Pharmaceutical drugs, and medical devices, are highly risky and dangerous instrumentalities. Some drugs and medical devices should not be on the market at all, and others may cause an adverse event, which is an injury resulting from use of the drug or medical device. The law concerning pharmaceutical drugs is not the same as that relating to medical devices. There are important distinctions. The involvement of the Food and Drug Administration causes many complexities because of a legal doctrine called preemption.
If you or someone you love has been injured by a pharmaceutical drug or medical device, you may have the option of filing a lawsuit for damages in connection with the injuries and compensable losses. Cliff Rieders at the law firm of Rieders, Travis, Dohrmann, Mowrey, Humphrey & Waters is one of the leading lawyers in this field of practice. Rieders has written “the book” that Pennsylvania attorneys use in medical liability areas, including cases concerning medical devices and pharmaceutical drugs. Rieders is a Board Certified attorney, Past President of the Pennsylvania Trial Lawyers, and lectures widely to other attorneys on the subject.
Liability with respect to pharmaceutical drugs and medical devices may be predicated upon a number of different bases. It is important to have an attorney who is experienced in connection with these cases. Some of the cases are brought directly, and others as class actions or multi-district litigation. Sometimes consolidating actions in state court are the way these claims are made.
Many lawyers advertise over the internet or on TV, but they do not actually handle these cases — they refer them to someone else. Call the attorney that other attorneys call: Cliff Rieders.
The Federal Food and Drug Administration defines a serious event as one in which the patient outcome is one of the following:
- Life-threatening condition
- Hospitalization (initial or prolonged)
- Disability – significant, persistent or permanent change, impairment, damage or disruption in the patient’s body function/structure, physical activities or quality of life
- Congenital anomaly
- Requires intervention to prevent permanent impairment or damage.
In 2011, the Food and Drug Administration received 179,855 reports of serious or fatal adverse drug reactions.
How are medical device and pharmaceutical drug cases handled?
It must be proven either that a pharmaceutical drug does not have a legitimate and proper purpose, given its serious side effects, or that there was a failure to warn about the risks of the drug. Also, there may be liability where there has been a misrepresentation or fraud to the Federal Food and Drug Administration by the manufacturer in seeking approval to market the product. Generic drugs are handled differently. The law of medical devices is somewhat different, because a medical device may malfunction or may be accompanied by advice given to the health care provider by manufacturer representatives. Needless to say, there are other possible bases of liability as well.
There are two major types of adverse drug reactions:
- Type A reactions are most common and are usually a consequence of the drug’s primary pharmacological effect (e.g., bleeding when using the anticoagulant warfarin).
- Type B reactions are not related to the pharmacological action of the drug and are typically unpredictable.
Sometimes drug manufacturers do not provide information about possible drug reactions to federal approving authorities, or information may even be false or misleading. There may be claims based upon the safety of the drug, the nature of the warnings, or possibly even the marketing of the drug. Manufacturers are required to report serious events within 15 days of becoming aware, but they do not always do so.
Each adverse drug event case is different and must be individually considered as to facts and the basis of liability. The seriousness of the adverse drug event is also an issue.
What drugs cause most problems?
By the end of 2015, the 10 drugs with the largest numbers of reports to the FDA by healthcare practitioners and consumers, in order of frequency, were: Pradaxa, Coumadin, Levaquin, Carboplatin, Zestril, Cisplatin, Zocor, Cymbalta, Cipro and Bactrim.
Cliff Rieders and Sasha Coffiner are concentrating on the following drugs:
- Testosterone: Replacement therapies such as AndroGel, Axiron, Testim or AndroDerm can potentially be linked to heart attack, stroke and pulmonary embolism.
- Byetta: This is an injectable drug that is prescribed to lower blood glucose levels in Type II diabetes. Recent studies have linked Byetta to conditions such as pancreatitis and pancreatic cancer.
- Januvia: A medication commonly prescribed for Type II diabetes, Januvia has recently been linked to pancreatitis and pancreatic cancer.
- Victoza: Another injectable drug for Type II diabetes, it has been linked by recent studies to serious conditions such as acute pancreatitis and pancreatic cancer.
- Xarelto: This drug can cause excessive bleeding or a hemorrhage.
- Mirena: Some individuals using the Mirena IUD for birth control have suffered serious injuries such as a perforation of the uterine wall, sepsis or pelvic inflammatory disease.
- Lipitor: Women have developed diabetes while taking Lipitor to lower their blood cholesterol, and this is a possible case against Pfizer.
Seek Legal Assistance.
If you or a loved one have been injured as a result of a drug or pharmaceutical, you may be entitled to financial restitution. We offer an authoritative knowledge of the law and of the scientific underpinnings of medical malpractice cases. We utilize a network of experts who provide consultation on specific medical topics, including ADEs, and we also employ nurses to help us evaluate cases.
We understand what you are going through and can help. Do not delay.
CALL FOR A FREE CONSULT. Contact Cliff Rieders, Pharmaceutical/Drug/Medical Device Attorney at (570) 323-8711.