February 5, 2013

Jeremy Taylor, Senior Attorney, National Legal Research Group

The U.S. District Court for the Northern District of Texas recently decided numerous choice-of-law issues in a products liability action brought by the family of a deceased helicopter pilot.  See Sulak v. Am. Eurocopter Corp., Act. No. 4:09-CV-651-Y, 2012 WL 4740176 (N.D. Tex. Oct. 3, 2012).  The decedent was a resident of Hawaii and was killed in Hawaii while piloting a helicopter manufactured and distributed by the defendants, who were located in France.  The decedent's family filed their action in Hawaii state court, and the defendants removed it to federal court in Hawaii.  The Hawaii federal court then transferred the action to the federal district court in Texas based on one defendant's insufficient contacts with Hawaii.

In light of the fact that the action ended up in federal court in Texas and that the crash had occurred in Hawaii, the court was faced with numerous choice-of-law issues involving both procedural and substantive questions.  Noting that it had jurisdiction over the lawsuit based upon federal diversity jurisdiction, the court stated that it was required to apply Texas choice-of-law rules to determine whether Texas or Hawaii law governed the plaintiffs' action.  Texas applies the most-significant-relationship test set forth in the Restatement (Second) of Conflict of Laws.  Under that analysis, it is not necessary that a single state's law control all substantive issues.  Each issue is, therefore, considered separately, and the state law that has the most significant relationship to the issue controls.

The court observed that under the Texas most-significant-relationship analysis, the law of the place of the injury governs questions of substantive law unless the policy considerations of the Restatement's choice-of-law principles show that another forum has a more significant relationship with such an issue.  The court contrasted this rule with the principle that the applicable procedural rules are those of the forum.  The court noted the general rule that if a Federal Rule of Civil Procedure or Evidence governs a disputed point, the Federal Rule is to be followed, even in diversity cases.  The court concluded that the Federal Rule of Evidence restricting the admissibility of subsequent remedial measures should govern in strict products liability cases.  The court also held that it would apply the Federal Rule of Civil Procedure governing the impleading of a third-party defendant, rather than Hawaii law governing the liability of third-party defendants, when the issue was not the substantive question of whether a potential third-party defendant was liable, but the procedural question of whether such a defendant could be impleaded.

September 25, 2012

Jeremy Taylor, Senior Attorney, National Legal Research Group

The U.S. Court of Appeals for the Sixth Circuit recently decided that an immunity defense given to a drug manufacturer by a state statute was preempted by the Federal Food, Drug, and Cosmetic Act ("FDCA").  See Marsh v. Genentech, Inc., Nos. 11-2373, 11-2385, 11-2419, 11-2417, 2012 WL 3854780 (6th Cir. Sept. 6, 2012).  Therefore, the manufacturer's entitlement to immunity had to be analyzed under federal law, despite the existence of an applicable state immunity provision.

The plaintiffs were consumers who alleged that they suffered life-threatening side effects from their use of the defendant's psoriasis drug "Raptiva."  Raptiva worked by suppressing T cells to prevent them from migrating to the skin and causing psoriasis.  However, because T cells fight infection, their suppression has been linked to life-threatening side effects.  Following reports of such effects, including a rare brain infection in patients taking Raptiva, the defendant removed the drug from the market in 2009. 

One of the plaintiffs in the consolidated cases had begun using Raptiva in 2004 and later suffered viral meningitis and a collapsed lung.  She sued Genentech under the theory of strict liability, alleging defective design and failure to warn, and also under the theories of negligence, breach of warranty, and fraud.  She argued that both before and after approval of Raptiva by the Food and Drug Administration ("FDA"), the defendant had known of the dangerous side effects, concealed them from the public, and not included them in the drug's labeling.  The plaintiff further alleged that Genentech had failed to update statements of contraindications, warnings, precautions, and adverse reactions based upon what the defendant knew and that Genentech had negligently failed to comply with various FDA regulations. 

The Lawletter Vol 37 No 3

Jeremy Taylor, Senior Attorney, National Legal Research Group

The U.S. District Court for the Western District of Pennsylvania recently decided a case involving issues of preemption under the Medical Device Amendments ("MDA") to the Federal Food, Drug, and Cosmetic Act ("FDCA").  See Gross v. Stryker Corp., Civ. No. 11-1229, 2012 WL 876719 (W.D. Pa. Mar. 14, 2012).  The case is important because it explains clearly both the grounds upon which a manufacturer may defend on the basis of MDA preemption and the basis upon which a plaintiff may circumvent the preemptive effect of the statute in bringing state tort claims.

In Gross, the plaintiff had received an implantation of an artificial hip prosthesis manufactured by the defendant.  The plaintiff alleged that the device was defective and that the defect had caused him to suffer a serious infection at the operation site, with attendant pain and the necessity of a corrective procedure.  The plaintiff sued under state law theories of strict liability, negligence, and breach of express and implied warranties.

The defendant argued that the plaintiff's state law claims were preempted by the MDA.  The MDA contains an express preemptive section, which provides that no State may establish any requirement for a medical device that is different from or in addition to any requirement imposed under the FDCA and that relates to the safety or effectiveness of the device.  See 21 U.S.C. § 360k(a).  The court agreed that the plaintiff's claims were preempted by the MDA.

Initially, the court noted that for a state cause of action to be preempted by the MDA, the medical device at issue must have been subject to specific federal requirements related to its safety and effectiveness and the plaintiff's claim must be premised on state law that imposes different requirements.  The court noted that, generally, state common-law claims contesting the safety and effectiveness of a device that received approval under the premarket approval process ("PMA") conducted by the Food and Drug Administration ("FDA"), such as the hip prosthesis at issue in the case at hand, are subject to express preemption.  This is because questions regarding a device's safety and effectiveness are requirements addressed in the PMA.

The court concluded that the plaintiff's state breach-of-implied-warranty claim imposed a requirement different from or in addition to the federal requirements and, therefore, was preempted by the MDA in light of the fact that Pennsylvania's "below commercial standards" requirement was not the same as the standards imposed by the FDA.  The court similarly concluded that the plaintiff's negligence claim ran afoul of the preemptive reach of the MDA, given that the plaintiff alleged that the defendant had been negligent in placing the device into the stream of commerce when it contained unsafe manufacturing residuals or bacteria.

June 5, 2012

Jeremy Taylor, Senior Attorney, National Legal Research Group

The U.S. Court of Appeals for the First Circuit recently affirmed a $21.06 million judgment, including $16.5 million for pain and suffering, in favor of a plaintiff who suffered severe injuries resulting from her use of "sulindac," the defendant's generic anti-inflammatory drug.  See Bartlett v. Mut. Pharm. Co., No. 10-2277, 2012 WL 1522004 (1st Cir. 2012).  Sulindac is known to cause a hypersensitivity reaction called Stevens-Johnson Syndrome and a related disease called toxic epidermal necrolysis ("SJS/TEN").  In December 2004, the plaintiff's physician prescribed sulindac under the brand name Clinoril for pain in the plaintiff's shoulder, and the plaintiff's pharmacist dispensed generic sulindac.

According to the court, the consequences for the plaintiff were "disastrous."  The plaintiff developed SJS/TEN early in 2005.  The court noted that TEN is diagnosed when 30% or more of the outer layer of skin on a patient's total body surface area has deteriorated, been burned off, or turned into an open wound.  The plaintiff suffered TEN over 60% to 65% of her body.  She was hospitalized for 70 days, including over 50 days in the burn unit.  She suffered permanent injuries, including permanent near-blindness, esophageal burns, vaginal and lung injuries, and disfigurement.  The plaintiff was unable to have sexual relations or to read, drive, or work.  The plaintiff asserted multiple causes of action against the manufacturer in New Hampshire state court.  The defendant removed the case to the federal district court.  After removal, all claims but the plaintiff's defective-design cause of action were dismissed on summary judgment or voluntarily by the plaintiff.

Initially, the court of appeals noted that under the governing New Hampshire law, the plaintiff, who alleged that sulindac was defectively designed, was required to show that the drug was unreasonably dangerous due to its propensity to cause SJS/TEN.  However, she was not required to establish that there existed an alternative, safer design for the drug.  In reaching this conclusion, the court rejected the manufacturer's argument that a safer alternative is an essential element of a design-defect claim, over and above the existence of an unreasonably dangerous product.  Hence, the district court had correctly permitted the plaintiff to establish that the sulindac was in a defective condition because it was unreasonably dangerous due to its propensity to cause SJS/TEN.  Interestingly, on the eve of trial, the defendant abandoned a potential defense that the drug was unavoidably unsafe but was sold with an adequate warning.

February 21, 2012

Jeremy Taylor, Senior Attorney, National Legal Research Group

The U.S. Court of Appeals for the Fifth Circuit recently ruled that some state law claims by a patient who had allegedly received a defective hip replacement survived federal preemption.  See Bass v. Stryker Corp., No. 11-10076, 2012 WL 266985 (5th Cir. Jan. 31, 2012).  The plaintiff sued the company that had designed, manufactured, and marketed a hip prosthesis that malfunctioned after it was surgically implanted into the plaintiff's body.  He brought his action in the U.S. District Court for the Northern District of Texas under various theories, including strict products liability, negligence, breach of warranty, and violation of the Texas Deceptive Trade Practices Act.  The defendant moved to dismiss, arguing that all of the plaintiff's claims were preempted under Medical Device Amendments ("MDA"), 21 U.S.C. § 360k(a), to the Food, Drug & Cosmetics Act ("FDCA").  The defendant asserted that the state law claims were preempted in light of the U.S. Supreme Court's interpretation of the MDA's preemptive reach in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  The district court granted the manufacturer's motion to dismiss on the basis of preemption.  The Fifth Circuit reversed in part, concluding that certain of the plaintiff's causes of action survived MDA preemption.

The court of appeals first noted that a state tort claim to recover for injuries allegedly caused by a medical device is preempted if (1) the federal government has established requirements applicable to the device, and (2) the claims are based on state law requirements that are different from or in addition to the federal requirements and that relate to safety and effectiveness.  Devices that are approved through the premarket approval ("PMA") process of the Food and Drug Administration ("FDA") automatically satisfy the federal-requirements prong of MDA preemption.  The court of appeals found that the district court had correctly determined that the hip replacement device at issue was subject to the PMA process and, for that reason, satisfied the federal-requirements element of preemption.

The court then noted, however, that the preemption provision of the MDA does not prevent a State from providing a damages remedy for claims grounded upon violation of the FDA regulations pertaining to a medical device.  According to the court, state duties in such a case are parallel to, rather than in addition to, the federal requirements.  In order to plead a valid parallel claim beyond the reach of MDA preemption, a plaintiff's allegations must be plausible within the meaning of the rules governing a motion to dismiss.  The court concluded that the plaintiff had sufficiently pleaded parallel claims insofar as his claims were based upon manufacturing defects resulting from a violation of the FDA regulations.  The court noted that the plaintiff had alleged that his injury had been caused by the hip replacement's failure to attach to his bone because the component at issue had been adulterated in violation of specific FDA regulations.  The court explained that if a plaintiff pleads that a manufacturer of a Class III Medical Device, which are all subject to the PMA process, failed to comply with either the specific processes and procedures approved by the FDA or the Current Good Manufacturing Practices promulgated by the FDA and that such failure was the cause of the plaintiff's harm, then the plaintiff has pleaded a sufficient parallel claim for purposes of MDA preemption.

November 8, 2011

Jeremy Taylor, Senior Attorney, National Legal Research Group

The U.S. Supreme Court recently decided a case involving the issue of federal preemption of state law warning claims against manufacturers of the generic drug metoclopramide.  See Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011).  The plaintiffs were users of the drug who filed state court actions alleging that their long-term use of metoclopramide had caused them to suffer tardive dyskinesia.  In the first case, the U.S. District Court for the Eastern District of Louisiana granted in part and denied in part the manufacturer's motion to dismiss, and the manufacturer appealed.  The U.S. Court of Appeals for the Fifth Circuit affirmed.  In the second case, the U.S. District Court for the District of Minnesota granted the manufacturers' motions for summary judgment, and the consumer appealed.  The U.S. Court of Appeals for the Eighth Circuit reversed in part.  The Supreme Court granted certiorari, and the cases were consolidated.  The Court ruled that federal law preempts state laws imposing a duty on generic drug manufacturers to change a drug's label.

Following approval by the Food and Drug Administration ("FDA") of the sale of metoclopramide under a brand name, generic manufacturers began producing the drug, which is used to treat digestive disorders.  The plaintiffs had been prescribed the brand-name drug but had received generic metoclopramide from their pharmacists.  After having used the drug for several years, both plaintiffs developed tardive dyskinesia, a severe neurological disorder.  They sued the manufacturers in state court for failing to provide adequate warnings of the dangers of the drug.  The manufacturers argued that federal statutes and the FDA regulations preempted the state products liability causes of action, and they asserted that because federal law required them to use the same safety and efficacy labeling as was used in their brand-name equivalents while state law required the use of a different label, it was therefore impossible for them simultaneously to comply with both federal law and state law.  The Court noted that evidence has mounted that metoclopramide can cause tardive dyskinesia.  As a result, warning labels for the drug have been strengthened and amended several times.  In 2004, the brand-name manufacturer requested, and the FDA approved, a label change to provide that therapy with the drug should not exceed 12 weeks.  In 2009, the warning was intensified to caution that treatment with the drug can cause tardive dyskinesia, an often irreversible movement disorder.

August 4, 2011

Jeremy Taylor, Senior Attorney, National Legal Research Group

A recent decision by the West Virginia Supreme Court of Appeals addressed the doctrine of forum non conveniens in the context of the availability of an action in another state whose law was significantly less favorable to the plaintiff than that of the chosen forum.  See Mace v. Mylan Pharm., Inc., No. 35710, 2011 WL 2446644 (W. Va. June 16, 2011).  The plaintiff in Mace was the estate of a patient who allegedly had died from an overdose of the defendants' drug delivery apparatus, called the "Mylan Fentanyl Transdermal System."  The purpose of the device was to introduce narcotic pain medication into the user's body.  The patient was a resident of North Carolina at the time of her death.  Her husband, as personal representative of the estate, filed suit in West Virginia against the manufacturer of the drug and related entities.  The defendants were variously incorporated in West Virginia and Pennsylvania and had their headquarters in West Virginia, Vermont, and Pennsylvania.

The plaintiff alleged that the patient had been prescribed "the patch" on October 21, 2005 and had died from an overdose a mere four days later while wearing the device.  The personal representative filed his action on July 1, 2008.  The plaintiff set forth claims for strict products liability, negligence, breach of express warranty, and breach of implied warranty.  The estate sought punitive damages based upon the defendants' "deliberate, intentional reckless and/or malicious behavior."  Id. at *3.  The complaint further alleged that the plaintiff had not known, and that a reasonable person under the circumstances would not have had reason to know, that "the patches" prescribed for the decedent were manufactured by Mylan until less than two years before filing the complaint.  The court noted that both West Virginia and North Carolina have two-year statutes of limitations for wrongful death claims.

The defendants filed a motion to dismiss based on the doctrine of forum non conveniens.  In support of their motion, the defendants argued that North Carolina was the appropriate forum because the decedent had been a resident of that state at the time of her death, she had been prescribed and had used the drug apparatus in North Carolina, and she had died there.  The defendants also asserted that the cause of action arose in North Carolina and that the lawsuit's only connection with West Virginia was that two of the defendants were incorporated under West Virginia law and one defendant had its headquarters there.

In resolving the defendants' motion, the court had occasion to apply West Virginia's forum non conveniens statute.  This statute provides that a West Virginia court may decline to exercise jurisdiction over a matter if it finds that in the interest of justice and for the convenience of the parties, a claim or action would be more properly heard in a forum outside the state.  In making this determination, the court may consider, among other things, whether an alternate forum exists in which the claim or action might be tried.

April 26, 2011

Jeremy Taylor, Senior Attorney, National Legal Research Group

A recent decision by a U.S. District Court in Pennsylvania combined, in an interesting way, the issues of removal of a case to federal court and of the potential responsibility under a products liability theory of the publisher of an "education monograph" containing warnings about a prescription drug.  See Slater v. Hoffman-La Roche, Inc., Civ. Action No. 10-6956, 2011 WL 1087240, at *1 (E.D. Pa. Mar. 24, 2011).  The plaintiff sued the manufacturer of the acne drug Accutane, alleging that the drug had caused him to develop colitis and ulcerative colitis.  The plaintiff also sued the publisher of a monograph explaining the dangers of Accutane.  The plaintiff was a resident of Wisconsin, the drug manufacturer was a resident of New Jersey, and the publisher of the educational monograph was a Delaware corporation with its principal place of business in Pennsylvania.  Following the plaintiff's filing in Pennsylvania state court, the defendants removed the action to the federal district court.  The plaintiff moved to remand the case to the state court.  The court noted that unless the publisher had been fraudulently joined, the claims against it had to be remanded, in light of the rule that removal to federal court is permissible only if none of the parties in interest properly joined and served as defendants is a citizen of the state in which the action has been brought.  See 28 U.S.C. § 1441(b).