Articles Posted in Pharmaceutical Litigation

Plaintiff Wendy Dolin, the wife of the decedent, Stewart Dolin, filed this lawsuit in the U.S. District Court for the Northern District of Illinois in Chicago alleging that the death of her husband, Stewart Dolin, was caused by the taking of the generic drug paroxetine, a form of the antidepressant Paxil. Stewart Dolin committed suicide at age 57 on July 15, 2010.

In the lawsuit, it was alleged that the labeling of the drug that was in existence at the time of his death did not warn of the drug’s association with an increased risk of suicidal behavior in adults. It was alleged that GlaxoSmithKline (GSK), the manufacturer and parent corporation of this drug, had knowledge of a statistically significant 6.7 times greater risk of suicide in adults of all ages. As a matter of fact, it was alleged that the label stated the opposite – that the suicidal risk did not extend beyond the age of 24.

The prescription medication Paxil (paroxetine hydrochloride or “Paxil”) is one of the class of medications known as selective serotonin reuptake inhibitors, or SSRIs.

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The plaintiff, Jo Huskey, and her husband filed a product liability lawsuit against Ethicon Inc. and Johnson & Johnson. After a nine-day trial, the jury returned a general verdict in the amount of $3.27 million for the Huskeys on their design defect, failure to warn and loss of consortium claims. Ethicon appealed after the trial judge denied its post-trial renewed motion for judgment as a matter of law or in the alternative for a new trial.

The court of appeals found that the Huskeys offered sufficient evidence to sustain the jury’s verdict and the district court committed no reversible error.

In 2008, Jo Huskey began suffering symptoms of Stress Urinary Incontinence (SUI).  In January 2011, after her condition worsened, she discussed treatment options with her physician. By this time, Mrs. Huskey was regularly leaking urine while coughing, laughing and sneezing. She also experienced pain during intercourse. At the suggestion of her physician, Mrs. Huskey agreed to have the doctor surgically implant a medical device called the Tension-Free Vaginal Tape-Obturator (TVT-O).

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Across the country there have been many lawsuits filed against the makers and distributors of talc. Most of these suits have been filed against Johnson & Johnson as the maker of the baby powder used by many. In some courts, there have been very large jury verdicts for individuals who have been able to prove that the use of the baby powder caused ovarian cancer.

In this New Jersey consolidated case, two plaintiffs alleged that the talc-based product manufactured by the defendant had caused each of them to develop ovarian cancer. The issue for the court to decide here was whether the plaintiffs had shown that their experts’ theories of causation were “sufficiently reliable as being based on a sound, adequately founded scientific methodology, to wit, that they [were] based upon methods which experts in their field would reasonably rely in forming their own . . . opinions about the cause(s) of each of plaintiffs’ ovarian cancers.”

The court was ruling on the defendants’ motion to bar testimony of each of the plaintiff’s several expert witnesses. Along with the motions to bar, the defendants also filed motions for summary judgment anticipating his successful motion to bar the experts’ testimony. The motions were received by the court at a plenary hearing conducted pursuant to the standards articulated in a New Jersey case. Continue reading

In the latest of the cases alleging that the anti-psychotic drug Risperdal caused a man to grow female-like breasts, a Philadelphia jury has signed a verdict of $1,750,000 in a case that ended on Nov. 11, 2015.

The report of the case indicated that the jury deliberated for 2 ½ hours after a two-week trial.

Risperdal is manufactured by Janssen Pharmaceuticals, which is a division of Johnson & Johnson. The Risperdal cases claim generally that the manufacturer chose not to warn health care providers and their patients of the condition known as gynecomastia, which causes boys and young men to grow female breasts. In this case, the 21-year-old plaintiff was Nicholas Murray.

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Takeda Pharmaceutical is a Japanese company that has been defending as many as 9,000 lawsuits or claims for individuals who were taking the medication Actos, which is a Type 2 diabetes drug. Takeda’s United States’ headquarters is located in Deerfield, Ill.

The filed complaints include 4,000 in Cook County, Ill., another 4,000 filed in Louisiana and about 800 filed in Florida. There are still other cases filed in federal court in the Western District of Louisiana; these are part of the Multidistrict Litigation (MDL). In one of those cases, tried to a jury in 2014, the verdict against Takeda and Eli Lilly was for $9 billion, which set a record. In that case Takeda was found to have destroyed evidence about Actos and its link to bladder cancer. It was also revealed that Takeda’s former employees and some top executives in the U.S. and Japan deleted files that if considered would have had negative impact. That verdict amount was later reduced by the presiding judge and is on the appeal filed by Takeda. That case as consolidated is titled In re Actos (Pioglitazone) Products Liability Litigation, 11- md-02299, U.S. District Court, Western District of Louisiana (Lafayette).

According to reports, the diabetes drug Actos produced $16 billion in sales since it went on the market for public use in 1999. In June 2011, the United States Food and Drug Administration (USDA) issued a written warning about the possible risk of bladder cancer for those patients who were taking Actos for a year or longer. In August 2011, the FDA issued a new warning about Actos stating that people taking Actos “may be an increased risk for developing bladder cancer.”

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The first of nearly14,000 patients given potentially tainted injections of pain medicine has sued the maker of the treatment. Many experts say this may be the first of a wave of lawsuits following a deadly meningitis outbreak that has killed 14 people.

Meanwhile, a medical practice specializing in pain management received a shipment of the tainted medication. The company has notified about 200 Chicago-area patients who may have received injections of a steroid medication linked to an outbreak of the deadly form of meningitis. APAC Centers for Pain Management is the only provider in Illinois known to have received the recalled product, according to the Illinois Department of Public Health. Three of the company’s clinic sites gave injections of the drug for back pain, including two in Chicago and one in Westchester. The Illinois Department of Public Health has reported that there have been no cases of meningitis linked to the pain mediication in the state.

The first lawsuit was filed last week in a Minnesota federal courtby a woman who said she had been given a steroid injection for back pain. She said she has experienced meningitis-like symptoms and is awaiting test results.

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DMAA is an ingredient of pre-workout energy boosters. A recent Chicago Tribune article describes DMAA supplements (a/k/a 1, 3-dimethylamylamine or methylhexaneamine) as being marketed as a natural substance that comes from geraniums. But substantial evidence negates that assertion.

The U.S. Food and Drug Administration (FDA) is now calling on the manufacturers of DMAA to verify the safety of their products. The regulators are saying that DMAA is a pharmaceutical compound marketed as a natural ingredient. This has led to renewed calls for federal regulations for dietary supplements.

Users of the products containing DMAA claim that it brings renewed energy, especially to competitive bodybuilders and athletes.

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The US Army is investigating whether the death of two soldiers was in any way caused by workout supplements. Both soldiers died after being engaged in physical activity on a Southwest Army base. Dimethylamylamine (DMAA), the active ingredient in these workout supplements, was later found in both soldiers’ toxicology reports. The Army is trying to determine whether there is a connection between health problems and these popular workout supplements.

Perhaps the most well known examples of these pre-workout “boosters” are Jack3d and OxyElite Pro, both manufactured by USPlabs. Both products contain DMAA and are advertised as being able to increase the taker’s energy and lead to better workouts. Currently both Jack3d and OxyElite Pro are classified as dietary supplements and subsequently do not need to be approved by the Food and Drug Administration (FDA).

A recent New York Times article quoted Kerri Toloczko, a USPlabs spokeswoman, as stating that “there have been over one billion doses of DMAA-containing products taken without a single corroborated serious” health problem among those taking the workout boosters as directed. But while those responsible for manufacturing and marketing these products claim they are safe when used as directed, medical experts are claiming there might be serious health concerns when taking DMAA.

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The U.S. Supreme Court examined a Vermont law that limited the use of patient information collected by pharmacies to determine whether or not 18 V.S.A. § 4631 violated pharmacies’ First Amendment rights. The Supreme Court held that the Vermont law did place unnecessary limits on the speech of pharmaceutical companies and had failed to justify these limits within the law itself. Therefore, the Court found Vermont’s Confidentiality of Prescription Information statute to be unconstitutional as it currently stands in Sorrell v. IMS Health, No. 10-779.

The Vermont law at issue, 18 V.S.A. § 4631, sought to limit pharmacies from selling their client’s demographic information to pharmaceutical companies. Basically, whenever a patient fills a prescription at a pharmacy, information on that patient is generated. The pharmacy then sells that information to “data miners,” who compile the data into coherent reports, which are then sold to pharmaceutical manufacturers. The drug companies then use this data for “detailing”, a process through which they promote their medications to doctors in the hopes of increasing the sale and use of their drug.

The goal of §4631 was to limit the practice of detailing by eliminating the role of the data miners; under the law, pharmacies were no longer able to sell patients’ information to data miners. The law sought to limit the commercial use of patient information and its sale to pharmaceutical companies. However, it did allow this information to be used in other ways, e.g., for medical research purposes. In fact, it was this arbitrary divide of what was allowed and what was not that led to the Supreme Court’s ruling in Sorrell.

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Federal preemption has long been a hot button issue in pharmaceutical drug cases, with consumer advocates arguing that drug companies should be held to the sometimes higher state standards. However, the U.S. Supreme Court appears to have reversed the federal preemption stance it took in Wyeth v. Levine. In Wyeth, the Court held that the negligence claim against the pharmaceutical company was not preempted by federal regulations and that the drug company was liable for its failure to provide adequate warning of its drug’s dangers.

However, in Pliva v. Mensing, No. 09-993, the Supreme Court ruled that a pharmaceutical manufacturer could not be sued under state law for failing to warn consumers about its drug’s risks. This decision seems to go against the Court’s ruling in Wyeth just two years ago; both lawsuits deal with federal preemption issues and involve states setting higher safety regulations than the Food and Drug Administration (FDA). Yet in Wyeth, the Court held the drug company responsible, while in Pliva, the Court ruled the pharmaceutical lawsuit was barred under federal preemption.

Yet on closer inspection, there appear to be some key differences between the facts surrounding the drug warning labels in Wyeth and Pliva. The main issue in both the Wyeth and the Pliva pharmaceutical cases involved an FDA regulation referred to as “changes being effected” (CBE). Under the CBE regulation, a drug manufacturer may modify its warning label without prior FDA approval if the modifications will improve the drug’s safety. Under CBE regulations, the FDA approval comes after the warning changes, not before; however, the assumption is that the warning changes in such matters are so important to consumer safety that the FDA will eventually approve those changes.

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