Posted On: December 30, 2010

Drug News Roundup

  • Prescription Drug Shortages. The idea here is a bill requiring pharmaceutical companies to notify the FDA when they limit or stop production on lines on prescription drugs. That does not seem too intrusive, giving the FDA a heads up (FOX 9 News).
  • Poor response to anti-anemia drug predicts higher risk of heart disease or death. This study is of interest to diabetes, kidney disease and anemia patients (Lab Spaces).
  • Omeros says urological surgery drug found safe in trial. Omeros is an anti-inflammatory agent and a muscle relaxant that is for patients undergoing ureteroscopy for removal of ureteral or renal stones (Reuters).
  • FDA Issues Warning to ProLatis (the incredible story of DSHEA)
Posted On: December 29, 2010

News Roundup

  • Santarus files for approval to FDA for anti-swelling drug Rhucin
  • Prescription Drug Coverage Is an Important Part of Your Health Care: Medicare Part D Needs to be Considered
  • Bone-Damage Concerns Lead to Halt of Pain-Drug Tests -Bloomberg
  • FDA Needs Four More Weeks to Review MannKind's Diabetes Drug Afrezza
Posted On: December 28, 2010

Steroid Recall

American Regent has recalled seven lots of injectable dexamethasone sodium phosphate because the agent may form particulates before its labeled expiration date. The recall involves 30-mL multiple dose vials at 4 mg/ml.

American Regent was silent on the issue of whether there have been any injuries or problems reported from this injectable steroid. This can mean they don't want to say or it can mean absolutely nothing. But the best thing to do is to just tell us from jump street whether anyone has reported injuries and whether those injuries were significant. Because if we are taking a drug or using a product, it is something we really want to know.

Posted On: December 27, 2010

Lawsuit Alleges Johnson & Johnson Overcharged AIDS Treatment Group

Johnson & Johnson has been sued by an AIDS treatment group claiming that J&J did not provide "discounts required by federal law for medicines used by nonprofit charities that provide treatment for people with HIV."

Johnson & Johnson has had such an awful recent history that it is hard to put anything past them. But I suspect they - rightly or wrongly - believe they have a defense. Because when you are down on your luck, as J&J clearly is from a PR standpoint, you don't sanely pick out the AIDS Healthcare Foundation as an enemy. I'm assuming there were settlement negotiations before this lawsuit. J&J would be crazy not to settle this case unless they were pretty confident they could win. Because even if they are right, they are taking another PR bath with this lawsuit. Five years ago, J&J would have gotten the benefit of the doubt. But that presumption of innocence is gone for doctors, patients and investors.

Posted On: December 10, 2010

Rolaids Recall

Johnson & Johnson has issued a recall Rolaids because of reports of metal and wood particles in the product. Not all Rolaids are in the recall but the recall includes Rolaids extra strength soft chews, Rolaids extra strength plus gas soft chews and Rolaids multi-symptom plus anti-gas soft chews. The problem appears to be yet another Johnson & Johnson manufacturing defect.

Someone gave a quote about J&J last week after all of these recalls to the effect the company used to be ''as pure as Caesar's wife' but look at it now. I didn't know Caesar's wife was so pure. I thought she was pretty mean in the HBO miniseries Rome. But as I said before, it seems amazing the J&J can't get its act together. Typically, this is harmless, like the Tylenol recall. But then you have the Depuy hip replacement recall and Levaquin and you realize that all of these little mistakes underscore deeper problems that are going to get more people hurt. J&J has to figure something out. I'm sure it can get back to the whole Caesar's wife thing. But they have to do something different. Because the game plan now is not spelling relief.

Posted On: December 3, 2010

The Best DePuy Hip Replacement Lawsuits

The best DePuy hip replacement lawsuits are going to be those cases where a DePuy ASR replacement came shortly before the recall. The F.D.A. has received hundreds of complaints about the failure rate on the ASR replacement. Even setting aside the "why did you put this thing on the market in the first place" argument, it seems abundantly clear that when the handwriting was on the wall that these hip replacements were lemons, DePuy decided to keep them on the market hoping against hope that the tidal wave of information that their hip replacements were causing patients all sorts of problems would miraculously go away. When I was a kid, I foolishly tried this strategy with parking tickets, hoping that putting them deeply enough into my glove box, would make them go away. That was stupid but relatively harmless. In this case, people who are already compromised - they need a hip replacement for crying out loud - were allowed to get a hip replacement that DePuy at some point knew was an inferior choice to others on the market.

DePuy needs to pay a lot of money in all of these ASR hip replacement cases. But the highest settlements in these cases, in my opinion, will be for those who got these replacements late in the game.

If you believe you may have a potential DePuy hip implant lawsuit, our lawyers are now investigating these claims. Call 800-553-8082 or get a free online consultation. Depuy demandas en Espanol aqui.