Lawsuits involving Zicam have been consolidated for discovery under U.S. District Judge Frederick J. Martone of the U.S. District Court for the District of Arizona. These Zicam lawsuits involve claims that Zicam caused patients to lose their sense of smell or taste.
People with type 2 diabetes taking the drugs Januvia or Byetta might have an increased risk of developing pancreatitis and pancreatic cancer. Our law firm is handling lawsuits on behalf of patients who were taking Januvia, Janumet, or Byetta.
We can all agree that these drugs are good at fighting diabetes, which is an awful disease. But there are a lot of drugs that fight diabetes. These drugs might be a little cheaper than some. But the problem with Januvia is that if it impacts the pancreas in a way that can cause it serious injury like pancreatitis, and even more seriously, pancreatic cancer.
Pancreatic cancer occurs when cancerous cells form in the tissues of the pancreas. The majority of pancreatic cancers start in what is called exocrine cells.
Remember Wyeth v. Levine, U.S. Supreme Court decision that held federal approval of labels drug warning labels does not preclude lawsuits under state law claiming inadequate warnings? Well, the government, through the FDA, has now added a final chapter to that story.
Wyeth v. Levine was a landmark U.S. Supreme Court case that involved a Vermont musician named Diana Levine who had her right hand amputated after being injected with Phenergan, an anti-nausea medication made by Wyeth, a pharmaceutical company that was later acquired by Pfizer.
Kugel hernia mesh lawsuits are settling, thanks in part to a change in defense counsel. The products, manufactured by Davol, are defective because the plastic ring can break off, causing perforation and infections. Left untreated, these injuries can be fatal. Davol has since eliminated the use of the plastic rings, in favor of a bio-absorbable ring.
Now represented by the New York firm Reed Smith, Davol has signaled a change in thinking to a more reasonable approach—these can be very meritorious cases worthy of settlement, and the expense of litigation is unnecessary. There are about 1,000 cases in the Rhode Island United States District Court MDL, and about 1,200 cases in Providence state court (the manufacturer, Davol, is a Rhode Island company). Right now, 4 federal suits have been settled, and one state claim has been settled. This looks to be the tip of the iceberg, as the parties move toward the first scheduled federal court trial in March 2010. That will be followed shortly thereafter by the first state court case in June 2010. The settlements will probably come in rapid numbers, now that discovery is coming to a close and the trials quickly approach.
For more on Kugel Mesh lawsuits and settlements, see our prior blog post.
Last week, we briefly mentioned the FDA’s new requirement of a black box warning (yes, we will continue calling it a “black box warning”). This week, we had a one day trial that turned into a three-day trial, so we’re just now getting to follow up on it.
The warnings will affect Pfizer’s Chantix (varenicline), GlaxoSmithKline’s Zyban and Wellbutrin (bupropion), and generic smoking cessation drugs (note—bupropion like Wellbutrin are often prescribed for depression and seasonal affective disorder). Besides the warnings, the manufacturers will be required to create patient medication guides to fully disclose the risks of neuropsychiatric symptoms. Symptoms to be on the watch for include: hostility, agitation, depression, suicidal ideation, and behavior changes not associated with nicotine withdrawal. Those medication guides will be given to all patients who have been prescribed the drugs. Finally, manufacturers are now required to conduct clinical trials to more fully explore causation.
The requirement comes on the heels of the FDA’s analysis of their MedWatch reports, which show that there may be a link between the drugs and suicidal events in patients with no history of psychiatric disease. However, the FDA first broached the topic of a potential problem back on November 20, 2007. See also the FDA’s recent newsletter on the topic here.
The makers of Levaquin (generic: levofloxacin) are currently embroiled in litigation, with 83 federal cases consolidated before Judge Tunheim of the United States District Court for the District of Minnesota. Federal cases were transferred to Minnesota almost a year ago. Currently, the Court and the parties are working on case-specific discovery for agreed-upon cases, from which bellwether cases will be selected. Frequently, bellwether trials give the parties a good idea of what juries think of the litigation and often provide momentum for settlement of the remainder of cases.
As background, Levaquin is a form of antibiotic, primarily used to treat specific bacterial infections of the lung, sinus, skin, and urinary tract. Ortho-McNeil-Janssen Pharmaceuticals (part of Johnson & Johnson) now warns on their website:
IMPORTANT SAFETY INFORMATION FOR LEVAQUIN
For two years, Florida attorney Frederick Schaffer has sought the answer to his lack of smell. He’s gone to doctor after doctor, searching for a solution and cause to the medical condition known as anosmia. He had a camera rammed down his nasal passage, as well as an MRI and a CT scan. He’s visited specialists. But he finally realized the problem when he saw the FDA’s recall of Zicam.
Schaffer’s claims really highlight what tort victims understand, but the general public often overlooks. Seemingly insignificant injuries often have a lifelong cost. Schaffer misses the smell of coffee (which most people use to help wake up). He misses his wife’s perfume. He misses the smell of his kids’ hair after they’ve taken baths.
The smell is also intricately enmeshed in our sense of taste. Imagine not being able to really taste homemade apple pie, much less smell it. Losing that one sense dulls the taste buds. And, if it can’t be corrected, that’s a lifelong condition. How much is that worth?
The blog Drug and Device Law posted today on the Bausch & Lomb cases. The lawyers working the keyboards, Jim Beck and Mark Herrmann, do a good job with their blog, and it’s always interesting to read. That said, they are clearly defense lawyers, and have the accompanying defense biases (note to readers—I’m a plaintiff’s lawyer and have my own set of biases). And Beck’s firm defends Bausch & Lomb. So, I’d like to supplement their post.
Drug and Device Law discusses the Daubert/Frye hearing that a federal and state judge will conduct for a few days in New York to determine whether the Plaintiffs have sufficient causation evidence to link the contact lens solution to non-Fusarium infections. This is, of course, an appropriate way to handle those cases (and kudos to the judges involved for conserving resources and tag-teaming the hearing). The judges will decide if the scientific link is strong enough to permit the cases to go forward—this is just one way the system works to make sure only meritorious cases get to juries.
However, there were also lawsuits filed on behalf of people who suffered from the eye infection known as Fusarium keratitis. That’s a nasty little bug that can damage the cornea, and may require corneal transplants or even eye removal. The Drug and Device Law blog gives cursory mention of those lawsuits, noting that “Some of the MoistureLoc lawsuits were naturally filed on behalf of people who actually suffered from Fusarium keratitis.”
With well over 100 cases filed in at least 21 states, the shoulder pain pump litigation is gaining steam. Pain pumps are small devices used to control post-operative pain. However, pump catheters placed near cartilage (usually the shoulder, but sometimes the knee or even toe) can cause the progressive deterioration of those cartilage cells, leading to painful and permanent bone-on-bone contact.
Defendants typically include the manufacturers and distributors of the pain pumps. However, some lawyers are adding anesthetic drug manufacturers. These are companies like AstraZeneca, Hospira, APP Pharmaceuticals Abbott Labs, who all supply local anesthetic (bupivacaine, marcaine, lidocaine, sensorcaine, ropivacaine, etc…) often selected for use in the pumps by doctors.
The case against the anesthetic manufacturers is indeed harder to prove than the case against the device manufacturers. However, inclusion may be important for a couple of reasons. First (though not a good reason to bring in a defendant by itself), the majority of the pain pump market share is owned by I-Flow. Discovery conducted to date indicates that I-Flow may have limited insurance to cover the flood of verdicts that may be coming.
Reglan (generic: metoclopramide) is a drug used to treat heartburn and slow gastric emptying in diabetes patients. The drug is commonly used to treat gastroesophageal reflux disease (GERD), gastroparesis, and other conditions affecting the digestive system.
The danger that Reglan lawyers are investigating is tardive dyskinesia (also known as TD), a neurological disorder that manifests as repeated involuntary movements. Injured patients may experience grimacing, protrusion of the tongue, lip-smacking, rapid eye blinking, and movement of the extremities. There is no treatment for tardive dyskinesia.
Not to say that heartburn isn’t painful, but how many of us would risk contracting tardive dyskinesia just to compensate for bad eating habits? Reglan lawyers have discovered that the label, unfortunately, minimized that risk, implying that there wasn’t much danger. The original label said it “may produce extrapyramidal reactions, although these are comparatively rare.” Other sections of the label likewise indicate that tardive dyskinesia is a low risk.
