Articles Posted in Pharmaceutical Drugs

Bayer, the manufacturer of Yasmin and Yaz birth control, is slowly moving in the right direction by strengthening its warning about blood clots. There is no plan to update the warning with respect to gallbladder injuries. Plaintiffs’ lawyers in the Yaz/Yasmin lawsuits contend that the progestin contained in the pills, drospirenone, is causing serious health problems in otherwise healthy women, including deep vein thrombosis (blood clots in the deep veins), strokes, heart attacks and gallbladder disease.yaz1

The FDA informed Bayer in a letter earlier this month that it is responsible for updating its warning on a key issue in the Yaz lawsuits: whether Yaz causes blood clots. Still, Bayer is not putting a warning on Yaz/Yasmin that is going to clear its duty-to-warn obligation in future blood clots cases (and, again, this warning has no impact on the Yaz gallbladder cases). The new Yaz/Yasmin labels make clear Bayer is not backing all the way down: “The serious side effects of the pill occur very infrequently, especially if you are in good health and are young.”

Bayer is in an interesting spot with Yaz/Yasmin. These birth control drugs combined were Bayer’s most profitable drug last year. Yaz and Yasmin are also Bayer’s biggest seller and the leading birth control pill in North America. I strongly suspect Bayer realizes a strong warning means less prescribing doctors which means less profits. But if Bayer ignores the growing evidence that Yaz and Yasmin are more dangerous than other comparable birth control pills, they are risking lawsuit payouts that exceed the generous profits they now enjoy. Nothing short of a Yaz recall is going to stop the flow of future lawsuits.

Sean Wajert’s MassTortDefense blog reports that Bayer moved last week to dismiss the master complaint in the federal MDL involving combination aspirin products pending in New York.

Plaintiff’s’ lawyers in this MDL allege Bayer marketed combination aspirin and dietary supplement products without approval from the FDA and deceived the plaintiffs and putative class members with respect to the safety and efficacy of the products.

So the plaintiffs used these products and suffered serious injury which is why we are making a federal case out of this? Not really. Instead, plaintiffs claim damages because they say they would not have purchased these products if they had known that Bayer did not file a new NDA for each of these combination products, but instead relied on prior FDA review.

The Courier-Journal in Louisville, Kentucky has an article on an amazing lawsuit in Kentucky in yet another derivative claim of the fen-phen litigation. Plaintiff claims that her lawyers told her that her echocardiogram showed that her heart was “like a tire that might burst” as a result of the use of fen-phen.

The claim made by a former paralegal of the law firm handling the case is beyond stunning: medical tests were altered to show more heart damage than expected and destroyed test results that were not consistent with plaintiffs’ lawyers’ theory of the case.

The law firm did what a lot of plaintiffs’ law firms do in product liability cases where there is a chance of significant recovery: they offer plaintiff a medical test at no charge which is characterized as an independent medical exam. In this case, the test was an echocardiogram.

A hospital did not breach a duty of care as a matter of law to a police office who was injured responding to a traffic accident allegedly caused by a just-released colonoscopy patient, Massachusetts’ highest court has ruled, affirming the trial court below.

The police officer responded to an emergency report of a pedestrian-automobile accident. On his way to the scene of the reported accident, Plaintiff’s police car was hit by another car, causing what were apparently pretty serious injuries. The pedestrian involved in the accident to which the Plaintiff was responding had earlier that day undergone sedation after a colonoscopy at Brockton Hospital. Plaintiff’s theory of the case was had the hospital provided an escort for the patient/pedestrian, he would not have had to respond and the accident would not have occurred.

Specifically, Plaintiff argued that a duty of care existed under two theories to back door the foreseeability problem: (1) a “special relationship” the hospital had with the patient and with Plaintiff, (2) a voluntary assumption of a duty of care by the hospital to protect third parties from harm caused by “impaired” patients.

The case generated some attention. Amicus briefs filed by the Massachusetts Academy of Trial Attorneys in support of Leavitt, and by the Massachusetts Defense Lawyers Association and the Professional Liability Foundation, Ltd., in support of the hospital.

The Massachusetts high court found that both theories were not distinctions from the duty and foreseeability problem in finding that a hospital owes a duty of care to a nonpatient third party to prevent a sedated patient from causing injury after the patient leaves the hospital.

Whether negligence extends to “an innocent third-party bystander” was recently decided in Maryland in Gourdine v. Crews. In that case, the family of a man killed in an auto accident brought a lawsuit against Eli Lily claiming that his death was caused by a diabetic who blacked out while under treatment with two insulin medications. Continue reading

Wyeth v .Levine!!!! Plaintiffs’ lawyers have seen drug (and medical device) injury victims take punch after punch. But in a huge win for patient safety, the Supreme Court upheld in a 6-3 ruling today that in a Vermont woman’s verdict against Wyeth for injuries she suffered after taking one of the drug maker’s medicines. Justice John Paul Stevens, writing for the majority, said FDA oversight of drug labeling doesn’t prevent the filing of state tort claims.

It is a little bit pathetic that this is a huge win. Gee, the law for the last 90 years is not going to be completely uprooted. Yippy! But the Drug and Device Law Blog predicted victory and those guys have been on the winning side of most everything lately. (A guest Drug and Device Law blogger also broke down the justices individually and predicted victory but I cannot find the post to link to it.) So I’ll admit I was more than a little scared. Now, I’m thrilled that even this conservative Supreme Court found decisively in favor of the Plaintiff.

The one downside: a loss may have mobilized Congress to act. This win in Wyeth v. Levine could ironically slow progress on a bill to overturn Medtronic v. Riegel.

The Supreme Court’s ruling in Medtronic v. Riegel has largely been ignored by broadcast media. But I found a clip from MSNBC’s “Countdown with Keith Olbermann” on preemption and President Bush’s efforts until the bitter end to push for preemption.

Keith Olbermann’s portrait on these things is not exactly “fair and balanced.” I think it is a mistake not to present more fully both sides of the argument because it is hard to change minds without presenting all of the facts. But I’m just thrilled to see some broadcast media discussion – albeit MSNBC – of the perils of preemption.

The Wall Street Journal has an article today on the oral arguments before the Supreme Court in Wyeth v. Levine. In an unrelated but very related story, The Washington Post had an article from a Republican suggesting that the RNC drop the focus on McCain and turn to salvaging the Senate races.

These stories are related because if the Democrats get to 60 senators, I think Wyeth v. Levine and Riegel v. Medtronic will become a moot point. There are interesting landmarks on the path to 60. The first is the outcome of Ted Stevens’ trial. If Stevens is acquitted, Republicans should hold that seat. Who knew Alaska could have the impact it is having in this election? The second is whether Al Franken can unseat Norm Coleman in Minnesota. I hope Franken wins and, like most of us, I enjoyed Stuart Smalley on “Saturday Night Live.” But after reading one of his books, I’m not sure he is a step towards a post-partisan movement. Franken sings the “all conservatives are evil and all liberals are righteous” spiel that the whole country is tired of hearing.

Last month, the Judicial Panel on Multidistrict Litigation (JPMDL) created MDL for the 11 NuvaRing lawsuits pending in federal court. Discovery for federal NuvaRing lawsuits – both pending and future – will be centralized for discovery purposes in the Eastern District of Missouri before Judge Rodney W. Sippel. More NuvaRing lawsuits are pending in New Jersey after plaintiffs defeated defendants’ efforts to remove all NuvaRing lawsuits to federal court.

These NuvaRing lawsuits involve blood clot-related injuries to women such as pulmonary embolisms, strokes, heart attacks, and deep vein thrombosis (DVT). Because NuvaRing is a birth control device, many of these injuries are occurring in young woman who are rarely at risk for non pharmacological induced blood clots.

Many of the NuvaRing cases are not going to have difficulty specifying causation problems because women who are on birth control are generally – although obviously not always – relatively young. Plaintiffs’ lawyers handling NuvaRing cases are going to have an easier time proving specific causation if general causation is established.

I was tagged by the Drug and Medical Device Blog with an Internet meme (I don’t know what this is but I get the idea) asking Maryland Injury Lawyer Blog to (1) to identify five non-law blogs that we find to be interesting, and (2) to tag five lawyers to do the same thing.

I’m glad to be included by the Drug and Medical Device Blog. I’ve made fun of this blog on many occasions because of its “ultra partisan” view on drug and medical device injury litigation. How do I know that their views are uncompromisingly pro-pharmaceutical company? Because I read every single post they write. Anyone involved in products liability litigation would be foolish not to read this blog. It is the most well-written and informative blog discussing drug and medical device litigation by a landslide. It is also – to the extent such a blog can be – funny and entertaining, which makes this blog all the more maddening to me: anyone smart and funny should be obligated to see the world though the same lens that I do. This should be a rule.

These are the non-legal blogs I like:

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