Articles Posted in Pharmaceutical Drugs

A mass tort that has been getting a lot of attention from lawyers around the country in recent weeks is Xeljanz blood clot lawsuits.

Xeljanz now has a boxed warning, the FDA’s most severe safety warning, for DVT and pulmonary embolisms.

These conditions can be fatal.  This is a big deal for Pfizer’s blockbuster drug.

A lawsuit against Gilead Sciences, a prominent drug company known for its HIV medications, has been allowed to continue in federal court after the company filed a motion to dismiss the claims. Although the ruling did dismiss some claims against the biopharma giant, it allowed all the core causes of action to continue making the decision a decisive victory for the plaintiffs.  There is still a long way to go but these cases may have legs that could take the plaintiffs to victories at trial and ultimately a global settlement for all the victims.

The legal allegations against Gilead involve the company’s groundbreaking prescription drugs used for the treatment of HIV.  In 2001, Gilead developed and released a first of its kind drug, tenofovir disoproxil fumarate (TDF) under the brand name Viread. TDF is a unique antiretroviral medicine that works by blocking an enzyme that the HIV virus cells use to replicate and multiply. By preventing the virus cells from replicating, Viread and Gilead’s other TDF drugs effectively stop HIV from growing and progressing into AIDS.

gavel-court-house-238x300Gilead’s TDF drugs (Viread, Atripla, Complera, Stribild) literally changed the treatment landscape for HIV patients. TDF made living long term with HIV a possibility and was being taken every day by hundreds of thousands of patients across the country.  You have to give Gilead a ton of credit for this.  They saved lives and a lot of them.

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                Zostavax Trials Set for 2020

U.S. District Judge Harvey Bartle of the Eastern District of Pennsylvania has selected the initial “bellwether” cases in the Zostavax MDL. The bellwether Zostavax cases will be grouped into two categories and prepared for five proposed trial dates that will take place between fall 2020 and summer 2021.

You never know how mass tort cases are going to go.  But I do think the Zostavax cases might be ripe for settlement long before these cases ever go to trial.

June 2018 Update:  Abilify lawsuits may be very close to a settlement.  There were three cases set to go to trial in the federal MDL.  They are settled.  These cases may settle very soon.  If you have not already brought a claim, contact a lawyer as soon as possible.

What is Requip?

facepalm-199x300Ropinirole, marketed under the name Requip, is a dopamine agonist.  The drug stimulates dopamine receptors and mimics the action of dopamine in the brain.   In 1995, GSK sought to submitted get Requip approved to treat the symptoms of Parkinson’s disease.  The FDA approved ropinirole for marketing and distribution for treating symptoms of Parkinson’s disease in 1997.

If you are on dialysis, you are vulnerable. Obviously. The last thing you need is someone who pretends to provide a product that helps while actually knowing that the product is going to create a risk to dialysis patients. That appears to be what we have in these Fresenius NaturaLyte and GranuFlo cases.

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I get so many emails from so many marketing companies. Just today I got an offer to write a guest post on this blog (no), an email telling me that I rank poorly in Salisbury, Maryland on the search engines (he’s wrong), and two more random emails from companies telling me they are the best in the world at getting me to the top of the search engines (unlikely since, you know, you are spamming me).

But I found one of these emails really interesting. This one was from New York City and it offered to provide leads for Actos, Yaz, Yazmin, and Ocella cases. These emails are always flying in, but this one actually provided the prices for the leads:

  • Actos: $450

The first line in this editorial adequately summarizes the problem that leads to unsafe drugs and medical devices:

What would your reaction be if the results of a football match were reported as 5:0 by one of the teams and as 3:1 by the other team?

This editorial underscores a point that I think the “FDA approval is the gold standard” crew completely ignores: it is painfully easy to rig drug testing to get the desired results at any stage of the research and testing process. Most of the injuries were at the end of the study? Change the end point. Most of the adverse effects were in patients with blonde hair? Take them out of the study.shutterstock_69220570

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.

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