It is estimated that several thousand people have been injured by Medtronic’s InFUSE Bone Graft system since it was approved by the US Food and Drug Administration (FDA) in 2002.
The controversial product has been deemed ineffective and dangerous, and officials at Yale University, after studying data and credible research, have said the InFUSE device offers little to no benefit.
Early clinical studies, including those reviewed by the FDA, show the InFUSE procedure has the potential to inflame nearby tissues and bone. 15 to 20 percent of people who have had the InFUSE surgery report regular pain, primarily in the legs and back.
There is also mounting evidence that the graft procedure stimulates cancer growth, and that higher doses of InFUSE carry a greater risk for developing cancer.
Many thousands of InFUSE recipients, and also most surgeons, were unaware of these possible risks at the time of operation. As a result, ongoing legal action holds Medtronic accountable for intentionally hiding adverse effects from doctors and their patients.
Bones grafts are pieces of bone or bone substitute that can replace damaged or diseased bone in a number of joints and bones in the body. The vast majority of InFUSE bone graft operations involve the spine. In spinal fusion, doctors surgically fuse together individual vertebrae, which is meant to eliminate the irritation of nerves in the spine.
Medical implant companies like Medtronic have developed synthetic concentrated protein, called bone morphogenetic protein (BMP), which are injected into the spine to help the body form cartilage and bone, ostensibly to alleviate pain.
While advancements in synthetic bone graft technology play a welcome role in modern medicine, they can cause a myriad of problems, in some cases even, sterility, cancer and death. Bone Graft surgeries are not to be taken lightly.
They should be reserved as a last-resort solution to a degenerative spinal condition. In recent years, there have been reports of patients being offered “unnecessary” spinal surgery for pain alone, without significantly abnormal radiographic findings.
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Joseph Lyon has 17 years of experience representing individuals in complex litigation matters. He has represented individuals in every state against many of the largest companies in the world.
The Firm focuses on single-event civil cases and class actions involving corporate neglect & fraud, toxic exposure, product defects & recalls, medical malpractice, and invasion of privacy.
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Bone Grafts are risky, and are associated with dangerous side effects. By spring 2011, the FDA had received hundreds of reports of adverse reactions associated with InFUSE Bone Grafts. Patients have reported the following:
• Back and Leg Pain
• Male sterility
• Sexual dysfunction
• Respiratory failure
• Excessive bleeding
• Fetal development problems
• Nerve damage
• Urinary problems
• Possible increased cancer risk
• Inflammatory reactions
• Implant displacement and failure
• Retrograde ejaculation
• Osteolysis (degeneration of bone tissue)
• Abnormal bone formation
These represent a large range of health issues. Many complications even require a second surgery to correct. Some studies suggest a 40 percent reoperation rate for patients over the age of 65, with a 20 percent non-age specific reoperation rate.
The evidence is now clear how risky these procedures can be. However, since Medtronic and its well-compensated research team misled the public, most of these adverse events were unpublished. The full story was not clear until 2011, when independent doctors came forward with their own observations and studies.
In recent years, Medtronic has faced increased scrutiny for the InFUSE Bone Graft system. In addition to harming thousands of patients with their product, Medtronic is accused of intentionally hiding dangerous side effects. Also, since its FDA approval, there are multiple reports of clinical investigators receiving generous “consulting” payments from the medical product industry, including Medtronic.
In June 2011, the U.S. Senate launched an investigation into these allegations, and revealed that a number of the researchers received royalties and consulting fees from Medtronic.
With the help of an incriminating article published in The Spine Journal, the official journal of the North American Spine Society, investigators found that researchers were paid millions to exaggerate the products’ benefits and grossly understate the risks.
The Spine Journal report observed that in multiple industry-sponsored trials, patients reported ZERO complications or adverse effects attributed to their own products. However, documents from FDA documents and other published data reveals a large gap in adverse reactions, and exposes the industry’s “internal inconsistencies,” which ultimately disregarded patient safety for profit.
It is estimated that Medtronic’s InFUSE system is used in about 25 percent of the 432,000 spinal fusion procedures a year in the United States. In 2010, they generated almost $900 million in sales.
Medtronic has a horrific ethical track record. In fact, the US Department of Justice (DOJ) has investigated Medtronic several times. In another incident, Medtronic paid $40 million to settle a case where the DOJ accused the company of paying kickbacks to doctors as an incentive to use InFUSE and other similar products.
The only InFUSE Bone Graft surgical technique that is FDA-approved is a procedure that operates through the abdomen. This procedure minimizes injury to the back muscles and nerves. Even so, Doctors have inadvisably used InFUSE in procedures not approved (“off-label”) by the FDA. Complications are so prevalent in some procedures, that many surgeons who once performed these operations no longer recommend it.
In 2008, the FDA issued a Public Health Notification to health care providers and surgeons regarding serious, even life-threatening complications arising from the unapproved (“off-label”) use of InFUSE in cervical (upper-back) spinal fusion.
The FDA received dozens of reports of serious complications, including swelling of neck and throat tissue, which resulted in compression of the airway, and neurological structures in the neck.
The seriousness of some events reported necessitated emergency medical intervention. Patients who suffered these events needed respiratory support, or even a tracheotomy. The FDA reiterated that “safety and effectiveness” have not been demonstrated and “these products are not approved for this use.”
Defective medical device litigation helps to improve patient safety and holds medical device companies accountable when defective products injure plaintiffs and clients.
When a medical device has the potential to fail and cause injury, companies should voluntarily issue a recall. When a company injures patients with defective medical devices, a medical device lawyer may help you recover financial losses, medical expenses and other damages incurred through litigation.
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.
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.
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.
Benefits: The 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).
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:
In determining whether a product is defective due to inadequate warning or instruction, evidence must be presented to prove:
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.
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 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.
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 Defective Device 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. Defective device 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 cases. The cases have involved successfully litigating against some of the largest companies in the world
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.
Nationwide Consolidation in U.S. District Court, Northern District of Ohio. The Depuy ASR Hip design was plagued with problems related to premature loosening and metallosis, caused by chromium and cobalt entering the blood stream. The resulting injuries were a result of the metal-on-metal friction inherent with the design of the product. Depuy recalled the ASR and entered into a global settlement valued at $2.5 Billion to cover an estimated 8,000 patients. The Lyon Firm represented several clients in the original settlement and continues to be active in this litigation. The settlement funds provided compensation for the revision surgeries, including compensating for medical costs, lost wages, and pain and suffering.
Nationwide Consolidation in U.S District Court, Northern District of Indiana. Similar to the Depuy ASR, the Biomet metal-on-metal hip design allegedly contributed to premature hip failures and metallosis due to the metal friction. Biomet entered into a global settlement valued at $56 million to cover a few thousand claims. The Lyon Firm represented several plaintiffs in the original settlement and continues to be active in this litigation.