Mistakes do happen but when you are the manufacturer of drugs or medical devices, it’s imperative that you identify your mistakes before they become a source of serious injury or death to consumers. When products such as prescription drugs and medical devices are unsafe, they can harm, injure and even kill consumers wherein lawsuits may be filed. Whether a drug or medical device is unsafe because of a manufacturing error, defective materials or a failure to provide adequate instructions, consumers injured by these products should seek the assistance of qualified personal injury attorneys as there is legal recourse available.
When drugs and medical devices are rushed to market as they often are, the manufacturers typically know that the products may be unsafe. In many cases, a needed change that would cost very little to implement could have prevented serious injuries or wrongful deaths. When manufacturers make mistakes with prescription drugs or medical devices, they do not pay the price for the errors but consumers do. Those people who took the drugs or used the devices expected them to be safe as they should have. Victims of unsafe drugs and defective medical devices are people who’ve been harmed through no fault of their own.
Unsafe Drugs Cause Unnecessary Harm and Death
It occurs over and over again. A large pharmaceutical company releases a new drug to the market and spends money advertising its benefits so that profits pour in. When patients start reporting having adverse reactions to the drug, it often is found that the drug company was aware of the problems with the drug that caused the health issues. Sadly, choosing profit over the health and welfare of consumers is common practice among major drug manufacturers.
Dangerous prescription drugs can and often do cause many serious medical problems and even the loss of life. Unfortunately, pharmaceutical lawsuits and the resulting multi-million dollar verdicts are often the only way to get through to large drug manufacturers.
Medications such as Zoloft, Fen Phen, Viagra, Paxil, Acetaminophen and Celebrex (just to name a few) are all medications that have been found to cause serious complications in users. One of the most well-known drug recalls was for the birth control medication Yaz that was found to cause strokes and heart attacks. While the worst cases can result in death, the most commonly occurring side effects of harmful medications such as those mentioned above include:
- Kidney failure
- Stomach ulcers
- Heart attacks
- Psychological complications
- Birth defects
- Irregular heartbeats
Who Can Be Held Liable for Unsafe Drugs
When an individual suffers serious harm from an unsafe drug, he or she may have a drug-related product liability claim. In order to win a claim for compensation, it is necessary to identify who is responsible. The entities and individuals that may be held responsible for the physical and/or emotional harm done to a victim of an unsafe drug may include:
- The Manufacturer – Drug manufacturers are typically large corporations that hire aggressive legal teams to help protect their best interests. For this reason, it’s always recommended to work with a personal injury attorney as professional legal assistance can go far in helping prove a manufacturer was indeed responsible.
- Testing laboratory – It’s likely that the drug that caused the serious health issue was put through a series of tests before it came to market. A testing laboratory could be held liable for a victim’s injuries if it was found the lab knew of the potential dangers before approving the drug for sale.
- Drug Sales Representatives – Pharmaceutical manufacturers typically hire sales reps to meet with hospitals, doctors and others in the medical community to sell their newest drugs and to make recommendations for how they are to be used. These representatives could be held liable if they knowingly recommended an unsafe drug that harmed a victim.
- Hospitals, clinics, pharmacies and physicians – Hospitals, clinics, pharmacies and physicians may be held liable for a victim’s health problems if they recommended or issued the unsafe drug that caused harm. These entities and individuals may also neglect to warn patients about potential side effects or to provide adequate instructions regarding how to properly use the drug.
The FDA’s Role in Monitoring Drugs
The Food and Drug Administration (FDA) is responsible for making sure drugs are safe and effective. The administration’s Center for Drug Evaluation and Research conducts evaluations of new drugs to ensure they work as they’re intended and that their health benefits outweigh known risks. While this group does not conduct testing on drugs, it does receive test results from the manufacturers. The experts at The Center for Drug Evaluation and Research then review the findings to determine whether or not the new drugs are safe, effective and of good quality.
When a drug has been approved by the FDA and released for sale, the manufacturer is responsible for reviewing and reporting any problems associated with the drug. Drugs are recalled when either the manufacturer or FDA makes the decision that the drug is unsafe and should therefore be taken off the market. At times, it is not necessary to do a recall when new studies have found the drug is too dangerous to be used by consumers.
There are numerous ways the manufacturer and FDA notify consumers about a drug recall. A recall can be reported to the media, it can be listed on the FDA website or the manufacturer can notify its direct accounts such as pharmacies and wholesalers to inform them of the recall. Consumers are encouraged by the FDA to report suspicious problems (on the agency’s website) with drugs, vaccines and medical devices that have caused serious adverse events such as health problems, admissions to hospitals, disabilities and the risk of death.
Defective Medical Devices
New medical devices are continuously being developed and released to the market each year. While these products are designed to benefit patients and to help improve their quality of life, poor designs or devices that were not tested properly often do more harm than good. Manufacturers of medical devices, who make huge profits from their products, have a responsibility to ensure that the devices they make are safe and work as they are designed to. This is not always the case however as far too many medical devices have injured unsuspecting, innocent people.
Among the types of medical devices which have been found defective in the past include:
Heart defibrillators – A heart defibrillator is designed to provide a shock to the heart to restore natural heart rhythm. Defective heart defibrillators have malfunctioned wherein they could not regulate heart rhythm, posing a threat to the lives of those using them.
Intrauterine devices or IUDs – An intrauterine device is used for birth control. Defective IUDs have resulted in high rates of pelvic disease among unsuspecting women.
Silicone breast implants – Many silicone breast implants have ruptured inside the bodies of women who had them implanted. Ruptured silicone breast implants have been associated with the development of fibromyalgia.
Heart valve implants – Many defective heart valve implants have leaked or been subject to strut fractures to result in patients having to undergo sometimes repeated surgeries. Other patients have suffered from heart failure due to defective heart valve implants.
Hip replacement components – Patients receiving defective hip replacement parts have suffered from severe hip pain and loss of balance. Many patients with defective hip replacement components have had to undergo corrective surgery to have the defective components removed and replaced.
Bronchoscopes – A bronchoscope is a flexible tube featuring a tiny camera that’s used to examine the lungs for disease. Loose biopsy ports on these medical devices have resulted in patients contracting serious bacterial infections.
Who Can be Held Liable for Defective Medical Devices
When an individual suffers a serious injury due to a defective medical device, he or she must identify any and all responsible parties. Among those who may be held liable for the injuries suffered from defective medical device includes:
- Manufacturers – In most claims brought by victims of defective medical devices, the manufacturing company that made the device is to blame for the defect. Most manufacturers of medical devices are large corporations that always have teams of high-priced attorneys defending them from liability lawsuits. This is why it’s very important to work with an experienced California personal injury attorney as ‘going it alone’ would almost certainly not turn out in the victim’s favor.
- Testing laboratories – The laboratories who were responsible for testing medical devices before being released to the consumer market may be found liable for a victim’s injuries. This is especially so if a laboratory is an independent company that is not directly associated with the manufacturer.
- Medical Device sales representatives – Most medical device manufacturers hire sales representatives who are paid to meet with physicians and others in the healthcare field to promote the devices with the hope that medical professionals will recommend the devices to their patients. These representatives can be held liable if they recommend a medical device that injuries innocent victims.
- Hospitals, clinics and physicians – When a hospital, clinic or doctor recommends a defective medical device to patients, they may be held accountable for any injuries suffered due to the use of the device.
- Retailers – While most medical devices are given directly to patients by hospitals, clinics and physicians, some are sold at pharmacies or other types of retail stores. A retailer may be found liable for injuries sustained by a defective medical device if it was found the retailer knew of the danger or if the retailer altered the device in some way or changed the package warning labels.
In order for a victim of a defective medical device to win a lawsuit, he or she must be able to prove:
- That their injuries were directly related to the use of the medical device in question
- That the medical device was designed in a defective manner or that the manufacturer deceptively marketed the device and,
- That the defect or improper marketing was what caused the injuries.
If you, or someone you love has been harmed by an unsafe drug or defective medical device, it’s important to seek the assistance of a personal injury attorney. It can be difficult to prove that your health problems or injuries are directly related to the drug or medical device you used. An experienced attorney can help you gather the necessary information and evidence to determine if you have good cause to file a claim against who is responsible for what happened to you.