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Medical Device Lawyers


INVESTIGATING DEVICE INJURY & COMPLICATIONS
Nationwide Success

Why Do You Need a Medical Device Lawyer?

You have a limited window to file suit over a defective medical device. With an attorney by your side, you’re far more likely to secure a comprehensive settlement to cover all that you have lost as well as ongoing medical treatment.

While many medical devices like pacemakers are truly life-saving, the increasing profit motive of medical device manufacturers creates a dangerous incentive in our healthcare industry.

Healthcare providers like doctors and surgeons rely on the judgment, honesty, and skill of medical device manufacturers to offer safe products. Unfortunately, the manufacturer of a medical device is often focused on sales first. That means that new products which haven’t been fully tested, or products that have been proven defective some percentage of the time, are still sold as safe to physicians and implanted in patients.

Headquartered in Ohio, The Lyon Firm has represented clients from all fifty states, and we’ve obtained numerous six- and seven-figure outcomes in medical device cases. We are currently investigating the following types of device injury cases:

  • Birth control devices
  • Breast implants
  • Catheters
  • CPAP
  • Hernia mesh
  • Hip implants
  • IVC filters
  • Knee implants
  • Shoulder implants
  • Surgical staplers
  • Ventilators

If you have an injury that may be related to one of these products, or need to speak with an experienced attorney about your rights and legal options, The Lyon Firm is ready to help. Contact us online to schedule a free consultation, or call us at (513) 381-2333. There are no upfront costs for our services — we only earn our fee after we have secured a successful settlement or verdict for you and your family.

Read on to learn more about how medical device cases are handled.

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CONTACT THE LYON FIRM TODAY

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ABOUT THE LYON FIRM

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.

NO COST UNLESS WE WIN

The Firm offers contingency fees, advancing all costs of the litigation, and accepting the full financial risk, allowing our clients full access to the legal system while reducing the financial stress while they focus on their healthcare and financial needs.

What Is Medical Product Liability?

Medical product liability applies when a person is injured from a defective medical product or drug after they did not receive appropriate warnings about the product’s potential side effects or known defects.

Patients have the right to “informed consent” choices about their medical treatment. If a company lies, misleads, or neglects to adequately inform doctors and patients of risks, they may be held liable (meaning financially responsible) for the harm the product causes. That responsibility extends to cases of wrongful death as well.

How Is A Medical Device Defined As “Defective”?

The Lyon Firm is headquartered in Ohio, where the legal definition of defective states that a medical device is defective if it is unreasonably dangerous for its intended use.

A legal cause of action can be based on several types of medical device product defects. Most jurisdictions have a version of one or more of these cause of actions:

  • Manufacturing/ construction defect of the medical device
  • Defective design and/or formulation of the medical device
  • Failure to warn or inadequate warning or instruction associated with the medical device
  • Misrepresentation of the safety or efficacy of the medical device
  • Fraud related to the safety or efficacy of the medical device
  • Negligent distribution or testing of the medical device

Your attorney will research the applicable law and build a case that meets the legal burden of proof required by the courts.

What Is the Average Payout for a Defective Medical Device Lawsuit?

There is no one number that accurately describes an “average” payout for defective medical device cases, as each case is unique. Some cases involve multiple plaintiffs injured by the same defective devices suing collectively in a class action or mass tort case. For individuals, the amounts are directly related to the severity of their injuries and the cost of their losses like medical bills, lost wages, and pain and suffering.

Here are case results The Lyon Firm has secured for clients injured by defective medical devices:

  • Multi-plaintiff results:
    • $5,500,000
    • $2,075,000
    • $1,520,000
    • $725,000
  • Single plaintiff results:
    • $1,200,000
    • $560,000

Multi-million dollar outcomes are a real possibility in cases that involve such invasive injuries. These amounts reflect the cost of reparative surgeries, the loss of a person’s prime earning years and career advancement, and the damage that long-lasting or chronic pain does to a person’s quality of life.

Can You Sue for Faulty Medical Equipment?

Yes, you can sue a medical device manufacturer for faulty medical equipment.

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

Here is the evidence your attorney may prepare to prove a medical device company is liable for damages:

  • The defective product: It is important to preserve the product in order for experts and medical professionals to make certain arguments. It is critical to preserve all physical evidence and medical records.
  • Regulatory documents: Documents obtained from the U.S. Food and Drug Administration (FDA) can prove insightful in understanding how the device was approved, any past adverse events reported by physicians and consumers, any warning letters issued to the company, and any testing that was or was not performed prior to marketing.
  • Corporate documents and depositions: Attorneys coordinate to compile and review company documents for pertinent materials. Paperwork may reveal internal admissions of negligence, and depositions (official sworn statements or interviews) may provide crucial clarity. Relevant topics may range from regulatory affairs, science and research, marketing and sales, to post-market surveillance.
  • Expert witnesses: These are professionals who can speak to medical, ethical, or economic concerns. Also treating physicians or implanting surgeons may need to testify that a different warning or instruction would have changed the manner in which the device was used, thereby preventing injury.
  • Demonstrative evidence: Computer graphics and other visuals are critical in assisting the jury to understand the medical science, the device, the risks, and the injury suffered.

Defective medical device litigation provides answers when medical device companies are unwilling to be honest with consumers and their physicians about the risks and dangers of their products.

Your decision to pursue justice for your case could prompt a recall that saves lives and prevents future suffering. Reach out to The Lyon Firm for representation online or by calling (513) 381-2333 directly.

What Is the FDA Approval Process for Medical Devices?

Many companies have been involved in medical device litigation for defective product designs and failure to adequately warn claims. The litigation often precedes a voluntary recall. Many critics have argued that an overly-lenient FDA approval process is partly to blame for the increase in medical device defects and injuries reported.

Here is a general summary of the two types of processes a manufacturer can utilize to gain FDA approval to access the U.S market to sell medical devices:

  1. Pre-market Approval Process (PMA): The pre-market approval process requires a medical device company to submit safety and efficacy data on the proposed device. PMA is a longer and more expensive process, and typically these products include innovative, cutting-edge technology.
  2. A 510K Process: The 510K approval process, however, allows medical devices to obtain FDA approval without submitting safety and efficacy testing data. A company may 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 above.

Many device models are put to market under the more lenient 510K pre-approval process and are not properly tested. This puts American consumers and recipients at risk of serious injury.

Can You Sue a Medical Device Company? Contact an Attorney for Representation

Although the FDA is responsible for making sure that medical devices are adequately tested, device recalls have become increasingly common. Medical device manufacturers are often slow to respond to consumer complaints and must be held liable for injuries caused by their products. You can hold them accountable with a personal injury lawsuit.

While defective medical device litigation involves complex science and requires both legal and medical experts to effectively build a case, that work is your lawyer’s job, not yours. Whether on a personal or class action scale (for widespread device failures), your attorney from The Lyon Firm will investigate, prepare evidence, and meet deadlines on your behalf. Your priorities are your health and the well-being of your family.

If you or a loved one has suffered an injury due to a defective medical device and have questions about the legal remedies available to improve quality of life and medical care, contact The Lyon Firm online or by phone at (513) 381-2333. You will speak directly with Mr. Lyon, and he will help you answer these critical questions, and possibly begin representing you right away.

Defective Medical Devices FAQ

How do defective medical device lawsuits lead to recalls and better safety?

Companies should voluntarily issue a recall when a medical device has an unacceptably high rate of failure or complication. However, because those companies are businesses, they sometimes hesitate to act until there is a profit incentive. A substantial settlement or verdict for you could help:

  • Prompt the company to issue a recall of a dangerous product before they are sued again
  • Inform physicians who are unaware of these dangers before they prescribe the device to new patients
  • Save other patients from enduring the pain and suffering you’ve experienced

According to plaintiffs and attorneys, defective medical devices may only be recalled after they are known to cause serious health problems or targeted by lawsuits.

What are some commonly recalled medical devices?

The following devices and implants have been recalled by various manufacturers at an alarming rate:

If you’ve been injured or experienced complications due to any of these medical devices, it may be due to product defectiveness. You could secure the resources you need to afford better care through a defective device lawsuit.

How does a lawyer prove a defect in a medical device lawsuit?

There are two methods that may apply to legally proving a defect in a medical device:

  • Defective design medical device 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 (e.g. the metal-on-metal design, the porosity and stiffness of transvaginal mesh).
  • A manufacturing defect claim arises when the medical device is released from the factory in a manner that deviates from the intended design or specifications. In defective medical device cases, the manufacturing defect is often related to performance standards (e.g., the metal does not meet the strength specification or has microscopic fractures).

Any personal injuries or economic loss that arise from the defect are compensable under Ohio defective product liability law.

How long do I have to file a defective medical device lawsuit?

The deadline for filing a defective medical device claim depends on your state. In Ohio, the deadline is two years from the date of implantation or the date of diagnosis of your injury. An example would be a defective metal-on-metal hip implant that works for years before you discover you have metal poisoning due to the device. An extension may also exist if there was a cover-up involved intended to hide information about a defective device from your knowledge.

Your window for justice may be closing rapidly. Joe Lyon has successfully litigated cases against some of the largest companies in the world like Johnson & Johnson, and Bayer. Contact The Lyon Firm at (513) 381-2333 as soon as possible for experienced representation.

Joe Lyon investigates defective medical device products

CONTACT THE LYON FIRM TODAY

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FAULTY MEDICAL DEVICES

Learn about Medical Device Approval Processes

Defective Medical Device Settlements

Please see THE LYON FIRM CASE RESULTS for more information. 

IN RE: DEPUY ASR

METAL ON METAL HIP IMPLANTS

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.

IN RE: BIOMET MSA MAGNUM

METAL ON METAL HIP IMPLANTS

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  on behalf of clients that did not participate in the national settlement.