Lawsuit Update Center

It’s a typical pain pump story—the patient has a minor shoulder injury and gets routine arthroscopic shoulder surgery; the patient recovers from surgery okay and feels better, but then within a year patient’s shoulder starts to really hurt. The patient returns to the doctor and discovers his cartilage is missing. The patient learns that the pain pump used after his surgery was to blame because it pumped anesthetic into his shoulder joint, which killed the cartilage.

In one case filed in the U.S. District Court for the Southern District of Florida, plaintiff Douglas Kilpatrick lost late last month on summary judgment. The defendant, Breg, Inc., argued that Kilpatrick did not prove the pump caused the injury. In its Daubert analysis, the court held that the causal link testified to by Kilpatrick’s expert, Dr. Gary Poehling, was excluded under the reliability prong of Federal Rule of Evidence 702.

The court’s ruling considered the following as deficiencies in Poehling’s testimony:

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.

Kugel Mesh patches, used to repair ventral and incisional hernias, were approved by the FDA in 1996. By 2002, Davol Inc. began receiving complaints but blamed injuries on the doctors who were installing the patches. However, they issued a recall in December 2005.

The patch has a “memory recoil ring” that breaks as it is placed into the body. Once broken, a patch-wearer risks bowel perforation, chronic intestinal fistulae, and abnormal connections between intestines and other organs. Sometimes, this can be fatal.

The best part of any litigation against a large corporation (in my opinion), is the documents. There is nothing better than requesting documents in discovery, receiving tens of thousands (or even hundreds of thousands, or sometimes millions) of pages of documents. Defendant corporations probably laugh as they hand over so many documents, thinking that we can’t possibly inspect them all. However, somehow, we manage to do just that. And that’s where you find out what the case is really about. Kugel Mesh lawsuits, now thickly embroiled in litigation, are no different.

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.

New from Twitter (side-issue—I’ve been trying to figure out decent work-related uses for Twitter for some time. This might be it—I can get instantaneous reports from the FDA about recalls and other safety issues related to drugs and devices—if you’d like to join the club, then just go to your Twitter account, search for the FDA, and click ‘Follow’): the FDA just posted a recall from AS Medication Solutions, LLC. AS Medication distributes Digoxin 0.25 mg tablets under the Caraco brand.

Digoxin is used to treat heart failure and abnormal heart rhythms. The drugs are being pulled because some tablets may have more or less of the active ingredient. I’ve been to seminars about this drug, and my understanding is that there is a very narrow range of therapeutic benefits. The analogy is that a patient’s digoxin levels are represented by a ball balanced on the point of a pyramid—too much digoxin, even by a bit, will cause the levels to rapidly change, with disastrous results (including cardiac instability, slow heart rate, and death).

Plaintiffs’ lawyers have been advertising for digoxin cases for some time—a word first came out of the problems with Digitek tablets in April 2008 (trademarked by Activis Totowa, distributed by Mylan Pharmaceuticals Inc. under a Bertek label, and distributed by UDL Laboratories, Inc. under a UDL label). Those pills, manufactured in New Jersey, were reported to have a similar problem—some of the pills were supposedly “double-thick.” While there were verified accounts of major problems with the manufacturing facility in that instance, I don’t know of any lawyers who actually located any double-strength pills. The cases moved rapidly in the beginning but seemed to lose steam.

Yesterday, the Health Subcommittee of the U.S. House Committee on Energy and Commerce held a hearing on the Medical Device Safety Act of 2009 (H.R. 1346). This new law that would restore important the rights of defective medical devices that were eradicated by the U.S. Supreme Court decision in Riegel v. Medtronic. The Medical Device Safety Act would restore the right of victims injured by a defective medical device to seek tort remedies for injuries and deaths.

Rep. Bruce Braley (D-Iowa) said at the hearing that the Supreme Court’s decision was flawed because preventing injured patients from suing device makers over FDA-approved products results in shifting the cost of caring for injured patients away from medical device companies who cause the injuries onto the already burdened American taxpayer.

Point of Law has a full list of those who testified before the subcommittee. One of those speakers is Michael Kinsley, a liberal columnist who wrote a silly editorial on Medtronic v. Riegel that showed off his complete lack of understanding of the facts of the case. I’m not saying an argument can’t be made – Justice Scalia did just that.