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Defective Medical Devices

Technological advances have led to an increase in the number of complex medical devices that may be used to treat any number of injuries. When a medical device functions properly, it can save a life. If a medical device malfunctions, however, the results may be fatal. 

Medical devices may be defective as the result of improper or inadequate testing, and investigations of specific causes can be extremely complex. People who have sustained serious injuries because of defective medical devices may be entitled to compensation for all medical bills, lost wages, and other damages.

Attorney for Defective Medical Device Injuries in West Chester, PA

If you suffered catastrophic injuries or your loved one was killed in southeastern Pennsylvania because of a defective medical device, it is in your best interest to quickly seek legal representation. Ciccarelli Law Offices represents clients in product liability actions all over Lancaster County, Delaware County, Chester County, Montgomery County, and the greater Philadelphia area. 

Our West Chester personal injury lawyers represent individuals on a contingency fee basis so you pay our firm nothing unless you receive financial compensation first. Call (610) 719-3190 to have our attorneys provide a complete evaluation of your case during a free initial consultation.


Chester County Defective Medical Devices Information Center


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Classification of Medical Devices in Pennsylvania

The Food and Drug Administration (FDA) is the federal agency within the U.S. Department of Health and Human Services that "is responsible for protecting the public health by assuring the safety, effectiveness, quality, and security of" medical devices (among several other items). The FDA has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels, and each generic type of devices is assigned to one of the three following regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device: 

  • Class I — Synonymous with General Controls (basic provisions of the May 28, 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act which apply to all three classes of medical devices), Class I is the least stringent of the three device classes provided in the Amendments. Class I devices are not intended for use in supporting or sustaining life or to be of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury. Examples of Class I medical devices include enema kits and elastic bandages. 
  • Class II — Special controls are regulatory requirements for Class II devices when general controls alone cannot insure safety and effectiveness. Special controls are usually device-specific and include performance standards, postmarket surveillance, patient registries, special labeling requirements, premarket data requirements, and guidelines. Examples of Class II medical devices include powered wheelchairs and some pregnancy test kits. 
  • Class III — Medical devices that usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury are classified as Class III devices. Under federal law, class III devices are subject to approval of a Premarket Approval Application (PMA). Examples of Class III devices include implantable pacemakers and breast implants. 

The FDA may on its own initiative or in response to a petition, reclassify a previously classified preamendments device based on “new information.” Section 608(c) of the Food and Drug Administration Safety and Innovation Act (FDASIA) requires the FDA to annually post the number and type of medical devices reclassified in the previous calendar year.


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Common Types of Defective Medical Devices in West Chester

When a medical device is defective, it can have several unwanted adverse side effects for patients. The nature of injuries can depend on the type of device and its essential function, but many recalls are the result of significant numbers of people experiencing the same problem with a medical device. 

A few of the most frequent medical device issues our firm handles include, but are not limited to: 

  • Bair Hugger forced-air warming blanket; 
  • Biomet hip replacement; 
  • DePuy hip replacement; 
  • Essure permanent birth control system; 
  • Inferior vena cava (IVC) filter; 
  • Medtronic, Inc. defibrillator; 
  • Mirena intrauterine device (IUD); 
  • NuvaRing birth control; 
  • Physiomesh composite mesh hernia patch; 
  • Stryker hip replacement; 
  • Wright Conserve hip cup; 
  • Zimmer Durom hip cup; and 
  • Zimmer NexGen knee replacement.

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Defective Medical Device Resources in Pennsylvania

Federal Food, Drug, and Cosmetic Act (FFDCA) | House Office of the Legislative Counsel — View the full text of the set of laws passed by Congress that comprise the FFDCA. The FFDCA is divided into 10 chapters, and Chapter V governs drugs and devices. Section 510 concerns registration of producers of drugs and devices, Section 513 covers classification of devices intended for human use, and Section 515 outlines the premarket approval process for class III devices.

Medical Devices | FDA — Access various kinds of information concerning medical devices on this section of the FDA website, including recalls, approvals, and other useful information. Sections include Products and Medical Procedures, Medical Device Safety, and Science and Research (Medical Devices). The News & Events (Medical Devices) section includes press releases, meetings, conferences, and other announcements of significant news and activities related to medical devices.


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Find a Defective Medical Device Injury Lawyer in West Chester, PA

Did you sustain severe injuries or was your loved one killed in southeastern Pennsylvania as the result of a defective medical device? Contact Ciccarelli Law Offices as soon as possible. 

Our personal injury attorneys in West Chester have office locations in Philadelphia, Springfield, Malvern, King of Prussia, Plymouth Square, Lancaster, Radnor, and Kennett Square. You can have our lawyers review your case and help you understand all of your legal options when you call (610) 719-3190 or fill out an online contact form to schedule a free, no obligation consultation.


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