Defective Drugs and Medical Devices
Defective Drugs and Medical Devices – Holding Big Pharma and Manufacturers Responsible
We expect drugs and medical devices to help us, not to cause harm (or even death). Tragically, however, thousands of people are harmed each year by the effects of prescription and over-the-counter drugs and a wide variety of medical devices.
When defective drugs and devices seriously injure or kill, our firm represents injury victims and their families in seeking full compensation from all those responsible. We represent victims not only in Salt Lake City, but also in West Jordan, West Valley City, and throughout Utah.
We are not a firm that seeks quick, highly-discounted settlements. We are trial lawyers, and accept cases with the mindset of going to trial in order to recover full compensation for our clients unless a fair and acceptable settlement to our clients is offered.
The following sections provide an overview of key aspects concerning defective drug and medical device litigation.
The FDA and Approval of Drugs and Medical Devices
The United States Food and Drug Administration (the “FDA”) is the governmental agency responsible for approving all drugs and medical devices. Prior to approval, there is a lengthy process that must be strictly followed to analyze whether drugs and medical devices are safe. This process includes detailed studies and peer review analysis by leading practitioners and scientists in the applicable field, all of whom have a role in carefully evaluating safety. The FDA then has final approval based upon the safety and efficacy evidence submitted.
Unfortunately, even with these safeguards in place, many pharmaceuticals and devices are made available that subsequently cause harm and even death.
Drug Classifications and Warnings
Not all drugs approved by the FDA are completely safe. In many cases, drugs may be approved even though they have known, and sometimes even potentially fatal, side effects. Drugs that are known to have extremely dangerous side effects require very careful oversight by physicians. For such drugs, physicians should also consider whether other drugs with less dangerous side effects might be a better alternative for treating a patient’s condition.
Nonetheless, in some cases, drugs that might be highly beneficial may be the best choice for patients with serious illness or conditions, such as cancer, particularly if the known side effects are extremely unlikely. Prudent physicians will then not only balance the benefits of a drug with potentially serious side effects, but they will also communicate the benefits and risks with their patients so that their patients can make a fully informed choice as to whether a particular drug should be used.
FDA Recalls of Drugs and Medical Devices
Each year, the FDA recalls hundreds of drugs and medical devices. Through these recalls, drugs may be removed entirely from the market, or the approved conditions for which drugs may be prescribed may be limited. Medical devices similarly may be recalled. Click to see a list of FDA recalled drugs and FDA recalled medical devices.
Understanding What Makes Drugs and Medical Devices Defective
Drugs and medical devices may be defective if the injuries or death from use was not expected or something for which the patient was not fully informed.
As an example, a cancer patient may opt to take a drug that is known to have a small chance of dangerous side effects because the drug may also have a good chance of curing the patient’s cancer. If the patient in fact is one of the unfortunate ones to develop a known side effect that the patient was informed of by their physician, it may be that no legal liability will exist.
If, however, the cancer patient develops side effects that were not known and/or which were not communicated to the patient, then the patient may be entitled to compensation arising from the unexpected side effects.
The side effects that were known at the time a drug was used and whether such risks were properly and adequately communicated to the patient are matters of fact. In representing a client harmed by a defective drug or medical device, we will want to learn all information possible about these matters so that we can determine whether legal liability exists.
Who May Be Liable for Dangerous Drugs and Medical Devices?
Those potentially liable for dangerous drugs and medical devices include:
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The manufacturers of such drugs and devices
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Resellers, distributors, and others in the sales chain
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Stores that sell dangerous drugs or devices “over the counter” (those that do not require a prescription)
The above is a partial list of the categories of defendants who are often sued in cases involving dangerous drugs and medical devices; other people or entities may also be liable in specific cases.
Seeking to Prove Liability – What We Do, and Seeking Punitive Damages
We are tenacious in seeking to prove liability against all those who we believe are legally responsible for injuries and death suffered by our clients which are caused by dangerous or defective drugs or medical devices.
All too often, the pharmaceutical manufacturers (often referred to as “Big Pharma”) will put profit over the public’s safety in seeking to rush drugs or medical devices to market, sometimes before the it is clear whether such drugs or devices are safe. Big Pharma companies earn hundreds of billions of dollars a year, and a single drug alone can make a company billions of dollars per year.[1]
It’s easy to see why companies may have little regard over product safety when there are potentially billions of dollars that can be made. Even when dangerous drugs and medical products are introduced and people are harmed or killed, generally the company responsible will still make significant money, even after litigation costs, settlements, and judgments are considered.
This is wrong.
Our role is to do everything possible to see full compensation for our clients and their families.
Punitive Damages
Not only do we want to recover for our clients every penny to which they are owed for past and future damages, but we will also seek, in all appropriate circumstances, punitive damages for our clients.
Punitive damages are designed solely to punish defendants and to send a strong message to others similar to them that reckless and egregious wrongful conduct will not be tolerated. As an example, if the manufacturer of a drug knew that the drug had a side effect of killing some patients but did not disclose this fact, punitive damages may be appropriate (in addition to compensatory damages for the actual harm suffered).
Punitive damages are calculated by jurors at trial, and represent a “message” that they want to send to defendants. Often, punitive damages are determined based upon a combination of the net worth of the defendant or the sales of the drug or device in question, and the jury’s belief concerning how wrongful the defendant’s conduct was. Because punitive damages can greatly exceed the actual damages, drug and device manufacturers know they will likely face enormous potential exposure beyond the actual damages that result to victims if they choose to act irresponsibly and recklessly.
[1] One report estimates that Americans will spend up to $610 billion by 2021. https://www.cnbc.com/2017/05/04/us-prescription-drug-spending-as-high-as-610-billion-by-2021-report.html. Ambien, for instance, has had muli-billion dollar annual sales. https://www.forbes.com/sites/daviddisalvo/2015/08/06/how-the-sleep-industry-is-making-billions-from-your-lack-of-shuteye/#5f78e1032542. A study found that in 2010, there were more than 131 million prescriptions written for Hydrocodone alone. https://www.webmd.com/drug-medication/news/20110420/the-10-most-prescribed-drugs#1
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We accept defective drug and medical devices on a contingency fee basis, and we advance client costs relating to litigation, so our clients do not have to come out of pocket for any fees or litigation costs while their case in progressing.
If you or a family member has been injured by a defective drug or medical device, please call our office to schedule a free consultation to learn how we can help.