COVID-19 Notice: We are providing FREE consultations via phone or video conferencing for your safety and convenience. Learn More »

COVID-19: Maryland Laws, Policies and Legal Resources from Miller & Zois. Includes information and updates on Maryland and Federal laws and regulations impacting Maryland residents and businesses.

Published on:

By

womanNexium, or esomeprazole, is a drug that is used to treat heartburn and excessive amounts of acid in the stomach. Specifically, it is used to treat duodenal and gastric ulcers, esophagitis, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome. Nexium is a proton pump inhibitor (PPI) that decreases the amount of acid produced in the stomach. Other drugs that are in the same class as Nexium include Prevacid and Prilosec. Approximately 15 million Americans use PPIs that are sold both as prescription and over-the-counter.  Nexium sales exceed $3 billion a year.

  • 2019 Update: These drugs have had a troubled history.  Zantac, which was long considered a great and safe drug, has now been associated with cancer.

Nexium is a controversial drug.  At one point, bone fracture lawsuits were all the rage because there was data suggesting Nexium, particularly the long-term use of Nexium, would cause bone fractures and breaks.  We believed many of these cases were meritorious.  But the litigation did not get very far.

Continue Reading

Published on:

By

The FDA has recently expressed concern about a certain group of medications called SGLT2 Inhibitors. This category of drugs includes popular prescription medications such as Invokana and Farxiga. Although these drugs have been, by all accounts, fairly successful when treating Type 2 diabetes. But they have produced their fair share of side-effects. Specifically, users of drugs such as Invokana are now reporting high levels of blood acid, the effects of which have landed some users in the ER.  While no deaths have been reported, there is no question that if these reports are accurate, these levels of blood acid could cause serious injury and death.  Accordingly, plaintiffs’ lawyers are investigating whether there is a connection between these drugs and these high acid levels and, if so, whether these drug makers knew about these risks and simply failed to inform patients and doctors.   If these dots are connected – and there is reason to think they might be – there are likely to be both serious injuries and lawsuits seeking compensation for those injuries.

The preceding paragraph was written some time ago.  In May 2017, there are 230 lawsuits pending in a federal MDL in New Jersey.

SGLT2 Inhibitors

Continue Reading
Published on:

By

pills2New data suggests an association between melanoma skin cancer and Viagra. This has led many patients suffering from erectile dysfunction to question whether the benefits of this drug justify the risk of death that may accompany it.

If you or someone you love has developed melanoma while taking Viagra, you may have an injury or wrongful death lawsuit against Pfizer, who has never adequately warned patients and their doctors of this risk. If you believe you have a claim, call our lawyers for free at 800-553-8082 or get a free Internet consultation. We can discuss your options with you.

The Association Between Viagra and Melanoma

The understanding of the potential risks of melanoma with Viagra took flight in 2014 for the general public when Harvard Medical School released a new study showing that Viagra users were 84% more likely to develop melanoma skin cancer.

Continue Reading

Published on:

By

testosterone2
Testosterone supplements have found themselves in the news quite a bit lately. Unfortunately, for manufacturers, this is not good news. Because these lawsuits are on the fast track to being a very big deal.

There is a lot of research coming out with a sudden fury that suggests that testosterone treatments for men can cause an increased risk of heart attacks and strokes that can lead to serious injury and death.  A study published this week in the medical journal Plos One indicated that researchers found a two-fold increase in the risk of a heart attack in the three months after an initial prescription among men aged 65 years and older and a two to three-fold increase among younger men with a history of heart disease.  This is huge, especially considering millions of men are taking these hormonal treatments, and many are learning for the first time of the extent of the risk.

Products in this category are:

Continue Reading
Published on:

By

da-Vinci-FlagstaffThe da Vinci lawsuits involve both medical malpractice and product liability claims.  Some of these are wrongful death cases, some of these claims are very minor, and there are a lot of cases in between.

The Insurance Journal reports on a malpractice case in Oregon where the plaintiff received a $100,000 award from an Oregon gynecologist who she alleges improperly removed a healthy ovary.

A jury verdict of $100,000?  Huh?  They took her ovary, and they found negligence.  The plaintiff asked for over a million.  So what gives?

Continue Reading
Published on:

By

It took a New Jersey federal jury one hour and twenty minutes to determine that Fosamax did not cause a Plaintiff’s femur fracture.  In the first verdict in a Fosamax case where the Plaintiff claims that the osteoporosis drug weakened her thigh bone, the jury said that Plaintiff did not prove her case.

After having taken Fosamax for eight years, Plaintiff, now fifty-eight, fractured her right femur requiring surgical repair.  She sued, alleging that Fosamax caused her atypical femur fracture and that its manufacturer, Merck, failed to warn her doctor about the risk.  Merck, pleased with the verdict, stated that the company provided appropriate and timely information about Fosamax to consumers.

Plaintiff’s suit had been transferred into the Fosamax femur fracture MDL, sometimes referred to as “Fosamax II” as an earlier Fosamax MDL was formed to deal with claims of osteonecrosis of the jaw (ONJ).  Merck has said that there are about 3,300 Fosamax femur fracture cases, and about 1,230 ONJ cases.

Continue Reading
Published on:

By

McNeil-PPC Inc. and Johnson & Johnson have asked that all New Jersey state court Tylenol liver injury cases be centralized before one Judge in the Middlesex County Superior Court, in order to avoid duplicative discovery, inconsistent rulings, and to conserve resources of the judiciary and the parties.  There are currently fourteen Tylenol cases pending in New Jersey state courts with Plaintiffs from twelve different states.

In their request that stated that since the federal Tylenol injury cases were centralized in April, thirty-three new federal cases have been transferred into the multi-district litigation (MDL).

The defendants are refuting the plaintiffs’ claims that McNeil and Johnson & Johnson failed to warn about the risk of liver injury.  They claim that the risk has been known “for decades” and further claim that the FDA has repeatedly said that Tylenol and acetaminophen are safe when used as directed, and when recommended dosages are not exceeded.

Continue Reading
Published on:

By

pills2According to a recent news release, regulators in Europe have concluded that there is little evidence that widely used drugs to treat Type 2 diabetes could cause pancreatic inflammation or pancreatic cancer.

Besides the European agency, the Food and Drug Administration has been reviewing the safety of a big class of drugs that includes Januvia by Merck and the drugs Byetta, Bydureon, and Onglyza, which are sold by Bristol-Myers Squibb and AstraZeneca.  These drugs, called incretin mimetics by the FDA, increase the body’s levels of a hormone that helps to control blood sugar levels.

They have, however, been linked to pancreatic inflammation known as pancreatitis.  While the European agency said that the clinical trials had shown no increased risk of pancreatic cancer, the FDA said the trials were too small to draw firm conclusions.

Continue Reading
Published on:

By

pills2The Food and Drug Administration (FDA) has considered changes to its labeling rules regarding generic drugs.  The changes could provide generic drug users with more protection.

Currently, those that have been injured by a brand-name drug can win compensation from the manufacturer if it can be shown that the drug was unreasonably dangerous or that the warning label did not disclose the risks properly.  Those injured by a generic medicine?  Not so much.  Those injured by a generic medicine can’t hold the manufacturer liable as long as the drug maker used the same active ingredients and displayed the same warnings as the brand-name drug.  Crazy, huh?

All of that could be changed by a new rule that the FDA expects to formally propose in September.  The new rule would “revise and clarify procedures for changes to the labeling” of approved drugs.  This will include both brand names and generics.  This change would either enable or require (not yet clear based on the information provided by the FDA) drug makers to announce possible changes to their warnings while the FDA is considering the warning.

Continue Reading
Published on:

By

medicationThe FDA has shut down 1,677 sites for selling counterfeit or substandard medication, or for selling drugs without appropriate safeguards.  Other sites received regulatory warnings.

While the prices look good, you never really know what you’re getting.  These products can have too much or too little of the active ingredient that people need for the treatment of their disease, and some could have toxic ingredients.  Several of the sites had sleek interfaces and names that could easily be confused with legitimate pharmacies.  Walgreens-Store.com, for example – the drugstore chain is actually Walgreens.com.

Though many of the sites present themselves as Canadian, most of them are based overseas – China, India, Pakistan, all around the world.  The National Association of Boards of Pharmacy recently performed an analysis of over 10,000 websites and found that 97% did not fully comply with state and federal regulations. 88% didn’t require a valid prescription, and almost half of them sold medicines lacking FDA approval.

Continue Reading