Drug Recall Lawyer Blog

Johnson & Johnson’s former sales representative (an employee tasked with selling products to doctors and hospitals) admitted in a New Jersey trial that he encouraged doctors to prescribe the drug for unapproved uses. Risperdal is an antipsychotic medication now approved by the FDA for treatment of schizophrenia, bipolar disorder and irritability in children with autism. It is specifically not indicated for treatment of patients with dementia-related psychosis. Previously, it had only been approved for treatment of schizophrenia.

Continue reading " More On Promoting Drugs for Unapproved Uses: Risperdal " »

Stryker and many of its executives have been indicted on charges of wire fraud, conspiracy to defraud the United States Food and Drug Administration, distribution of a misbranded device, and making false statements to the FDA. The charges were made by the U.S. Attorney’s Office for the District of Massachusetts.

Continue reading " Patterns Of Behavior: Stryker Encourages Off-Label Use " »

As happens with all Prempro trials, the news is reporting updates at a frenzied pace. Back in September, a jury held that Pfizer must award Connie Barton $3.7 million in compensatory damages for their role in causing her breast cancer. The judge put the punitive damages phase of the trial on hold, but yesterday the jury convened for 25 minutes and agreed that Pfizer must pay punitive damages to Connie Barton. Punitive damages are imposed on a Defendant who acts in circumstances of “violence, oppression, malice, fraud, or wanton and wicked conduct” according to Black’s Law Dictionary. And, the reports of the trial indicate that the jury had ample proof of that type of conduct.

Unfortunately, we won’t know what the punitive damage award is, at least until the conclusion of another hormone therapy trial that is continuing in the same courthouse (Court of Common Pleas, Philadelphia, Pennsylvania). But, it must be a good one—Pfizer’s lawyer said that “We are disappointed with the jury’s verdict.”

Congratulations, Ms. Barton. You deserve every penny, and more.

This is the sequel to “NuvaRing MDL: Plaintiffs’ Motions Victory,” blogged on August 21, 2009. We saw the post by our friends at Drug & Device Law and, predictably, we have a slightly different interpretation.

As we reported earlier, a master complaint was filed in the NuvaRing MDL (Missouri), largely at the request of Defendants. Then, attempting to perform an end-run around the procedural rules, they filed a motion to dismiss that master complaint, ignoring the fact that they had already answered most of the individual complaints (with no motions to dismiss having been filed). The judge held (we thought properly) that Defendants could not file the motion to dismiss.

The judge has reevaluated his position, and has stricken the master complaint (it looks like this was in response to motions for interlocutory appeal, which would have really gummed up the works). This basically puts things back to the status quo—each individual case in the MDL will have to be decided on its own. This may not be as arduous as it seems—if answers have been filed, motions to dismiss are improper. But, there are procedural tools around that, so Defendants will likely get their chance to argue dismissal the individual cases. So, the judge acted wisely again to keep the litigation moving.

Tough to say. It’s in German. And, my German skills were at their highest back in high school. During my trip to Munich for the holidays last year, I was able to competently read road signs and to order a cheeseburger from the local McDonalds. That’s about the extent of my current abilities.

But, Bayer is singing the praises of the new report, claiming that it shows YAZ is as harmless as any other birth control pill, particularly with regard to deep venous thrombosis. The report was written by officials at Swissmedica (the FDA’s Switzerland counterpart). Swissmedica experts reviewed existing studies. Bayer’s website cites the Swissmedica press release that “contraceptives containing the active substance drospirenone have a comparable safety profile to that of other preparations available on the market.” Then, Bayer goes on to state that they’ve examined post-marketing studies on more than 42 million women years of drospirenone use, basically implying that the pill is fine.

But, what does the press release really say?

Continue reading " What Does A New Report Say About YAZ? " »

This week a terrific victory was achieved by plaintiff Peggy Stevens of Missouri in her quest to hold Novartis responsible for covering up the dangers of their osteoporosis drug Zometa. Like Fosamax and other bisphosphonate-drugs, Zometa can cause a condition known as osteonecrosis of the jaw, particularly when the patient undergoes invasive dental procedures (tooth extractions, root canals, etc.). The jury of 12 deliberated for eight hours over 2 days in the Missoula District Court before concluding that Novartis was responsible for $822,000 in lost income and $2,378,000 in non-economic damages (pain, mental anguish, inconvenience, etc.), for a total verdict of $3.2 million.

Ms. Stevens showed the jury that Novartis hid relevant information, and failed to appropriately and reasonably warn patients of the drug’s dangers. The only warning about osteonecrosis of the jaw was given in a 20-fold pamphlet inside the drug’s box, in tiny print. Look at the picture—is this something that should not be front and center? Additionally, internal company e-mails revealed that the company worked to suppress information on the dangers.

There are about 550 other Zometa lawsuits, most of them consolidated in an MDL in Tennessee federal court, and the others grouped in New Jersey state court. The next Zometa trial is scheduled for March 2010 in New Jersey. Many expert witnesses will be the same in these trials.

The manufacturers of Super Poligrip, the zinc-containing denture adhesive that can cause numbness, decrease in strength, tingling, balance problems and other issues, has updated its product with a new warning.

Now, consumers are warned that the denture adhesive contains zinc, and that they should talk with their doctor if they are taking zinc supplements because of the potential for zinc-toxicity. It also warns that excessive amounts of Poligrip can cause serious health effects. Finally, diagrams are included detailing proper use, and the labeling informs consumers about how long a tube should last. This is a good step forward. The problem with the adhesive up to now has been that many consumers with ill-fitting dentures use prodigious amounts of adhesive, causing extensive neurological injuries. These warnings may go a long way to prevent further problems.

Continue reading " Super Poligrip Warning Update " »

Be sure to check out our website detailing up-to-date information the recalled Stryker hip implant litigation. The lawyers on both sides of the cases are engaging in settlement talks, and we're optimistic about where these talks are heading.

Orthopaedic devices are fascinating. The ability to go in and surgically replace or reinforce deteriorating body parts almost seems like science fiction. It’s not so much that regular people become six million dollar men or Borg, but we can get a renewed chance for a good, normal life because of many of these products.

Hip implants are no exception. I don’t know what the life expectancy of Neanderthals was, but I doubt many of them made it to the age where arthritis was an issue. And, if they fractured a leg while fleeing predators, they were probably done for. Today, we have the ability to give futures to people with osteoarthritis and traumatic arthritis.

Continue reading " Stryker Hip Implants " »

The Drug Recall Lawyer Blog, along with six other high-quality legal blogs, have teamed up to form one Twitter page. The connection between the blogs is that they are all written by members of my firm. Some are national in scope, and some deal with Maryland, specifically. Here's a list of the blogs that automatically link to Twitter through Twitterfeed (this is a great way to stay updated, assuming you do not use Google Reader or some other RSS feed software):

• Accident Injury Lawyer Blog
• Baltimore Injury Lawyer Blog
• Drug Recall Lawyer Blog
• Maryland Accident Lawyer Blog
• Maryland Injury Lawyer Blog
• Maryland Lawyer Blog
• Maryland Medical Malpractice Attorney Blog

The Washington Post featured an informative article this weekend about efforts by people and groups connected to medical device manufacturers to resist inclusion in health care reform. One issue is whether medical device manufacturers are partly responsible for driving up the costs of healthcare. Here are some interesting talking points from the article:

• Profit margins of many medical devices are over 20%. The industry makes $130 billion per year. Many are concerned that medical devices are “overutilized” in the United States.
• Medical technology represents 6.2 percent of total national health expenditures in 2006.
• A $40 billion tax (over the next 10 years) on device makers was approved by the Senate Finance Committee earlier this year.
• Prominent manufacturers of medical devices in Minnesota, Indiana, New Jersey and others find support against the proposed tax from their states’ political representatives, many of whom are concerned about jobs in these states.
• Concerns still abound about inappropriate marketing, lobbying and payouts by device manufacturers to the FDA and doctors.
• The medical device industry spent $15.7 million on lobbying in the first 6 months of this year. Money sometimes goes to political candidates and representatives.

Last week, Kimberly-Clark Corporation and I-Flow Corporation announced their agreement for the sale of I-Flow to Kimberly-Clark. News reports reveal that the transaction is valued at $276 million. I-Flow has net sales of over $1 billion, and has always had the largest market share of the pain pump business. However, there have long been concerns about I-Flow’s financial viability, specifically with regard to the shoulder pain pump litigation. It was disappointing that the press release did not mention the impact to pending litigation, or the degree to which that litigation affected the transaction. However, it appears that there is a shareholder lawsuit brewing over the expected sale.

For our money, the sale is a good thing. First, Kimberly-Clark, though having low medical device experience, is a reputable company that will hopefully steer I-Flow in the right direction (away from the mismanagement and dollar-focused predecessors). Second, it means that there may be some assets available so injured patients don’t end up being left with only I-Flow’s parking lot…

For more on Pain Pumps, see our website.

A new article on Business Week came out yesterday on gadolinium, with the focus on GE. First, a little background:
Gadolinium is a metal that is injected as a contrast agent into patients before specific diagnostic tests, MRIs and MRAs. The metal allows physicians to better visualize damaged parts of the body. Most of us excrete the gadolinium easily with the help of our kidneys.

However, many people have kidney disorders, like renal impairment, and they cannot get the gadolinium out of their bodies. The metal is toxic to the body, and long-term toxicity causes a condition known alternatively as Nephrogenic Systemic Fibrosis (NSF) and Nephrogenic Fibrosing Dermopathy (NFD). The hallmarks of that disease is painful swelling of the limbs, skin lesions, discoloring of the skin, and hardening of organ tissues. There is no cure, and the disease itself is oftentimes fatal. In fact, it is one of the most horrific diseases I have ever seen. Patients are disfigured, and robbed of their mobility and their health.

Continue reading " Gadolinium and General Electric " »

The Boles’ case, tried and mis-trialed is coming back. From the Shearlings Got Plowed blog, we came across this tidbit from Judge Keenan’s October 7 order stating that “As for the second request, it would be fruitless for Plaintiff to file the motion. The Court intends to retry this case.”

We’re looking into determining what the plaintiff’s request was that spawned the order (perhaps motion for reconsideration of motion for judgment?). At any rate, it’s not surprising. The judge did not have many other options. Of course, Ms. Boles is going to have to wait in line—there are other Fosamax trials set for December and January.

As Ron Miller posted yesterday, the Judicial Panel on MultiDistrict Litigation approved an MDL for Zicam on October 9, 2009. Here’s a link to the Order.

The moving plaintiffs requested that the JPML send ten consumer class action cases to a federal district court, along with 30 later discovered related actions (“tag-along actions”). The Defendants, Matrixx Initiatives, Inc., Zicam, LLC and Zicam Swab, LLC, supported centralization, while other plaintiffs opposed it.

Continue reading " Zicam MDL Approved " »

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.

An e-mail from the Seroquel litigation, dated May 14, 2001, contains some talking points for Seroquel’s Product Managers and Marketing Managers. AstraZeneca understood that they had a big problem with the weight-gain issue. The e-mail reflects their approach:

• “The global strategy is to demonstrate to customers that Seroquel has a weight neutral profile in the long term
• Seroquel is not associated with diabetes nor its exacerbation

Does this make any sense at all? Are they trying to say that, with Seroquel, patients gained weight rapidly in the short-term, but then lost that weight over the time they were on the drug? And, what is the short-term, anyway? This is far-fetched, and is another example of a desperate company trying to fiddle with studies and data that leave one inescapable conclusion—they should warn people about dangers associated with their drug.

Ask any pharmaceutical or medical device lawyer—one of the biggest problems in tackling these cases is product identification (sometimes referred to as PID). As an example, in the gadolinium MRI cases, it can take months (or longer) to go through and determine (1) whether the patient had gadolinium used for any particular MRI or MRA scan, and if so then (2) what brand of gadolinium was used. The brand is important because the lawsuit must identify a proper defendant.

Continue reading " Tracking Defective and Recalled Drugs and Medical Devices " »

Bayer’s YAZ woes continue (see prior posts here, and website here) with the advent of lawsuits just filed by pension funds for firefighters and Philadelphia city employees in the U.S. District Court for the Eastern District of Pennsylvania (Philadelphia). The complaints, filed by Philadelphia Firefighters Union Local No. 22 Health and Welfare Fund and the American Federation of State, County and Municipal Employees, District Council 47 Health and Welfare Fund, alleges, like the product liability cases consolidated in an MDL, that Bayer unlawfully promoted the birth control pill and concealed the increased risks of side effects—including blood clots (which cause strokes, heart attacks, pulmonary embolism deep vein thrombosis) and gallbladder disease.

Continue reading " Pension Fund Lawsuits Against Bayer for YAZ " »

Bayer, the manufacturer of other terrific products (YAZ and Yasmin birth control pills: improperly advertised, cause blood clots, and can necessitate gallbladder removal, among other things; gadolinium-based contrast agents: turn skin orange and hard, make movement difficult, and can harden organs; and Trasylol: blood-clotting drug that causes clots, heart attacks, amputations, and kidney failure), also makes multi-vitamins. Today we’ll talk about the selenium-containing Men’s One A Day (MOAD) multivitamin.

Continue reading " On Multivitamins and Medical Benefits " »

The Judicial Panel on MultiDistrict Litigation (JPML) today approved MDL-2100, In Re: Yasmin and YAZ (Drospirenone) Marketing, Sales Practices and Products Liability Litigation. The hearing was just on September 24—a seven day turnaround time and a great victory for Plaintiffs.

The effect of the order is to transfer all YAZ and Yasmin drug defect cases that are now or later filed in federal courts to the United States District Court for the Southern District of Illinois. The judge in charge of coordinated and/or consolidated proceedings there will be Chief Judge David R. Herndon (a Clinton appointee who, while in private practice, primarily represented plaintiffs in FELA railroad cases).

This is a terrific and exciting move for the YAZ and Yasmin litigation. The MDL will enable attorneys to spend more time working on the common discovery in all of their cases, and less time on case management orders and case-specific motions practice. Consolidation will truly promote judicial efficiency, and will probably lead to a better result for all concerned.

For more on the YAZ, Yasmin and Ocella injuries and lawsuits, see other posts of the DrugRecallLawyerBlog, and our Yasmin/Yaz website.

Judge Herndon

Defective Heparin lawsuits, a blood thinner manufactured by Baxter Healthcare, will finally go on trial in November, 2010. The recalled batches of Heparin killed at least 81 people according to the FDA from late 2007 to early 2008, and they caused injuries and sickness to hundreds more. The drugs caused severe allergic reactions because one of the component ingredients was replaced by over-sulfated chondroitin sulfate. That ingredient mimics the properties of Heparin. It was obtained by Baxter from a Chinese supplier, and that supplier’s facilities were determined to be deficient by the FDA. Furthermore, evidence obtained in discovery indicates that the chondroitin sulfate was intentionally used as a cheaper alternative, despite the life-threatening injuries it can cause.

The Heparin lawsuits are consolidated in an MDL in the U.S. District Court for the Northern District of Ohio, and case selection will start around May of 2010.

For more information on Heparin, see Heparin Allergic Reaction Lawyers.