative Evidence: Computer graphics and slides are critical to assisting the jury to understand the device, the risks and the injury suffered.

Medical Device Recalls

It is not uncommon for medical devices to present numerous risks, though the industry and some surgeons have downplayed the possible complications and touted the success rates of certain procedures.

The FDA medical device approval process has arguably not evolved with the level of technology seen today in medical science. With a lagging regulation process, injury is more likely. Devices are far more complex today and may require much more scrutiny and pre-market clinical testing, which at the moment is not legally necessary.

As a result, many patients are implanted with what they think is a safe product and face serious complications and revision surgeries down the line. Medical device companies and surgeons encourage devices far beyond what is safely predictable and injured plaintiffs may contact a personal injury attorney and file an injury claim to recover damages and medical costs.

A list of medical devices recently recalled includes the following:

  • Physio-Control Inc. Defibrillation Electrodes—Incorrect placement instructions for infants depicted on artwork
  • OriGen Biomedical Medical Reinforced Dual Lumen ECMO Catheter—Separation concerns
  • Jude Medical Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D)—Premature battery depletion
  • Spectranetics Corp. Bridge Occlusion Balloon Catheter—Risk of blocked guidewire preventing balloon utilization
  • Leonhard Lang Multi-function Defibrillation—Electrode malfunction
  • Datascope Corp./MAQUET Intra-Aortic Balloon Pumps—False blood detection alarm and ingress of fluid into the Intra-Aortic Balloon Pump
  • Cook Medical Inc. Zenith Alpha Thoracic Endovascular Graft—Potential formation of thrombus inside the device after implantation
  • Datascope Corp./MAQUET Intra-Aortic Balloon Pumps—Risk of valve failure preventing balloon inflation and deflation
  • Oscor ATAR Reusable and Disposable Extension Cable—Risk of cable separation from connector
  • Penumbra Inc. 3D Revascularization Device—Wire material may break or separate during use
  • Vascular Solutions Inc. Venture Catheters—Excess material may split or separate during use
  • Magellan Diagnostics Inc. LeadCare Testing Systems—Inaccurate test results
  • Zimmer Biomet Implantable Spinal Fusion Stimulators—Potential of harmful chemicals which may be toxic to tissues and organs
  • Magellan Diagnostics Inc. LeadCare Plus and Ultra Testing Systems—Inaccurate test results
  • Abbott-Thoratec HeartMate II LVAS Pocket System Controller—Risk of patient injury and/or death during Backup Controller Exchange
  • Respironics California V60 Non-invasive Ventilator—Faulty cable pins that may cause the device to shut down unexpectedly
  • Abbott Vascular Coronary Catheters—Risks stemming from difficulty removing Balloon Sheath
  • ReFlow Wingman 35 Crossing Catheters—Tip separation
  • Medtronic Mechanical Circulatory Support (formerly HeartWare Inc.) Ventricular Assist Device Controllers and DC Adapter
  • Medtronic HeartWare Splice Kit Intended to Repair the Driveline of its Ventricular Assist Device—May cause electrical issues or Pump Stops
  • Newport Medical Instruments Inc. Newport™ HT70
  • Medtronic StrataMR Adjustable Valves and Shunts—May cause fluid buildup in the brain
  • Merit Medical Systems, Inc. Prelude® Short Sheath Introducer—Sheath may separate during use
  • Phillips Healthcare HeartStart MRx Monitor/Defibrillator—Electrical issues may prevent the device from operating properly
  • Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps—Failure of Priming Bolus
  • Physio-Control Inc. LIFEPAK 1000 Defibrillator—Electrical issue may cause the device to shut down unexpectedly
  • Zimmer Biomet Comprehensive Reverse Shoulder—High Fracture Rate
  • Physio-Control LIFEPAK15 Monitor/Defibrillator—Failure of electrical shock delivery
  • CareFusion Alaris Pump Module—Alarm Error may cause interruption of therapy
  • Bard Peripheral Vascular Inc. Halo One Thin-Walled Guiding Sheath—Sheath separation or tip damage
  • bioMerieux NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents—Inaccurate Test Results
  • Nurse Assist Inc. Normal Saline Flush IV Syringes—Possible Burkholderia Cepacia bloodstream infections

Ohio Medical Device Litigation


Joe Lyon has successfully represented individuals throughout the United States in complex medical device litigation. These cases are generally filed in Federal Court, though State Court options may be available in certain cases.

New medical technology can greatly influence the quality of life for thousands of ailing American consumers. When devices are deemed necessary, doctors, health care providers and patients rely on the good judgment, honesty, and expertise of medical device manufactures to offer safe products.

Unfortunately, manufacturers and distributors may be negligent and offer defective devices, causing medical device injuries and complications. If medical devices are inadequately tested, and sold with dangerous defects, medical device companies may be held liable for injuries that result.

In many cases medical device recalls try to preempt injuries, but unlike many consumer products, surgically implanted devices are difficult to recall and revise. Revision surgeries are not uncommon and may merit legal counsel.

The Lyon Firm works with design engineers, metallurgists, and biomechanical engineers, and medical professionals to determine the root cause of a medical device failure.

If you or a family member have been injured by a defective medical device and need an Ohio medical device lawyer, call our offices today for a free consultation at (800) 513-2403 to learn more about medical device litigation.