Drug Recall Lawyer Blog

The FDA just released its Drug Safety Newsletter (Vol. 2, No. 2). The purpose of the newsletter is to provide post-market information to doctors and other healthcare providers about drugs on the market, and to encourage reporting of adverse events through the FDA’s MedWatch program. You can find the newsletter here.

The current issue focuses on three drugs, highlighted here:

1) Qualaquin (quinine sulfate): approved to treat malaria, Qualaquin is frequently prescribed off-label for nocturnal leg cramps, restless leg syndrome, neuropathy, and other problems. The adverse reporting system indicates that it may hematologic events, including thrombocytopenia (low platelet count). There’s no indication that the off-label use is effective.
2) Reclast (zolendronic acid): Reclast is used to treat osteoporosis and Paget’s disease. This bisphosphonate may cause acute renal failure.
3) R-Gene 10 (argine hydrochloride injection): R-Gene 10 is used to evaluate pituitary function. Most of the adverse event reports center around medication errors, including fatal overdoses, hypersensitivity, and other events.

Of course, consumers and healthcare providers should take care to notify the FDA of potential problems with any drug or medical device at www.fda.gov/medwatch/report.htm or 1-800-FDA-1088. This will help to get dangerous drugs recalled, and provides the impetus for additional safety tests.

Accutane is being taken off of shelves by manufacturer Roche Holding AG, after yet another successful jury verdict found that the drug causes inflammatory bowel disease (IBD). Jury verdicts for IBD have totaled about $33 million to date.

The drug was introduced in 1982, has been taken by 13 million people, and was the company’s second-best selling drug before generic drugs began competing with it in 2002. After that time, the manufacturer only has 5% of the market share.

The drug has been besieged by lawsuits for some time. In addition to suits alleging the drug causes IBD, others suits allege the drug causes birth defects and depression. You may recall a recent suit by U.S Representative Bart Stupak of Michigan, who alleged that his son’s suicide was caused by Accutane (the judge granted summary judgment in favor of the company, there).

Of course, the company stated that it stands behind its drug, but simply had to withdraw because of insurmountable competition and the rising cost of personal injury lawsuits. It’s too bad they can’t just recognize that there may be problems with the drug. It’s like medical malpractice—sometimes, people just want an apology.

Week one of trial will conclude this week in Alabama (Montgomery County Circuit Court) in the state’s prosecution of drug company Watson Pharmaceuticals for overpricing. The claim is that Watson inflated the prices of drugs provided to participants in the state’s Medicare program. As a result, the state argues that it overpaid by approximately $23 million from 1991 to 2005. Watson manufactures generic and brand-name drugs, including OxyContin.

Alabama has already settled similar lawsuits against sixteen other drug companies for a total of about $124 million. Furthermore, the state has won at trials involving four other drug companies, totaling $352.4 million. This is terrific work by the state on behalf of its taxpayers. Attorney General Troy King is really taking these companies to task for greedy behavior. You can see King’s news release here:

• A.G. Secures $89 Million in New Drug Company Settlements

Watson retorts that, had the prices been set any lower, pharmacists would have lost money in Medicaid transactions, and their prices “kept Alabama drug stores in business.” That might be a little tough to prove—number one, that it’s the drug company’s job to keep pharmacists in business; and number two, that a significant number of Alabama pharmacies would have gone out of business but for the higher prices. I can’t see the judge really allowing testimony on that. It's too speculative without expert testimony, and it really doesn't bear on the issues of the case. Odds are, the AG office will continue its record of exemplary verdicts.

It’s a new world we live in. In recent years, public recognition of the importance of food safety has grown, and is being fed by the media and our federal government. Perhaps this is because we all need to eat to live; perhaps this is because of the movement toward more organic food and healthy foods; or perhaps it is because we have the technology now to digest complicated facts and determine the genetic make-up of various strains of e-coli, linking them to the source. Whatever the reason, promoting healthy food processing is a good thing.

At any rate, food recalls are often most important for the elderly and young. Those two groups traditionally have weaker immune systems than the rest of us, and salmonella or e-coli can have a disastrous and frequently deadly effect. (For the rest of us, eating tainted food may result in a few days or weeks of terrible stomach pain, and sometimes hospitalizations). We’ve been learning these lessons on a regular basis in the past few years—lettuce, spinach, hamburger, peppers, peanuts, peanut butter, pistachios and pot pies are the teachers.

With the media regularly focused on tainted food products, the legislature is moving to take action. A U.S. House panel recently approved giving the FDA the power to order food recalls. Though the FDA is overworked and understaffed, this is a step in the right direction. Of course, the primary responsibility must fall on the agricultural industry to educate itself, police itself, and protect the public.

Of course, the Drug Recall Lawyer Blog, by its very title, does not include the word “food.” So, we won’t regularly post on this issue. But, the FDA regulates food and drugs, so there’s a connection here. And, drug manufacturers can learn a lesson from how the agriculture industry reacts to issues of contamination—often by immediately segregating potentially contaminated products despite the cost (and, farmers have more to lose than the CEOs and stockholders of drug companies). That really tells you the value of human life.

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, and 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.

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?

Following the disbarment and recent conviction of William Gallion and Shirley Cunningham, two (former) Kentucky lawyers, a Kentucky federal judge today held that prosecutors can seize approximately $30 million. A jury in April found that the two stole $94.6 million in settlement funds from the fen-phen litigation. This is an improvement over the potential sentences of up to 20 years in prison and paltry fines of up to $250,000.

This really shows that the system does work. As lawyers, we are a self-regulating profession, and the disbarment ensures that neither will be in a position to hurt people like this again. The criminal system swooped in to provide for appropriate jail time, and now we have seizure of assets. It’s terrible that good people were hurt by those they trusted—as lawyers, our job is to help people. That really gets lost in the common misperceptions of lawyers as greedy sharks (or bulldogs, pick your “fierce” animal). Sure there are some who abuse the system or are only in it for themselves, but most lawyers I know really work hard for their clients, for the betterment of the legal system, and for people in pro bono activities and charitable work. Lawyers like Gallion and Cunningham do a disservice to the entire profession.

The FDA is highlighting more potential problems with drugs that contain zinc—we blogged earlier about the zinc-containing Fixodent and Poligrip denture cream products. Now, the FDA is advising consumers to immediately stop using zinc-containing nasal sprays. You can view today’s news release here.

There have been over 130 reports submitted to the FDA revealing a potential relationship between three Zicam products (Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Nasal Swabs, Kids Size). Many reports indicate the loss of smell occurred after one use. A warning letter has been sent to Matrixx Initiatives, the manufacturer, advising them that they cannot market the products without FDA approval.

Lawsuits have been filed against the manufacturer of Zicam products. They post on their website that “No plaintiff has ever won a court case, because there is no known causal link between the use of Zicam Cold Remedy nasal gel and impairment of smell." This ignores the fact that they settled around 340 cases for $11.9 million back in January of 2006. It doesn’t sound like they are being entirely forthcoming, does it?

It’s important to remember—Zicam is an alternative therapy, and is not thoroughly regulated the by the FDA. As a homeopathic remedy, the manufacturer has not had to prove the products’ safety. If they have data showing it is safe, now is the time to do it. And, a company like that should be checking out those 130 reports to determine exactly what happened.

More problems for the Seroquel lawsuits, recently. Plaintiffs in the Seroquel litigation generally allege that the drug causes diabetes and other metabolic disorders. Judge Joseph Slights, III of the Delaware Superior Court granted summary judgment in the Scaife case. In its Daubert argument, AstraZenceca persuaded the court that the plaintiff’s expert witness, an endocrinologist, provided opinions which were not scientifically reliable. The three bases for this opinion are that the physician (1) failed to rule out other likely causes of plaintiff’s diabetes; (2) found causation between the drug and the injury to a large degree because of the timing of plaintiff’s ingestion of the drug and onset of the disease; and (3) failed to use a rigorous methodological analysis of available data to support her conclusions. The court excluded plaintiff’s expert witness, then held that summary judgment was appropriate and the plaintiff had no means to prove her case.

The opinion reveals the unfortunate human cost of drug litigation. These cases can be difficult to prove, often because plaintiffs who take medication are frequently sick people (of course, this is why they take medication). Sick people oftentimes make for problematic plaintiffs because every medical issue becomes another complicating factor in the causation analysis and the epidemiological data. Then, if the cases get to a jury, it’s all too easy to dismiss habitually sick people as those who will always have problems, regardless of whether they are caused by a defective product. In the Scaife case, the plaintiff was frequently overweight, had an extremely poor diet, suffered from hypertension, and smoked prodigiously. In this case, though, it’s hard to know if the problem was poor case selection, or an expert who was not properly vetted. Or some other reason…

Graves’ disease is a type of hyperthyroidism, and autoimmune disease. The immune system attacks the thyroid gland, and causes it to mass produce the thyroxine hormone. This increases the body’s metabolic rate, and can be life-threatening. The thyroid grows, often to more than double its original size.

Propylthiouracil is used to treat hyperthyroidism associated with Graves’ disease. However, these reports may indicate that methimazole is a better alternative. Symptoms of hepatoxicity (liver damage) include dark urine, yellow eyes, and elevated liver enzymes.

The FDA reports at least 32 cases of severe liver injury, including 13 deaths and 11 liver transplants, in patients treated with Propylthiouracil. By comparison, only 5 cases of severe liver injury (3 resulting in death) have been reported to the FDA Adverse Events Reporting System (AERS) for methimazole.

The U.S. Department of Justice recently revised its 2005 Civil Justice Survey of State Courts. This stuff is fascinating--it is a chance to see the overall work our state courts are doing. As lawyers, we tend to become myopic, and only pay attention to our caseload and, perhaps, our practice niche. Statistics like these allow us to see how our cases are part of the bigger picture.

Unfortunately, there’s not a lot on pharmaceutical or medical device cases. Those are lumped into the non-asbestos product liability category, about 265 trials in 2005, representing only 1% of the total state court trials. It is interesting to note that, of those 265, the plaintiffs won at trial in 19.6% (this is much higher if you factor in asbestos cases). The median award in non-asbestos product cases is $500,000, with 36.5% of plaintiffs in those cases being awarded over $1 million.

Specific to the drug arena, though, the Survey does address class action lawsuits. There were 14 class-action certified trials in 2005, and nine of these were product cases: 3 were asbestos, five were drug cases, and one was a defective automobile part. Plaintiffs won in ten of the 14 cases, with a median award of $1 million.

Keep in mind, those cases that go to trial tend to be those outliers where there is a significant debate as to liability or damages. Most cases tend to settle before trial—those statistics, though probably not available, would give us a better idea of the number of truly meritorious claims brought every year.

Yesterday, the FDA listed nineteen types of drugs that it has flagged as potentially dangerous to consumers. From October to December 2008, the FDA’s Adverse Event Reporting System (AERS) has catalogued potential problems with each of the drugs. Of course, the FDA’s investigation is not complete; however, the goal is to notify consumers so that they can discuss their medications with their physician.

Miller & Zois has discussed some of these products already—see Reglan (polyethylene glycol oral laxative), Chantix (Varenicline) and Testosterone Gel. Other drugs on the list include:

 Apomorphine (Apokyn)
 Choriogonadotropin alfa (Ovidrel)
 Clomiphene citrate (Clomid)
 Clozapine orally disintegrating tablet (FazaClo)
 Darifenacin (Enablex) and Solifenacin (Vesicare)
 Drospirenone/ethinyl estradiol (Yasmin)
 Efavirenz (Sustiva)
 Fibrin sealant, human (Evicel)
 Hydrochlorothiazide
 Imiquimod cream (Aldara)
 Modafinil (Provigil) and Armodafinil (Nuvigil)
 Orlistat (Xenical, Alli)
 Raltegravir (Isentress)
 Selegiline (Emsam)
 Sumatriptan/naproxen (Treximet)
 Tolterodine tartrate (Detrol)

Of course, if you or a loved one take any of these medications, talk with your doctor to determine if the benefits outweigh the risks.

Yesterday, the FDA listed nineteen types of drugs that it has flagged as potentially dangerous to consumers. From October to December 2008, the FDA’s Adverse Event Reporting System (AERS) has catalogued potential problems with each of the drugs. Of course, the FDA’s investigation is not complete; however, the goal is to notify consumers so that they can discuss their medications with their physician.

Miller & Zois has discussed some of these products already—see Reglan (polyethylene glycol oral laxative), Chantix (Varenicline) and Testosterone Gel. Other drugs on the list include:

 Apomorphine (Apokyn)
 Choriogonadotropin alfa (Ovidrel)
 Clomiphene citrate (Clomid)
 Clozapine orally disintegrating tablet (FazaClo)
 Darifenacin (Enablex) and Solifenacin (Vesicare)
 Drospirenone/ethinyl estradiol (Yasmin)
 Efavirenz (Sustiva)
 Fibrin sealant, human (Evicel)
 Hydrochlorothiazide
 Imiquimod cream (Aldara)
 Modafinil (Provigil) and Armodafinil (Nuvigil)
 Orlistat (Xenical, Alli)
 Raltegravir (Isentress)
 Selegiline (Emsam)
 Sumatriptan/naproxen (Treximet)
 Tolterodine tartrate (Detrol)

Of course, if you or a loved one take any of these medications, talk with your doctor to determine if the benefits outweigh the risks.

Oral phosphate sodium drugs, including the over-the-counter drug Fleet Phospho-soda (manufactured by C.B. Fleet Inc.), and the prescription drugs Visicol and OsmoPrep (both manufactured by Salix Pharmaceuticals), are laxatives and bowel-cleansers, often used by doctors before colonoscopies and similar procedures. In late 2008, the FDA added a black box warning (the most stringent warning available) to these products.

The danger of the drugs is that they may cause acute phosphate nephropathy, a serious kidney injury which is characterized by the accumulation of calcium-phosphate crystals in renal tubles, renal impairment, and sometimes death. Affected patients may require dialysis or kidney transplants. Symptoms include lethargy, low urine output, and swollen legs and ankles. Patients are at a higher risk of contracting acute phosphate nephropathy if they are: over 55, dehydrated, have a history of kidney problems, have active bowel colitis, or take other medications that affect kidney function.

C.B. Fleet did an admirable job of voluntarily recalling its products once the FDA notice came along. They will work with the FDA to determine if their products are better used by prescription, only. However, they may have had an obligation to take action even sooner—the overworked folks at the FDA cannot be responsible for setting the benchmarks for response to injuries and complaints. Tellingly, there have been indications of problems since 2003, when a medical case report was published about acute phosphate nephropathy and renal insufficiency in a woman who took OsmoPrep. Then, in 2005, doctors published an article describing injuries, including renal failure, to 21 people who used OsmoPrep products. More potential cases were later identified by the FDA’s Adverse Event Reporting System.

You can see the FDA’s April, 2009 notice about the stronger boxed warnings here.

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 Bauch & 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 be conducting for a few days in New York to determine whether 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.”

Well, “some” may not be the best word. Bausch & Lomb has stated that it has settled “the vast majority of fungal infection cases.” The vast majority being approximately 600 cases, at a cost of over $250 million. That leaves about 500 lawsuits being challenged in the New York hearings. The point is, those 600 cases were meritorious. We’ll just have to wait and see about the other 500.

The other point of contention I have with the blog posting centers around this statement:

Bausch & Lomb conducted a massive study and concluded that, under certain conditions simulating consumer noncompliance with the package insert, MoistureLoc could allow the formation of a polymer film on a contact lens that permitted some strains of Fusarium to survive and thrive despite later disinfection with MoistureLoc.

(Emphasis added). The problem is, drug companies frequently try to defend cases based on noncompliance. We addressed this with the Denture Cream post a few days ago. The issue is really whether that “noncompliance” is foreseeable, i.e., do consumers regularly misuse the product in an expected way? The second part of that issue that consumers were never warned about the consequences of misuse—if Bausch & Lomb had a warning on their package saying users could lose their eye if they didn’t follow directions, people would have made sure to follow instructions to the letter. This defense just doesn’t hold any water. And, the company settled those cases, anyway, which indicates that they knew it couldn’t carry the day.

With well over 100 cases filed in at least 21 states, the shoulder pain pump litigation is gaining steam. We discuss pain pumps in more detail here; but suffice to say that 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 the anesthetic drug manufacturers. These are companies like AstraZeneca, Hospira, APP Pharmaceuticals Abbott Labs, who all supply local anesthetic (bupivicaine, marcaine, lidocaine, sensorcaine, ropivicaine, etc…) often selected for use in the pumps by doctors.

Continue reading " Shoulder Pain Pump Anesthetic Manufacturers--Viable Defendants? " »