ROBOTIC SURGERIES


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Modern technological advances in surgical equipment has brought many new devices onto the market. Some devices have the ability to help patients and doctors a great deal, while others have a history of complications and malfunctions, with the potential for serious patient injury.

When defective medical devices are used in the healthcare industry, patients have the right to file Da Vinci surgery lawsuits following any related injury.

Many medical device defects are not known until after an accident occurs because equipment may not be properly tested before it is distributed to hospitals and medical clinics. The DaVinci Surgical Robot has been linked to severe complications and has been targeted by personal injury and product liability attorneys in da Vinci surgery lawsuits due to injury.

Joe Lyon is an experienced CIncinnati, Ohio product liability lawyer and medical device attorney reviewing da vinci surgery lawsuits for injured plaintiffs nationwide.


Da Vinci Surgery Injury


Manufactured by Intuitive Surgery, the Da Vinci Robot Surgical System has been utilized in thousands of American hospitals for hysterectomies, prostate removals and other types of surgery. The system is partially manned with a surgeon using a joystick to guide a robot during the surgery.

But after injuries, reports and complaints say that the system is poorly designed and manufactured. The following complications and side effects have been reported:

  • Sepsis
  • Internal bleeding
  • Impotence
  • Punctured organs
  • Bowel injuries
  • Incontinence
  • Revision surgery
  • Wrongful Death

Da Vinci Recall & FDA Warning


After the U.S. Food and Drug Administration (FDA) received thousands of reports of the Da Vinci Surgical Robot malfunctioning—mechanical and software issues—the FDA issued a device recall. The company itself admitted the Da Vinci Surgical Robot malfunctions after reports of “instrument cable breaks.”

Studies indicate that the malfunction risk is low, from around 0.4-2.4 percent of all procedures, though that amounts to hundreds of patients compromised each year. An FDA recall was issued in 2016 after thousands of adverse events from the Da Vinci Surgical System have been reported to the FDA.


Da Vinci Lawsuits


The Da Vinci surgical robot is manufactured by Intuitive Surgical. The machine is used in various operations, including hysterectomies. The Da Vinci surgeries are marketed as minimally invasive alternatives to a traditional abdominal incision hysterectomy. The Da Vinci process produces less trauma, which allows for a faster recovery time.

Unfortunately, Wrong Site Surgery Lawsuits have been reported. The overuse of robotic surgery in benign cases leads to tissue damage, bleeding, scarring, and other robotic surgery injuries. The risk of these complications is increasing with the growing popularity of robotic surgery. The range of surgical complications has hurried corrective procedures, encouraged by the FDA.

The Da Vinci device performs hysterectomies, among other procedures. A Hysterectomy is the surgical removal of the uterus. It is a very common procedure with over 600,000 performed each year in the U.S. With 90 percent of hystorectomies performed being benign. In some cases the uterus is removed and in others, only partially removed.

There are risks involved in any operation, but particularly with a hysterectomy which affects hormonal balances and the overall health of a patient. Hysterectomy patient complications include:

  • Bleeding
  • Cramping
  • Bladder injuries
  • Scarring
  • Chronic pelvic pain
  • Vaginal injuries
  • Revision Surgeries

Robotic Surgery Injuries


Healthcare professionals say Intuitive Surgical pressures hospitals into using their technology, and accuses hospital management of not adopting technologically sophisticated tools if they do not use the robot. They also say hospitals and physicians will lose market share if they do not implement robotic tools.

Intuitive Surgical denies that there is a high level of risk related to robotic surgery. However, the over-use of robotic surgery in benign gynecological cases causes problems that may not occur if the surgeries were performed manually. Intuitive Surgical and hospitals are responsible for the complications associated with robotic surgery, and are liable when injuries result.

Why are hospitals using the robot so much? Records show that since 2013, Intuitive has paid over $144 million to doctors and hospitals, ostensibly for education, but some plaintiffs question the overall motivation for using the product and risking the health of patients.

An NBC News look into FDA adverse event reports over the past 10 years was quite telling of the risks. The database showed more than 20,000 adverse events related to the da Vinci robot. The reports were filed by the company itself, hospitals, doctors and patients. The amount of da Vinci robot surgeries performed in the U.S. has increased by over 50 percent since 2013, to nearly 700,000 operations.

More than 2,000 adverse events seen by NBC were categorized as involving injuries, 274 were categorized as deaths. Thousands of Da Vinci device malfunctions were reported, and now hundreds of malpractice and product liability lawsuits are pending.

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A Voice for Those who have suffered 

Why are these cases important?

Many product liability cases have had a positive impact on public health and safety, and we have witnessed improved lives and future injuries prevented as companies are forced to remove products and change designs and warnings as a result of litigation.

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Questions about Product Liability & Case Types

What is a Product Liability Lawsuit?

Product liability lawsuits often contain causes of action for strict liability, negligence, and breach of warranty. Strict liability applies to different factors than negligence-based claims.

In negligence cases, the actions of the defendant are the focus. In strict liability claims, the focus is on the condition of a product at the time it left the manufacturer. If a product is determined to be defective, the company is liable for any foreseeable injuries that are in-part caused by the defective condition of the product.

What are some examples of Product Liability?
How is a Product Defined as Defective?
Ohio Definition of Defective

A product is defective if it is unreasonably dangerous for its intended use. A legal cause of action can be based on several types of product defects. The following are Cincinnati product liability and strict liability claims available in Ohio and in most jurisdictions nationwide:

(1)  Manufacturing/ Construction Defect:

These issues arise where the product is released from the factory in a manner that deviates from the intended design or specifications. The defect can be a result of using the wrong materials, including the wrong or completely foreign materials (e.g., Tylenol contamination, food poisoning, damaged car part from factory installation).

As a result of the deviation, the product enters the market in an unreasonably dangerous condition and the consumer is exposed to or purchases a product that is defective. Any personal injuries or economic loss that arise from the the defect are compensable under Ohio product liability law.

(2) Defective design and/or formulation:

Defective design product liability cases arise not because a mistake was made during the manufacturing process, but rather the original design of the product is unreasonably dangerous. A “risk benefit analysis” is used to determine whether safer/less expensive alternative designs were available to the manufacturer.

Federal regulations set minimum standards for the design of many consumer products, and preemption defenses may preclude liability in some situations if the manufacturer follows and obtains federal approval for a product. Automotive recalls and product liability cases are usually a result of a defective design. Common cases include the Toyota Brake Recall, Chrysler Gen III seat belt buckle, lap belt only cases, Metal on Metal hip implants, transvaginal mesh.)

(3) Failure to warn or inadequate warning or instruction associated with the product:

All consumer products come with necessary and appropriate warnings and instructions for use. If the lack of a warning makes the product and use of the product unsafe, the manufacturer is liable for the failure to place the warning. The most common area of litigation for failure to warn is in pharmaceutical litigation.

Pharmaceutical manufacturers are required to warn of the known or foreseeable side effects and update the warnings in a timely manner. Litigation arises where there is evidence the manufacturer failed to timely update a warning in light of new data or simply ignored the risk and failed to conduct sufficient research to identify and then disclose the risk.

(4) Misrepresentation:

The product fails to conform to a representation or warranty. Warranty claims are more common in commercial and economic loss cases than in personal injury cases. In many States, The Product Liability Act does not apply to cases with only economic loss, because the Commercial Code provides recourse for breach of warranty.

The warranty may be written or implied based upon the products intended purpose and merchantability. An example of a breach of warranty cases are cases involving automotive defects.

How do you prove design defects?

Risks:  The following factors are considered under Ohio law when determining the risks associated with the design of a product:  (1) the magnitude of the risk of injury; (2) ordinary consumer awareness of the risk for injury; (3) the likelihood of causing injury; (4) the violation of a private or public standard; and (5) the consumer’s expectation of the performance of the product and level of danger. Ohio Revised Code 2307.5 (B) Product Defective in Design or Formulation.

BenefitsThe following factors are considered under Ohio law when determining the benefits associated with product design: (1) the utility of the product; (2) availability of an alternative design; (3) the magnitude of risks associated with an alternative design. Ohio Revised Code 2307.5 (c)

Defenses for Defective Design(1) a pharmaceutical drug or medical device is not defective by design if it contains an adequate warning of an unavoidably unsafe aspect of the pharmaceutical or medical device; (2) the dangerous aspect is inherent to the product, recognizable, and cannot be eliminated without compromising the product’s usefulness; (3) a lack of a feasible alternative design. 2307.75 (d)(e)(f).

EXAMPLES:

What is a manufacturing defect?
  • A manufacturing defect is based on a defect that occurred during the manufacturing process. Many auto companies have been involved in this kind of product liability lawsuits in recent years, due to defective airbags, software defects, tire failure, and other dangerous manufacturing errors.

    Most manufacturing defect cases are based on a products deviation from the intended specification, formula, performance standards, or design model. In such cases, it may be easy to determine the product did not comply with the intended design.

    The product may be recalled as a specific lot is identified as being non-compliant and defective. A product may be defective in manufacture or construction, materials and assembly, and a manufacturer or distributor may be subject to strict liability, even though it exercised all possible care.  Ohio Revised Code 2307.74.


    Manufacturing Defect Examples:

What is a failure to warn lawsuit?

In determining whether a product is defective due to inadequate warning or instruction, evidence must be presented to prove:

  • The manufacturer knew, or in the exercise of reasonable care, should have known about a risk
  • A reasonable manufacturer would have provided a warning of the risk
  • The manufacturer failed to provide the warning
  • The person was injured due to a lack of warning. The same elements apply whether the claim is based on a warning present during the marketing or post-sale warnings.

Defenses to Failure to Warn Claims(1) the risk was open and obvious or a matter of common knowledge; and (2) in cases of a pharmaceutical drug or medical device, the warning was provided to the prescribing physician (“Learned Intermediary Doctrine”).

Many pharmaceutical companies have been targeted in failure to warn lawsuits for either failing to place warnings on medication guides and packaging or failing to properly test their product before putting it to market.


 

What are consumer product safety regulations?

Design and manufacturing defects result in thousands of product recalls each year in the United States, initiated by federal safety agencies. Following injury and illness, regardless of recall status, victims and plaintiffs may pursue legal action and contact a product liability lawyer to begin the litigation process. Rightful compensation can be sought and help plaintiffs recover medical costs and other related damages.

Product liability law overlaps with regulatory law, which are the systems of legislative rules and administrative agencies, and part of federal and state governments. These agencies regulate the safety of the products sold to the public. Examples include:

  • The Food and Drug Administration (FDA)
  • The National Highway Traffic Safety Administration (NHTSA;)
  • The Consumer Product Safety Commission (CPSC)

The listed government agencies, however, may initiate recalls of dangerous products but do not provide remedies or compensation for damages where an individual is injured due to the defective product.

Why should I hire The Lyon Firm?

Our Firm will help you find the answers.  The Firm has the experience, resources and dedication to take on difficult and emotional cases and help our clients obtain the justice for the wrong they have suffered. 

 Experience:  Joe Lyon is an experienced Cincinnati Product Liability Lawyer. The Lyon Firm has 17 years of experience and success representing individuals and plaintiffs in all fifty states, and in a variety of complex civil litigation matters.   Product Liability lawsuits can be complex and require industry experts to determine the root cause of an accident or injury.  Mr. Lyon has worked with experts nationwide to assist individuals understand why an injury occurred and what can be done to improve their lives in the future. Some cases may go to a jury trial, though many others can be settled out of court.

Resources/Dedication: Mr. Lyon has worked with experts in the fields of accident reconstruction, biomechanics, epidemiology, metallurgy, pharmacology, toxicology, human factors, workplace safety, life care planning, economics, and virtually every medical discipline in successfully representing Plaintiffs across numerous areas of law. The Lyon Firm is dedicated to building the strongest cases possible for clients and their critical interests.

Results:  Mr. Lyon has obtained numerous seven and six figure results in personal injury,  automotive product liability, medical negligence, construction accidents, and auto dealership negligence casesThe cases have involved successfully litigating against some of  the largest companies in the world 

Learn About the Medical Malpractice Legal Process

Video: Investigating Medical Malpractice

The process for investigating a medical malpractice claims involves the following steps: 

  1. Gather a full and informed history from the family addressing their concerns and thoughts on what went wrong; 
  2. Gather the complete medical records including film studies, if any; 
  3. Review of the records and applicable medical literature by attorneys; 
  4. Review of the records by a qualified physician practicing in the relevant areas on standard of care and causation; 
  5. Final consultation with expert to review opinions;
  6. Signing of Affidavit of Merit by the Expert before case filing, for cases where medical malpractice is identified. 

Our Victories

The Lyon Firm aggressively, professionally, and passionately advocates for injured individuals and families against companies due to a defective product or recalled product to obtain just compensation under the law. 

DEFECTIVE LAP BELT RESTRAINT

SPINAL CORD INJURY

(Pikeville, Kentucky): Confidential settlement for Plaintiff who suffered spinal cord injury resulting in paraplegia due to defectively designed seat belt. Four passengers with three-point (lap/shoulder) belts walked away from the accident, and the only passenger wearing a two-point belt (lap only) suffered a debilitating spinal cord injury. The settlement assisted with home improvements to assist in daily living. GM entered federal bankruptcy during the process and no longer manufactures two-point lap belts for vehicles.

DEFECTIVE PROPANE WALL HEATER

WRONGFUL DEATH 

(Hillsboro, Ohio): Confidential Settlement for the family of elderly man who was catastrophically burned while operating a propane wall heater. The burns resulted in his unfortunate death. The heater, manufactured and sourced from China, was alleged to allow the flame to reach outside the grid area in violation of ANSI standards. The Defendant resolved the case following discovery and mediation. The recovered funds were paid to the victim’s surviving spouse and children. The company no longer manufactures this type of heater.

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