Product Liability - Pharmaceutical and Medical Device Litigation

Goodell DeVries Wins on Preemption in Wyoming Federal Court

Linda S. Woolf, Kamil Ismail, Joseph B. Wolf, and Brandon L. Goodman, representing Pfizer Inc, obtained dismissal of a product liability case involving a porcine circovirus vaccine on the basis that all of the plaintiff’s claims were federally preempted.  In Wyoming Premium Farms v. Pfizer Inc, et al., filed in the United States District Court for the District of Wyoming, the plaintiff alleged that the circovirus vaccine was defective and had resulted in a high rate of mortality among its livestock.  The plaintiff asserted claims for strict liability, negligence, breach of warranty, and misrepresentation.  On behalf of Pfizer, Goodell DeVries moved for judgment on the pleadings on the basis that all of the plaintiff’s claims were preempted pursuant to the federal Virus-Serum-Toxin Act (“VSTA”).  On April 29, 2013, United States District Judge Alan B. Johnson issued an opinion in which he agreed with Goodell DeVries that all of plaintiff’s claims were federally preempted.  Accordingly, Pfizer’s motion for judgment on the pleadings was granted.

Goodell DeVries Wins Daubert Motion then Summary Judgment on Behalf of Bayer HealthCare Pharmaceuticals Inc. in Louisiana Federal Court

Thomas J. Cullen, Jr., Michael J. Wasicko, and Kali A. Enyeart, representing Bayer HealthCare Pharmaceuticals Inc., obtained a judgment dismissing a products liability and failure to warn case with prejudice in the United States District Court for the Western District of Louisiana.  In Rhodes v. Bayer HealthCare Pharmaceuticals Inc., et al., the plaintiffs alleged that Ms. Rhodes suffered peripheral neuropathy after ingesting the fluoroquinolone antibiotic Avelox®.  The plaintiffs proffered Professor Emeritus of Pharmacy and Medicine, Dr. Stephen Hamilton, from the University of Oklahoma Health Sciences Center as their causation and liability expert.  On behalf of Bayer, the Goodell DeVries attorneys moved to exclude the testimony of Dr. Hamilton.  After full briefing, on March 26, 2013, United States District Judge, S. Maurice Hicks, Jr., granted Bayer’s motion to exclude Dr. Hamilton’s testimony, holding that: (1) Dr. Hamilton was not qualified to give the opinions he renders; and (2) Dr. Hamilton’s opinions lacked valid and reliable scientific predicate and foundation, and were not products of reliable scientific methodologies.  The Court subsequently granted Bayer’s Motion for Summary Judgment on March 28, 2013, finding that the plaintiffs’ lack of admissible causation evidence was fatal to their claims and that their failure to warn claim was barred by the Learned Intermediary Doctrine.  Accordingly, the Court dismissed the plaintiffs’ claims with prejudice.  


Goodell DeVries Obtains Dismissal of Qui Tam Action in Florida Federal Court

In January 2013, Thomas J. Cullen, Jr., Cheryl Zak Lardieri, and Eben S. Flaster, representing Eisai, Inc., obtained an order granting a motion to dismiss a False Claims Act lawsuit in the United States District Court for the Southern District of Florida.  In United States of America, et al., ex. rel. Michael Keeler v. Eisai, Inc., the plaintiff claimed that Eisai violated numerous False Claims laws by engaging in off-label promotion of two drugs, providing kickbacks to health care providers, and falsely reporting pricing information. Through motions practice and oral argument, Goodell DeVries’ attorneys persuaded the Honorable Kathleen M. Williams that plaintiff’s claims were improperly pled and fatally unsubstantiated. She granted the Motion and dismissed the case with prejudice. 


Goodell DeVries Wins Daubert Motion then Summary Judgment on Behalf of Bayer Corporation in Connecticut Federal Court

In April 2012, Thomas J. Cullen, Jr. and Renee N. Sewchand scored a significant victory for Bayer Corporation when they won a Daubert motion to exclude a general causation expert, which led to an order of summary judgment and termination of Avelox litigation in Connecticut.  In Simjian v. Bayer Corp., et al., the plaintiff alleged that she sustained multiple tendon-related injuries due to her ingestion of the fluoroquionolone antibiotic Avelox.  The Goodell DeVries attorneys successfully argued to the Honorable Robert N. Chatigny that before engaging in costly fact discovery, the plaintiff should first have to prove that Avelox can cause tendon-related injuries. The plaintiff proffered Alabama physician Dr. Donald Marks as her general causation expert.  After full briefing and a lengthy Daubert hearing, on December 6, 2011, Judge Chatigny granted Bayer’s motion to exclude Dr. Marks, on two grounds: (1) Dr. Marks was not qualified to render a general causation opinion about Avelox; and (2) Dr. Marks’s opinion lacked a valid factual predicate because there was insufficient scientific data on the record to support the opinion that Avelox can cause tendon injury.  Based on that ruling and the resultant absence of admissible causation evidence in the record, on April 10, 2012, the district court granted summary judgment to Bayer.


Goodell DeVries Obtains Successful Defense Verdict for Pharmaceutical Companies After Three-Week Jury Trial in Suit alleging Breast Cancer Caused by Hormone Therapy

In November 2011, leading a multi-firm trial team, Charles P. Goodell, Jr. and Shayon Smith, obtained a defense verdict on behalf of two pharmaceutical companies in the United States District Court for the Southern District of West Virginia after a three-week jury trial. The plaintiff alleged that her breast cancer was caused by her use of hormone therapy medications manufactured and sold by the defendants. The jury found that the defendants’ medications did not cause the plaintiff’s breast cancer and that the plaintiff failed to timely file her lawsuit within the statute of limitations.


Goodell DeVries Assists Pharmaceutical Company in Securing Dismissal in First Trial Alleging Suicide Caused by Neurontin

Goodell DeVries' partners Charles P. Goodell, Jr. and Richard M. Barnes, partnering with attorneys from Boies, Schiller & Flexner and Skadden, Arps, Slate, Meagher & Flom, represented Pfizer Inc in the first Neurontin case to go to trial. The case was pending in the United States District Court for the District of Massachusetts. The plaintiff, who alleged that Neurontin caused the decedent’s suicide, voluntarily dismissed the case with prejudice after just one day of trial. The dismissal was announced on July 29, 2009.


The Court of Appeals for the Fourth Circuit Upholds Summary Judgment Ruling that Statute of Limitations Protects Oral Laxative Manufacturer from Untimely Personal Injury Claim

On May 14, 2009, the United States Court of Appeals for the Fourth Circuit affirmed a summary judgment ruling for C.B. Fleet Company, a manufacturer of an over-the-counter oral saline laxative commonly used in colonoscopy prep.  Quillin v. Fleet, (4th Cir. 2009).  Richard M. Barnes and Thomas J. S. Waxter, III led the successful appeal, which affirmed the ruling of the United States District Court for the District of Maryland, holding that the statute of limitations had run and that the plaintiff was on inquiry notice as a matter of law more than three years before filing suit.  Plaintiff had argued that he was not on notice of a possible claim for damages for his renal failure until he read an advertisement from a personal injury lawyer.  His lawyers argued at summary judgment, on motion for reconsideration, and on appeal that actual notice was a jury question not fit for resolution before trial and that more discovery was needed.  At each stage, Goodell DeVries persuaded the presiding judges that plaintiff was on actual implied notice because he had a duty to diligently investigate his potential claim after he was injured and that he also had a duty to file a Rule 56(f) affidavit if he needed more discovery.  Both courts recognized that plaintiff's failure to investigate did not toll his claim and he was not entitled to re-open discovery to bolster his claim. Goodell DeVries attorneys Paula Krahn Merkle and Derek M. Stikeleather were an instrumental part of the success in this case.


Goodell DeVries Obtains Summary Judgment in Favor of the Manufacturer and Distributor of a Medical Product Under the Doctrine of Federal Preemption

In June 2008, Richard M. Barnes and Michele R. Kendus of Goodell DeVries obtained summary judgment in favor of their clients in a medical product liability case before the Honorable Judge Benson Legg in the United States District Court for the Northern District of Maryland. The plaintiff in the case brought claims against the manufacturer and distributor of a prescription medical product known as a dermal filler, which is used in cosmetic procedures to reduce the appearance of wrinkles. The plaintiff claimed that her plastic surgeon injected the dermal filler into areas of her face and she experienced an inflammatory response that required surgical excisions to treat. The plaintiff's claims sounded in negligence, strict product liability, breach of express and implied warranties, and violation of the Maryland Consumer Protection Act.

Following oral argument on all of the issues, the Court issued a 10-page unpublished opinion awarding summary judgment. The Court agreed with the defense arguments that all of the plaintiff's claims sounded in failure to warn, and that all such claims were pre-empted because the product had undergone rigorous review by the FDA in accordance with the Pre-Market Approval process. The Court also commented in its opinion that even if the plaintiff's claims were not pre-empted, the available warning was adequate as a matter of law.

Goodell DeVries Defends Cardiac Pacemaker Lead Manufacturer

From 1994 to 2001 Goodell DeVries acted as national trial counsel for a Colorado-based manufacturer of pacemaker leads in thousands of individual cases. The national team, which included Charles P. Goodell, Jr., Richard M. Barnes, and several other Goodell DeVries attorneys, coordinated national discovery, participated in a summary jury trial following class certification and Multidistrict Litigation status, and successfully negotiated a favorable class action settlement in the United States District Court for the District of Ohio. Goodell DeVries also successfully opposed efforts to have a second class action certified as to a different, but related, model lead, and successfully opposed an international class action.  A number of opinions have been reported in connection with this litigation, including In re Telectronics Pacing Systems, Accufix Atrial J Lead Litigation, 168 F.R.D. 203 (S.D. Ohio 1996) (on motion for reconsideration, Goodell DeVries earned decertification of an international and nationwide product liability class action involving allegedly defective cardiac pacemaker leads).


Summary Judgment obtained by Goodell DeVries on Behalf of Artificial Heart Valve Manufacturer

In a case where plaintiff sued the manufacturer of an artificial heart valve that malfunctioned, summary judgment was entered in favor of the defendant on the basis of federal preemption of state law breach of warranty claims and on intentional infliction of emotional distress and fraud claims arising out of exhumation. Kemp v. Pfizer Inc. and Shiley Inc., 851 F. Supp. 269 (E.D. Mich. 1994) (vacated in light of Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). Charles P. Goodell, Jr. and Richard M. Barnes assisted in the defense of Pfizer Inc.

Goodell DeVries Briefs and Argues Blood Products Case, Affirming Maryland’s Adoption of Comment k, §402A Restatement (Second) of Torts

In a seminal Maryland product liability case, summary judgment was affirmed for a manufacturer of a blood clotting agent that allegedly caused a hemophiliac to contract HIV, and in which Maryland’s highest court certified its adoption of comment k to section 402A of Restatement (Second) of Torts.  The case was Jane Doe v. Miles Laboratories, 927 F.2d 187 (4th Cir. 1991). Charles P. Goodell, Jr. and Thomas J. Cullen, Jr. assisted in the defense of Miles Laboratories.


Plaintiff's Claim for Damages Based on Present Fear of a Future Injury Rejected:  Summary Judgment obtained by Goodell DeVries on Behalf of Heart Valve Manufacturer Affirmed by Fourth Circuit

The United States Court of Appeals for the Fourth Circuit affirmed the trial court’s entry of summary judgment in favor of the defendant heart valve manufacturer, holding that Maryland law precludes recovery based on future harm unless the harm is more likely than not to occur, and rejecting plaintiff’s claim to damages based upon a present fear that future injury will occur.  Hagepanos v. Shiley, 846 F.2d 71 (4th Cir. 1988). Charles P. Goodell, Jr. and Richard M. Barnes assisted in the defense of Shiley.