Medical Device Lawsuit Watch - May 2008
This summary of key lawsuits affecting medical device companies is provided by the Health Care Law Group of Crowell & Moring LLP, in collaboration with the firm’s Torts, Antitrust, Commercial Litigation, and Intellectual Property Groups.
Cases in this issue:
The U.S. District Court for the Western District of Louisiana granted the defendants’ motion for summary judgment on the grounds that the plaintiff’s state law claims regarding Polytef®, a paste containing Teflon®, were preempted by the Medical Device Amendments (“MDA”) to the Food, Drug and Cosmetics Act, even though Polytef was approved prior to the enactment of the MDA.
In 1984, the plaintiff, Wanda Mathis, underwent a procedure in which Polytef was injected into her throat to stabilize her vocal cords and restore her ability to speak. In 2004, Mathis began having trouble breathing, and was diagnosed as having a Teflon granuloma in her throat. In 2006, she filed this lawsuit, alleging that defendants had violated the Louisiana Products Liability Act ("LPLA") and negligently failed to warn her of the risks associated with the Polytef product.
The Food and Drug Administration ("FDA") approved Polytef for use in 1972, pursuant to the New Drug Application ("NDA") process, the regulatory scheme in place before the enactment of the MDA. This approval specifically covered the use of Polytef for the procedure undergone by Mathis. In 1976, when Congress enacted the MDA, Polytef and other "transitional devices" approved under the NDA process, were automatically designated as Class III medical devices under the MDA. The MDA requires all Class III devices to pass a rigorous premarket approval ("PMA") process before being offered for sale. Under the MDA, Polytef and other transitional devices were deemed to have PMA approval if they had been approved pursuant to the NDA process. Accordingly, since Polytef had met the NDA requirements, the court found the fact that Polytef was approved prior to the enactment of the MDA irrelevant to its preemption analysis.
Instead, the court's preemption analysis focused on the "comprehensive and rigorous" review of Polytef by the FDA. The FDA had reviewed and approved the design, chemical composition and manufacturing process for the product, as well as its labeling and instructions for use. The manufacturers of Polytef were obligated to continue to provide regular information regarding the product to the FDA and were required to obtain FDA approval of any proposed changes. The court held that federal law preempted the plaintiff's Louisiana Product Liability Act ("LPLA") claim because it was "clear that there are specific federal requirements applicable to Polytef." A state law cause of action alleging failure to warn of the risks associated with Polytef would threaten the federal requirements applicable to the product because the FDA had approved Polytef's labeling and warnings after a detailed and thorough review. The record showed that the FDA was aware of potential side effects and post-operative problems, including Teflon granulomas, when it issued its approval of the product. For this reason, to permit Mathis' state law claims would "displace the FDA's exclusive role and expertise in this area and risk imposing inconsistent obligations." The court granted the defendants' motion for summary judgment.
The Ohio Supreme Court upheld the constitutionality of state statutes limiting allowable non-economic and punitive damages in a medical device case, emphasizing both the deferential standard of review for facial constitutional challenges, and the role of the legislature, not the court, as the maker of state policy.
In Arbino v. Johnson & Johnson, the plaintiff brought a product liability action in the Southern District of Ohio arguing that she had suffered blood clots and other side effects after using the Ortho Evra® Birth Control Patch, a hormonal birth control medication created by Johnson & Johnson. Arbino's complaint argued that several Ohio tort reform statutes were facially unconstitutional. The district court certified these challenges to the Ohio Supreme Court, which found the statutes to be constitutional. In doing so, the Ohio Supreme Court emphasized deference to the Ohio General Assembly, finding that the distinctions the legislature drew in refusing to limit certain injuries were rationally related to the legitimate state interest of improving Ohio's civil justice system and its economy.
The Court rejected all of Arbino's constitutional challenges to a statute limiting non-economic damages in tort actions to the greater of $250,000 or three times the economic damages up to a maximum of $350,000, or $500,000 per single occurrence. The limits did not apply in cases in which the plaintiff had suffered certain serious injuries. The Court found that the statute did not violate the plaintiff's right to a jury trial because it did not allow the court to alter the jury's fact-finding regarding the extent of the plaintiff's injuries. The statute only limited the maximum reward as a matter of law; the right to a trial by jury did not extend to questions of law. The Court also rejected the plaintiff's contention that the statute violated her right to a remedy and/or to open court because the statute "neither forecloses [plaintiffs'] ability to pursue a claim at all nor completely obliterates the entire jury award." The limitation on non-economic damages did not violate the constitution's promise of "due course of law," because the legislative record showed that the uncertain system of measuring non-economic damages had negative effects on the Ohio tort system and the economy; the decision of the General Assembly was "tailored to maximize benefits to the public while limiting damages to litigants." Similarly, the Constitution's equal protection clause was not violated because the legislature rationally determined that the most severe injuries offer more definite evidence of non-economic damages, and "thus calculation of these damages poses a lesser risk of being tainted by improper external considerations." The statute did not run afoul of separation of powers, because the legislature is allowed to regulate the amount of damages available in certain circumstances.
Arbino also challenged an Ohio statute limiting the recovery of punitive damages in certain tort actions to a maximum of twice the total amount of compensatory damages awarded to a plaintiff per defendant. Further limitations applied if the defendant was a small employer or individual. Arbino pressed the same constitutional arguments as above with regard to the punitive damages statute, and again, the court found the statute did not violate: 1) the right to trial by jury because it only limited damages as a matter of law and "legislatures enjoy broad discretion in authorizing and limiting permissible punitive damages awards;" 2) the right to a remedy and to open court because it did not prevent plaintiffs from bringing successful claims for their injuries; 3) the right to due course of law because the legislature rationally decided that the tort system was harming the Ohio economy and that limiting punitive damages would make the justice system more predictable; 4) the right to equal protection because the statute was rational; and 5) separation of powers because "statutory damage limits do not intrude on the judicial power to determine damages." The Court refused to hear Arbino's challenge to a collateral-source statute, because it found that Arbino lacked standing.
The United States District Court for the Northern District of Mississippi denied Boston Scientific’s Motion to Dismiss, finding that David Scoggins identified the proper defendant within the statute of limitations.
Scoggins filed his complaint against "Unknown Manufacturer of Cautery Machine" on June 21, 2007, one day before the statute of limitations expired. The complaint alleged negligent design, manufacture, construction assembly and inspection and sale arising from a cautery machine malfunction that sent electric shocks into Scoggins' colon during a colonoscopy procedure. On the same day he filed the complaint, Scoggins also served a subpoena on the hospital requesting the identity of the manufacturer of the cautery machine that allegedly malfunctioned. On January 7, 2008, Scoggins amended his complaint, naming as defendant the manufacturer incorrectly identified by the hospital. On January 28, 2008, Scoggins filed a second amended complaint, naming Boston Scientific as the defendant. Boston Scientific moved to dismiss the claim for failure to file before the statute of limitations had run.
The district court denied the motion to dismiss, rejecting Boston Scientific's argument that the second amended complaint did not relate back to the original complaint. Boston Scientific further argued that Scoggins failed to conduct a reasonably diligent inquiry as to the identity of the defendant. The court determined that Scoggins correctly substituted Boston Scientific into his amended complaint as the defendant. The court then found that Scoggins conducted a reasonable diligent inquiry, reasoning that he filed his original complaint before the statute of limitations expired, and that the seven-month period between the filing of the original and second amended complaint was not unreasonably long.
Boston Scientific has since filed an appeal of this decision with the United States Court of Appeals for the Fifth Circuit.
In a second opinion, the Texas Court of Appeals for the Second District, reiterated its prior holding that a device maker was not liable for its alleged failure to warn when the physician knew of the risks of the device but proceeded to use the device anyway.
Dianne Meyer sued her doctor and Ethicon Endo-Surgery after staples used in her surgery to repair her intestine separated, causing infection, additional surgical procedures and a lengthy hospitalization.
After settling with her doctor, Meyer proceeded to trial against Ethicon Endo-Surgery for alleged design, manufacturing and marketing defects of the TLC-55, a linear cutter/stapler. A jury found that the TLC-55 was defectively marketed and awarded $538,281.73 in damages to Meyer.
On appeal, the court overturned the jury's verdict in favor of Meyer and issued a "take-nothing" judgment. The appellate court agreed with Ethicon Endo-Surgery that the doctor's independent knowledge of the risks of the TLC-55 "conclusively negated producing cause" even if Ethicon Endo-Surgery failed to warn him of those risks. The doctor had testified that he had used surgical staplers and linear cutters to reconnect intestines "hundreds to thousands of times," that he was independently aware that a staple line could leak and that he had learned first-hand from a previous procedure of the risks of staple-line failure. The court acknowledged that even though Texas courts had previously applied the independent knowledge doctrine to drug cases, case support existed for its application in the medical device context.
One judge dissented, finding that the doctor's testimony did not conclusively negate producing cause because the doctor "was not aware of the full extent of the risks at the time of [ ] Meyer's surgery."
A federal judge remanded a products liability action to state court after rejecting a medical device maker’s assertion that a state hospital was fraudulently joined to defeat federal diversity jurisdiction.
Sharon Phillips had originally filed the action in Illinois state court alleging that she suffered personal injuries as a result of a defective hip replacement device surgically implanted in her body. Phillips alleged, among other claims, strict products liability against both Anderson Hospital and Howmedica.
Howmedica removed the action to federal court on the basis of diversity jurisdiction and contended that Anderson, an Illinois citizen for jurisdiction purposes, had been fraudulently joined to defeat diversity jurisdiction. Howmedica asserted that Illinois law broadly exempted hospitals from products liability claims. It also argued that Anderson could not be liable to Phillips in products liability because it furnished medical services to her.
The district court disagreed. The court explained that under Illinois state law, "all persons in the chain of distribution of a defective product . . . are liable for injuries resulting from the product." The court acknowledged that under the so-called "seller's exception" to products liability, a non-manufacturing defendant who has not contributed to an alleged product defect is entitled to automatic dismissal upon proof of the product manufacturer's identity. However, the court noted that the "seller's exception" statute was "not an appropriate basis" for finding fraudulent joinder because such a defendant may be reinstated under certain enumerated circumstances at any time before a judgment.
The court deferred to the state court on the issue of Anderson's alleged products liability as a services provider, concluding that "whether Anderson was distributing a product for purposes of strict liability . . . [was] not one the [c]ourt [could] resolve in evaluating fraudulent joinder."
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This material was prepared by Crowell & Moring LLP attorneys Bernadette Stafford, Chandra Westergaard, Jennifer Burdman, Jessica Hall, and Lauren Kim. It is made available on the Crowell & Moring website for information purposes only, and should not be relied upon to resolve specific legal questions. If you have questions or want additional information, please call your regular Crowell & Moring contact or you may contact the editor of Medical Device Lawsuit Watch.
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