Zofran is an anti-nausea drug. It works to prevent nausea and vomiting by blocking the effects of serotonin, a chemical in the body that triggers nausea and vomiting. The drug was designed to help cancer patients dealing with the side effects of chemotherapy but it was also approved by the FDA for those suffering nausea due to radiation therapy, anesthesia and surgery. Nevertheless, GlaxoSmithKline (GSK) eventually pushed to market and sell Zofran to pregnant women. Women who are pregnant are often plagued by morning sickness, and some can suffer from extreme nausea. The problem is, the FDA never approved the use of Zofran for pregnant women; it’s an “unapproved” use of the drug. Unfortunately, “off-label drug use” is very common. I wrote about off-label drug use and its potential dangers here.

By 2013, 110,000 monthly prescriptions of Zofran were issued to pregnant women. If this were an approved use, we could rest easier, as an approved use means the drug has been thoroughly tested and evaluated, with the determination backed up by “strong scientific data.” For unapproved uses there is none of that. If a drug is approved for any use, a doctor can then use his best judgment to prescribe the drug for any other purpose.

more Does Zofran Cause Birth Defects?

In 2014 a study of Zofran was published by the American Journal of Obstetrics & Gynecology (AJOG). Among other findings, the study noted a two-fold increased risk of heart defects in infants whose mothers used Zofran during their pregnancies, which led to a 30% increased risk of major congenital malformations. Other birth defects potentially caused by the pregnant mother’s use of Zofran include cleft palate and cleft lip, skull deformities, and club foot. The AJOG study also noted that other anti-nausea drugs (doxylamine and pyridoxine) were approved for use in pregnant women, which means they were thoroughly tested for use by pregnant women. So why should pregnant women use Zofran, the study asked.

In 2016 a study published in Reproductive Toxicology indicated that researchers did not see a connection between use of the drug Zofran during pregnancy and birth defects. The study appeared to focus on “extreme morning sickness,” and concluded that extreme morning sickness could be worse for the health of the baby than being exposed to Zofran.

Studies on the connection between Zofran and birth defects are continuing.

Zofran Multidistrict Litigation (MDL 2657)

Still, many children born to mothers who used Zofran during pregnancy have been born with serious birth defects. Hundreds of these families have filed lawsuits against GSK. So far more than 400 lawsuits have been filed. A multidistrict litigation (MDL) court was established in 2015 in federal court in Massachusetts (In Re: Zofran (Ondansetron) Products Liability Litigation, Case No. 1:15-md-2657). Because thousands of women have been prescribed Zofran during their pregnancies, this number will likely increase dramatically over the next few years.

MDL Judge Allows Fraud Claims to Stay in Lawsuits

In April 2017, the judge presiding over the Zofran MDL denied GSK’s motion to dismiss all fraud claims from the litigation. Now fraud is a special kind of claim against a defendant, and it requires careful and detailed allegations in the lawsuit in order to survive a motion to dismiss. In a simple negligence action, for example, a plaintiff can simply lay out basic facts to support negligence (“the driver was negligent when he was speeding along the highway, and the driver’s speed caused the car crash”). But fraud is a different animal: it essentially alleges that the defendant was intentionally deceptive, misleading, or untruthful. Fraud claims are big, and if a plaintiff proves fraud in court, the defendant can be exposed to additional damages, including punitive damages, which can explode a trial verdict.

Because fraud claims can be very expensive and burdensome on defendants, the Rules of Civil Procedure require that plaintiffs “state with particularity the circumstances constituting fraud . . . .” In the Zofran MDL, GSK argued to the Court that the plaintiffs had failed to meet this pleading burden, and therefore that the fraud claims should be dismissed.

Judge Dennis Saylor disagreed, at least with regard to allegations of GSK’s misrepresentations in its Zofran labeling. He ruled in April that plaintiffs had satisfied Rule 9(b) of the Federal Rules of Civil Procedure.

The master complaints, according to Judge Saylor, “allege generally that plaintiffs and their physicians relied on the misrepresentation in the label in prescribing and ingesting Zofran and/or ondansetron. [citations omitted] In this context, at least, that is sufficient. Pharmaceutical product labeling is highly regulated, and its very purpose is to advise prescribing physicians, who may reasonably rely on the representations in such labeling.” Memorandum and Order, pp. 14-15.

So What Does All this Mean?

The fraud claims in the Zofran MDL can move forward against GlaxoSmithKline. This is a big court victory for the 400+ plaintiffs in the litigation. But there is still work to do. If the plaintiffs can win their fraud claims at trial, they stand to recover punitive damages, and these damages are extra damages meant to punish a “bad actor.” Punitive damages are intended to send a signal to a defendant found to have intentionally or recklessly harmed someone else, and these damages are intended to be large enough to change behavior. In a recent Depuy Pinnacle hip trial in Texas, a jury awarded one billion dollars in punitive damages to plaintiffs harmed by the bad actions of Depuy, Inc. A billion dollars can certainly change behavior, even in a huge company like Depuy or GSK.

Despite the plaintiffs’ recent win regarding the fraud claims in the Zofran MDL, GSK will still vigorously defend itself. At this point, GSK refuses to admit Zofran is unsafe. However, more lawsuits will be filed, bellwethers cases will soon be tried, and we will get a better sense of the strength of these cases in the coming months.

If you took Zofran during your pregnancy and your child was born with a birth defect, contact me or another product liability attorney to discuss your potential case against GlaxoSmithKline.

There is an unsettling criminal case being tried in Massachusetts federal court this week. Two executives of a company called Acclarent are being prosecuted for fraud in the marketing of a medical device known as “Stratus.” The Stratus was a device that was supposed to relieve symptoms of sinusitis using saline. It consisted of a tube with a balloon attached to a sharp pin. The device would be implanted in the patient’s sinus, where it would be left in place for two weeks. It was reported to work as similar devices which created space in the sinus area using saline, which allowed patients to breathe easier. But according to testimony in the criminal trial, Acclarent had other intentions for the Stratus. Instead of using saline, the Stratus was intended to deliver “Kenalog,” a steroid found in medications like Nasacourt.

But I should back up.

more Again, The Flawed 510(k) Medical Device Approval Process

The Stratus was first approved for sale by the FDA utilizing the 510(k) process. The Code of Federal Regulations allows a manufacturer to notify the FDA of its intent to market a device (like the Stratus). It then allows the company to apply for market approval without rigorous testing or clinical trials. The company must explain how a new device is “substantially equivalent” to an existing product that did undergo testing. Many of the medical devices that have led to thousands of lawsuits (metal-on-metal artificial hips, artificial knees, transvaginal mesh) reached the market under the 510(k) process. In the case of Stratus, Acclarent reported to the FDA that the device was similar to other devices on the market which utilized saline to open the sinus area and to relieve pressure in the sinus. On the basis of these representations, the FDA approved the Stratus for sale in 2006.

The Allegations Against Acclarent Executives

Federal prosecutors allege that two executives committed fraud by obtaining market approval from the FDA under false pretenses. The claim is that Acclarent represented the Stratus was much like devices on the market which used saline, but then intentionally marketed the Stratus instead to deliver the steroid Kenalog. There was virtually no testing of the Stratus and its safety and effectiveness in delivering Kenalog directly into the sinus of patients. Prosecutors state that this intentional misrepresentation defrauded the FDA, the doctors who prescribed the device, and Johnson & Johnson, which purchased Acclarent in 2010 for $800 million. J&J pulled the product in 2013.

Evidence From The Acclarent Criminal Trial

One surgeon testified that he was very concerned that Acclarent had not properly tested the Stratus as safe when using the drug Kenalog. Dr. Michael Armstrong testified that he believed the marketing jumped ahead of the research on the medical device. Although it got approval for the Stratus using saline, Acclarent gave presentations to doctors focusing on the device delivering the steroid. This was not the proper use the FDA approved. Training materials developed by Acclarent showed a white liquid which was not saline (and believed to be Kenalog).

Prosecutors also called to the stand a former sales rep of Acclarent. She testified that the major emphasis in her sales training was in promoting the off-label use of the device and the steroid Kenalog. Because sales reps are not allowed to suggest off-label uses of drugs, the sales reps at Acclarent joked that they wanted to make buttons stating: “Ask me about Kenalog.” The sales rep also testified that Acclarent representatives told her the device was approved only for use with saline, but that doctors would probably not use saline with the Stratus.

At least from this testimony, it seems clear that Acclarent wanted to press ahead (recklessly) to sell the Stratus as a device to deliver the steroid Kenalog, which was not approved by the FDA and which had not undergone sufficient testing. This does not mean the executives will be found guilty of criminal fraud. But it does suggest a rush to market and a dangerous promotion of an off-label use of a drug.

The Takeaway

As consumers, we cannot presume that companies will always act ethically and responsibly. We all need to be vigilant when obtaining products and services. If you are planning to hire an attorney or a home builder or an accountant, check client references. If you are undergoing surgery, do some research in advance on your physician, and check with other people who know the doctor in your community. Is he a good surgeon? Is he responsive? Does he explain the procedure in helpful ways? Does he have a decent bedside manner? And if you are undergoing a procedure where a medical device is being implanted, investigate before the surgery. Ask your doctor about the specific product being used. Get a second opinion from another physician if possible. Ask your doctor why she chose one medical device product over another. Check out the articles on the medical device at the FDA website. Do a check on pending lawsuits against the manufacturer of the device. I know it sounds paranoid, but you may find some useful information and avoid a bad result or even an injury. No one can eliminate all risk in this life (especially when surgery or medical care is involved) but we should never blindly trust doctors or medical device companies.

The criminal case is titled: United States v. Facteau et al, 1:15-cr-10076 (U.S.D.C. Massachusetts). I will let you know the results of the trial when the jury reaches a verdict.