Articles Posted in Dangerous and Defective Drugs

Too often people are intimidated by health care providers and follow their direction without asking important questions. They often fail to do what they can to protect themselves by asking those questions and not being afraid to do so or by going on the internet to research a drug prescribed or a surgical procedure recommended.

I always encourage people to ask questions, do research and even call me for advice BEFORE undergoing a surgical procedure or taking a particular drug. In my work as San Francisco injury lawyer, I have represented many patients who ultimately became harmed by drugs and procedures they did not know would hurt them. Sometimes they were never informed of the risks involved in taking the medication or having a particular surgical procedure or medical device implant.

Health care providers are required by law to obtain an informed consent whenever they recommend treatment. In California, our supreme court has established that a physician is required to disclose “all information relevant to a meaningful decisional process.” Cobbs v. Grant (1972) 8 Cal.3d 229, 242. That means doctors and other medical practitioners must tell patients what alternatives exist to recommended treatment, what risks are presented by the recommended treatment, and what to expect if they follow the medical advice being given them.

In our law practice, we have represented many clients who have suffered serious injury as a result of having been inadequately informed. At trial involving patient injuries, often the jury instructions we propose which are well-established in California have to do with informed consent, the failure to provide informed consent and related issues that a jury must decide.

When a doctor prescribes a drug, the patient needs to ask the following questions:

First, why are you prescribing this drug and are there other drugs that perform the same or similar functions?

Second, is this a new drug on the market? (Doctors are very susceptible to persuasion by drug reps that they should try new drugs which do not have a track record and can be dangerous);

Third, what are the side effects of the drug; are there any side effects that can cause death or serious injury?;

Fourth, what should I look for when taking the drug to determine whether or not I am suffering ill effects from the drug; what should I do if any changes occur after I begin to take the drug?

After these questions are answered, the patient should go on line and research the drug for side effects. The Food and Drug Administration has a website where one can access adverse event reports pertaining to drugs and medical devices which are on the market. That is also a good resource for information. Taking these steps might well avoid the types of serious injuries that our clients have suffered from drugs prescribed by their physicians.

If you have concerns after asking these questions and researching the drug itself, call your doctor and discuss these with him or her. Do not feel that you are being a “difficult” patient or are outside your rights to be very comfortable about your own health. Do not let your physician or medical staff cause you to believe that you do not have a right to know these things. You do. If you believe that your doctor is not willing to fully discuss and address your concerns, consider finding a physician that is more open and willing to go through this process with you.

The same issues and concerns for patients apply to recommended surgical procedures. Next post, I will share important information about informing yourself about surgical risks.
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As California defective drug lawyers, we closely follow The Food and Drug Administration’s (FDA) warnings and updates for adults and children with regard to medications and medical devices. The FDA has just issued a caution about a medication called SimplyThick that they say may cause injury and death to newborns and infants.

Specifically, the concern with this medication is the potential effect it has on the intestinal tissues of infants. An earlier warning had narrowed the concern to the use of the drug with premature babies, but it is now thought to be a concern for infants of any age.

The condition that can develop from the use of SimplyThick is called necrotizing enterocolitis (NEC). Premature babies and infants who have taken this have developed inflammation and the dying off of intestinal tissues. This can lead to injury and death and it is suspected that there is a link between infant illness and deaths and SimplyThick.

The use of this medication is intended to assist in swallowing. SimplyThick is used as a thickening agent for breast milk and infant formula and is sold to both health facilities and the public. It is intended to help premature babies with swallowing and is also used in older kids and adults.

The Journal of Pediatrics just published findings that expanded the concern to infants in general. Parents are asked to seek their physicians advise before using this drug for premature babies or infants. More study is underway on this situation.

The FDA has published a list of symptoms that should be a warning to parents or caregivers using this medication. They include: “bloated stomach, greenish-tinged vomiting and bloody stools.”

We will keep readers apprised of further developments about SimplyThick.
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As California trial and injury lawyers, we have litigated cases involving dangerous supplements and medications that have caused injury and even death. We have represented victims and families whose lives have been changed by dangerous products that have ultimately been recalled by the FDA.

In our view, public access to medical and health information can be a good thing. But is also a mixed blessing when consumers have access without sufficient information or clinical testing.

We cannot foresee the future of the use of mobile media devices and medical information, but the Food and Drug Administration has just published draft guidelines that might give us all an indication as to where things are headed.

The Sacramento Bee reported recently that an effort is underway in California to pass a consumer-related bill that would protect consumers from renting or buying a car from a rental car company that is subject to a federal safety recall.

California Assembly Bill 753 is supported by the mother of a young woman and her sister who were both killed in a tragic crash in Monterey County in 2005.

Carol Houck’s daughters were killed in a head-on collision on Highway 101 when they were driving a rented Chrysler PT Cruiser that had been subject to a safety recall. Ms. Houck has been dedicated to getting legislation passed to protect drivers from what happened to her children.

The California Injury Attorney Blog tracks national drug and product recalls. Most recently, the nation has been under a massive recall of shell eggs. This is a significant food safety issue and we want our readers to take precautions to avoid illness.

The recent recalls became necessary after hundreds of consumers across the country became ill with Salmonella Enteritidis (SE). This illness can be serious and is a common cause of food poisoning.

Millions of shell eggs have now been recalled from store shelves. The FDA also has extensive questions and answers on its website to help consumers avoid becoming ill from these eggs.

The California Injury Attorney Blog has kept our readers posted on the heart-related dangers associated with the diabetes drug, Avandia. Last week, after months of anticipation, the FDA advisory panel convened to provide its conclusions on the RECORD study, funded by the drug’s manufacturer GlaxoSmithKline. The panel’s recommendations move on to the FDA.

The public has needed clarity on this for some time now, but they did not get it from the advisory panel’s recommendation to the FDA. Although the Advisory Panel did not pull the drug from the market, the debate was heated and the vote interesting as 17 members voted to keep the drug on the market but want new restrictions, three said nothing needs to be added to the warnings, and 12 sought a recall of the drug from the market.

Avandia’s competing drug Actos does not appear to have the same level of cardiovascular risk associated with it. At least that is what the scientific community is saying at the moment.

The California Injury Attorney Blog has posted previously on boxed warnings issued by the United States Food and Drug Administration (FDA) for such drugs as Avandia. It is very important to learn about any warnings related to medications you are taking. These warnings are very important for both the public and healthcare professionals. This time we share important information about the drug Plavix.

Earlier this year, the FDA added a boxed warning to Plavix, which is used as an anti-blood clotting medication. Plavix has been the second-best selling drug in the world.

The drug is intended to reduce various risks, including heart attack, stroke and death in patients with heart disease. The drug is supposed to make platelets less likely to form blood clots.

Reuters is reporting that an email from an FDA reviewer and known whistleblower appears to confirm findings that the diabetes drug Avandia carries a risk of serious cardiovascular problems. The findings have not yet been published, but as the California Injury Attorney Blog noted recently, the FDA is about to host its public meeting scheduled in July to report on the safety risks associated with Avandia.

The latest study apparently shows increased risks in the following percentages: risk of stroke 27%; risk of heart attack 25%; and, risk of death 17%. The research was based on data from about 230,000 patients, mainly over 65 years of age.

These findings, as well as the FDA’s review of another major study, will be presented at the July advisory panel meeting. Avandia sales have dropped since a 2007 Cleveland Clinic study. It is widely thought the drug may be taken off the market after the July meeting.

The story of Fen-Phen is long and arduous. The drug Fen-Phen caused serious injury and death and although it has been off the market for over ten years now, many patients were not diagnosed with the serious medical conditions that it caused until after they had stopped taking the diet pill.

The lawyers of Hersh & Hersh, who bring you the California Injury Lawyer Blog, were the first firm to take action against the drug manufacturer who made Fen-Phen. The firm was the first to file and settle a lawsuit making the connection between Fen-Phen diet pills and the progressive and potentially fatal disease, primary pulmonary hypertension (PPH).

The impact of the drug was of historic proportions, but not in a good way. Many people were harmed as these pills caused such serious injury in some cases the only way to survive was lung transplantation. The symptoms for many Fen-Phen users did not appear immediately. And when they did, they were serious or fatal.

Sadly, this is not the end for the impact that diet drugs and supplements can have on the unsuspecting public. The long term adverse health effects of taking some of these quick-fix drugs and supplements can be very dangerous indeed.

Diet drugs, supplements and other substances are sold to the public by the millions. We want our readers to be aware that there can be not only adverse medical consequences for taking diet drugs and herbal substances, but it is possible for these substances to interfere with other prescription medications a person is taking at the same time.

It is important to be knowledgeable about what you are taking and in what combinations. There are many resources available for this information. For example, the Mayo Clinic website has an entire section devoted to the importance of knowing what you are taking and how it will interact with your other medications.

The story of Fen-Phen is tragic. Arm yourself with information before taking herbal or other supplements that claim to be helpful or good for you.
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