Medical device recall: aluminum tainted dialysis fluid

Massachusetts based manufacturer NxStage Medical Inc. recalled 140,000-150,000 units of concentrated dialysis fluid because it contained excess aluminum. Intended for portable home systems used for kidney dialysis, the tainted fluid was made between April 2013 and February 2014.  According to the Boston Globe: "…the recall has shocked and upset patients, who, because their diseased kidneys can’t clean wastes from blood, rely on NxStage’s products almost daily…Patients said bad concentrate raised their aluminum levels to two, three, or even four times their normal levels, causing them to feel anemic and sick."

Dangerous Drug Alert: Pradaxa lawsuit settles for $650 Million

The German company Boehringer Ingelheim, the makers of the blood thinning drug Pradaxa, will reportedly settle 4,000 dangerous drug lawsuits brought by consumers who alleged that the drug caused serious and sometimes fatal bleeding. According to the New York Times, Institute of Safe Medication Practices implicated Pradaxa in more than 1,000 deaths. Pradaxa generated $1.6 billion in revenue last year.

Dangerous Product Alert: Medical Devices for Children Tested in Adults

According to a recent study, almost all medical devices that have been approved for use in children were not actually tested on children first. The study “Postmarketing Trials and Pediatric Device Approvals” was published in the Pediatrics journal, and discusses how devices can be approved for pediatric use after being tested on subjects between 18–21 years old. The study was meant to see how the 2007 Pediatric Medical Device Safety and Improvement Act is working.  According to an article in Reuters, the lead author Thomas J. Hwang remarked that “children are not simply ‘small adults,’ and a device found to be safe and effective in adults may have a very different safety and effectiveness profile when used in a pediatric population.” 

Actos Bellwether Trial: $9 Billion Verdict for Plaintiffs

A jury in Lafayette, Louisiana, handed down the seventh-largest award in US history against Takeda Pharmaceutical, Asia’s largest drugmaker, and Eli Lilly & Co according to Bloomberg. The federal court jury found the companies hid the cancer risks of their Actos diabetes medicine and ordered them to pay a combined $9 billion in punitive damages. The verdict will most likely be reduced because the US Supreme Court has said punitive verdicts, imposed for bad conduct, must be proportional to the actual damages that underlie them. Takeda and Lilly have announced they will appeal. Plaintiff Terrence Allen blamed the drug for his bladder cancer. His lawyer, Mark Lanier, said that he hoped the Takeda executives in Japan heard what the jury had to say loudly and clearly.

It was learned during the trial that Takeda officials intentionally destroyed documents about the development, marketing and sales of Actos. Because Takeda failed to properly protect the documents, US District Judge Rebecca Doherty penalized the company by instructing jurors they could infer that the files may have reinforced Allen’s claims that the company wrongfully hid the medication’s health risk.

Though a long court battle is still ahead, today the verdict sends a message to global corporations that they must put health and safety ahead of profits or American juries will hold them accountable. 

Lawsuits Against Testosterone Manufacturers

You’ve seen the ads ––take a testosterone supplement to feel younger, more vibrant, and stronger.  It’s a compelling message for men. Unfortunately, it may also be a deadly one.  The Journal of the American Medical Association conducted a study of more than 8,000 men and found that men who used testosterone supplements were 29% more likely to suffer a heart attack or stroke within three years of taking the supplement.

Another study showed that men over the age of 65 had a double risk of a heart attack within 90 days of starting testosterone therapy.

In January of this year, the U.S. Food and Drug Administration issued an alert stating that it was investigating the risk of stroke, heart attack, and death in men taking testosterone products.

Just how dangerous can testosterone be?   In 2010, the New England Journal of Medicine reported that a clinical study found a higher rate of adverse cardiovascular events in older men resulting in the study being brought to a halt by the study’s Data and Monitoring Board

None of the testosterone products came with any kind of a warning to the patients or even to their prescribing doctors.  Those who have suffered adverse effects from testosterone are eligible to file claims of a defective product, breach of warranty, negligence, and misprepresentation.

Here at SGB we are dedicated to victims of dangerous products.  We are based in Seattle, but our work covers all of Washington State.  Our team of litigation attorneys is ready to assist you.   If you or someone in  your family has suffered a heart attack or stroke sometime after having taken testosterone, we welcome your inquiry - we would be happy to provide a prompt and confidential evualtion of your case.