Articles Posted in Pharmaceutical Litigation

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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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The first case to go to trial in the series of Cook County pharmaceutical negligence lawsuits against Baxter International received a $625,000 verdict against the pharmaceutical manufacturer. The Illinois lawsuit of Estate of Johansen v. Baxter International, Inc., et al., 09 L 11175, was filed after the plaintiff, Steven Johansen, died as a result of receiving contaminated Heparin distributed by the defense.

Hundreds of lawsuits have been filed against Deerfield-based Baxter International, Inc. and Scientific Protein Laboratories, its supplier, after the Food and Drug Administration (FDA) discovered that the companies had been selling contaminated Heparin. The tainted Heparin was discovered to contain oversulfated chondroitin sulfate, which is a synthetic chemical created from animal cartilage that is typically distributed as a dietary supplement. According to tests run by the FDA, the false chemical mimics the real drug, Heparin.

However, not only does the oversulfated chondroitin sulfate not have the same blood thinning effects of Heparin, but can actually cause adverse reactions in patients taking it. The synthetic chemical has been found to cause vomiting, difficulty breathing, a drop in blood pressure, and other severe reactions. The plaintiff, Steven Johansen, first received low doses of the contaminated Heparin during dialysis treatment in December 2007, with no obvious reaction. However, Johansen later received a second, much higher dose of the contaminated Heparin, which resulted in his death five days later.

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The Food and Drug Administration (FDA) voted to allow Trilipix, a cholesterol lowering medication, to continue to be marketed as a drug that can prevent heart attacks. The approval comes despite government studies showing that there were no substantial changes in incidences of heart attacks in patients taking Trilipix in conjunction with other cholesterol lowering medications.

In addition to allowing Abbott to continue marketing Trilipix as reducing the risk of heart attacks despite evidence to the contrary, the FDA also voted against measures that would have forced the drug manufacturer to change the drug’s label to include disclaimers of the drug’s effectivenss.

The only stipulation the FDA imposed on Abbott was that it must conduct its own study on Trilipix’s effects on reducing heart attacks. Experts have suggested that this study could cost Abbott over $100 million to conduct. While this might seem like a large sum of money, it pales in comparison to the $1.6 billion that Abbott Laboratories made last year off sales of Trilipix and TriCor, another cholesterol lowering drug.

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A New Hampshire jury awarded the state’s highest product liability verdict ever when it awarded Karen Bartlett $21 million for the injuries she incurred as a result of taking Sulindac, an anti-inflammatory prescription drug manufactured by Mutual Pharmaceutical Co., Inc. The jury found the drug company liable for Bartlett’s injuries based on the concept that it should have known that the drug was unreasonably dangerous. Bartlett v. Mutual Pharmaceutical Co., Inc.

Bartlett was initially prescribed Sulindac to treat her shoulder pain. However, quickly after beginning the medication she began to experience skin irritation and a sensation of having “pebbles” in her throat and eyelids. Eventually these symptoms worsened as the drug continued to essentially burn Bartlett from the inside out, leaving her with burns to over 65% of her body. In addition, Bartlett was left legally blind despite undergoing 12 eye surgeries. Bartlett was eventually diagnosed with Stevens-Johnson Syndrome and toxic epidermal necrolysis (SJS/TEN).

The main legal issue in the pharmaceutical liability case was whether or not the drug, Sulindac, was unreasonably dangerous and whether the pharmaceutical company should have known that it was dangerous. At the trial the plaintiff’s attorney presented evidence demonstrating that Sulindac has been linked with incidents of SJS/TEN. Furthermore, plaintiff demonstrated that the occurrences of SJS/TEN among consumers taking Sulindac was higher than any other anti-inflammatory medication on the market.

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A recent Illinois Appellate Court case reviewed what a drug store’s duty is to its customers regarding possible drug interactions in an Illinois pharmaceutical lawsuit. In DiGiovanni v. Albertson’s, Inc., No. 04 L 3580, the decedent’s estate alleged that the pharmacy had a duty to warn the decedent about a possible interaction between her two prescribed medications, an interaction that eventually caused her death. However, both the Cook County trial court and the appellate court agreed that the pharmacy did not have a duty to warn the customer of the possible drug interaction in the present pharmaceutical malpractice case.

The decedent had been prescribed Tenoretic, a medication to treat high blood pressure, by her longtime doctor, Dr. Shastri. When filling the prescription the pharmacy noted that Tenoretic could interact with lithium, which the decedent was also taking to treat her manic depression. Upon noting the possible interaction the pharmacist called Dr. Shastri, who had prescribed both medications, to determine whether he should continue to fill both prescriptions. Dr. Shastri directly told the pharmacist to fill the prescriptions and stated that he would monitor the decedent for possible interactions.

The following week DiGiovanni returned to the same pharmacy for a prescription refill of the same medications. At the time a different pharmacist again noted the possibility of a drug interaction between the two medications. However, the pharmacist refilled both prescriptions after reviewing a note on the decedent’s file indicating that her doctor would be monitoring her for possible drug interactions.

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The U.S. House Committee on Oversight and Reform are accusing Johnson & Johnson of being uncooperative, providing false information, and employing delay tactics during its interactions with the House Committee. The congressional investigation launched on May 27, 2010 against Johnson & Johnson, was done so in response to widespread drug recalls by the pharmaceutical company.

According to the House Committee, Johnson & Johnson told members of its staff that the recall involves 6 million bottles of children’s medicine, but then informed the FDA that the recall actually involved more than 136 million bottles. The chairman of the House Committee, Edolphus Towns, said, “We need to know where the spin is and where the truth begins.”
Johnson & Johnson has denied the allegations claiming the company provided misinformation, instead providing an alternate interpretation for the wide discrepancy between the two values. Its spokesperson stated that the discrepancy in numbers was in response to two different questions from government officials. Johnson & Johnson says the 6 million bottles refers to the total number of the product in stores at the time of the recall, while the 136 million bottles refers to the estimated amount in the hands of customers.

However, it is unclear whether these estimates include the two new recalled products Johnson & Johnson added to its recall list as of yesterday. Benadryl Allergy Ultratab tablets and Extra Strength Tylenol have now be added to the list of recalled Johnson & Johnson products.

The already recalled products include Children’s Benadryl, Children’s Motrin, Children’s Tylenol, and Infants’ Tylenol. A complete list of all the recalled Tylenol products can be found at the company’s website.

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The first Avandia case set for trial against drug manufacturer GlaxoSmithKline (GSK) settled for an undisclosed amount. The pharmaceutical litigation case was brought against GSK after new studies of Avandia revealed that using the drug could increase the risk of heart attacks and strokes.

No details of the settlement or the terms were announced except a statement indicating that the details of the settlement were to remain confidential. And while GSK would not indicate how many plaintiffs were involved in the recent settlement, according to reports by Deutsche Bank, as many as 5,000 claims for damages were reportedly consolidated in this Philadelphia case.

If the alleged number of settled claims is correct, then this could mean that GSK has settled almost half of the pending Avandia claims. Analysts have been evaluating the progress of GSK’s Avandia lawsuits and had originally estimated there to be around 13,000 claims against GSK that would take around $6 billion in total to settle. While GSK has yet to confirm the actual numbers in any of the Avandia cases, according to a recent Reuters’s article by Ben Hirschler, the recent developments indicate that GSK’s final payout would be considerably less. New estimates indicated that the final payout might be close to $1.1 billion instead of the $6.6 billion originally anticipated.

It will be interesting to see whether GSK plans to settle the next set of claims, which is scheduled for an October 2010 trial in Philadelphia. To date it has not settled any of its multi-district litigation claims that are pending in federal court.

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Yesterday the House Committee on Oversight and Government Reform Johnson & Johnson’s Recall of Children’s Tylenol and Other Pediatric Medicines” in order to further investigate McNeil Consumer Healthcare/Johnson & Johnson’s recall of numerous children’s medicines.

Since its April 10, 2010 voluntary recall, Johnson & Johnson has recalled around 136 million bottles of more than 40 different types of popular medicines. A complete list of all the recalled children’s Tylenol products can be found at the company’s website. The list of drugs recalled by McNeil include Infants’ Tylenol, Children’s Tylenol, and Children’s Benadryl, and Children’s Motrin.

The massive recall of children’s Tylenol products was the result of manufacturing defects and poor quality control at McNeil’s manufacturing plants that caused the medications to contain either too much of the active ingredients, inactive ingredients that failed to meet testing standards, or metal specks within the medications.

The House committee’s investigation was set into motion by Chairman Towns and Darrell Issa (R-CA) earlier this month due to the large number of medicines included in the Tylenol recall. McNeil Consumer Healthcare could face a number of repercussions from the Food and Drug Administration (FDA), including seizures of its current products, criminal penalties, and/or additional sanctions.

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Yet another weight loss drug has been accused of posing a safety risk due to its potential causing of liver damage or failure. Yesterday the U.S. Food and Drug Administration (FDA) completed its safety review of the the weight loss drug Orlistat, which has been marketed under the names of Alli and Xenical, in connection with reports of severe liver injury. Alli is manufactured by GlaxoSmithKline (GSK), while Xenical is manufactured by Hoffmann-La Roche (Roche).

These reports of potential liver damage due to a weight loss drug come on the heels of similar reports of liver injury associated with Hydroxycut, which led to a massive recall of the weight loss supplement.

After undergoing an investigation into the safety of Xenical and Alli, the FDA found that Alli and Xenical could in fact cause liver damage in rare cases and therefore has approved the weight loss drugs to stay on the market as long as their labels are changed to include warnings of potential liver damage.

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The U.S. Food and Drug Administration (FDA) announced what could amount to a nationwide recall of children’s Tylenol and dozens of other over-the-counter medicines. The FDA conducted an inspection at a McNeil drug plant in Pennsylvania that has resulted in the recall of more than 40 varieties of liquid pediatric medicines Tylenol, Motrin, Benadryl and Zyrtec. These products may contain metal particles over the limit allowed to meet safety requirements.

Following the discovery that some of the Tylenol products from its plant could contain metal, McNeil initiated a voluntary recall of all products manufactured at that plant. According to McNeil, its April 2010 recall was a precautionary measure and was not based on “adverse medical events”. The McNeil recall included not only Tylenol products, but also other popular children’s medicines, such as children’s Motrin, Zyrtec, and Benadryl products
Tylenol is one of the brands made by a unit of Johnson & Johnson. One of the major distributors of these pediatric liquid products is Perrigo, a company based in Michigan that supplies children medicines to big pharmacy companies like Walgreens and CVS. Perrigo has also received a warning from the FDA that it has committed serious manufacturing errors of its own. Tablets of ibuprofen reportedly contained metal shavings.

Also reported by the FDA are questions of safety and reliability of these products. Other deficiencies in the report included bacterial contamination of raw products, inadequate maintenance of equipment and the fact that no follow up was conducted to investigate 46 consumer complaints as to foreign materials and black or dark particles in the products. Some of the complaints are more than a year old.

Click here for the full list of all the recalled Tylenol products.

For additional information on the timeline of the Tylenol recall, see Parija Kavilanz’s article at CNNMoney.com.

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