Drug manufacturers are required by law to manufacture prescription drugs and medical devices that are safe and free from unreasonably dangerous defects. This means that drug companies must design, manufacture and sell prescription drugs and medical devices that are safe and comply with all of the obligations and regulations of the Food and Drug Administration (FDA).
Unfortunately, this does not always occur. Drug companies, either because of inattention and error or as the result of intentional fraud, sell drugs or medical devices that are dangerous and unsafe to consumers. At the law firm of Heygood, Orr & Pearson, we believe when a drug company sell dangerous, unsafe drugs or medical devices, they should be held responsible for the damage caused by doing so.
The pharmaceutical industry is the third largest in the United States, accounting for approximately $300 billion in annual sales. With the earning potential of a single drug or medical device in the millions of dollars (and often times exceeding a billion dollars) each year, prescription drug and medical device manufacturers have immense financial incentive to ensure that their product stays on the market and off the FDA’s radar. This often leads to a prescription drug company being less than honest with the FDA concerning the risks and known dangers of a drug, despite laws that require them to do so.
Manufacturer’s Responsibility to Research
A drug company’s obligation to insure that the drugs they manufacture and sell are safe does not end after obtaining initial FDA-approval of the drug or medical device. After a drug or medical device has been approved for sale to the public, drug makers must conduct continue to research to ensure the sustained safety of the drug or medical device and must share the results of such research with the FDA. Their failure to do so can result in the FDA being unaware of the dangers and risks associated with a particular drug or medical device. Without FDA warnings, unsuspecting doctors prescribe drugs and medical devices that they never would have prescribed if they had known of the dangers involved and risks associated with such a drug or medical device.
Manufacturer’s Responsibility to Report
FDA regulations require drug companies to timely report all adverse drug reactions and any dangers of their drugs so that the FDA can continually evaluate them and potentially:
- require the pharmaceutical company to change the labeling and warnings that accompany such drug, including requiring a black box warning when appropriate (the most severe warning possible),
- require distribution of information to doctors and consumers about the risks associated with such drug and/or
- recall the drug and remove it from the market altogether.
The entire regulation of pharmaceutical drugs in the United States is based upon this fundamental premise: drug companies voluntarily comply with the FDA’s reporting requirements and telling the FDA what they know about their drugs. When pharmaceutical companies fail to do so and fail to comply with the laws and regulations of the FDA, dangerous and unsafe drugs get approved and sold to unsuspecting patients. At Heygood, Orr & Pearson, we have learned through extensive experience that oftentimes the only method of forcing a drug company to forthrightly provide the information they know about the risks associated with a prescription drug or medical device is by making them answer for their conduct in a court of law.
Get Help with Your Pharmaceutical Liability Claim
It is an unfortunate truth in the United States today that all too often a drug company’s decision regarding whether to conduct research about a drug or medical device or sharing the results of such research with the FDA and the public is not based on the health, safety and welfare of the people who use their drugs and medical devices. It is instead motivated by their desire to avoid taking responsibility for their mistakes and interrupting their enormous profits. Given the billions of dollars the pharmaceutical industry profits from the sale of their drugs each year, it is no wonder so many companies hide negative research results.
At Heygood, Orr & Pearson, we have spent years holding drug companies and medical device manufacturers responsible for the injuries and deaths caused by their reckless conduct. From dangerous fentanyl pain patches to defective hip and knee implant devices to Actos, the lawyers at Heygood, Orr & Pearson have made it a career priority to hold drug manufacturers accountable and responsible for their actions.
The law firm of Heygood, Orr & Pearson has the resources and experience to protect a person’s rights and the rights of their loved ones against irresponsible pharmaceutical companies and medical device manufacturers. If you have been injured or have lost someone you care about because of defective or dangerous prescription drugs or medical devices, you deserve to have the manufacturer held responsible for such and deserve proper compensation. Contact us for a free consultation to find out more about your legal options.