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Gray, Stefani & Mitvalsky, PLC
101 2nd St. SE
Cedar Rapids, IA 52401
Phone: (319) 364-1535
Fax: (319) 364-1562

Drugs and Medical Devices Information Center


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Medications that have not been approved for sale in the United States may not have been manufactured under quality assurance procedures designed to produce a safe and effective product.


Drugs and Medical Devices Resource Links

United States Food and Drug Administration (FDA)
The FDA is the main federal agency charged with drug and medical device safety. The FDA's Web site includes news, product reports and approvals, safety alerts and recalls.

MedWatch
This Web site contains the FDA safety information and adverse event reporting program used by consumers to report defective drugs or medical devices or to check the status of medical products.

Breast Implants on Trial
From PBS's Frontline, this Web site includes news, documents, studies and other information related to breast implant defects and litigation.

Institute for Safe Medication Practices
The Institute for Safe Medication Practices is a nonprofit organization devoted to medication safety and serving health care providers and consumers.

RegSource.com
this Web site offers regulatory information and news on drugs, biologics, medical devices and pharmaceuticals.


Iowa Product Liability Information

At Gray, Stefani & Mitvalsky, PLC, our harmful drugs and defective medical device recall lawyers have the experience and knowledge you need to successfully litigate your case. We have tried cases involving breast implants, medical devices, pharmaceuticals, drugs, biologics, and much more. We have also successfully obtained judgments for our clients in cases involving alleged defects in tampons, latex gloves, and blood factor concentrates. Our attorneys have served as local counsel for the state of Iowa in product liability cases that became a part of Federal Multi-district Litigation. These cases include MDL proceedings involving bendectin, breast implants, blood clotting factor concentrates, fen-phen and Baycol. From our offices in Cedar Rapids, IA, we represent clients in Cedar Rapids and Iowa City in Linn and Johnson Counties, and across the state of Iowa.

We invite you to contact us for sound legal counsel related to harmful drugs or defective medical devices.

Drugs and Medical Devices - An Overview

The costs of defective drugs and medical devices are great. Having defective drugs and medical devices on the market can lead to significant health risks in consumers. Risks can cause serious injury, disabilities and hospitalization. In some cases, injuries lead to more intensive surgeries than where originally necessary to correct the damage caused by the defect. Some harms caused by defective prescription drugs and medical devices also cause death. Fatal injuries caused by defects have been on the rise the past decade. This increase has lead to drugs being pulled off the markets, class action lawsuits, safety concerns and liability issues; we want to know who to blame.

If you believe you may have a claim against a drug manufacturer, you should not hesitate to seek legal advice from a lawyer at our firm with experience in this area.

Defective Drugs and Medical Devices

There have been many cases involving defective drugs and medical devices in recent years. In an age of advanced medical knowledge, technology, product testing and FDA testing it seems that this should not be the case. Then why are class actions involving prescription drugs and medical devices on the rise? If you believe you have been injured by a defective medical product, contact a lawyer do discuss your legal options today.

There are a variety of reasons for an increase in drug and medical device lawsuits. One reason that will always be present is human error. Human error may be found in the manufacturing and development of medical products and also in the quality control of those products. Another possible reason for defects is that the goal for any company is to make a profit, drugs and other medical device manufacturers are no different. Patents, research, development, testing and government approval take time and money. Companies may sometimes hide negative information to move the process along towards approval. Once a product is approved, the company gains more time with their product on the market reaping the benefits of their development costs. Accordingly, there is also pressure on the government to approve drugs and medical devices to enter the market. Lobbyists for companies may put pressure on the FDA to approve drugs or medical devices to start making money on these products as soon as possible. There is also pressure on the FDA to reform the approval process to make it easier to bring new drugs and devices into the market. The public also pressures the government for approval of new drugs and medical devices. Those suffering from disease or other medical aliments hope to seek benefits from new products as soon as they can. Any of these reasons may contribute to the development and release of defective drugs and medical devices on the open market. Once a medical product is approved by the FDA and made available to consumers, the underlying defects or harmful effects of the products may become apparent. These defects cost consumers and companies alike.

Who is liable?

The liability for a drug of medical device defect differs depending on the individual facts of your case. If the defect is in the design, development or manufacturing of the medical product, the manufacturer may be liable. Generally, if claims are against the manufacturer they will be for strict liability or negligence. Strict liability focuses on whether the medical product is unreasonably unsafe to consumers. Negligence cases focus on development, manufacturing and quality control of a medical product. It must be determined whether the manufacturer was responsible for the defect and the injury that occurred.

If the drug or medical product is not shown to be defective or unreasonably unsafe due to manufacturing, the physician or pharmacist may be at fault. Doctors sometimes use drugs for unapproved purposes. This is called off-labeling prescriptions. Although this practice is legal, injuries may result when incorrect dosages are prescribed, contradictory medications are used or the patients are not warned of the dangers associated with the unapproved treatment.

Pharmacists may also be liable for failing to warn consumers of the dangers associated with a prescription. Other pharmacy liabilities include incorrect labeling, dispensing the wrong dosage and insufficient instructions. If you feel you have been injured by a defective medical product, physician negligence or pharmacist error, contact an attorney at our firm.

Conclusion

Unfortunately, sometimes the medications and other medical products we rely on to improve our health may do the opposite. If you have suffered injury from a defective drug or medical device, do not wait to take action. Plaintiffs who have claims for damages they suffered as a result of using a defective drug or medical device should consult an attorney at our firm as soon as they are aware of the resulting injuries to avoid the possibility that the time for bringing suit will expire.

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