Drug Recall Lawyer Blog

The 6th Circuit in Smith v. Wyeth rejected last week the three Reglan lawsuits that sought to end run the U.S. Supreme Court's recent generic drug preemption Pliva v. Mensing, a case so depressing I never blogged about it.

These three Reglan cases were classic failure to warn claims. Plaintiffs were taking generic Reglan to treat gastroesophageal reflux disease. Because Reglan's patent expired, it was now generically available (and cheaper). Plaintiffs all developed tardive dyskinesia, a neurological disorder with Parkinson's disease-like symptoms. Something awful to get for any reason but particularly for this one: had there been an adequate warning on the drug, these plaintiffs, at least arguably, would not have taken them.

Plaintiffs sued, among others, including the manufacturer of Reglan itself, the generic manufacturers for the failure to warn of the risk of tardive dyskinesia. Keep in mind, this is not saying that the product should be recalled. Instead, it just says, "Hey, you know the risks of Reglan and you should have told us about it (and we wouldn't have taken it)."

Continue reading " Reglan Generic Lawsuit Fails " »

Two pharmaceutical manufacturers, Watson Pharmaceuticals and Sandoz/Geneva Pharmaceuticals, have settled drug pricing lawsuits for $145 million, according to a settlement agreement filed in federal court. Watson makes generic drugs; Sandoz is owned by Novartis' generic drug division (did you know they had one?).

By now, the allegations in these claims are commonplace. The lawsuits alleged that these drug companies charged government health care programs inflated prices for prescription drugs. This case spun out into an MDL in the District of Massachusetts.

Both lawsuits were filed under the U.S. False Claims Act - a whistleblower statute - by Ven-A-Care of the Florida Keys Inc., a specialty pharmacy. The law allows whistle-blowers to file on behalf of the government and share in any recovery. Their lawyers are pocketing some real cash, Ven-A-Care gets some found money (between the two, $8.3 million), and the states make out well, too. The big ones bring home the real bacon: Texas will receive $29.5 million, Florida $20.2 million, and New York $79 million.

Continue reading " More False Claim Act Settlements: Watson and Sandoz " »

Brain stents, which are used by cardiac surgeons to open up a blocked artery and are designed to prevent strokes in high-risk individuals, may paradoxically and tragically actually increase the risk of stroke and death. How much more? According to a recent New England Journal of Medicine article, patients receiving brain stents were found to have twice the rate of strokes and death compared to those without brain stents. The risks became so apparent that the National Institute of Neurological Disorders and Stroke called off enrollment in a clinical trial.

Continue reading " Stryker Brain Stent Strokes: New Study " »

Bloomberg ran an interesting article yesterday that raises the issue of whether or not there should be a vaginal mesh recall. There is a lot of data coming out now that supports the idea of a recall. At some point, these pharmaceutical companies need to cut their losses and not only stop making these vaginal mesh products but also recall the ones that are already on the market.

New information continues to underscore what is becoming increasingly obvious: these surgical implants are unsafe. The FDA is starting to get wind of this fact, and last month expressed more concerns about the risks of transvaginal surgical mesh used to treat pelvic organ prolapse.

This article also talks about the issue moving forward: how these defective mesh implants came on the market in the first place. As it should, it takes a long time to get the approval to put new drugs and medical devices on the market. But the FDA has a loophole called the 510(k). This process is a backdoor through the approval process companies usually have to go through to get a medical device on the market. It allowed vaginal mesh manufacturers a free pass on proving their product was safe and effective since it is "substantially equivalent" to others already for sale. One problem with this loophole: the definition of "substantially equivalent" is ever expanding. The FDA is finally catching on to this. Later this week, the FDA will gather more opinions from doctors and researchers as to whether we need to rewrite 510(k) to make it harder to get untested products on the market.

Continue reading " Vaginal Mesh Recall? " »

A new study from Canada suggests that women who use relatively benign painkillers like ibuprofen and naproxen early in pregnancy may have an increased risk of miscarriage.

Researchers found that of nearly 52,000 Quebec women who had been pregnant, those who had taken these commonly used painkillers with a favorable safety profile were more than twice as likely to suffer a miscarriage. The study included all non-aspirin NSAIDS such as Advil, Motrin, Aleve, Naprosyn, and Celebrex.

Is there a cause and effect relationship? No one really knows. But pregnant women are already advised to avoid using any medication if they possibly can. What should you do? I think that is something you want to address with your doctor. Everyone is different. But is it worth mentioning this study to your doctor? I think it is.