Drug Recall Lawyer Blog

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 of 2005.

The patch has a “memory recoil ring” that tends to break 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.

Davol knew or should have known about a significant number of problems with the patch well before the recall. However, in the interests of the profit margin, or because the company was incompetent, the manufacturer decided that the reports did not justify warning the public or doctors of the potential problems. (See New York Times article). In fact, an FDA inspection of the facility uncovered serious problems with the company’s manufacturing process as well as the methods it used to handle product complaints. The FDA believes that these problems hindered Davol’s ability to timely and effectively deal with the problems. A company that negligently (or intentionally) fails to monitor complaints, all the while making money on every product used will not recall a product as early as possible. These are considerations of safety, and it is astounding how many companies end up placing profit over safety.

Some products are so ordinary and seemingly simple that we are surprised when problems arise. One series of lawsuits at a potential turning point this month surrounds an every day household item—denture cream. About 34 million Americans use dentures, appliances to replace missing teeth. One-third of those use denture cream to temporarily “glue” the dentures in their mouth, so they can do everyday things like eating apples and talk confidently knowing their teeth will stay in their mouth (you’ve seen the commercials).

The denture cream lawsuits allege that two manufacturers of denture cream, Glaxo Smith Kline (Poligrip) and Proctor and Gamble (Fixodent) failed to warn of the dangers their products pose to users. The science, according to a 2008 article in the medical journal Neurology cited by lawyers, is basically that some users suffer from zinc poisoning. The manufacturers include zinc in their products to help make the dentures stick. That’s not a problem if the dentures are perfectly fitted and consumers only have to use a small amount of cream. However, anecdotally, it seems that most denture wearers complain that they never fit right. The result is that many consumers must liberally apply denture cream in order to keep their teeth locked in place. A company that makes denture cream would probably know that.

Continue reading " Denture Cream Lawsuits Poised for MDL Treatment " »

Reglan (generic: metoclopramide) is a drug used to treat heartburn and slow gastric emptying in diabetes patients. 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.

However, earlier this year the FDA required makes of Reglan and other metoclopramide medications to put a black box warning on their labels, the most stringent act the FDA can take. That label now reads:

Tardive Dyskinesia

Chronic treatment w/ metoclopramide may cause tardive dyskinesia, a serious, often irreversible movement disorder; risk increases with treatment duration and cumulative dose, and in elderly patients, especially women; Discontinue metoclopramide if signs or symptoms of tardive dyskinesia develop; avoid prolonged treatment over 12 weeks in all but rare cases where benefit may outweigh risk.

Reglan drug injury lawyers are accepting these cases on an individual basis—no class actions are filed, and none are expected. However, Reglan lawyers have petitioned for consolidation and/or coordination into an MDL (“MultiDistrict Litigation”). Basically, the hope is that these cases are grouped together for the purpose of common discovery, then individually litigated. If approved, this makes these cases more inexpensive for injured clients. The Judicial Panel on MultiDistrict Litigation (JPML) is hearing arguments for and against consolidation today. Rulings typically come within about 2 months after the hearing.

Our lawyers are investigating Reglan drug injuries subject to this new warning for patients with tardive dyskinesia. If you want to speak with a Reglan lawyer about potential lawsuits involving Reglan, call 800-553-8082 or click here for a free Reglan lawsuit case evaluation.

Last week, the President issued a memo for the executive department on preemption. In a nutshell, preemption refers to the supremacy of a federal law where it conflicts with or is inconsistent with a state law. In the context of drug and device cases, this has been something of a hot topic lately, with the legislature and courts wrestling with the question of whether particular federal laws preempt the ability of the states to permit certain product liability suits.

The memorandum shows that the executive branch is taking a traditional approach—“preemption of State law by executive departments and agencies should be undertaken only with full consideration of the legitimate prerogatives of the States and with a sufficient legal basis for preemption.” The directive to executive agencies and departments is clear—they should not make statements about preemption, even in regulatory preambles, unless the underlying regulation addresses preemption. Furthermore, they are asked to review the past 10 years of regulations to determine whether existing statements about preemption are accurate.

This is a phenomenal memo. Preemption has lately been the scourge of victims and injured consumers (see Riegel), but we are making good ground to provide avenues of relief for people who have been hurt by others (see also Wyeth v. Levine).

Lobbying efforts, particularly by injured victims and their counsel (as well as manufacturers of medical devices), are continuing for the Medical Device Safety Act of 2009. It’s no surprise that each side takes the position it takes—the victims hoping to pass the legislation to prevent more blanket immunity for manufacturers of devices that hurt or kill patients; and manufacturers hoping to reap the benefits of zero liability for some of their devices which cause injury. However, it is interesting to note that one group, which has typically opposed the desires of victims, has also weighed in.

Physicians are coming out in support of the Medical Device Safety Act. Typically, they support tort reform and anything to prevent or limit lawsuits against healthcare providers. However, in a New England Journal of Medicine Editorial of April 9, 2009, three physicians took a stand behind the proposed legislation.

Continue reading " Medical Device Safety Act of 2009--Rebuilding the Status Quo " »

The issue is this—when corporations like drug companies and pharmaceutical manufacturers have a product to sell, they oftentimes go to the source—doctors. The only way for them to sell products is for doctors to know about them. In an ideal world, a doctor would hear about a product, research the product with the company and in the medical literature, ask colleagues about it, learn the risks, benefits and alternatives, and then decide whether the product is good for his/her patients.

In reality, what happens too often is that a sales rep for the corporation (frequently, with no medical training) will stop by the doctor’s office with lunch or “toys” (stress balls with the corporate logo, calendars with the corporate logo, pens with the corporate logo, stationary with the corporate logo, etc…), and try to convince the doctor to use the product. If I was a doctor, I’d feel a little obligated to return the favor if someone bought me lunch. I’m betting most doctors feel the need to reciprocate a little, by ordering some of the product for patients. However, the conversations doctors have with these sales reps often times are rushed (doctors are busy people); and one-side (and, did I mention that most sales reps don’t have medical training?).

Continue reading " Marketing by Pharmaceutical Companies and Medical Device Manufacturers " »

It seems the Australians are riveted by the trial surrounding Merck’s drug Vioxx. Here in the U.S., civil trials don’t typically get as much attention as criminal trials, but the facts surrounding Vioxx are compelling.

This is typical bad behavior for pharmaceutical companies—we see it time and time again in many cases. Some examples of what’s coming out in the plaintiffs’ case:

• Merck created and distributed a marketing publication disguised as an independent medical journal
• Merck armed its sales representatives with a training manual called the “Vioxx Objection Handling Module” to debate safety concerns
• Prior to the 1999 introduction of Vioxx in Australia, Merck created an advisory board of influential physicians, ostensibly to educate the medical community about painkillers. However, internal company documents reveal that the board was tasked to “accept the data and positioning of Vioxx,” and “publicly state that Vioxx is superior.”

Rather than settle out, Merck is litigating because they believe their company acted responsibly in marketing the drug. However, even academic publishing company Elsevier admits that its Australian office published six fake journals for Merck from 2000 to 2006. None of the journals revealed Merck’s sponsorship, leading doctors to believe it was real science. Instead, those journals were just advertisements in sheep’s clothing. Elsevier’s CEO admits that “[t]his was an unacceptable practice.”

Vioxx was recalled in 2004 amid concerns that it increased the risks for heart attacks and strokes. Here in the States, a $4.85 billion settlement program is well underway for approximately 50,000 people with cardiovascular injuries.

In the 63-page opinion of Blackwell v. Wyeth, the Maryland Court of Appeals affirmed the trial court’s exclusion of plaintiffs’ experts and grant of summary judgment. Maryland’s highest court is the latest to rule on cases alleging a connection between childhood vaccines with thimerosal (an organic mercury-based preservative) and autism and related injuries. The ruling basically holds in two parts that (1) a causal connection between the vaccines and autism is not generally accepted in the relevant scientific community; and (2) the plaintiffs’ experts were not qualified to give expert testimony under Maryland Rule 5-702.

The opinion is informative for any lawyer who relies on experts (which is most of us). The issue of expert testimony is frequently a tough one—it is common knowledge that fingerprints and DNA evidence are reliable science, but those methods were once on the fringe of accepted science. One of the responsibilities of judges is to play the role of gatekeeper—in general, they must keep the jury from hearing about many things, frequently including insurance, previous criminal activity, and they must not allow testimony on “junk” science. The scientific issue makes me uncomfortable for a number of reasons—one of the reasons I’m a lawyer is that I’m not a scientist, and I probably could never be a scientist. My brain just doesn’t work that way. I think a lot of lawyers and judges are in the same boat. It can be a difficult proposition for a person with little to no scientific training to be forced to rule on whether something is or is not “accepted science.”

It’s hard not to sympathize with the plaintiffs in these cases. Autism is not as easy to live with as movies and television depict—only a very small percentage of people with autism can be classified as “savants.” It may be that there is no causation between thimerosal and autism; or it may just be that the scientific community is still working out its internal struggles on the issue. Or perhaps, in close cases, it should be left to a jury to decide.

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 benefit. 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 little 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—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.

It’s hard to say whether there are any injuries caused by either Digitek or the Caraco brand of digoxin. It is curious that the same type of medication, though manufactured separately, has very similar manufacturing problems. Of course, if you feel you or a loved one may have been harmed by any medication, it is important to save whatever remaining medication you have—in some cases, it may be the only way to identify the specific drug used, and whether it was in fact defective.

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 was 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 devicemakers 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.

But Kinsley column was riddled with confusion. He can’t figure out why we don’t defer blindly to the powers that be at the FDA. He seems blithely ignorant of the fact that fact that the FDA does not have anything resembling equal post-marketing information about a medical device the drug manufacturer does. Kinsey's argument really should be that we should just get rid of juries and let the "smart people" decide. But President Obama can make decisions about the national security and the economy even though he is not a general or an economist. He does what juries do: listen the the arguments and make the call. It is called the jury trial system and it has a long history.

I think Kinsley is doing what liberals sometimes do: flash conservative ideology by pretending to be balanced by picking on targets with populist appeal. When Kinsley wants to appear balanced, he attacks things like deficit spending (which he supports while atttacking - its bizarre) and, everyone's favorite target, trial lawyers.

Biosite Incorporated has announced a voluntary recall for one lot of its Triage Cardiac Panel (Catalog No. 97000HS, Lot #W44467B). The test is designed to be used by healthcare professionals to help diagnose heart attacks. The issue, as I understand it, is that the recalled lot may report falsely low values of CK-MB, myoglobin, and troponin I, which are proteins that increase when a heart attack is occurring. What this means is that the test underreports potential heart attacks—the worst possible scenario.

Kudos to the manufacturer, Biosite for instituting the recall. However, I can’t help but notice that Biosite’s website makes absolutely no mention of the recall—despite today being one week after the press release. If I’m a doctor and I hear about the recall in passing, my first stop will be to the internet to get some solid information. This is the information age—there is no excuse not to use the most widely means of communication, especially when lives are in danger.

What were we just saying about responsible corporations?

Universal ABC Beauty Supply International has joined Hydroxycut in issuing a recall for several brands of its diet pills. Universal ABC Beauty Supply International's recall covers more than 30 brands.

The FDA said the recalled diet pills contain sibutramine. Sibutramine (sibutramine hydrochloride monohydrate) is an FDA-approved drug for weight loss drug manufactured by Abbott Laboratories. The Universal diet pills because those pills are not regulated because they are not "drugs." I cannot put my mind around this logic.

Sibutramine can substantially increase blood pressure and heart rate something that could be fatal for people with a history of heart disease or other heart problems (as many obese people do). Drug safety expert Dr. David Graham, who has spoken up on a lot of FDA drugs that need to be recalled such as Seroquel, has testified before a Senate Finance Committee hearing that sibutramine may be more dangerous than obesity.

It has been a bad few weeks for quick fix diet drugs.

The title of this blog sounds like an oxymoron. But it is the subject of an interesting article in Reliable Plant which writes about how a swift recall and restitution to consumers can minimize harm to the company – and even improve customer satisfaction after the recall.

Of course, it depends on the product. Hydroxycut is through. Samantha Jones herself could not save Hydroxycut. But the author cites the Tylenol scare in the 80s as a good example:

The best example of how to deal with a product recall is the Tylenol tampering case in the 1980s. Johnson & Johnson demonstrated that the safety of consumers was paramount by swiftly recalling the product, cooperating fully with regulators, and communicating openly about the issue, the researchers noted. Subsequently, the firm undertook a series of operational and design measures to ensure that such tampering would not occur again.

The big problem that drug and medical device companies usually fall into is that they wait too long to cut their losses. Look at drugs like Chantix and Seroquel that have not been recalled and remain on the market. If the manufacturers of these drugs would cut their losses and recall the product, it would be a good outcome not only for patients but for the companies themselves.

Baxter is having more problems with its heparin. The FDA is investigating whether the deaths of two patients in Delaware are linked to a brand of heparin blood thinner Baxter sells in intravenous bags. Thankfully, the FDA reports that this "appears to be an isolated incident." China Heparin Debacle #2.

It is hard to understate how important of a product heparin is. Baxter sells about 100,000 vials a day. There are approximately 450,000 people in this country on dialysis and Heparin is used by virtually almost all of them. Heparin is also frequently used in heart surgery.

You can read more about this latest heparin scare here.

The FDA is now requiring the makers of two prescription topical testosterone gel products to include a boxed warning on the labels. The move comes after reports of inadvertent exposure to eight children, aged nine months to five years. The drug is used topically on the shoulders, arms, or abdomen. When transferred to children through secondary exposure (for example, children touching skin covered in the gel), the drug can cause enlargement of the genitalia, premature development of pubic hair, advanced bone age, and aggressive behavior.

The manufacturers of these products, Solvay Pharmaceuticals (AndroGel 1%) and Auxilium Pharmaceuticals (Testim 1%), already warn against exposure to the drug by children; however, the black box warning will enhance the visibility of the warning on the package inserts. Black box warnings are among the strongest safety measures the FDA can take, being reserved for medications with serious or life-threatening dangers.

There’s nothing to indicate that the companies did anything wrong—the dangers of secondary exposure are clearly noted in PDR guides, which warn against allowing others to come into contact with gel-covered skin. And of course, doctors who prescribe the medication should warn their patients about these risks.

On Friday, May 1, the FDA issued a press release warning consumers to stop using Hydroxycut products, which have been associated with serious liver injuries. The manufacturer, Iovate Health Sciences Inc. has recalled Hydroxycut (also marketed under the MuscleTech brand name) from the market. The FDA reports that over 9 million units of Hydroxycut products were sold in 2008.

The recalls come on the heels of 23 reports of injury, including one death, over the past seven years. Those injuries include liver failure, jaundice, seizures, rhabdomyolysis (muscle damage) and cardiovascular problems. Symptoms may include brown urine, nausea, vomiting, fatigue, stomach pain, itching and light-colored stools.

The recall affects:
• Hydroxycut Regular Rapid Release Caplets
• Hydroxycut Caffeine-Free Rapid Release Caplets
• Hydroxycut Hardcore Liquid Caplets
• Hydroxycut Max Liquid Caplets
• Hydroxycut Regular Drink Packets
• Hydroxycut Caffeine-Free Drink Packets
• Hydroxycut Hardcore Drink Packets (Ignition Stix)
• Hydroxycut Max Drink Packets
• Hydroxycut Liquid Shots
• Hydroxycut Hardcore RTDs (Ready-to-Drink)
• Hydroxycut Max Aqua Shed
• Hydroxycut 24
• Hydroxycut Carb Control
• Hydroxycut Natural

While 23 potential injuries out of millions of units sold (if not more) may not sound significant, this notice by the FDA could signal the opening of the floodgates—now doctors should know to ask their patients about whether they took Hydroxycut products. Likewise, patients who hear about Hydroxycut are more likely to tell their doctors that they take the supplements. The FDA (and undoubtedly Iovate) is continuing to investigate.

Weight-loss is serious business in our oftentimes fast-food culture. The manufacturers of Hydroxycut clearly put some thought into marketing and naming their products to appeal to those wanting an energetic, fun and fast-paced lifestyle—‘Hardcore,’ ‘Max,’ ‘Ignition Stix’ and ‘Liquid Shots.’ One wonders if this type of product is actually condoned by physicians, or if it is simply an opportunity to take advantage of a society that wants to solve its problems with pills. Regardless, time will tell about whether the products are dangerous.