In Alabama, a Pre-Filing Settlement Agreement Can Survive Death

In Nationwide Mutual Ins. Co. v. Wood, No. 1111486 (Ala. Feb. 22, 2013), the Alabama Supreme Court ruled on an interesting fact scenario and I believe ruled correctly.

On March 16, 2011, D.V.G., a minor, was injured while a passenger in a vehicle being driven by K.C.T.  Apparently, the accident was due to K.C.T.’s negligence.  K.C.T.’s liability carrier was Nationwide and D.V.G. was entitled to UM/UIM benefits under a policy issued by State Farm.  As D.V.G’s attorney, Stan Brobston contacted both insurers.  Nationwide agreed to pay policy limits ($50,000), as did State Farm ($50,000).  While no lawsuit was filed, everyone agreed that, through a pro ami hearing, a court would have to approve the settlement since D.V.G. was minor.

On September 15, 2011, before any pro ami hearing, D.V.G. died as a result of injuries sustained in an unrelated motor vehicle accident.

Nationwide and State Farm instituted a dec action in federal court asking the federal court to determine the status of the settlement agreement.

The Alabama Supreme Court answered the following certified question in the affirmative:  “Under Alabama law, is an insurance company bound to a settlement agreement negotiated on behalf of an injured minor, if that minor dies before the scheduling of a pro ami hearing which was intended by both sides to obtain approval of the settlement?”

The Alabama Supreme Court held that the settlement created a contract and any contract claim survived D.V.G.’s death. They reasoned that as long as D.V.G or her representative did not disavow the settlement, the settlement was enforceable against the two insurers.

D.V.G.’s death did not make it impossible to conduct the pro ami hearing.  The opinion noted that, while D.V.G’s mother wanted to have a pro ami hearing, the two insurers refused to cooperate.  The Alabama Supreme Court was not going to allow the insurers to prevent the conducting of a pro ami hearing and, then, argue that the settlement could not be enforced until a pro ami hearing was held.

The Alabama Supreme Court declared that the two insurers could not avoid the settlement simply because D.V.G. died before the pro ami hearing was held. 

 

Pradaxa Lawsuits on the Rise

Pradaxa® is a direct thrombin inhibitor that is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Pradaxa® was approved by the Food and Drug Administration in 2010. The FDA approved two dosages: 75 mg and 150 mg, to be taken twice daily. Pradaxa® was the first anticoagulation medication approved in the U.S. in more than 50 years for patients with non-valvular atrial fibrillation.

            Prior to the FDA’s approval of Pradaxa®, warfarin was the only oral

anticoagulation available in the U.S. for reducing stroke and systemic embolism in patients with atrial fibrillation. Unlike patients who use Pradaxa®, users of warfarin must follow dietary restrictions and regularly monitor their blood levels (INR) by undergoing blood tests and potentially adjusting the dose of their medication. Warfarin is actually a form of rat poison.

            The advantages of warfarin over Pradaxa® is that warfarin is heavily monitored and requires constant blood tests to make sure that it is working properly, and most importantly, has an antidote (Vitamin K) to help stop uncontrollable bleeding.

            We believe that the manufacturers of Pradaxa® overstated the efficacy of Pradaxa® with respect to preventing stroke and systemic embolism and failed to adequately disclose to patients that there is no drug, agent or means to reverse the anticoagulation effects of Pradaxa® and that such irreversibility could have permanently disabling, life-threatening and fatal consequences.

            From October 2010 until the end of March 2011, approximately 272,119 prescriptions for Pradaxa® were written in the US. During that same period, there were 932 Pradaxa®-associated “Serious Adverse Event” (“SAE”) Medwatch reports filed with the FDA, including at least 120 deaths and over 500 reports of severe, life-threatening bleeding. From April 1, 2011, until the end of June 2011, there were an additional 856 Pradaxa®-associated “SAE” Medwatch reports filed with the FDA, including at least 117 deaths and over 510 reports of severe, life-threatening bleeding.

            During March, 2011, the manufacturers of Pradaxa® modified the US labeling and prescribing information for Pradaxa®, which included additional information regarding the use of Pradaxa® in patients taking certain medications. Also, almost 1800 SAE Medwatch reports were filed with the FDA, including at least 237 deaths and over 1,000 reports of severe, life-threatening bleeding.

            All over the country, hundreds of lawsuits have been filed against the manufacturers of Pradaxa®. Most of these cases have been consolidated into an MDL.

            Common side effects from Pradaxa® include:

• Brain Hemorrhaging/Bleeding
• Gastrointestinal (GI) Bleeding
• Kidney Bleeding
• Internal Bleeding
• Heart Attack/ Cardiac Injury
• Death

            Our firm is currently investigating claims for those people who have been injured by taking Pradaxa®. If you would like a free case evaluation, please contact Booth Samuels at toll free 1-866-515-8880 or at booths@pittmandutton.com.

 

 

 

 

 

Suprising Result From Alabama Supreme Court on Generic Drug Warnings

              Last month, the Supreme Court of Alabama issued a suprising opinion related to generic drug manufacturers' warnings. In Wyeth, Inc. v. Weeks, ___ So. 3d ___, 2013 WL 135753 (Ala. Jan. 11, 2013), Weeks alleged that he suffered injuries as a result of his long-term use of the prescription drug metoclopramide, which is the generic form of the brand-name drug Reglan.  It was undisputed that Weeks ingested the generic form of the drug.  In this opinion, the Alabama Supreme Court addressed the following certified question:

            Under Alabama law, may a drug company be held liable for fraud or misrepresentation (by misstatement or omission), based on statements it made in connection with the manufacture or distribution of a brand-name drug, by a plaintiff claiming physical injury from a generic drug manufactured and distributed by a different company?

 

            In an 8 to 1 decision, the Alabama Supreme Court answered:

            …  Under Alabama law, a brand-name drug company may be held liable for fraud or misrepresentation (by misstatement or omission, based on statements it made in connection with the manufacture of a brand-name prescription drug, by a plaintiff claiming physical injury caused by a generic drug manufactured by a different company.  Unlike other consumer products, prescription drugs are highly regulated by the FDA.  Before a prescription drug may be sold to a consumer, a physician or other qualified health-care provider must write a prescription.  The United States Supreme Court in Wyeth v. Levine recognized that Congress did not preempt common-law tort suits, and it appears that the FDA traditionally regarded state law as a complementary form of drug regulation.  The FDA has limited resources to monitor the 11,000 drugs on the market, and manufacturers have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge; state-law tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly and serve a distinct compensatory function that may motivate injured persons to come forward with information.  Wyeth v. Levine, 555 U.S. at 578-79.

 

            FDA regulations provide that a generic-drug manufacturer’s labeling for a prescription drug must be exactly the same as the brand-name-drug manufacturer’s labeling.  The Supreme Court in PLIVA held that it would have been impossible for the generic-drug manufacturers to change their warning labels without violating the federal requirement that the warning on the brand-name version, preempting failure-to-warn claims against generic manufacturers.

 

            In the context of inadequate warnings by the brand-name manufacturer placed on a prescription drug manufactured by a generic-drug manufacturer, it is not fundamentally unfair to hold the brand-name manufacturer liable for warnings on a product it did not produce because the manufacturing process is irrelevant to misrepresentation theories based, not on manufacturing defects in the product itself, but on information and warning deficiencies, when those alleged misrepresentations were drafted by the brand-name manufacturer and merely repeated by the generic manufacturer.

 

            This opinion includes discussions of (a) Alabama’s Pharmacy Act which permits a pharmacist to select in place of a brand-name drug a less expensive generic version and insurance plans’ promoting of using generics; (b) FDA’s regulations; (c) prior conflicting opinions on this question; and (d) the learned-intermediary doctrine.  As to the last item, the Alabama Supreme Court observed that Weeks “must show that the manufacturer failed to warn the physician of a risk not otherwise known to the physician and that the failure to warn was the actual and proximate cause of the patient’s injury,” that is, “but for the false representation made in the warning, the prescribing physician would not have prescribed the medication to his patent.”

NCAA Lawsuit Update

Below are a few links to articles regarding the NCAA/EA Sports/CLC lawsuit. The case is heating up, with the big fight coming in June of this year.

http://www.al.com/sports/index.ssf/2013/01/ed_obannon_plaintiffs_gain_vic.html

http://espn.go.com/espn/otl/story/_/id/8895337/judge-rules-ncaa-athletes-legally-pursue-television-money